Medtronic Recalls Lots of Paradigm® Quick-Set® Infusion Sets in the United States

Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

More about the recall here.

FDA News Regarding Darvon and Propoxyphene

The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.

The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

“Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label,” said Janet Woodcock, M.D, director of the FDA’s Center for Drug Evaluation and Research. “Prescribers and patients should be aware of propoxyphene’s potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.”

To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

Source here.

News from A Friend's Firm: Lawsuit in MD

I count Rick Kuykendall as one of those lawyers whom I trust. He's with the Murphy Firm in Baltimore, and there is this news this week:

The Murphy Firm of Baltimore and Henry & Associates of Largo have announced the filing of a 12-count civil suit that charges Prince George's county officials and some of the County's correctional and law enforcement officers with responsibility for the 2008 death of 19-year-old Ronnie L. White, who, the suit states, was “assaulted and killed by the very same correctional officers who were supposed to be there to insure his safety.”

White died of a broken neck and asphyxiation 34 hours after he was received in custody by the Prince George's County Correctional Center. Following an autopsy, the Office of the Chief Medial Examiner for the State of Maryland ruled that White's death was a homicide.

The suit, filed on behalf of White's mother, Angela L. White, states that Ronnie White’s death was “the direct result” of excessive force and gross negligence by County officials, and that his constitutional and civil rights were violated. The suit is seeking $153,600,000 in compensatory and punitive damages.

Link here
.

We talked this morning, and he said his real issue front and center today is making sure his daughter Amalee Kuykendall gets to college on time. I worry about that day as well!

Weight Loss Supplements Recalled

The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

Here's the product list:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

Dietary Supplement Recall

Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx.

An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil. Benzamidenafil is in the same pharmacologic class as the phosphodiesterase type 5 (PDE5) inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved and poses a threat to consumers because it may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the most susceptible to adverse effects from this product.

Source here.

FDA To Discuss Liver Risks With Tylenol,Other Painkillers

Image via Wikipedia

The FDA will be taking a look at painkillers such as Tylenol next week.




The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America.


Acetaminophen is found in more than 100 products, including many prescription drugs administered by pharmacies. Much of its popularity is because - when taken at recommended doses - acetaminophen does not cause stomach discomfort or bleeding, unlike other drugs commonly used to reduce pain and fever, such as aspirin, ibuprofen and naproxen.

When, however, it's taken over the maximum amount of 4 grams per day, acetaminophen can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure (ALF), and even death; a problem not caused by other over-the-counter painkillers.

Despite efforts since the early 1990s to reduce the incidence of acetaminophen-related liver damage, liver injury from acetaminophen overdose remains a serious public health problem. Source.



You'll be able to see the FDA at work by logging on to FDAAdvisoryCommittee.com


Source here.

Problems With Homeopathic Remedies?

An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.


According to reports:

The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. At least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.

Source here.

Given recent recalls of over the counter products, it's imperative that consumers carefully read the label of products like Zicam and others.

Zicam Recalled

Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.

Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered. Officials have not yet determined if the condition is permanent, and fear the intranasal gel spray may be damaging nerves. The FDA expressed concern that consumers are using Zicam for a minor, “self-limiting condition” (such as a cold) and inadvertently risk damaging their quality of life permanently.

The affected products have been pulled from store shelves across the country and the FDA have advised that all remaining product should be discarded and not used for any reason.

Source here.

Zyprexa news

From Public Citizen and other sources:

Eli Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the FDA showing Zyprexa was not effectively alleviate dementia symptoms in older patients, the company started to market the drug to such patients, so says documents unsealed in insurer suits against the company.

Lilly has pleaded pleaded guilty earlier this year to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

Source here.

Liberty National Life Insurance News: Florida Licensure At Risk?

Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.

Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied.

The OIR order to Liberty National gives the company 21 days to provide proof that it didn't violate state laws that prohibit discrimination.

Liberty National, based in Birmingham, Ala., didn't return a call from The Miami Herald asking for comment on Thursday's order.

According to OIR's order, 52.6 percent of Haitian applicants were denied compared to 18.2 percent of other foreign-born applications. For instance, although Liberty National's life insurance application asks if consumers have lived in the United States for more than a year, it applied a selective 10-year residency requirement to customers born in certain countries such as Haiti or Colombia.

TRAVEL CONCERN

Applicants with plans to travel to such countries as Haiti, Liberia or Honduras were also denied.

Investigators reviewed some 7,000 applications and found 1,149 violations, including 1,053 involving discriminatory practices.

Read more here.

Calrcon Skin Product: Partial Recall and Warning

he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Link here.

Recent Avandia Medical Article

Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.

The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures.


You can find the article here.

Graves Disease Drug: Increased Risk for Liver Injury?

The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.

The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication. In the pediatric population, the FDA said there were one death and six transplants linked to PTU use.

"Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy," the FDA said.

Source here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

412(i) Tax Shelter Litigation

My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:

Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself). These groups will use insurance brokerages and sub-agents (licensed in the various states) to sell the policies themselves.

HOW THESE PLANS WORK:

In the late 1990’s, the individuals and groups above devised a scheme to sell abusive tax shelters under the auspices of Section 412(i) of the tax code. A 412(i) is a defined benefit pension plan. It provides specific retirement benefits to participants once they reach retirement and must contain assets sufficient to pay those benefits. A 412(i) plan differs from other defined benefit pension plans in that it must be funded exclusively by the purchase of individual life insurance products. To create a 412(i) plan, there must be a trust to hold the assets.

The employer funds the plan by making cash contributions to the trust, and the Code allows the employer to take a tax deduction in the amount of the contributions, i.e. the entire amount. The trust uses the contributed funds to purchase some combination of life insurance products (insurance or annuities) for the plan. As the plan participants retire, the trust will usually sell the policies for their present cash value and purchase annuities with the proceeds.

The revenue stream from the annuities pays the specified retirement benefit to plan participants. These defendants (with the aid and knowledge of the insurance companies) used the traditional structure and sold life insurance policies with excessively high premiums. The trust then uses the large cash contributions to pay high insurance premiums and the employer takes a deduction for the sum of those large contributions. As you might expect, these policies were designed with excessively high fees or “loads” which provided exorbitant commissions to the insurance companies and the agents who sold the products.

The policies that were sold were termed Springing Cash Value Policies. They had no cash value for the first 5-7 years, after which they had significant cash value. Under this scheme, after 5-7 years, and just before the cash value sprung, the participant purchases the policy from the trust for the policy’s surrender value. In theory, you have a tax free transaction.

The IRS does not recognize the tax benefit of such a plan and has repeatedly issued announcements indicating that such plans are contrary to federal tax laws and regulations. These plans were targeted to high net worth individuals, including doctors, dentists, corporate executives, and professional athletes.

Read more at his blog, here.

Bausch and Lomb Settles Fungal Infection Lawsuits

Image via Wikipedia

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

Read more from this article here.

Reglan: JPML Hearing held in Louisville, KY

A motion to form an MDL, or Multidistrict Litigation, was argued yesterday before the JPML sitting in Louisville, Kentucky. There are at least 15 Reglan lawsuits pending in 11 different district courts throughout the United States.

Reglan is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying.

Request for Reglan lawsuit consolidation was opposed by the attorneys for companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.

Life Investors Insurance Class Action: Deadline Looms

Our firm is currently representing consumers who have cancer insurance policies with Life Investors Insurance Company of America as well as Transamerica.

Good and honest people bought cancer policies for a simple reason - To provide for a reimbursement amount of “actual charges” to be paid when incurred or billed. When claims were submitted, we believe that these two companies do not pay the “actual charges.” Instead, these insurers will pay a discounted amount for those same cancer treatments, contrary to the terms of the policy. We are pursuing individual cases.

Many people who bought a cancer insurance policy may have a received recently a class action notice in the case of Runyan v. Life Investors Insurance Company of America / Transamerica. The time period that applies to any policy bought during the years 2004 - 2006.

In our experience, the class action relief asked for is simply not an adequate remedy. As we see it, the Runyan class settlement is inadequate relief for policyholders.

We believe that “opting out” of the class action may be more appropriate to protect their individual rights. Alternatively, filing an objection to the class may be even more appropriate. We are currently evaluating both of these options for these policyowners, but we are nonetheless accepting cases for those who wish to either opt out or object to the class settlement in its entirety. The deadline to exclude yourself from this class is June 29, 2009.

The deadline to object to the settlement is June 29. 2009.

Tech: PDF For Lawyers

The site, that is. http://www.pdfforlawyers.com/ Is worth a look. Tips include: "Using Acrobat to put Exhibit stamps on digital documents." Also, learn how to OCR with the ScanSnap to create searchable PDF files at just the push of the “scan” button…


Worth your time. We use the Scansnap at work, and it's a must have.

Hydroxycut Lawsuit; Hypertensive retinopathy associated with Hydroxycut Usage

Here's a report on the use of performance-enhancing and weight-loss supplements is prevalent in the United States. The report notes that with new restrictions placed on such products, companies have been marketing caffeine-based ephedra-free herbal supplements.


The report notes, "less is known about the potential side effects of these products. We present the case of a 42-year-old, previously healthy man who developed malignant hypertension and hypertensive retinopathy while taking Hydroxycut, a caffeine-based ephedra-free supplement."

Find the abstract here.

Flomax and Cataracts

Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

It's not the first time that Flomax (tamsulosin) has been linked to cataract complications. A study in 2005 found that men taking Flomax or other alpha-blockers before cataract surgery had complications during and immediately after the procedure. The U.S. Food and Drug Administration called for stronger warnings about the drug, and Boehringer Ingelheim Pharmaceuticals, which makes Flomax, sent warning letters to doctors about the potential problems.

In the new study, 7.5 percent of the men who had taken Flomax in the two weeks before cataract surgery had a serious complication, compared with 2.7 percent of those who had not taken the drug, for a 2.3 times greater risk.

Read more at this source, here.

Reglan: FDA Video from YouTube

Interesting that the FDA now uploads video to youtube.com

Hydroxycut Lawsuit Filed in Georgia State Court

Our office filed in Georgia State Court a lawsuit where a consumer claims she suffered an injury related to her use of Hydroxycut. The multi-count lawsuit claims, among other things, what most would expect: Negligence, Breach of Warranty, and other claims of wrongdoing.

We don't file class actions in my office, believing that the best way to seek some measure of justice for someone is to make a specific claim for each person in separate lawsuits. Other lawyers may go the class action route; it's just not for me.

I will post a few pages of the Complaint filed in the next day or so.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

David Hodge: $17 Million Dollar Verdict in AL on 5/13/09

A guy who I consider a friend is David Hodge, a Birmingham, Alabama lawyer. Not too excitable, loves Bama football, family man, dog man like me.

David went to Hale County, which is right here:





His firm's client was Chapman Logging. The case involved the sale of a defective logging skidder equipped with a Cummins engine. David's firm is found here pdkhlaw.com. A skidder looks like this:

Image via Wikipedia

I know what you're thinking: How in the world did the jury come back with that verdict? I'm thinking the same thing, but will have to hear more about it tomorrow. Well done. I will tell you this - if you run across David Hodge in any case, take a get ready pill.

That Pesky Drug known as Cheerios

Image via Wikipedia

Sometimes you just shake your head in amazement. This warning letter from the FDA to the CEO of General Mills (never mind that people are getting ill or dying from bad foods):

(FDA source)

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:

The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

If you can ...ummm ...stomach the rest of that letter, you are a better person than I.

Lawyer Etiquette: Is Your Blackberry Use Hurting your Reputation?

Image by Getty Images via Daylife

I attended a meeting of lawyers this month, and when about 5-6 of us were sitting together talking shop, one member of the group brought up a good subject. As we talked, that same person started typing away on his Blackberry. He was so distracted, he missed two questions posed to him. I was to be candid appalled. It was rude and insensitive. I didn't know this person very well, but I will remember him now for that mistake.

I went searching on the web for a quick list of suggestions that I lawyers could read to help them when using a Blackberry, since at least 50% of its users forget basic courtesies:

From the Legalease Blog:


1. If you are attending an event, meal, meeting or presentation, turn off your electronic devices. If you put MUST keep them on, turn them to silent or vibrate, do not place them on the table so that the vibration disturbs those around you;

2. If you are awaiting an important call or email, consider not attending the event so that you can attend to your important business;

3. If it is imperative that you attend the event, be sure that you keep your focus or attention on the event. Advise your companions at the outset that you are waiting for an urgent call, and sit near the door. Leave the room or the table discreetly if you absolutely MUST check your email or voice mail or return a call or email;

4. Remember that those around you are forming an impression of you AT ALL TIMES; if you are with a client and are checking your BlackBerry, reading emails, surfing the web, the client is going to think that you don't care about them and that they are not important to you;

5. Be aware that if you are replying to important emails while at dinner, a networking event or another meeting, you are not presenting your best self either at the event or in the email. Not only are you unable to devote your complete attention to the event and the people you are with, but you are also unable to devote your full attention to the email message. You may be making a poor impression on two groups of people at the same time.

6. Even if your device is under the table or you think you are being discreet others in the room are well aware of what you are doing. Regardless of what you think, you are NOT getting away with it!

7. The smaller the meeting, the more noticeable your behavior. But even in large meetings, be mindful of those around you, since they will certainly be aware of your behavior, so if your boss or an important client or colleague is sitting near you, refrain from checking your BlackBerry. And if the presenter, meeting facilitator or your boss is standing, seated on a dais or is behind you, they will be aware of your behavior even in a large room.

8. Reconsider your definition of what is an 'urgent' matter and what can wait. Think about your priorities, not just in the short term (answering this email immediately as opposed to 10 minutes from now), but also in the long term (if the client thinks I'm rude, I may lose the account).

There's more at the link above.

Take heed, lawyers!

Autism: Are Children able to "Recover?"

A close friend has a child with autism, and the frustrations, worries and concerns are etched on his face when we get together. I could never imagine what he and his family must address each day.

From several sources, including Yahoo, this article:

"Leo Lytel was diagnosed with autism as a toddler. But by age 9 he had overcome the disorder. His progress is part of a growing body of research that suggests at least 10 percent of children with autism can "recover" from it — most of them after undergoing years of intensive behavioral therapy.

Skeptics question the phenomenon, but University of Connecticut psychology professor Deborah Fein is among those convinced it's real.

She presented research this week at an autism conference in Chicago that included 20 children who, according to rigorous analysis, got a correct diagnosis but years later were no longer considered autistic.

Among them was Leo, a boy in Washington, D.C., who once made no eye contact, who echoed words said to him and often spun around in circles — all classic autism symptoms. Now he is an articulate, social third-grader. His mother, Jayne Lytel, says his teachers call Leo a leader.

The study, funded by the National Institute of Mental Health, involves children ages 9 to 18.

Autism researcher Geraldine Dawson, chief science officer of the advocacy group Autism Speaks, called Fein's research a breakthrough."

Read the rest here.

Hydroxycut: UPC Codes Released today (Georgia, Alabama, Florida)

Here's news on the Universal Product Codes related to the Hydroxycut products:

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

The UPC numbers being added to the May 1 list are as follows:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets



On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA.

Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

Source here.

FDA: Testosterone Gel Puts Children at Risk

From various sources, including the AP:

The FDA issued a statement that adults using prescription testosterone gel should be cautious and avoid its contact with children to avoid causing serious side effects. This week a black box warning was added to several products, AndroGel and Testim.

AndroGel is approved to be applied to the abdomen and shoulders and arms, while Testim can only be applied to the arms and shoulders. An FDA rep. has informed that in a few reports people had applied the product to their chest and then held their children without wearing shirts.

As of December 2008, the agency had received eight cases of secondary exposure to the products in children ranging in age from nine months to five years. Other reports have since come in, the FDA said. In most cases the side effects in children regressed after they weren't exposed to the product, but in a few instances enlarged genitalia didn't fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age. Source here.

Certain Epilepsy Drugs Get a Suicide Warning

the FDA has approved new labels for epilepsy drugs that include warnings about an increased risk of suicidal thoughts and behaviors associated with the medicines.

The labeling for the epilepsy drugs Topamax, Lamictal, Tegretol and Trileptal come after the FDA ordered the drugs' labels be updated with warnings about suicidal risks with the medications.

In December, the FDA issued a public-health advisory about the drugs, saying a review of clinical studies showed there was one additional case of suicidal thoughts or behaviors for every 500 patients treated with an anti-epileptic drugs compared with a placebo, or fake pill.

Source here.

Botox Warnings

Allergan Inc.will work with the Food and Drug Administration to appropriately update labeling for its Botox and Botox cosmetic products.

"We are pleased that the FDA has emphasized that the dosing units are different between the products," Chairman and Chief Executive David Pyott said on the earnings call, adding he was happy with Botox's first-quarter sales, which declined 5.8%.

Last week the FDA said it was strengthening warnings on Allergan's Botox and similar products about the possibility of life-threatening breathing and swallowing problems.

Link here.

Hydroxycut Recall: TV Report (Georgia, Alabama, Florida)

Image by size8jeans via Flickr

From NBC and Tom Costello and NBC: The government issued an urgent warning to immediately stop using the dieting supplement after reports surfaced of liver damage and at least one death. FDA's limited ability to oversee is discussed. Report notes that 114 million people use OTC supplements.

Hydroxycut Lawsuit from 2003

Found this from 2003, a press release from the then Missouri A.G.:


Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut, marketed to consumers as a safe and tested over-the-counter way to lose bodyfat rapidly. Hydroxycut is sold in several retail store chains, through television ads and on several Web sites.

Nixon said manufacturer MuscleTech Research and Development Inc., based in Mississauga, Ontario, did not disclose safety risks associated with Hydroxycut containing ephedra, and that claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false.

"MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product," Nixon said. "The disclaimers and warnings on the bottle label are so small as to be useless to many consumers, so they would not be able to read that the disclaimers would preclude use of Hydroxycut by most of the adult population of the United States, including anyone who drinks coffee or cola containing caffeine."

The lawsuit claims that in order to obtain the research results it sought, MuscleTech would replace research subjects who had to drop out of the company's studies because they could no longer tolerate the Hydroxycut or because it became too dangerous for them to continue. In at least one study, Nixon said, those dropouts were concealed and not treated as an adverse effect of Hydroxycut. In another study cited in the lawsuit, one subject was rushed to the hospital due to a serious change in heartbeat. This incident was not treated as an adverse reaction in the final study.

From the Complaint:

JEREMIAH W. (JAY) NIXON,
Attorney General of the State of Missouri
Plaintiff

Vs

MUSCLETECH RESEARCH &
DEVELOPMENT, INC.,
Defendant.


1. Defendant MuscleTech Research and Development, Inc. (“MuscleTech”) has made and sold purported weight loss products under the name “Hydroxycut” containing ephedra alkaloids. Such products continue to be sold at least at the retail level. The product is not “clinically proven” to be a “fat-burner,” as MuscleTech claims. MuscleTech’s own study showed that Hydroxycut has no efficacy as compared to placebo with the possible exception of an appetite-suppressing effect. Moreover, the serious adverse health risks of Hydroxycut with ephedra – including death – were not adequately described or disclosed in marketing and labeling of the product. This conduct violated the Missouri Merchandising
Practices Act.

16. MuscleTech used deception, misrepresentation, unfair practice and/or the concealment, suppression, or omission of material fact in connection with the sale and advertisement of MuscleTech in regard to Hydroxycut’s safety – or lack of safety – including but not limited to the following:

a. MuscleTech’s web site and advertisements [b]did not adequately disclose safety risks associated with Hydroxycut.[b/] Some advertisements or material supplied by MuscleTech to magazine publishers specifically stated that Hydroxycut is effective in reducing bodyfat “without any unwanted side effects,” that it is “extremely safe” and that “studies” have shown the herbal equivalents to ephedrine and caffeine to be “very safe,” that potential users can be “reassured” that Hydroxycut is “safe,” and that even prescription drugs do not yield as much fat loss as the ingredients in Hydroxycut “with as little negative side effects.”

iii. In at least one instance, a subject was rushed to a hospital for atrial fibrillation, which is a precursor to ventricular fibrillation (a lethal arrythmia that results in sudden cardiac death). The study of which he was a subject did not treat this event as an adverse event for purposes of its statistical analysis.


However, the results of MuscleTech’s studies regarding safety did not accurately indicate the safety risks for most consumers of Hydroxycut because MuscleTech carefully screened all study subjects for health risks. This screening meant that there was no testing done on persons with physical and health characteristics of many consumers purchasing Hydroxycut over the counter (such as high blood pressure), making the results of such studies misleading for those consumers. Moreover, even after this screening was performed, MuscleTech’s studies were still tainted in at least the following respects:

c. MuscleTech has not disclosed in any of its marketing or advertising materials that its own consultants believe there are serious concerns as to the safety of Hydroxycut. At least one person whom MuscleTech hired as an expert in litigation stated under oath that he believes people should not take products with ephedra and caffeine, such as Hydroxycut, and that he cautions people not to take these “drugs.” Both he and another expert hired by MuscleTech testified separately that they would not recommend Hydroxycut to anyone.

17. a) Another study commissioned by MuscleTech showed that the subjects using a “new and improved” version of Hydroxycut showed no statistically significant weight loss that was greater than the placebo group, and even lost less weight than the placebo group. MuscleTech misrepresented the true results of this study by having one of its marketing persons submit a letter to the researcher suggesting that the researcher attribute the study’s result to the horrific events of 9-11-01. The researcher complied, without explaining why the events of 9-11-01 would affect the placebo group differently.

b) b. MuscleTech ran advertisements using deceptive “before” and “after” pictures. The pictures are deceptive in that, among other things:

i. The pictures use different lighting to convey an artificial fattening and slimming effect.

ii. The models in the pictures use different poses to convey an artificial fattening and slimming effect.

iii. The pictures and the accompanying copy do not fully disclose the extent of weight loss and muscle toning activities used by the models in conjunction with the use of Hydroxycut.

iv. MuscleTech has used one picture (in multiple advertisements) showing a “before” photograph of a woman with a much larger abdomen than in the after picture. A copy of one such advertisement is attached as Exhibit B. [b]The advertisements identify the woman as Marla Duncan and tout that she lost 35 pounds. At least some advertisements did not indicate that the “before” picture reflected post-pregnancy weight. Nor did the advertisements state that Marla Duncan has been a swimsuit and fitness model since at least 1983 (when she was 19 years old), has appeared on more than 100 magazine covers, and was Miss Fitness USA in 1990.

Hydroxycut News Part 2/Background

Herbs that have been associated with liver disease include:

- Black Cohosh

• Buckthorn (Rhamnus cathartica).

- Callilepsis laureola ( Impila)

- Cascara Sagrada

- Celandine ( also known as greater celandine) (Chelidonium majus)

• Chaparral (also known as creosote bush or greasewood) (Larrea taridentata).

• Comfrey and other herbs containing pyrrolizidine alkaloids (heliotropium, senecio, crotalaria, symphytum)

- Doxidan ( Danthron 1,8-hydroxyanthroquinone and dioctyl calcium sulfosuccinate)

• Germander (Teucrium chamaedrys).

- Green tea leaf

• Groundsel (Senecio vulgaris).

- Impila root

• Jin Bu Huan.

- Kava ( also known as kava kava or Piper methysticum)

- Kombucha

• Lobelia (Lobelia inflata).

• Ma huang (ephedra).

• Mate (also known as paraquay tea) (Ilex paraguariensis).

• Mistletoe (Viscum album).

• Nutmeg (Myristica fragrans).

• Pau d’arco (La pachol).

• Pennyroyal (Mentha pulegium).

• Poke root (Phytolacca americana).

• Ragwort (Senecio jacoboea).

• Sarsparilla (Smilax species).

• Sassafras (Sassafras albidum).

• Saw palmetto – the main ingredient of the herbal preparation known as “Prostata”.

• Senna (Casio acutifolia).

• Skullcap (Scutellaria laterifolia).

- Soy phytoestrogen

• Sweet clover (Melilotus officinalis).

• Tansy (Tanacetum vulgare).

• T’u-san-chi.

• Valerian (Valeriana offinalis).

• Woodruff (Galium odorata).













Found this article posted a while back by a "doctor" who commented on Hydroxycut:

"Hydroxycut made headlines for over a controversial compound that it contained called Ephedra. This compound is banned by FDA. Now you can get a Ephedra-free product that claims to increase your metabolism and energy while suppressing your appetite, therefore cutting caloric intake and hence causing weight loss. Claims made by there manufacturers are pretty bold. They say that Hydroxycut can decrease body fat by 8%, and increase norinephrine by 40%. Among the most important ingredients in this product are:

Hydroxagen™: This is a compound which has been shown to decrease the activity of the enzyme which is responsible for the conversion of excess carbohydrates into fat. This subsequently makes it extremely effective for low fat diets. There may some added advantage of it curbing hunger and cravings.

Guarana Extract: Guarana, is the herbal form of caffeine and this has been shown to stimulate fat stores and resulting in fat being utilized as energy. Caffeine also facilitates the effectiveness of ephedrine, thus making it a more potent.

L-Carnitine: This is an amino acid that has been reported to carry fats to the interior of cells where it can be metabolized as energy. The addition of L-carnitine is an absolute necessity to get fat burning.

Chromium Picolinate: It has been shown that dosages of chromium as that contained in Hydroxycut can cause fat reduction and increases in muscle tone.



It should be understood that many people do experience side effects with these “stimulating” medications. Some say that feel anxious, others complain of increased libido. If you have heart condition, hyperthyroidism etc you should stay clear from this product (see all contraindications before starting)."

Source here.



Firm handling it is: www.bunchandjames.com/hydroxycut/

FDA Recalls Hydroxycut

Government health officials are announcing the recall of popular weight loss pill Hydroxycut, after reports of liver damage and other health problems.

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural



Food and Drug Administration officials said Friday the manufacturer of Hydroxycut has launched a nationwide recall of the dietary supplement, used by people trying to shed pounds and by body builders to sharpen their muscles.

Hydroxycut is advertised as made from natural ingredients. It accounts for about 90 percent of the market for weight loss supplements, with sales of about 1 million bottles a year.

Dietary supplements are not as tightly regulated by the government as medications. Manufacturers don't need FDA approval ahead of time before marketing their products.

Sources include: AP and FDA.

Reglan: MDL Petition to be Heard on 5/28 in Louisville, KY

Link to the Order here.

I mentioned last week that counsel on cases (friends of mine) had file the Petition - looks like it will be argued next month.

Early indications? Plaintiffs' lawyers want it in Las Vegas.

Botox - Unapproved Use Warning

Health officials are warning doctors and patients about potentially deadly risks of using anti-wrinkle drug Botox and similar drugs for unapproved uses to treat muscle spasms.

The Food and Drug Administration says Botox and two other injections have been linked to rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulism-based drug also is widely used for muscle-spasm conditions.

Regulators say the majority of deaths are in children with cerebral palsy taking the drugs for spasticity in their legs.

Botox and competitors Myobloc and Dysport will carry a boxed warning, the most serious type available.

Link here.

Accu-Chek Insuling Pump Recall

Another day another recall - how is the public expected to know about these nearly once a day recalls?

Roche Holding AG(RHHBY) unit is recalling Accu-Chek Spirit insulin pumps that were sent to the U.S., the Food and Drug Administration said Thursday noted in a recall notice posted on its Web site.

The Roche unit, Disetronic Medical Systems Inc., said the "up" and "down" buttons can malfunction on some pumps. The buttons are used to override pre-programmed settings or to deliver an additional bolus dose of insulin.

The affected units have serial numbers ranging from SN02119552 through SN10006093, all of which were shipped to the U.S. The company said pumps with serial numbers of SN10006094 and above are not affected.

Disetronic said the defect was discovered through its own quality-control monitoring process.



It's all well and good that the FDA puts it on the site - how about asking news outlets to run recall information on its news crawl at the bottom of each page?

Excessive Selenium Kills 21 Polo Ponies

My office is investigating the damage selenium has caused to people who took an over the counter supplement known as Total Body Formula. This week there is news that selenium killed nearly two dozen horses:

The 21 polo horses that died last week shortly before they were to compete in the U.S. Open polo tournament fell victim to a fatal overdose of selenium, a mineral ingredient in a medication meant to help them recover from exhaustion, according to Florida's state veterinarian.

"Signs exhibited by the horses and their rapid deaths were consistent with toxic doses of selenium," Dr. Thomas J. Holt said today of the circumstances surrounding the loss of the horses, which were all owned by the Venezuela-based Lechuza Caracas team.

The medication was prepared by an Ocala, Fla., retail and compounding pharmacy called Franck's Pharmacy at the request of the veterinarian who treated Lechuza's horses while in Florida. Franck's Pharmacy announced last week that an internal review prompted by the horses' deaths showed that the compound, a substitute for a medication called Biodyl that is unapproved for use in the U.S., was mixed incorrectly.

Sources are many, including here.

Nail Polish Remover Recall

The U.S. Food and Drug Administration announced a nationwide recall of Personal Care-brand non-acetone nail polish remover because of a claimed safety hazard.

The FDA said Personal Care Products Inc. of Bingham Farms, Mich., initiated the recall of the polish remover-conditioner enriched with gelatin because it doesn't meet product specifications and might cause chemical burns to the fingers of users.

Treanda and Stevens Johnson Syndrome

The cancer drug Treanda, in combination with another therapy, may have caused two people taking it to develop a serious skin condition known as Stevens Johnson Syndrome and one has died.


The patients developed a severe form of the condition known as toxic epidermal necrolysis, which is characterized by a blistering and peeling of the top layer of skin, causing it to peel off, leaving damaged areas which can become infected.

Both patients were also taking a drug called allopurinol, which is often used in patients taking chemotherapy to lower high levels of uric acid in the body. The drug is already known to be associated with Stevens Johnson Syndrome/toxic epidermal necrolysis.

Source here.

NSAIDS: Increase Risk of Dementia?

Those who use non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen, shouldn't bank on the drugs helping them ward off dementia.

A study in Neurology suggests that NSAID users do not have lower rates of dementia and that increased use of the pain relievers may actually raise the risk of cognitive decline.

Read the article here.

Golimumab Approved, with a Black Box Warning

Image via Wikipedia

Simponi Approved for Immune-Related Arthritis



From HealthDay News:

Simponi (golimumab) has been approved by the FDA to treat three forms of arthritis that occur when the body's immune system attacks the joints.


The injected drug will be prescribed to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

It arrives on the market with a black box warning in place: Users will face an increased risk of tuberculosis and invasive fungal infections.

Reglan: Generic Drug Makers and Metoclopramide

Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

Four generic drug makers named as Defendants in a Reglan lawsuit that is pending in a USDCT in Vermont won't be granted an immediate appellate appeal the Trial Court’s decision not to grant a pending motion for summary judgment. The argument was that the generic makers did not develop the drug’s warning label.

The lawsuit was filed against Wyeth, which manufactured the drug metoclopramide under the brand name Reglan, and others including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

You can read the opinion here, in PDF format. (D and B blog)





My office is investigating claims of injury related to Reglan, www.markzamora.com

Advanced Bionics Cochlear Implant Recall

Update on a cochlear implant recall:

In 2004, Advanced Bionics issued a recall for the Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system. Advanced Bionics eventually began to distribute the HiRes90k. The FDA had, however, written to the company about the product.
Advanced Bionics then had a 2nd recall on Vendor B HiRes90k implants.

What we are hearing: As many as 20% of HiRes90k vendor B units may fail.

What are the symptoms of a failed or failing Advanced Bionics HiRes 90k or Clarion Cochlear Implant?

*Delays in hearing

*Popping sounds

*Crackling sounds

*Shocks/pain in the head/face

*The implant turns on/off without warning

*Your child is not telling you that the batteries on the implant need charging

*Your child is turning the implant off

What amazes me is how little the news has been out on this recall.Talk to us, on the web at: http://www.markzamora.com/Implant/index.html

Digoxin Recall

Caraco Pharmaceutical Laboratories, has issued a nationwide recall of DIGOXIN, a medicine used to treat heart failure and abnormal heart rhythms. The tablets are being recalled because they may differ in size and could have more or less of the active ingredient, digoxin.

This recall includes all lots of Caraco brand digoxin tablets distributed before March 31, 2009:

Digoxin 0.125 mg tablets - NDC# 57664-437-88 or NDC# 57664-437-18

Digoxin 0.25 mg tablets NDC# 57664-441-88 or NDC# 57664-441-18

Digoxin tablets from other manufacturers are not included in this recall. Last year a similar problem was reported with another manufacturer’s brand of digoxin. At the time this resulted in a massive recall of the heart drug, affecting 60% of the nation's supply. It also helped spur reports of at least 650 patient deaths. However, a direct link to defective tablets was difficult to assess click here.

This source comes from the FDA and other sites.

We're investigating this recalled drug. You can always reach us at markzamora.com/contact

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

Fitness Balls Recalled by EB Brands Due to Fall Hazard;

News this past week that three million fitness balls ... just like the one your spouse first used when it arrived a Christmas or two back have been recalled.

From the CPSC site:

Hazard: An overinflated fitness ball can unexpectedly burst while in use, causing the user to fall to the floor.

Incidents/Injuries: EB Brands has received 47 reports of fitness balls unexpectedly bursting, including reports of a fracture, and multiple bruises.

Folks are being told how to inflate a ball properly. Expect that the instructions will lead to mass confusion and possibly rioting in the streets.

Link here.

Tysabri and PML

I wrote an earlier post this week on PML. Today, there is this report:


Biogen revealed another new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri.

That means that six patients have developed the potentially deadly brain infection since Tysabri (natalizumab), which is partnered with Ireland’s Elan Corp, was reintroduced to the market in July 2006. The case was confirmed late last week.


In the latest case, the patient had been on the drug for 31 months, the longest duration so far. The previous high had been 26 months and the average now is 19 months.

Source here.

U.S. Supreme Court: Tuna/Mercury Poisoning Case

Image via Wikipedia

An interesting case, and the SCOTUS' decision to let stand a lower court ruling (thanks to the WSJ.com site):

The Supreme Court left in place a lower court ruling that allowed a New Jersey woman to sue a tuna-fish producer over the mercury poisoning she allegedly suffered after her diet consisted almost exclusively of canned tuna for five years.

The woman, Deborah Fellner, said Tri-Union Seafoods LLC, the maker of Chicken of the Sea brand tuna, failed to warn her of the risks of consuming tuna fish.

Tri-Union said U.S. Food and Drug Administration regulations prevented it from placing a mercury warning label on its products. The company said that Fellner's suit should be thrown out because it conflicted with the FDA's regulatory regime.

A federal trial judge had tossed Fellner's lawsuit, but an appeals court in Philadelphia reinstated it, saying the FDA had taken no regulatory action that preempted her legal claims.


"Tri-Union argued that the appeals court ruling put it in the untenable position of facing legal liability under state law for not including a warning label that would have rendered its products misbranded under federal law."

More at the source.

Reglan News: Lawyers seeking to Consolidate in Nevada

What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada.

Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, because those conditions are usually chronic problems, it is often prescribed for longer periods of time. Illnesses include essential tremors, Tardive Dyskinesia, and other movement disorders.

We're investigating this drug and how it may have harmed Georgia consumers. Go here for more information.

Raptiva pulled; An explanation of PML

Raptiva is used to control moderate to severe cases of plaque psoriasis, the most common form of the autoimmune disease, which causes red scaly patches on the skin that can itch and hurt.

PML is a serious infection of the nervous system caused by a virus. It's referred to as the JC virus. This virus attacks the brain's white matter and disrupts nervous system activity.

What are the symptoms? Look to where in the brain the virus hits. Common symptoms include deficits in speech, vision, movement and thought processes. The disease progresses rapidly and inexorably toward serious disability and death.

It's important to note that PML is also seen in those with HIV. PML also does not occur without some underlying risk. The highest risk comes from HIV infection.

With Raptiva off the market, is there another treatment for psoriaris?

There is. The drugs Enbrel, Humira and Remicade are medications for its treatment. None has been linked to PML and all three act in a way different from Raptiva.

Sources are here, as well as here and here.

Law Review Articles: Using Facebook in Litigation, and the Daubert Revolution

From the Torts Prof Blog, links to a recent law review articles worth reading.

Facebook:

Here is an article worth reading on how Facebook.com's pages are deemed discovery in the context of Canadian Court. In the U.S., expect the same treatment.

A quote from the article:Canadian courts have considered web-based networking sites such as Facebook and MySpace pages to be ‘documents’ subject to discovery.

I always ask my client if he/she uses Facebook, Myspace, or other S.M. If you're not, be ready for a surprise at your client's deposition, and I don't mean surprise as in surprise party - I mean it as in, "Wow, is that really you doing a tequila body shot at a Panama City Beach bar? I thought you needed back surgery."


Daubert:

A paper addresses Daubert's limitations and suggests that the relevant problems demand resolution before one can conclude that the Daubert revolution is complete.

Download it here.

Trucking: CVSA Out of Service Criteria Handbook

Attending a lawyer convention this week, I had a chance to hear from a Public Safety Officer regarding truck inspections.

The bible for an officer when conducting an inspection? A book called the North American Standard Out-of-Service Criteria.

Part I details violations which place a driver out-of-service.

Part II identifies critical vehicle inspection items and criteria for placing a vehicle out-of-service.

Part III details unsafe hazardous materials transportation, including both conditions which fail to communicate a hazard and those which are themselves hazards.

Part IV outlines the criteria for placing a motor carrier out-of-service.

If you investigate wrecks involving tractor trailers, it's worth buying. Get it
here.

Intra Aortic Balloon Pump Recall

Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters Recalled.

The FDA announced a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.

The recall is being conducted because of a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.



http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow

FDA stops firm marketing unapproved cold medicines

Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Source here.

Raptiva Recalled

There will be a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.

Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Authorities in Europe, where Raptiva is sold by Merck KGaA (MRCG.DE), recommended in February that the drug be suspended in light of the PML risk.

The European Commission is expected to follow that advice.

There have been three cases of diagnosed PML in patients receiving Raptiva, two of which were fatal, and a fourth patient who developed progressive neurologic symptoms and died of unknown causes.

Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or light therapy.

PML has also become an issue for patients treated with multiple sclerosis drug Tysabri, which is sold by Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I).

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Rhino ATV Recall

Yamaha Motor Corp. USA recalled about 145,000 off-highway recreational vehicles Tuesday, after two models were involved in 46 deaths and hundreds of injuries.

The two-passenger Rhino 450, 660 and 700 vehicles are designed for those older than 16 with driver's licenses, though some deaths involved children who were passengers or operated vehicles against recommendations, said the Consumer Product Safety Commission.

All Rhino 450, 660 and 700 model vehicles were recalled to reduce rollover risk and improve handling and keep riders' limbs in the vehicles. Reported deaths occurred between the fall of 2003, when the vehicles were first distributed, through this year.

Nationwide Voluntary Recall of Propafenone HCL Tablets: Oversized Tablets

One lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc. The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled.

Alabama: Hydroxycut Information

Bunch and James have been investigating Hydroxycut related injury claims; their firm is Alabama. Their # is 888-422-2882, and their site is bunchandjames.com

The product Hydroxycut Max has these ingredients:

The active ingredients in Hydroxycut Max are: green tea extract, caffeine anhydrous, xanthinol nicotinate, yohimblne HCI, black tea extract, wu long tea extract, rooibos tea extract, cissus quadrangularis extract, soy isoflavones, rose hip powder, hibiscus extract, garcinia cambogia extract, L-lysine HCI, diacylglycerol, dandelion powder, juniper powder, terminalia chebula powder, angelica keiskel powder, mangosteen extract, chaste extract, citrus peel, soy phospholipids, raspberry extract, and policosanol. The inactive ingredients include: sesame oil, gelatin, FD&C Red No. 40, caramel color (may contain sulfites and wheat), polysorbate 80, ink (shellac, dehydrated alcohol, isopropyl alcohol, butylalcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide).

On one site, there are these disadvantages:
Disadvantages

* The product is expensive compared with similar products.
* Hydroxycut Max contains over twenty unexplained ingredients.
* No money-back guarantee is evident on the manufacturer’s website at this time.
* Consumers cannot purchase this product directly from the manufacturer.

Source here.

More on Reglan, Octamide and Maxolon

Some have emailed asking what is Metoclopramide.

Metoclopramide is used to treat the slow stomach-emptying that can occur in diabetes, and as a second-line treatment for heartburn caused by gastroesophageal reflux. It's sometimes used for the nausea and vomiting that accompany cancer treatment, and migraines.

Regulan or its generic stimulates the stomach to move things along, reducing fullness and reflux of the stomach's contents. It also quashes the urge to vomit. It works by blocking dopamine, a neurochemical that induces vomiting and stomach-slowing.

What is TD?

Tardive dyskinesia is a disorder in which the tongue, mouth and jaw move uncontrollably in abnormal ways. Movements can include eye-blinking and face-jerking, and can occur elsewhere on the body. The movements are "pretty much constant," says Dr. Jeff Bronstein, a neurologist at UCLA's David Geffen School of Medicine, except during sleep.

The disorder can persist for months and years, and in some cases appears to be permanent. Severity can vary, Bronstein says. "Some people can get so bad it's hard for them to eat and swallow because of their tongue movements. And obviously, cosmetically, it's horrible."

Tardive dyskinesia occurs as a side effect of drugs that block dopamine. Once diagnosed, patients are usually taken off the drug. In some patients, the symptoms get better. In many cases, it becomes a permanent neurological disorder. No standard therapy exists, but various drugs have been used as treatments.

How big is the risk?

Jankovic analyzed all 443 tardive dyskinesia patients seen over 25 years at his Baylor clinic. Prior to 2000, the antipsychotic Haldol was the main culprit; since then, metoclopramide has moved to first place.

"It is a public health problem," Jankovic says. "Many of these patients who have metoclopramide-induced movement disorders aren't recognized until . . . they're at pretty advanced stages of the disease."

The main way to limit the risk is by limiting how long the drug is used. The drug is already labeled for short-term use, defined as four to 12 weeks. But a 2007 FDA study found that 20% of patients were prescribed the drug for longer than this.

Researcher Faked Data for 21 Studies

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben's "research", it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

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Bills Pending In the Georgia Legislature for 2009

Just a few days remain before what is called crossover day - when a proposed bill must crossover to the other chamber. Here is a list of bills pending, with a hat tip to the GTLA blog:



SB 39 and HB 277 - Two approaches to transportation funding are moving through the General Assembly. The Senate passed SB 30 that would allow a one-penny sales tax for transportation (TSPLOST) to be approved for the metro Atlanta region and in individual counties outside metro Atlanta. The legislation was sent to the House, where it has been put on the back burner while House members consider their own transportation funding solution. The House passed HB 277, which provides for a ten-year, statewide sales tax for transportation with specific projects listed in the legislation. Status: It is likely that a conference committee will be formed to work on a consensus proposal for transportation funding before the Governor for signature or veto.
SB 54 - Prohibits abusive home loan practices as part of the Georgia Fair Lending Act. Status: Senate read and referred to committee.

SB 55 - Alters factors to be considered in determining fair market value of real property in relation to ad valorem taxes. Status: Senate passed, read second time in House.

SB 60 - Authorizes each local board of education to determine the maximum age of mandatory education from 16 to 18 for its local school system. Status: Senate read and referred to committee.

SB 71 - Prohibits engaging in certain outdoor sporting activities while under the influence of alcohol, drugs, and other substances. Status: Senate read and referred to committee.

SB 83 - Increases the amount of the statewide homestead exemption for ad valorem taxes. Status: Senate Passed, House Committee favorably reported, passed House vote on March 4, House voted to reconsider on March 5.

SB 84 - revise provisions relating to eligibility for election as a local board of education member; limit the size of local boards of education; revise provisions relating to per diem and expenses of local board of education members; provide for the fundamental roles of local boards of education and local school superintendents; prohibit certain conflicts of interest of board members; provide for a code of ethics for local board of education members. Status: Passed in Senate, read a second time in House.

SB 90 - Establishes vouchers to use taxpayer funds for families to pay private school tuition. Status: Senate committee favorably reported, read a second time in the Senate.

SB 108 - Provides tort reform to allow the charging of attorney fees to plaintiffs when a judge grant's a defendant's motion to dismiss. Status: Senate Committee favorably reported, read a second time in Senate.

SB 142 - Creates the Georgia Family Violence Offender Registry and enhances penalties for an act of family violence. Status: Senate read and referred to committee.

SB 169 - Restricts stem cell research in Georgia; provides that it shall be unlawful for any person or entity to intentionally or knowingly create or attempt to create an in vitro human embryo by any means other than fertilization of a human egg by a human sperm; provides for standards for physicians and facilities performing in vitro fertilizations; defines a living human embryo as a person, not property; prohibits the destruction of a living human embryo for any reason, such as disposal of unwanted frozen embryos kept at a fertility clinic or scientific research. President Barack Obama has announced a lifting of restrictions on federal dollars for such research. Status: Senate Committee favorably reported.

SB 175 - Provides for a moratorium on the administration of a death sentence. Status: Senate read and referred to committee.

SB200 and HB605 - proposed by Governor Perdue with the support of Lieutenant Governor Cagle and Speaker Richardson, would implement sweeping changes in statewide transportation planning, including the merging of the Georgia Regional Transportation Authority (GRTA) and the State Road and Toll way Authority (SRTA) into a new State Transportation Authority (STA), which would be responsible for planning, policy and funding decisions. The current Department of Transportation would remain responsible for operations, maintenance and certain construction projects. SB200 passed the Senate on March 5. HB 605 has been read a second time in the Senate.

HB 39 - Cigarette tax increase in the amount of $1 per pack - currently in the House Ways and Means Committee. Status: Read a second time in the House.

HB 67 - Suspending exemption on sales and use tax on certain food and beverages, reinstating a four-cent sales tax on groceries. Status: House Committee favorably reported.

HB 118 - Mid-year adjustments to the current year's budget, including reinstatement of the Homeowners Tax Relief Grant to local governments. Status: passed both House and Senate, now in conference before going before the Governor for signature or veto.

HB 119 - Fiscal year 2010 budget including a 10 percent cut in spending and a $1.2 billion stimulus package - currently in the House Appropriations Committee.

HB 160 - "Super Speeder" bill to boost fines $200 for drivers exceeding 85 mph on interstates and 75 on other roads. Also increases the fees paid for reinstatement or restoration of suspended or revoked drivers' licenses. Passed the House on Monday (March 9) and headed to the Senate.

HB 209 - Allowing the use of valid student identification cards issue by a public or private college or university in Georgia as proof of identity in order to vote. Status: House Committee favorably reported.

HB 228 - Reorganizing and reestablishing various state health and human services agency and reassign various functions of the Department of Community Health and the Department of Human Resources and abolish the Board of Community Health and the Board of Human Resources and establish the position of State Health Officer and the Behavioral Health Coordinating Council. Status: House Committee favorably reported.

HB 261 - Providing for an income tax credit for a limited period of time for the purchase of one eligible single-family residence. Status: House Committee favorably reported.

HB 277 - Levying a 1 percent sales tax statewide for specific transportation projects over the coming 10 years - passed the House, currently in the Senate Finance Committee. Status: Passed house, read in Senate and referred to Senate Committee.

HB 385 - Repealing the date on which the State Commission on Family Violence shall cease to exist. Status: House Committee favorably reported.

HB 517 - Imposing a cap on property assessment increases at the inflation rate or 3 percent. Status: Read a second time in the House.

51 resolutions under consideration in the Georgia General Assembly. Many are associated with House or Senate Bills currently under consideration. Adopted resolutions are constitutional amendments to the Georgia Constitution and require voter approval following adoption and signature by the Governor. For a complete list of Resolutions and their status, see the link posted above.

FDA - Political Lobbying Drove Process on a Medical Device Application

From the WSJ:

"The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.

The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions."

For the rest of the story, go here.

Reglan Gets a Blackbox Warning: Tardive Dyskinesia

News about Reglan:


What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines. People that suffer from diabetes sometimes suffer from a slow gastric emptying, which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals, so they take Reglan as well.



In February of 2009, the FDA issued a warning about Reglan:


Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.



Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.



Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

United States Supreme Court Rules for Consumer, against claim of Drug Preemption

Opinion just came in today, and it's worth a read:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration.

Footnote 11 is worth your read alone:

11In 1955, the same year that the agency approved Wyeth’s Phener-gan application, an FDA advisory committee issued a report finding“conclusively” that “the budget and staff of the Food and Drug Admini-stration are inadequate to permit the discharge of its existing responsi-bilities for the protection of the American public.” Citizens AdvisoryCommittee on the FDA, Report to the Secretary of Health, Education,and Welfare, H. R. Doc. No. 227, 84th Cong., 1st Sess., 53.

and ...

(“The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for postmarketing drugsafety work are especially inadequate and that resource limitationshave hobbled the agency’s ability to improve and expand this essentialcomponent of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Postmarket Decision-making and Oversight Process 5 (GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf (“FDA lacks a clear and effective process for making decisions about, and providingmanagement oversight of, postmarket safety issues”);

FDA; 189,000 Food Plants Worldwide; 96 Inspected

No your eyes are not deceiving you. That's the total of plants inspected in 2007 by the FDA. The FDA is broken.

From the AJC.com

The FDA’s inspection record underscores the need for more regular, comprehensive food inspections. But it also speaks to the importance of prevention and transparency, not crisis management, in protecting the safety of our food supply.

An efficient safety network prevents contamination before food products are shipped to schools, senior centers and grocery stores. An efficient system also tracks illness outbreaks quickly and recalls tainted products with equal speed.

Today, the U.S. food-safety network does not meet those standards, and Americans are literally dying as a result.

For more go here to read the posted opinion.

Seroquel Internal E-mails Unsealed

Documents recently unsealed in a U.S. federal court case showed AstraZeneca may have known about the risk of weight gain and diabetes in 2000.

At least one lawyer prosecuting the cases said internal e-mails and other documents showed AstraZeneca officials had evidence of the drug's link to weight gain but used promotions suggesting Seroquel had no effect on weight or could lead to weight loss. Weight gain is a risk factor for development of diabetes.

The drugmaker believes that the Seroquel label has always provided adequate and appropriate information and warnings based on available data.

Source here.

Alabama: Jury Orders Makers of Sandoz to Pay State $78.4M

News from Alabama yesterday:

Jurors ordered Sandoz Inc. pay the State Government of Alabama $78.4 million for causing the state Medicaid program to pay too much for prescription drugs from 1991 to 2005.

Evidence at trial? The evidence included a company memo that said: "Go forward and take the position of a Roman legion, be greedy and take no prisoners."

Source here.

Vytorin: Cancer Risk for This Heart Drug?

From various sources, link below. Several larger studies say no, one smaller study suggests yes.

Last year, a heart researcher (Terje Pedersen) released a from an 1,800 patient study. According to it, 47% of those taking the cholesterol drug Vytorin were more likely to develop cancer than those taking a placebo.

Pedersen and other scientists conducting two Vytorin studies tried to refute the findings. An analysis of data from two larger but unfinished Vytorin studies showed no increased risk of cancer.

A 18,000-patient larger study, called IMPROVE-IT, which began in October 2005 and is set to continue until 2012, didn't have enough useful information to give any answers. Another 9,000 patient test (which began in June 2003) in patients with kidney issues, code-named SHARP, showed no increased risk of cancer.

Source here.

Happy Mardi Gras - From Our Family to Yours

For my 1,000th post, I'm happy to say to folks today, Happy Mardi Gras. For many, the beads tossed have a less than family oriented connotation, but make no mistake - Carnival in New Orleans is heavily family oriented (Yes, the French Quarter and that certain street are exceptions).

Mardi Gras for families is as much sitting along St. Charles all day, with a ladder for the kids to better catch trinkets as it is a time to laugh, eat, and be with friends. For college students, it's a day/night long tailgate without the football game.

For me, it was a time to dine at great restaurants (Antoine's, NOLA, Mr. B's), to enjoy a lawyer seminar (yes, held this past week, during Carnival), and to talk to folks enjoying the parades.

It's good to see that the City I love is coming back.

Outsourcing of Drug Trials

The most recent issue of the NEJM, here discusses the globalization of clinical trials.

Concerns noted in the article include:

Wide disparities in education, economic and social standing, and health care systems may jeopardize the rights of research participants;

There may be a relative lack of understanding of both the investigational nature of therapeutic products and the use of placebo groups; and

In some places, financial compensation for research participation may exceed participants' annual wages, and participation in a clinical trial may provide the only access to care for persons with the condition under study.

Worth a read.

Tech Talk: Lawyer(s) Suddenly Laid Off? Looking to Set up an Office?

A couple of friends across the USA have either suddenly been let go, or made the decision to depart before the ax fell. Most have the same problems: How to quickly set up an office presence if a lawyers decides to open up shop.

Here are a few quick - perhaps interim only - suggestions:

1.Email: When I left my prior firm, I was sweating the purchase of an email server. After a day of searching, I settled on MailTrust.com.For about $3-$5 per mail box, you get POP, IMAP, & Webmail, Business-class email, sharing, & mobility. I set up my system for $70 a month. Plus, no contract terms to worry about long term. I am able to control the number of users, add or remove mailboxes, and I have an email address with a specific domain.

2.FAX: I signed up and receive faxes through efax.com. I'm able to get a local FAX number, and within about 10 minutes I was ready to go.

3.Phones: Obviously a concern. I am able to tell you that we now use VOIP, but in the beginning we went cell. An attorney I know who was let go suddenly actually only had his personal cell. He went to tossabledigits.com for a disposable phone number.

At the very least, get another cell phone line for the first several days of your new career. You can always forward it to a main number when you're set up.

4.Internet/Website My suggestion to anyone reading this is to acquire and manage your own domain. I'm not talking about building a page, merely about controlling the domain name. That is, don't entrust any internet hosting company to build your site and administer/control the .com name. Why? I can tell you horror stories of a firm passing off its .com to a host, only to have that host go under, and with it the .com name. Another story involves a hosting company getting angry about losing business and refusing to turn over the domain name.

I simply use godaddy.com or yahoo.com, buy the domain name, and forward it to the site that is ultimately built. I can go into detail about modifying an A record, but that is for later.

5. Openoffice and PDF995.com: Openoffice is the free version of the typical office system like MS Word/MS Office. It allows you to create a document and save in .doc or other formats. It also allows you to save as a PDF. Pdf995.com is just that - converts a document into PDF. There is a free version as well.

Reglan and Movement Disorders

Reglan now has a blackbox warning, pursuant to the FDA. We're investigating those who may have been harmed by this drug.

Movement disorders describe a variety of abnormal movements of the body that have a neurological basis. These abnormal movements are characterized by changes in the coordination and speed of voluntary movement. They may also involve the presence of additional movements that are not voluntary.
Description

Movement disorders are sometimes referred to by medical professionals as extrapyramidal diseases because this class of disorders is distinct from the disorders caused by disorders of the pyramidal region of the brain. Researchers have determined that movement disorders are caused by diseases in various parts of the brain, including the substantia nigra, the subthalamic nucleus, the globus pallidus, the striatum, and the basal ganglia.

Movement disorders are usually broken down into two types of movement: hyperkinetic movement and hypokinetic movement. Hyperkinetic movement disorders are characterized by a significant and excessive amount of motor activity. This type also includes cases in which there is a significant amount of abnormal involuntary movement. Hypokinetic movement disorders are those in which there is an abnormally reduced amount of intentional motor activity.

Hyperkinetic movement disorders are characterized by two types of behavior: rhythmical and irregular. Tremor is a rhythmic movement that is further divided into three forms: rest, postural, and intention. Rest tremor is most prominent when an individual is at rest and decreases with voluntary activity. Postural tremor occurs when an individual attempts to support a position against gravity (such as holding an arm outstretched). Intention tremor occurs during voluntary movement toward a specific target.


A side effect is a movement disorder, like Dystonia:


What is Dystonia?

Dystonia is a movement disorder characterized by involuntary muscle contraction leading to abnormal postures and twisting movements. The frequency of this disorder is similar to multiple sclerosis.

Are there different types of dystonia?
Several types are known and they are classified according to age of onset, distribution of dystonia, and cause. The primary dystonias are diseases that are characterized with only dystonia as their clinical feature. They are classified as early onset or adult onset disease.

* Early onset dystonia
The characteristic form of early onset form is called "primary childhood onset dystonia" otherwise known as Oppenheim's dystonia or DYT1 dystonia. This disease begins frequently with dystonia in a limb and with onset under the age of 28. It characteristically progresses to involve other body parts and ultimately becomes generalized.

* Adult onset dystonia
The adult onset dystonias are far more common and cervical distribution (otherwise known as spasmodic torticollis) is the most common type. The adult onset dystonias usually remain localized to specific areas such as neck, face or vocal cords. And they generally do not spread and are much less frequently hereditary.

* Cervical dystonia (or spasmodic torticollis)
For cervical dystonia, typical age of onset is around 40 years and women are more affected than men.

What causes dystonia?
The cause of dystonia is unknown although genetic studies may shed some light on this in the next decade. The genetic nature of this disorder has recently come to light as it is autosomal dominant and a number of genes have been isolated.

How is dystonia treated?
The primary treatment for the focal adult onset dystonias is Botulinum toxin. There are currently two types of toxins - Type A (approved in 1989) and Type B (approved in 1999). The most recent advance in the treatment of dystonia is deep brain stimulation surgery similar to that utilized in Parkinson's disease and essential tremor.

Another side effect is an essential tremor

What is essential tremor?

Essential tremor is probably the most common of movement disorders affecting about 5-10% of the population.

What are its symptoms?
It is characterized by tremors. But unlike Parkinson's disease

* Essential tremor is associated with postural and action tremors, which interfere with such activities as writing, eating and performing fine motor movements.

* With Parkinson's disease, tremors occur while sitting at rest.

Essential tremor can occur at any age. It is sometimes very mild and not troublesome but it can be progressive and result in severe disability.

What causes essential tremor?
The cause of essential tremor is unknown. We do know that it is inherited in an autosomal recessive manner in many cases, meaning that each child of a person with this disease has a 25% chance of inheriting it. Two genes have recently been associated with essential tremor and further research may delineate a cause.

How is it treated?
Currently there are some medications that may be helpful in diminishing the tremor. These include:

Medical Treatments

* Propranolol
* Primidone
* Gabapentin
* Topiramate
* Benzodiazepines

Unfortunately, there is no medicinal treatment that is capable of completely stopping tremor.

Surgical Treatments
In the last 10 years, developments in surgical therapy have helped some to slow the progression of essential tremor. For those who are severely disabled by tremor and do not respond to medicinal treatments, a surgical procedure known as deep brain stimulation may ease symptoms. During deep brain stimulation, a part of the brain is exposed to electrical pulses to help abolish or partially abolish tremor, Patients who undergo deep brain stimulation have continued to experience symptom improvement for years after the procedure for years.

FDA Targets Starcaps and Other Diet Pills

The FDA says that certain weight-loss capsules, including StarCaps are promoted as natural dietary supplements using papaya, but could be hazardous to your health. In violation of the law, the FDA found, the capsules also contained a drug called bumetanide that can have serious side effects.

In a continuing investigation, the FDA has concluuded that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs.

Expect a detailed list to be published soon.

Our office is investigating alleged wrongdoing by the matkers of StarCaps. The recall information is here.

Source here.

FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs (Fentanyl)

From the FDA's very own site:

Certain ffected opioid drugs will be reviewed, and include brand name and generic products that are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks.

Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. The FDA, drug manufacturers, and others have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

Read more here.

GA: Medical Malpractice Ruled Unconstitutional

In Atlanta, State Court Judge Diane Bessen ruled that the Georgia statute that capped medical malpractice non-economic damages (O.C.G.A. Sec. 51-13-11) violated the Georgia Constitution. Known as the Nestlehutt decision, some highlights of the Order include: "A limit or cap on noneconomic damages ... invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury... ."

Read the Order here.

Consumers At Risk with Proposed Georgia Legislation

From the GTLA: Governor Perdue wants to place the safety of Georgia’s citizens in the hands of a mismanaged federal bureaucracy

Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval.

In essence SB 101 seeks to rely on the federal Food and Drug Administration (FDA) amidst grave controversy while giving large pharmaceutical companies who harm Georgians a “Get out of Jail Free” card

Governor Perdue suggests that a federal bureaucracy embroiled in heavy controversy, the FDA, should have all the power in deciding the safety of pharmaceuticals and medical devices. SB 101 bars any Georgia citizen from bringing a products liability claim against a pharmaceutical corporation so long as it is headquartered or has 200 employees in Georgia and the product in question, either a drug or a medical device, is FDA approved.

“Vioxx was an FDA approved drug that harmed at least 139,000 people. If there were to be a drug or medical device made here in Georgia that injured or killed people like Vioxx did, Georgia residents would have absolutely no recourse. A person in Phoenix City, Alabama could pursue justice; a person in Columbus could not,” said Fred Orr, President of the Georgia Trial Lawyers Association. “The Governor believes SB 101 will bring corporations to Georgia. But I don’t think we want the kind of business this legislation would attract as this bill says, “Move to Georgia! You can harm or kill our citizens and you will not be held accountable!”

The Governor stated early in the session that FDA approval “should mean something” and that it should protect corporations from lawsuits.

“The FDA can’t protect us from peanut butter. How can we possibly rely on the FDA to protect us from dangerous drugs and medical devices?” said Orr. “If a pharmaceutical corporation manufactures a drug or medical device that seriously harms or kills an innocent person, that corporation should not, under any circumstance, be shielded from accountability. The Governor has simply gone too far with this proposal.”

On February 2, 2009 President Obama had harsh words for the FDA and he urged Congress to conduct a complete review of the FDA after the agency failed to protect the public from contaminated peanut butter. At this time the contaminated peanut butter has killed 8 people and sickened over 500 people.

In addition to the agency’s failure to protect the public from peanut butter, as recently as the last month, the FDA has been at the center of three other nationally publicized controversies concerning alleged corruption, mismanagement, and claims of serious financial conflicts of interest. First the federal Government Accountability Office (GAO) released a report revealing that the FDA has failed to comply with a congressional mandate set nineteen years ago that requires manufacturers of medical devices to provide proof of rigorous testing and safety analysis to the FDA for all Tier 3 medical devices (classified as those devices that are implanted or that a person relies on for life) prior to approval.

Second, a group of FDA scientists went public with their allegations of corruption, mismanagement and coercion within the FDA. The scientists stated that the scientific review process for medical devices “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” They allege that managers at the FDA lacked scientific knowledge and clinical expertise regarding medical devices and that they have ignored the experts and scientists within the FDA. The authors stated that they had been ordered to modify their findings and evaluations of medical devices—allowing for the approval of products that may not be safe.

And third, the Inspector General of the Department of Health and Human Services (HHS) issued a report uncovering a troublesome conflict of interest inherent in the FDA approval system. The FDA failed to collect information on financial ties between those that perform clinical tests and the pharmaceutical companies that manufacture the product being tested in an alarming 42% of the cases. HHS claims that such financial ties may compromise the safety of the people in the clinical trials and the authenticity and integrity of the final research data.

“The scientists working at the FDA think that Americans are in danger. Other governmental entities report that the FDA is inept at keeping the American public safe. Yet Governor Perdue inexplicably thinks we should trust a corrupt federal bureaucracy to keep Georgians safe,” said Andy Childers, an Atlanta attorney.

National leaders in medicine don’t think that FDA approval is enough to keep people safe either. In a friend-of-the-court brief filed in association with the case of Wyeth v Levine, multiple editors of the New England Journal of Medicine stated, “The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety." The doctors went on to say that without civil lawsuits and the discovery they produce, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."


NOTE: For more information on the FDA approval process and other Government reports, please contact Rebecca DeHart at GTLA.



The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgians

FDA Advisory Committee Hearing Will be Webcast 2/3/09

Te Cardiovascular and Renal Drug Advisory Committee Meeting scheduled for February 3rd, 2009 will be webcast.

The FDA's Cardiovascular and Renal Drug Advisory Committee Meeting is being held to decide whether or not to approve a competitor drug to Plavix, the second-biggest selling drug in the world. The new drug in question is called prasugrel and would be marketed by Eli Lilly & Co with potential co-marketing by Japan's Daiichi Sankyo Co., the drug's discoverer.

Reports issued suggest that prasugrel may be more effective than Plavix in preventing heart attacks, but also a higher risk to cause dangerous bleeding. These are the issues that have been considered and will likely be commented upon as the Advisory Committee decides on approval.

Webcast here.

Source here.

Pres. Obama Weighs in on FDA: Critical Comments

Nice to hear he is going to have a complete review of the agency that is failing Americans every day:

"President Obama had critical words for the Food and Drug Administration yesterday in the midst of a massive recall of peanut products linked to a nationwide outbreak of salmonella illness that has killed eight people and sickened another 550.

"I think the FDA has not been able to catch some of these things as quickly as I expect them to catch them, so we're going to be doing a complete review of FDA operations," Obama told Matt Lauer during an interview broadcast on NBC's "Today" show."

Source here.

Peanut Butter Recall: Peanut Corp. of America

The King Nut Food Supply Company announced an immediate recall of their institutional brands King Nut and Parnell's Pride peanut butter. Minnesota State Health officials linked the country's latest outbreak of Salmonella food poisoning to tainted peanut butter. King Nut is a large scale distributor of peanut butter and other foodservice products to hospitals, schools, and nursing homes. The company does not manufacture their brand of peanut butter.

The peanut butter in question was produced by the Peanut Corporation of America, which issued a statement expressing dismay over the discovery of salmonella bacteria in a King Nut five gallon jar of peanut butter. However, the company instatly struck a defensive position, insisting that the chain of custody of that peanut butter jar had not been fully established, and more conclusive facts needed to be revealed.

Minnesota Health officials established in preliminary laboratory testing that the Salmonella found in a jar of King Nut peanut butter was identical to the strain responsible for the large outbreak of salmonella bacteria food poisoning in the United States since September of 2008. This same salmonella outbreak has been responsible for hundreds of cases of salmonella poisoning and hospitalizations in 42 states.

Peanut Butter Recalls: Save Your Proofs of Purchases

I've been reading (as have most) about the recall of tainted peanut butter products. I think bad advice is being given in an overly simplistic way - that is, advice to simply "throw away" the bad product.

Obviously, most of the producers of the bad product hope most consumers throw away any proof they may have. I suggest you keep the jar lids as a bare minimum. Keep the proof of purchase or the label. You're going to need it later, perhaps.

Denied Insurance Claim Blog Debuts

Blog just starting, http://deniedclaim.wordpress.com/

Posts include:

Health Insurance Takes a Hit; and

An article about a Court case involving Unum which states:

First Unum Life Insurance Co. has filed a petition for rehearing with the Second Circuit U.S. Court of Appeals, saying that the court “misapprehended key facts and law” when it recently decided that it arbitrarily denied long-term-care disability benefits to a tax attorney with colon cancer.

The court denounced the”arbitrary and capricious nature not only of Unum’s tactics against its insured, as well as its claims practices generally.

Unum’s insured sued First Unum in the U.S. District Court for the Southern District of New York, alleging bad faith denial of claims under an original and conversion policy. The Second Circuit reversed.

GTLA's 2009 Convention Highlights

Georgia Trial Lawyers April 2009 convention has been revamped. From the GTLA site:

With a completely redesigned format, this two-day extravaganza features multiple trackes covering a wide variety of topics for all practics areas!

* Champions Trial Skills College
* Civil Rights
* Class Actions/Mass Torts
* Criminal Defense
* Ethics/Professionalsim
* Evidence/Expert Witnesses
* Family Law
* Investor/Consumer Protection
* Motor Vehicle/Premises Liability
* New Plaintiffs Lawyers
* Professional Negligence
* Product Liability
* Social Security
* Technology
* Trucking
* Workers' Compensation

FDA's Device Review Inadequacies: More

Here's this tidbit:

At least 228 medical devices between 2003 and 2007 were approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, despite assurances from FDA officials that holes in the approval process were being addressed, according to the report by the GAO.

Nearly 230 devices in essence were crammed through the process? Read the complete GAO report here in PDF.

Source here.

FDA Heavily Criticized - Device Testing is Inadequate

From the NYT:

Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators from the GAO have concluded.

'In recent years, the accountability office, Congress’s auditing arm, has chastised the F.D.A. as failing to put into effect its own plan to protect the nation’s food supply, as failing to adequately inspect the foreign drug plants that provide most of the nation’s medicines and as being so hobbled by bureaucratic infighting that it fails to detect emerging drug dangers.

Each time, the agency has largely agreed with the investigators’ findings and promised to do better. The difference this time is that nine scientists within the agency’s device division are echoing critics’ claims of a corrupted review process.'

More here.

This should not come as a surprise, since the alarm has been sounded for years now. Nonetheless, with a failed system desperately in need of a ground up repair, courts simply shrug their shoulders and rely on a preemption preamble to shield device makers from being held accountable in a court. The FDA in its current form is a disgrace to the american public.

This same week, another report shows the mess that is the BPA investigation (the ingredient in some plastic bottles, including baby bottles). From the Trib:

"In late October, an advisory panel to the FDA found fault with the agency's conclusion [regarding BPA]. The panel said that the FDA had only considered studies financed by the plastics industry and had ignored evidence of the potential harm from BPA. The FDA created "a false sense of security" about the safety of BPA, the panel said." Link.

Got that? The FDA ignored evidence it had before it. Should Americans be frightened?

GA: Legislative Bill Tracker on GTLA's website

The Georgia Legislature is in session now, and the Georgia Trial Lawyers Association has a good session tracker for bills that may impact consumers.

You can see the work here.


Sample layout:


HB 0024 Work Evidence; revise, supersede, and modernize provisions; provide definitions Willard,Wendell 49th
House Second Readers Judy -

Pre-filed Bills Rules of Evidence


This bill attempts to modernize Georgia's Rules of Evidence and bring those rules more in line with the Federal Rules, both with Civil and criminal, without making substantive policy changes. GTLA has been a part of this process and has attended every meeting for the last 6 months. GTLA will continue to monitor this bill carefully.

It's worth a look.

MyDeniedClaim.com Debuts

MyDeniedClaim.com site debuts. From that site:

HOW CAN WE HELP

Helping people battle insurance companies is our life’s work. If you or someone you care about is being mistreated by an insurance company, hopefully we can help. By law, insurance companies have to treat you fairly. Here is some helpful information. We've obtained real results for real people.

FDA Warning Regarding Skin Numbing Products

The Food and Drug Administration has issued an advisory to remind patients, caregivers and health professionals about the potentially serious hazards of using skin-numbing products -- topical anesthetics -- for relieving pain from conditions and medical tests, including mammograms. The warning applies to over-the-counter anesthetics as well as prescriptions.

A topical anesthetic works by blocking the skin's pain sensations. When used, it appears that some of the anesthetic may can pass through the skin and into the bloodstream.

Under these circumstances, the amount of anesthetic medication that reaches the bloodstream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death.

The FDA warning is here.

From the FDA site:

The FDA strongly advises consumers not to:

* make heavy application of topical anesthetic products over large areas of skin;
* use formulations that are stronger or more concentrated than necessary;
* apply these products to irritated or broken skin;
* wrap the treated skin with plastic wrap or other dressings; and
* apply heat from a heating pad to skin treated with these products.

Rhino MDL Hearing: 1/29/09

The U.S. Consumer Product Safety Commission is currently considering new standards for Yamaha Motor Corp. USA's Rhino off-road vehicle and other currently unregulated "utility terrain vehicles." The Yamaha Rhino, which was first introduced in 2003 by Yamaha Motor Corp., is a side by side four wheel all-terrain vehicle (ATV), which is a cross between smaller recreational off-road vehicles and larger utility vehicles

Several plaintiffs who have cases are requesting that the 57 Rhino ATV now pending lawsuits be transferred from 33 different U.S. District Courts to one court where they will be coordinated as part of an MDL, or Multidistrict Litigation.

We're hearing that at least one Defendant wants to have the cases transferred to the United States District Court in Georgia. My bet is that is where the litigation will end up, at least when it comes to federal court cases.

An MDL is a federal procedure which allows multiple cases with common underlying facts to be consolidated for pretrial litigation in a manner similar to how a Yamaha Rhino class action lawsuit would be managed. However, throughout the litigation the cases remain individual claims, and if the litigation does not settle or otherwise resolve during pretrial proceedings, the cases are returned to the original jurisdiction where they were filed for a jury trial.

The Judicial Panel on Multidistrict Litigation will consider the Motion filed by some of the plaintiffs to form a Yamaha Rhino ATV Products Liability MDL at a hearing scheduled for January 29, 2009 at the U.S. Courthouse and Federal Building in Fort Myers, Florida.

Sprint Fidelis Litigation: Court Dismisses Cases Based on Preemption

My office investigated issues relating to Sprint Fidelis and their recall back in 2007. What are Sprint Fidelis Leads? Made by Medtronic Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur.

I was concerned about how preemption would play out regarding these, so we decided to pass. I felt badly for folks who had these recalled leads in their bodies; the looming preemption effect would turn out to be significant.

Last week, a Court dismissed all cases involving the leads. The decision is here. (PDF)

All 21 counts of the Master Complaint were dismissed. With prejudice. Will there be an appeal? Talking to lawyers who chose to take a chance by filing suit in the hopes that an injured person would obtain some measure of justice, as of yet many are undecided as to what to do. Many lawyers are now waiting on two major developments: The Wyeth v. Levin SCOTUS decision, and likely legislation in Congress regarding preemption.

Stay tuned.

Study: Antipsychotic Drugs Increase MI Risks

Heart attack risks were near two times great for those people taking antipsychotic drugs such as Zyprexa and Risperdal - at least that is what a study found, released by the NEJM. The article is here.

The risk of heart attack for people getting the newer drugs, actually increased with their dosage, says thestudy authors.

Here is the Conclusion: Current users of typical and of atypical antipsychotic drugs had a similar, dose-related increased risk of sudden cardiac death.

Is the Current Economy Creating More "TV" Lawyers?

Everyone has seen the injury lawyers on TV. Everywhere, and for many of us the ads from injury lawyers are inescapable.

I travel extensively throughout the south, and in the past 4-8 months, and especially the last two months, I have seen lawyers advertising in areas other than personal injury.

I am now seeing on TV and hearing on radio ads for bankruptcy lawyers with increasing regularity. This week alone, three different firms' ads on the radio alone. Divorce lawyers, criminal law attorneys, even in Florida a lawyer advertising that he can help you stop or workout a foreclosure.

I see billboards for many of these new entrants in the media markets. Some billboards are filled with nonsense, including a roster - in small print no less - of ALL of the types of work a firm does.

For those jumping into advertising, time and again I see the same mistakes. Lawyers simply fail in the basics, such as mentioning the law firm number enough times. Worse, there is a difficult to recall number (a big pet peeve of mine on radio ads). In one ad, the attorney used (592)406-2758. It was a mess, and only repeated twice.

My suggestions:

1.If you choose to advertise, get a toll free or local number, and make sure each is easy to remember. 866 is ok; perhaps use a vanity number, like my friend's use of 888-4ACCUTANE.

2.If you mention a .com in any ad, make it easy. I also heard something like, stopforeclosuresnowlaw.net. Can anyone spell that, much less remember it?
Buy a .com that is the same as your number, so that the ad can have a tag that says, "our website's the same as our number." Bill Harrell in Jacksonvile, FL goes this route, and it is memorable.

3.Don't give me 60 seconds of crap, a lecture filled with jargon. Without music. Radio ads should max out at 30 seconds, and 15 seconds works just as well. I actually heard an ad start with something like, "At the firm of Big and Pompous, we are skilled in the following areas ... ." Really? "In the following areas?" I don't know anyone other than lawyers who talks like that.

4. Speak english. When I spoke with a lawyer from the NE asking for help with an ad, the lawyer and I fought over, and I kid you not, her insistence to say in an ad, "If you took {drug here} and have any of the following sequelae ... " Use terms like "we can help." Don't use, call now for a free consultation, as if using those words separates you from the pack. They don't. I know.

5. Billboards- 1 billboard may make you feel better, but in a city like Atlanta, you might as well just throw your money in the trash. I see one firm's billboard on the way to the airport. It's been there for a couple of years, and trees' leaves partially obscure it in the spring and summer. I asked the lawyer if it worked, and he said, "not really." The number? You got it, hard to recall.

My best suggestion - use an agency to develop a marketing. Alas, the lawyers who could benefit most from suggestions like there probably won't take the time to scan the internet for posts like these. You know the lawyers ... either so worried about their current approach or so arrogant about what 'works' that they won't take the time to perform due diligence.

FDA Scientists Complain to Obama About Managerial Misconduct

Here is something worth watching: News from the FDA's scientists. A group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the FDA.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, written on the agency's Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.


In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said.

Why does this matter? Because all is not as it seems when it comes to medical device approval it now seems. So, when a Court considers the FDA's preamble in knocking out potentially legitimate injury claims, it shows that the very foundation of a drug's approval is shaky, IMO. It's not a clean system, and obviously protectionist legislation solved nothing.

More here.

Another Fentanyl Patch Recall

PriCara®, announced that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled.

ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir.

The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.

As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.

Source here.

Article Detailing Antibiotics' Dangers (Cipro, Levaquin)

From the AJC and excellent reporter Alison Young:


"When Dr. J.T. Cooper hobbles around his Marietta medical office, the boot brace on his right foot is a reminder of a danger posed by some of the most popular —- and misprescribed —- antibiotics on the market.

Like thousands of others who have taken Levaquin, Cipro and other fluoroquinolone antibiotics, Cooper suffered a near-rupture of his Achilles tendon. Tendon side effects have been reported for at least 20 years, but drug makers only began sending letters to doctors warning them of the problem in recent months."

:In 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics, according to IMS Health, a health care information company. Some studies have found these drugs are often misprescribed, chosen first by doctors when other antibiotics are more appropriate —- or when none are needed."

Read more here.



While rare, the tendinitis and tendon rupture side effects can be disabling, making it difficult or impossible to use the affected limb. In some cases surgery is required to repair the tendon. Cooper said he was hospitalized for six days and lost two weeks of work. After weeks in the boot brace, he is only now being allowed brief periods out of it, in a special shoe. It will be the end of the month before he can start driving again.

The experience, he said, is prompting him to limit prescribing fluoroquinolones for his patients when other antibiotics will work, and to try to get the word out to other doctors and patients.

“I don’t want other people to experience the same thing,” said Cooper, 73.

Healon D Recall News

FDA Announces Class I Recall of Ophthalmic Surgical Device:

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Georgialawyer's 09 Resolutions

I make them every year. Each helps guide me, focus my office, and serve as a component of the office Business Plan. In no particular order, here they are:

1. Each employee will have two monitors. I have used two monitors, and I can tell you that productivity increased. Having two monitors gives me access to the firm database as well as to the current project I may be working on, and cuts down on constant switches to other programs.




2. Go completely paperless. From the moment mail comes in, to the moment we turn the lights off at the end of the business day/night. We are almost there now.

3.Declutter. From excessive cables at a desk, to 'Mt. Paper' around the office. Seems like simple resolution, but this one will be the most difficult.

4.Remember who we work for, always: I have this habit of telling a client, "You're my boss" when a contract is signed. I mean it, but sometimes in the daily grind not all who work for any one person may. This year we reinforce this basic premise every day. I so see lawyers who tout their skills or speak of a result as if the client was nothing more than an asterisk to the story being told. I don't like it, and plan to also point it out to those who forget.

5.Tech: Figure out what Social Media is, how it relates to the people we work for, and determine the value of it. Not sure about this one, but I plan to figure it out. Stay tuned, as this subject looks to be one front and center on this blog.

Do you make any resolutions?

From the Blog Drug & Device Law 10 "Worst" Decisions of 08

The Drug and Device Law Blog is a must read for me. This month, the folks there compiled a list of "worst" court decisions. Why are these the worst? Read on ... and read the complete list by going here:


"1. Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008). It’s only an intermediate appellate court decision, but the implications are staggering. The court held that the manufacturer of a pioneer (name-brand) drug can be liable for the inadequate warnings on a competing generic product. The mere label (“misrepresentation”) on the cause of action throws out 50 years of justifying product liability on the basis that the party profiting from the product should bear the burden of compensating product-related injuries.

2. In re Zyprexa Products Liability Litigation, 253 F.R.D. 69 (E.D.N.Y. 2008). It’s Judge Weinstein. It’s a class action. That means that the result favors the plaintiffs, and the certification order is accompanied by a plausibly reasoned (if you think all class actions should be certified) opinion that goes on forever. Having had class certifications shot down by the appellate courts on market share, nuisance, and consumer fraud, this time Judge Weinstein tries non-reliance RICO. So it’s off to the Second Circuit again.

3. Hyman & Armstrong, P.S.C. v. Gunderson, ___ S.W.3d ___, 2008 WL 1849798 (Ky. April 24, 2008). In federal court, Parlodel stroke cases have almost always been thrown out on Daubert grounds - no scientific basis for causation. In Kentucky, they go to the jury and produce eight-figure verdicts – and they get affirmed by the Kentucky Supreme Court on the basis that you can prove causation with a dog and pony show featuring a bit of this and a bit of that, when none of the bits are valid science in and of themselves. "

Those are three of the ten. Biting commentary included. I'm not an attorney who advocates class actions cases, and find them particularly troubling in cases involving unsafe/recalled drugs. In fact, I despise them generally speaking. The other cases mentioned are worth a read of each opinion. Otherwise, you're essentially stuck with reading a movie review only of each case.

Happy reading!

FDA News: Recall of a Medical Device: "Vibe"

The Food and Drug Administration has issued a recall notice for a device made by a Colorado man that some claim cures cancer and other diseases. The FDA says the "Vibe" has not been shown to be safe and effective at curing or treating diseases.

Source here.

Social Media for Lawyers

I've been reading/catching up on Social Media for Lawyers. One site list the top myths regarding it, and here is one highlight:

Myth: Social media tactics are too time consuming.

Truth: Social media tactics could take hours and days, but they do not have to take that much time to be effective. The simple solution is to allot a certain amount of time each day for social media efforts. Set aside an hour or so and blog on Monday, network using LinkedIn or Facebook on Tuesday, use twitter when you have some down time, etc. Remember to go your own pace and plan what works best according to your personal preferences and goals. If you decide you do not want to take on the responsibilities yourself, hire someone in-house to or outsource your social media campaign to a marketing company.

Source here, from Tom Foster.

Good advice. Will lawyers listen? At the end of the day, a lawyer has to wan to go online and post to a blog, use LinkedIn, or use Twitter. I remember the first six months of this blog - I was certain no one was reading it. That has changed, and it has taken "only" two years to have folks ergularly comment on or reply to posts.

FDA Recalls Custom Stryker Cranial Implant Kits

Stryker has had an interesting 2008. Pain pumps made by that company have been the subject of litigation. (The Stryker Pain Pumps are infusion devices designed to deliver controlled amounts of local anesthetics to the patient for post-operative pain management. Medication is delivered directly to the surgical wound site or in close proximity to the nerves associated with the surgical area. The pump infuses the medication at an hourly flow rate or combination of an hourly flow rate and controlled bolus doses.)

It also made news because of it was claimed to have been been running illegal YouTube.com ads that a group alleged violated some U.S. Food and Drug Administration (FDA) requirements. Source here.

Now there is this news: The FDA has issued a class 1 recall for Stryker Custom Cranial Implant Kits, manufactured by Stryker Leibinger USA, because of lack of assurance of sterility and risk for infection, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. Class 1 recalls warn of situations in which there is a reasonable probability that use of the recalled products will cause serious injury or death.

The recall affects all sizes of the cranial implant kit distributed from November 5, 2007, through October 23, 2008. These custom implants are individually designed to correct patient-specific trauma-related and/or other defects of the lower jaw (mandibular), upper jaw, and face (maxillofacial), or the cranium and the face (craniofacial bone).

A letter dated October 24, 2008, notified sales representatives, risk managers, implanting surgeons, and other appropriate healthcare professionals of the recall, stating that sterility could not be assured and that there was a risk for serious infections. In addition, clinicians were advised to follow up with patients for infections for at least 6 months after surgery, and instructions were provided for identifying and returning any remaining implant kits.

Source here.

Season's Greetings

It's in the air here in Atlanta today: High 20's, steel gray sky, moderate winds. As I ran this morning with gloves, hat - anything to keep me warm - I kept my mind on the reason for the season.

Have a safe and happy holiday. I'd ask Santa for snow, but it looks like the forecast for us is a day in the low 60's. I can always dream, right?

I'm On Twitter

Look for me there: ageorgialawyer would be me. Go figure. Thought I'd give it a spin, see what the buzz is about. While at that site, found this from David Barrett:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.


Duh. The web is more de-centralized than ever. After we do our initial searches through the Google, we start looking for communities of likeminded people. Your best customers are the ones that are passionate and want to have a conversation about you, your product, or something related (news, pictures, whatever). You need to be there to have the conversation WITH your customers. Otherwise, they will have it behind your back. You might not be able to rank right away on search engines anymore, but you can get to the top of a news or industry specific site for a few days with good content.

also this gem:


8. Your website is only a billboard

You can have the most beautiful website in the world, and without traffic, it might as well be a billboard in the middle of a cornfield in Iowa. Just ask all those big corporations who paid millions to have their beautiful flash sites built, and forgot to hire a SEO. You launched your site, and now you need traffic, or it’s been there for a long time, and you need MORE traffic and exposure. You listened to the search engines, and created great content! (after all, content is king!) But you still don’t seem to have much traction, and only your Aunt Frita, Uncle Merv, and 6 other people are visiting your site every day.

OK, I'm in. Follow me?

ObTape Vaginal Sling: MDL in GA

Between 2003 and 2006, approximately 35,000 women who underwent a transobturator surgical procedure to treat stress incontinence and bladder leakage received a defectively designed ObTape vaginal sling manufactured by Mentor. Estimates have suggested that 17% to 18% of these women could suffer severe and debilitating complications, including infection, vaginal extrusions and urinary tract erosions.

Problems include:

* Vaginal or Pelvic Pain
* Chronic Infections
* Severe Pain in the Back, Hips and Legs
* Cellulitis
* Vaginal Extrusions
* Urinary Tract Erosions


The United States Judicial Panel on Multidistrict Litigation has ordered that all federal lawsuits involving the Mentor ObTape Transobturator Sling be consolidated in the U.S. District Court for the Middle District of Georgia for pretrial proceedings as part of an MDL, or Multidistrict Litigation.

Mentor Corp. currently faces at least 22 ObTape lawsuits pending in 12 different Courts. The cases have been filed by women who have suffered severe complications allegedly caused by a defective design in a vaginal bladder sling previously sold by Mentor to treat stress urinary incontinence.

The Mentor ObTape Sling contains a “nonwoven” design, which has been found to block essential nutrients and oxygen, potentially resulting in severe pain, vaginal extrusions, urinary tract erosion or infection.

In October 2008, Mentor filed a petition with the Panel on Multidistrict Litigation to consolidate all of the ObTape lawsuits that are currently pending or may be filed in the future. They asked that all of the cases be centralized before one judge for coordinated pretrial litigation in the Western District of Oklahoma or, in the alternative, in the Northern District of Oklahoma or Northern District of Ohio.

At a hearing on the petition November 20, 2008, attorneys representing women who have filed these lawsuits opposed the formation of an MDL, arguing that the litigation only involves one defendant and there are currently only a limited number of ObTape law firms investigating cases. However, they asked that if an MDL was formed, that the cases be transferred to the Middle District of Georgia, where the most cases are currently pending and the first ObTape lawsuit was filed.

Gadolinium Lawsuits Line Up

Lawyers for the plaintiffs and lawyers for the manufacturers of gadolinium based MRI contract agents have filed a joint list of 193 NSF lawsuits which are eligible to be among the first cases prepared for trial in the consolidated federal litigation.

There are over 350 NSF lawsuits that have been filed in federal and state courts throughout the United States alleging that the manufacturers of five different gadolinium MRI contrast agents failed to adequately test their products or warn that they could cause a progressive and potentially fatal condition associated with the hardening and thickening of the skin, severely restricting movement.

All of the federal cases have been consolidated in an MDL, or Multidistrict Litigation, in the United States District Court for the Northern District of Ohio, where they are being handled by Judge Dan Polster for pretrial litigation.

The 193 cases consist of those lawsuits where the parties have agreed that there has been a “good faith substantiation” of which of the five different gadolinium contrast agents were used and where the plaintiff alleges that they have been diagnosed with Nephrogenic Systemic Fibrosis (NSF). The list was narrowed down from over 250 cases which have been consolidated in the MDL.

From various sources, including lawyer colleagues,

Tainted Weight Loss Pills

he FDA warned consumers Monday to neither consume nor purchase a slate of more than 25 different weight-loss products. Each may contain "undeclared, active pharmaceutical ingredients that may put consumers' health at risk," the FDA said in a release.

The drugs the FDA warns could be tainted:

# 2 Day Diet
# 3x Slimming Power
# 3 Day Diet
# 5x Imelda Perfect Slimming
# 7 Day Herbal Slim
# 7 Diet Day/Night Formula
# 8 Factor Diet
# 999 Fitness Essence
# Extrim Plus
# Fatloss Slimming
# GMP
# Imelda Perfect Slim
# Japan Lingzhi 24 Hours Diet
# Lida DaiDaihua
# Miaozi Slim Capsules
# Perfect Slim
# Perfect Slim 5x
# Phyto Shape
# ProSlim Plus
# Royal Slimming Formula
# Slim 3 in 1
# Slim Express 360
# Slimtech
# Somotrim
# Superslim
# TripleSlim
# Venom Hyperdrive 3.0
# Zhen de Shou

The FDA warning comes after an analysis found that the "undeclared active pharmaceutical ingredients" in some of the products contained a controlled substance, a drug not approved for marketing in the United States and a suspected cancer-causing agent.

According to the FDA:

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

Source here.

2008 Resolution Recap

Sitting in the South on a rainy weekend, I'm taking stock of some of my resolutions (those posted here), seeing how I did:

Back about this time last year, I resolved these:

1.When speaking with a person - client, attorney, etc. - I will not pick up my cell phone to see who it is. I will not check my blackberry while in a business setting.

Met. In fact, I now ask those who (like a true addict) start nervously peering down to a PDA/blackberry or cell phone while talking to me about a business matter to STOP and pay attention. I now leave my phone in the car or turned off. There are exceptions, but they are rare.


2.My office will march forward to going paperless. We already move all FAX transmissions to our servers, and basic items such as Incident Reports and medical records are scanned. Next up: Other records and documents.

Met in a big way. Thanks to the Scansnap and a high powered copier/scanner, my office is far ahead of where I thought I'd be. I attended a day long mediation last week and had a portable hard drive with me of a key litigation matter. I was able to have access to thousands of pages that were sitting in my office, while I was in another state.

3.Use of IM and texting of clients: Angel Reyes uses texting to reach a client. We will as well. The use of IM in our offices works well, as we are spread out. Next is asking for the IM screen name of clients. I have found that nearly 60% of all clients use IM, even if only on a semi-regular basis.

Met. Maybe a little too much. Clients now routinely IM me, so much so that I have moved to another username, and my office monitors the main IM.

4.Copying clients on case costs payments. In the old days, there would be sticker shock when a case resolved and the client saw for the first time the costs incurred in a case for matters such as expert witnesses, deposition transcript costs, and the like. Now, clients get all copies of letters showing payments to any entity (but they don't get a copy of the check). This will be a 100% rule in 2008.

Wow, I really posted that? Didn't get to 100%, but closer to 75% now.

5.Compliments: Seems like the law field is one area where compliments to staffers, fellow lawyers, etc. are rare. Not in my office. 2008 is the year of compliments and of 'well done' comments.

I am handing them out, but there is always room for improvement here. Funny how the toughest one - this last resolution - is free, yet was harder to implement, since it required human capital.

Coming soon: 2009 Resolutions.

FDA News: Antiepileptic Medications Must Carry Suicide Warnings

News today from the FDA:

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

Study: Hormone Use Increases Cancer Risk

From Yahoo News:

Taking menopause hormones for five years doubles the risk for breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of the dangers of these still-popular pills.

Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer. And when they stopped taking them, their odds quickly improved, returning to a normal risk level roughly two years after quitting.

Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women.

Link here.

You can read more about a recent Prempro verdict here. The article discusses a four-week trial in which a jury said Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, were defective products and found Wyeth was negligent in producing, marketing and selling the drugs.

Did Wyeth Pay to have Journal Articles Written?

A US Senator claims that Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors.

According to papers from lawsuits suggest the drugmaker hired DesignWrite Inc. of Princeton, New Jersey, to draft manuscripts related to the Wyeth products and breast cancer risks, according to letters released today from Senator Charles Grassley of Iowa to the companies. Wyeth makes the hormone replacement drugs Prempro and Premarin.

For more, including the Wyeth response, go to the Bloomberg article here.

Weekend Post: First Christmas Without My Lab

I tend to post simply about things that interest me: News regarding pharmaceutical litigation, tech items of interest. What most folks comment on in emails? The pictures of the dogs - to the right on this blog.

This year, along with the happiness of the season, there is some sadness in my home. My 14 year old yellow lab named Pudge won't be around. He died earlier this fall. If you aren't a dog person, it's hard to explain. If you are ...

Pudge was the biggest and most rambunctious pup of the litter. He - like me - could be headstrong, aggravatingly persistent, funny, and high energy (all at the same time). He loved water (like his dad) - from a hose, a dirty puddle, even a half empty creek.

Pudge heard countless closing arguments from me while on our runs together. If I put on my running shoes, he knew what it meant: Running and talking. LOTS of talking.

He spent weekends sleeping and snoring away at the office as I prepared for trials. His favorite spot was always next to my chair as I would sit, dictating away. When I mean next to me, it was quite literally next to me, with his rump touching my leg. Pudge would look up from time to time as I worked, and the "thump thump thump" of his heavy tail hitting the floor seemed to say that he knew that my drivel was directed towards him. I cannot tell you how many times a dictated transcript would include (upon its return) a sentence like "Plaintiff deposed witness "B Smith" who ... Pudge lie down, get out of the trash can .... " as he happily distracted me.

Christmas time usually meant his tail wagging around the tree with a crash, followed by an ornament breaking for all to hear. No wine glass was safe on the coffee table when he was in the house. If there was a fire going in the fireplace, you would have to step over his content body as he quite literally spread out in front of it.

As Pudge aged, the runs ended; the walks became shorter, the car rides less frequent. We went from closing arguments on our walks to opening statements. Towards the end, he was totally deaf and partially blind. We communicated with hand signals more often than not. His tail still wagged furiously, though, even when he was ill.

Through it all, Pudge made me and then my family laugh. He was as much my law partner, the silent one we lawyers all dream about, and the one who never argues about strategy or long hours, as he was my friend. This Christmas won't be the same without him at our house.

As I go about my end of the year tasks at the office, there is one less confidant in my life. I hope Santa rectifies that this year with another dog to add to the menagerie in our home. It won't be the same, but I hope that if a dog needs rescuing, love, and care, I know Pudge will be there in spirit and memory.

FDA Panel Hearing Regarding Asthma Drugs

FDA staffers who police drugs after approval spoke before an advisory panel this week. What did the FDA panel hear? That none of the medicines known as long-acting beta-agonists (LABAs) should be given to children with asthma.

It was also argued that two Serevent and Foradil, should not be used by asthma patients of any age.

"We now know with high certainty that LABAs increase asthma mortality. Do the health benefits justify that?" asked FDA drug safety reviewer David Graham, who has been outspoken on medication risks and criticized the FDA's ability to manage them.

Graham said the answer clearly was no, as he saw little improvement among asthma patients treated with LABAs, particularly children. He estimated that as many as 14,000 deaths could be attributed to LABAs since 1994.

For more, go here.

Hospira Recall News

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Media Contact:
Dan Rosenberg
(224) 212-3366

FOR IMMEDIATE RELEASE -- LAKE FOREST, Ill., Dec. 8, 2008 -- Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA: Asthma Drugs Serevent, Symbicort and Foradil Subject of Hearing

The FDA has informed that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients.

The safety of the drugs - Serevent, manufactured by GlaxoSmithKline P.L.C.; Symbicort, made by AstraZeneca P.L.C.; and Foradil, from Novartis AG - will be reviewed by outside medical advisers to the FDA at a two-day hearing next week in Rockville, Md.


A fourth drug, Advair made by GlaxoSmithKline, had no increased risk of respiratory complications, FDA staff said. Advair has about $4 billion in annual sales and is Glaxo's biggest product.

Medical experts will consider the potential risks of all LABAs, including Advair, at the two-day hearing Wednesday and Thursday, will hear presentations by the drugmakers, and will make recommendations. The drugs already carry strong warnings, but the findings next week could lead to more specific instructions for patients.

Souurce here.

FDA: Drugmaker Suggested Off Label Use for Seroquel

Seroquel is indicated for the treatment of both depressive episodes associated with bipolar disorder acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex as well for the treatment of schizophrenia. Seroquel XR is indicated for the treatment of schizophrenia.

The FDA issued a warning letter to AstraZeneca, Seroquel's maker, claiming that a company sales rep recommended or suggested to a healthcare professional an off-label use for Seroquel and Seroquel XR.

The comments, according to the agency, created a new "intended use" for Seroquel and Seroquel XR for which the products lack adequate directions. The FDA said that in addition to the reps oral comments, AstraZeneca sent a mailing to the same health care professional regarding unapproved uses for Seroquel. The agency said these promotional activities and materials misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act.

Source here.

Will Preemption Rules be Introduced?

The clock is ticking for lawyers specializing in consumer safety litigation as they wait to see what "midnight regulations" the Bush administration squeaks through before leaving office in January.


There are dozens of rules now under review by the administration that affect everything from prescription drug labeling to water quality to auto roof safety, according to the Office of the Federal Register, the government's official daily publication for rules, proposed rules and notices of federal agencies.

Midnight regulations are last-minute federal rules and regulations that a president issues before leaving office, usually in the last three months of his term.


Defense counsel are counting on the Bush administration to leave behind regulations that offer greater liability protection to manufacturers and less regulation. The plaintiffs' bar fears just that, warning that as many as 21 possible regulations could be a nightmare for consumer safety and the environment.



Pre-emption is front and center. What may show up in the last days of the current President's term:



• A proposed regulation that would require auto manufacturers - for the first time in 35 years - to increase the strength of vehicle roofs. Plaintiffs' lawyers say the roof strength standards are still too low, and that automakers that meet that rule will be granted complete immunity from all lawsuits, according to the AAJ.



• A proposed rule by the U.S. Food and Drug Administration (FDA) to revise warning labels regarding the use of prescription drugs during pregnancy and breast-feeding, and to update them with more detailed information, including clinical trial results.

This rule includes a pre-emption clause, which the AAJ fears will offer drug makers blanket immunity and give injured women no recourse.


• A proposed FDA rule that would shield companies from liability for potentially harmful over-the-counter drug ingredients. The proposed rule changes the status of some ingredients used in over-the-counter drugs, making them subject to additional FDA approval. Once they were approved, manufacturers no longer could be held accountable should the ingredients cause harm, according to the AAJ.

Stay tuned.

Source: Fulton Daily Report.

Is Rieperdal A Concern when used by Kids?

From the WSJ Health Blog:

Concerns about Risperdal use by kids:

One particularly troubling side effect is the growth of breasts in some male patients taking Risperdal. The alleged problem stems from prolactin, a hormone involved in lactation, that can be elevated in males and females who take the medicine. Two minors currently involved in a lawsuit required mastectomies to get rid of their bosoms.

Source here.

Starcaps FDA Recall Notice

Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient


FOR IMMEDIATE RELEASE -- November 26, 2008--- Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.

The company has received no reports of illness associated with this product.

To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.

The recalled lot totaling just over 10,000 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.

Consumers who purchased STARCAPS Lot 12/2011 – 84810 should immediately discontinue their use and return it to Balanced Health Products, Inc at the address on the product label.

Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.

Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.

Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.

This recall is being made in cooperation with the US Food and Drug Administration.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.

Vaginal Sling News-Mentor Ob Tape

Urinary stress incontinence is a common problem for women - some 13 million of them in this country alone - particularly after childbirth and as they age. There are diaper-like products on the market for such women, but many choose to medically correct the problem so they no longer have this inconvenient embarrassment in their life. Imagine their horror when the very procedure meant to help them ends up harming them far worse than the original incontinence. This is what has happened to many women who had the Mentor ObTape Vaginal Sling surgically inserted.

Mentor is a California company that manufactured an ObTape Vaginal Sling, an implanted device that is designed to replace eroded or weakened muscles in the urethra and support the bladder. The problems occur because the material the sling is made of doesn’t allow the tissue where the sling is attached to heal; the material itself prevents the needed nutrients and oxygen from reaching the tissue. Women have suffered infection, scarring, painful intercourse, vaginal discharge, pain, mesh extrusions, abscess, and return of the very condition meant to be rectified by this device – urinary stress incontinence. The complications from the Mentor ObTape Vaginal Sling often required patients to undergo surgery and, unfortunately, often serious and permanent injuries. Mentor’s ObTape Vagina Sling came on the market in 2003, and in less than 3 years was taken off the market. Mentor never stepped up and issued a recall; Mentor simply stopped marketing the Ob Tape in March, 2006, but it never actually recalled the product – Mentor just let it die a slow death.

In October, 2006, the Journal of Urology reported on a study which looked at 67 women who had been implanted with the Mentor ObTape Vaginal Sling. More than 13% developed vaginal extrusions. Others had chronic vaginal discharge, and one patient developed an abscess that led to complications. The most telling part of the study was that none of the control group of 56 women who used another type of vaginal sling experienced the complications seen with the Mentor ObTape Vaginal Sling.

This Mentor ObTape Vaginal Sling tried a new innovative design, which is commendable, but you cannot put a product on the market without adequate testing. Apparently, the ObTape Vaginal Sling pushed into and through the vaginal wall causing tearing, cutting, and sometimes permanent erosion of the vaginal tissues.

ObTape lawyers intend to argue that although Mentor won approval of ObTape from the FDA because it was "substantially equivalent" to slings already on the market, the ObTabe Sling is actually a very different product grounds ObTape was a new and unique product. But the Mentor ObTape Vaginal Sling was different because vaginal slings had historically been made with a mesh design, allowing the sling to breathe and get nutrients to the body’s tissue.

Mentor ObTape Vaginal Sling lawyers will argue to consolidate for discovery purposes the 22 filed Mentor ObTape Vaginal Sling lawsuits in an MDL (basically a class action for discovery purposes). Oral arguments will be held in late November in Charleston, South Carolina.

There are approximately 35,000 women used the Mentor ObTape Vaginal Sling between 2003 and 2006. This means that 7,000 women have potential OBTape Vaginal Sling lawsuits. Why only 22 ObTape lawsuits? Of course, many women have a hard time coming forward because this is such a private issue. There are 13 million women with this problem, yet many – between 50-70% in some studies – do not receive any treatment for urinary incontinence, most likely because of the privacy issues involved (and because they don’t realize how many others – including their friends and family - suffer from the same condition). But I also think many women do not realize that there are ObTape lawsuits pending around the country and there is a great possibility these women will receive the financial compensation they deserve for the Mentor ObTape Sling injuries.

Tech: ReQall - A "Memory" Tool

Playing around with ReQall now.

From their site:

"ReQall is the best memory tool you may ever have, connecting all the ways you communicate in one easy, seamless system. Best of all, reQall works with the technology you already use—nothing to buy, nothing to install."

Worth a look if you have time.

Thanks to Nicole Black, whose blog talked about ReQall here.

Duragesic: Justice in Chicago

My good friends at Heygood, Orr, Reyes, Pearson & Bartolomei received long due justice in a case involving a Duragesic pain patch for a client after a long trial in Chicago.

The story: Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy.

The mother of three died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever fentanyl, according to her family's lawyers.

The jury was told that fentanyl is a painkiller 100 times more powerful than morphine. The patches, prescribed for people combating chronic pain, are to be worn for 72 hours and then discarded. Janice DiCosolo was found wearing one when she died.

At least one lot of Duragesic patches in February 2004 was recalled, a day after DiCosolo died, because of improper sealing of the adhesive backing of the devices, defense lawyer David Sudzus wrote in a court filing. The patch worn by DiCosolo was from that lot, he said.

The jury forewoman, Peggy Rounsfull, 51, of Glenview, said, it was the fentanyl that appeared to have killed DiCosolo.

``There was no way of getting around the fact that she had too much fentanyl,'' Rounsfull said. (Link here)

The Johnson & Johnson units that make and sell the Duragesic pain-killing patch must now pay $16.6 million to the family of a Chicago-area woman.

Vehicle Tires: Time to Replace Them?

From my friend and fellow lawyer Rob Bunch, this article:


With all of the information contained on a tire’s sidewall, it’s no wonder the average consumer has difficulty deciphering it all. While most know how to tell a tire’s size and width, the manufacturer, and the maximum inflation pressure, the tire’s DOT serial numbering system may not be so easy to understand. A tire’s DOT number contains valuable information, especially when a tire was manufactured, but it was never meant to be very consumer friendly and was never meant to be decoded by the consumer. Having the means to tell when a tire was manufactured can mean the difference between safety and catastrophic results.

Some experts believe that tires have a shelf life and ignoring that could be fatal. Tires can sit on store shelves for years before they are sold; sometimes as long as five years; each can still be sold as new tires. There is no expiration date on tires, but research and tests show as tires get older, even if they haven’t even been driven a mile, the tires may begin to dry out, and the degradation process starts to take place.

After six years of age, tires can become unreliable or even dangerous. Tires may look great on the outside, but not much is known about what is going on inside the tire. After a time, tires begin to dry out and become less elastic even if they are not in use, making tread separation more likely even if they have plenty of tread depth and appear new. When a tire detreads at highway speeds, it becomes difficult if not impossible to retain control of a vehicle.

For decades, the tire industry has taught drivers to use the so-called “penny test” as a way to tell when a tire needed to be replaced. As late as last summer, they have recommended that the “penny test” is outdated, compromises safety, and should give way to the “quarter test.” Why not arm consumers with the knowledge of determining when their tires were manufactured by decoding the DOT serial number and then recommend that they replace them at a certain age, no matter what the tread depth? Or better yet, why not imprint an expiration date on the tires?


The U.S. tire industry has fought efforts to require an expiration date on tires. The industry says, given the improvements in tire production, age is not a key factor in a tire’s performance. However, the British Rubber Manufacturer’s Association issued a forceful warning to its British consumers stating “BRMA members strongly recommend that unused tires should not be put into service if they are over 6 years old . . .”. This is something that would come as news to most U.S. car owners, but seems to be known by everyone but the American consumer. In fact, the head of the U.S. Rubber Manufacturers Association has gone on record saying that there is no need for U.S. drivers to be given the same warning that British car owners have received.

U. S. car manufacturers have been warning their customers for years about the problems with aging tires. In fact, Ford Motor Company has asked the federal government to impose a 6 year age limit or expiration on tires.

So just how do you tell when your tires were manufactured? Begin by locating the DOT number on the sidewall of your tire. Up until last year, the DOT number was molded on the inside of tires, making it extremely difficult to locate. To read it, the consumer either had to put their vehicle on a lift or crawl under it with a flashlight to find it. Once you have located your DOT number, identify the 3 or 4 numbers at the very end of the serial number. If a tire has three numbers, it means that the tire was made prior to January 2000. If a tire has four numbers, it indicates that the tire was manufactured after January 1, 2000. The first two numbers in the date of manufacture indicate the week in which the tire was made.

I your tire has 036 as the last three digits of your DOT number, it indicates that the tire was manufactured in the third week of 1996. If your tire has 4604 as the last four digits of your DOT number, it indicates the tire was manufactured in the 46th week of 2004. Experts urge motorists to check their tires’ manufacturing date and replace them after six years of age.

Voluntary Recall of Potentially Oversized Tablets Expanded

From the medical news site www.medpagetoday.com:

ETHEX Corporation announced the voluntary recall of lots of five generic medications because they may contain more than the labeled amount of active ingredient, the FDA said.

The recall applies to 150-, 225-, and 300-mg propafenone HCl tablets, 30- and 60-mg isosorbide mononitrate extended-release tablets, 15-mg morphine sulfate extended-release tablets, 15- and 30-mg morphine sulfate immediate-release tablets, and 10-mg dextroamphetamine sulfate tablets.

Overdoses of all four of the drugs can have serious and life-threatening complications, according to an FDA press release announcing the recall.

These include arrhythmias and low blood pressure with propafenone HCl, fainting and low blood pressure with isosorbide mononitrate, respiratory depression and low blood pressure with morphine sulfate, and rapid heart rate and high blood pressure with dextroamphetamine sulfate, the agency said.

Earlier this year, the drug maker voluntarily withdrew three lots of 5-mg dextroamphetamine sulfate tablets and 60-mg morphine sulfate extended-release tablets. (See: Dextroamphetamine Sulfate Tablets Recalled)

The following lots are involved in the current recall and were shipped before May 22:

* 150-mg propafenone HCl tablets (73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011)
* 225-mg propafenone HCl tablets (71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011)
* 300-mg propafenone HCl tablets (72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011)
* 30-mg isosorbide mononitrate extended-release tablets (62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009)
* 60-mg isosorbide mononitrate extended-release tablets (63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009)
* 15-mg morphine sulfate extended-release tablets (81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010)
* 15-mg morphine sulfate immediate-release tablets (77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011)
* 30-mg morphine sulfate immediate-release tablets (75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011)
* 10-mg dextroamphetamine sulfate tablets (73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011)

Source here.

The Internet, Clients and My Law Office

This recent report caught my eye:

A report, released in August, says 40% of people 50 to 64 years old and 27% of adults 65 and older are getting information online every day, compared to about 55% of those 18 to 49. The study surveyed 2,251 adults 18 and older from April 8 to May 11 of this year. Source here.

Does your law office make an extra effort to gather your clients' emails? We have done so, aggressively, this year. The result? I am now seeing a decrease in postage and copy costs. I filed a lawsuit for a client, and when we received a "Notice of Removal" on the matter, simply emailed it to her. No need to copy and send 125 pages. We explained it in detail in an email PDF letter, asked her to call, and spoke at length. In that one case, we probably saved the client $20 just on one mailing. Now, multiply that over a typical caseload, and you have substantial (to me) savings to the client.

I've sent settlement papers, updates and other papers to client over the age of 65. All appreciate the ease of email. Informally, nearly 2/3rds of our clients over the age of 50 in our office now have and use email.

Are you doing all you can to gather your client's emails?

Relion Syringe Recall

From the FDA:

FDA is urging patients and health care professionals to check packaging carefully for syringes labeled as 100 units for use with U-100 insulin from lot number 813900.

The recall applies to the following product information:
-- ReliOn 1cc, 31-gauge, 100 units


The syringes were distributed by Can-Am Care and sold only at Wal-Mart stores and Sam's Clubs.

Recalled syringes should be returned to a local Wal-Mart or Sam's Club pharmacy for a replacement.

Consumers and health care professionals who suspect they have the recalled product are asked to call toll-free at (866) 780-5436 or go to www.relion.com/recall.

The Tyco Healthcare Group LP (Covidien) is recalling ReliOn brand syringes because they may lead to patients receiving an overdose of as much as 2.5 times the intended dose. An overdose of insulin can lead to hypoglycemia, serious health consequences, and even death.

My Law Partner's Verdict For The Little Guy: $2.298Million

One of my law partners just completed a retaliatory discharge case in Alabama involving Dollar General.

A retaliatory discharge claim against an employer is generally allowed where an employee has been fired for exercising a right under state law, or the discharge of the employee violate public policy.

The former employee was allegedly fired from Dollar General after she reported an injury. Joey James said: "My client proved that Dollar General has a company policy that fines its’ managers $7500 for every employee injury reported from their store. The money comes straight out of the manager’s yearly bonus check.”

The former Dollar General employee hurt her hand on the cash drawer. It then became infected and her arm had to be amputated. Dollar General denied her worker's compensation claim three days after her arm was amuptated.

The jury deliberated less than three hours before reaching the $2,298,000 verdict.

This to me is a clear victory for all working men and women.

Preemption Before U.S. Supreme Court

A good piece on the WSJ Law Blog regarding the Levine v. Wyeth case, which is front and center on the preemption issue.

Preemption simply stated is the position that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.


In part from the WSJ Blog:

"At the center of the case is the delivery technique for an antihistamine called Phenergan. Diana Levine, the plaintiff, sought treatment for nausea. Clinicians administered Phenergan using a delivery technique called “IV push,” as opposed to “IV drip.” As a result, Levine, a guitar player, developed gangrene in her arm, which eventually required its amputation. Both Wyeth and the FDA were aware that the “IV push” risked inadvertent arterial injection and gangrene, but the FDA nevertheless approved labeling for Phenergan that warned against – but did not prohibit – IV push administration. (For more background, go to Scotus blog.) Superior court in Vermont had instructed a jury that the label’s compliance with FDA regulations did not establish its adequacy when considering Wyeth’s negligance. The jury awarded Levine more than $6 million in damages. "

Go here for more.

From various sources, it looks like the justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, Justice David Souter said. “And it simply didn’t do it.” Source.


You can also read the transcript of the argument here.

Avandia Update: Consumer Group Seeks Ban of Drug

The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.

The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.

"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition. "Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.

Links: Here and here.

Fen Phen Verdict - Primary Pulmonary Hypertension

From Bloomberg.com:

A recent verdict regarding Wyeth's Pondimin drug resulted in a decision that the cause of Gloria Stribling's primary pulmonary hypertension was caused by Fen Phen. The trial loss was Wyeth's first in four years in a case involving the often-fatal illness.

Wyeth sought to resolve most fen-phen users' claims through a $3.75 billion national settlement program. The accord didn't cover people stricken with the fatal lung disease.

For more, go here.

1 Million Cribs Recalled

The recall announced by the U.S. Consumer Product Safety Commission involved older cribs that are no longer on the market but are often reused by families or sold at resale shops and online at sites such as Craigslist. The recall covered cribs sold in the U.S. from 1995 to 2007 by Delta Enterprise, the largest distributor of cribs in the world.


Delta is recalling all cribs with the “Crib Trigger Lock with Safety Peg” drop side hardware design. When the safety pegs are missing from the lower track, the crib locks can disengage and detach if lowered below the peg hole, creating a hazardous gap which can lead to entrapment and suffocation.

The model numbers for the recalled Delta cribs with the "Crib Trigger Lock with Safety Peg" drop side hardware are: 4320, 4340, 4500, 4520, 4530, 4532, 4540, 4542, 4550, 4551, 4580, 4600, 4620, 4624 (production dates 01/06 through 11/07), 4640, 4660, 4720, 4735, 4742, 4750 (production dates 01/95 through 12/00), 4760, 4770, 4780, 4790, 4820, 4840, 4850, 4860, 4880, 4890, 4892, 4900, 4910, 4920, 4925-2, 4925-6, 4930, 4940, 4943, 4944, 4947, 4948, 4949, 4950, 4958, 4963, 4968, 4969, and 4980.

The recalled cribs have date codes ranging from 1995 though December 2005; one model (4624) was made in 2007. The model numbers are located on the top of the mattress support board. The cribs, made in Taiwan and Indonesia, were sold at major retailers, including WalMart, Kmart, and Target.com from January 1995 through September 2007 for about $100 and may also have been sold secondhand.

Go to the Delta site for more.
http://www.cribrecallcenter.com/

Total Body Formula Litigation: MDL is in AL

In the Total Body Formula lawsuits, the MDL for all of the litigation, including the Total Body Class Action, will be Birmingham, Alabama. Judge Proctor drew the cases.

The Transfer Order may be found here. (PDF Alert)

Expect an initial hearing in Birmingham soon.

New Blog: Georgia Justice Blog

You may find it here. http://georgiajustice.blogspot.com/

What is it? It's the blog from the Georgia Trial Lawyers Assoc. The most recent post starts with a recap of this:

A Great Escape and a Great Man
The Georgia Trial Lawyers Association honors Judge Anthony A. Alaimo

Atlanta, GA—Hailed as what will be the largest gathering of judges and attorneys in the history of the state of Georgia, the Georgia Trial Lawyers Association [GTLA] is hosting The Height of Excellence—an event honoring excellence in Georgia’s judiciary and where Judge Anthony A. Alaimo, a Senior United States District Court Judge of the Southern District of Georgia, will be the first recipient of the inaugural Anthony A. Alaimo Award for Judicial Excellence.

“It is very appropriate that the first award given by the members of GTLA for judicial excellence carries the name of Judge Anthony A. Alaimo and that he will be the very first recipient,” said GTLA President Fred Orr. “Judge Alaimo, at age 88, remains one of the hardest working judges in the entire country. He is among the most beloved and respected judges of the federal judiciary. He is a true American Hero.” More on their site.

It's worth reading, and worth adding to a blogroll.

Pfizer Settles Bextra and Celebrex

From various sources:

Pfizer has announced that is has offered a total of $894 million to settle heart attacks, strokes, and other damages caused by its painkillers Bextra and Celebrex.

According to Pfizer, the settlement ends about 90 percent of the 7,000 personal injury lawsuits brought by those who were allegedly hurt by the painkillers.

The proposed settlement also would ends lawsuits filed by insurers and patients looking for reimbursement for the money they spent on Bextra and Celebrex, as well as claims by state attorneys general over Pfizer’s improper promotion of Bextra.

The AP link is here.

FDA Regulators Missing Deadlines

From Reuters:

Several U.S. deadlines for reviewing new drugs have come and gone without a decision from the FDA. Here is a partial list:

Prasugrel, a blood thinner from Eli Lilly and Daiichi Sankyo. A decision was due Sept. 26. The application remains pending.

Promacta, a drug for a clotting disorder. The deadline was Sept. 19. No decision has been made.

For more go here.

FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority

From the AAJ:

"In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ). The documents released today detail how helping corporations escape accountability for dangerous products has been the administration’s top priority.

“This is the real Bush legacy,” said AAJ President Les Weisbrod. “In effect the Bush administration made the safety of Americans secondary to corporate profits.”

The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to corporations instead.

AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. Beginning in 2005, carbon copy statements claiming that federal agency rules preempt state law began surfacing in the “preambles” of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.

“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” Weisbrod added. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.

Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.

Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”

In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.

AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.

Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.

“Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers,” said Weisbrod."

Vioxx Study: Heart Risks Last Nearly One Year

From various sites:

A long-term analysis of people who took the arthritis drug Vioxx confirms it doubles the risk of strokes and heart attacks. The risk seems to decline a year after people stop taking it. And other drugs in the same class of painkillers known as Cox-2 inhibitors may cause similar harm. Link here. The study may be found in the journal known as The Lancet. Vioxx articles are linked here.

Price Gouging Update: GA does nothing, FL getting results

Just after Hurricanes Gustav and Ike wreaked havoc, I posted on price gouging going on in Florida and Georgia.

It's been about a month. What has happened?

Florida:

A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general.

Kelly Junior #9, a gas station in Quincy, Fla., will also pay the American Red Cross $2,000 under terms of the agreement and pay the costs of the state's investigation into the price gouging.

The price of unleaded gasoline at Kelly Junior #9, individually owned by S and K of Quincy, Inc., increased twice on September 12, starting at $3.99 and ending at $4.29.

That's one of 4,000 being investigated.

Georgia:

Nearly 150 Georgia gas stations are having to defend why they charged inflated prices after Hurricanes Gustav and Ike made fuel scarce over the past month.

The state has subpoenaed sales records from businesses following complaints from 1,500 customers angry over what they were paying at the pump. State officials received reports of gas as high as $9.99 a gallon for regular unleaded, said Bill Cloud, spokesman for the Governor's Office of Consumer Affairs.

He said his office is still getting a few dozen calls a day about gas prices.

One station in Cobb County was charging $8.82 a gallon, and a Houston County gas station was asking customers to pay $7 per gallon, Cloud said.

Source here.

How many will ultimately be found to have gouged GA consumers? Does it really take a month to figure out that charging $9.99 is gouging?

Eli Lilly to pay $62 million in Zyprexa settlement

From Reuters:

Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.

The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.

Source here.

Total Body Formula Lawsuit: State Court Hearing 10/13/08

On Monday October 13, 2008 at 9:00 a.m. in Decatur, GA Judge A. Wong will hold the first hearing on cases involving folks who claim they were injured by a supplement known as Total Body Formula and Total Body Mega Formula.

I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.

Stay tuned.

Raptiva Brain Link?

From Bloomberg:

A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.

The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.

For more go here.

More Misleading Pharma Ads (FDA sez)

The FDA sent letters to Lilly, J&J, Novartis, Shire, and Covidien' Mallinckrodt with complaints about certain promotions.

Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said.

Go here for the source.

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"

From the FDA site:

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

More here.

Georgia Federal Court: Recent Daubert Ruling

You can see it by going to Slideshare.net. The nutshell version: Daubert should only apply to junk science.

Daubert Order GA Law

View SlideShare document or Upload your own. (tags: georgia law)

Zimmer Hip Cup Recall

Zimmer Holdings, the largest producer of orthopedic devices in the United States, recently halted sales of a hip replacement implant which has been failing in unacceptably high numbers. The Durom Cup hip socket implant, introduced by Zimmer in 2006, has been implanted in over 13,000 patients across the nation. Of those, doctors say that hundreds will most likely need to undergo more expensive and painful surgery to replace the replacement.

Over 5% of patients implanted with the Zimmer Durom Cup hip replacement experience serious problems, according to research conducted by the company and orthopedic surgeons. In these patients, the metal hip implant fails to bond properly with the existing bone structure. Instead, the metal socket loosens and separates, grinding painfully against bone as it moves.

Although Zimmer Holdings was alerted to problems with its Durom Cup hip replacement as early as 2007, it did not launch an investigation until April 2008, and did not cease its sales of the defective device until July 2008. Because of the company’s delay, even more unsuspecting patients were implanted with the faulty Durom Cup hip replacement. Each may need hip replacement surgery, which is a lengthy and expensive procedure, costing anywhere from $30,000 to $40,000.

The Zimmer Durom Cup Hip Implant – A Timeline

2006 – The Zimmer Durom Cup hip implant is introduced. A metal hip socket replacement originally designed for a 15- to 20-year lifespan to accommodate young, active patients, the Durom Cup implant begins to show signs of trouble not long after its debut.

2007 – Prominent orthopedic surgeon Dr. Lawrence Dorr, alerts Zimmer Holdings, the implant’s manufacturer, after noticing that the Zimmer hip replacement implant has an abnormally high failure rate. Dorr states that many of his patients return to his office complaining of extreme pain only months after undergoing hip replacement surgery. Despite Dorr’s extensive experience, Zimmer Holdings blames the implant failures on Dorr’s surgical technique and brushes the warning aside.

2008 – In April, Dr. Dorr goes public with his concerns, warning other orthopedic surgeons against using the Durom Cup hip implant. Zimmer responds by launching an investigation, but refuses to take any further action for months. In July 2008, after its own investigation reveals an implant failure rate of over 5%, Zimmer suspends sales of the device but promises to resume business after doctors are trained to ‘properly’ install the implant.

Ex-Medtronic Lawyer: Company took Docs to Strip Club

From the Minneapolis paper:

'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million.'

The suit, filed by former senior legal counsel Ami P. Kelley, claimed that the company lavished spine surgeons with a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.

Link.

OK, so why does this matter? Senator Grassley has been investigating such activities to determine if the perks offered by Medtronic to doctors induce them to use the company's spine products in "off-label" ways not approved by the Food and Drug Administration (FDA). The FDA has warned that surgeons' off-label use of a Medtronic bone graft called Infuse has led to potentially life-threatening side effects in dozens of patients.

The Infuse Bone Graft has been claimed to cause complications when used in surgeries on the cervical spine, or the area around the neck. The bone protein is approved for use in a variety of spinal, oral and dental graft procedures, but the paper reported that Infuse has been linked to complications when used in "off-label" procedures, or operations for which is has not specifically been approved.

Earlier this summer, the FDA warned doctors that it could cause dangerous complications when used in neck surgeries. The complications included swelling that caused difficulty in swallowing, breathing and speaking, which in some cases lead to tracheotomies and further surgeries. Source here.

Spirivia and Atrovent Slammed by JAMA

So says Medline Plus. You can access the JAMA abstract here.

The drugs Spirivia and Atrovent are prescribed for chronic obstructive pulmonary disease (COPD), and according to a recent report, each is associated with an increased risk of heart attack, stroke and other cardiovascular problems.

Spiriva and Atrovent are the most commonly prescribed once a day drug for treatment for COPD.

Chronic obstructive pulmonary disease (COPD) is a lung disease in which the lungs are damaged, making it hard to breathe. In COPD, the airways—the tubes that carry air in and out of your lungs—are partly obstructed, making it difficult to get air in and out.

Cigarette smoking is the most common cause of COPD. Most people with COPD are smokers or former smokers. Breathing in other kinds of lung irritants, like pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD.

The airways branch out like an upside-down tree, and at the end of each branch are many small, balloon-like air sacs called alveoli (al-VEE-uhl-EYE). In healthy people, each airway is clear and open. The air sacs are small and dainty, and both the airways and air sacs are elastic and springy. When you breathe in, each air sac fills up with air like a small balloon; when you breathe out, the balloon deflates and the air goes out. (See the How the Lungs Work section for details.) In COPD, the airways and air sacs lose their shape and become floppy. Less air gets in and less air goes out because:

* The airways and air sacs lose their elasticity (like an old rubber band).
* The walls between many of the air sacs are destroyed.
* The walls of the airways become thick and inflamed (swollen).
* Cells in the airways make more mucus (sputum) than usual, which tends to clog the airways.

Source.


There was a 58 percent increased risk of cardiac death, heart attack or stroke in people taking these drugs according to Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. Singh was lead author of a paper published in the Sept. 24 issue of the Journal of the American Medical Association.

Medline Plus link is here.