A Georgia Lawyer

Cold Remedies by Prescription?

2012-01-26T06:29:00.000-08:00

Maybe, at least if you live in West Virginia.

Several lawmakers in that state are arguing for legislation that makes pseudoephedrine products prescription-only in that state.

Pseudoephedrine is a key element in some popular medicines, but it's also the key ingredient in the street drug methamphetamine. Pseudoephedrine products already have been put behind the counter. An ID is required to buy them, and there is a limit on how much one person can buy in a month.
None of that has stopped the meth problem in that state (and others, like Georgia).

The article is worth a read, if only to see how the industry is seeking to block the legislation for a problem that is a national epidemic.

If it passes, look for other states to follow, and for lawmakers to get the full court press on killing similar bills.

http://www.dailymail.com/News/statehouse/201201230208

Study links statins to higher diabetes in older women

2012-01-25T13:28:00.001-08:00

An interesting read from the USA Today:

Study authors advise patients not to stop taking their medications without talking to a doctor, because statins' proven power to prevent heart attacks and strokes outweighs any potential increase in type 2 diabetes risk. But the results — a nearly 50% increase in diabetes among longtime statin users — should throw cold water on the idea of prescribing these drugs to healthy people, which some have recommended as a way to prevent disease, says co-author JoAnn Manson, a professor of medicine at Harvard Medical School. In recent years, statins' success in preventing heart attacks — even among people without high cholesterol — has led some doctors to joke about "putting them in the water supply."

In the study, 6.4% of women who didn't use statins developed diabetes during the eight to nine years of follow-up, Manson says. That rate rose to 9.9% among statin users.

Jones Seasoning Voluntarily Recalls Original and Spicy Southwest Blend Mock Salt Because of Possible Health Risk

2012-01-25T13:27:00.000-08:00

Image via Wikipedia

Just came in this afternoon:

University Place, Washington- Jones’ Seasoning Blends LLC announced a voluntary recall of Jones’ Mock Salt Original as well as Jones’ Mock Salt Spicy Southwest Blend due to the potential contamination of Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

No illnesses have been reported to date in connection with this voluntary recall.

This recall has been initiated due to possible Salmonella contamination of the celery seeds ingredient used in Jones Mock Salt. Jones Seasoning Blends LLC is not responsible for the contamination of Salmonella. The supplier of the celery seeds has been recalling the product and Jones Seasoning Blends LLC has also taken every action possible in notifying the public.

The following affected products were directly distributed to grocery stores and markets in California, Minnesota, and Washington and it was also sold through internet orders on www.jonesmocksalt.com:

Jones’ Mock Salt Original: Organic Salt Free Seasoning, 1.6 oz bottles (UPC 0 94922 16616 6), 12 oz bags (UPC 0 94922 07199 6) and 16 oz bags (0 94922 16616 6).

Jones’ Mock Salt Spicy Southwest Blend: Organic Salt Free Seasoning, 1.6 oz bottles (UPC 0 94922 01560 0).

There is no lot number identifying the bottles or bags.

Rexall recalls calcium supplements (1/25/2012)

2012-01-25T12:17:00.000-08:00

Rexall Inc. in Deerfield Beach recalled more than 13,500bottles of calcium soft-gel capsules because they mistakenly were filled with tablets of the wrong product.

A company spokesman said Tuesday the recall involves 60-capsule bottles of Rexall Calcium 1200 mg plus 1000IUVitamin D3, sold at Dollar General. The glucosamine tablets mistakenly put in the bottles are made from shellfish that can cause allergic reactions.

No illnesses have been reported, and the company said many of the bottles were removed before they were distributed to retail stores.

The affected bottles carry the UPC code 3 01220 45211 3, expiration date 8/15 and lot number 387651-04. Return for a refund. Information: 888-534-6370 or fda.gov/safety/recalls.

Levaquin Trial: J and J Didn't Hide Risks

2012-01-25T11:48:00.000-08:00

News from a trial involving Levaquin:

In a pending lawsuit, Plaintiff Clifford Straka claims he hurt his two Achilles tendons after taking the drug Levaquin for pneumonia. He sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

The lawsuit is the third federal case to go to trial in Minnesota alleging J&J and its unit, now known as Janssen Pharmaceuticals, downplayed the risks of the antibiotic to boost sales. J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year. The company also won the first state case in October.

Counsel for the defendant has argued that “the label from day one in 1996 was adequate,” James Irwin, J&J’s lawyer, said in closing arguments. “The information was out there and available to the doctors and everyone else.”

http://www.bloomberg.com/news/2012-01-24/j-j-unit-didn-t-hide-levaquin-health-risks-company-lawyer-says-at-trial.html

FDA Issues Warning About Lymphoma Drug Brentuximab

2012-01-24T11:49:00.001-08:00

TheFDA has issued a warning to healthcare professionals about the lymphoma drug brentuximab.

Two new cases of progressive multifocal leukoencephalopathy (PML), which is a rare but serious brain infection, have been reported. Because of the seriousness of PML, which can result in death, a new boxed warning highlighting this risk has been added to the drug label, according to the FDA.

In addition, a contraindication was added, warning against the use of brentuximab with the cancer drug bleomycin because of the increased risk for pulmonary toxicity.

Brentuximab was in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.

The signs and symptoms of PML can develop over the course of several weeks or months. They can include changes in mood or usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech, or walking; and decreased strength or weakness on one side of the body, the FDA says.

Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.

Brentuximab generated much excitement among experts when study results were presented at the American Society of Hematology annual meeting in 2010. Some of the responses seen in refractory lymphoma were described as "amazing." The new drug is the first to be approved by the FDA for Hodgkin's lymphoma in more than 30 years, the company said.

Source is here: http://www.medscape.com/viewarticle/756886

Georgia Yaz News 1/24/2012:

2012-01-24T09:11:00.000-08:00

A watchdog group is calling on the FDA reconsider a a joint committee's vote in support of the Yaz/Yasmine oral contraceptive because four members of the committee – including a Stanford University professor of obstetrics and gynecology – had ties to the maker of the birth control pill that were not disclosed to the public during the meeting.

Four of the members who cast crucial votes in support of the contraceptives had ties to Bayer HealthCare Pharmaceuticals Inc., the manufacturer of Yaz and Yasmin, according to public documents unearthed by the Project On Government Oversight and detailed in its Jan. 11 letter to the FDA.

That included Dr. Paula Hillard of Stanford’s School of Medicine. Hillard is listed on the medical school’s website as a paid consultant receiving $5,000 or more annually from a division of Bayer in 2010. Hillard was selected as a temporary voting member for the FDA committee in 2011.

Link: http://californiawatch.org/dailyreport/stanford-doctor-birth-control-vote-had-ties-pills-maker-14545

J and J settles Risperdal Texas case for $158 Million

2012-01-24T08:29:00.000-08:00

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Johnson & Johnson has agreed to pay $158 million to settle charges with the state of Texas over allegations that the global drug manufacturer overcharged through Medicaid and illegally promoted the anti-psychotic drug Risperdal to doctors and other providers for use in children and young patients.

The trial on those charges began Jan. 10 in Austin, Tex., which is where the settlement was announced.

The Texas court case was just one of dozens involving the J&J and its Janssen Pharmaceuticals subsidiary. J&J is in New Brunswick, N.J., and Janssen is in nearby Titusville. The Texas case was filed in 2004. J&J is reportedly also negotiating a settlement with federal government, but there are 63 individual cases pending in Philadelphia.

Whistle-blower Allen Jones was originally working for the Pennsylvania Inspector General's office when he uncovered Janssen's practices in Texas.

The evidence presented before Thursday showed that Janssen “subverted science and induced others to betray the people they were supposed to take care of,” Jones said, according to Bloomberg News. “To me that’s reprehensible.”

Janssen issued this statement:

"Janssen Pharmaceuticals, Inc. announced today it has reached a settlement with the State of Texas in ongoing litigation related to sales and marketing of the anti-psychotic prescription medication Risperdal (risperidone).

Northern snobbery fuels the Paula Deen fingerpointing

2012-01-24T08:18:00.000-08:00

I read the title to a recent web post and agree. The author wrote:

The Bronx cheer for Deen, a prototypical Southern mother with a lifetime's recipes of irredeemably deep-fried dishes, is less a reflection of the culinary elitism that runs through Bourdain's vice-ridden travelogues than the regionalist snobbery that fuels its appeal.

From food to faith, the mythic Dixie--soulful and abundant, passionate and insubmissive--has always clashed with the rigidly cosmopolitan north, which keeps an ever watchful eye on we, her unlearned, drawling wards.

Yet the northern perspective of the South amounts to little more than a crude distillation of the most specious of stereotypes, the uncouth yang to their cultured yin. Reserving unparalleled contempt for the region's myths and manners, fundamental to northern exceptionalism is the notion of southern inadequacy.

http://www.foxnews.com/opinion/2012/01/21/god-guns-and-grease-its-northern-snobbery-that-fuels-paula-deen-fingerpointing/#ixzz1kElmONWT

She will surely be ripped for many things, but for me the biggest let down is the piling on of needless put downs of the south along with the Deen hits.

FDA takes enforcement action against Pennsylvania dietary supplement maker

2012-01-23T19:40:00.000-08:00

The FDA took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S

Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

This is the first time FDA has taken legal action against a dietary supplement manufacturer of this
size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.
The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size.
This company's compliance date came into effect in 2010, and they did not meet the relevant
cGMP requirements after that date.

The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF
Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies.

The cGMP regulations require manufacturers to ensure quality in their dietary supplements by controlling all aspects of
their processes and procedures. MADE makes more than 400 dietary supplements, including vitamins and minerals,
under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively
from MADE and distributes them throughout the United States.

“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for
regulatory affairs. “Today’s injunction reinforces our commitment to ensuring that these supplements meet the
cGMP requirements the law establishes.”

The government's complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania,
alleges that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed
to report serious adverse events associated with their products. In one case an individual who consumed one of the
products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.

Dietary supplement pulled from AAFES subject of Calif. lawsuit

2012-01-23T19:33:00.001-08:00

Revelations that the weight-loss and bodybuilding supplement DMAA might be linked to two soldier deaths and serious health problems in others have resulted in litigaiton.

The suit was filed on behalf of California consumers following a report on the soldier deaths by Stars and Stripes and it claims Dallas-based USPlabs sold fitness supplements containing the amphetamine-like substance even though they are dangerous and ineffective.

Supplements containing DMAA are still widely available to the public, but last month the military pulled at least 18 of the popular fitness products from store shelves around the world, and the Army launched an ongoing safety review after mounting evidence of health problems and two deadly heart attacks among soldiers training at an unnamed Army base in the southwest.

The USPlabs marketing about the safety of its supplements Jack3d and OxyElite Pro is “false and misleading,” according to the complaint filed by Ferrell in California district court Dec. 19. As evidence, the lawsuit cites a Department of Defense statement published just days earlier in Stars and Stripes saying that DMAA might be linked to death, organ damage, seizures, loss of consciousness, heat injury and muscle breakdown among servicemembers.

New Guidance on Recalls of Polymyxin B, Vecuronium

2012-01-23T16:03:00.000-08:00

Image via Wikipedia

The FDA yesterday issued an updated guidance on voluntary product recalls involving Bedford Laboratories injection drugs that were initially made on August 2, 2011, after the discovery of glass particles in some vials.

The drugs and lot numbers include:

polymyxin B for injection USP, 500,000 units/vial: NDC 55390-139-10, lot 1942980 (expiration date August 2013) and lot 1895027 (expiration date June 2013);
vecuronium bromide for injection, 10 mg/vial: NDC 55390-037-10, lot 1865067 (expiration date May 2012);
vecuronium bromide for injection, 20 mg/vial: NDC 55390-039-10, lot 1865069 (expiration date February 2012).

Polymyxin B is an antibiotic indicated in the treatment of acute infections caused by strains of Pseudomonas aeruginosa. Vecuronium bromide is a muscle relaxant used as an adjunct to general anesthesia to assist with endotracheal intubation or to enable relaxation of skeletal muscles during surgery or mechanical ventilation.

The FDA notes that there have been no reports of adverse events for the lots being recalled; however, hospitals, emergency departments, clinics, physician offices, and other healthcare facilities and providers are warned not to use the affected product lots and to immediately quarantine any product for return to the manufacturer.

Potential adverse events related to the injection of particulate matter in the bloodstream include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death, according to the FDA.

FDA Recalls for January 2012

2012-01-23T15:56:00.001-08:00

Image via Wikipedia

The FDA has reported a recall of all Winn-Dixie LEASA Brand Living Alfalfa Sprouts sold in the 6 oz. package with a UPC code of 7546555912. According to the Federal Drug Administration (FDA), the product is potentially contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA has also expanded its voluntary recall of Vanilla Pre-Soaked Sponge Cake to include the Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored because of the possibility that small plastic fragments from the packaging were contaminating the product. Last week, the Rich Products Corporation expanded its January 5, 2012 recall of one fourth Sheet Vanilla Soaked Sponge Cake Artificially Flavored to include the 8 inch Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored (Product Code: 62938) because of the possibility that small plastic fragments from the packaging were contaminating the product.

Finally, the FDA has released a recall for two of USA Far Ocean Group Inc.'s products sold as cosmetic under the names Vagifresh Ball and Vagifresh Gel. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid).

Motrin May Have to Warn About Skin Loss

2012-01-23T15:05:00.000-08:00

Image via Wikipedia

Johnson & Johnson must face allegations that it did not properly warn consumers that Children's Motrin may cause permanent disabilities like blindness and massive skin loss, a federal judge ruled.

It has been known for decades that generic ibuprofen can cause Stevens-Johnson Syndrome (SJS) and its deadlier form known as Toxic Epidermal Necrolysis (TEN). These extremely rare life-threatening conditions can cause the top layer of skin to detach, resulting in massive skin loss. They especially affect mucous membranes such as the mouth, eyes and female genitalia.

Read more here: http://www.courthousenews.com/2012/01/18/43145.htm

FDA: Novartis recall may also affect painkillers

2012-01-11T17:36:00.000-08:00

Image via CrunchBase

But there are reports that the risks are low:

The FDA warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.

The issue stems from manufacturing problems at a Lincoln, Nebraska, facility which triggered a recall Sunday of 1,645 lots of Novartis' over-the-counter drugs, including Excedrin, Bufferin, NoDoz and Gas-X. The Swiss-based company has received hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. Consumers are advised to stop using the products and contact the company for a refund.

FDA officials warned Monday that some of Novartis' over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

source here: http://finance.yahoo.com/news/FDA-Novartis-recall-affect-apf-1013338683.html?x=0

Parents sue, claiming Zoloft cause birth defects

2012-01-08T06:04:00.000-08:00

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A group of parents who claim their children suffered severe birth defects because of Zoloft has filed a lawsuit against the drug's manufacturer.

Mary and David Saville, Terry and Todd Cochran, Anita Kinslow, Wendell Houchens, Erica Woodley and Antwynette Golliday joined a lawsuit filed Dec. 2 in St. Clair County Circuit Court against Pfizer Inc. Pfizer is the manufacturer of Zoloft, the antidepressant medication at the center of the suit.

According to the nine-count complaint, the female plaintiffs were all prescribed Zoloft during their pregnancies, despite the alleged risks posed to their unborn children. The mothers claim their babies were all born with major medical defects, including heart damage.

Read more here: http://www.madisonrecord.com/news/240766-parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft

Friday Tech: A Few Key Office Tools

2012-01-06T04:33:00.001-08:00

The flood of blog posts and law magazine articles updating attorneys on the latest gadgets and must have tech tool can be overwhelming to read. For me, just wading through them all, much less trying the items/tools out is daunting. Over the past several years, though, I have a set of time and battle tested tech that work for me, and just might for you. These are:

1.Speak-write: In the 1990's and early 2000's, my firm actually had transcription only employees. No more. I do see younger lawyers typing their own work. That works, sometimes. For us, Speak-write is an every day product. What is it? From their site:

SpeakWrite allows you to submit your dictation and other work to us for transcription using a variety of methods, without having to change the way you normally create your work. Simply record your dictation, submit your work into our system and in about 3 hours your completed document will be delivered to your email as an attachment in your preferred word processing software. Available 24 hours a day, SpeakWrite can handle as much of your work as you require with no advance notice or request, and with no special equipment.

Once your dictation is submitted to our secure system it is routed to our trained and qualified typists located throughout the U.S and Canada who type your work according to your specific requirements. Your completed document is then delivered to your email as a word processing attachment, all in about 3 hours.

Sign up is free, and if you don't use it there is no fee. You can dictate over the phone, upload digital voice recordings, or scratch out a letter and fax it. We couldn't be as effective as we are without it.

2. Court Reporting Companies with online deposition repositories: Our office took more than 150 depositions last year alone. One company we use is Freedom Court Reporting, and that company houses all depositions and exhibits online. We made the choice to only use court reporters who have online hosting. Why? The last thing I need is more paper at any other deposition. Access to a prior deposition online and without an additional charge for online storage that is secure is to me a no brainer.

We find the online option useful even for cases with few depositions. We actually make the strategic decision before a case's depositions start to go with a reporting service that will allow us to go this route. The next step is convincing opposing counsel to use the same reporter (which happens for us in some MDL litigation), or talking the reporting company to allow an upload from another reporter.

3.VPN/Logmein.com If you don't have remote access to your office computers, my question is, why the hell not? In our office, we have litigation that is ongoing from San Francisco to Philadelphia. We are in airports, hotels, and courthouses all over the place. Access to our servers is a fundamental part of our practice at all times.

We use a VPN and on our iPads use Log Me In Ignition. If yours is a smaller office, and you may from time to time work outside of it consider a tool like this (Or Go to my pc).

New tools come and go in my office. It may take some time for you to hone your list of tools down, but for us, these three are must haves. Each is battle tested, reliable, and key to the success of what we do.

Appellate Court: Pfizer Must Pay $45 Million in Prempro Cases

2012-01-05T10:00:00.000-08:00

News from Bloomberg:

Connie Barton and Donna Kendall, both won jury verdicts against Wyeth and Pharmacia & Upjohn over their menopause medication known as Prempro. This week, each had their verdicts affirmed.

Prempro contains a combination of conjugated estrogens and medroxyprogesterone. Conjugated estrogens are a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries that is necessary for many processes in the body.

Medroxyprogesterone is also a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

Prempro is used to treat the symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation, and to prevent thinning of the bones (osteoporosis).

“We are very disappointed with the court’s decisions in these cases and continue to believe there was no basis in fact or law for the jury verdicts,” Chris Loder, a spokesman for New York-based Pfizer, said in an e-mailed statement. Pfizer officials will ask the Pennsylvania Supreme Court to review the lower court’s findings, he said.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. At one point, Pfizer and its units faced more than 10,000 lawsuits over the medications.

http://www.bloomberg.com/news/2012-01-04/pfizer-must-pay-45-million-in-prempro-cases-pennsylvania-court-rules.html

Tech Round up, January 2012

2012-01-04T11:32:00.000-08:00

Image via CrunchBase

Our office is kicking the tires on new tools for help in our blogging and twitter feeds. Here's a quick hit list:

Buffer: The site schedules tweets. As the site notes, "keep that Buffer topped up and you will then be tweeting consistently all day round, all week long." The site finds times of day, you set them, and add a quick post link on a toolbar (we use Chrome). You're set after that - and its free.

http://bufferapp.com

Twylah: This new service to me has great promise. The site creates Twitter brand pages for you.Tweets are being dynamically categorized based on what you tweet most.

Read more about the service here:
http://windmillnetworking.com/2011/09/09/twitter-seo-think-twylah/

Echofon: Echofon is a family of Twitter apps. Previously Echofon for iPhone was called “TwitterFon” and Echofon for Firefox was called “TwitterFox”. It's what we use to access Twitter on our phones.

Zemanta: Zemanta is a tool that looks over your shoulder while you blog and gives you tips and advice, suggests related content and pictures and makes sure your posts get promoted. Our favorite app by far for blogging.

http://www.zemanta.com/

Pingler: It's a pinging site, as you may not have known from the title. Our ping site of choice.

We're playing with a few others, but to keep a business advantage, will keep those to ourselves.

2012: A Georgia Lawyer Blog Turns 7

2012-01-04T11:04:00.000-08:00

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Sort of. The A Georgia Lawyer Blog turns 7 at month's end. Nearly 1700 posts later, we've been blogging on average about 5 times a week, each year from 2005 until the end of 2011.

Hopefully you've not grown tired of our twist on pharma litigation, tech, and things southern - dogs, college football, Mardi Gras, and the heat.

For 2012 stay tuned. We'll spend a little more time on tech for the office and outside of it. More story telling, more basic news without an agenda (and some news with it). More information on trials. More news about dogs, sweet tea, the crazies in New Orleans, goings on in the SEC and beyond, MDL reports, jury trials, and more.

Lawyers: Jumping in to Twitter in 2012? A Do/Don't Do List

2011-12-26T14:01:00.000-08:00

Image by Getty Images via @daylife

Having just completed year three on Twitter, I've been spending some time looking at how so called experts tout the site to lawyers. I was considering attending a seminar in January that has at least two hours devoted to all things social media. The CLE brochure lost me, however, when it breathlessly explained to me that one hour would be devoted to "getting new clients through social media like Twitter."

Having read that type of pitch for probably the 500th time, and seeing no real explanation for lawyers new to Twitter, here's my Do/Don't List. Think of it as Twitter 101. You can't become a millionaire via social media quickly any more than you can graduate from law school and litigate a multi-million dollar case in US District Court. Before you count your money, learn the basics.

1.Do select a name that will identify you and/or your firm. I've seen many Twitter accounts with names like "AZ Personal Injury" or "Accident Lawyers." This isn't the yellow pages. Whether it's your first and last name, or your firm name, or (like me) a geographic ID that ties in with your business, website, or blog, focus on how others will find/see you.

2. Do explain your practice or firm in the profile: Obviously, with an account like @ageorgialawyer, you know where my practice is based. The profile is equally important. Mine says:

Injury/Pharma Lawyer in Atlanta/Savannah, licensed in FL &GA, Litigator. Runner, College Football Fan , Labs owner.

Atlanta, Savannah, FL · http://www.ageorgialawyer.blogspot.com

It helps to list your city or a telephone number. Website or blog? I know that I will click on that link at some point. Describe what you do, but don't go overboard, remember this is a profile. If you work in the personal injury field, why clutter your profile with "Personal Injury, Wrongful Death, Divorce and Bankruptcy"

when you can keep it simple?

3.Don't be too pithy, vague, or hip in your profile: To me there is nothing more irritating to stumble upon a twitter account, only to read this: "Biglaw maven." Or better, "lawyer/rock star in the land of commercial litigation." Yes, nothing says rock star like a photo of a balding, over 40, horn rimmed glasses head shot of a guy in a grey suit.

4.Do select an avatar or image that might possibly make you stand out: I think that head shots work just fine. I also appreciate a firm logo, or a pic of a lawyer's office. Do us all a favor though. No more courthouse. I actually was working up a list, and in one lawyer's list of followers, there were 3 twitter accounts in a row with a courthouse. Also, skip the scales of justice.

For me I have been using a pic of my three labradors since starting my blog nearly seven years ago. It's a conversation starter, and if you came to my office you'd likely see one of those animals here. Plus, I have a face for radio.

5.Don't EVER make your account private: One of the biggest mistakes I see for new lawyers is locking or making your account private. Stupid. Got it? Dumb. Just really stupid, and it makes you look uninformed to the ways of Twitter. Twitter's purpose is to start conversations, pass along information (among other things). In other words, you miss out on what makes the site valuable.

6. Don't use a validation service for potential followers. Placing barriers in the way of communication is essentially the same thing as locking your Tweets. What is the point of joining a network if you don’t want to communicate? Take the time to filter out followers on your own. If @GuyKawasaki and @MariaShriver don't use a validation service, why should you? Could you imagine going to a lawyer social and demanding to see a business card before you shook a person's hand?

7. Do realize that whatever you want your Twitter account to be, your goal(s) will change after about 3-4 months: I know what some lawyers are thinking even now as 2012 nears - "I'll go on Twitter and get lots of cases!" or ... "Twitter will make my blog hum with visitors!" Sure. Well, not really.

I started off thinking that way, changed my mind about six months in, and now appreciate Twitter for what it is - essentially a news service ticker with some funny comments, wry insight, and spam mixed in. It's a bit like news talk radio - you get information, it might make you mad, or you can ignore it at your leisure.

For me Twitter does help update others with blog posts. If that is all it does, you are ahead of the game, business wise.

8. Do know that it's okay to be human on Twitter: While I may not be crazy about reading a tweet about what you are making for dinner, or worse - clicking on a pic of it - you don't have to be a 140 character version of a billboard.

To me, I like to see that @btannebaum is not only a lawyer, but a "Type II Diabetic." Or that Gwynne Monahan (@econwriter5) not only writes cogent posts, but is also unafraid to complain about having to run errands for family - a twitter post she had during the holidays. I know that @lizstrauss not only links to useful news/tips, but that her pix of the lakefront in her hometown are worth a look nearly every day.

I am a voracious consumer of legal news, but I also connect on Twitter with runners, with beach people, with folks who like music, and with smartasses (you know who you are). I post about my trail runs and SEC football. It's ok if you post about your 3rd grader'sschool honor. It gives me some measure of comfort that Twitter is not a bot site.

9.Don't spam with me with repeated crap about your firm: By this I mean - be careful about how often you post on Twitter, in a row, rapid fire style. I've stopped following someone who will post 15-40 times in a row within 5 minutes. This is not what Twitter is best at - spamming those who follow you.

Use your judgment, post when reasonable, and back off if you start hammering away.

10. Don't tweet something to another person on the site, then get in a huff when someone (like me) comments. Just before you hit the "tweet" button remember that others may see it, especially if you use a hashtag like #Obama.

In one instance, I found someone ripping in to a judge, and there was a # hashtag in the tweet. When I replied to the author's diatribe, I received back a curt "butt out, that wasn't for you to read." Well, I did, and I replied.

Remember that whatever you post is the equivalent of it being said in a crowded grocery store line for all to hear. So, toughen up when you get blindsided out of nowhere. If someone does not like what you wrote, it comes with the territory. Respond, ignore, or even block.

That's the start of my list - if you want to add to it, send it to me on Twitter.

Happy Holidays 2011

2011-12-23T14:03:00.001-08:00

Merry Christmas, and see you after the holidays, from the folks at our office.

Bad News for Qnexa

2011-12-22T07:25:00.000-08:00

Vivus, which makes an experimental weight-loss pill, received bad news this week after an ingredient in the medicine was claimed to be associated with oral clefts in babies whose mothers took it in pregnancy. Vivus’s diet pill, Qnexa, combines topiramate with the appetite suppressant phentermine.

Earlier in 2011, the FDA asked Vivus earlier this year to use existing databases to determine the risk of oral cleft in children whose mothers took topiramate. The drug is used to prevent migraines and seizures, and is marketed as Topamax.

The analysis, dubbed Fortress, found the risk of cleft palates or cleft lips was 5.44 times higher for the group in which mothers had taken topiramate alone or in combination with other anti-seizure drugs in the first trimester of pregnancy, Vivus said yesterday in a statement.

From the Vivus briefing documents submitted to the FDA:

QNEXA, or VI-0521, is an investigational weight-loss therapy that is a novel combination of low-dose immediate-release phentermine (1/8 to 1/2 of marketed dose) and controlled-release topiramate (1/16 to 1/4 of marketed dose); both drugs are approved and marketed in the United States. The prescription use of these drugs spans more than 50 years for phentermine and more than 13 years for topiramate. Phentermine hydrochloride, at a labeled dose up to 37.5 mg/day (Adipex-P package insert 2005; Appendix 1), is the most prescribed weight-loss drug with approximately 6.1 million prescriptions written in 2009 (Information Management System [IMS] data). The phentermine label, restricted to short-term management of obesity, limits its clinicalpplication for the chronic treatment of obesity and weight-related co-morbidities. The primary mechanism of action of phentermine for weight loss is an anorectic effect occurring through the release of norepinephrine in the hypothalamus.

Topiramate is approved for treatment of seizure disorders at recommended doses up to 400 mg/day and for migraine headache prophylaxis at recommended doses up to 100 mg/day (Topamax package insert 2009; Appendix 1). More than 9 million prescriptions were written in 2009 for topiramate (IMS data). Available pharmacological evidence suggests that topiramateinduced weight loss may result from increased satiety due to decreased gastrointestinal motility (Topiramate Summary Basis for Approval 1995), increased taste aversion (Supuran 2008), increased energy expenditure, and decreased caloric intake (Bray 2003; Richard 2000; Richard 2002; Picard 2000). Moreover, published clinical studies have shown that topiramate monotherapy produces significant and dose-related weight loss in conjunction with clinically meaningful improvements in lipids, glycemic control, and blood pressure (Ben-Menachem 2003; Wilding 2004; Bray 2003). While the positive effects of topiramate on co-morbidities are primarily driven by weight loss, data from nonclinical and clinical studies provide evidence for additional positive effects of topiramate on glycemic parameters, blood pressure, and lipids (Stenlöf 2007; Astrup 2004) that are independent of weight reduction. Topiramate, however, is not approved for weight loss and is also associated with dose-limiting side effects, which prevent or limit its use as a single agent at the doses necessary to produce significant weight loss or cardiometabolic benefits.

Source here: http://www.bloomberg.com/news/2011-12-21/vivus-drops-as-diet-drug-ingredient-affiliated-with-defects.html

and here: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm218821.pdf

From 2008: The First Christmas without Pudge (my oldest lab)

2011-12-21T15:25:00.000-08:00

The post I've copied is probably the one most personal to me on this site. While our house now has one helluva playful lab named Bruno (he puts the NO! in Bruno), I always think back to the first real confidant I had - a dog named Pudge who died at 14. Here's my holiday post - and somewhere I hope Pudge is chasing cats on a cloud ...

******* (2008)

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 from me.

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. My office typed exactly what I said, and his name was in many a draft of a document.

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 started, then became shorter, the car rides less frequent. I had to pick him up and put him into my truck his arthritis was so bad. His tail? Wagging like crazy. 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 barked madly at strangers, and guard my kids when each was little. 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.

****
PS: Santa did bring us another dog, Bruno. He's a rescue. When we took him for a walk with our remaining brood, he fit right in.

Even now, he is eerily like Pudge. He sits next to me when I work, his rump to my knee. I know we have extended his life by rescuing him, and he seems to appreciate that just fine.

If you are thinking about a dog, go the rescue route, at least to look. It will be worth it ,



Merry Christmas to all

M

Holiday Time 2011

2011-12-21T15:20:00.000-08:00

Some oldies but goodies in these few posts:

Snow in NOLA, 2008

December 2011, Conserve Hip Systems and possible failure?

2011-12-21T12:39:00.000-08:00

In 2009, the FDA approved the Conserve Hip Systems, made and sold by Wright Medical Technology, Inc.

Since 2009, there have been more than two hundred adverse reports where people claimed that the Conserve Hip Implant failed to do what it was promised to.

At year end, there is now a pending Petition for an MDL regarding those cases. The issues relate to the Conserve Plus Total Hip Replacement System and the Conserve Plus Resurfacing System. The total replacement system has four parts-- a metal femoral stem, metal femoral head, metal modular neck and the metal Conserve cup. The resurfacing system has two components: the metal femoral head cap and the Conserve Plus metal acetabular cup. Both systems are intended to be used as a hip-replacement implant when a patient’s hip joints are damaged or diseased as a result of fractures, osteoarthritis, rheumatoid arthritis and avascular necrosis.

The common component in both systems—and what is at the heart of the lawsuits—is the “Conserve cup”, which is a cast cobalt chromium molybdenum piece that holds the metal femoral head, mimicking the natural movement of a hip joint. It is that unlined cobalt part that is allegedly causing serious harmful effects to patients who receive the implant device. The problem is that these two metal components cause the release of metal particles around the hip joint and surrounding tissue. As a result, a high percentage of patients have developed metallosis and biologic toxicity and are experiencing a high and early failure rate of the device.

Our office is investigating people who think this product failed after implant.

From the FDA site:

CONSERVE® Plus Total Resurfacing Hip System - P030042

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: CONSERVE® Plus Total Resurfacing Hip System
PMA Applicant: Wright Medical Technology
Address: 5677 Airline Road, Arlington, Tennessee 38002
Approval Date: November 3, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030042a.pdf

What is it? The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because only the surface of the ball (femoral head) is removed to implant the femoral head resurfacing component.

How does it work? The CONSERVE® Plus Total Resurfacing Hip System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).

The cup replaces the damaged surface of your hip socket (acetabulum).
The cap covers the ball-shaped bone at the top of your thigh (femoral head), and the cap has a small stem that is inserted into the top of your thighbone.

The cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.

When is it used? The CONSERVE® Plus Total Resurfacing Hip System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Degenerative joint diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.

The CONSERVE® Plus Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

What will it accomplish? The CONSERVE® Plus Total Resurfacing Hip System is intended to relieve pain and improve hip function.

FDA to investigate death of patient who was prescribed Gilenya?

2011-12-21T09:29:00.000-08:00

Image via Wikipedia

News today that follows the report earlier this month on Gilenya:

The FDA has received a report of a patient with MS who died within 24 hours of taking the first dose of Gilenya.

FDA has said it cannot conclude whether the drug resulted in the patient's death, but was evaluating the case.

The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.

The drug's maker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug.

Source: http://news.yahoo.com/novartis-ends-study-drug-high-risk-patients-072623672.html

Our 12/13/2011 post is here: http://ageorgialawyer.blogspot.com/2011/12/death-involving-patient-taking-gilenya.html

December 2011 News: Multaq gets a Black Box Warning

2011-12-20T08:16:00.000-08:00

The FDA has told that Sanofi must add a black box warning to Multaq, taking this action after a company study linked the tablet to higher rates of heart attack, stroke and death in a subset of patients.

The boxed warning will possibly address the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the Food and Drug Administration.

The label, written by the FDA in cooperation with drugmaker Sanofi, instructs physicians to check patients' heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued.

The FDA said Monday that Multaq remains a beneficial drug when used appropriately.

Source: http://finance.yahoo.com/news/FDA-adds-new-heart-warning-apf-3993337584.html?x=0

Another Setback for Avastin to Treat Breast Cancer? Treatment

2011-12-14T06:01:00.000-08:00

Another trial of Avastin as a treatment for metastatic breast cancer has failed to meet the mark. The drug lost its approval recently last month as a treatment for breast cancer.

The latest trial - had it met with success may have helped obtain new approval for use, is because the study tested Avastin as a treatment for the roughly 20 percent of breast cancers that have elevated levels of the Her2 protein. The old and now revoked approval was for the other 80 percent of tumors that are Her2-negative.

Read the rest of the story at the source: http://prescriptions.blogs.nytimes.com/2011/12/08/new-setback-for-avastin-as-breast-cancer-treatment/

Death Involving Patient Taking Gilenya Makes News

2011-12-13T06:06:00.000-08:00

Novartis AG has reported that a multiple sclerosis patient died in November after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Multiple sclerosis (abbreviated MS, known as disseminated sclerosis or encephalomyelitis disseminata) is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms.

MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other effectively. In MS, the body's own immune system attacks and damages the myelin.

Whether Gilenya had any effect in this death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker wrote. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It is among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan.

Read more at the source of this post. MS is a devastating disease that affects the loved ones of the person diagnosed with the condition, and it has a profound impact on many lives. Let's hope this is an abnormal and rare result, because the promise of any drug for MS sufferers gives them some hope.

http://www.businessweek.com/news/2011-12-13/novartis-confirms-patient-died-after-starting-gilenya-drug.html

Federal Judge Grants Permanent Injunction Against Brooklyn Sleep Products

2011-12-12T08:13:00.000-08:00

This news from the CPSC:

A federal judge granted a default judgment a and permanent injunction ordering Brooklyn Sleep Products Inc., of Brooklyn, N.Y., and its president Francisco Chavez, to stop manufacturing, importing, renovating and selling mattresses until they provide evidence that their mattresses comply with federal flammability laws.

Additionally, United States District Judge Roslynn R. Mauskopf of the Eastern District of New York ordered Brooklyn Sleep Products and Chavez to recall all mattresses, mattress sets or mattress pads sold to consumers that failed federal flammability tests. If the firm fails to comply with the judge's order, it can face fines of $1,000 per day.

In 2008, CPSC conducted inspections and collected mattress samples at Brooklyn Sleep Products' facility in Brooklyn, N.Y., and at retail stores selling the firm's mattresses in Fall River, Mass., and Providence, R.I. CPSC collected a non-compliant mattress made by Brooklyn Sleep products at a Newark N.J. store in 2010. The mattresses failed flammability tests conducted by CPSC for open flames.

Find the Judge's Order here: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12039.pdf

HCG Product Warnings in the News

2011-12-12T08:03:00.001-08:00

The U.S. Food and Drug Administration and Federal Trade Commission issued seven warning letters to companies marketing over-the-counter HCG products that are labeled "homeopathic" for weight loss.

Human chorionic gonadotropin, also known as HCG, is a hormone produced by the human placenta and found in the urine of pregnant women, the FDA said. HCG is FDA-approved for the treatment of some cases of female infertility and other medical conditions, but there is no FDA-approved HCG drug product for weight loss and there is no evidence that HCG helps in weight loss.

Homeopathy is a medical philosophy that believes the body can heal itself.

The letters warn the companies that they are violating federal law by selling drugs that haven't been approved and by making unsupported claims for the substances.

"Deceptive advertising about weight loss products is one of the most prevalent types of fraud," said David Vladeck, director of the FTC's Bureau of Consumer Protection. "Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence."

The "homeopathic" HCG products recommend taking the drug while on a very low calorie diet, which could in fact result in increased risk for side effects, including gallstone formation, electrolyte imbalance, and heart arrhythmias, the FDA said.

Source: http://www.marketwatch.com/story/feds-issue-7-warnings-to-firms-for-hcg-products-2011-12-06

Lawyer Marketing: I'm being spammed by Scumbag Lawyers

2011-12-12T07:59:00.000-08:00

What you see above is an excerpt of a little experiment I conducted. It seems that somehow, some way, attorneys have decided that spamming millions of email boxes is the new way to generate cases or case 'leads.'

In one of my personal email boxes I received out of the blue a solicitation - from a law firm - telling me that if I had been injured by Avandia, now is the time to make a claim. So I set up another email account, and used that address to fill in the blanks. Hidden way down at the bottom of the spam link was language in small font indicating that unless I checked the box, I would agree to accept other 'similar' emails in the future.

I checked the box to opt out, but purposely made errors in the questionnaire. When corrected the checkbox was now blank, in essence having me agree to opt in to future emails.

Well, I hit send. Guess what? A pro forma 'rejection' or no representation came my way. Is that that end of it? Of course not ... what you see in the screen shot is what the inbox for that other email account looks like. I've been asked if I have any claim relating to these drugs/products: 1)Zoloft 2)Mesh patch 3)Asbestos 4)Prozac; 5)Actos 6)Avastin; 7)Paxil; 8)Tylenol 9)SSRI meds.

By my count there are more than 200 emails soliciting me for information or a potential case. Why? Where are the Bar Associations regarding email spam by lawyers in far flung states seeking cases? How can this be allowed to happen?

These scum - and that is the only way to describe them - know little about the litigation involved included in the spam emails. In fact, I have been cold called to see if I was interested in 'qualified leads' that come from this type of spam. Non lawyers are selling the data. I'm not interested in this type of sale, but I am interested in finding a way to turn in those who are practicing in this way.

Get ready law spammers. I'm sending these along to the Bar Associations in your state. Will it do any good? Stay tuned.

Prempro Jury Verdict Settled

2011-12-12T05:16:00.000-08:00

Pfizer has agreed d to settle claims that its menopause drugs caused cancer in three women who won a $72.6 million jury award earlier this week, a lawyer said.

The New York-based company agreed to resolve claims by Susan Elfont, Bernadette Kalenkoski and Judy Mulderig that hormone-replacement drugs made by two Pfizer units caused their breast cancer, Ted Meadows, a lawyer for the women, said in an interview today. A Philadelphia jury awarded the three women $72.6 million in compensatory damages on Dec. 6.

“They’re just glad to be able to go on with their lives,” said Meadows, who declined to disclose the amounts of the settlements because they are confidential.

The accord comes a day before jurors were to begin hearing testimony in a second phase of the case. The panel would have been asked to decide whether Pfizer should face punitive damages over its handling of the menopause drugs.

Source: http://pharmagossip.blogspot.com/2011/12/pfizer-settles-prempro-case-that-led-to.html

“The parties have entered into a mutual agreement to resolve this case under confidential terms,” Chris Loder, a Pfizer spokesman, said in a telephone interview. The earlier verdict will be set aside as part of the settlement, he said.

Concern that diabetes drugs like Byetta and Januvia are linked to Pancreatitis?

2011-12-12T05:11:00.000-08:00

Image via WikipediaThere may be dialogue concerning these meds, given a report/study published in a gastroenterology journal. The journal article is titled: Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies.

The study noted that Glucagon-like peptide-1−based therapy is gaining widespread use for type 2 diabetes, although there are concerns about risks for pancreatitis and pancreatic and thyroid cancers. There are also concerns that dipeptidyl peptidase-4 inhibitors could cause cancer, given their effects on immune function.

The article's conclusion: That case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1−based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.

Read the full article here: http://www.gastrojournal.org/article/S0016-5085(11)00172-7/fulltext

Multaq Report on Risk to AF Patients

2011-12-11T19:01:00.000-08:00

Image via Wikipedia

Final results from the PALLAS study showed that risk of stroke, heart attack or death from cardiovascular causes was 2.2 times greater for patients taking Multaq (dronedarone) than for those on placebo.

The illustration to the right shows atrial fibrillation. A-fib) is the most common cardiac arrhythmia (abnormal heart rhythm). It is a common cause of irregular heart beat, identified clinically by taking a pulse. Chaotic electrical activity in the two upper chambers (atria) of the heart result in the muscle fibrillating (i.e., quivering), instead of achieving coordinated contraction. The presence of AF can be confirmed with an electrocardiogram (ECG or EKG) by the absence of P waves and an irregular ventricular rate. Presence of AF in a population increases with age, with 8% of people over 80 having AF

Multaq is licensed to treat adults who have had atrial fibrillation (AF) in the past, or who currently have intermittent AF, but PALLAS was evaluating it in patients who were 65 years old or more with permanent AF and other risk factors for vascular events.

The trial was halted in July after researchers found evidence of serious vascular events and deaths - less than a third of the planned 10,800 patients eventually took part.

Delegates at the American Heart Association’s Scientific Sessions 2011 were told that 43 people taking Multaq, and 19 in the placebo arm, suffered a stroke, heart attack, systemic blood clot or cardiovascular death.

http://www.inpharm.com/news/169951/multaq-raises-risk-death-permanent-af-patients

Yaz News for December 2011

2011-12-11T18:58:00.000-08:00

The FDA's report of its study of women using contraceptives:

Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints

We conclude that the study results add to the small body of literature which shows that the NGMN transdermal patch is associated with higher risk of VTEs relative to standard CHC pills and provides another positive finding to the increasing body of evidence linking DRSP to increased risk of VTE relative to standard low-dose
CHC pills. DRSP was associated with higher risk of ATE in new users overall with this finding restricted to women in the 35-55 years age group only. The finding of increased risk of VTE with the ETON vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.

Source: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf

Does Lantus Double Cancer Risk? Diabetics Study Released

2011-12-08T07:51:00.000-08:00

Lantus more than doubled the risk of developing cancer among people with diabetes, researchers are now claiming.

LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk, according to the study presented yesterday at the San Antonio Breast Cancer Symposium. Researchers examined medical records of 23,266 patients in southern Sweden.

The drug's maker noted flaws in the study. The population was too small and had flaws that make it impossible to definitively address any potential risk from Lantus, according to Riccardo Perfetti, vice president for medical affairs at Sanofis.

The drug's label is found at various sites, including this one: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=39109

Read more at the source: http://www.bloomberg.com/news/2011-12-06/sanofi-s-lantus-doubled-risk-of-cancer-in-study-of-diabetics-study-finds.html?cmpid=yhoo

11th Circuit Decision Regarding Removal - Remand's Standard is "Lax"

2011-12-08T07:36:00.000-08:00

Just came out this week, a decent decision that discusses the elements regarding remand.

The opinion actually discusses two cases. In the first, the insured sued Allstate and his agent in State Court. Allstate contended that the agent had been fraudulently joined and the district court agreed. The district court then granted summary judgment to Allstate in that case. The 11th Circuit reversed the district court's decision not to remand the case with good language about the applicable standard.

The Court first explained the doctrine of fraudulent joinder.To establish fraudulent joinder, “the removing party has the burden of proving [by clear and convincing evidence] that either: (1) there is no possibility

the plaintiff can establish a cause of action against the resident defendant; or (2) the plaintiff has fraudulently pled jurisdictional facts to bring the resident defendant into state court.” Crowe v. Coleman, 113 F.3d 1536, 1538 (11th Cir. 1997). This burden is a “heavy one.” Id. (internal quotation marks omitted).

The Court went on to note that the standard to determine the issue of fraudulent joinder " is a lax one." “To determine whether the case should be remanded, the district court must evaluate the factual allegations in the light most favorable to the plaintiff and must resolve any uncertainties about state substantive law in favor of the plaintiff.” Crowe, 113 F.3d at 1538.

In fact, the Court wrote that the case need not even be a winnable one:"The plaintiff need not have a winning case against the allegedly fraudulent defendant; he need only have a possibility of stating a valid cause of action in order for the joinder to be legitimate."

The opinion helps explain the difference between the possibility and the plausibility standard, which as many who practice in the USDCT know is a much more difficult standard

Take a moment to read the opinion, here: http://www.ca11.uscourts.gov/opinions/ops/201110422.pdf

U.S. Marshals seize products containing banned ephedrine for dietary supplements

2011-12-07T15:08:00.000-08:00

U.S. Marshals today seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements.
The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market.
Judge Gary A. Feess of the Central District of California issued a warrant for the seizure of more than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing the ephedrine alkaloids.
"Working in close coordination with our federal colleagues in U.S. Customs and Border Protection, Immigration and Customs Enforcement and the Drug Enforcement Administration, the FDA helped identify and remove these potentially dangerous products from the marketplace,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “We will continue to take enforcement action that prevents potentially harmful products from reaching consumers and endangering their health.”

Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Prior to 2004, dietary supplements containing ephedrine alkaloids had been extensively promoted for aiding weight control and boosting sports performance and energy. But available data showed little evidence of the compound’s effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raised blood pressure and otherwise stressed the circulatory system.

These effects were linked to significant adverse health outcomes, including heart attack, stroke and death.
FDA’s chemical analysis confirmed the presence of these alkaloids in the shipment, but the shipping drums carried no labels indicating that the material contained the banned ephedrine alkaloids.

CPSC November 2011 Recall List (From FDARecalls.wordpress.com)

2011-12-07T06:57:00.000-08:00

Here is last month’s list of CPSC recalls from this past month, courtesy of http://fdarecalls.wordpress.com/2011/12/06/cpsc-november-recall-list/

-Serious Head Injuries to Infants Continue Due to Falls from Bumbo Baby Seats Used on Elevated Surfaces;
Injuries occurring despite previous recall warning; parents urged to use caution
Due to the serious risk of injury to babies, CPSC and Bumbo International Trust of South Africa (“Bumbo International”) are urging parents and caregivers to never place Bumbo Baby Seats on tables, countertops, chairs or other raised surfaces. Infants aged 3-10 months old have fallen out of the Bumbo seat and suffered skull fractures and other injuries.

-Motion Sensing Wall Switches Recalled by HeathCo due to Electrical Shock Hazard
In cooperation with the U.S. Consumer Product Safety Commission, HeathCo, LLC of Bowling Green, Ky., is voluntarily recalling about 75,000 Heath®/Zenith and WirelessCommand® motion sensing wall switches. When the switches are in the auto mode and the light is off, a small amount of leakage current passes through the electric circuit, including the socket. If consumers fail to disconnect the power at the circuit breaker and make contact with both terminals inside the socket while replacing the bulbs, there is a risk of an electric shock.

-Columbia Sportswear Recalls Batteries Sold With Jackets Due To Fire Hazard
In cooperation with the U.S. Consumer Product Safety Commission, Columbia Sportswear Company, of Portland, Ore., is voluntarily recalling about 220 pairs of Omni-Heat™ Lithium-Polymer rechargeable battery packs (two battery packs sold with each of 220 jackets). The batteries have a cell defect which can cause overheating, posing a fire hazard.

-Collective Brands Recalls KEDS Girls’ Shoes Due to Laceration Hazard
In cooperation with the U.S. Consumer Product Safety Commission, Collective Brands, Inc., of Topeka, Kan., is voluntarily recalling about 45,000 KEDS® “Know It All” girls’ shoes. Ornamental stars on the heel of the shoe may loosen, posing a laceration hazard.

-Children’s Animal Slippers Recalled Due to Choking Hazard; Sold Exclusively at Family Dollar Stores
In cooperation with the U.S. Consumer Product Safety Commission, Family Dollar Services Inc., of Matthews, N.C., is voluntarily recalling about 160,000 Kidgets® Animal Sock Top slippers. The animal’s eyes can detach from the slippers, posing a choking hazard to young children.

-Liebherr Expands Recall of Refrigerators Due to Injury Hazard; Door Can Detach
In cooperation with the U.S. Consumer Product Safety Commission, Liebherr-Canada Ltd of Ontario, of Canada, is voluntarily recalling about 8,000 Liebherr Freestanding 30-Inch Wide, Bottom Freezer Refrigerators (About 5,700 built-in 30-inch wide, bottom freezer refrigerators were recalled in March 2011). The refrigerator’s door can detach, posing an injury hazard to consumers.

-Toys Safer This Holiday Season Due to Stronger Safety Rules; Recalls and lead violations are down; 180,000 child injuries per year is too high
It’s that time of year again, when parents, grandparents, and friends begin to prepare holiday toy shopping lists. The U.S. Consumer Product Safety Commission (CPSC) wants consumers to know that while safety should be at the top of everyone’s toy list, stronger federal rules are making a positive impact and restoring confidence in the safety of toys.

-Build-A-Bear Recalls Teddy Bear Swimwear Set Due to Strangulation Hazard
In cooperation with the U.S. Consumer Product Safety Commission and Health Canada, Build-A-Bear Workshop®, of St. Louis, is voluntarily recalling about 19,720 (in the United States) and 1,100 (in Canada) sets of swimwear with inflatable inner tube. The inner tube accessory can be pulled over a small child’s head, posing a strangulation hazard.

-Michaels Stores Recalls Ashland Brand Glass Vase Due to Laceration Hazard
In cooperation with the U.S. Consumer Product Safety Commission and Health Canada, Michaels Stores Inc. of Irving, Tex., is voluntarily recalling about 28,000 (in the United States) and 1,800 (in Canada) Ashland™ glass vases. The glass vases can break or fracture when a consumer picks them up, posing a laceration hazard.

-Arctic Cat Recalls ATVs due to Crash Hazard
In cooperation with the U.S. Consumer Product Safety Commission, Arctic Cat Inc., of Thief River Falls, Minn., is voluntarily recalling about 1,384 Arctic Cat All-Terrain Vehicles. The ATV’s steering tie-rod can bend, causing loss of control which poses a crash hazard.

-W.P. Appliances Recalls Combination Grills/Griddles Due to Overheating and Electrical Shock Hazards; Sold Exclusively at HSN
In cooperation with the U.S. Consumer Product Safety Commission, W.P. Appliances Inc., of Hollywood, Fla., is voluntarily recalling about 27,000 Wolfgang Puck Electric Reversible Tri-Grill/Griddles. A defect in the electrical wiring of the electric grills/griddles can pose a risk of overheating, melting and an electrical shock hazard to consumers.

-Federal Judge Grants Permanent Injunction Against Brooklyn Sleep Products and Francisco Chavez
A federal judge granted a default judgment and a permanent injunction ordering Brooklyn Sleep Products Inc., of Brooklyn, N.Y., and its president Francisco Chavez, to stop manufacturing, importing, renovating and selling mattresses until they provide evidence that their mattresses comply with federal flammability laws.

-Joss Rock Climbing Cam Units Recalled by Sierra Trading Post Due to a Fall Hazard; Sold Exclusively by Sierra Trading Post
In cooperation with the U.S. Consumer Product Safety Commission, Sierra Trading Post, of Cheyenne, Wy., is voluntarily recalling about 1,280 Joss rock climbing cams. The recalled cams can fail unexpectedly after being set, posing a fall hazard.

Plaintiff Sues Whirlpool over Washing Machine Fire

2011-12-06T03:59:00.000-08:00

A class action lawsuit has been filed against Whirlpool Corporation (“Whirlpool”), Sears Holdings Corp, and Sears Roebuck & Co, Inc. (“”Sears”) (collectively “Defendants”) in the United States District Court for the Central District of California (styled Steve Chambers, Lynn Van Der Veer, David Brown, Bach-Tuyet Brown, Kevin O’Donnell, Joseph Cicchelli, Kurt Himler, Susan Milicia, Gary LeBlanc and James Cashman v. Whirlpool Corporation, Sears Holdings Corp, and Sears Roebuck & Co, Inc. et al Class Action Case No. CV11-1733), alleging, among other things, that Whirlpool & Sears designed, manufactured, advertised, marketed, and sold KitchenAid and Kennmore brand dishwashers that contained defective electronic control boards that can overheat causing the control board and Dishwasher components to melt, smoke and burst into flames.

The electronic control board overheating class action lawsuit complaint reportedly asserts claims for alleged violations of the California Consumer Legal Remedies Act, violations of unfair business practices act, fraudulent concealment, breach of implied warranty, breach of express warranty, strict products liability and failure to warn, unjust enrichment and negligence.

Find the lawsuit here:

Low Cholesterol Does Not Cause Heart Attacks

2011-12-06T03:36:00.000-08:00

Image by Getty Images via @daylifeDespite plenty of evidence that people with low levels of "good" cholesterol are more prone to heart attacks, a large new study suggests that the lacking lipid is not to blame.

"Association itself doesn't mean causality," said lead author Dr. Ruth Frikke-Schmidt, a consultant in the Department of Clinical Biochemistry at Rigshospitalet in Copenhagen.

More here: http://www.reuters.com/article/2011/12/01/us-low-cholesterol-idUSTRE7B02S820111201

A Silver Bullett for Hangovers?

2011-12-06T03:31:00.000-08:00

Image by mariotto52 via FlickrMaking the rounds is news that a pill called Blowfish will serve as the method to end that pesky post holiday party hangover.

The creator of the product (Brenna Haysom) says the tablets consist of 1,000 milligrams of aspirin, 120 milligrams of caffeine and a stomach-soothing agent split up into two tablets designed for consumption the morning after a night of heavy drinking.

Once dissolved in water, the remedy claims to knock out multiple hangover symptoms in just 15 to 30 minutes.

11th Circuit News: Voluntary E Filing starts in January

2011-12-06T03:24:00.000-08:00

The Eleventh Circuit has the Public Notice copied below on its website indicating that voluntary electronic filing will begin on January 1, 2012.

According to the Pacer Service Center, "Beginning December 1 you may register for electronic filing with the 11th Circuit through the Appellate ECF application at http://www.pacer.gov/reg_ap.html."

December Yaz Litigation News: Bayer Withheld Yasmin Data From U.S., Former Agency Chief Tells Court

2011-12-06T03:17:00.000-08:00

From Bloomberg:

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said.

David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.

The report also didn’t include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said.

Kessler’s report and four other expert opinions were released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives. The experts were paid by the plaintiffs’ lawyers, who submitted the reports to the FDA, which is considering safety findings on Yasmin and its sister product Yaz at a hearing Dec. 8.

http://www.bloomberg.com/news/2011-12-05/bayer-withheld-yasmin-clot-risk-data-from-u-s-ex-agency-head-tells-court.html

Front Row recalls grape tomatoes because of possible Salmonella contamination

2011-12-05T09:34:00.001-08:00

From al.com:

Front Row Produce of St. Louis, Mo., is recalling its 10 ounce pint and 10 pound bulk grape tomatoes because they have the potential to be contaminated with Salmonella, according to the FDA.

Front Row Produce of St. Louis MO is recalling its 10oz pint and 10lb bulk grape tomatoes supplied by Rio Queen Citrus, Mission TX, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled 10oz pint and 10lb bulk grape tomatoes were distributed throughout Missouri and Illinois to foodservice distributors and retail stores.

The product for retail sale is packaged in a 10-ounce, clear plastic package marked with a Front Row Produce “Grape Tomatoes” label on the top of the package. Currently, the lot number does not appear on the clear plastic package but it does appear on the case label. The lot numbers on the cases containing the 10-oz. packages are 2310802, 2310405, or 2510401. The 10lb bulk grape tomatoes are packaged for wholesale in a plain brown cardboard box labeled only with lot # 2310801.

As of 12/1/2011, all shipments of Front Row Produce Grape Tomatoes packaged in clear 10-oz. plastic packages sold in retail stores will now have a green lot number sticker placed on the bottom side of each package. The lot number will consist of a 7-digit number used to aid in identifying specific shipments of product. Any packages that do not contain this green sticker should be considered suspect and under recall.

No illnesses have been reported to date in connection with this problem.

The contamination was noted after random testing by Rio Queen Citrus, Mission TX, revealed the presence of Salmonella in some 20lb bulk containers.

Production of the product has been suspended while FDA and the company continue their investigation as to the source of the problem

Warning Letter to Precision from the FDA

2011-12-05T09:32:00.001-08:00

These are worth reading if only for the detail that the FDA goes into. Here is the latest one:

Cheryl A. Cahill, President
Precision Formulations, LP
800 W. Sandy Lake Rd., Suite 200
Coppell, Texas 75019

Dear Ms. Cahill:

The U.S. Food and Drug Administration (FDA) inspected your facility located at 800 W. Sandy Lake Road, Suite 200, Coppell, Texas, on May 2-19, 2011. During our inspection, we evaluated the manufacturing of several of your products, including Braz a Vie Acai, (b)(4)(2.5 fl. oz.), (b)(4)(2.5 fl. oz.), (b)(4), and (b)(4). Because you label these products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with the Current Good Manufacturing Practice (CGMP)regulations for dietary supplements in 21 CFR Part 111. However, this letter should not be interpreted to mean that FDA agrees with your characterization of the products or their ingredients.

During the inspection, our investigators found a number of violations of the dietary supplement CGMP regulations. These violations cause your products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These inspectional observations were provided to you on the FDA-483 form issued at the conclusion of our inspection on May 19, 2011.

You can find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov¹.

The following violations were observed during the inspection:

1. You failed to conduct at least one appropriate test or examination to verify the identity of the dietary ingredient, (b)(4), as required by 21 CFR 111.75(a)(1)(i), for Lot # (b)(4), (b)(4), and (b)(4) prior to using it in the manufacture of Braz a Vie Acai, Lot #(b)(4).

We received your reply to the FDA-483 dated June 10, 2011. Your response is inadequate because the documentation you provided with your response indicates that the samples from the (b)(4) referenced lots of (b)(4) were not submitted to your contract laboratory until 5/3/2011 and the results were not reported until 5/20/2011. According to your Quarantine Release Report, you released Braz a Vie Acai, Lot #(b)(4) on 4/20/2011, which was before the samples of the (b)(4) were submitted for identity testing. Your response only addresses a single lot and fails to indicate whether you have made changes to your procedures that will ensure that all components will be tested to verify identity before use in the manufacture of your dietary supplement products.

2. You failed to establish the specifications required by 21 CFR 111.70. Specifically:

• You failed to establish component specifications, as required by 21 CFR 111.70(b)(2), for the (b)(4), Lot # (b)(4), (b)(4), and (b)(4) that are necessary to ensure that specifications for the purity, strength, and composition of Braz a Vie Acai, Lot #(b)(4), manufactured using these components are met. You told our investigators that you have not established component specifications for purity, strength and composition.

• You failed to establish product specifications for the strength of the finished batch of dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established specifications for the strength of the dietary ingredients (b)(4) found in the proprietary blend used in your (b)(4) Lot # (b)(4) and (b)(4) Lot # (b)(4) products. The supplement facts panel for both products declares (b)(4) of the proprietary blend per (b)(4) fluid ounce serving. You told our investigators that you check the finished product against the finished product label declaration. This does not satisfy the requirement to establish specifications for strength of the finished batch of dietary supplement.

In your June 10, 2011 response letter, you stated that MMRs (master manufacturing records) with more detailed specifications are being put together and will be completed by August 31, 2011. Your response is inadequate because you have not provided documentation to indicate that you have established specifications for specific points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.

3. You did not prepare a written master manufacturing record (MMR) for each batch size of dietary supplement that you manufacture to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you manufacture batches of product in various sizes; however, your MMR for (b)(4), Braz a Vie Acai, and (b)(4) are for (b)(4) only.

In your June 10, 2011 response you stated that your MMRs are under review to have additional instructions and specifications added to the manufacturing process. You stated this would be completed by August 31, 2011. Your response is inadequate because you have not indicated that you have developed MMRs for each batch size or forwarded them for our review.

4. Your master manufacturing records (MMRs) for (b)(4), Acai, and (b)(4) do not include the following information required by 21 CFR 111.210:

• The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label [21 CFR 111.210(d)]. Specifically, your MMR for (b)(4) fails to declare the identity and weight or measure of several dietary ingredients such as (b)(4) and (b)(4) that are declared on the Supplement Facts label of the dietary supplement.

• A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]. Specifically, your MMRs for (b)(4), Braz a Vie Acai, and (b)(4) do not contain any of this information.

• A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]. Specifically, your MMRs for (b)(4) , Braz a Vie Acai, and (b)(4) products do not contain this information.

• Written instructions, including procedures for sampling and a cross-reference to procedures for tests or examinations; specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and corrective action plans for use when a specification is not met [21 CFR 111.210(h)]. Specifically, your MMRs for (b)(4), Braz a Vie Acai, and (b)(4) products do not contain this information.

In your June 10, 2011 response you stated that your MMRs are under review to have additional instructions and specifications added to the manufacturing process. You stated this would be completed by August 31, 2011. Your response is inadequate because you have not indicated that you have completed your revisions and forwarded these records for our review.

5. Your batch production records (BPRs) for your (b)(4), Braz a Vie Acai and (b)(4) products do not include the following information required by 21 CFR 111.260:

• The unique identifier that you assigned to packaging used [21 CFR 111.260(d)]. Specifically, the BPR for (b)(4), Lot # (b)(4), does not include complete lot number information for bottles used.

• A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. Specifically, your BPR for (b)(4), Lot #(b)(4), Braz a Vie Acai, Lot #(b)(4), (b)(4), Lot # (b)(4), and (b)(4), Lot # (b)(4), lack this information.

• Documentation, at the time of performance, of the manufacture of the batch including the initials of the person weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)]. Specifically, the BPR for (b)(4) Lot # (b)(4) is missing this information for the reverse osmosis water and organic green tea leaf components. The BPR for (b)(4) Lot # (b)(4) is missing the initials for the person who added each component. The BPR for (b)(4), Lot # (b)(4), is missing all of the above information for the reverse osmosis water component.

• Documentation at the time of performance that quality control reviewed the BPR for the results of any tests and examinations on the finished batches of dietary supplements [21 CFR 111.260(l)(1)(ii)]. Specifically,

o Your BPR for (b)(4), Lot #(b)(4), indicates on the Quarantine Release Report that it was released on 3/27/2011. However, your records indicate that quality control reviewed the microbiology results on 4/4/2011.

o Your BPR for Braz a Vie Acai, Lot #(b)(4), indicates on the Quarantine Release Report that it was released on 4/20/2011. Your records indicate that microbiology results were not completed until 4/23/2011, although quality control documented having reviewed the record on 4/20/2011.

o Your BPR for (b)(4), Lot # (b)(4), indicates on the Quarantine Release Report that it was released on 3/26/2011. Your records indicate that microbiology results were not completed until 3/29/2011 although quality control documented having reviewed the record on 3/26/2011. In addition, the results of finished product dietary ingredient analyses for (b)(4) were not completed until 4/8/2011.

o Your BPR for (b)(4), Lot # (b)(4), indicates on the Quarantine Release Report that it was released on 2/5/11. Your records indicate that the microbiology results were not completed until 2/8/11, although quality control documented having reviewed the record on 2/5/11. In addition, the results of finished product dietary ingredient analyses for (b)(4) were not completed until 2/14/2011.

You told our investigators that some results are checked and the product is released verbally but that documentation for these dietary supplements can take up to one week before it is completed. In addition, you have a practice to release finished product after you receive an acceptable (b)(4) hour microbiology test result, but do not wait for the completed (b)(4) microbiological result.

In your June 10, 2011 response, you stated that an additional hire was approved that will ensure that Quarantine tags, which include the unique lot number, are applied to all raw materials, packaging, and labels; new MMRs will state where yield data will be available; you stated that you are changing the sequencing that you close out batch production records; you authorized a new hire to give more time for the Lab Manager to put the completed batch records together properly and in sequence; and your SOP for release will be modified to cover more details on microbiological release, early and routine. You also provided the batch ticket from (b)(4) Lot # (b)(4).

This response is inadequate because it does not address how you will ensure that lot numbers are documented in the BPR; the BPR must contain yield data, not a reference in the MMR to where it can be found; and you have not provided your modified SOP or provided details on how your proposed changes will ensure that your BPRs contain documentation at the time of performance that quality control personnel reviewed the results of any tests or examinations. The batch ticket provided does not correspond to the lot numbers referenced above, nor have you explained how you will ensure that this type of error does not occur in the future.

6. You failed to identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the label, the status of the label (e.g. quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR 111.160(d)(1). Specifically, on your Label Receiving Report dated (b)(4), you documented receiving (b)(4) sleeve labels for your (b)(4) product with an Item Key of (b)(4). This is a general number used for this label regardless of the date the labels are received. There is no information contained in the section for Lot No. In addition, the Quarantine Release Report in your BPR for Braz a Vie Acai Lot # (b)(4) lists the Label # (b)(4). However, this is a general part number, not a unique lot number. It is pre-printed on each label for this product.

In your June 10, 2011 response, you stated that an additional warehouse hire was approved who will assure that the Quarantine tags, which include the unique lot number, are applied to all the components, packaging and labels in the future. You also stated that you are recommending that a small, unique part number and "revision" number be printed on each label supplied by your customer and you will do this on labels you approve in house. We will verify your correction at the time of the next inspection.

7. You failed to control the issuance and use of labels and reconciliation of any issuance and use discrepancies, as required by 21 CFR 111.410(b). Specifically, according to the Precision Formulations Usage Report in the BPR for (b)(4) Lot # (b)(4), (b)(4) labels were used. However, in the notes section the form indicates that only (b)(4) bottles were labeled while (b)(4) bottles were not labeled. The form does not account for the (b)(4) labels that were not used.

Your June 10, 2011 response does not address the discrepancy described above.

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and FDA's implementing regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

We note that your BPR for (b)(4) Lot #(b)(4) indicates bottles should be hot filled at (b)(4) degrees. However, your records show that the (b)(4) temperatures recorded for this batch never reached this temperature. In your June 10, 2011 response, you stated that you have changed your specification to (b)(4), and that the (b)(4) temperature does not correspond to the bottle fill temperature. If the (b)(4) temperature is not a measurement of bottle fill temperature, it is unclear how you monitor the bottle fill temperature and document that your product meets this specification.

Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.

Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Seri Essary at (214) 253-5335.

December, 2011 Actos News: Takeda May Face 10,000 U.S. Suits Over Actos Cancer Claims

2011-12-02T06:46:00.000-08:00

I just attended the JPML hearing regarding petitions to centralize the Actos litigation. A full court room in the USDCT in Savannah, GA. Takeda seeks an MDL placement in Illinois, given that it is based in that state. Others seek Louisiana among other states. I'm hearing a decision will be made by year end.

On the heels of that hearing there is this report from Bloomberg:

Takeda may face as many as 10,000 lawsuits in U.S. courts over allegations that its Actos diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated.
U.S. regulators found in June that an analysis of a company-sponsored study showed some users of Actos, the world’s best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease.

Source:
http://www.bloomberg.com/news/2011-12-01/takeda-may-face-10-000-u-s-suits-over-actos-cancer-claims.html

From the FDA
[6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

Facts about pioglitazone

Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).
Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.
From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.²

This safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study¹, described in FDA's September 2010 ongoing safety review¹ and in the Data Summary below. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.
FDA is also aware of a recent epidemiological study conducted in France² which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.
FDA recommends that healthcare professionals should:

Not use pioglitazone in patients with active bladder cancer.
Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.

FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.

Additional Information for Patients

There may be an increased chance of having bladder cancer when you take pioglitazone.
You should not take pioglitazone if you are receiving treatment for bladder cancer.
Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

FDA sues dietary supplement maker ATF Fitness

2011-11-29T09:14:00.000-08:00

The FDA has sued a dietary supplement manufacturer, ATF Fitness Products and Manufacturing ATF Dedicated Excellence (MADE), for non-compliance with the Federal Food, Drug, and Cosmetic Act.
The company has been charged with, by the US Department of Justice, adulteration and mislabeling of its products, besides violation of current Good Manufacturing Practice (cGMP) regulations.

ATF buys dietary supplements including vitamins and minerals from MADE which markets them across the US under the brands Sci-Fit, Nature's Science and For Store Only.

Source: http://otc.pharmaceutical-business-review.com/news/fda-sues-dietary-supplement-maker-for-violating-laws-281111

Nevada Supreme Court

2011-11-28T09:01:00.000-08:00

Image via WikipediaThe Nevada Supreme Court has rules that "when a pharmacist has knowledge of a customer-specific risk with respect to a prescribed medication, the pharmacist has a duty to exercise reasonable care in warning the customer or notifying the prescribing doctor of this risk."

The case is Klasch adv. Walgreens, and the opinion may be found here.

In that case, a consumer had a prescription filled at a Walgreen's pharmacy. The consumer had completed a patient profile that indicated known allergies. When a prescription was to be filled, a Walgreens employee called the consumer (Klasch) and conveyed that her prescription had been flagged because of her sulfa allergy. In response, Klasch reportedly indicated that she had taken Bactrim in the past and that she had not experienced any adverse reaction to it. Satisfied with this clarification, a pharmacist then manually overrode the computer system’s flag, and the prescription was released. The consumer took the drug, and developed a horrible condition called SJS. She ultimately died from the complications of that condition, which the survivors in a lawsuit claim were caused by the prescription filled by Walgreens.

The complaint alleged that Walgreens’ pharmacist breached her duty of care by failing to adequately warn Klasch of the prescribed medication’s risks in light of her allergy to it or, alternatively, by failing to call her doctor to clarify whether he really meant to prescribe a medication to which she was allergic.

The Court held that : "The learned-intermediary doctrine does not foreclose a pharmacist’s potential for liability when the pharmacist has knowledge of a customer-specific risk."

The Court denied a Motion for Summary Judgment, in its ruling. It's worth reading.

Recent State Court decision detailing Post -Mensing Rulings (Reglan)

2011-11-23T09:05:00.000-08:00

From a PA State Court, this decision does a good job noting recent post Mensing decisions:

Moss order11.18.11 order denying mensing mtd

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Merck Agrees to Pay US $950 M to Settle Vioxx Claims

2011-11-23T04:23:00.000-08:00

Image via WikipediaMerck will pay $950 million and a unit of the company will plead guilty to a criminal misdemeanor charge to resolve a U.S. probe of its illegal marketing of the painkiller Vioxx.

The criminal plea is tied to Merck’s off-label promotion of rofecoxib for rheumatoid arthritis (RA) from 1999 until 2002, since the drug did not have an indication for RA at that time. The civil settlement is tied to a broader range of allegedly illegal conduct by Merck, including statements about the cardiovascular safety of rofecoxib made by Merck representatives. The company will also enter into an expansive corporate integrity agreement with the government.

From a press release:

Under civil settlement agreements signed with the United States and individually with 43 states and the District of Columbia, Merck will pay approximately two-thirds of the reserved charge to resolve civil allegations related to Vioxx. As a result, the United States and the participating states have released Merck from civil liability related to the governments' allegations regarding the sale and marketing of Vioxx in the United States. Previously disclosed litigation with seven states remains outstanding.

The civil settlement does not constitute any admission by Merck of any liability or wrongdoing.

"We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said Bruce N. Kuhlik, executive vice president and general counsel of Merck.

Separately, the company agreed to plead guilty to a misdemeanor under the Federal Food, Drug, and Cosmetic Act arising out of the marketing of Vioxx by company representatives to physicians in the United States for the treatment of rheumatoid arthritis before the FDA's approval of that indication in April 2002. The company will pay a fine of approximately one-third of the reserved amount to the federal government as part of the plea agreement.

Georgia November 21, 2011 Yaz News

2011-11-22T05:42:00.000-08:00

Image via WikipediaAs the litigation moves along in the cases involving the Yaz birth control products, there is this news from recent discovery responses:

Bayer may have considering marketing the birth- control pills for unapproved uses according to company e-mails.

Bayer reps discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome. Salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz.

From the email: “This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women battling premenstrual dysphoric disorder, the most severe form of PMS, wrote Matt Sample, a Berlex sales consultant, according to a copy of the e-mail produced as evidence.

The FDA approved Yaz only for the most severe form of PMS. Yaz is approved to treat Treat premenstrual dysphoric disorder (PMDD).

Premenstrual dysphoric disorder—PMDD—is the most severe form of PMS. That is, the only actual difference between the two syndromes is the severity of their symptoms. Even that is not always clear, since there are severe cases of PMS that do not happen to meet the criteria for PMDD.

One characteristic that can distinguish PMDD from PMS is the intensity of the emotional or psychological symptoms. In PMS, physical symptoms or emotional symptoms can be the primary cause of concern. The related cardinal feature of premenstrual dysphoric disorder is the degree to which it interferes with work and relationships. Of course, severe (or even moderate) PMS can have a tremendous impact on a woman's enjoyment of life and her productivity at work and at home. Source

The FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.

http://www.bloomberg.com/news/2011-11-21/bayer-may-have-touted-birth-control-pills-for-unapproved-use-e-mails-show.html#

Army drops use of anti-malarial drug

2011-11-21T06:07:00.000-08:00

From the source below. The news today is that the Army will stop using Mefloquine. Mefloquine is used to treat malaria (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death) and to prevent malaria in travelers who visit areas where malaria is common. Mefloquine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.

From the article:

Mefloquine is a zombie drug. It’s dangerous, and it should have been killed off years ago,” said Dr. Remington Nevin, an epidemiologist and Army major who has published research that he said showed the drug can be potentially toxic to the brain. He believes the drop in prescriptions is a tacit acknowledgement of the drug’s serious problems.

Over the past three years, the Army slashed by almost 75 percent the amount of mefloquine it prescribes, even as it sent thousands more soldiers to malaria-prone Afghanistan.

The decrease in doses followed two orders from military and Pentagon leaders in 2009. One, from the Army’s surgeon general, ordered the branch to limit its use to specific circumstances. Other branches, however, continue to favor mefloquine.

http://www.washingtonpost.com/business/army-drops-use-of-anti-malarial-drug-blamed-on-causing-psychiatric-symptoms/2011/11/19/gIQA5gEXbN_story.html

November 17, 2011 Update: encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

2011-11-18T12:37:00.000-08:00

Image via Wikipedia
From the Cooper Vision Site:

encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

Q: What is the cause of the encore100 Toric and encore100 Sphere recall?
A: The recall was initiated on limited lots of encore100 Toric and encore100 Sphere because
CooperVision identified certain lots that did not meet our updated quality requirements due to the
level of a residue (silicone oil). The presence of the residue may cause hazy vision or discomfort,
severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same
symptoms.

Q: What happens if a contact lens wearer puts an impacted lens in their eye?

A: We have received complaint reports for the encore100 Toric lenses that began as hazy vision.
After the recall, some patient complaints were received that began as hazy vision but progressed to
severe eye pain or eye injuries requiring medical treatment. Not every patient has the same
symptoms. Health and safety of patients are our top priority so the recall was expanded to the limited
lots of encore100 Sphere lenses.

Q: What should I do if I personally experience these symptoms?

A: Remove the lenses from your eyes immediately if you are currently wearing them. Contact your
eye care practitioner to let them know you are experiencing symptoms. Follow your eye care
practitioner’s instructions.

Q: If I have symptoms how long will they last?

A: If the lens is removed promptly after the onset of symptoms it likely will clear up within 15 to 30
minutes. If you leave the lens in your eye for a prolonged period of time the symptoms may progress
to a more serious condition. Contact your eye care practitioner to let them know you are
experiencing symptoms.

Q: Has anyone had permanent damage to their eye because of these symptoms?

A: To date we have not received any reports of permanent damage to a patient’s eye after wearing
the affected lens.

Q: What should be done with product that I currently have at home?

A: A small percentage of encore100 Toric and encore100 Sphere lenses are affected by this
situation. Please check the lot number on the carton or blister label you have by using the search
box on the www.coopervision.com/international-recalll website to see if your product has been
impacted by the recall, and if so, discontinue wear and return the lenses to your eye care
practitioner. You may also call our Consumer Care hotline at 1-855-526-6737.

Q: Will I be able to re-order my encore100 Toric and encore100 Sphere lenses?

A: We expect that encore100 Toric will be available for ordering in the spring of 2012. We anticipate
minimal disruption to availability of encore100 Sphere and you may continue to order through your
practitioner.

http://coopervision.com/pv_obj_cache/pv_obj_id_B84970CE53ADAF9E19484A5FD2C6ABD949630000/filename/encore100_Toric_and_encore100_Sphere_Consumer_FAQs_v7.pdf

Georgia Law: Recent Order Limiting Ex Parte Interviews with Treating Doctors

2011-11-18T12:23:00.000-08:00

From our office:

Garrett orderdoctorexparte

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Keime Inc dba Barry's Vitamins Conducts a Nationwide Voluntary Recall of Virility Max Dietary Supplement

2011-11-18T12:12:00.001-08:00

Image via WikipediaNovember 10, 2011 - Keime Incorporated announced today that it is conducting a voluntary recall of one lot of the companies dietary supplement product sold under the following name: Virility Max. The company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug.

The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
Virility Max is used for sexual enhancement. It is distributed in 10 count, white plastic bottles to retail customers in the South Florida area.

No illnesses have been reported to the company to date in connection with this product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this produc

Breast Cancer: FDA Revokes Avastin Approval

2011-11-18T12:10:00.000-08:00

Image via WikipediaFrom ABC:

The U.S. Food and Drug Administration today announced it will revoke the approval of Avastin for breast cancer, citing a lack of evidence that the benefits outweigh the risks.

Avastin was approved for metastatic breast cancer in February 2008 under the agency's accelerated approval program, which offers patients early access to promising drugs while confirmatory clinical trials are carried out.

"Unfortunately the additional studies failed to confirm Avastin's initial promise," FDA Commissioner Dr. Margaret Hamburg said today.

The additional studies, carried out by Avastin maker Genentech, found only a small effect on tumor growth and no evidence that patients lived longer than they would taking standard chemotherapy. Because the drug can cause severe high blood pressure, bleeding, heart failure and perforations in the nose, stomach and intestines, an FDA advisory panel in June recommended revoking its approval.

Cooper Expands Recall Of Avaira Lenses

2011-11-16T08:06:00.000-08:00

Image via Wikipedia

The Cooper Companies contact lenses unit CooperVision expanded a recall of some of its Avaira brand lenses. Under the expanded recall, CooperVision is now including limited lots of Avaira Sphere contact lenses, in addition to limited units of Avaira Toric lenses.

Cooper, along with the FDA, found certain lots of Avaira Sphere lenses did not meet new quality requirements linked to silicone oil residue levels, and plans to replace them with available inventory.

http://torontostar.morningstar.ca/globalhome/industry/news.asp?articleid=447269

Kimberly-Clark Recalls Kotex Tampons

2011-11-16T07:41:00.000-08:00

Kimberly Clark has recalled about 1,400 cases of Kotex tampons out of fear they may be contaminated with bacteria.

The recall applies specifically to 18-count and 36-count boxes of Kotex Natural Balance Security Unscented Tampons Regular Absorbency with sku numbers 15063 and 15068. All other Natural Balance tampons with other SKU numbers are safe to use, the company said.

The recalled tampons were sold at Walmart, Fry's and Smith's stores in Texas, Iowa, Kansas, Missouri, Nebraska, New Mexico, Arizona and Utah.

Source: http://www.nbcdfw.com/news/business/Kimberly-Clark-Recalls-Kotex-Natural-Balance-Unscented-Tampons-133817778.html

Mizuho OSI Modular Table Systems Recall

2011-11-15T18:53:00.000-08:00

From the FDA site:

Product: OSI Modular Table Systems (including Modular Bases, Jackson Spinal, Imaging, Lateral, & Orthopedic Tops)

Manufacturing From: January 1992 - June 2011

Distribution From: January 1992 - June 2011

The affected models and lot numbers can be found below:

Model	Product Name
5803/5803I	Advanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz
5890	Retractable “I” Base - Manual tilt & lock functions
5891	Non-Retractable “I” Base - Manual tilt & lock functions
5892	Advanced Control Retractable “I” Base - electric powered tilt & lock
5855	Orthopedic Trauma Table Top
5895	Maximum Access Lateral Top
5927	Radiolucent Imaging Top with Tempur-Med
5840-726	Imaging Top w/ Tempur-med pad (part of Model 5827 System)
5840-831	Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System)
5943	Jackson Spinal Table
5843AP	Jackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz
5943API	Jackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz
5996/5996I	Advanced Control Pad System Variable Speed
6977	AXIS Jackson System with Advanced Control Pad System 100/230 VAC 50/60Hz

Use: For patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures.

Recalling Firm:
Mizuho Orthopedic Systems Inc
30031 Ahem Avenue
Union City, CA 94587

Reason for Recall: There are reports of injury related incidents while using Mizuho OSI Modular Table Systems. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death

Pine Nut Recall Sees Second Lawsuit

2011-11-15T18:47:00.000-08:00

Image via Wikipedia

The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts distributed by Sunrise Commodities, based in Englewood Cliffs, New Jersey, after FDA tests confirmed the presence of Salmonella on the product.
FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and State public health and agriculture officials to investigate a multistate outbreak of Salmonella Enteritidis infections. To date, the CDC reports there are at least 42 illnesses associated with the outbreak in Maryland, New Jersey, New York, Pennsylvania and Virginia.
As part of FDA’s investigation, the Agency collected and tested samples of Turkish pine nuts from a warehouse used by Sunrise Commodities and from a warehouse used by a customer of Sunrise Commodities. Additional testing by the FDA confirmed Salmonella Enteritidis, matching the outbreak strain, was found on FDA's positive samples of pine nuts. FDA's State partners also collected samples of pine nuts distributed by Sunrise Commodities; some of those samples tested positive for SalmonellaEnteritidis and matched the outbreak strain.

Sunrise Commodities has voluntarily recalled four lots of the implicated product, totaling more than 21,000 pounds of pine nuts. Each lot was packed in 22-pound boxes and included the markings:
Warehouse Lot 27963 with the identifying code “PO#: 50165”
Warehouse Lot 29628 with the identifying code “PO#: 50558”
Warehouse Lot 27713 with the identifying code “PO#: 49595”
Warehouse Lot 27427 with the identifying code “PO#: 50032”
Sunrise Commodities distributed the Turkish pine nuts in bulk to various food vendors in Florida, New Jersey, New York and Canada. Sunrise Commodities issued a recall notification to its customers dated November 3, 2011, alerting them of the test results and of the epidemiologic investigation and asking them to notify their subsequent customers of the recall.

Already lawsuits have been filed:
Kimberly Waterbury filed suit Tuesday in federal court on behalf of herself and her minor child against American Pistachio Commodity Corp., which does business as Sunrise Commodities of Englewood Cliffs, New Jersey
The suit claims that Sunrise Commodities was strictly liable for the contaminated product. The suit also claims the company was negligent for not using reasonable care in the manufacture, distribution and sale of the product, and for violating federal, state and/or local food safety regulations.

http://www.democratandchronicle.com/article/20111115/NEWS01/111115031

Study Suggests Multaq Doubled Deaths From Heart Disease

2011-11-15T11:23:00.000-08:00

Multaq - a drug that is approved to treat patients whose hearts intermittently race with quick and inefficient contractions may have double the risk of serious injury for those who have some type of erratic heart rhythm, according to a recent study.

A Multaq trial of more than 3200 patients was recently halted, supposedly because of the dangers to trial participants.

The study was paid for by Paris-based Sanofi and published in the New England Journal of Medicine. There were 21 deaths from cardiovascular causes in the Multaq group, compared with 10 among those getting placebo.

From the NEJM:

BACKGROUND

Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular anti-arrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation.

METHODS

We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death.

RESULTS

After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02).

CONCLUSIONS

Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.)

More here: http://www.nejm.org/doi/full/10.1056/NEJMoa1109867?query=featured_home#t=articleDiscussion

Under Armour Recalls Chin Straps for Football Helmets -- Laceration Hazard

2011-11-11T07:56:00.000-08:00

Image via Wikipedia

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the retailer named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled product immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: UA Defender Chin Straps

Units: About 541,000

Retailer: Under Armour, Inc., of Baltimore, Md.

Importer: JR286, Inc., of Redondo Beach, Calif.

Hazard: The metal snap that connects the chin strap to the helmet has sharp edges, posing a laceration hazard when the user’s metal snap comes into contact with another player.

Incidents/Injuries: Under Armour has received six reports of injuries that required stitches.

Description: This recall involves all UA Defender Chin Straps. They were sold in the following colors: white and black, red, midnight, navy and royal and have a hard nylon shell, a padded chin area and a plastic strap with “Under Armour” printed on it. The chin straps have metal clasps that tighten the straps and attach them to the helmet.

Sold at: Sporting goods stores and Under Armour outlet stores nationwide and at www.underarmour.com from January 2008 through September 2011 for about $20.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled chin straps and contact Under Armour for a free replacement chin strap.

Consumer Contact: For additional information, contact Under Armour

Veteran's Day Thank You

2011-11-11T05:59:00.000-08:00

Image by lukemontague via Flickr
It's hard to put into words sometimes how you feel, how to say thanks. Today is not one of those days. My father in law was a World War II bomber pilot, and I have family in the Navy as well as the Army. Our family is grateful to all who have served. From those in the greatest generation, to those now in harm's way anywhere our US Forces are ... thank you.

A friend of the family - in his 40's, two kids - was called to serve in Afghanistan, and he did two tours. You can't fathom the fear and anguish in a family or the military man until you see it firsthand.

You keep us free, you protect us, you are willing to die for us. My family and I am grateful and pray for your safety.

Public Citizen Calls on FDA to Require Black Box Warning on Label for the Antibiotic Tigecycline

2011-11-09T06:17:00.000-08:00

From PC:

The FDA should place a black box warning on an antibiotic used to treat a wide range of infections because of a higher mortality rate associated with taking the drug than other widely used antibiotics, says Public Citizen.

The antibiotic, tigecycline, also known as Tygacil, was approved by the FDA in 2005 to treat complicated skin infections and intra-abdominal infections and in 2009 to treat community-acquired pneumonia.

In 2010, the FDA issued a safety alert to health care professionals informing them of an increased mortality rate associated with the use of intravenous tigecycline compared to that of other antibiotics. The agency said that alternatives to tigecycline should be considered in patients with serious infections. At the same time, the FDA required that the drug label be modified to include data about the increased mortality risk, but these warnings were inadequate, Public Citizen said in the petition. Critical safety information does not appear in a black box warning at the top of the label and fails to describe appropriate restrictions on the use of the drug.

“Given the approximately 30 percent higher rate of mortality in subjects receiving tigecycline, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the content and placement of the warnings in the current drug label are woefully insufficient,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Because of the increased death rate and the likely inappropriate use of tigecycline as a first-line, rather than last-resort, antibiotic for serious infections without simultaneous administration of other antibiotics, it is inexcusable that there is currently no black box warning for tigecycline. Such a warning, accompanied by stronger warnings describing appropriate restrictions on its use in other parts of the label, clearly is warranted to more effectively advise physicians about the dangers of using tigecycline to treat serious infections and to better protect public health.”

Public Citizen calls on the FDA to add a black box warning to the antibiotic’s label indicating the increased risk of death and advising that it should be used only as a last-resort antibiotic and then only in combination with one or more bactericidal antibiotics (antibiotics that directly kill bacteria, rather than interfere with bacteria growth). Public Citizen also is petitioning the agency to require an FDA-approved medication guide to be distributed to patients, as well as a “Dear Doctor” letter to physicians, warning them of the dangers of the drug and the need for restricted use.

http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3440

FDA: Warnings on Methylene Blue, Linezolid, and Serotonergics

2011-11-09T06:14:00.000-08:00

The FDA has updated warning to avoid prescribing either methylene blue or linezolid (Zyvox, Pfizer) in combination with serotonergic agents because of the potential to cause serotonin syndrome.

Today, the FDA announced that the risk for this harmful interaction appears to be confined, in general, to 2 specific types of serotonergic drugs: selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors.

Methylene blue is a dye used in diagnostic procedures and in the treatment of conditions ranging from cyanide poisoning to methemoglobinemia. Linezolid is an antibacterial agent. Both drugs inhibit the action of monoamine oxidase A, an enzyme that breaks down serotonin. This allows the levels of the neurotransmitter to rise.

When serotonin builds up to excessive levels in patients taking serotonergic agents, the result can be serotonin syndrome. Its signs and symptoms include confusion, hyperactivity, memory problems, and other mental changes; muscle twitching, excessive sweating, shivering, or shaking; diarrhea; trouble with coordination; and fever.

http://www.medscape.com/viewarticle/751978

Zyprexa: First Verdict is for Eli Lilly

2011-11-08T10:33:00.001-08:00

Eli Lilly & Co. isn’t responsible for the death of college student who was taking the drugmaker’s Zyprexa antipsychotic medication, a jury ruled in the first case to go to trial over the drug.

Jurors in state court in Los Angeles deliberated about 11 hours over two days before clearing Lilly of responsibility for the 2007 death of Cody Tadai, a 20-year-old community college student who succumbed to diabetes-related illnesses while taking Zyprexa for mental illness. His family alleged the company hid the drug’s diabetes risks to protect sales.

Source: http://www.businessweek.com/news/2011-11-07/lilly-not-responsible-for-zyprexa-user-s-death-jury-finds.html

FDA has approved Xarelto bloodthinner for atrial fibrillation

2011-11-07T12:49:00.000-08:00

From the FDA:

The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people

who have abnormal heart rhythm (non-valvular atrial fibrillation).

Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart’s two upper heart chambers (atria) is irregular and poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots. Non-valvular atrial fibrillation refers to atrial fibrillation in patients who do not have significant problems in their heart valves.

“Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “This approval gives doctors and patients another treatment option for a condition that must be managed carefully.”

A stroke occurs if the flow of blood to a portion of the brain is blocked. If brain cells die or are damaged because of a stroke, symptoms occur in the parts of the body that these brain cells control. Stroke symptoms include sudden weakness; paralysis or numbness of the face, arms, or legs; trouble speaking or understanding speech; and trouble seeing.

The safety and efficacy of Xarelto were evaluated in a clinical trial with more than 14,000 patients comparing Xarelto with the anti-clotting drug warfarin. In the trial, Xarelto was similar to warfarin in its ability to prevent stroke.

For people taking the drug for atrial fibrillation, Xarelto should be taken one time a day with the evening meal so that it will be completely absorbed.

As with other anti-clotting drugs, Xarelto can cause bleeding that, rarely, can lead to death. Bleeding was the most common adverse event reported by patients treated with Xarelto in the major clinical trial for the prevention of stroke in non-valvular atrial fibrillation. In that trial, Xarelto’s risk of major bleeding was similar to that of warfarin; however, it caused less bleeding into the brain and more bleeding into the stomach and intestines.

Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their health care professional. Discontinuing the drug can increase the risk of stroke.

Insight Pharmaceuticals Issues A Voluntary Nationwide Recall Of "Nostrilla Nasal Decongestant"

2011-11-05T06:03:00.001-07:00

Insight Pharmaceuticals, LLC of Langhorne, Pa., is recalling one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.

Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis). However, the possibility of infection is remote in healthy individuals.

Nostrilla Nasal Decongestant, lot #11G075, UPC Code 6373673005, was distributed nationwide through normal retail outlets and pharmacies. The product comes in a 1/2 ounce, plastic bottle marked with lot #11G075 on the label and with an expiration date of 05/2014 stamped on the side. No illnesses have been reported to date in connection with this problem.

The recall was initiated following internal investigations which determined the potential presence of a microbial contaminant that exceeds the product specifications and may consequently result in a subpar product. This contaminant has been found sporadically throughout only the respective manufacturing lot, #11G075.

Consumers who have purchased "Nostrilla Decongestant, lot #11G075" are urged to return the product and contact the company at 1-877-546-9059 Monday through Friday from 9 am-5 pm EST time zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this produc

The Coming Diabetes Tidal Wave

2011-11-05T05:59:00.000-07:00

Image via WikipediaHalf of all American adults are may develop diabetes or pre-diabetes by 2020 unless changes in their activities of daily living are not made, so says the Centers for Disease Control and Prevention.

If current trends continue, the ranks of American adults with excessive blood sugar levels would swell from 93.8 million this year (about 28 million diabetics and 66 million more with pre-diabetes) to 135 million in 2020 – and cost society $3.35 billion by decade’s end. In addition, diabetes is becoming one of the most common chronic diseases in children and adolescents. According to the American Diabetes Association, one in every four children is currently diagnosed with diabetes.

Source:
http://www.newswise.com/articles/view/582544

Glaxo Settles with US for $3 Billion Sales/Marketing of Avandia

2011-11-05T05:55:00.001-07:00

GSK has agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.

Source: http://www.bloomberg.com/news/2011-11-03/glaxo-agrees-to-pay-3-billion-to-settle-u-s-probe-into-sales-marketing.html

FL State App. Court Rules that Lit. Privilege does not Extend to Websites

2011-11-02T16:00:00.000-07:00

Image via WikipediaAn interesting read:

After the plaintiffs filed suit against the defendants for (among other things) reach of contract, the defendants placed warnings to the public on their website stating that plaintiffs had violated certain trademarks. A memorandum on the defendants’ website stated that the plaintiffs were selling products and labeling them as D’Lites when they actually were not. The defendants’ website stated that “you need to know the product they are passing off as D’Lites Emporium ice cream is in fact a hoax.”

The Plaintiffs then amended the complaint claiming defamation. Disagreeing that a litigation privilege existed regarding the publication, the Court stated:

"We analogize the publication of statements on the internet to calling a press conference with the media or otherwise publishing defamatory information to the newspapers or other media. Other courts have
considered the issue of whether statements to a newspaper or other media are made in connection with a judicial proceeding. In Buckley v. Fitzsimmons, 509 U.S. 259 (1993), the Supreme Court held that a
prosecutor was not entitled to absolute judicial immunity for making defamatory statements at a press conference regarding a criminal prosecution, because comments to the press do not have any functional
tie to a judicial proceeding."

The Court went on to note:

The website publication in this case was not made in connection with the judicial proceeding. It was not made in the proceedings itself, nor was it made to a participant connected to the proceeding such as a witness. Like statements to the newspapers or press conferences, these statements have n o part in the judicial
proceedings. Instead, they were made to the world at large through the website and accused the plaintiffs of fraud and perpetrating a hoax on the public. These statements were not “necessarily preliminary” to
judicial proceedings, because unlike either Ange or Stewart the statements were not steps in the judicial process."

Read the opinion here: http://www.4dca.org/opinions/July%202011/07-27-11/4D09-4859.op.pdf

Cancer Risk Doubles After Organ Transplant

2011-11-02T15:46:00.000-07:00

Says a recent study. In any given year, the risk of developing cancer after a transplant is just 0.7 percent.

Results of the study are published in the Nov. 2 issue of the Journal of the American Medical Association.

In 2010, almost 30,000 solid-organ transplants were performed in the United States, according to background information in the article. Kidney transplants accounted for more than half of that total, followed by livers, hearts and lungs.

After transplant, the recipient must take powerful immune system-suppressing medications to prevent the new organ from being rejected.

From the article:

Design, Setting, and Participants Cohort study using linked data on solid organ transplant recipients from the US Scientific Registry of Transplant Recipients (1987-2008) and 13 state and regional cancer registries.

Main Outcome Measures Standardized incidence ratios (SIRs) and excess absolute risks (EARs)

assessing relative and absolute cancer risk in transplant recipients compared with the general population.

Results The registry linkages yielded data on 175 732 solid organ transplants (58.4% for kidney, 21.6% for liver, 10.0% for heart, and 4.0% for lung). The overall cancer risk was elevated with 10 656 cases and an incidence of 1375 per 100 000 person-years (SIR, 2.10 [95% CI, 2.06-2.14]; EAR, 719.3 [95% CI, 693.3-745.6] per 100 000 person-years). Risk was increased for 32 different malignancies, some related to known infections (eg, anal cancer, Kaposi sarcoma) and others unrelated (eg, melanoma, thyroid and lip cancers). The most common malignancies with elevated risk were non-Hodgkin lymphoma (n = 1504; incidence: 194.0 per 100 000 person-years; SIR, 7.54 [95% CI, 7.17-7.93]; EAR, 168.3 [95% CI, 158.6-178.4] per 100 000 person-years) and cancers of the lung (n = 1344; incidence: 173.4 per 100 000 person-years; SIR, 1.97 [95% CI, 1.86-2.08]; EAR, 85.3 [95% CI, 76.2-94.8] per 100 000 person-years), liver (n = 930; incidence: 120.0 per 100 000 person-years; SIR, 11.56 [95% CI, 10.83-12.33]; EAR, 109.6 [95% CI, 102.0-117.6] per 100 000 person-years), and kidney (n = 752; incidence: 97.0 per 100 000 person-years; SIR, 4.65 [95% CI, 4.32-4.99]; EAR, 76.1 [95% CI, 69.3-83.3] per 100 000 person-years). Lung cancer risk was most elevated in lung recipients (SIR, 6.13 [95% CI, 5.18-7.21]) but also increased among other recipients (kidney: SIR, 1.46 [95% CI, 1.34-1.59]; liver: SIR, 1.95 [95% CI, 1.74-2.19]; and heart: SIR, 2.67 [95% CI, 2.40-2.95]). Liver cancer risk was elevated only among liver recipients (SIR, 43.83 [95% CI, 40.90-46.91]), who manifested exceptional risk in the first 6 months (SIR, 508.97 [95% CI, 474.16-545.66]) and a 2-fold excess risk for 10 to 15 years thereafter (SIR, 2.22 [95% CI, 1.57-3.04]). Among kidney recipients, kidney cancer risk was elevated (SIR, 6.66 [95% CI, 6.12-7.23]) and bimodal in onset time. Kidney cancer risk also was increased in liver recipients (SIR, 1.80 [95% CI, 1.40-2.29]) and heart recipients (SIR, 2.90 [95% CI, 2.32-3.59]).

Conclusion Compared with the general population, recipients of a kidney, liver, heart, or lung transplant have an increased risk for diverse infection-related and unrelated cancers.

http://jama.ama-assn.org/content/306/17/1891.short

Bike Trailer Recall

2011-11-01T04:15:00.000-07:00

From the CPSC:

Units: About 2,700

Manufacturer: Weehoo Inc., of Golden, Colo.

Hazard: The receiver on the trailer's seat post hitch can crack and cause the trailer to detach, posing fall and crash hazards.

Description: 2011 Weehoo iGo bicycle trailers manufactured between April and July 2011 have a steel frame with an adjustable seat for passengers 38 to 52 inches tall, two pedals with straps, an enclosed sprocket and chain, a 20-inch wheel, two pannier pockets, a flagpole and a flag. The seat, pannier pockets and flag are made of red, heavy-duty nylon.

Sold at: Bicycle retail stores nationwide from April to July 2011 for about $390.

Lawsuit Involving Mr. Heater Corp. Resolves

2011-11-01T04:08:00.000-07:00

As the cold weather months arrive, here is news about tragedy in Wisconsin:

DeVere R. Clay, 68, and his wife, Barbara J. Clay, 57, and their grandchildren Erin Briney, 10, and Hope Briney, 13, all of Tomah, died of carbon monoxide poisoning while sleeping in the living quarters of their horse trailers in an Alliant Center parking lot during a horse show. A gas-powered heater used to keep the trailer warm malfunctioned.

The parents of the Briney children sued the manufacturer of the heater, Mr. Heater Corp., and in June settled for more than $250,000, according to online court records. Jay Urban, the attorney for the Briny children, said his clients actually got much more than that. "I can tell you it was substantial," Urban said.

You cannot see or smell carbon monoxide (CO), but at high levels it can kill a person in minutes. It is the leading cause of poisoning death, with over 500 victims in the United States each year.
Carbon monoxide is produced whenever a fuel such as gas, oil, kerosene, wood or charcoal is burned. The amount of CO produced depends mainly on the quality or efficiency of combustion. A properly functioning burner, whether natural gas or liquefied petroleum gas (LPG), has efficient combustion and produces little CO. However, an out-of-adjustment burner can produce life-threatening amounts of CO without any visible warning signs.

When appliances that burn fuel are maintained and used properly, the amount of CO produced usually is not hazardous. But if appliances are not working properly or are used incorrectly, dangerous levels of CO can collect in an enclosed space. Hundreds of Americans die accidentally every year from CO poisoning caused by malfunctioning or improperly used fuel-burning appliances. Many more people are harmed to some degree each year.

Proper installation, operation and maintenance of combustion appliances in the home are most important in reducing the risk of CO poisoning. Some rules are:

Never idle the car in a garage, even if the garage door is open. Fumes can build up very quickly in the garage and living area of your home.
Never use a gas oven to heat your home, even for a short time.
Never use a charcoal grill indoors, even in a fireplace.
Never sleep in a room with an unvented gas or kerosene space heater.
Never use any gasoline-powered engines (mowers, weed trimmers, snow blowers, chain saws, small engines or generators) in enclosed spaces.
Never ignore symptoms, particularly if more than one person is feeling them. You could lose consciousness and die if you do nothing.

Link: http://www.zacks.com/research/get_news.php?id=294e8509

Lightening Creams: Too Much Mercury?

2011-11-01T04:01:00.000-07:00

More than a dozen skin-lightening cosmetic products may pose dangers to health after they were found to have high levels of mercury, an ecological group said. EcoWaste Coalition said the mercury levels in these products were as high as 52,100 parts per million (ppm) – way above the 1 ppm safety limit.

The tests showed 76 percent (19 of 25) of the samples had mercury levels ranging from 1,395 ppm to 52,100 ppm. None of these samples listed mercury as an ingredient. They included:1. Long Dian Tu Glutathione Pearl Natural Whitening Essence Cream, 52,100 ppm.

2. Beauty Girl 10-Day Double Whitening Speckles Removed Essence Cream, 42,400 ppm

3. Jonathan 12-day Clearing Facial Spots Cream, 28,200 ppm

4. Feique Rose Refining Nourishing Set Cream, 21,600 ppm

5. Lianglibai Qingbanxuejizuhetaozhuang Cream, 15,000 ppm

6. Pretty Model Whitening and Freckle Removing Cream, 11,000 ppm

7. Yudantang Aloe Pearl 10-Day Whitening Speckles Removed Essence Cream, 10,700 ppm

8. Women of Flower Whitening and Speckle Removing AB Series Cream, 9,643 ppm

Sourcehttp://www.gmanews.tv/story/236962/nation/group-high-levels-of-mercury-in-19-skin-lightening-creams

Study: Aspirin Reduces Bowel Cancer Risk by 63%

2011-11-01T03:58:00.000-07:00

Image via WikipediaTwo aspirin pills a day may keep the oncologist away, according to a study spanning more than a decade published in The Lancet medical journal.

Participants who took 600 milligrams of the common painkiller daily for at least two years had a 63 percent lower rate of colorectal cancer than those who took a placebo, according to the study led by John Burn, a professor of clinical genetics at Newcastle University in England. The participants all were carriers of Lynch Syndrome, a genetic condition that predisposes a person to developing certain cancers.

Link: http://www.businessweek.com/news/2011-10-28/aspirin-reduces-bowel-cancer-risk-by-63-percent-in-study.html

Georgia: Actos Hearing before JPML in Savannah, GA

2011-10-31T13:16:00.000-07:00

The first plaintiffs filing a motion to consolidate made a request for all federal Actos claims to be transferred to U.S. District Court Judge G. Patrick Murphy in the Southern District of Illinois. Other plaintiffs have since filed responses requesting that different U.S. District Judges preside over the Actos litigation.

Takeda - responsible for Actos - has asked that the Northern District of Illinois be deemed the situe for all consolidated litigation because that is the location of the drug maker’s headquarters and the location of many of the company's records. Alternatively, the drug maker has asked that the Court centralize the Actos MDL in Western District of Louisiana because at least 16 lawsuits are now pending in that district.

Plaintiffs claim that each developed of bladder cancer as a side-effect of taking Actos, and that Takeda neither researched the medication properly nor issued proper warnings about the risk.

While Takeda’s attorneys do not agree with all of the plaintiffs’ assertions, they agree that the case qualified for a MDL consolidation in order to reduce or eliminate duplicative discovery and contradictory rulings.

A schedule for oral arguments on the consolidation motion is expected when the U.S. Judicial Panel on Multidistrict Litigation holds a hearing on December 1, 2011 in Savannah, Georgia. We'll be attending the hearing that day.

Lilly pulls sepsis drug Xigris

2011-10-25T18:28:00.000-07:00

Eli Lilly and Co withdrew its sepsis drug Xigris from all markets after the product, deemed a potential big seller when it was approved a decade ago, failed to improve survival in a clinical trial.

Sepsis is a severe, often life-threatening illness caused by the immune system's over-aggressive response to infections -- releasing inflammatory proteins that cause shock and shut down multiple organs. The condition occurs in 1 to 2 percent of all hospitalizations in the United States.

Xigris, which has never reached its lofty initial sales projections, had global sales of about $100 million in 2010. It has garnered total sales of $1.5 billion since being approved in the United States in 2001 and in Europe the following year.

http://www.reuters.com/article/2011/10/25/elililly-idUSN1E79O08320111025

Source here:

Listeria outbreak: Victims file lawsuits: Collection an issue?

2011-10-18T10:39:00.000-07:00

“Jensen Farms is not a major corporation that has significant financial assets,” says Fred Pritzker, a Minneapolis-based attorney specializing in food-poisoning cases who is representing two victims in Illinois and New York. “When you factor in the severity of the illness and the number of deaths and illnesses that will be attributed to this in the days and weeks to come, you just know they don’t have nearly enough assets to fully compensate them.”

So begins the report on the Listeria outbreak: Read more here.

Encision Announces Voluntary Recall of Certain Electrode Product

2011-10-18T09:04:00.000-07:00

Encision Inc. (ecia:PK), a medical device company owning patented surgical technology that is emerging as a standard of care in minimally-invasive surgery, announced today that it initiated a voluntary recall on August 24, 2011 of certain electrode tips used in its AEM® surgical systems after determining that certain tips could become susceptible to breaking off as a consequence of aggressive cleaning of the tip. The tips covered by the voluntary recall are Encision's ES388X Series Reusable Suction-Irrigation Electrodes. All of the affected instruments will be replaced at no charge to the customer.

Encision has contacted customers by letter and will provide them with replacement instruments as soon as they are available. The Company has developed a replacement instrument and is currently working with the FDA to obtain approval of the replacement. Until the FDA provides its approval, the Company will not be able to provide replacement products to customers. In the interim, the Company has provided customers with the prior version of the product, which is not susceptible to the same issues as the recalled product.

Read more at the source.

Sprycel Warning from the FDA

2011-10-17T17:20:00.000-07:00

The FDA issued a warning regarding the safety of leukemia drug Sprycel. Sprycel is indicated for treating certain adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). The drug, which has treated approximately 32,882 patients since launch, blocks the action of an abnormal protein that causes tumor growth.

The US regulatory body stated that treatment with the drug may elevate the risk of high blood pressure in the lungs’ arteries. The disorder is referred to as pulmonary arterial hypertension (PAH). The FDA stated that due to high blood pressure the heart has to work harder to pump sufficient blood through the lungs. Consequently, the heart muscles stand the risk of becoming weak which may cause them to loose the ability to perform the above function. Breathlessness, fatigue and swelling of body parts (such as the ankles and legs) are the common symptoms associated with PAH.

Source here.

Johnson & Johnson Wins Zero Verdict Over Levaquin's Side Effects

2011-10-17T17:15:00.000-07:00

Johnson & Johnson on Friday won a significant lawsuit concerning whether it adequately alerted doctors to the risks in prescribing Levaquin.

J & J is facing more than 2,000 lawsuits from plaintiffs who claim the company was slow in fully warning doctors about reports linking Levaquin to tendonitis and tendon ruptures. In a New Jersey state court in Atlantic City, lawyers for the drug maker told jurors that the Levaquin label had included information about tendon problems since the FDA approved the drug in 1996.

Read more here.

Should You Take a Multivitamin?

2011-10-16T19:13:00.001-07:00

From ABC News:

video platform video management video solutions video player

Home Fires Prompt Dehumidifier Recall Reannouncement from LG Electronics

2011-10-16T19:10:00.001-07:00

From the CPSC:

LG Electronics Tianjin Appliance Co., in cooperation with the U.S. Consumer Product Safety Commission (CPSC), is urging consumers to check if they have recalled Goldstar or Comfort-Aire dehumidifiers. The firm is re-announcing the recall of about 98,000 of the dangerous dehumidifiers that pose a serious fire and burn hazard, and are believed to be responsible for more than one million dollars in property damage.
The power connector for the dehumidifier’s compressor can short circuit, posing fire and burn hazards to consumers and their property.
The dehumidifiers were first recalled in December 2009 following eleven incidents, including four significant fires. Since that time, the company has received sixteen additional incident reports of arcing, smoke and fire associated with the dehumidifiers, including nine significant fires. No injuries have been reported. Fires are reported to have caused more than $1 million in property damage including:

$500,000 in damage to a home in Gibsonia, Pa.
$200,000 in damage to a home in New Brighton, Minn.
$183,000 in damage to a home in Hudson, Mass.
$192,000 in damage to a home in Valparaiso, Ind.
$139,000 in damage to a home in Salem, Ohio
$129,000 in damage to a home in Brielle, N.J.
$ 95,000 in damage to a home in Philadelphia, Pa.

Because of the severity of the risks, CPSC and LG Electronics are concerned with the lack of consumer response to the recall. Only two percent of the 98,000 consumers who purchased these units have received a free repair, which means that consumers and their property remain at serious risk.
Anyone who has the recalled dehumidifiers is strongly encouraged to immediately stop using them, unplug them, and contact LG Electronics for the free repair.
The recall involves the 30 pint portable dehumidifiers sold under the Goldstar and Comfort-Aire brands. The dehumidifiers are white with a red shut-off button, controls for fan speed and humidity control, and a front-loading water bucket. “Goldstar” or “Comfort-Aire” is printed on the front. Model and serial number ranges included in this recall are listed in the table below. The model and serial numbers are located on the interior of the dehumidifier, and can be seen when the water bucket is removed.

Brand	Model No.	Serial Number Range	Sold at
Goldstar	GHD30Y7	611TAxx00001 through 08400 611TAxx08401 through 40600 612TAxx00001 through 20400 612TAxx21001 through 30600	Home Depot
Goldstar	DH305Y7	612TAxx00001 through 00600 701TAxx00001 through 16800 702TAxx00001 through 03000	Walmart
Comfort-Aire	BHD-301-C	611TA000001 through 001697 612TA000001 through 004200 701TA000001 through 000578 710TA000001 through 000599	Various retailers, including Ace Hardware, Do It Best and Orgill Inc.

The recalled dehumidifiers were sold at The Home Depot, Walmart, Ace Hardware, Do It Best, Orgill Inc., and other retailers nationwide from January 2007 through June 2008 for between $140 and $150. They were manufactured in China.