Sunday, August 23, 2015

Iowa Dietary Supplement Firm Shuts Down Under Consent Decree

U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.  
 
The company and its owners marketed their products online athttp://stores.iowaselectherbs.com/ and through online marketplace websites, such as eBay, Amazon and buy.com. They also sold their products through a retail location in Cedar Rapids, Iowa. 
“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458752.htm

FDA: CBD oil not a dietary supplement

A warning letter went to a seller of CBD Oil: 


This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.hempoilcare.com[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops,” which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of claims observed on your website https://www.hempoilcare.com that establish the intended use of your products include, but may not be limited to: 
 
On the “CBD oil – Pure Vape E-Drops 50mG” product webpage, https://www.hempoilcare.com/product/cbd-oil-pure-vape-drops/:
 
• “A literature review from 2009 recapped CBD’s documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . .”
 
On the “Hemp oil – Dixie Botanicals Dew Drops” product webpage, https://www.hempoilcare.com/product/hemp-oil-dixie-botanicals-dew-drops-100mg/:
 
• “EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries)”
 
On the “CBD Oil” webpage, https://www.hempoilcare.com/cbd-oil/:
 
Under the heading, “Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment”:
 
 “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer.”
 “[T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . ..”
 
Under the heading, “CBD May Help Reduce Psychotic Symptoms of Schizophrenia”:
 
 “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . ..”
 “[Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both ‘safe and effective’ but they declared CBD superior . . . .”
 
It is clear from the claims above that your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
 
Your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Additionally, your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Your marketed products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115.  For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
 

Friday, July 31, 2015

Akttive High Performance Fat Burner Gold capsules recalled

783 bottles of Akttive High Performance Fat Burner Gold capsules weight loss supplements have been recalled. 

The product contains Sibutramine, desmethylsibutramine and Phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States. These undeclared ingredients make the product an unapproved new drug for which safety and efficacy have not been established.

No illnesses or injuries have been reported to the company to date in connection with this product.

The product, marketed as a dietary supplement for weight loss, is packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17.

Teva recalls Adrucil cancer drug for a second time

Teva has issued a voluntary recall for its intravenous cancer medicine Adrucil because of the potential presence of impurities.
As Philadelphia Business Journal reported, Teva recalled six lots of Adrucil because they may contain small amounts of silicone rubber pieces and fluorouracil crystals. In May, it recalled eight lots of the cancer medicine for the same reason.
No adverse events have been reported, but a company statement on the FDA website said “administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.”

http://www.phillyvoice.com/teva-recalls-cancer-drug-second-time/

Bexco recalls DaVinci brand cribs

Bexco recalled about 11,700 DaVinci brand cribs in the United States and Canada because a metal bracket that connects the mattress support to the crib can break, creating an uneven sleeping surface or a gap. If this occurs, a baby can become entrapped in the crib, fall, or suffer lacerations from the broken metal bracket.

The recall includes DaVinci brand full-size cribs including the Reagan crib (model #M2801), the Emily crib, (model #M4791), the Jamie crib (model #M7301), and the Jenny Lind crib (model #M7391) manufactured from May 2012 through December 2012.

The company has received 10 reports of the mattress support brackets detaching. No injuries have been reported. For more information, go to the U.S. Consumer Product Safety Commission websit

Read more at http://www.philly.com/philly/blogs/healthy_kids/Bexco-recalls-DaVinci-brand-cribs.html#KRWQ2uiHVmzRbhE4.99

Monday, July 27, 2015

Bard IVC Filters and Potential Claims (July 2015)



Inferior vena cava (IVC) filters sold by Bard have been found to have a high failure rate in a study published in  the Archives of Internal Medicine.
IVC filters are implanted in patients to help prevent pulmonary embolism due to blood clots moving into the lungs. Patients who receive IVC filters such as the Bard Recovery and the G2 by Bard are often patients who are either unresponsive or unqualified due to other medical problems for anti-coagulant drugs.
The tiny vena cava filters are shaped similarly to a cone with legs that extend to catch blood clots. When these legs break off the pieces or the entire filter can migrate through the body to affect other body parts, perforate veins and even cause sudden death. The result of this study caused the FDA to take notice of the dangers involved in using IVC filters and issued a warning to physicians to monitor their patients and remove the filters once the risk of blood clotting has passed.  
The FDA issued a communication on this: 
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided. 
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm

If you have been harmed by one of these products, call us at 866.373.1800 and ask for Ms. Cragin.

Xarelto Trials Set for 2016

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Now, more than 500 Xarelto lawsuits have been consolidated and are currently pending in federal district court in the Eastern District of Louisiana, and District Court Judge Fallon recently announced that the first bellwether trial is scheduled for August 1, 2016.
Besides the Xarelto trial set for August 1, 2016, the court also scheduled three more bellwether trials for August 22, September 12, and October 17, 2016. The first two trials will take place in the Eastern District of Louisiana, the third will be held in the Southern District of Texas, and the fourth is scheduled for the Southern District of Mississippi.
You can also find the Order regarding case-specific discovery here: 
http://www.laed.uscourts.gov/Xarelto/Orders/PTO14.pdf



Friday, June 19, 2015

Lumber Liquidators MDL Goes to Alexandria Virginia United States District Court Judge

Nationwide there is litigation involving Lumber Liquidators over claims of formaldehyde in several of the company's laminated flooring products. You can read more about the claims here.

Lawyers working on the cases asked to have the many different lawsuits centralized in one Court. Lumber Liquidators, based in Virginia asked to have all related cases sent to its home state. After hearing from various lawyers, the Judicial Panel on Multi District Litigation chose Alexandra Virginia. Here's the Order  


St. Mary's Hospital: Children's Deaths from Open Heart Surgeries at St. Mary's Hospital in West Palm Beach Prompt Federal Investigation

A West Palm Beach, Florida hospital, St. Mary’s Medical Center, is the subject of an investigation from The Centers for Medicare & Medicaid Services, as the hospital reportedly has one of the highest rates of death from open heart surgeries on children. Between the years 2011 and 2013, the mortality rate had risen as high as 12.5% among surgery recipients, according to reports.
CNN managed to obtain the data that the hospital is required to report to the state in order to calculate the 12.5% mortality rate.. This means that the death rate is nearly three times higher than the national average in hospitals around the country who perform heart surgery on infants and children. There is large concern among parents who have lost their children, as well as federal authorities, that the facility may be neglecting the basics of care, especially with regard to their Medicaid and Medicare patients.

The majority of patients who underwent open heart surgery at St. Mary’s Hospital were Medicaid patients. St. Mary’s Medical Center’s parent company, Tenet Healthcare, has declined to comment further on the claims that have been made about its program which opened in December 2011. This raises concerns over whether or not the hospital has been withholding its facts and figures.
CNN discovered after reviewing the information the hospital supplied to the State of Florida that 12.5% of the babies who underwent heart surgery since the progam’s beginning died. Heart surgery is often necessary to correct congenital heart defects. In centers which perform the highest number of surgeries to correct these defects, he mortality rate is very low regardless of the difficulty of the surgery.

According to physicians hired by the State of Florida to look into its program, St. Mary’s did not perform enough surgeries each year to become proficient. In fact, they did not perform even two surgeries per month over the life of the program. In fact, these investigators determined that St. Mary’s needed to stop all surgeries on infants immediately. St. Mary’s ignored the recommendations in this report and continued to operate on babies some of whom were injured or died.




Thursday, May 07, 2015

FDA Warns 14 Sports Supplement Companies Of Illegal DMBA (AMP Citrate)

BMPEA is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.
BMPEA is also known as:
  • ╬▓MePEA
  • R-beta-methylphenethylamine
  • R-beta-methylphenethylamine HCl
  • Beta-methylphenethylamine
  • ╬▓-methylphenylethylamine
  • 1-amino-2-phenylpropane 
  • 2-phenylpropan-1-amine 
  • 2-phenylpropylamine
  • alpha-benzylethylamine
  • 1-phenyl-1-methyl-2-aminoethane
  • beta-methylbenzeneethanamine
  • beta-phenylpropylamine
  • 2- phenyl-1-propanamine 
On April 23, 2015, the FDA issued warning letters to five companies regarding a total of eight products for which the product labeling lists BMPEA as a dietary ingredient. Two of the companies further identified the source of this stimulant as the botanical Acacia rigidula.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
While BMPEA was listed as a dietary ingredient on the product labels, the substance does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement. Additionally, relating to the two companies that identified the botanical Acacia rigidula as the source of the BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula.  FDA considers these specific products to be misbranded for this reason, as well.
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law.


Saturday, April 25, 2015

Toxic Diet Pills Kill a 21 Year Old DNP

News of a tragic death this week involving a diet pill with DNP.

2,4-Dinitrophenol (2,4-DNP, DNP) is an organic compound with the formula HOC6H3(NO2)2. It is a yellow, crystalline solid that has a sweet, musty odor. It sublimes, is volatile with steam, and is soluble in most organic solvents as well as aqueous alkaline solutions. It is a precursor to other chemicals and is biochemically active, inhibiting energy (ATP) production in cells with mitochondria. DNP is considered an important environmental contaminant by the United States Environmental Protection Agency.

From various news sites:

The tablets that Parry is believed to have taken shortly before her death are being tested for a toxic substance called dinitrophenol or DNP, police said. Generally described as a yellow, powdery substance in medical literature, dinitrophenol has been used as a black market weight-loss drug for decades, authorities said.
The substance is illegal for use in a diet drug or supplement in the United States, according to a spokeswoman for the U.S. Food and Drug Administration.
Parry's mother, Fiona Parry, recounted the details leading up to her daughter's death on a post on the police department's website.
Fiona Parry said her daughter became ill after taking the diet pills but didn't initially realize the gravity of her situation. Even after taking herself to a local hospital, her daughter said she did not initially feel gravely ill, Fiona Parry recalled.
https://gma.yahoo.com/police-investigate-diet-pills-containing-dnp-womans-death-192949806.html

Saturday, April 18, 2015

NECC Litigation News

I'm one of seven lawyers appointed by a Federal Court Judge to prosecute the civil case involving New England Compounding Pharmacy. I'm NOT a class action lawyer. An interesting and compelling read from Newsweek this week:

http://www.newsweek.com/2015/04/24/inside-one-most-murderous-corporate-crimes-us-history-322665.html

2015_04_17_Cover_600 x 800

Monday, April 13, 2015

Lumber Liquidators: Litigation and News for April 2015

Concerned?  Contact us today using the form to the right of this post. 
Certified laboratory testing performed on laminate wood flooring purchased from Lumber Liquidators locations in Virginia, Florida, Texas, Illinois, and New York revealed levels of formaldehyde, a known carcinogen, that exceed those permitted by the California Air Resources Board (CARB) and the Formaldehyde Emissions Standards for Composite Wood Products Act, which will take effect nationwide this year. According to this testing, certain laminate flooring samples contained up to 20 times the legal level of formaldehyde. The 60 Minutes report indicates that these extreme levels of formaldehyde raised concern among laboratory employees, who suspected that their testing equipment may be faulty.
A certain amount of formaldehyde is present and legally permissible in laminate flooring manufactured by Lumber Liquidators in America, and by other companies. Lumber Liquidators laminate flooring sold at Home Depot and Lowes stores is CARB-compliant, as it contains levels of formaldehyde which the California Air Resources Board has deemed safe. 

These Lumber Liquidators lumber products  may contain excessive and illegal amounts of formaldehyde

  • 8 mm Bristol County Cherry Laminate Flooring
  • 8 mm Dream Home Nirvana French Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Antique Bamboo Laminate Flooring
  • 12 mm Dream Home St. James Oceanside Plank Bamboo Laminate Flooring
  • 12 mm Dream Home Kensington Manor Warm Springs Chestnut Laminate Flooring
  • 15 mm Dream Home St. James Sky Lakes Pine Laminate Flooring
  • 12 mm Dream Home Ispiri Chimney Tops Smoked Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Imperial Teak Laminate Flooring
  • 12 mm Dream Home St. James Vintner’s Reserve Laminate Flooring
  • 12 mm Dream Home Kensington Manor Cape Doctor Laminate Flooring
  • 12 mm Dream Home St. James Cumberland Mountain Oak Laminate Flooring
  • 12 mm Dream Home Ispiri Americas Mission Olive Laminate Flooring
  • 12 mm Dream Home Kensington Manor Glacier Peak Poplar Laminate Flooring
  • 12 mm Dream Home Kensington Manor Golden Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Handscraped Imperial Teak Laminate Flooring (SKU 10029601)
  • 12 mm Dream Home Kensington Manor Handscraped Summer Retreat Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Sandy Hills Hickory Laminate Flooring
  • 12 mm Dream Home Kensington Manor Tanzanian Wenge Laminate Flooring
  • 8 mm Dream Home Nirvana Royal Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Blacksburg Barn Board Laminate Flooring
  • 12 mm Dream Home St. James Brazilian Koa Laminate Flooring
  • 12 mm Dream Home St. James Golden Acacia Laminate Flooring
  • 12 mm Dream Home Ispiri Poplar Forest Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Fumed African Ironwood Laminate Flooring
  • 12 mm Dream Home St. James African Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Chimney Rock Charcoal Laminate Flooring
At high levels, formaldehyde is considered a known human carcinogen because it can cause various types of cancer, including myeloid leukemia and nasopharyngeal cancer. At low levels, formaldehyde exposure can cause a number of additional problems such as respiratory issues, asthma and irritation of the eyes, nose and throat. According to the 60 Minutes report, children may be most susceptible to these issues, as they are often in close contact with the flooring.


Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. This type of cancer usually gets worse quickly if it is not treated. It is the most common type of acute leukemia in adults. AML is also called acute myelogenous leukemia, acute myeloblastic leukemia, acute granulocytic leukemia, and acute nonlymphocytic leukemia.


Nasopharynx cancer or nasopharyngeal carcinoma (NPC) is the most common cancer originating in the nasopharynx, the uppermost region of the pharynx ("throat"), behind the nose where the nasal passages and auditory tubes join the remainder of the upper respiratory tract. NPC occurs in children and adults. NPC differs significantly from other cancers of the head and neck in its occurrencecauses, clinical behavior, and treatment. It is vastly more common in certain regions of East Asia and Africa than elsewhere, with viraldietary and genetic factors implicated in its causation. It is most common in males. It is a squamous cell carcinoma or an undifferentiated type. Squamous epithelial cells are a flat type of cell found in the skin and the membranes that line some body cavities. Differentiation means how different the cancer cells are from normal cells. Undifferentiated is a word used to describe cells that do not have their mature features or functions.

Tuesday, March 10, 2015

Herbal Supplements, their Safety and Marketing: State Prosecutors to Form Coalition


The states are getting their respective acts together. This report today:

 A group of attorneys general is expected to announce on Tuesday that they are forming a coalition to crack down on fraud and quality control issues in the herbal supplement industry.

The coalition would signal a shift in the way law enforcement agencies ensure the safety of herbal supplements, a $5 billion-a-year industry that has been plagued by complaints of mislabeling. An investigation by the New York State attorney general’s office led to accusations last month that four national retailers were selling supplements that contained either little or none of the medicinal herbs advertised on their labels or, in many cases, included cheap fillers and contaminants like powdered rice, wheat and houseplants.

The retailers — GNC, Target, Walmart and Walgreens — were forced to pull the products from their shelves. The state attorney general, Eric T. Schneiderman, later issued subpoenas to the manufacturers of the products, demanding that they explain how they verify the quality of their products and what testing they do to support a variety of claims on their labels, like “gluten free” and “hypoallergenic.”


Critics of the industry have argued that the Food and Drug Administration does not have enough power to keep fraudulent or dangerous products from reaching store shelves. The F.D.A. is restricted by a 1994 federal law — sponsored by Senator Orrin G. Hatch, Republican of Utah, who has strong financial ties to the industry — that prevents it from subjecting supplements to the strict approval process applied to prescription drugs.

As a result, unsafe herbal products generally are pulled from stores only after they have caused harm. But Dr. Arthur P. Grollman, an expert on herbal supplements at Stony Brook University, said he believed that greater action at the state level might pressure the supplement industry to address some of its safety issues.
Dr. Grollman was among the experts who more than a decade ago led calls for a ban on ephedra, an herbal supplement that was linked to many heart attacks, strokes and deaths. The F.D.A. eventually banned ephedra in 2004, only after several states and counties had introduced legislation outlawing its sale in their local stores.

http://well.blogs.nytimes.com/2015/03/09/safety-of-herbal-supplements-pulls-prosecutors-together/?_r=0

Monday, March 09, 2015

New York AG asks Retailers to Halt Sales (GNC, Target, Walgreens), Round 2

Round 2 continues, as a number of companies have received letters. These include Pharmavite (the Nature Made brand); NBTV - which makes Sundown Naturals, Nature's Bounty, Met-Rx and Solgar. Also named were Nature's Way, and Nutraceuticals Corp.  

Previously, these companies were sent letters: 

 GNC:

  • Six “Herbal Plus” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from four locations with representative stores in Binghamton, Harlem, Plattsburgh & Suffolk.
  • Only one supplement consistently tested for its labeled contents: Garlic. One bottle of Saw Palmetto tested positive for containing DNA from the saw palmetto plant, while three others did not. The remaining four supplement types yielded mixed results, but none revealed DNA from the labeled herb.
  • Of 120 DNA tests run on 24 bottles of the herbal products purchased, DNA matched label identification 22% of the time.
  • Contaminants identified included asparagus, rice, primrose, alfalfa/clover, spruce, ranuncula, houseplant, allium, legume, saw palmetto, and Echinacea.
Target:
  • Six “Up & Up” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Valerian Root, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Nassau County, Poughkeepsie, and Syracuse.
  • Three supplements showed nearly consistent presence of the labeled contents: Echinacea (with one sample identifying rice), Garlic, and Saw Palmetto. The remaining three supplements did not revealed DNA from the labeled herb.
  • Of 90 DNA tests run on 18 bottles of the herbal products purchased, DNA matched label identification 41% of the time.
  • Contaminants identified included allium, French bean, asparagus, pea, wild carrot and saw palmetto.
Walgreens:
  • Six “Finest Nutrition” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Brooklyn, Rochester and Watertown.
  • Only one supplement consistently tested for its labeled contents: Saw Palmetto. The remaining five supplements yielded mixed results, with one sample of garlic showing appropriate DNA. The other bottles yielded no DNA from the labeled herb.
  • Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 18% of the time.
  • Contaminants identified included allium, rice, wheat, palm, daisy, and dracaena (houseplant).
Walmart:
  • Six “Spring Valley” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three geographic locations with representative stores in Buffalo, Utica and Westchester.
  • None of the supplements tested consistently revealed DNA from the labeled herb. One bottle of garlic had a minimal showing of garlic DNA, as did one bottle of Saw Palmetto. All remaining bottles failed to produce DNA verifying the labeled herb.
  • Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 4% of the time.
  • Contaminants identified included allium, pine, wheat/grass, rice mustard, citrus, dracaena (houseplant), and cassava (tropical tree root).
The Attorney General’s investigation follows an important study conducted by the University of Guelph in 2013 that also found contamination and substitution in herbal products in most of the products tested. As was said at the time by a spokesperson for the University of Guelph, “The industry suffers from unethical activities by some manufacturers.”
The market for herbal supplements is significant. The Natural Products Foundation estimates that the dietary supplement industry contributes $61 billion dollars to the national economy. A 2013 study from the Canadian Institutes of Health Research estimated there are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.
That same study also found that more than half of Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012 were dietary supplements. Class I recalls are reserved for drugs or supplements for which there is a “reasonable probability that [their use] will cause serious adverse health consequences or death.”
The Attorney General thanks Dr. James A. Schulte II of Clarkson University in Potsdam, N.Y. for providing his expertise in DNA barcode testing for this investigation.
The case is being handled by Executive Deputy Attorney General Marty Mack and Assistant Attorney General Deanna Nelson with the assistance of NYAG’s thirteen regional offices.

Friday, February 27, 2015

Walgreens, Walmart, GNC and Target Pull Dietary Supplements from Shelves

Four large retailers were ordered  by the New York State Attorney General’s Office to immediately stop selling their store brands of herbal dietary supplements due to allegedly mislabeled or adulterated product content.
Attorney General Eric T. Schneiderman and Executive Deputy Attorney General Martin J. Mack issued cease-and-desist orders to GNC Holdings, Inc., Target Corporation, Walgreens, Wal-Mart Stores, Inc., regarding the marketing of up to seven herbal supplements: Gingko [sic] biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Saw Palmetto, and Valerian root. (Valerian was only tested from Target, in place of Ginseng.).
http://www.forbes.com/sites/davidkroll/2015/02/03/cease-and-desist-orders-hit-walmart-walgreens-and-others-for-herbal-supplement-sales/

Tuesday, February 24, 2015

Zofran Making the News- A Timeline (as of February 2015)

In recent months, our law firm have been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries involving this product. 
Call us anytime, or email me directly - mark(at)markzamora.com    (You can also read more at www.zofran-injuries.com)
What is it? Ondansetron (INN), originally marketed under the brand name Zofran, is a serotonin 5-HT3 receptor antagonist used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. For some women, it was used to treat nausea. 
We believe there is now evidence that Zofran may allegedly  be the cause of defects in children. The FDA never approved this drug for morning sickness and GlaxoSmithKline (GSK), the maker of this drug, paid a $2 billion settlement in a civil lawsuit that involved allegations that GSK illegally promoted its Zofran drug to be prescribed to expectant mothers.  This settlement did not include payments for injuries suffered due to the use of Zofran. 
Here is a timeline of this product: 
January 5, 1993:  The New York Times reported that the FDA approved a pill form of Zofran.

January 4, 1991:  The FDA approved Zofran (ondansetron) for chemotherapy-related nausea and vomiting 

June 22, 1995:  GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride)

June 24, 1997:  The FDA approved GlaxoWellcome's New Drug Application (see June 22, 1995, entry).

March 9, 1999:  The FDA issued a warning letter to GlaxoWellcome regarding its marketing of anti-nausea drug Zofran. According to that letter, Glaxo failed to warn consumers about Zofran's adverse side effects while touting its effectiveness with statements such as:
·         "Zofran can,"
·         "24-hour control," and
·         "Prevention of emesis I to 2 days after chemotherapy."

June 22, 1995:  GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride) 

June 24, 1997:  The FDA approved GlaxoWellcome's New Drug Application 
December 27, 2006:  The FDA approved generic versions of Zofran .
August 2011:  To test Zofran's cardiac risks, GlaxoSmithKline began a study titled "A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects" 
September 2011: GlaxoSmithKline revised Zofran labels to include the following, per the FDA:
  • "Information regarding post-marketing case reports of Torsade de Pointes;
  • Recommendation to avoid use in patients with known congenital long QT syndrome;
  • ECG monitoring recommendation in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation."
September 15, 2011:  The FDA issued a Drug Safety Communication regarding Zofran  That alert stated that:
  • Zofran may change the heart's electrical activity and that change could cause an abnormal heart rhythm such as Torsade de Pointes; and
  • Zofran's labels would therefore be revised. Per the FDA:
The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.
The FDA also ordered Zofran maker GlaxoSmithKline to conduct QT prolongation studies.
January 2012:The CDC’s Nation Center on Birth Defects and Developmental Disabilities publishes a report finding that Zofran (ondansetron) taken during the first trimester of pregnancy doubles the risk of a cleft palate birth defect.

There were over 9,000 pregnant women in the study overall, both cases and controls; 67% reported NVP and 15% used some kind of agent to treat NVP. The study used data from the National Birth Defects Prevention Study, looking at the association between NVP and treatments for NVP and cleft palate, and other noncardiac birth defects. Link here

June 2012: GlaxoSmithKline (GSK), the maker of Zofran, pleads guilty to federal criminal health care fraud charges for violations of the Food, Drug, and Cosmetic Act relating to three of its branded drugs. At the same time, GSK also agrees to pay $1 billion in criminal penalties as well as $2 billion in civil penalties to resolve a federal whistleblower lawsuit that included claims that GSK wrongfully promoted Zofran for off-label promotion for use in expectant mothers, and paying kickbacks to doctors to prescribe Zofran for such off-label use.
This $3 billion dollar penalty is the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States. 
August 2013: Two papers relating to Zofran and birth defects are presented at the International Society of Parmacoepidemiology. The first paper concludes that Zofran (ondansetron) taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. Importantly, the second paper includes the data from the first paper but covered more years and more pregnant woman that the first study and came to an opposite conclusion: There is a doubling of the risk of cardiac malformations. Specifically, there was a significant increase in the prevalence of major congenital heart defects in children whose mothers redeemed a presdription of Zofran (ondansetron) during in the first trimester of pregnancy. 
August 2013: Two papers relating to Zofran and birth defects are presented at the International Society of Parmacoepidemiology. The first paper concludes that Zofran (ondansetron) taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. Importantly, the second paper includes the data from the first paper but covered more years and more pregnant woman that the first study and came to an opposite conclusion: There is a doubling of the risk of cardiac malformations. Specifically, there was a significant increase in the prevalence of major congenital heart defects in children whose mothers redeemed a presdription of Zofran (ondansetron) during in the first trimester of pregnancy. 
July 2014: American researchers confirm earlier reports that Zofran (ondansetron) crosses the placental barrier during pregnancy in relatively high concentrations (approximately 40% of the maternal plasma levels) after just three oral doses. The authors conclude that the high lipid solubility of Zofran (ondansetron) increases its ability to be taken up into fetal tissue in larger amounts. 

August 2014: A Swedish study investigating the risk of birth defects from Zofran (ondansetron) reports that this drug poses a significantly increased risk for cardiac septum defects in the offspring of women who took Zofran during the first trimester of pregnancy. 


From the FDA in 2013:

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January– March 2013


The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2013 in the FAERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) January - March 2013

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of March 1, 2014)

Metoprolol succinate extended release products
Lack of therapeutic effect, possibly related to product quality issues

FDA decided that no action is necessary at this time based on available information.
Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz)
Serotonin syndrome
FDA is continuing to evaluate this issue to determine the need for any regulatory action.