Articles Posted in Dietary Supplement Litigation

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A U.S. district court judge has rejected the attempts of Takeda Pharmaceutical Co. and Eli Lilly & Co. to overturn the combined $9 billion punitive-damage award that a jury recently returned. The verdict came down in a case that involved claims that the drug makers chose to hide the cancer risks of their Actos diabetes drug. The presiding judge held that the jury properly considered evidence that showed officials of the Osaka, Japan-based Takeda, and Indianapolis-based Lily had advance knowledge that Actos was associated with bladder cancer and chose not to properly and efficiently warn doctors and patients about those risks.

However, although the judge upheld the jury’s verdict, the judge is still considering another motion that was brought post-trial by the defendants for a new trial. That motion is pending for a case of Terrence Allen v. Takeda, et al., which was the first federal trial over claims that Actos causes bladder cancer.

The widespread sales of the Actos pharmaceutical product reached its highest level on March 2011 when the product had sales of $4.5 billion and accounted for 27% of Takeda’s revenue in total. Since the time Actos was released by Takeda in 1999, it had made sales in excess of $16 billion. Today Takeda must contend with generic competition from other drug makers.

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USPLabs LLC, which is the maker of dietary sports supplements purchased over the counter, is now asking to consolidate nine federal lawsuits that have been brought against the company by individual injured plaintiffs. The company makes the product OxyElite Pro, which has been associated with liver injuries and hepatitis.  The motion to consolidate was brought before the United States District Court for the Southern District of California in the Multi-District Litigation (MDL). USPLabs is a defendant in lawsuits pending against it in California, Florida, Hawaii, Pennsylvania and Texas.

There are at least six personal injury lawsuits pending as well as three proposed class-action lawsuits. It was alleged that OxyElite Pro and the product Jack3d contained unsafe ingredients or adulterated ingredients as defined by the U.S. Food and Drug Administration (FDA).

The unsafe ingredient, known as DMAA, contains two substances that have been associated with fatalities and liver failure. USPLabs is located in Dallas, Texas, which has been named in these lawsuits along with GNC Holdings Inc., which has partnered with USPLabs in marketing these dietary supplement products.

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Several dietary supplements are being tested again in the United States and the Netherlands because of a new synthetic stimulant widely used in these products. The stimulant has been untested on humans. Federal regulators have taken no action, although the government has been urged by scientists to look closer.

The chemical DMAA, a stimulant as labeled by the U.S. Food and Drug Administration (FDA), is illegal when mixed with dietary supplements or any other product consumed by humans. DMAA is an ingredient that carries the risks of heart attacks, seizures and neurological problems. That compound is also listed on labels as AMP Citrate. AMP Citrate is a close relative of the compound DMAA.

Pieter Cohen, an assistant professor at Harvard Medical School and a co-author of an article of the scientific journal Drug Testing and Analysis, stated, “We want the FDA and we want the stores to immediately remove these products from the store shelves,” referring to products sold to the public containing DMAA. According to the research published, 14 products were tested that listed AMP Citrate, 4-amino, 2-methylpentane citrate or some of the other chemical names used to describe the new stimulant. According to Cohen, these are marketing names.

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The U.S. Justice Department reached a settlement with Johnson & Johnson, which is the maker of Risperdal. The settlement of $2.2 billion and a misdemeanor plea comes after a long investigation into the marketing of the pharmaceutical product, Risperdal. It is an anti-psychotic drug known to deliver harmful side effects, especially to young boys and young men most often prescribed the medicine.

In this case, the Department of Justice engaged several whistleblowers around the country to help the investigation and act as Johnson & Johnson informants. In fact, collectively, the whistleblowers will receive upwards of $167 million for their efforts.

The whistleblowers took great risk in assisting the Department of Justice in this investigation. Some of the whistleblowers went undercover, wore a wire, helped in prepping the department lawyers for depositions and otherwise risked their livelihood and their careers.

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Phusion Projects Inc. manufactures and distributes the alcoholic beverage Four Loko. The product contains alcohol in addition to caffeine, guarana, taurine and wormwood. Guarana is a plant that has one of the highest concentrations of caffeine in any plant. It’s often used as a supplement to energy drinks, including this one. Taurine is an organic acid or an amino acid that some research shows may be a contributing factor to improved athletic performances. Wormwood is an herb. Some uses of wormwood are said to be for digestive disorders and to increase sexual desires and stimulate the imagination.  Wormwood is also used for healing wounds and countering insect bites. It is also used in some alcoholic beverages, such as vermouth and absinthe. 

Phusion purchased insurance coverage from two members of the Liberty Mutual Group. Both of the insurance policies contained clauses that excluded coverage for bodily injury or property damage when Phusion could be held responsible by reason of causing or contributing to intoxication.

Phusion was sued by five separate plaintiffs. All of them alleged that the consumption of Four Loko caused their injuries in whole or in part.

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According to a recent study and a New York Times report, dietary supplements containing high concentrations of green tea extract result in up to 20 percent of liver injuries in patients who turn up in hospitals. This new data was analyzed by a national network of liver specialists. 

Dietary supplements are regularly purchased at nutrition stores promising weight loss or build up of muscle mass.  Many who take dietary supplements are young, but the studies show that middle-aged women and men are also often buying these products. 

Americans spend $32 billion a year on dietary supplements. The dietary supplement distribution is by and large unregulated. 

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