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Pharmaceuticals

Word "Recall" in Foreground with Hospital Hallway in Background

Valsartan is used to treat high blood pressure and congestive heart failure. A number of drug makers offer generic versions of the drug, but the complaint for this class action alleges that some recent lots have been contaminated. It brings suit against Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Major Pharmaceuticals, Zhejiang Huahai Pharmaceuticals, Ltd. (ZHP), Huahai U.S., Inc., and Rite Aid Corporation.

Package for Mylan Valsartan

When American companies make generic prescription drugs, they may use active pharmaceutical ingredients (APIs) manufactured overseas, where standards may be lower. The complaint for this class action alleges that Mylan Pharmaceuticals, Mylan NV, and Rite Aid Corporation sold medicines containing valsartan contaminated with N-nitrosodiethylamine (NDEA).

Package of Irbesartan from Westminster

Federal law requires that drug manufacturers follow “current Good Manufacturing Practices” (cGMPs) in making their pharmaceuticals. Nevertheless, the complaint for this class action claims that a company in India sold an active pharmaceutical ingredient that was adulterated with a probably carcinogen, and that the ingredient found its way through two American companies to the pharmacy at Walmart. 

Lidoderm Packaging

Three settlements resolve class actions against a number of companies:

Two Aggrenox Capsules

This settlement is a pricey one for Boehringer Ingelheim, requiring $54 million to settle claims alleging that it delayed the availability of a less-expensive version of its drug Aggrenox through illegal agreements with Barr (later acquired by Teva).

Scynexis Office Building in New Jersey

Scynexis didn’t disclose health and safety risks for its lead drug candidate, says the complaint for this class action. Risks of thrombotic events were uncovered in Phase 1 studies, but according to the complaint, they were not mentioned in the company’s Registration Statement for its initial public offering (IPO) or other filings for the next three years, in order to inflate its stock prices, in violation of the Securities Act of 1933 and the Securities Exchange Act of 1934. 

Aradigm Bulding

Aradigm develops drug delivery systems for the lungs, to improve the delivery and effectiveness of drugs and to reduce the need for injections. However, the complaint for this class action claims that the company’s statements on its new drug Linhaliq were overly optimistic, given the deficiencies of its Phase 3 clinical trials. Later, the FDA spoke of the need for better Phase 3 trials, because of the new route of delivery for the drug, the uncertainties that could not be addressed by a single Phase 3 trial, the mixed results of other inhaled drugs for the disease, and the need for longer trials for efficacy and safety tests.

Gleevec Bottle and Tablets

Can a company be sued for not bringing out a drug soon enough? The complaint for this class action alleges that the reason the drug was not promptly put on the market was an illegal anti-competitive agreement between two drug manufacturers. According to the complaint, Novartis and Sun entered into an anti-competitive agreement saying that Sun would not to bring its generic to market until February 1, 2016; and in exchange, Novartis agreed not to compete against Sun’s generic with an authorized generic. The complaint claims that this agreement violates antitrust laws.

Menactra Packaging

Sanofi has agreed to settle a class action alleging that it engaged in antitrust behavior, preventing competition and forcing customers to pay higher prices than necessary for its Menactra vaccine.

Hand Holding Remicade Bottle

In 2010, Congress enacted a Biologics Price Competition and Innovation Act to enable biosimilar drugs to receive approval, to spur price competition for drugs. However, the complaint for this class action alleges that when other companies developed competitors for Remicade, Johnson & Johnson (J&J) unfairly blocked their access to the market, with exclusivity contracts and other provisions with insurers, requiring consumers to pay significantly higher prices than they would otherwise have.

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