Germain v. Teva Pharm, USA, Inc, No. 12-5368 (6th Cir. 2014)Annotate this Case
In 1957, the FDA approved propoxyphene for the treatment of mild to moderate pain, under the trade name Darvon. In 1972, the manufacturer obtained FDA approval to market another product combining propoxyphene with acetaminophen, under the name Darvocet. Because the new drug application (NDA) process is onerous, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, (Hatch-Waxman Act) to make available more low cost generic drugs. Generic drugs require an abbreviated new drug application (ANDA) showing that the drug is equivalent to and that labeling proposed is the same approved for the brand-name drug. Several companies obtained approval to market generic versions of Darvon and Darvocet. Complaints about perceived risks associated with propoxyphene began in 1978; eventually the United Kingdom withdrew it from the market. Two FDA advisory committees recommended withdrawal from the market, but the FDA ordered the NDA holder to change the label to include “Black Box” warnings and to undertake a clinical trial to assess the risks of a particular cardiac complication. In 2010, the FDA determined that the risks of propoxyphene outweighed its benefits and ordered its removal from the market. Plaintiffs in 68 consolidated cases alleged that they ingested propoxyphene products prior to its withdrawal and that manufacturers continued marketing propoxyphene after they knew or should have known that risks exceeded benefits. The district court dismissed. The Sixth Circuit affirmed, except with respect to one plaintiff.