A pain medication known as Darvocet has been on the market since 1972, when it first received approval from the U.S. Food & Drug Administration. Less than six years later, the medical community acknowledged a link between the drug (a combination of propoxyphene and acetaminophen) and heart trouble. The concerns were serious enough that the United Kingdom pulled it from shelves.
Here in the U.S., however, the FDA simply required the new drug application holder change the labels to include a “Black Box Warning.” It also required the drug manufacturer to undertake a clinical trial to assess the connection between the medication and certain heart complications. Generic drug manufacturers continued to produce the drug, too. It wasn’t until 2010 the agency finally determined the risks of the drug outweighed the benefits and pulled it from shelves.
Since then, there have been a number of lawsuits filed against the makers of Darvocet. Our Boston defective product attorneys know some of these cases have floundered because they have been brought against generic drug manufacturers.
Those kinds of claims have been largely quashed by the 2011 decision in Plivia Inc. v. Mensing, where the U.S. Supreme Court ruled state-law design-defect claims hinging on the adequacy of a drug’s warnings, are pre-empted by federal law. This position was strengthened in the 5-4 ruling (divided along political lines) in Mutual Pharmaceutical Co. v. Bartlett in June 2013.
In essence, those who are harmed by generic drugs have been left without remedy, unable to sue the generic drug manufacturer because that company relied on labels released by the brand name maker. However, injured plaintiffs can’t pursue the brand name manufacturer because those companies didn’t make the product they actually consumed.
That brings us to the case of Germain v. Teva Pharm, USA, Inc. This was a multi-district litigation action involving 68 plaintiffs who sued the generic manufacturers for labeling defects.
Citing the previous case law set by the U.S. Supreme Court, the appellate court upheld an earlier decision to dismiss all claims – except one. That is the case of a widow whose husband died of heart problems after nearly 40 years alternately using both the brand name and generic form of the drug. The district court dismissed the claim on the grounds the wife failed to adequately plead her husband used a drug made by the brand name manufacturer. The district court also indicated that even if she did adequately make that claim, she failed to properly assert the drug had injured him. The appellate court disagreed on both counts. The court noted firstly the complaint dates back to the early 1970s, a time when only the brand name manufacturer was making the drug. Secondly, the court noted the plaintiff named the drugs and then indicated “those drugs” caused his heart problems. Therefore, the court reversed the earlier dismissal and allowed the claim to continue.
We anticipate at some time in the future, the legislature will take on this issue of limited accountability for generic manufacturers. In the interim, it’s important that your claim be carefully weighed by an experienced product liability law firm.
If you are the victim of Massachusetts product liability, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
Germain v. Teva Pharm, USA, Inc., June 27, 2014, U.S. Court of Appeals for the Sixth Circuit
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Is Pradaxa Worth the Risk? Aug. 31, 2014, Boston Dangerous Drug Lawyer Blog