Two federal appeals courts have recently upheld the right of consumers to bring defective product lawsuits over prescription drugs, rejecting the claims of manufacturers that only federal regulators — and not the courts — can decide whether a drug is dangerous.
The so-called preemption issue is a crucial one in drug liability suits. The Bush Administration, reversing a long-standing legal policy, announced that federal approval of a drug “preempts,” or bars, suits in state courts. That stance could have made it nearly impossible for consumers to sue drug manufacturers on such claims as failing to adequately warn of a drug’s dangers on the product label.
But in 2009, the U.S. Supreme Court pierced the drug companies’ new liability shield. It acted in the case of a Vermont woman who alleged that the maker of a brand name anti-nausea drug, Phenergan, did not provide an adequate warning that directly injecting the drug into a patient’s vein creates a significant risk of catastrophic consequences. Even if the U.S. Food and Drug Administration did not require that specific warning, the woman’s claims were not preempted, the high court said in Wyeth v. Levine.
The San Francisco-based 9th U.S. Circuit Court of Appeals has now extended that line of thinking to generic drugs. It ruled in a Jan. 24 opinion that Perrigo Pharmaceuticals, which makes a generic version of ibuprofen, could be sued for failing to warn consumers that the drug could cause liver damage when used in combination with certain other drugs.
Generic drugs have a less demanding approval process than brand-name drugs and Perrigo argued that, once the FDA approved its product, it did not have a duty under state law to warn of additional risks. But the 9th Circuit said that while federal laws “were meant to provide an inexpensive and easy way for generic drugs to enter the market, they were not intended as a relief from the fundamental requirement of the [Federal Food, Drug, and Cosmetic Act] that all marketed drugs remain safe.”
The 6th Circuit Court of Appeals, in Cincinnati, also followed the Wyeth ruling earlier this month in finding that a consumer could sue a drug company under Missouri law for failing to manufacture a hypertension medication in compliance with federal regulations. KV Pharmaceutical had previously admitted in a settlement of an FDA complaint that it did not use proper quality control procedures in making the drug. The Wyeth decision “strongly” implies that preemption does not apply to the case, the court said in LeFaivre v. KV Pharmaceutical Company.
The Supreme Court is currently reviewing two other cases in which lower courts found no preemption of failure-to-warn claims involving generic drugs.
Medical devices have a different regulatory scheme from medications. As a result, the Indiana Court of Appeals ruled this month that the manufacturer of a heart pacemaker was immune from being sued for failing to add warnings related to its implantation in pediatric patients.
