Activists pressure FDA for more generic drug regulation
Last month the U.S. Supreme Court set aside a 21 million jury verdict for a woman who was injured as a result of an adverse reaction to a generic drug, similar to common pain medication like ibuprofen. In Mutual Pharmaceutical Co. Inc. v. Bartlett, the court ruled that the consumer’s design defect claim against the company was pre-empted, since generic drugs must be designed the same way as their brand-name counterparts. The decision, the latest in a string of drug-regulatory cases helps to shield generic drug makers from personal injury litigation claims and signals another victory for the industry.
Two years ago, the court ruled in Pilva Inc. v. Mensing that generic drug manufacturers could not be held liable for failure to warn claims. In response, several Democratic leaders introduced opposing legislation that called for stricter regulation of the industry and that would hold generic drug manufacturers to more responsibility for adding new warning labels.
Although the Mutual ruling does protect generic drug makers from design-defect claims, the Court refused to address design-defect allegations that parallel the federal mis-branding statute, which requires that drugs be removed from the market if proven to be dangerous to consumers’ health. Litigation experts view this as promising for plaintiffs, saying that by avoiding this question, the court leaves plaintiffs with some opportunity to avoid preemption state-law claims in future personal injury litigation.
Both sides in the Mutual case agreed that a generic drug only falls within the misbranding statute if new scientific information is found that differs from what the FDA has already released. The statue did not apply in the Mutual case since the jury in the case was not asked to consider any new scientific evidence. Still, plaintiff attorneys say that future parallel claims could include allegations that a generic drug maker failed to update a drug’s warning label, or conversely, that a generic drug is not as potent as its label claims. Failure-to-update cases have slowly gained momentum following a 2012 study reported warning label discrepancies in 78% of generic drugs when compared to their brand-name equivalent.
For additional information about how this decision may impact your current coverage or pending claim, please feel free to contact WGA’s Life Science Practice Group.
About the Author
Ann Mizner McKay is the General Counsel and Senior Vice President at WGA. She manages the legal affairs of the company and also manages the Claims Department.