We’ve talked about federal preemption here before, and now it looks like the issue will finally be resolved by the Supreme Court.
To bring you up to speed, at issue is the following question: Should manufacturers of generic drugs be held liable for the defective designs of the branded drugs they mimic?
Generic drug manufacturers claim that this state claim should be barred because their hands are tied due to federal law requiring that their labels be the same as the labels on the brand name equivalents. The plaintiff in this case, a New Hampshire woman who won a $21 million judgment against Takeda Pharmaceutical when she was severely and permanently injured by a generic anti-inflammatory drug, disagrees, arguing that the Supreme Court does not need to hear the case.
But the Supreme Court will hear the case. The case comes to the highest court from the First U.S. Circuit Court of Appeals, which sided with Ms. Bartlett in a May ruling denying the federal preemption argument.
In June of 2011, the Supreme Court ruled that federal law did preempt state law claims based on inadequate label warnings regarding side effects. But the Court of Appeals, in this case, does not believe the Supreme Court’s ruling should be extended to design defect claims. A decision is expected sometime next summer and will clarify an area of liability that is hotly debated.
We don’t believe that generic drug manufacturers should be shielded by their FDA approval, especially given that patients are rarely if ever given a choice in whether they receive generic or branded equivalents. Has a nurse ever walked into your hospital room and asked whether your IV medication should be generic or brand-name? No, that hasn’t happened to us either. If you suffered a major, life-altering reaction to such a drug as Ms. Bartlett did, would you find it fair to be barred from compensation because of what amounts to a technicality? Ms. Bartlett now has permanent near-blindness and burn-like lesions over most of her body, all because of a defectively designed anti-inflammatory drug. We do not believe that any drug manufacturer, generic or branded, should be able to throw their hands up and be excused of responsibility when they do have the option to petition to get their labels changed. Let’s hope the Supreme Court protects consumer rights.
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