Jury finds the risks of an FDA-approved drug outweighed its benefits

In a case called Bartlett v. Mutual Pharmaceutical Co., No. 08-358 (D.N.H.) the plaintiff allegedly developed Stevens-Johnson Syndrome after taking a generic drug called Sulindac. The court dismissed part of the original claim but allowed plaintiff to proceed to trial on a design defect claim and earlier this month the jury returned a $21 million verdict in favor of the plaintiff. The Drug and Device Law Blog has argued that the design defect claim in this case raised serious preemption issues because it asked the jury to second guess the FDA’s decision that the benefits of the drug outweigh its risks. This is not a frivolous argument but I have not seen any of the documentation or read any details about the case to really know if it is accurate as applied to this case itself. What is clear is that the defendant will probably appeal and the case will probably result in an interesting decision on the subject of possible liability for generic drugs and on the preemption issue.