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Case Notes
FDA Approval Is Absolute Defense
A drug approved by the FDA is immune from a product liability claim, even if it is used in a drug trial for a purpose different from that for which it was approved. Griffus v. Novartis Pharmaceuticals Corp., Case No. 06-10891, U.S. District Court for the Eastern District of Michigan, Southern Division, Sept. 6, 2006.
Griffus filed a claim against Novartis on the grounds of negligence, breach of implied warranty, and breach of express warranty, claiming she suffered injuries as a result of her participation in a clinical trial sponsored by Novartis. The research trial was to determine whether the drug Trileptal', which is FDA approved for the treatment of seizures and epilepsy, is also effective in treating pain associated with diabetic neuropathy. Novartis moved to dismiss, and the court granted the motion. It held that each of Griffus' claims was barred by the Mich. Comp. Laws '600.2946(5), which states that FDA approval provides an absolute defense to a product liability action so long as the drug and its labeling were in compliance with the FDA's approval at the time it left the control of the manufacturer or seller. The court considered that the Michigan Legislature was aware at the time it instituted the legislation that there is always a possibility that in some circumstances drugs will
be used for purposes other that those for which they were approved by
the FDA.
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