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Supreme Court: No Liability for Generic Medication Manufacturers

Recent calls into my office have sparked my thoughts back to the non sequitur that is the recent decisions of our U.S. Supreme Court with regard to which injured plaintiffs may recover from drug manufacturer.

The U.S. Supreme Court has recently had divergent opinions with regard to how Federal Law preemption will be interpreted with regard to civil liability for safety standards for brand-name and generic medications.  In Wyeth v. Levine, the Court held that a drug manufacturer was responsible for updating and controlling their own labels regardless of what was required by the FDA (Food and Drug Administration) and therefore could be held liable for not properly updating the label with information discovered after the drug was approved by the FDA.  However, in Pliva v. Mensing, the Court found that as generic drug manufacturers were required to have the same labeling as the brand-name drug they could not be held civilly responsible for not updating the label.

Both opinions interpret similar law with opposite results.  Why would the Court find that brand-name manufacturers have the ability to update their labels, and can be found civilly liable for not doing so; yet find that a generic drug manufacture should have no civil liability for the same label simply because they did not spend the same money to develop their own medications?  The logic just doesn’t appear to carry the smell test.

Practically, the Supreme Court’s decisions result in a situation where two patients with the same physician who both take a medication for diabetes where the manufacturers are both aware of a side effect that should have been identified on the label and was not and only the patient who took the brand name medication has a claim against the manufacturer.  The lack of logic in the above contradiction is shocking.

Leonard Glantz, in the New England Journal of Medicine, August 25, 2011 discussed the political contradiction by the Court in these divergent opinions.  He mentions that the conservative justices appear to have abandoned their belief in small government and judicial oversight by failing to allow the states to use their historical police powers.

The Court’s failure of logic with regard to dealing with the conflict between these two opinions is not responsible when you look at the practical effect of denying one a recovery without a clear reasoning.


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