Sunday, May 11, 2014

Court of appeals for the third circuit affirms dismissal claims against generic drug manufacturers on preemption grounds

The Third Circuit recently affirmed a trial court’s order dismissing a claim against a number of generic drug manufacturers in a case related to the drug Fosamax. The Court found the claims were preempted because recognizing the claims would be incompatible with federal law or rules. To avoid the claim, the defendants would have had to acted in ways that was not allowed under federal law. The defendants could not, for example, have changed the products labeling (because they are required by federal law to use the same labeling used by the brand manufacturers) or have changed the design of the product (for the same reason). Given the applicable federal law requirements, the only other alternative for the defendants would have been to stop selling their product. Unless it is decided that the product is so dangerous it should have never been put on the market to begin with, it is unlikely a court will recognize a claim. The Abnormal Use blog has more here including a link to more information.

Interestingly, as you probably remember, the FDA has proposed a new rule that would allow generic drug manufacturers to change or update warning labels even if the brand name manufacturers don't do it.  For more on that issue go here, here and here or go here and scroll down for more stories.

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