Saturday, January 12, 2013

Ninth Circuit Allows Failure to Warn Medical Device Case to Proceed

Sheila Scheuerman at TortsProf Blog reports: "Muddling the preemption waters, the Ninth Circuit has ruled that a plaintiff can bring a state law failure to warn claim against a medical device manufacturer.  The court found the claim was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act."
The Ninth  Circuit, in a unanimous en banc decision Stengel v. Medtronic, reverses the panel and trial judge below who had dismissed the action as preempted by the 1976 Medical Device Amendments to the Food Drug & Cosmetic Act.  In an amended complaint Richard Stengel alleged that "Medtronic had violated a state-law duty of care by failing to report known risks associated with use of its medical device to the Food and Drug Administration" The decision allows Stengel to proceed with his 
"proposed new claim under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted. Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior. Plaintiffs’ claim is brought under settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers. “‘The whole  modern  law  of  negligence,  with its many developments, enforces the duty of fellow-citizens to observe in varying circumstances an appropriate measure of prudence to avoid causing harm to one another.’” 
The Circuit Court was constrained by the deplorable decision of the United States Supreme Court in Riegel v. Medtronic which barred design defect claims against manufacturers of Class III medical devices.  Thus victims of unreasonably dangerous products like Medtronic's implanted intrathecal spinal pain pump are limited to manufacturing defects and - now thanks to the 9th Circuit - at least one type of state law claim for failure to warn the FDA of product dangers.  As the concurring opinion points out Stengel faces a formidable obstacle in proving causal relationship.  He must show that had Medtronic submitted information to the FDA that his doctors would not have inserted the Medtronic pain pump which left Stengel paraplegic.  The decision does not recognize a duty to warn the patient directly.

The 9th Circuit opinion is consistent with what I have called the duty of product stewardship, and the Institute of Medicine in its 2006 report The Future of Drug Safety called a "life-cycle approach" to drug safety.  The heart of the approach is that a product manufacturer has an affirmative duty to monitor how its product actually performs after marketing permission is granted by the FDA.

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1 comment:

  1. In an amended complaint Richard Stengel alleged that "Medtronic had violated a state-law duty of Medical Device Company care by failing to report known risks associated with use of its medical device to the Food and Drug Administration