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Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices

Jan 3, 2008 | Parker Waichman Alonso LLP

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, has asked the US Supreme Court to shield it and other medical devices makers from state product liability lawsuits.  In Reigel vs. Medtronic, the medical device maker argued before the Supreme Court on December 4 that the mere fact that medical devices are approved by the Food & Drug Administration (FDA) preempts patients from bring lawsuits in state courts if they are injured by a defective device.  If Medtronic somehow convinces the court to ban such lawsuits, consumers will lose an important protection against defective medical devices.  

Medtronic vs. Reigel stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval.  The case was thrown out by a US District Court judge and then by the US Court of Appeals.   The family is now appealing to the US Supreme Court.

Medtronic is arguing that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.  That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims.  But Medtronic believes that the amendments do just that.  Before the Supreme Court, the company argued that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

This is not the first time Medtronic has tried this argument. In a Florida court in 1993, Lora Lohr and her husband had sought damages for an allegedly faulty pacemaker lead manufactured by Medtronic. The company argued that the Medical Device Amendments preempted any damages claims because the device had been approved for marketing by the FDA. In Medtronic vs. Lohr,  the Court  held that none of the Lohrs' damages claims were preempted by the 1976 law.

In the Reigel lawsuit, Medtronic is trying the preemption argument again, but this time, the FDA is on its side.   During the Lohr lawsuit, the FDA sided with consumers and argued that the 1976 law did not disallow state lawsuits against FDA approved devices.   But now, the agency has reversed itself and is arguing Medtronic’s side.  In fact, US Deputy Solicitor General Edwin Kneedler, on behalf of the Bush Administration, argued before the Supreme Court on December 4th in support of Medtronic’s position.  The Bush Administration believes that the FDA approval process is adequate to protect consumers from dangerous medical devices.  Unfortunately, past experience has not proven this to be true.

The past several years have proven that FDA cannot be trusted to keep consumers safe.  In some case, the agency has approved drugs - like Vioxx and the Ortho Evra birth control patch – based on sloppy or falsified test data. In other cases,  the FDA testing process completely missed defects.  This is what happened with the Medtronic Sprint Fidelis Lead, where its high fracture rate did not become apparent until it had been implanted in tens of thousands of people.  In many cases, it is only through litigation that it is discovered that medical manufactures withheld information about defective products from the FDA and the public.  

The Supreme Court’s decision in Reigel vs. Medtronic will have serious implications for consumers.  If Medtronic is successful, patients injured by defective medical devices will have no recourse in state courts to seek compensation for their injuries.   And manufacturers like Medtronic will not have to fear the financial consequences of unleashing dangerous medical devices on an unprotected public.