Medical Device Link.

FROM THE EDITORS

The alleged heartlessness of the medical device industry was decried by its critics in late February when Medtronic won a U.S. Supreme Court case over federal preemption of premarket approval (PMA) products that are not in violation of FDA requirements. The decision means that patients injured by PMA devices cannot sue manufacturers in state courts if the devices are not adulterated or misbranded.

But this is not the stripping-of-legal-rights scenario that the industry’s critics, including some prominent congressional Democrats, make it out to be.

The high court ruled 8–1 that because FDA has already made a determination about the safety and effectiveness of a PMA product, state lawsuits are barred when they would impose different requirements. The ruling pertained to a case brought by the family of Charles Riegel, who was injured in 1996 by a Medtronic catheter.

The Medical Device Amendments of 1976 explicitly say that states cannot impose standards of safety and effectiveness on medical devices that are inconsistent with federal regulations. Sen. Edward Kennedy (D–MA) and Rep. Henry Waxman (D–CA) said that Congress did not intend for that provision to limit lawsuits against manufacturers.

Ignored by these critics is the fact that the decision does not apply to the majority of medical device product-liability cases. In most cases, patients can still sue manufacturers. The Riegel case was a rare exception—and the problem was that his family sued the wrong party.

“The notion that this means patients are being stripped of their right to sue is a bunch of hogwash,” says Kevin Quinley, senior vice president of Medmarc Insurance Group (Chantilly, VA). Medmarc insures life sciences companies against product liability claims.

A substantial majority of devices come to market via the 510(k) process. The decision does not apply to them. This makes sense because CDRH does not review them as rigorously as PMA devices, and thus 510(k) clearance does not carry the same level of confidence in safety and effectiveness as premarket approval does.

Critics might be making a big deal nonetheless, says Quinley, because cases involving PMA products “often involve devices whose use can determine life or death, and those cases come with high legal costs and high potential awards. But the financial impact is disproportionate to the frequency.”

Also, manufacturers of PMA devices can still be sued by patients in state courts if the device is proven to be adulterated or misbranded as per FDA regulations.

Neither of these factors pertained to Riegel’s case. His doctor used Medtronic’s catheter in a way that was not approved by FDA, nor encouraged by the company. There was no evidence of a manufacturing defect or any other adulteration. It was not Medtronic’s fault that the procedure failed and Riegel was injured; it was his doctor’s. His family should have sued the doctor, not Medtronic. But it didn’t. Quinley believes that was because the family thought it could get a bigger settlement out of the deeper-pocketed Medtronic. Charles Riegel’s injury was a terrible thing. Holding the wrong party liable would also have been a terrible thing.

The case is a victory not only for Medtronic, but for FDA and the device industry as a whole. A loss would have meant that state courts could have made their own determinations as to what constituted safety and effectiveness. This would have undermined FDA’s authority, exposed device companies to increased liability, and potentially thrown the whole medical device regulatory system into chaos. Could you imagine having to navigate 50 different interpretations of safety and effectiveness?

Erik Swain for The Editors