Immunity for device makers threatens patient safety, NEJM editors say

Patients who believe they have been harmed by a medical device now can sue its manufacturer, but the Supreme Court is considering whether US Food and Drug Administration approval of devices before they are sold shields their makers from product-liability litigation. The court’s ruling, expected in the spring, could have far-reaching implications for the safety of both medical devices and drugs, three editors of the New England Journal of Medicine write in an editorial appearing tomorrow.

The case involves Charles Riegel of New York, who sued equipment maker Medtronic after a balloon ruptured during coronary angioplasty, a procedure to open blocked heart vessels. Medtronic argued last month before the high court that a 1976 federal law preempting state laws about medical devices also bars lawsuits brought in state courts. Congress passed the law after thousands of women were killed or injured by the Dalkon Shield, an intrauterine device that underwent no review for safety or efficacy by a federal agency. The law gave the FDA oversight over medical devices and prevented state laws from conflicting with federal regulations.

Dr. Gregory D. Curfman, the journal's executive editor, said he and his co-authors Stephen Morrissey and Dr. Jeffrey M. Drazen found it implausible that Congress intended to immunize manufacturers against liability suits when it gave the FDA the power to regulate all medical devices. The authors contend that this interpretation would weaken federal protections.

“If the Supreme Court were to rule in favor of Medtronic it would have a major effect of removing one layer of regulation of the safety of medical devices because the manufacturer would no longer have the potential threat of a product liability suit hanging over them,” Curfman said in an interview.

Next month drug makers will have their turn, when the court will consider whether FDA premarketing approval of the Warner-Lambert drug troglitazone gives the company immunity from liability, the editorial notes. The diabetes drug was taken off the market in 2000 because it was linked to liver toxicity.

Both court decisions will be critical for patient safety, the authors write.

"As good as premarket testing of drugs and devices is, it is imperfect and it will always be imperfect so there need to be ways in the post-marketing setting to continue surveillance after approval,” Curfman said. “One way is to have the FDA do it and to have doctors do it, but another way is for a patient to have the ability to bring lawsuits, which also puts pressure on companies to make sure they are keeping a very close eye on their products.”