This nonsensical situation: Prohibition on personal injury lawsuits about medical devices

In 1994, the U.S. Food and Drug Administration issued its pre-market approval for the use of a balloon catheter made by Medtronic for widening coronary arteries. Two years later, Charles Riegel underwent angioplasty – a form of heart surgery that uses a special balloon device to mash plaque against the walls of the artery to allow blood to flow more freely. The balloon catheter burst while being inserted, injuring him. He filed a lawsuit against Medtronic, the device maker, but the case was dismissed. He died after the lawsuit was filed, and his widow, Donna, carried on the case, appealing the dismissal of the case to the U.S. Supreme Court.

The Supreme Court decided on Wednesday that makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed and the device meets the FDA's specifications.
The case turned on what Congress had meant by a clause in the 1976 Medical Device Amendments statute that bars states from imposing different requirements from federal requirements. The justices apparently decided on the Congress' intent without asking either of two current congressmen who had key roles in moving the bill forward back in 1976. Both the Senate’s sole sponsor of that legislation – Sen. Teddy Kennedy – and Rep. Henry Waxman, a member of the House panel that approved the bill, were sharply critical of the decision.

Sen. Kennedy commented, "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices." Rep. Waxman said, "The Supreme Court's decision strips consumers of the rights they've had for decades. This isn't what Congress intended, and we'll fix this nonsensical situation."

Advice to people who may need surgery to implant a medical device: Do your homework carefully to understand the safety of various devices.

Browse for related stories in the index at the very bottom of this page, or read a medical device malfunction story.

Thanks to Linda Greenhouse for the source article in today's NY Times.