LawyersUSA

Democrats in the House have introduced a bill that would reverse a U.S. Supreme Court decision from earlier this year that barred patients from suing over injuries they claim were caused by medical devices.

In February, the Court held in Riegel v. Medtronic, 128 S.Ct. 999, that state law tort claims alleging unsafe medical devices are preempted by Food and Drug Administration approval under the Medical Device Amendments of 1976. (See "Supreme Court makes preemptive strike," Lawyers USA, March 10, 2008. Search terms for Lawyers USA website: trio and Riegel.)

The new bill, sponsored by Reps. Frank Pallone, Jr., D-N.J, and Henry A. Waxman, D-Calif., is called the "Medical Device Safety Act of 2008," H.R. 6381.

The sponsors said that FDA approval doesn't adequately protect patients from unsafe medical devices. The legislation would explicitly allow patients to bring state product liability suits over allegedly unsafe medical devices.

"This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product," Pallone said in a statement about the bill. "Congress should pass this legislation so that we can protect patients from dangerous and defective medical devices."

Sens. Edward Kennedy, D-Mass., chairman of the Senate Health, Education, Labor, and Pensions Committee, and Patrick Leahy, D-Vt., chairman of the Senate Judiciary Committee, plan to introduce a similar measure in the Senate soon.

"The extraordinary power to preempt state law and regulation lies with Congress alone," said Leahy in a statement. "It should not be left to the discretion of bureaucrats or the political appointees in the executive branch."