After the Supreme Court ruled that Food and Drug Administration approval doesnt insulate pharmaceutical companies from product liability, key congressional leaders said that they would renew a push to make the same true for medical devicemakers.
The Medical Device Safety Act seeks to reverse the Supreme Courts 2008 ruling in Riegel v. Medtronic that device companies are immune to state liability claims if theyve complied with FDA requirements, citing 1976 legislation giving the FDA pre-emptive authority over safety in the industry.
The medical device bill was reintroduced by U.S. Rep. Henry Waxman (D-Calif.), chairman of the Energy and Commerce Committee, and Rep. Frank Pallone Jr. (D-N.J.), chairman of the panels Health Subcommittee.
In a news release, Waxman and Pallone pointed to the courts decision this week upholding a jury verdict for a Vermont woman whose arm was amputated after she suffered gangrene from an injection of Wyeths nausea drug Phenergan. As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety, Waxman said in the release. Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) introduced a companion bill last year.