The day after the US Supreme Court ruled against Wyeth in an FDA pre-emption case. Congress has gotten in the act to level the playing field and eliminate pre-emption for medical devices.
The Medical Device Safety Act of 2009 would reverse the Supreme Court’s ruling by explicitly stating that state product liability laws are not pre-empted by federal laws for the regulation of medical devices
The Medical Device Safety Act is sponsored by Frank Pallone Jr. (D-NJ) has the support of 65 co-sponsors in the house. In addition a companion bill has been introduced in the Senate by Ted Kennedy and has 17 co-sponsors.
The Supreme Court decision in Wyeth vs. Levine case has given the supporters of the bill significant leverage for passing this bill in this Congress.
So for at least a day the device industry had some solace in knowing that they were pre-empt from prosecution for FDA on-label uses. Now instead of meeting one standard, there will be hundreds of standards depending on the venue for your case.
WSJ Blog: Dems Move to Remove Pre-emption of Medical Device Law Suits