New pre-emption fight looms - March 06, 2009
Just hours after the US Supreme Court ruled that federal warning labels do not protect drug companies from being sued, Democrats in Congress moved to make the same rule apply to medical device manufacturers.
On Wednesday the Supreme Court ruled that federal regulations did not override – or ‘pre-empt’ – a plaintiff’s right to sue in state courts (see: FDA-approved warning labels won't protect companies). Yesterday House Representatives Frank Pallone and Henry Waxman introduced a bill to overturn a previous Supreme Court ruling that gave medical device manufacturers pre-emption immunity.
“As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety,” said Waxman yesterday (press release). “The Court noted that these lawsuits ‘uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly’. The same is true for medical devices.”
The WSJ’s Health Blog notes:
The question now is whether the bills have enough votes to pass. Similar legislation failed last year, although it may have better odds now as a result of the Democrats’ election gains.No doubt there will be a hard fight. Mark Herrmann, a Jones Day lawyer who represents drug and medical device companies, as well as a drug and device law blogger, noted that the federal law for medical devices has a provision talking specifically about preempting state laws and requirements, while the one for drugs does not.
Stephen Ubl, president and CEO of device industry group the Advanced Medical Technology Association, says, “If enacted, this legislation would effectively allow state courts to review medical devices and ultimately lead to a patchwork of inconsistent and confusing guidance on the use of medical treatments for patients and physicians, or limit their availability altogether.”
