Harrison
February 26th, 2008, 3:58 pm
Court takes up Michigan Drug Law
WASHINGTON (AP) — The Supreme Court on Monday wrestled with a Michigan law that shields pharmaceutical companies from product liability lawsuits, unless they committed fraud to get their drug approved.
At issue is whether that fraud exception, which allows lawsuits to proceed, is preempted by federal regulation of pharmaceuticals.
Carter Phillips, a lawyer for Pfizer Inc., told the justices that it should be.
‘‘There is a very unique federal interest’’ in the Food and Drug Administration’s regulation of pharmaceuticals, he said. ‘‘There is no legitimate state interest here.’’
The dispute stems from several suits against Warner-Lambert over its diabetes drug Rezulin. Warner-Lambert is now owned by Pfizer.
Justices Stephen Breyer and Anthony Kennedy appeared to side with Pfizer, expressing broad skepticism about product liability suits against pharmaceutical companies. Breyer said they essentially second-guess the FDA’s decision to approve the drug.
Breyer’s remarks are significant because the court has already accepted a case for its next term, which begins in October, that takes on the broader issue of when drug companies can be held liable for products that have been approved by the FDA. That case is Wyeth v. Levine, 06-1249.
Other justices, however, were more sympathetic to allowing the suits to proceed. Justice John Paul Stevens dismissed concerns raised by the Bush administration that they would prove burdensome to the FDA as ‘‘theoretical.’’
Monday’s case is one of several before the court that tests the limits of federal preemption of state regulations in areas such as drugs, medical devices and online tobacco sales.
The justices ruled last Wednesday in a case involving Medtronic Inc. that federal regulation of advanced medical devices preempts lawsuits in state courts against their manufacturers.
The case before the court Monday won’t provide as broad a shield against lawsuits as the Medtronic case, because it won’t apply to all pharmaceutical suits.
Instead, it focuses on a specific issue: whether state courts can consider allegations that a drug company misled the Food and Drug Administration to win approval for a drug.
WASHINGTON (AP) — The Supreme Court on Monday wrestled with a Michigan law that shields pharmaceutical companies from product liability lawsuits, unless they committed fraud to get their drug approved.
At issue is whether that fraud exception, which allows lawsuits to proceed, is preempted by federal regulation of pharmaceuticals.
Carter Phillips, a lawyer for Pfizer Inc., told the justices that it should be.
‘‘There is a very unique federal interest’’ in the Food and Drug Administration’s regulation of pharmaceuticals, he said. ‘‘There is no legitimate state interest here.’’
The dispute stems from several suits against Warner-Lambert over its diabetes drug Rezulin. Warner-Lambert is now owned by Pfizer.
Justices Stephen Breyer and Anthony Kennedy appeared to side with Pfizer, expressing broad skepticism about product liability suits against pharmaceutical companies. Breyer said they essentially second-guess the FDA’s decision to approve the drug.
Breyer’s remarks are significant because the court has already accepted a case for its next term, which begins in October, that takes on the broader issue of when drug companies can be held liable for products that have been approved by the FDA. That case is Wyeth v. Levine, 06-1249.
Other justices, however, were more sympathetic to allowing the suits to proceed. Justice John Paul Stevens dismissed concerns raised by the Bush administration that they would prove burdensome to the FDA as ‘‘theoretical.’’
Monday’s case is one of several before the court that tests the limits of federal preemption of state regulations in areas such as drugs, medical devices and online tobacco sales.
The justices ruled last Wednesday in a case involving Medtronic Inc. that federal regulation of advanced medical devices preempts lawsuits in state courts against their manufacturers.
The case before the court Monday won’t provide as broad a shield against lawsuits as the Medtronic case, because it won’t apply to all pharmaceutical suits.
Instead, it focuses on a specific issue: whether state courts can consider allegations that a drug company misled the Food and Drug Administration to win approval for a drug.