In February, the U.S. Supreme Court ruled 8-1 that a patient injured by a balloon catheter manufactured by Medtronic Inc. was not entitled to damages because Medtronic was shielded from liability. The Supreme Court ruled in Medtronic’s favor because the device in question met the specifications of the Food and Drug Administration (FDA). Early last week, former U.S. Solicitor General Paul Clement spoke to the Philadelphia chapter of the Federalist Society that this ruling may be a precursor of “sweeping protections for pharmaceutical makers.” Clement served as solicitor general from June 2005 until June of this year.
Clement stated that a case involving a pharmaceutical is up for review this fall and bears a striking resemblance to the Medtronic case last February. In the case coming up, a patient sued Wyeth, alleging the anti-nausea drug Phenergan injured her. She contends Wyeth, the drug’s maker is liable, while Wyeth contends the patient violated FDA rules and administered the drug in an unsafe way. Wyeth is based in Madison, N.J. and employs 5,300 people at its pharmaceutical headquarters.
As solicitor general, Clement filed a brief in favor of liability protection for manufacturers of pharmaceuticals. He believes that because the Supreme Court relied on the finding that the FDA extensively tested medical devices in the Medtronic ruling, they will apply the same kind of protections for drug makers. This principle is known as preemption.
Perhaps in a related note, both Chief Justice John Roberts and Justice Samuel A. Alito Jr. were once active members of the Federalist Society, a conservative legal group that leans toward siding with pro-business concerns, and has been the source for many of the Bush administration’s judicial nominees and the top executive branch. However, Clement notes that the assumption of the Roberts court being pro-business many not be correct because they have ruled against corporate defendants in many employment cases.
As has been noted elsewhere, the FDA may not be the best judge of what is ready for the market. They are admittedly understaffed and underfunded, and we can assume this will affect all aspects of the agency’s oversight, including what medical devices and pharmaceuticals are used by consumers.
If you or a loved one has been injured by a defective pharmaceutical or medical device, please contact an experienced injury lawyer in your area to find out if you have a claim.
