James Beck, a defense lawyer with Reed Smith, blogged on Friday about the first time that an appellate court has held that a claim that a brand-name manufacturer were negligent in the design of its drugs has been preempted because it would be impossible for the drug company to comply both with federal regulations and state tort law.
It's the first appellate authority to recognize impossibility preemption of a design defect case against a brand-name manufacturer since the U.S. Supreme Court issud its ruling in Mutual Pharmaceutical Co. v. Bartlett two years ago, Beck says.
The U.S. Court of Appeals for the Sixth Circuit ruled that it would have been impossible for Ortho-McNeil-Janssen Pharmaceuticals to come up with an alternative design for one of its birth control patches either before it was approved by the Food and Drug Administration or after it was approved. The appeals court also rejected the argument that Ortho could have complied with state tort law by never starting to sell its birth control patch.
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