Friday, June 11, 2010

Preemption debate regarding generic drugs

In what promises to be a very important upcoming case, the U.S. Supreme Court has asked the U.S. Department of Justice to "express the view of the United States" on whether the FDCA preempts failure to warn claims against generic drug manufacturers. The drugmakers claim federal law preempts state lawsuits because otherwise they would be required to write labels that are different from what appears on the label of the brand-name medication. Here is a quick background information to put the issue in its proper context. Federal law or regulations require manufacturers of generic drugs to use exactly the same warnings used by the manufacturers of the original drugs. The original manufacturers, on the other hand, are permitted to update the warnings when newer information becomes available to them that suggests the warning should be improved or strengthened. But generic manufacturers can't do this; they can't change the warnings unilateraly. Based on this, in 2008, a Court of Appeals in California ruled in Conte v. Wyeth that a brand-name drug manufacturer could be held liable for harm to individuals who take the generic version of their name-brand product for alleged deficiencies in the generic drug’s labeling. The decision was based on the notion that if the federal law requires generic drug labeling to be the same as brand-name labeling, then injured plaintiffs should be allowed to recover against brand-name drug manufacturers who could change their labeling to provide stronger warnings without violating the Act. Liability in such case would encourage original manufacturers to improve warnings which would be the only way to get generic manufacturers to improve theirs. Since that decision, not one other reported case has followed its reasoning and there are several that explicitly reject it. Then, late in 2009, the U.S. Court of Appeals for the Eighth Circuit decided a case called Mensing v. Wyeth, Inc (available here) in which the court rejected arguments that failure to warn claims against generic manufacturers are preempted by the FDC Act. The Court also rejected the reasoning set forth by the California Court of Appeal in Conte v. Wyeth and held that brand-name drug manufacturers were not liable for harm caused by a plaintiffs’ use of a generic version of the pioneer’s brand-name drug. Shortly after the Eighth Circuit issued its decision in Mensing, the U.S. Court of Appeals for the Fifth Circuit came to a similar conclusion in Demahy v. Actavis. The Supreme Court's request for comment came as part of the cert petition process in the Mensing case. The Petitions for Writ of Certiorari in Mensing are available here and here. Apparently, the other case has not been appealed yet. This promises to be a very hot topic in product liability this year. Stay tuned... Fore more information (with lots of comments and links) on the subject go to these posts in: Pharmalot, the FDA Law Blog,, the Drug and Device Law Blog and the Washington Legal Foundation. UPDATE 7/9/2010: In the consolidated appeal of the Smith v. Wyeth, Wilson v. Pliva, and Morris v. Wyeth cases, the Sixth Circuit has formally requested the FDA's views on this subject, and has given the FDA until July 29, 2010 to file its brief. UPDATE: 11-03-10. The Solicitor General has filed its brief. Go here for details.

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