HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Sunday, March 15, 2009

Physicians Respond to Wyeth Ruling

AmNews has a brief story discussing physicians' responses to the Supreme Court's recent ruling in Wyeth state court warning label lawsuits against drug manufacturers are not preempted.  Amy Sorrel writes,

Some physicians say a recent U.S. Supreme Court ruling preserves a key safeguard in holding pharmaceutical manufacturers accountable for drug safety -- the courts.  But other doctors worry the decision could stifle drug access if juries are allowed to second-guess scientific determinations on the risks and benefits of certain medications.

On March 4, the high court ruled 6-3 that federal law does not preempt state claims against drugmakers over allegedly inadequate warning labels, despite approval of those labels by the Food and Drug Administration.  "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness," Justice John Paul Stevens wrote for the majority. "The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information ... as new risks emerge." . . .

Some doctors said the threat of liability has helped ensure drug manufacturers monitor their drugs and report new or revised safety information to doctors and the FDA.  "Many times the manufacturer is the only one with that information," said Francisco Silva, California Medical Assn. vice president and general counsel. "Most importantly, the ruling does not shift the burden to physicians," who could be left liable if patients had no recourse against drug manufacturers. . . .

But other doctors fear juries are not equipped with the expertise that trained medical professionals and regulators possess to decide safe and effective medication use.  "If that [duty] is switched over to a court or jury, it creates significant variability and uncertainty" that could interfere with physicians' medical judgment, said Brian F. Keaton, MD, past president of the American College of Emergency Physicians, which filed a brief in the case.  The decision also could result in commonly used drugs, such as Phenergan, becoming so tightly regulated "that it takes it out of [doctors'] hands," Dr. Keaton said.  Wyeth attorney Bert W. Rein said in a statement that FDA experts "are in the best position" to weigh medication benefits and risks, and convey them in warning labels. . . .

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