Preemption Gets Boost from Bush - Pharmaceutical Executive

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Preemption Gets Boost from Bush


PharmExec Direct

A lawyer for the Bush administration declared last week that manufacturers of drugs and devices approved by FDA could not be held accountable for liabilities in state courts. The lawyer spoke in support of preemption in Riegel v. Medtronic, a Supreme Court case that could change the legal landscape of the pharma industry.

The case in question concerns Charles Riegel, a New York resident who was hurt during a routine angioplasty. His family is suing Medtronic, claiming that the balloon catheter inserted into Riegel was faulty and that improper labeling instructions led to the device bursting during surgery.

"The continuing conflict over the ongoing preemption battle, presently before the Supreme Court in the Riegel v. Medtronic case, will hopefully give all sides the guidance which they have sought," said Joe Price, partner with Faegre & Benson in Minneapolis. "A ruling for Medtronic will place these important medical/health matters in the hands of those who know and understand the complexities of medical device safety—the FDA. It is bad public policy to let state-court lay jurors make medical decisions that will broadly impact the health and safety of all device users."

Why Now? Although state- versus federal-preemption legal battles have popped up regularly over the years, it has become a hot topic in pharma only in the last few months.

"We are asking the court to decide who is in the better position or who has the responsibility to determine whether drug labels are appropriate," said Andy Bayman, partner and practice group leader at King and Spalding. "On behalf of the large industry, FDA has the expertise and the ability to evaluate the risks and benefits of a medication so that doctors have the best information to make prescribing decisions, unlike a state court jury."

A frequently cited example: Without preemption, a jury on the state level could find that a pharmaceutical company had failed to warn of a danger even though FDA had already found that there was no substantial evidence to support the warning.

"If you allow state court juries to make that determination, you run the risk of being subject to a patchwork of different labels that vary from state to state for no good scientific reason," Bayman said.

Yet to be determined is whether preemption can be invoked in the pharma arena. "The analysis is a little different for drugs against devices, but the result is more dramatic in drugs," said Mark Herrmann a partner at Jones Day. "There is the possibility that all product-liability claims against manufacturers will be displaced by FDA regulations." One case on this topic, Wyeth v. Levine, is working its way toward the Supreme Court. The Court has not yet agreed to hear the case, but that could change before the end of the year.

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