Thursday, March 07, 2002

High court leaves door open

More suits could follow split ruling for medical-device maker

By Andrew Welsh-Huggins
The Associated Press

        COLUMBUS — A divided Ohio Supreme Court on Wednesday ruled for a company fighting a suit over one of its medical devices, in a decision that left open the possibility the court could hear similar cases.

        The ruling involved a 1995 lawsuit by Mary Resha of Cincinnati against Memphis, Tenn.-based Smith & Nephew Inc.

        Ms. Resha said she suffered chronic pain following the insertion of a Rogozinski Spinal Rod System in 1993.

        Smith & Nephew had argued that Ohio law requires companies to warn only doctors — and not their patients — of possible side effects of medical devices.

        Justice Paul Pfeifer, writing for the majority, agreed with two lower courts that the law requiring drug makers to notify doctors of possible side effects was meant to include medical devices.

        That had the effect of upholding an appeals court ruling in favor of Smith & Nephew.

        However, only Justices Francis Sweeney and Evelyn Lundberg Stratton agreed with Justice Pfeifer on that issue.

        Justices Alice Robie Resnick and Andy Douglas disagreed, while Chief Justice Thomas Moyer and Justice Deborah Cook did not address whether the law covered the devices.

        Since a majority did not reach a conclusion, the issue could come before the court again.

        The lack of a majority ruling “means it's still an open question for the court,” said Marianna Brown Bettman, a University of Cincinnati law professor and former state appeals-court judge.

        “I think it's fair to say that a lawyer could bring this question back up.”

        Ms. Resha had argued that Smith & Nephew had a duty to inform her both of the device's risks and that the device had yet to receive final approval from the Food and Drug Administration, although its use was permitted.

        The company said it told her doctor about the risks and the status. Her doctor testified that he then told her, the company said.

        Traditionally, Ohio common law required drug makers to explain warnings about their products to doctors, who then explained possible side effects to patients.

        When the law went on the books in the 1990s as part of the state's Product Liability Act, it omitted the phrase “medical devices.”

        Smith & Nephew had argued that the law meant to cover the devices.

        If true, that would remove liability from manufacturers, since it's up to the doctor to discuss the device's potential harm with a patient.

        Ms. Resha's attorney disagreed, arguing the law applies only to prescription drugs. If so, that would mean medical-device manufacturers would have to warn both doctors and patients about their products.


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