Medical devices ruling's impact overstated
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THE SEPT. 27 editorial "No haven for dangerous drugs" overstates the impact of the Supreme Court's 8-1 preemption decision in the medical device arena. The court's decision does not grant immunity for medical device makers, but instead reaffirms well-established federal law.
For decades, patients have been able to sue and recover damages if they are harmed by a device that was defectively made or approved based on knowingly falsified or incomplete data submitted to the Food and Drug Administration. Nothing about the court's decision changes that. The FDA has preemptive authority with only about 2 percent of medical devices - those that go through the most rigorous FDA premarket approval process.
The alternative to preemption is a move from a deliberate multiyear, science-based review and national approach to determining device safety to a patchwork of determinations based on jury deliberations in individual cases made without regard to patient access to critical medical technologies. An environment fostering different safety standards in different states at different times would only impede development and access to new lifesaving technologies.
STEPHEN J. UBL
President and CEO Advanced
Washington 
