Preemption at Issue in Medical Device Safety Act of 2009
BY LAUREN UZDIENSKI, MAY 20, 2009
Last year's Riegel v. Medtronic Supreme Court case upheld preemption for medical devices, meaning FDA approval superseded any action that could be brought against a manufacturer in state court, effectively preventing product-liability lawsuits. That ruling is being challenged in the Medical Device Safety Act of 2009 (MDSA), which would overturn preemption and allow patients to sue devicemakers over faulty devices. The bill was introduced in the House by Frank Pallone Jr. (D-NJ), who, interestingly, is at the center of the Wall Street Journal's allegations that ReGen Biologics relied on political influence to obtain FDA clearance for its Menaflex device.
At a House Energy and Commerce Health Subcommittee hearing last week, proponents of the bill argued that preemption effectively shifts liability from a device manufacturer to the taxpayers who have to care for those who are harmed by devices. It should be noted that Riegel pertains only to devices that are approved by PMA, so it's these devices that would be impacted if the MDSA is passed.
As expected, the device industry strong opposes the MDSA, arguing that the legislation would stifle innovation and largely strip the FDA of its regulatory power, as the final say on the safety and effectiveness of devices would rest with the courts. Both the MDMA and AdvaMed have raised concerns about innovation and patient access to new technologies, with the latter hosting its own event where patients described their own histories with lifesaving medical devices and advocated against the MDSA.
It's unclear how this legislation will proceed, though the Journal says it won't happen this year. Congress is focused on other aspects of healthcare reform, and Rep. Pallone says it's unlikely the MDSA will be included in that package.
