ATRA CRITICIZES 'MEDICAL DEVICE SAFETY ACT' AS LATEST 'TRIAL LAWYER EARMARK'

Washington, DC, May 12, 2009 -- As a House subcommittee today considered a bill that would reverse longstanding law which preempts state civil lawsuits against the makers of certain federally approved medical devices, American Tort Reform Association president Tiger Joyce dismissed the legislation as “little more than an effort to stimulate the economy for personal injury lawyers.”

The Medical Device Safety Act of 2009 would “undo last year’s near unanimous Supreme Court decision in Riegel v. Medtronic and the lower court decisions on which it was based,” Joyce explained. “Riegel reaffirmed the Food and Drug Administration’s preeminence when it comes to regulating the design and safety of certain medical devices, and the personal injury bar didn’t like that.

“Despite what some on Capitol Hill are saying these days,” Joyce continued, “Congress clearly intended in the preemption clause of the Medical Device Amendments of 1976 to make the FDA the nation’s top authority in assessing the benefits and risks of these lifesaving and life-enhancing medical devices. This is a responsibility best left in the hands of experts.

“Trial lawyer lobbyists and supporters of the bill are simply wrong about patients’ legal rights under existing law,” Joyce added. “Patients already have redress if a device is manufactured improperly, and since fraudulent behavior or misrepresentations to the FDA during the approval process by a manufacturer are not shielded under current law, this purported legislative ‘fix’ is really just another ‘trial lawyer earmark.’

“It’s easy enough to understand why the litigation industry is looking to expand liability and the prospect of more fees,” Joyce observed. “But it’s unfathomable that Congress would help these personal injury lawyers threaten manufacturers of critical medical technologies - and thus the health of patients who benefit from them - with speculative, potentially bankrupting lawsuits filed invariably in some of the nation’s least fair civil courts.

The Health Subcommittee of the House Energy and Commerce Committee conducted today’s hearing and is chaired by Rep. Frank Pallone (D) of New Jersey. Joyce noted “the irony” in that several Garden State counties have been cited as “Judicial Hellholes” in the past two years for, among other things, the targeting of the important in-state pharmaceutical and medical device industries.

“The desire to compensate individuals who have suffered is understandable, and certainly the FDA is not without its bureaucratic shortcomings. But its experts are still far better suited to regulate the safety and effectiveness of medical devices than are lawsuits driven by personal injury lawyers. Congressional leaders would be well-advised to abandon this latest gift to the politically powerful litigation industry and instead seek broad, bipartisan support for strengthening and reforming the FDA, as needed,” Joyce concluded.

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The American Tort Reform Association (ATRA) is the only national organization dedicated exclusively to tort and liability reform through public education and the enactment of legislation. ATRA's membership includes non profits, small and large companies, as well as state and national trade, business, and professional associations.

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