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

Suggests Lincoln, an Original Tort Reformer, Would Be Disappointed by Congress's Willingness to Boost Litigation at Expense of Lifesaving Technologies, Economy

Washington, DC, February 11, 2009 -- On the 200th anniversary of the birth of Abraham Lincoln, American Tort Reform Association president Tiger Joyce suggested that “President Lincoln might join our criticism today of the litigation industry and its political allies in Congress as they prepare to reintroduce the Medical Device Safety Act.”

Sen. Edward Kennedy (D-Mass.) and others are expected to formally reintroduce the bill shortly, Joyce noted, in “their effort to undo the Supreme Court’s near-unanimous Riegel v. Medtronic decision last year, which reaffirmed longstanding law that preempts state civil claims challenging the design and safety of certain medical devices already approved by the federal Food and Drug Administration.

“Despite what some of the historical revisionists 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 certain lifesaving and life-enhancing medical devices.

“Personal injury lawyer lobbyists and the lawmakers who are beholden to them are simply wrong about patients’ legal rights under existing law,” explained Joyce. “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, the 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 with speculative, potentially bankrupting lawsuits filed invariably in some of the nation’s least fair civil courts comprising our ‘Judicial Hellholes’ list.

“Considering the deepening recession,” Joyce continued, “it’s equally unfathomable that, beyond the preemption issue, Congress also appears poised to pass an additional litany of litigation-growing, economy-sapping legislation that would limit arbitration agreements, invite more questionable consumer lawsuits from sometimes politically motivated state attorneys general, encourage an extraordinary volume of whistleblower litigation under the False Claims Act, or even criminalize the accidental or isolated manufacture of defective products. And consumers will ultimately pay the costs for such litigation with higher prices and lost jobs.”

Returning to Sen. Kennedy’s medical device bill, Joyce concluded, “The desire to compensate individuals who have suffered is understandable. But one doesn’t have to believe that the FDA is without its bureaucratic imperfections to believe 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 agency, as needed.”

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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.