New House Legislation Would Allow Patients to Sue Devicemakers
BY LAUREN UZDIENSKI, FEBRUARY 23, 2009
House Democrats Henry Waxman and Frank Pallone announced plans to introduce a bill that would allow patients to sue medical device manufacturers over failed implants. Per last year's Reigel v. Medtronic ruling, FDA approval of a device preempts state tort proceedings.
Since Reigel, a number of product liability cases have been dismissed from state courts. Among them is a squeaky hip case filed against Stryker. Representative Pallone told the New York Times that he anticipates the House Energy and Commerce Committee will hold hearings on the PMA process to assess whether it's sufficient to assure a new product's safety and effectiveness.
The industry, notably trade group AdvaMed, has spoken out against the new legislation. The Times quotes Christopher White, AdvaMed's general counsel, as saying, "We are clearly very troubled by this legislation . . . Our concern is that it would undermine the FDA process," thus limiting patient access to new technologies and slowing innovation.
The FDA's device approval and clearance processes have been under scrutiny for some time, with the GAO recently recommending that the pathway to 510(k) clearance become more stringent. Whether this bill gains traction in this session of Congress remains to be seen--Reps. Pallone and Waxman introduced a similar bill to the last Congress, though it never made it out of committee.
Edward Kennedy and Patrick J. Leahy said they would back a similar bill in the Senate in the coming months.
