Democratic lawmakers recently announced plans to introduce legislation in the House and Senate that would overturn a February Supreme Court decision that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts, CQ HealthBeat reports. House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), a co-sponsor of the legislation, said that if device manufacturers are not held liable, financial incentives will lead them away from ensuring the safety of their devices. Waxman in a release said the Supreme Court "decision protects the financial interests of medical device companies at the expense of patients harmed by FDA-approved devices." House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.), another co-sponsor of the bill, in the release said, "This bill reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product."

Companion legislation is expected to be introduced in the Senate by Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and Judiciary Committee Chair Patrick Leahy (D-Vt.). Leahy in a release said, "The extraordinary power to pre-empt state law and regulation lies with Congress alone. It should not be left to the discretion of bureaucrats or the political appointees in the executive branch."

Opposition
Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said the Supreme Court decision "re-affirmed what most federal courts have regarded as settled law since 1976 -- that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology." In a statement, Ubl said that Congress gave FDA pre-emptive authority for device approvals in 1976 and further review by state courts "will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs."

Brett Loper, senior executive vice president of AdvaMed and director of its Government Affairs Department, said the pre-empted claims only address the design and labeling clause, and companies still could be held liable for other issues such as faulty manufacturing if something goes wrong. He added, "We're not breaking new ground in the court decision."

Medical Device Manufacturers Association Executive Director Mark Leahy said the organization supports the Supreme Court decision, adding that deferring scientific judgment from FDA employees to lay juries would create a system where each state would have its own requirements, which would be cost prohibitive and difficult for small companies (Parnass, CQ HealthBeat, 6/27).

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