Lawmakers to curb court protection of FDA-approved medical devices

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Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Subcommittee on Health. Source: National Governors Association  

Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced June 26 in the House to preserve state product liability lawsuits.

Saying a previous Supreme Court decision that favored preemption of state tort laws by the FDA’s authority over medical devices “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers,” reported FDA News.

Reps. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, introduced the bill last week.

Pallone and Waxman hope to reverse the Supreme Court’s decision in Riegel v. Medtronic, in which the court ruled 8 to 1 that the express preemption provision of the federal Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by devices with premarket approval.

“This bill reverses [that] decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product,” Pallone said in a statement.

Waxman wrote a letter June 26 to FDA Commissioner Andrew von Eschenbach, requesting all documents about preemption since Jan. 20, 2001, related to the FDA’s intervention in specific product liability cases and development of Section D — “Comments on the Product Liability Implications of the Proposed Rule” in the preamble to the 2006 drug labeling rule.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, in commenting on the bill, said that “a patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients.”

“This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher healthcare costs,” Ubl concluded.