FDAnews Drug Daily Bulletin

Lawmakers Introduce Bill to Curb FDA Preemption

June 30, 2008

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 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,” 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 H.R. 6381.

They hope to reverse the court’s decision in Riegel v. Medtronic, in which the court ruled 8–1 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 Thursday 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.

H.R. 6381 is available at www.house.gov/waxman/pdfs/bill_MDSA_2008.pdf. Waxman’s letter can be accessed at oversight.house.gov/documents/20080626115635.pdf.