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Congress vs. 'Defensive Medicine'

By Rebecca M. Stadler
April 01, 2003

Due to the rising cost of “defensive medicine,” the U.S. House of Representatives recently passed legislation to limit or ban punitive damages in product liability lawsuits over injuries allegedly caused by FDA-approved products. 2003 H.R. 5. The HEALTH “Help Efficient, Accessible, Low-Cost Timely Healthcare” Act of 2003 was introduced in the House on February 5. This bill passed in the House on March 13 and is currently on the calendar of the Senate.

Sec. 7(c)(1)(A) of the bill addresses punitive damages for FDA-approved products (drug, device, or biological product intended for humans). “Punitive damages may not be awarded against the manufacturer or distributor of a medical product … on the basis that the harm to the claimant was caused by the lack of safety or effectiveness of the particular medical product involved, unless the claimant demonstrates by clear and convincing evidence that: 1) the manufacturer or distributor … failed to comply with a specific requirement of the Federal Food, Drug, and Cosmetic Act or regulations promulgated thereunder; and 2) the harm attributed to the particular medical product resulted from such failure to comply with such specific statutory requirement or regulation.

The 'FDA Defense'

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