The FDA Excuse

Medical Malpractice Proposals Give Drug Companies a Pass for Selling Dangerous Products

Immunity for Drug Companies
A series of medical malpractice bills proposed by the Bush Administration in the 108th Congress—H.R.5, H.R. 4280, S. 11, S. 2061, and S. 2207—included provisions giving drug companies immunity from punitive damages. Those bills provided that any drug or medical device approved by the FDA would not be subject to punitive damage awards unless the company flat out lied to the FDA or bribed an official. They also dangerously extended such immunity to those drugs and devices that are not FDA-approved, yet are "generally recognized as safe and effective," and to products that comply with bureaucratic packaging regulations.

Measure Unrelated to Malpractice
Although cleverly disguised as a medical malpractice liability reform measure, language from last year's legislation contains a product liability provision that is wholly outside the scope of medical malpractice (see italics below). Similar language will undoubtedly be included in the Administration's bill to be introduced in the 109th Congress early next year.

Sec. (7)(c) NO CIVIL MONETARY PENALTIES FOR PRODUCTS IN COMPLIANCE WITH FDA STANDARDS-

1. PUNITIVE DAMAGES-
   1. IN GENERAL- In addition to the requirements of subsection (a), punitive damages may not be awarded against the manufacturer or distributor of a medical product, or a supplier of any component or raw material of such 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 of the particular medical product, or supplier of any component or raw material of such medical product, failed to comply with a specific requirement of the Federal Food, Drug, and Cosmetic Act or the 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.

It is outrageous to use compliance with FDA or other government regulations as a basis for immunity when those very regulations have proven inadequate. Government safety standards, at their best, establish only a minimum level of protection for the public. At their worst, they can be outdated, under-protective, or under-enforced. Congress should not reduce any incentives for industry to police itself above and beyond government regulation.

Punitive damages are rarely awarded, but are necessary to punish wrongdoers for conscious, flagrant disregard for patient health and safety and to deter bad behavior. By shielding manufacturers of dangerous and defective drugs from exposure to punitive damages, the FDA excuse removes incentives for manufacturers to make the safest products and to quickly withdraw dangerous products already on the market.

Take, for example, Vioxx. A consumer who had a heart attack due to Vioxx would be barred from even asking a jury to punish the manufacturer. Punitive damage awards discourage companies such as Merck from marketing dangerous products in the first place. Internal memos unearthed by the Wall Street Journal show that Merck may have known about Vioxx's dangers as far back as 1996, and that sales representatives were instructed literally to dodge questions about the cardiac risks.

Updated February 3, 2005