Several 1995 versions of proposed product liability reform legislation state that punitive damages shall not be awarded if a drug was approved by the FDA. Under this government standards defense, the manufacturer could still be forced to pay actual damagescompensation for injuries or lossesto anyone harmed by the medication. Table 1 summarizes the key provisions in the legal reform bills passed by the House, those introduced by Sens. Jay Rockefeller (D-W.Va) and Slade Gorton (R-Wash.), and proposals made by Sen. Orin Hatch (R-Utah) [44,45].
Perhaps for products with great social benefit, liability risks should be adjusted accordingly with special liability protection. While there is optimism for passage of tort reform legislation in this Congress, various reforms have been proposed in the past to give manufacturers an absolute defense if the plaintiff was under the influence of alcohol or illegal drugs at the time of an accident; limited immunity from suit for certain needed products; provisions for out-of-court settlements; two-year statute of limitations to begin when the claimant discovers the harm or cause; and federal preemption and restriction of punitive damages [46].
Federal preemption has been interpreted for medical devices under the 1976 Medical Device Amendments. Courts have not allowed state suits [47].
Table 1 Proposed Tort Reform
Provision
House Bill
Rockefeller-Gorton Bill
Hatch Bill
Punitive damages
Immunity if FDA approved unless false information provided
No FDA defense
Includes FDA defense clause
Noneconomic damages
Limited to $250,000
No cap
Limited to $250,000
Statute of repose
Within 15 years
Twenty years
None
Statute of limitations
None
Two years
Two years
Joint and several liability
Abolishes joint liability for noneconomic damages, allows it for economic damages
