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Executive Summary

PRODUCT LIABILITY CLAIMS SHOULD MEET OBJECTIVE CAUSATION STANDARDS in cases where injury is not manifest for many years after exposure to a drug, the Pharmaceutical Mfrs. Assn. (PMA) maintained in an Aug. 19 letter to the Senate Commerce/Consumer Subcmte. In preliminary comments that reiterate basic assn. positions expressed in President Mossinghoff's testimony before the subcmte. in June ("The Pink Sheet" June 24, p. 5), PMA said: "While we recognize the special problems these situations present, we believe that claimants should still be required to meet some of the objective standards of causation." The assn. said it "cannot agree" to the "toxic" injuries provisions in the subcmte.'s "staff working draft," released July 15 ("The Pink Sheet" July 22, T&G-6). The draft states that in claims involving toxic injuries, which become evident only many years after exposure to the causative agent, "the product shall be deemed to have been a substantial factor in producing the claimant's toxic harm if (1) the claimant was exposed to the product, and (2) exposure in such dose would significantly increase the risk of incurring the toxic harm" -- unless another toxic agent "is more likely to have independently produced the claimant's" injury. PMA argued that "warnings as to unavoidable risks must be a defense," particularly with regard to pharmaceuticals. PMA's comments on the draft bill were based on an initial review by "lawyers and others within the pharmaceutical industry," according to the letter, which was signed by PMA Asst. General Counsel Geoffrey Smith. In addition, plans for the assn.'s Compensation Study Group to generate a report on the no-fault compensation concept in the fall are said to be on schedule. The assn. said it is "encouraged" by the working draft's "clear statement of negligence as the basic standard of liability." However, the draft does not go far enough in saying that a company is presumed not to be negligent if it has complied with FDA regulations in making and labeling a drug product, PMA contended. Such a presumption "should be subject to rebuttal only if a showing is made that the mfr. withheld material information from FDA or made material misrepresentations to the agency," the assn. maintained. PMA said it has "very serious problems" with the draft's definition of an "unreasonably dangerous" product. The proposed definition -- that a product is unreasonably dangerous if a reasonably careful person, knowing about the danger that caused the claimant's harm, would not have marketed the product -- "can be read as requiring a mfr. to provide compensation by imputing to it knowledge that was in fact capable of being known given the state of scientific and medical knowledge at the time the product was sold," the assn. argued. "At this time we do not have any basis for estimating what the economic impact of such a provision could be or if there is any way that this potential liability can be insured or otherwise provided for in a way that does not put at risk the viability of our industry."

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