HOUSE PRODUCT LIABILITY BILL EXPECTED TO PASS ENERGY & COMMERCE CMTE. JUNE 14; MEASURE EXCLUDES PROTECTIONS FOR ABORTIFACIENTS, CONTRACEPTIVES

Rep. Richardson's (D-NM) Product Liability Bill (HR 1115) is expected to be passed by the House Energy & Commerce Committee at a markup scheduled for June 14. When Committee Chairman Dingell (D-Mich.) adjourned a June 9 markup session, he said three amendments remain for consideration. The committee passed an amendment offered by Rep. Tauke (R-Iowa) to exclude contraceptives or abortifacients from the defenses provided by the legislation. The amendment, adopted by a 23-19 vote, leaves to current product liability law "any drug or device which is used as a contraceptive or abortifacient and which has as one of its known effects the interference with implantation of a fertilized human ovum or embryo or the termination of pregnancy after implantation." Tauke's amendment was considered after a broader amendment offered by Rep. Sikorski (D-Minn.) fell a single vote short of being adopted. The key vote on the first amendment was by Rep. Bilirakis (R-Fla.). The Floridian changed his vote from "pass" to "no" to make the tally 21-21. The Sikorski amendment would have exempted from the bill's protections "any drug or medical device that may result in fetal malformation or death or that may be harmful to the human reproductive system." Dingell maintained that Sikorski's amendment potentially would have removed "all drugs from the protections" of the bill. The amendment would have affected aspirin, corticosteroids, "all drugs, products like saline solution and heating pads. It ultimately "would remove some necessary and needed drugs from the marketplace," Dingell said. The amendment is unnecessary, he added, considering that the FD&C Act is "the best food and drug law in the world" and "protects American people very adequately from unsafe pharmaceuticals." Furthermore, Dingell said his Oversight Subcommittee has "found that the drug industry had done a pretty good job of late in terms of protecting the public health." Rep. Bliley (R-Va.) contended that to encourage drug development and marketing, the bill should make standards for providing drug manufacturers' liability stricter. He pointed out that "almost nobody will make" diphtheria-pertussis-tetanus vaccine "because of the potential for liability" under current law. Sikorski argued that his amendment simply would maintain the status quo for manufacturers of products that affect "two of the most vulnerable groups in society, women and children." Several committee members voted against Tauke's amendment after supporting Sikorski's. For example, Rep. Waxman (D-Calif.) supported the Sikorski amendment on the grounds that "tort law should be able to operate as a check on the FDA." However, Waxman opposed the Tauke amendment because he said it singles out specific types of drugs rather than acts against harm. He argued that "manufacturers of any drug or device that causes that kind of harm [should] know that we expect them through the tort system to make that product as safe as possible." He said the bill's defenses should be withheld from products with indications as diverse as the Dalkon Shield, DES, or Accutane. By a unanimous voice vote, the committee agreed to an amendment by Reps. Collins (D-Ill.) and Slattery (D-Kan.) to bar court orders that seal information relevant to product safety. Such orders are commonly made part of settlement agreements by defendants and withhold case records from pertinent government agencies and future plaintiffs. The committee also agreed, buy a 13-3 vote, to a Waxman amendment requiring the Justice Department to establish federal procedures for resolving small product liability claims of $ 10,000 or less.