State Senate OKs Bill to Shield Drug Makers in Liability Suits

The state Senate on Thursday narrowly passed fiercely contested legislation to exempt pharmaceutical manufacturers from paying punitive damages to a consumer injured by federally approved medication.

Proponents argued such a shield is necessary to encourage drug makers to invest in the development of new, life-saving medications without the chilling threat of having to face “harassing” lawsuits.

Because of lawsuits seeking punitive damages for injuries caused by medications and medical devices, argued Sen. Barry Keene (D-Benicia), there are “drugs and devices not being marketed today, and this is being paid for by lost lives.”

But opponents--supported by Ralph Nader, the Consumers Union, California Trial Lawyers Assn. and a variety of women’s groups--mounted a heavy attack against the bill, declaring that the highly profitable pharmaceutical industry, like other manufacturers, must be responsible for the safety of its products.

‘Stamps Out’ Punitive Relief

Senate opponents of the bill noted that punitive damages in product liability cases are seldom awarded but do provide a deterrent against the marketing and sales of unsafe medications. Punitive damages are awarded as a punishment in lawsuits apart from actual damages.

“This bill stamps out the only form of (punitive) relief that injured, maimed people have in this society,” said Sen. Quentin L. Kopp (Ind.-San Francisco), a trial attorney.

After a heated consumer vs. manufacturer floor fight, the bill went to an uncertain future in the Assembly on a 22-12 vote, one more than the simple majority required in the 40-member Senate. The votes crossed usual ideological lines, pitting conservative against conservative and liberal against liberal.

The bill was sponsored by the Pharmaceutical Manufacturers Assn., a generous source of election campaign contributions to legislators.

Essentially, the legislation would immunize drug and medical device producers from paying punitive damages for injuries their products cause if the products have won approval of the federal Food and Drug Administration.

However, drug manufacturers could be liable for punitive damages if it was demonstrated that they knowingly withheld or misrepresented safety information submitted to the FDA. In such cases, they still would be liable for compensatory damages as they are now, including payment for pain and suffering.

Keene, the usually liberal Democratic floor leader and author of the bill, noted that “risks are associated with new technology” that may save hundreds of thousands of lives. But he insisted that payment of “excessive” punitive damages in product liability cases siphons away funds “and prevents the early marketing of products designed to save lives.”

However, liberal Sens. Nicholas C. Petris (D-Oakland) and Bill Lockyer (D-Hayward) warned against putting great trust in the FDA. They cited a list of highly publicized cases over the years in which products received FDA approval but were later determined to have caused deaths or serious injuries.

These included DES, the drug some women took about 30 years ago to prevent miscarriages; the Dalkon Shield, a women’s contraceptive device; Zomax, a painkiller; Oraflex, an arthritis medication, and ultra-absorbent tampons.

In some cases, Petris said, the manufacturers continued marketing the products or “unloading” them to Third World countries even after companies notified the FDA of adverse reactions to the products.

“This industry is being presented as the kindly benefactor of mankind,” Petris boomed out. “That is not true.”

Sen. John Doolittle of Rocklin, the Republican caucus chairman who unflinchingly sides with business on virtually every issue, cast a surprising “no” vote on the bill, saying that he had an unspecified “personal” reason for doing so.

“There (are) tremendous, enormous amounts of money in this industry,” he told the Senate. “Sometimes, greed gets the best of people. Punitive damages act as a disincentive to this type of behavior.”