Firms Win Protection Against Lawsuits Over Defective Drugs : State High Court Ruling Big Victory for Manufacturers

SAN FRANCISCO — The California Supreme Court today extended to drug manufacturers greater protection against lawsuits for injuries caused by defective prescription drugs.

The unanimous decision was a big victory for the pharmaceutical industry, which gained protections from lawsuits that do not apply to makers of most other products.

It immediately involved 69 cancer patients who blamed the anti-miscarriage drug DES for their disease but also extended protections to drug makers and their insurance companies for a vast array of potentially flawed drugs.

The court ruled drug makers can be held liable for injuries to consumers only if the firms are proven negligent. The drug makers are exempted from the legal theory of strict liability and from claims of fraud in drug promotion.

Ruling ‘Anti-Consumer’

“It’s appalling. It’s very regressive,” said Nancy Hersh, attorney for an Alameda woman whose mother took DES during her pregnancy. Hersh called the ruling “anti-consumer” and “a boon to the drug industry and the insurance industry.”

The decision exempted pharmaceutical firms from liability because the court said the public interest requires protection of drugs’ development, availability and the ultimate reasonableness of their prices.

“Public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction,” said the opinion by Justice Stanley Mosk.

Fault Not an Issue

Under a legal doctrine pioneered by the California court in 1963, and now followed by nearly all states, a consumer harmed by a defective product can sue the manufacturer and retailer without proving either was at fault. The rationale was that proof of fault can be extremely difficult and that injuries caused by a product should be considered part of the cost of doing business.

But Mosk said that if drug manufacturers were subjected to that standard, “they might be reluctant to undertake research programs to develop some pharmaceuticals that would prove beneficial or to distribute others that are available to be marketed, because of the fear of large adverse monetary judgments.”

The opinion’s immediate effect is to protect approximately 170 makers of DES including Eli Lilly, Squibb and Upjohn. The drug DES, diethylstilbestrol, is blamed for causing vaginal and cervical cancer in thousands of daughters of women who took it in the 1950s and 1960s. DES was removed from the market in 1971.