Enriched and emboldened after successful fights against asbestos and tobacco companies, some of the nation's top plaintiffs' lawyers have trained their sights on drug makers, claiming that many giant pharmaceutical companies have hidden the dangers of medicines the lawyers say have harmed thousands of people.
In some cases, the drugs at issue have already been pulled off the market, such as Rezulin, a diabetes treatment from Pfizer that the Food and Drug Administration has linked to liver damage and is the target of almost 9,000 suits. Other suits name some of the industry's current best sellers, including Paxil, an antidepressant that plaintiffs contend is addictive - a claim denied by the drug's maker, GlaxoSmithKline.
In some instances, teams of plaintiffs' lawyers are spending several million dollars preparing cases for trial in hopes of winning billions of dollars in settlements and jury verdicts from the drug companies, which have some of the deepest pockets among American corporations.
The lawyers pursuing the suits say that the FDA has systemically failed to protect patients from dangerous drugs, and that the companies have tried to hide side effects. But the agency says medicines are safer now than they have ever been.
Within the industry, some experts on drug development say that juries might be ill-equipped to make the complicated cost-benefit analysis that the FDA performs when it decides to approve new drugs.
Also, companies have begun to consider the threat of lawsuits when deciding which new medicines to pursue, said Kenneth I. Kaitin, the director of Tufts Center for the Study of Drug Development, a nonprofit group that is supported by the industry.
Companies, for example, have mostly stopped developing contraceptives, which are vulnerable to lawsuits, Kaitin said.
Drug companies have always faced isolated claims about side effects from their medicines. But the new lawsuits are much larger, covering more drugs and many more plaintiffs. In addition to the 8,700 people who have sued Pfizer, the world's largest drug company, over Rezulin, an additional 32,000 people have said that they might sue, giving notice to avoid missing the opportunity to file such claims.
Wyeth, another big drug company, has set aside $14 billion since 1997 for claims by people who say they were injured by its diet drugs, and the company has been informed by an additional 90,000 people that they might sue. Johnson & Johnson and Bayer have also been named in thousands of suits. Drugs from Bristol-Myers Squibb, Eli Lilly and Merck have also been named in lawsuits.
