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【drug-news】律师关注针对药厂的法律诉讼官司
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.
(The New York Times / May 18, 2003) -- In some cases the drugs at issue have already been pulled off the market, like 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 the 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 Food and Drug Administration 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, meanwhile, some experts on drug development say that juries may be ill-equipped to make the complicated cost-benefit analysis that the F.D.A. performs when it decides to approve new drugs. And 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 very vulnerable to lawsuits, Mr. 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 may sue, giving notice to avoid missing the opportunity to eventually file such claims.
Wyeth, another big drug company, has already 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 may sue. Johnson & Johnson and Bayer have also been been named in thousands of suits. Drugs from Bristol-Myers Squibb, Eli Lilly and Merck have also been named in lawsuits. A spokesman for the Pharmaceutical Research and Manufacturers of America, the industry's trade group, declined to comment on the wave of lawsuits.
With hundreds of thousands of people claiming that they have been injured by dangerous medicines and deserve compensation, the drug makers say that they are now spending several billion dollars each year to defend themselves from lawsuits and settle claims.
The new wave of lawsuits has come at a difficult time for the companies, which face heavy pressure over drug prices and accusations that they abuse patents to keep less-expensive generic competitors off the market.
Plaintiffs' lawyers say that the suits have increased because drug makers have introduced dangerous drugs and hidden their risks. In some cases, documents obtained from the companies themselves during pretrial investigations appear to back that claim. A note from an official at Bayer, introduced this spring in a Texas lawsuit over the company's cholesterol treatment, Baycol, was offered as evidence that Bayer deliberately avoided studying potential links between Baycol and a rare muscle disorder. "If the F.D.A. asks for bad news, we have to give, but if we don't have it, then we can't give it to them," the note said.
Bayer stopped selling Baycol in 2001 after more than 30 deaths from the disorder were linked to the drug. The company has said the drug was marketed properly and is safe when properly used.
The industry's focus on producing drugs for chronic conditions like depression and diabetes has vastly increased the pool of potential plaintiffs, because medicines for those diseases are taken by millions of people for years on end. And because clinical trials for new drugs are conducted on only a few thousand subjects, the tests do not always discover rare but dangerous side effects that surface after a drug is approved, according to experts on drug development — even at the F.D.A.
"All drugs have side effects, and even the safest approved drugs have side effects," said Dr. Janet Woodcock, the director of the agency's Center for Drug Evaluation and Research. "It is very likely that the newer classes of drugs in general are safer than older drugs, but you have to recognize that many more people are taking medicines now than used to."
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作者:admin@医学,生命科学 2010-10-13 05:11
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