Trial Lawyers Are Taking Aim at the Drug Industry ( NYT )
Sun, 18 May 2003
It appears that trial lawyers will produce the results that government oversight agencies--in particular, the FDA--have failed to do. Namely, to protect the public against an increasing number of unsafe drugs.
The pharmaceutical industry whose efforts to hide the adverse effects of its drugs, are setting aside huge funds to fight lawsuits brought on behalf of hundreds of thousands of patients who had been exposed to defective, in some cases, lethal medicines that had been approved by the FDA. The drugs had continued to be marketed even as the human casualties mounted.
The New York Times reports about the lawsuits brought against Bayer (re: Baycol), Bristol Myers Squibb (re: Serzone), GlaxoSmithKline (re: Paxil), Johnson and Johnson (re: Propulsid), Pfizer (Rezulin), and Wyeth (re: Redux & Pondimin).
An illuminating internal document by a Bayer official that was introduced in a Texas court involving its cholesterol drug, Baycol, reveals the culture at pharmaceutical companies. To avoid obtaining negative data about suspected risks, the companies deliberately fail to test for those risks: "If the FDA asks for bad news, we have to give, but if we don't have it, then we can't give it to them."
Aggressive trial lawyers such as J. Michael Papantonio, are working cooperatively on behave of plaintiffs, and are prepared to invest the necessary resources to fight these corporate giants' huge war chests-- for example, Wyeth set aside $14 billion.
Of note, whereas the number of suits involving drugs for heartburn, cholesterol, weight loss, and diabetes are reported, the number involving antidepressant drugs remain unknown. The antidepressants named in the article were Serzone and Paxil. For unknown reasons, the Times fails to report anything about the suits against Eli Lilly involving Prozac. Neither did the Times reporter tell readers about the possible financial conflicts of interest that the consulted experts might have.
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, 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."
Medical trends aside, plaintiffs' lawyers acknowledge that much of the momentum behind the suits comes from the increasing aggressiveness and wealth of the trial bar. These days, the battle between drug companies and plaintiffs' lawyers is no longer one between corporate goliaths and individual advocates on a shoestring budget.
"We've got plenty of a war chest," said J. Michael Papantonio, a lawyer in Pensacola, Fla., who is a leader in drug litigation. "It's a different day out there. It's not like they're going to look across a table from us and say, `We're going to dry you up.' "
Plaintiffs' lawyers can now finance enormously complicated suits that require years of pretrial work and substantial scientific expertise, in the hope of a multibillion-dollar payoff. Scores of firms collaborate on a case, with some responsible for finding claimants, others for managing the millions of documents that companies turn over, others for the written legal arguments, and still others for presenting the case to a jury. Some 60 firms have banded together, for example, in the Baycol litigation.
And even when they do not form explicit partnerships, plaintiffs' lawyers are working much more closely together than they once did. At conferences around the nation with names like "Mass Torts Made Perfect" — that one was organized by Mr. Papantonio and the lawyer-celebrity Johnnie L. Cochran Jr. — and "The Knowledge to Conquer," lawyers trade information and legal strategies.
"The plaintiffs have learned how to communicate and share information," said Robert J. Gordon, of Weitz & Luxenberg in Manhattan, which is among the largest plaintiffs' law firms in the country, with about 400 employees, including 70 lawyers.
In addition, the plaintiffs' bar has refined a technique in drug lawsuits that it has used effectively against many asbestos companies. Lawyers file a few cases with very sick plaintiffs in states and counties considered favorable to plaintiffs, while building big "inventories" of less seriously ill patients, or so-called pill-taker cases, even people who have used the drug but are not sick.
If the lawyers can win large verdicts in the early cases, they then refuse to settle the claims of their other very sick clients unless the defendants also agree to pay the claims of people who are less sick. Under those circumstances, the companies face a difficult choice. If they go to trial in a case that includes a few seriously injured plaintiffs and hundreds more who are less affected, they risk losing hundreds of millions of dollars in a single case, frightening Wall Street and spurring more suits. But if they settle cases without a trial, they risk being perceived as an easy mark for lawyers.
Finally, the Internet and television advertising have made finding potential plaintiffs much easier, plaintiffs' lawyers say. If a drug is withdrawn from the market or given a "black box" warning by the F.D.A., indicating that it has significant dangers, "the plaintiffs' lawyers make sure that word gets out," said Charles S. Zimmerman, a Minneapolis lawyer involved in the Baycol litigation and other drug lawsuits. "We're looking to make sure that people know they have a claim, and they know they're represented if they choose to be."
Plaintiffs' lawyers say that their new aggressiveness has not led them to attack good drugs. Instead, their new resources and methods have simply made them better able to press claims in what they say are the many cases when companies introduce dangerous drugs and hide their risks — which they say the F.D.A. does not adequately monitor once drugs are approved.
The public risks have increased over the last decade, the lawyers said, as the industry tries to meet Wall Street's demands for steady growth in profits. Some doctors agree.
"Are there systemic problems with the drug companies?" said Dr. David Egilman, a clinical associate professor in public health at Brown University who often consults for plaintiffs' lawyers. "The answer to that in some cases is yes," he said. Companies often hide information about the dangers of their drugs, he said, or market them in ways that increase the odds they will be prescribed inappropriately.
But medical experts who act as industry consultants say such accusations are unfair. "I've never seen a situation where a drug company encouraged the manufacturing of a drug that was potentially unsafe," said Mr. Kaitin of Tufts. And yet, drug companies are pressing the F.D.A. to approve drugs more quickly, he said, and those fast approvals can increase the risk that a medicine's side effects are not fully known when it is approved.
Mr. Kaitin, and some other public health specialists, say that juries are willing to make large awards in drug cases in part because the public misunderstands the risks and benefits that prescription medicines are supposed to provide.
No medicine is completely safe for everyone, said Dr. Kin-Wei Chan, a Harvard epidemiologist who also practices at a clinic in Boston and has consulted for both plaintiffs and defendants.
Because tests are conducted on a few thousand patients, drug companies cannot immediately know every side effect of their medicines, Dr. Chan said, but the family of a person who has been injured or died after taking a new medicine may have a difficult time accepting that fact. "For a family it's not one in a thousand or one in a million, it's one in one," he said. "But from a public health perspective, and I'm coming from a public health perspective, this is something we have to live with. We all have to recognize that we have to live with some nonzero risk."
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