Trial lawyers are now focusing on lawsuits against drug makers:NYTimes

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http://www.nytimes.com/2003/05/18/business/18DRUG.html?th

Trial Lawyers Are Now Focusing on Lawsuits Against Drug Makers

By ALEX BERENSON

 

 

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 run the risk of 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 clinical trials 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. "

 

New York Times