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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