Painkillers set to become the new wave in American courts


Laura Vozzella and Ivan Penn


December 24, 2004


  
Hundreds of patients sought lawyers via a website after regulators' `great concerns' about Pfizer-made Celebrex.
BLOOMBERG

Hours after the safety of a blockbuster arthritis drug was called into question last week, a new page popped up on injuryboard.com, inviting patients to summarise their ``Celebrex experience'' and click a button to submit their ``case'' to a personal injury lawyer.

Move over tobacco, asbestos and fen-phen.

The next big wave of lawsuits to hit courthouses across the United States is likely to target the makers of Celebrex, Vioxx and Bextra - similar and enormously popular painkillers now suspected of increasing the risk of heart attacks and strokes.

``It sounds a little like the tobacco business,'' said Donald Saiontz, senior partner of a Baltimore firm that advertises heavily and has been seeking Vioxx patients on its own website. ``They know they're going to get their rear ends sued.''

The anticipated flurry of lawsuits doesn't mean the cases will be slam-dunks. Some personal injury lawyers concede that the suits will be difficult because the problems blamed on the drugs - heart attacks and strokes - are common afflictions with many causes.

Individual patients have filed lawsuits claiming they have been harmed by the drugs almost since their inception in the late 1990s. But the case volume is expected to explode now that Vioxx has been pulled from the market, a clinical trial of Celebrex has been shut down, and federal regulators are questioning the safety of Bextra for some heart patients.

Since the Celebrex study was halted last week and the Food and Drug Administration (FDA) expressed ``great concerns'' about the drug, hundreds of patients have sought lawyers through the Celebrex page on www.injuryboard.com.

The website, which solicits a wide variety of personal injury claims, has provided information about Celebrex almost since the site launched in 2001, according to its president, Nick Carroll. But when bad news about Celebrex broke, the drug got a separate page - and a flood of responses. ``We've had four-fold increase in volume just in the last several days,'' Marc Bern, whose New York law firm gets referrals from the site, said.

The same is true for lawyers who get cases the old-fashioned way. ``Celebrex numbers have shot through the roof,'' said Paul Sizemore of an Alabama law firm that claims to have more Vioxx cases - 400 - than any other. ``I can't tell you how many lawyers have contacted us.''

Merck pulled its painkiller Vioxx from the market on September 29 after identifying an increased risk of heart attacks and strokes. The company plans to fight the cases along with efforts to consolidate them into class-action suits. As of November 30, about 475 Vioxx cases had been filed, representing 1,100 plaintiffs.

``We're going to defend any lawsuits brought against us vigorously, and we do wish to try these cases individually because they are individual,'' spokesman Tony Plohoros said. ``Each plaintiff is an individual based on his or her medical history.''

Federal researchers halted a clinical trial of Celebrex as a potential cancer-fighter last week after they found that subjects taking 400 milligrams of the drug were 2.5 times as likely to have serious heart problems as those taking a placebo. At a dose of 800 milligrams, the risk was 3.4 times higher.

On Monday, the US government halted another Celebrex trial, this one testing its effectiveness in preventing Alzheimer's disease. Although that trial did not indicate problems with Celebrex, the results did indicate that the painkiller naproxen, also being tested on Alzheimer's, might increase the risk of heart attack. So the naproxen trial was discontinued.

Pfizer, which makes Celebrex, has kept the product on the market, arguing that its own studies have shown no increased risk of heart problems.

The company also continues to sell Bextra, the subject of an FDA warning that the drug might pose hazards to those recovering from heart bypass surgery.

``We don't make decisions based on concerns about litigation,'' Pfizer spokesman Bryant Haskins said. ``We make decisions on what's in the best interest of our patients.''

The flood of lawsuits hardly guarantees success for plaintiffs, the pharmaceutical industry and trial lawyers agree. That will be especially true if several pieces of Republican-sponsored legislation, which died in the past session of Congress, are revived as expected early next year, said Carlton Carl, spokesman for the Association of Trial Lawyers of America.

Under the proposed medical malpractice bills, the maker of any drug or medical device approved by the FDA would not be subject to punitive damages, unless the maker deceived or bribed the agency to win approval.

Vioxx, Celebrex and Bextra were all approved by the FDA. Although its decisions have come under fire, the agency itself is immune from lawsuits under the Federal Tort Claims Act.

THE BALTIMORE SUN

 


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