Lining up suits against painkillers

THE BALTIMORE SUN

Hours after the safety of a blockbuster arthritis drug was called into question last week, a new Web page popped up on injuryboard.com, inviting patients to summarize their "Celebrex experience" and then 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 America 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 Saiontz, Kirk & Miles, a Baltimore firm that advertises heavily and has been seeking Vioxx clients on its Web site.

"They know they're going to get their rear ends sued."

But 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 heart attacks and strokes - the problems blamed on the drugs - are common afflictions with many causes.

Individual patients have filed lawsuits involving the new class of painkillers almost since their inception in the late 1990s.

But the 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 Friday, when the Celebrex study was halted and the Food and Drug Administration expressed "great concerns" about the drug, hundreds of patients have sought out lawyers through the Celebrex page on injuryboard.com.

A Celebrex page

The Web site, 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 Friday, the drug got a separate page - and a flood of responses.

"We've had fourfold increase in volume just in the last several days," said Marc Bern, whose New York City firm, Napoli Bern LLP, gets referrals from the site.

The same is true for personal injury attorneys who get cases the old-fashioned way. "Just since last Friday, the Celebrex numbers have shot through the roof," said Paul Sizemore of Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, Ala.

The firm claims to have more Vioxx cases - 400 of them - than any other.

"I can't tell you how many lawyers have contacted us," Sizemore said.

Suits against Vioxx

Merck & Co. pulled its painkiller Vioxx from the market Sept. 29 after identifying an increased risk of heart attacks and strokes. As of Nov. 30, the firm was aware of about 475 Vioxx lawsuits, involving approximately 1,100 plaintiffs, he said.

Tony Plohoros, a Merck spokesman, said the company plans to fight the suits - and oppose efforts to consolidate them into class-actions.

"We're going to defend any lawsuits brought against us vigorously, and we do wish to try these cases individually because they are individual," 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 Friday after finding that subjects taking 400 mg of the drug were 2.5 times as likely to have serious heart problems as those taking a placebo. At a dose of 800 mg, the risk was 3.4 times higher.

On Monday, the 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, too.

Pfizer Inc., which makes Celebrex, has kept its 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 last week that the drug might pose hazards to those recovering from heart bypass surgery.

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

The flood of lawsuits hardly guarantees success for the plaintiffs, the pharmaceutical industry and trial lawyers agree.

Protection for makers

That will be especially true if several pieces of Republican-sponsored legislation - all of which died in the past session of Congress - are revived as expected early next year, according to Carlton Carl, spokesman for the Association of Trial Lawyers of America.

Under those measures, 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, Carl said.

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 proposed changes, Carl said, "would protect not the users of prescription medicines, but the makers of dangerous medicines."

Victor E. Schwartz, general counsel for the industry-backed American Tort Reform Association, said the legislation would not protect drug makers who conceal problems from the FDA.

"It doesn't provide some sort of secret, improper protection. It creates incentives to report any problems to the FDA and it doesn't let any wrongdoer off the hook," he said. "Tort means wrong. Tort means twisted. It doesn't mean mistakes. It doesn't mean whoops. It means we've done something [recklessly or intentionally] wrong."

Problem of proof

The lawsuits will confront another obstacle - proving that these drugs were specifically responsible for plaintiffs' heart problems.

Personal injury lawyers note that some products are associated with unusual "signature diseases," making it relatively easy to win suits against their makers. Asbestos, for example, is linked to a rare form of cancer.

Baycol, an anti-cholesterol drug taken off the market in 2001, is blamed for sometimes-fatal destruction of muscles. "There are very few [other] things that cause that - if you have a crushing injury like a car accident, or if you're a serious body-builder using steroids," said Edward J. Parr Jr., a Washington lawyer who specializes in pharmaceutical torts for Ury & Moskow, LLC.

Not so with heart attack or stroke. Patients who smoke, lead stressful lives, avoid exercise or subsist on fat-laden fast food might have trouble pinning their cardiovascular woes on Merck and Pfizer.

"Obviously someone who has participated in partially self-destroying themselves would be an area of concern for us," said Joanne Suder, a Baltimore malpractice attorney whose firm and affiliates are reviewing "quite a few" Vioxx and Celebrex claims.

As a result, trial lawyers say they'll have to be picky about the cases they take - but there are still plenty of potential plaintiffs. Twenty-million Americans took Vioxx, and 27 million have used Celebrex, according to their makers. Figures for Bextra use were not available.

The so-called COX-2 inhibitors in these three drugs work by blocking an enzyme that is important in the process of inflammation. They became wildly popular, in part because they offered pain relief without the serious gastric problems that often result from use of other nonsteroid anti-inflammatories, such as ibuprofen and naproxen.

Ads for consumers

The COX-2 drugs also caught on quickly because the drug companies advertised them directly to consumers. Critics such as Dennis O'Brien, spokesman for the Maryland Trial Lawyers Association, are seizing on that issue now that problems with the drugs have surfaced.

"You now have patients coming in to the doctor, asking for a specific drug, because they've seen Dorothy Hamill skating around on TV," said O'Brien, referring to the Olympian-turned-Vioxx-pitchwoman. "Unless you, as a physician, have seen the negative studies, you're not going to have any reason not to prescribe it."

Critics say those ads, and the huge sales they generate, exacerbate problems with faulty drugs.

Although adverse side effects often surface after medications have been on the market for a while, they become a much more serious problem when tens of millions of advertising-driven customers start popping the new pills, said Bern, the New York attorney.

Millions of patients

Even when just a small percentage of patients is hurt, the number of people affected can still be large - simply because so many are taking the drug.

The 47 million people who have taken Vioxx and Celebrex represent "one hell of a cohort," Bern said, using the term for individuals in a drug study.

While Pfizer has kept Celebrex on the market, it has stopped advertising to consumers at the request of the FDA. However, the company continues to promote the drug to doctors.

Edward F. Sherman, a law professor and former law dean at the Tulane University Law School in New Orleans, said halting consumer ads is likely to reduce Pfizer's liability in any lawsuit.

But Sherman added that Pfizer isn't likely to have as strong a legal position as Merck because Pfizer continues to offer Celebrex, despite questions about its safety.

"If they really wanted to protect the litigation posture, they would have pulled it off the market altogether, as Merck did with Vioxx," Sherman said. "My guess is the income is so large that they don't want to do that."

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