Pfizer Inc.s decision to stand behind Celebrex rather than withdraw its painkiller, as rival Merck & Co. did with Vioxx on Sept. 30, puts the company on a risky legal path.
Since Friday, Pfizers chief executive, Henry McKinnell, has been adamant that the company has no plans to take Celebrex off the market. Mr. McKinnell had learned the night before that a government-sponsored cancer-prevention study found an increased risk of cardiovascular events in people receiving high doses of Celebrex compared with those taking a sugar pill. However, a similar company-sponsored cancer-prevention trial that was reviewed by the same group of experts that examined the worrisome study didn't find such a link.
Lawyers including the ones suing both Pfizer and Merck agree that the cases against Merck are much stronger than the ones against Pfizer. Plaintiffs attorneys can point to numerous studies of Vioxx over several years that had fingered the drug and its potential cardiovascular risks, while Celebrex mostly eluded such implications.
But if more is found to be wrong with Celebrex in the weeks and months ahead, Pfizers decision could backfire in the courtroom.
From a liability and lawsuit view, my advice would be to pull the drug off the market. Thats the safest course, says Joseph Capobianco, a partner with Reisman Peirez & Reisman, Garden City, N.Y., which specializes in representing companies.
Mr. Capobianco, who has no connection with Pfizer, recommends withdrawal of Celebrex because plaintiffs attorneys could say in court, You knew that this drug was potentially dangerous and yet you continued to sell it. That could anger a jury and result in higher punitive damages, he says.
Still, it can be argued that Pfizer could save Celebrex and help itself by simply putting all the risk information out there, alerting doctors and patients and letting them make the choices. That course seems to have helped the company manage product-safety questions about another blockbuster, Viagra. After Viagra was launched in 1998, Pfizer and regulators received reports that some men taking the impotence drug had serious reactions, including fatal heart attacks. The Viagra label warned the drug should be used with caution in patients with a history of heart disease and should not be used in combination with nitrate drugs used to treat angina warnings that proved a helpful defense to the company.
An early case in New York that sought $85 million in damages for a heart attack allegedly caused by Viagra was dismissed on summary judgment, as were many others like it, a Pfizer spokeswoman said yesterday.
The problem with simply disclosing risks, say some lawyers, is that patients and even some doctors don't always follow directions. In addition, merely adding a stiffer warning to the drugs label might also be construed as some admission of guilt, Mr. Capobianco argues. Theres a certain element that by doing that you're saying this is a dangerous drug.
This view would possibly be compounded if the Food and Drug Administration were to ultimately order Celebrexs with drawal an eventuality that would translate into a much greater liability problem for Pfizer in court. It would show the callousness of the drug company, says Andy Birchfield, of the Beasley Allen Law Firm in Montgomery, Ala., which had filed 53 cases against Pfizer before Fridays announcement.
Paul Rheingold, another plaintiffs attorney, had turned down Celebrex cases in the past, but now is gearing up to file suits over Celebrex. He sees Pfizers withdrawal of advertising as a plus for his cases. Are they really admitting something when they stopped promoting to the public? What are they saying, Its only half dangerous? asks Mr. Rheingold. Its certainly encouraged us to get going on these cases.
In court, Pfizer will be facing cases like that of David Henry Englert, a 68-year-old retiree who began taking 400 milligrams of Celebrex daily in October 1999 after knee surgery. In March 2000, he had a peptic ulcer that landed him in the hospital; his doctor said the ulcer was related to his Celebrex use. Then, a couple of weeks later, Mr. Englert suffered a fatal heart attack.
Other cases will show younger users. Todd Michael Tangen, a 38-year-old father of three young boys, took 200 milligrams of Celebrex for 14 months. In December 2000, while he was hunting for mountain lions in Bozeman, Mont., he had a heart attack. He has since recovered but has sued Pfizer, as has a relative of Mr. Englerts.
Product-liability concerns don't dictate our decision making, a Pfizer spokeswoman says. Rather, its the health and well-being of patients along with the guidance that we receive from the FDA that inform our decisions.
The decision to keep Celebrex on the market may backfire in the court of public opinion. If their strategy is to minimize legal ramifications by keeping the product on the market, thats a short-term gain that will have long-term repercussions, says Paul Argenti, a professor specializing in corporate communications and reputation management at Dartmouth Colleges Tuck School of Business, and who has done consulting work for drug companies (but not for Pfizer or Merck).
Consumers aren't looking at this as a scientific problem anymore because the science is confusing at best, Mr. Argenti says. They see these drug companies are taking advantage of people with expensive advertising and then trying to rationalize about things that are emotional like the sense of danger. Pfizer will be lumped together with Merck. Consumers cant tell the difference between Vioxx and Celebrex and Bextra. They're now seen as equally bad.
Yet, if Pfizer succeeds in keeping Celebrex on the market despite the negative hoopla, it could be viewed as a legal plus in court. Thats because a drug still approved for sale on the market makes it much more difficult to prove in a court of law that it is unsafe. That certainly makes the plaintiffs job much more challenging, says Mr. Birchfield, the attorney in Montgomery, Ala.
Meantime, congressional Republicans are expected to reintroduce legislation early next year that would sharply limit damage awards to patients injured by drugs approved by the FDA.
Such legislation has been introduced in the past, but has failed in the Senate because of opposition from Democrats. The Republican majority in the Senate grew in the last election. The drug industry has argued that it shouldn't have to pay punitive damages for a product that was approved by the FDA, unless the manufacturer misled the agency or otherwise failed to comply with FDA rules.