Lawsuits question safety and efficacy of Plavix.

At least eight lawsuits have been filed against the makers of the blood-thinning drug Plavix, alleging that it has caused injury and death and that the manufacturers misled doctors and the public about its risks and effectiveness.

The drug was "touted as a 'super-aspirin' that would give a person even greater cardiovascular benefits than a much less expensive daily aspirin, while being safer and easier on a person's stomach than aspirin," according to a complaint filed in a New Jersey federal court. However, it alleges, "defendants knew or should have known that when taking Plavix, the risk of suffering a heart attack, stroke, internal bleeding, blood disorder, or death far outweigh any potential benefit." (LaBarre v. Bristol-Myers Squibb Co., No. 3:06-cv-06050 (D.N.J. filed Dec. 18, 2006).)

The plaintiff in that case is the wife of a man who died after taking the drug. Edward LaBarre took Plavix in combination with aspirin (called "dual therapy") after having bypass surgery and a stent implanted in 2002. In 2004, he suffered a hemorrhagic stroke and died days later. His wife filed suit, alleging the manufacturers negligently designed, marketed, and sold Plavix. Bristol-Myers Squibb and Sanofi-Aventis jointly manufacture and market the drug.

In a similar case, also filed in federal court in New Jersey, the plaintiff took Plavix after a cardiac catheterization and stenting procedure and suffered a brain hemorrhage, which required a lengthy recovery. (Moscinski v. Bristol Myers Squibb Co., No. 3:06-cv-06055 (D.N.J. filed Dec. 18, 2006).) Another case was filed as a class action by third-party payers, including HMOs. (Skilstaf, Inc. v. Bristol-Myers Squibb Co., No. 3:06-cv-04965 (D.N.J. filed Oct. 17, 2006).)

Nancy Hersh, a San Francisco lawyer who represents the plaintiffs in eight of these cases, said that word spread about the problems associated with Plavix through a study published in the New England Journal of Medicine in April 2006. The study, funded by Sanofi-Aventis and Bristol-Myers Squibb, found that "the combination of clopidogrel [Plavix] plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular disease among patients with stable cardiovascular disease or multiple cardiovascular risk factors. Furthermore, the risk of moderate-to-severe bleeding was increased." (Deepak L. Bhatt et al., Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events, 354 New Eng. J. Med. 1706 (2006).)

The manufacturers' Web site for Plavix, which at press time said it was last updated in April 2006, includes this statement: "When taking Plavix alone or with some medicines including aspirin, the risk of bleeding may increase." A Bristol-Myers Squibb spokeswoman declined to comment.

"Getting the word out is the essence of products liability litigation," Hersh said. "Not everybody reads the New England Journal of Medicine--laypeople don't."

Hersh's cocounsel Michael Miller, of Orange, Virginia, agreed. "Information about drug risks doesn't come to light often enough, and in many cases, it has come to light only because of litigation," he said. "It is our job as trial lawyers to step into the role that the FDA has abdicated."

Plavix has been marketed heavily, and plaintiffs contend that it was rushed to market in 1997--through a priority regulatory review by the FDA--at the expense of safety.

Since then, the FDA has reprimanded Plavix's manufacturers. The agency's Division of Drug Marketing, Advertising, and Communications sent four warning letters to Sanofi in 1998 and 2001, saying that in its advertising and promotional materials, the company overstated Plavix's efficacy, made unsubstantiated claims that it was superior to aspirin, minimized the role of doctors in obtaining it, failed to present risk information, and implied that it is safe at a dose four times higher than the label's recommended dose. The agency demanded that these materials be withdrawn.

It's important to make doctors aware of the dangers of prescribing Plavix as the manufacturers have recommended, Hersh said.

"As far as I can tell, they're still promoting dual therapy with aspirin as safe and effective," she said, "but it's neither safe nor effective." She added that a blood disorder that Plavix causes has warranted a "black box" warning with other drugs in the past.

The LaBarre complaint alleges that company drug representatives misinformed physicians about Plavix.

"In past cases--Zyprexa, for example--it became clear that it was company policy for the drug reps to fail to completely represent the safety of the product," Hersh said. However, she noted that this practice "has to come from the top down. It's not misbehavior of the sales reps--it's misbehavior of the company."

Last year, Bristol-Myers Squibb announced it was terminating its CEO and senior vice president/general counsel, in accordance with a federal judge's recommendation. That recommendation followed an inquiry into the company's corporate governance in connection with negotiations aimed at reaching a settlement agreement in patent litigation over Plavix.

Noting that Plavix is a popular, multibillion-dollar drug and that plaintiffs alleging injury from it are relatively young, Hersh said the manufacturers need to warn doctors and patients about its risk so that they can make informed decisions.

"If the physicians were told, 'This drug is not effective and not safe,'" she said, "do you think they would prescribe it?"