March 26, 2001 -New Drug Lawsuits: PPA
A new study raises urgent questions about the safety of a popular drug. Under pressure from the Food and Drug Administration, manufacturers pull the product off the shelves and hold their collective breath, waiting for the lawsuits to hit.
It's a familiar scenario, with only the name of the hot drug to be filled in. Last time, it was Fen-Phen, which produced a bonanza for plaintiffs' lawyers. This time, the drug is phenyl-propanolamine (PPA). Until November, it was a ubiquitous ingredient in over-the-counter cold remedies and diet aids found in practically everyone's medicine cabinet. Plaintiffs' lawyers, many with experience battling big pharmaceutical companies over diet drugs, are getting ready to file lawsuits on behalf of hundreds, maybe thousands, of clients who claim that PPA triggered strokes and caused other damage. Although the numbers don't promise to be as big as fen-phen's, plaintiffs' lawyers are preparing for the prospect of many cases involving devastating injuries and deep-pocket defendants.
The list of companies whose products contained PPA reads like a drug industry Who's Who. They include American Home Products Corp., Schering-Plough Corp., Bayer Corp., Bristol-Myers Squibb Co. and Novartis Corp. (All of these companies declined to comment on the situation or did not return telephone calls). Likewise, among the products containing PPA were many familiar names, such as Alka-Seltzer, Contac, Tavist-D, Robitussin, Acutrim and Dexatrim.
Opportunity knocks
In recent years, drug manufacturers have been forced into several high-profile recalls after drugs approved by the FDA proved to be unreasonably dangerous. Last year alone, manufacturers recalled the prescription drugs Lotronex (used to treat irritable bowel syndrome), Rezulin (diabetes) and Propulsid (heartburn). All are the subject of lawsuits. Litigation continues over diet drugs, including Redux and Pondimin, removed from drugstore shelves in 1997. Critics of the FDA claim that it has compromised patient safety, speeding up the approval process for new drugs in response to criticism in the early '90s that it had been moving too slowly.
So far, only a few individual PPA cases have been filed. But since the recall, plaintiffs' lawyers across the country have been advertising, on Web sites, television and radio, looking for clients. There has been "tons of TV," says Mr. Rheingold. "I was on a ski trip in Utah, and I saw commercials for two firms competing against one another." He says that the Association of Trial Lawyers of America is set to organize litigation groups for PPA and ephedra, a related compound found in many herbal remedies. Mr. Rheingold's firm has been ahead of the curve on PPA, having already settled four cases.
Extrapolating from medical journal articles and reports of adverse reactions to the FDA, plaintiffs' lawyers estimate that the drug has been responsible for hundreds of strokes every year. Before PPA was pulled from the shelves in November, they say, few victims and families thought to question whether a stroke might have been triggered by a cold remedy or diet pill. Some lawyers are busy screening individual cases, and class actions have already been filed across the country.Still, defense lawyers and many plaintiffs' lawyers question whether class actions will play a major role in the litigation, in light of Supreme Court and other appellate court rulings limiting the use of mass tort class actions in recent years. More important, they say, will be individual wrongful death cases and personal injury cases involving severely disabled plaintiffs.
PPA's safety has been a matter of dispute for years. Public Citizen, a Washington, D.C.-based consumer group, warned in 1981 that PPA was dangerous. And in 1990, Representative Ron Wyden, D-Ore., held hearings on the safety of diet drugs containing the chemical.
In 1994, researchers at Yale University School of Medicine began an industry-supported study into the possibility of a link between PPA and hemorrhagic stroke, which occurs when a blood vessel in the brain bursts. It was completed in May 2000, with results that were devastating to PPA. The study found an increased risk of hemorrhagic stroke for its subjects, aged 18 to 49, including a 16-fold risk for women using diet aids containing PPA. Although the chances that a particular person would suffer a stroke were small, the risks seemed not to justify use of the product to aid weight loss or to dry up a runny nose. Under FDA pressure, the industry took products containing PPA off the market in November, replacing it with another chemical.
Plaintiffs' lawyers are confident that the Yale study gives them the support they need to survive anticipated challenges to their scientific evidence linking PPA to stroke. In fact, in one case predating the study, the U.S. Court of Appeals for the 6th Circuit ruled to allow the testimony of an expert who said that the plaintiff's stroke was the result of taking Dexatrim diet pills. Plaintiffs' lawyers say injuries that occurred after the completion of the Yale study in May will be particularly good cases.
Not so fast
Still, defense lawyers say plaintiffs shouldn't bank their money just yet. A long list of contributing factors must be considered in a stroke case, including age, race, socioeconomic status, use of oral contraceptives, illicit drugs, alcohol and tobacco. And the industry should be judged by its knowledge of the risk at the time of each claimed injury, he says, not with the hindsight provided by the Yale study and other more recent information. Lawyers also expect that defendants will try to poke holes in the Yale study, which the industry has criticized.
One big difference between Fen-Phen and other big drug products liability cases is that PPA was most often used in over-the-counter, rather than prescription, drugs. As a result, drug companies will generally be unable to defend their cases by showing they provided proper warnings to doctors. On the other hand, plaintiffs' lawyers often sue treating physicians, who typically live in the same states as the plaintiffs, to defeat federal jurisdiction based on diversity of citizenship and to keep the cases in friendlier state courts. As a result, lawyers expect many PPA cases will end up in federal court. Plaintiffs' lawyers generally see state judges and juries as more receptive to novel scientific theories. Plaintiffs' lawyers also have high hopes for suits over diet supplements containing ephedra. Compared with over-the-counter and prescription drugs, the FDA has little authority over these products. In February, an Alaska jury awarded $ 13.3 million to a woman who suffered a stroke while using a weight-loss supplement containing ephedra and synthetic ephedrine
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