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The first two juries to consider the alleged stroke-related dangers of a drug used in cold medications have returned defense verdicts, getting the attention of plaintiffs’ attorneys who have filed thousands of similar suits. The January verdicts revealed a weakness in the case against the makers of phenylpropanolamine (PPA) at precisely the point where one would expect it to be strongest-on the safety of the product. According to Food and Drug Administration documents, worries that PPA might increase the risk of stroke surfaced sporadically beginning in 1969. In 1991, at the FDA’s prompting, the industry selected researchers at the Yale University School of Medicine to conduct a large-scale study. Soon afterward, the researchers reported an association between PPA use and stroke. In 2000, the FDA asked the industry to remove it from prescription and over-the-counter medications and counseled consumers to avoid it. Notwithstanding that history, the two juries-one in New Brunswick, N.J., and the other in Los Angeles-ruled that two pre-2000 products containing PPA were not defective and were adequately labeled, even though they lacked warnings about the risk of stroke. On Jan. 16, the New Brunswick jury unanimously cleared Novartis Consumer Health Inc. of liability for a 1996 stroke suffered by Rose Kronfeld. Kronfeld blamed the stroke on her use of the cold medication Tavist D, which contained PPA prior to the FDA’s 2000 request. Kronfeld v. Novartis Consumer Health Inc., No. L00303402 (Middlesex Co., N.J., Super. Ct.). On Jan. 22, the Los Angeles jury likewise found Novartis blameless for Linda Lutz’s 1996 stroke and Pearl O’Neill’s 1995 stroke. Lutz had used Tavist D, while O’Neill had taken another Novartis product, Triaminicin, that once contained PPA. In re PPA litigations, No. JCCP-4166 (Los Angeles Co., Calif., Super. Ct.). Causation avoided Since neither jury found the products to be unsafe, they never got to the “proximate causation” stage, where they would have had to decide whether Kronfeld, Lutz and O’Neill suffered strokes because of PPA or because of some other risk factor. Kronfeld’s attorney, Jerry Kristal of the Cherry Hill, N.J., office of New York’s Weitz & Luxenberg, expressed surprise that the jury found safe a product with an ingredient condemned by the FDA. He speculated that the jury may have been unconvinced about causation, perhaps thinking that Kronfeld’s high blood pressure, and not PPA, resulted in her stroke. The jury then voted as it did on the threshold questions of safety and labeling simply to get the deliberations over as quickly as possible. Kristal said that a neurologist testified on Kronfeld’s behalf that Tavist D was a contributing factor in her stroke, while an expert for Novartis said that only massive doses would have had such an effect. Kristal said that his firm is handling more than 100 PPA cases. He doesn’t believe three defense verdicts merit a change in course, he said. “If you see five or six defense verdicts in a row, then maybe you’ll see a change in our strategy,” he said. Paul D. Rheingold, co-chairman of the Association of Trial Lawyers of America’s PPA Litigation Group, said the three verdicts were certain to be the object of intense discussion when the group holds its winter convention in February. Rheingold, who is a partner in New York’s Rheingold, Valet, Rheingold, Shkolnik & McCartney, cautioned that he was “only speaking as a lawyer with a hunch,” but suggested that with respect to Tavist D, the juries may have been swayed by the fact that Tavist D, which was a prescription-only medication at one time, had “gone through the FDA’s approval process.” Thus, although PPA by itself was old enough to be kept on the market without extensive testing because of grandfathering provisions, Tavist D had been found to be safe and effective by the FDA under its most rigorous procedures at a time when it still contained PPA, he argued. That approval may have led the jury to think Tavist D with PPA was safe despite the Yale study, he added. But that would not be a stumbling block in the many cases challenging products that had not been through the full approval process for new prescription drugs, Rheingold suggested. PPA is said to have been used in hundreds of prescription and over-the-counter medications, primarily cold and cough treatments and weight-loss pills. A Web site maintained by Dallas’ Waters & Kraus-www.ppa-injury-attorney.net-lists well-known products like Acutrim, Alka-Selzer Plus Cold Medicine, Bayer Cough Syrup, Dimetapp DM and many others. There seems to be no dispute that the industry turned to substitutes following the FDA’s 2000 request. According to Randolph S. Sherman of New York’s Kaye Scholer, which represents Novartis A.G., the pharmaceutical companies named most often in PPA lawsuits are Bayer Corp., Wyeth, GlaxoSmithKline PLC and Novartis. As firmwide overseer of Novartis’ strategy, Sherman had a hand in both the New Jersey and California trials. Taking on Yale Sherman dismissed Rheingold’s theory that FDA approval of Tavist D blinded jurors to the dangers of PPA by pointing to the Lutz case in California. The jurors found that Triaminicine was not a defective product, despite the fact that it had not been through the more rigorous procedures required of newer medications like Tavist D, he said. Neither of the plaintiffs’ attorneys in the California cases-Mark P. Robinson Jr. of Newport Beach, Calif.’s Robinson, Calcagnie & Robinson and Ramon Lopez of the Newport Beach office of Los Angeles’ Lopez, Hodes, Restaino, Milman & Skikos-returned calls seeking comment. Sherman said that in the New Jersey trial, it wasn’t necessary to challenge the Yale study head-on because Kronfeld did not fit the profile of those found to be at risk for stroke by the Yale researchers. For instance, the researchers found that women using a cough or cold medicine with PPA for the first time had a heightened risk of stroke. “Kronfeld took Tavist D every morning and every night, for a total of some 2,800 doses,” according to another of Novartis’ attorneys, Gita Rothschild of Newark, N.J.-based McCarter & English. “Why would the 2,801st Tavist D cause a stroke?” She said that Kronfeld had several risk factors for stroke, including weight gain and untreated chronic hypertension. When the FDA warned consumers away from PPA in 2000, it did not restrict its message to that segment of the population specifically found to be at risk in the Yale study. Thus, although only women were explicitly found to be at greater risk (for reasons that remain disputed), the agency did not suggest that PPA was safe for men. Of the two California plaintiffs, Lutz, like Kronfeld, was not a first-time user of a PPA medication, and thus fell outside the at-risk profile, Sherman said. In addition, Lutz was overweight and suffered from hypertension and undiagnosed diabetes, “a recipe for a stroke,” according to Kaye Scholer Los Angeles partner Jan Dodd, who tried the California cases. But because the second California plaintiff, O’Neill, did fit the at-risk profile, parrying her lawsuit required the firm to point out methodological and other weaknesses in the Yale study, Sherman said. O’Neill was only 35 years old when she suffered her stroke, Dodd said, and showed no risk factors for stroke other than a history of smoking since her teenage years. Among the evidence the defense introduced to impeach the Yale study was expert testimony that about 20% of victims of the type of stroke O’Neill suffered are similarly difficult to trace to any particular cause and that that percentage has not gone down since PPA was withdrawn from the market, according to Dodd. One of the Yale researchers, Dr. Walter N. Kernan, a professor in the school of medicine, said, “I’m aware that the industry has made an effort to criticize the study in terms of its methodology and conduct. The investigators are very confident about the study’s methodology and conduct. We have a high degree of confidence in the study’s conclusions.” Not all the news has been good for the industry or Novartis. In December, 2000, the New York Times reported that the year before, Novartis had paid $1.3 million to a 28-year-old woman who suffered a stroke after taking Tavist D. And, although Sherman said that the January verdicts put “a significant dent in the plaintiffs’ bravado,” he also conceded, “We can’t say that the plaintiffs will just fold up their tents.” According to records on the Web site of the U.S. District Court for the Western District of Washington, more than 1,300 cases have been filed in federal courts around the country. Under rules pertaining to multidistrict litigation, all of those cases have been transferred to Judge Barbara Jacobs Rothstein of the western district. She has overseen discovery of information at issue in multiple trials and ruled on evidentiary and other pretrial issues. Sherman, who is one of two lead defense counsel in the federal multidistrict litigation, said that Rothstein is expected to decide on Feb. 13 which of the cases are ready to be sent back to their courts of origin for trial. The western district Web site also reveals that 67 state court judges in 16 states have PPA cases on their docket. That doesn’t convey the full magnitude of the litigation. For instance, both Judge Marina Corodemus, who presided over the New Jersey trial, and Judge Anthony Mohr, who presided over the California trial, have hundreds of PPA cases on their dockets. Arthur Sherman of Los Angeles’ Sherman Salkow Petoyan & Weber, one of two lead counsel in the federal multidistrict litigation, disputed the idea that the January verdicts foreshadow hard times for plaintiffs. Sherman observed some of the California trial and said, “It was a close call here; it could have gone either way.” He pointed out that the jury came back with 9-to-3 verdicts on the third day of deliberations, after being deadlocked, 6-to-6, on the second day. “We [plaintiffs' attorneys] are operating on a contingency basis,” he said. “We really believe in these cases. We’ll learn from the verdicts, but they’re not going to hold us back.” Young’s e-mail address is [email protected].

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