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A Philadelphia judge has announced the certification of a class of asymptomatic Pennsylvania users of the cholesterol-reducer Baycol who seek medical monitoring benefits from pharmaceutical giants Bayer and GlaxoSmithKline. The class counsel in Lewis v. Bayer are already working on a court-approved print media campaign to notify potential class members. Arnold Levin and Fred Longer of Levin, Fishbein, Sedran & Berman, who are representing the class along with Sol Weiss of Anapol, Schwartz, Weiss, Cohan, Feldman and Smalley, said placing the notices in 78 newspapers across the commonwealth would cost them over $200,000. Publications of the notices — which are to appear in the Pittsburgh Post-Gazette, Philadelphia Inquirer and Philadelphia Daily News, among other newspapers — are set to run within the next week, according to Longer. A Nov. 18 order from Philadelphia Common Pleas Judge Mark I. Bernstein, who certified the class in an opinion made public the same day, approves a legal notice that seeks responses from readers who are Pennsylvania residents who have taken Baycol or Cerivastatin and have not been diagnosed with rhabdomyolysis or congestive heart disease. According to Bernstein’s certification opinion — written in March, Levin and Longer said, but only made public Nov. 18 — Bayer and GlaxoSmithKline entered into a co-promotional agreement regarding Baycol, the marketing name for Cerivastatin. Bayer voluntarily removed Baycol from the market in August 2001, following increasing reports that use of the drug was linked to rhabdomyolysis, a potentially fatal disease marked by destruction of the muscles, according to the opinion. The plaintiffs in Lewis have further alleged that Baycol also lessens the liver’s production of coenzyme Q10, depletion of which has been known to cause congestive heart failure and related health problems, Bernstein wrote. Four separate classes were proposed for certification in relation to the Lewis action, according to the opinion. Class I was to include asymptomatic Pennsylvanians who have taken Baycol. That proposed class put forward claims for medical monitoring, unjust enrichment and violation of Pennsylvania’s Unfair Trade Practices Consumer Protection Law (UTPCPL). Class II was to include all people in the United States who have taken Baycol but are currently asymptomatic, according to the opinion. Class II, like Class I, would have brought claims for medical monitoring, unjust enrichment and violation of the UTPCPL. Class III would have included all U.S. residents who have taken Baycol and now “suffer from personal injury,” according to the opinion. That class’s claims were for negligence and unjust enrichment, as were those of proposed Class IV, which was to include Pennsylvanians who have taken Baycol and are exhibiting symptoms. In certifying Class I as to its medical monitoring claims, Bernstein found that there were individual questions as to some of the proposed members’ unjust enrichment and UTPCPL violation claims. He also ruled that the other three proposed classes did not meet certain class certification requirements. In analyzing the strength of the various claims, Bernstein cited the five criteria of Pennsylvania Rule of Civil Procedure 1702 that govern certification: numerosity, commonality, typicality of the named parties’ claims, adequacy and fairness of the named parties’ claims in being representative of the class, and potential effectiveness of a class action in resolving the underlying matter. Bernstein concluded that all proposed classes had met the numerosity requirement, as the plaintiffs claimed that roughly 700,000 people had ingested Baycol and that 10.6 million new and refilled prescriptions were dispensed in 2000 alone. Bernstein held that individual questions of law and fact existed as to the claims of classes II, III and IV. “A myriad of individual causation inquiries exist,” Bernstein wrote. “These inquiries must necessarily include, but are not limited to, family history, preexisting medical history, age, gender, lifestyle, quantity of Baycol ingested, date of prescription, duration of the course of treatment … and most importantly whether any injury is causally related to Baycol use.” He then turned to the individual questions of law as to the latter three classes. “The law applicable to [classes II and III] differs from jurisdiction to jurisdiction,” he wrote, adding later, “After conducting the applicable choice of law analysis, this court concludes that the substantive law applicable to the putative classes should be the law of the jurisdiction in which each class member was prescribed and sold Baycol.” Bernstein then held that the unjust enrichment and UTPCPL violation claims of proposed Class I also involved certain individual questions. “Class action treatment is not a proper method of adjudication for Baycol unjust enrichment claims generally,” Bernstein wrote, adding later, “[But] common issues of fact and law predominate as to those Pennsylvania consumers who purchased Baycol medication but were advised by the company to discontinue use.” Bernstein declined to carve out a similar “subclass” as to the UTPCPL claims of the proposed Class I members. “Since the reasons each proposed plaintiff began taking Baycol are different … the UTPCPL is not a proper claim for class certification,” he wrote. Bernstein went on to find that the typicality requirement had been met as to Class I’s medical monitoring claim only. He also ruled that Class I’s medical monitoring claim had satisfied the adequacy of representation and efficiency of adjudication requirements. Bayer was represented in the matter by Albert Bixler of Eckert Seamans Cherin & Mellott. Bayer spokeswoman Andrea Calise said Bayer would not estimate the number of possible class members. She also said, “Bayer believes that a medical monitoring class is not appropriate because the claims of the possible class members involve too many diverse and individual issues.” Levin said that he could not guess how many class members there might be without viewing Bayer’s sales records, to which he has not had access. The opt-out and discovery deadlines have been set for March 1, 2005, according to orders from Bernstein, and the trial is expected to begin sometime in July 2005.

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