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A Philadelphia judge has refused to certify three proposed classes of consumers who used the anti-cholesterol drug Baycol, but at the same time approved a fourth class composed of consumers who used the drug in Pennsylvania and are seeking court-supervised medical monitoring of health problems they may develop as a result of having taken the drug. Baycol’s manufacturer, Bayer Corp., pulled the drug off the market in 2001 after reports that some patients who used it were suffering from rhabdomyolysis, a condition of severe muscle deterioration that can be fatal. The plaintiffs in Lewis v. Bayer brought suit against Bayer Corp., headquartered in Pittsburgh, and GlaxoSmithKline , the Philadelphia-based pharmaceutical company that assisted Bayer in marketing and distributing Baycol, according to court records. The certification was a partial victory for plaintiffs’ attorneys Arnold Levin, Fred Longer and Daniel Levin at Levin Fishbein Sedran & Berman. “I was grateful for what [the judge] did give me and disappointed for what he didn’t,” Arnold Levin said. Levin said the certified class could number in the hundreds of thousands. Bayer Corp. said in a statement, “Having opposed certification of any class, Bayer will evaluate its legal options regarding the medical-monitoring class certification in Pennsylvania. The certification ruling is only the first procedural step in aggregating claims for a possible class action trial at a later stage in the proceedings and does not infer liability.” The representatives of the certified class have not been diagnosed with rhabdomyolysis or other conditions allegedly caused by Baycol ingestion but claim they are at a significantly increased risk for developing the side effects associated with Baycol. Thus, their lawsuit asks the court to order the defendants to pay for periodic medical exams that could detect the onset of the side effects, according to the opinion Common Pleas Judge Mark I. Bernstein issued last week. “The theory is that if you can diagnose something early, you can prevent the injuries from occurring,” Levin said. Bernstein explained that proposed classes must present substantial evidence to make a prima facie case from which a Pennsylvania court can conclude that the five elements required under state class certification rules are met. Of the four classes proposed by plaintiffs, Bernstein found that only Class I, the Pennsylvania class seeking medical-monitoring benefits, met the five elements – numerosity, commonality, typicality, adequacy of representation, and a fair and efficient method of adjudication. “The recommended monitoring program proposed by plaintiffs applies to all class members regardless of dose or duration,” Bernstein said. But Bayer believes a medical-monitoring class is inappropriate “because the claims of the possible class members involve too many diverse and individual issues,” according to the company’s statement. “Some of these include differences in medical histories and care, Baycol dosages, and Baycol use with other drugs.” Bayer also believes the class is improperly defined. In its complaint , Class I presented claims for medical monitoring, unjust enrichment and violation of the state Unfair Trade Practices and Consumer Protection Law, according to Bernstein’s opinion. Bernstein certified the class’ claim for medical monitoring but found the other claims failed to meet all required class certification elements. Plaintiffs alleged that more than 700,000 consumers used Baycol in the United States, satisfying the numerosity requirement, Bernstein said. Class I also met the commonality requirement on its medical-monitoring claim and established that this claim and the defense of this claim would be typical of the entire class, he said. Because the named representatives of Class I have not been diagnosed with rhabdomyolysis, they would fairly and adequately assert and represent the interests of the entire class, Bernstein concluded. Also, a class action represents a fair and efficient method of adjudicating the medical-monitoring claim because of the common issues of law and fact the class presents. The second and third classes proposed by plaintiffs’ counsel would have been composed of people who used Baycol nationwide – not just in Pennsylvania. Class II would have been nationwide users seeking benefits for medical monitoring, relief for unjust enrichment and violation of the Pennsylvania consumer protection act. Class III would have comprised people nationwide who used Baycol and were bringing claims for personal injury and unjust enrichment, according to the opinion. “We took the position that the defendants were in Pennsylvania, and so Pennsylvania law would apply,” Levin said . But after analyzing what law would apply to these classes, Bernstein found that different states have different requirements for claims of medical monitoring, unjust enrichment and products liability. Finding a conflict of law, Bernstein concluded that Pennsylvania law would not apply to these classes because the state’s contact with non-Pennsylvania litigants was insufficient, causing Classes II and III to fail the commonality requirement. “In this case, Pennsylvania’s only contact is the fact that the company does business in Pennsylvania,” the judge wrote. “The contacts of the states where the putative class resides are more substantial and have stronger interest in applying their applicable law to the sale, prescription and ingestion of pharmaceuticals within its borders, which is the conduct which gave rise to the class members’ claims.” Class IV would have comprised Pennsylvania consumers claiming personal injury as a result of ingesting Baycol and the corporation’s unjust enrichment, according to the opinion. But Bernstein said the negligence claims of Classes III and IV presented questions of fact as to what caused individual plaintiffs to suffer their alleged personal injuries, also causing these classes to fail the commonality requirement. “Although this case involves the use of only one product and one manufacturer, the failure to warn claims involve date-sensitive factual determinations of what the defendant knew or should have known, what the claimant physician knew or should have known, the effect of warning label changes and of course the legal cause of any injury,” Bernstein wrote. “The need for individualized determinations of liability predominates and therefore defeat any claim for commonality.” Albert G. Bixler at Eckert Seamans Cherin & Mellott represented Bayer Corp., and Fred Magaziner at Dechert represented GlaxoSmith-Kline. The Complex Litigation Center of the Court of Common Pleas of Philadelphia has been inundated with Baycol filings, court officials said. At least 2,000 cases remain in its inventory, although the number of cases reached as high as 4,000 as recently as August 2003. (Copies of the 46-page opinion in Lewis v. Bayer , PICS No. 04-0447, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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