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Class action status has been denied plaintiffs in the multibillion-dollar litigation over the controversial diabetes drug Rezulin. Southern District of New York Judge Lewis A. Kaplan found that the individual personal injury claims of people allegedly harmed by the drug predominated over other claims in the lawsuits, and that “very serious difficulties would be encountered in managing the putative class action were it certified.” The decision was a setback for plaintiffs’ lawyers in the more than 800 cases transferred to Kaplan by the Judicial Panel on Multidistrict Litigation in Rezulin Products Liability Litigation, 00 Civ. 2843. Judge Kaplan said several complications were posed by the disparate nature of the cases. Some cases involve people allegedly injured or killed by the drugs and had multimillion-dollar injury claims. Others, he said, involve potential plaintiffs who had yet to be injured and sought only a refund of the purchase price. And some of those plaintiffs who had manifested no injury also sought to be certified as a subclass seeking the relief of ongoing medical monitoring, a motion also rejected by Kaplan. “Those members of the class who in fact sustained physical injuries arguably attributable to Rezulin — in other words, those with real personal injury cases — obviously have an overwhelming interest in pursuing their own lawsuits rather than being submerged in a class seeking a refund of the purchase price of the drug,” he said. The putative class involved well over 1 million people, or their survivors, who were prescribed Rezulin when Warner-Lambert Corp., now a subsidiary of Pfizer Inc., first gained approval from the Food and Drug Administration to begin marketing the drug in 1997. But Warner-Lambert was forced to pull Rezulin off the market in 2000 after a study showed that more than 60 people taking the drug died from related liver problems. Warner-Lambert has already been forced to pay substantial damages in state court suits over the drug. But even the federal cases consolidated before Judge Kaplan, he said, were based on a number of different theories and state laws. “This case abounds with often difficult issues with respect to conduct-regulating laws,” Kaplan said. “These include, but by no means are limited to, the standard governing strict liability claims against pharmaceutical manufacturers, the scope and impact of the learned intermediary doctrine, and the rules governing disclosure in the advertising of ethical pharmaceuticals. “Critical liability questions therefore presumptively will be governed by the law of the states in which particular members of this million person putative class reside,” he said. The plaintiffs had claimed that Rezulin is toxic to the liver and the heart, and cited repeated changes in the warnings that the Food and Drug Administration ordered affixed to the label since it was first marketed. The changes directed users to have ever more frequent liver-function testing. The plaintiffs also claimed that Warner-Lambert knew the risks of heart and liver problems, and failed to disclose them to patients and their physicians. But Judge Kaplan said the plaintiffs did not claim Rezulin injured the liver or heart “in all or even most who ingested it.” And the plaintiffs’ own experts acknowledged that the vast majority of patients who took the drug suffered no injury as a result. “Thus, while nothing turns on the proposition at this stage of the proceedings, it appears that such injuries, if any, as Rezulin caused may well have been both rare and idiosyncratic, although this would not excuse any concealment of the risks of such injuries,” he said. After finding that the interest of class members “in individually controlling the prosecution of claims is paramount,” the judge noted that the claims “overwhelmingly arise under state rather than federal law.” In denying the motion to certify a subclass for medical monitoring purposes, Kaplan said the subclass action “would not be sufficiently manageable or efficient.” In closing, the judge said, “If Rezulin and its marketing was as bad as plaintiffs claim, defendants will doubtless get their comeuppance in the hundreds or thousands of personal injury cases already pending against them.” He said that these “plaintiffs, however, have not satisfied the requirements of Rule 23″ of the Federal Rules of Civil Procedure, which governs class certification. “Their rhetoric affords no basis for an unjustified stretch to fit this square peg into a round hole.” Representing the plaintiffs were Charles A. Mathis of Herman, Mathis, Casey & Kitchens; Arnold Levin of Levin Fishbein Sedran & Berman; Melvin I. Weiss and Regina L. LaPolla of Milberg Weiss Bershad Hynes & Lerach; and Ramon Rossi Lopez of Lopez, Hodes, Restaino, Milman, Skikos & Polos. Kaye Scholer’s David Klingsberg, Maris Veidemanis, Allan M. Pepper, Bert L. Slonim and Robert Grass represented the defendants.

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