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The maker of a substance used in the production of the diet drug fen-phen cannot be sued over the drug, a Philadelphia Common Pleas Court judge has ruled, because the defendant in the mass tort litigation that resulted in a $4 billion settlement was found by the trial court to be solely responsible. Furthermore, as the producer of only a component ingredient, the instant defendant, Les Servier, owed no duty to the plaintiffs, Judge Allan L. Tereshko said in Sokoloski v. American Home Products Corp., et. al. The named plaintiffs, Judith and Joseph Sokoloski, led 22 other plaintiffs in the appeal. The action was part of the fen-phen mass tort litigation in Philadelphia against American Home Products Corp. When that litigation settled, Les Servier was left as the only open defendant. Les Servier filed for and received a grant of summary judgment. As Tereshko explained, Les Servier, whose principal place of business is in France, manufactured the bulk, powdered ingredient in two drugs that were used in the production of fen-phen, Pondium and Redux. The powdered product was licensed and sold to AHP, which converted it into fen-phen. The U.S. Food and Drug Administration approved the final product for sale by AHP, Tereshko said. Les Servier argued AHP was the sole manufacturer, distributor, marketer and promoter of Pondium and Redux, because AHP was the sole licensee of Les Servier and had exclusive approval from the FDA. In considering whether that argument was correct, Tereshko looked to Senior U.S. District Judge Louis C. Bechtle’s decision in Re Diet Drugs, in which he certified the class. Bechtle adopted several facts asserted by the plaintiffs, including that “the instant class involves a single manufacturer defendant — AHP.” Therefore, Tereshko said, it was clear that the plaintiffs seeking class certification argued AHP was the only manufacturer, distributor and promoter of Pondium and Redux and that the trial court entered that argument as a conclusion of law. That put a lid on the plaintiffs’ claim, Tereshko said. “Basing its determinations in the instant matter upon the doctrine of judicial estoppel, this court holds that plaintiffs’ actions in the class action litigation mentioned above necessarily prevent plaintiffs from here proceeding against a different and additional defendant, namely against Les Servier,” he said. Therefore, he said, Les Servier should be granted summary judgment. Although the doctrine of judicial estoppel applied, Tereshko took some time to address other rationales for the grant of summary judgment. One of the plaintiffs’ claims against Les Servier was for negligence. However, Tereshko said that because the plaintiffs had not proved Les Servier was involved in the manufacturing, distribution or selling of the diet drugs in question, it followed that Les Servier owed them no duty. “It is clear that a determination of manufacturers, distributors or sellers status is critical under the FDA regulatory scheme, not just for the initial approval of the drug, but also for the continuing monitoring of the safety and efficaciousness of the drug,” Tereshko wrote. “Once AHP has been determined to be the exclusive manufacturer, distributor and seller of the drug here at issue, it follows a priori that Les Servier cannot be identified as a manufacturer, distributor or seller of the drug here at issue, and that it must be precluded from the class of companies to be held liable for said manufacturing, distribution or sale of the drug.” Inherent to the negligence claim was a claim for failure to warn, Tereshko said. He cited a 1989 Superior Court case, White v. Weiner, in dismantling that argument. White involved litigation over the drug protamine sulfate. The court found the responsibility for labeling a drug fell exclusively to the manufacturer, distributor or packer of the drug. And for the same reasons, Tereshko said, Les Servier, as merely the supplier of a bulk ingredient used in the final product, could not be held liable for the negligent design of the drug. The plaintiffs also claimed Les Servier committed a breach of its express warranty that its products were safe for medical use. Tereshko said that was not the case. “While Les Servier may have marketed those component ingredients of Redux and Pondium, there is no evidence that they made an affirmative promise regarding the safety of these drugs,” Tereshko said. “As suppliers of ingredients in bulk form, it was not Les Servier’s role or obligation to warrant their product to those who would eventually use” fen-phen. Again citing the caselaw of White, Tereshko said, in Pennsylvania “privity does not exist between bulk suppliers of a component ingredient in a compound and a party injured from ingesting the compound.” Finally, Tereshko said the plaintiffs could not make a valid claim against Les Servier for the fraudulent advertising and promotion of their drugs.

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