BioCentury
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Takeda inflammation news

December 10, 2012 8:00 AM UTC

The U.S. Supreme Court agreed to hear an appeal from Mutual Pharmaceutical Co. Inc. for Mutual Pharmaceutical Co. v. Bartlett, Karen L., which may determine whether manufacturers of generic products are responsible for defects in the branded version. The case is looking to overturn a $21.1 million judgment granted in 2010 by a district court in favor of Bartlett. The district court ruled that Mutual's generic sulindac was in a "defective condition" as a result of the NSAID being "unreasonably dangerous" because of its propensity to cause Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). In its appeal, Mutual claims that the district court "misunderstood" New Hampshire law on a number of claims, including design defect and labeling. Mutual also said in court documents that it cannot legally change the labels of generic products because federal law requires that generic products have the same label as the branded product. The products liability and personal injury suit was filed by Karen Bartlett in August 2008 after she developed SJS/TEN following treatment with Mutual's sulindac. In May, the U.S. Court of Appeals for the First Circuit affirmed the judgment ordered in September 2010 by the U.S. District Court of New Hampshire. ...