John M. Rhude 0000-00-00 00:00:00
Shoulder pain for a New Hampshire woman almost a decade ago has resulted in her being awarded the single largest damages amount in New Hampshire history, raising the stakes for product liability cases across the country and raising questions about whether the $26 million compensatory damages award and the case attached to it is headed for the United States Supreme Court. Karen Bartlett’s record 2009 damages award was upheld this May after the U.S. Court of Appeals for the First Circuit reaffirmed the decision that the woman’s injuries had been a direct result of design defect claims caused by the use of a generic substitute for the drug Clinoril. Philadelphia-based Mutual Pharmaceutical Co., Inc., manufactured the generic drug Suldinac and marketed it in the state of New Hampshire, thereby making the state’s design defect law applicable. According to Bartlett and her legal counsel, the generic equivalent for Clinoril caused toxic epidermal necrolysis (TEN) and Stevens John Syndrome (SJS), which caused the top layer of Bartlett’s skin to detach from lower layers of skin. Bartlett reported suffering the external burns over 60 percent of her body. She also suffered damage to her mucus membranes. The end result for Bartlett was months in the hospital where, according to news reports, she was placed in a medically-induced coma. Bartlett’s injuries included damaged lungs, a difficulty breathing, inability to eat and an almost complete loss of her sight. Not surprisingly, the New Hampshire woman’s injuries have also kept her from working. Examining The Case According to federal law, generic drug manufacturers must essentially duplicate the design of the brand name drug the company is copying. Because the brand name drug, in this case Clinoril, had been approved and had met requirements set by regulatory officials, the generic equivalent should have been just that - an equivalent of the brand name drug. In Bartlett’s case, the generic drug, Sulidinac, resulted in her injuries. Bartlett’s attorneys proceeded with the case based on a New Hampshire law that states a finding of product liability against the manufacturer if a drug is considered defective. Defective drugs can be classified as such if the risks outweigh the benefits to the user. Earlier this year, the U.S. Court of Appeals for the First Circuit reaffirmed the decision that awarded Bartlett the record sum. The court concluded that the case Wyeth v. Levine was applicable in Bartlett’s case. The Wyeth v. Levine decision held that pharmaceutical manufacturers of brand name drugs could be held liable for failing to provide sufficient warnings to consumers. Given the known side effects, the First Circuit ruled that while Mutual Pharmaceutical could not alter the composition of Suldinac, the company could have chosen not to produce the drug. Mutual Pharmaceutical had argued that design defect issues were immaterial given amendments to the Federal, Drug and Cosmetic Act after the 2011 Supreme Court decision in the case of PLIVA v. Mensing. What Does the Decision Mean? Not surprisingly, Mutual Pharmaceutical is expected to appeal the decision, setting the stage for a possible review before the Supreme Court. At issue for many legal experts is that the judgment is at odds with previous product liability cases. In upholding the judgment, the First Circuit pointed to the conflicting rulings in PLIVA v. Mensing and Wyeth v. Levine as evidence that the high court should clear up the discrepancy. According to the Alliance for Justice, more than 75 percent of pharmaceutical drugs prescribed by physicians in the United States are generic equivalents of name brand drugs. These statistics, along with the introduction of legislation to allow generic drug manufacturers to revise labeling to reflect new side effects, will certain weigh in the Supreme Court’s decision whether or not to hear the case. While Bartlett’s injuries are permanent, only time will tell if her $26 million award will withstand Supreme Court scrutiny.
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