In a 5-4 ruling the Supreme Court held that the FDA is the primary authority on pharmaceuticals, and overturned the verdict and award for the plaintiff by the New Hampshire state court in Bartlett v. Mutual Pharmaceutical Company (Mutual Pharma). The Justices reasoned that generic drugs are exempt from legal liability for mislabeling, side effects and all other adverse reactions. Eighty percent of all drugs consumed in the United States are generic.
Originally, the Court of Appeals for the First Circuit upheld the jury verdict in favor of the plaintiff from the Federal District Court for the District of New Hampshire. The jury determined that Mutual Pharma was liable for mislabeling the generic anti-inflammatory drug, Sulindac, after it was deemed responsible for Ms. Bartlett’s suffering a “flesh-eating side effect.” That risk not included on the warning label. In overruling the lower court, the Supreme Court extended a 2011 ruling, which held that only the original inventors and manufacturers may be held liable for fraud or adverse side effects.