$21 Million To Compensate For Woman’s Injuries Due To Drug Tossed By United States Supreme Court.

In 1978, an anti-inflammatory drug was approved by the Food and Drug Administration [FDA], and in 2004, the drug was prescribed for plaintiff to treat her shoulder pain. The United States Supreme Court noted: “The results were horrific. Sixty to sixty-five percent of the surface of [plaintiff’s] body deteriorated, was burned off, or turned into an open wound.” Plaintiff sued the drug company in New Hampshire. The drug insert warned the drug could cause “severe skin reactions,” but the plaintiff’s doctor admitted he had not read the box label or insert. A jury awarded plaintiff $21 million in damages. Once a drug is approved by the FDA, a manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients or in the specifications provided in the approved application.” [21 C.F.R. §314.70(b)(2)(i)]. New Hampshire imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. In finding for the drug manufacturer, the high court stated: “When federal law forbids an action that state law requires, the state law is ‘without effect.’”  Mutual Pharmaceutical Company v. Bartlett  (U.S. Sup. Ct.; June 24, 2013) 133 S.Ct. 2466, [186 L.Ed.2d 607].