From litigating pharmaceutical and medical device cases to litigating worker safety and motor vehicle cases, pre-emption is an issue. While one can appreciate that new facts continually invite the re-examination of old law, the seemingly inconsistent opinions regarding pre-emption — in addition to the "pro-pre-emption" affinity of the Supreme Court of the United States — give many practitioners pause.
Mutual Pharmaceutical v. Bartlett (Docket No. 12-0142) is the most recent example of the U.S. Supreme Court's attempts to guide the lower courts to broadly pre-empt state tort law. The 5-4 decision, authored by Justice Samuel Alito (joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy and Clarence Thomas), bars state design-defect claims regarding the adequacy of a drug's warnings against generic drugmakers. The decision directly opposes the high court's holding regarding pre-emption and brand-name drugs. In barring claims against generic-drug manufacturers, the court hinged its opinion on the fact that generic manufacturers do not have the right or responsibility to change their warning label. Bartlett gives less rights to plaintiffs injured by generic drugs for claims against off-patent producers than a similarly injured plaintiff has against brand-name manufacturers. Generic manufactures have a free ride while brand-name manufacturers remain liable for manufacturing, informational and design defects, and the injured have less rights.
