Respondents: Philip K. Howard, Vice Chairman, Covington & Burling; John C. O'Quinn, Former Deputy Associate Attorney General, United States Department of Justice
On March 4, the Supreme Court ruled in Wyeth v. Levine that the Food and Drug Administration’s extensive labeling review, authorized by federal statute, did not preempt state common law “failure to warn” claims. Pharmaceutical manufacturers in America now face a hazardous path; since regulatory compliance will not protect them from crippling tort lawsuits, they are likely to respond by adopting drug contraindications injurious to public health.
In a new report, In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation, Manhattan Institute senior fellows James Copland and Paul Howard offer an alternative solution to the costly and unpredictable litigation system. They propose broad preemption of state pharmaceutical tort claims, coupled with a new federal compensation program that would offer a remedy for parties injured by unknown drug side effects.