Insights & Events

At the request of two separate groups of amici curiae, Hollingsworth LLP has submitted briefs to the United States Supreme Court in Wyeth v. Levine explaining why preemption of prescription drug product liability claims advances the public health and the most beneficial allocation of incentives in drug labeling.

On behalf of Washington Legal Foundation (WLF) and the American College of Emergency Physicians (ACEP), we explained to the Court that the minimum standards argument advanced by plaintiffs in attacking preemption fails to account for FDA’s legitimate concerns about the public health consequences of drug labels that overwarn and discourage beneficial drug use.  Click here to view the brief.  WLF/ACEP provided the Court with specific examples drawn from the scientific and medical literature showing the adverse public health consequences of excessive warnings in leading to drug underutilization.  Click here to view the WLF press release that provides a more detailed description of the brief.

Our second brief was submitted on behalf of economists John E. Calfee, Ernst R. Berndt, Robert Hahn, Tomas Philipson, Paul H. Rubin, and W. Kip Viscusi.  Click here to view the brief.  This brief focused on the regulatory incentives that cause FDA to be overly cautious in drug approval and drug labeling and the extent to which state tort litigation against drug companies exacerbates that problematic approach and imposes additional requirements that lead away from the outcome most beneficial to society.