Protect PreemptionWhen the Food and Drug Administration (FDA) approves a pharmaceutical product it also dictates what warnings about side effects and other risks must be given to consumers. Labeling must strike a balance between notifying users of potential dangers while not deterring beneficial uses through over-warning. In addition, warning fatigue has the effect of diluting the value of all warnings, and hinders patients and doctors in distinguishing the most significant risks from the less-likely.

Because the approval both of the product and the label are so closely regulated by the FDA, the standard rationales for state tort law, deterring unreasonably dangerous products and compensating victims of products that should not have been made, simply do not apply. The analysis that the jury or judge would make has already been made by the FDA because we as a society choose to give the responsibility of regulating to the experts. However, a consumer who suffers harm from after taking an FDA-approved drug will derive little comfort and no compensation from a discussion of the social contract and the regulatory system, thus they turn to the courts.

Some judges, even here in the nation’s medicine chest, have begun to allow injured consumers to file suits over FDA regulated drugs. There are a number of reasons why allowing these lawsuits is ill-advised:


  • The emotional pleas of a plaintiff will likely trump the dry, scientific, evidence of the cost benefit analysis performed by the FDA over years of study.
  • The uncertainty of what the outcome in any one case may be does not allow the industry to properly adjust the price it charges consumers to cover its liability costs.
  • These lawsuits often create a striking inequity between proprietary and generic drug companies. Because generic drug-makers lack the ability to even seek permission to alter the labeling, generics are protected from this theory of liability. Instead, it is solely the companies who undertake the risk and research costs of developing new products who bear this risk.


New Jersey should adopt legislation that prohibits common law lawsuits against manufacturers of FDA-approved drugs, and in the meantime, discourage these types of lawsuits.



FDA Preemption: The Battle for Supremacy

Legal Experts Wary of Growing Number of Common Law Lawsuits over FDA-Approved Drugs, NJCJI, February 2015

Wyeth, Inc. v. Weeks, — So.3d —-, 2014 WL 4055813 (Ala. Aug. 15, 2014).

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

Wyeth v. Levine, 555 U.S. 555 (2009).

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

78 FR 67985 – Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

73 FR 49603 – Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices

Paul D. Clement, Legal Reform, The Framers and First Principles, U.S. Chamber Institute for Legal Reform, October 2013.