Supreme Court Rules State Law Claim Not Preempted by FDA Approval of Drug Warnings

Yesterday, in the case of Wyeth v. Levine, the U. S. Supreme Court ruled 6-3 that a claim of failure to warn of hazards related to a drug were not precluded by FDA approval of the drug warnings.  Though my practice in Atlanta deals mostly with truck accident cases in Georgia, I spent a few hours last night picking apart the 80-page decision. I won’t try to brief the case here, as it would put too many readers to sleep.

The far-reaching impact of the decision will extend beyond pharmaceutical  and medical device cases to other areas of product liability. In recent years several federal agencies asserted that their actions should preempt any state law tort claims. Now the majority of the Supreme Court has rejected that, at least in the context of this case.

The analysis of when federal law preempts state law under the Supremacy Clause of the U.S Constitution is seldom simple. The Wyeth decision and the dissent cover most of the major  arguments on both sides.

Whether we argue for or against federal preemption in particular context, we will parse the words of the Wyeth case to find support for our positions.

Ken Shigley is a trial attorney in Atlanta, Georgia who was recently listed for the fifth consecutive year as a “Super Lawyer” (Atlanta Magazine).  He is also included among the “Legal Elite” (Georgia Trend Magazine) and in the Bar Register of Preeminent Lawyers (Martindale).  Mr. Shigley has long experience representing parties in truck and bus accidents, catastrophic personal injury, wrongful death, products liability, brain injury, spinal cord injury and burn injury cases.  A Certified Civil Trial Advocate of the National Board of Trial Advocacy. he now serves as Secretary  of the 40,000 member State Bar of Georgia.