Something Old And Something New: Two Items From July 3, 2008 NEJM Show Why Preemption Applied In These Types Of Cases Is Bad Public Policy

(Posted by Tom Lamb at DrugInjuryWatch.com)

We start with the something “old”, which only goes back in time a few months.

In March 2008 William H. Maisel, M.D., M.P.H., wrote a “Perspective” piece The New England Journal of Medicine (NEJM), “Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices”, in which this expert on medical device safety at Boston’s Beth Israel Deaconess Medical Center said that the Medtronic Sprint Fidelis recall was a prime example of how medical device companies and the FDA failed to provide the public with timely information about device malfunctions.

In the July 3, 2008 edition of the NEJM there was a Correspondence exchange between Daniel G. Schultz, of the FDA, and Dr. Maisel about this Sprint Fidelis recall piece.

For those interested in how the FDA is doing as regards its oversight of medical devices you may want to read this brief July 2008 exchange, entitled “Medical-Device Safety and the FDA”. 

Now we move on to the “new” and more obvious item from the July 3 NEJM, simply titled “Why Doctors Should Worry about Preemption“, a Perspective piece by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.  

This July 3 NEJM Perspective article starts by setting the stage:

A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine), drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.

A medical-device company won such a victory in April. In Riegel v. Medtronic, the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning.  (footnotes omitted)

And as for the answer to the issue raised by Curfman, Morrissey, and Drazen in the title of their piece:

Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.

In addition to the well-reasoned text, there is an interactive graphic “Timeline of Safety Problems Associated with Four Drugs” which accompanies this July 3 NEJM Perspective article.

My position before and after reading this NEJM article by Curfman, Morrissey, and Drazen is that application of the federal preemption doctrine to personal injury or wrongful death lawsuits concerning unsafe drugs and defective medical devices is bad public policy.

What do you think?