by David Egilman, MD, MPH

I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays’ (R-CT) comments.  Christopher Shays is the last remaining Republican congressman from New England.  Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.

He repeatedly stated that he “had no dog in this hunt” concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA’s actions are appropriate.  It’s one thing to have no opinion; it is in another to imply that there is no reason to have opinion.

Unfortunately for Shays, he did express an opinion.  His opinion repeated over and over again was that it was incredible to think that layman on juries would have the power decide whether or not a pharmaceutical or medical device company acted appropriately in warning or not warning customers of hazards that they knew or should have known about.  How absurd a system that allows layman to make technical decisions!  Apparently Mr. Shays has spent too much time in Congress and not enough time watching TV or reading the constitution (entitled to jury of peers not experts) or newspapers. 

It turns out in America lay juries decide all kinds of technical questions ranging from patent infringement on complex chemical formulas and drugs, to medical evidence in murder trials, to determinations of product failures due to design defects and complex medical malpractice.  Companies in suing each other, rely on lay juries to determine all sorts of complex technical issues.  They (unlike injured patients) could choose to use expert panels or arbitration.

So the question is not whether or not laymen are going to make technical decisions on important issues while serving on juries.  The question is whether we are going to exempt pharmaceutical and medical device companies from the kind of scrutiny they placed on each other when they sue each other.  Loyal Republican Christopher Shays seems to think corporate persons should be evaluated by experts and be exempt from suits by live persons but should have their own inter-corporate disputes decided by layman when they sue each other.

The hearing was chaired by Congressman Henry Waxman (D-CA) who noted in his opening statement:

“Currently, when Americans are injured by any sort of defective product, they have a remedy. In most states, they can sue the manufacturer of that product for damages in state court.  Under a radical legal doctrine being advocated by the pharmaceutical and device industries and the FDA, this would change. Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries. This is known as “preemption.”  The result is that one of the most powerful incentives for safety — the threat of liability — would vanish.

Today we will be considering a fundamental question with high stakes for everyone in America who depends on drugs and medical devices: Should the companies that produce these products be absolved of their legal obligation to ensure the safety of their products?”

Witnesses at the hearing included former FDA Commissioner David Kessler and Georgetown Law Professor David Vladeck, who recently coauthored a paper entitled: “A Critical Examination of the FDA Efforts to Preempt Failure-to-Warn Cases.”

David Egilman, MD, MPH is Clinical Associate Professor at Brown University’s Department of Community Health.  His previous post on The Pump Handle “The Truth is Not Free” is here.