Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall

Justinian Lane's Blog

Justinian's Blog

The Menaflex Debacle Proves That Preemption Is Bad Policy

The tort “reform” crowd often argues that if a federal agency approves a product, the manufacturers of that product should be immune from suit.  For instance, drug manufacturers always argue that since the FDA said that a drug was safe and effective, then the drug is safe and effective and no one should be able to sue the manufacturer regarding that drug. 

As frequent readers know, the legal term for such an argument is “preemption,” because federal laws can preempt state laws.  Frequent readers also know that I don’t believe that preemption is good policy with respect to FDA-approved drugs and medical devices.  Here’s why: 

WASHINGTON — The Food and Drug Administration said Thursday that it would rescind the approval of a patch for injured knees that it granted in error in 2008 after being unduly pressured by four New Jersey congressmen and its own commissioner.


The agency responded by releasing a detailed report last year that found that the agency’s scientific reviewers had repeatedly and unanimously over many years declared Menaflex unworthy of approval, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman. The report also concluded that Dr. Andrew C. von Eschenbach, then the agency’s commissioner, had become inappropriately involved in the decision, and that agency procedures had been bypassed.

All four lawmakers made their inquiries about Menaflex after receiving significant campaign contributions from ReGen, which is based in Hackensack, N.J. (Emphasis added.)

Source: F.D.A. Vows to Revoke Approval for Menaflex Knee Patch - NYTimes.com

There has always been the possibility that the FDA would accidentally approve a drug that did not meet FDA standards.  Now we have proof that the FDA, in at least one instance, intentionally did so. 

The tort system acts as a check and balance to the FDA.  The situation with Menaflex shows that eliminating that check and balance through preemption would be a very bad idea.