The Preemption Battle

There is an ongoing battle that has been quietly taking place for years. Unfortunately, most Americans are clueless of its existence or consequences.

Despite it at best being background noise to most, the “preemption” debate raises fundamental questions about how our society will protect the public from dangerous products, drugs, food, medical devices, etc.

Its outcome is critical, especially in an environment where our regulatory agencies no longer serve their intended function in part because they are understaffed, underfunded and overwhelmed. Often they rely on data from the very entities they are supposed to be regulating…. it’s an honor system gone wild.

The FDA is one of the poster children for this phenomenon. The Government Accountability Office and the National Academy of Science’s Institute of Medicine criticized the agency’s abilities to keep unsafe products off the market and respond effectively to observed hazards. During a Congressional hearing, Dr. David Graham, a 20 year employee of the FDA, testified that the FDA is “broken” and has “let the American people down.” He explained; “We are virtually defenseless.”

So, who will protect the public, how, and on whose nickel? What role will our regulatory agencies play? And the tort system? And is there a strategic alliance between the two?

The Supreme Court has been wrestling with these critical issues and a conundrum of sorts exists in the current preemption jurisprudence which hopefully will be corrected soon by both the Court and Congress. Some argue that the present rulings provide inconsistent remedies for victims that should be treated similarly. More particularly, it seems obvious that victims of faulty medical devices should have the same rights afforded to victims of defective drugs.

Recently, in Wyeth v. Levine the Supreme Court ruled on a key preemption issue and decided not to grant sweeping immunity to drug manufacturers. The Court rejected Wyeth’s claim that it could not be sued if a product and its label had been approved by the FDA.  However, last year in Riegel v. Medtronic, the Supreme Court provided fuel for many to argue that device makers could not be sued for damages if the device was approved by the FDA. Inconsistent? Maybe. Moot? Probably.

Congress appears to be poised to remedy this problem and 1. provide similar rights to the victims of faulty medical devices and 2. make it clear that medical device laws do not provide immunity to manufacturers from liability under state laws. Hopefully, the legislation recently introduced in both the House and the Senate will put an end the divisive and counterproductive preemption battle. Good news for patients and consumers.

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