New CPR Paper: Regulatory Preemption and Its Impact on Public Health

Matt Shudtz

April 15, 2009

Avery DeGroh, a three-year old from Illinois, had a defibrillator implanted in her heart to deal with a congenital condition called “long QT syndrome.” It was a brand-new model with a specially designed wire (or “lead”) that is thinner and easier for doctors to install. Unfortunately, due to a problem with the new lead, one day the defibrillator shocked Avery unnecessarily nine times, sending jolts of electricity through her young heart. She was rushed to the hospital and had the device removed. She’s doing well with a portable defibrillator now, but the episode was just the beginning of a new battle for her parents.

Removing the device, of course, was incredibly expensive. But even though the company that manufactured the defective defibrillator, Medtronic, recalled the device, it refused to reimburse Avery’s parents for any of the costs associated with getting a replacement since they didn’t use a Medtronic-branded alternative.

Unfortunately for Avery and her parents, the Supreme Court’s February 2008 ruling in Riegel v. Medtronic prevents them from suing Medtronic to receive compensation for her injuries or medical costs. In that case, the high court held that FDA approval of a medical device preempts state law claims for damages on theories of negligence, breach of implied warranty, and strict liability. So Avery and her parents went to Capitol Hill two weeks ago to tell their story. They were joined by many other patients with medical devices for a lobbying day in support of the Medical Devices Safety Act of 2009, which is aimed at reversing the Supreme Court’s Riegel decision.

Legislation like the Medical Devices Safety Act, designed to specifically address anti-consumer judicial decisions of the last decade, is one of several ideas presented in CPR’s recently released white paper, The Truth about Torts: Regulatory Preemption and its Impact on Public Health. The paper argues that the doctrine of federal regulatory preemption should not be used as a tool for eliminating corporate liability. And it argues that optimal preemption policies are defined by multiple stakeholders, including state and local government officials and all branches of the federal government, not just federal agencies and the courts.  (Read a web article on the paper, here.)

Our paper outlines a number of actions that Congress and the President could take to ensure that federal regulatory preemption does not undermine positive strides in public health policy. Congress should enact laws to prevent overbroad preemption claims not just in the context of medical devices, but also on vehicle safety and consumer product safety. Additionally, Congress should design legislation that would improve federal agencies’ accountability to Congress and state officials when the agencies argue in favor of preemption.

For the executive branch, the paper recommends ideas for a new Federalism Executive Order that would enable the President to articulate a clear philosophy on preemption and enforce that philosophy across the Executive Branch. The Executive Order should recognize the important role that state law plays in protecting consumers from harm.

The new white paper is the collaborative effort of six CPR Member Scholars: William Buzbee, William Funk, Thomas McGarity, Nina Mendelson, Sidney Shapiro, and David Vladeck. (I provided the staff support.) It is the sixth paper in CPR’s Truth About Torts series.

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