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

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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Matt Shudtz | April 15, 2009

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

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 […]

Rena Steinzor | April 14, 2009

The People’s Agents: Rewarding Polluters with a Plaque on the Wall

Say you live in an urban neighborhood where crime is worrisome but not overwhelming. The police are chronically understaffed, with no money to walk the beat, and instead depend on what we might call a “deterrence-based enforcement system” – making high-profile arrests, prosecuting the worst violators, and relying on the resulting publicity to frighten others […]

Yee Huang | April 13, 2009

Water Buffaloes Ready to Charge… Over the Rain?

A recent article in the Los Angeles Times described the latest absurdity in the never-ending search to quench the thirst for water: ownership of rainwater and, more precisely, the illegality of rainwater harvesting.  Residents and communities in parts of Colorado are turning to this ancient practice of collecting and storing rain to fulfill their domestic […]

William Buzbee | April 10, 2009

Waxman-Markey: Federalism Battles

On Tuesday, March 31, House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Rep. Edward Markey (D-MA) released a “discussion draft” of the American Clean Energy and Security Act of 2009 — a climate change bill that will serve as the starting point for long-delayed congressional action on the world’s most pressing environmental program. […]

James Goodwin | April 8, 2009

Climate Change: Endangering Our Future, Destroying Our Past

The large earthquake that struck central Italy on Monday is devastating not only for the immense human suffering—people killed and injured, and communities disrupted—but also for the priceless losses of Italian cultural heritage.  The Italian Ministry of culture has reported that the earthquake damaged a number of buildings of immeasurable historical significance, including the Basilica di […]

Ben Somberg | April 7, 2009

Waxman-Markey: Adaptation

On Tuesday, March 31, House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Rep. Edward Markey (D-MA) released a “discussion draft” of the American Clean Energy and Security Act of 2009 — a climate change bill that will serve as the starting point for long-delayed congressional action on the world’s most pressing environmental program. […]

Holly Doremus | April 6, 2009

EPA Asserts Itself on Mountaintop Removal Mining

This item is cross-posted by permission from Legal Planet. EPA is finally flexing its muscle on mountaintop removal mining, taking on the Corps of Engineers and stepping in for states that have been reluctant to attack the practice. Mountaintop removal mining involves blasting the tops off of mountains, typically in Appalachia, to get at coal. […]

Thomas McGarity | April 3, 2009

One More Thought on the Entergy Case and Cost-Benefit

On Wednesday, April 1, the Supreme Court issued its ruling in Entergy vs. EPA, holding that it was permissible for EPA to use cost-benefit analysis as its method of regulatory analysis in devising a regulation on power plant water intake structures.  Member Scholar Amy Sinden blogged on the decision that day, here.  Member Scholar Thomas […]

Matthew Freeman | April 3, 2009

What Barack Obama Can Do to Rescue Science from Politics

The Bush Administration earned its reputation for being contemptuous of science. From suppressing an EPA global warming report so as not to put the federal government’s imprimatur on the scientific consensus that climate change was real and human-caused, to simply refusing to open an email containing formal scientific findings inconvenient to its policy objectives, the […]