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The Facts—Riegel vs. Medtronic

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The Facts—Riegel vs. Medtronic 

Complete immunity preemption is truly a stealth issue. It began quietly and without much fanfare only after President Bush was inaugurated in 2005 for a second term. Federal agencies—without any authority from Congress—started putting language in the preamble of regulations. Previously the preamble was used as the agency’s interpretation of the regulation. Suddenly, the agencies shifted to use the preambles to change to law. That same year, Business Week’s cover story on “How to Fix the Tort System” described preemption as Corporate America’s preferred solution to litigation that might also fall under regulatory realms.i

Preemption in 2008

To date, seven federal agencies—many times without any opportunity for public comment which is required by law (the Administrative Procedure Act)—have issued over 56 rules with preemption language in the preamble to the rule. The Constitution of the United States holds that the decision to preempt state law rests entirely with the United States Congress. Where the intent of the Congress is not clear, it is the responsibility of the Judiciary to interpret. As a result of these preambles, states have had their authority curtailed by federal agencies.

While the American Association for Justice believes these regulatory preambles to be unconstitutional, some trial courts have given federal agencies the force of law. Moreover, some agencies have adopted these regulations in the absence of federal regulation or even in direct contradiction to Congress’ direction. In addition, these new rules have not been voted on by any member of Congress, and in some cases not even revealed during the public comment period.1

Government regulations only set a minimum safety standard and can’t guarantee safety. Through the preamble language, the agencies argue that federal standards override state safety standards and that all state tort claims should be discarded. State remedies were designed to complement, not conflict with, federal health and safety regulations. The agency action is a direct affront to the authority of state courts, state legislatures, and Congress.

RIEGEL V.MEDTRONIC, INC.

The Evergreen Balloon Catheter is a prescription medical device that Medtronic, Inc. developed for patients with coronary disease. Physicians use it during angioplasties to open patients’ clogged arteries, essentially by inserting the catheter into the clogged vessel, inflating the catheter like a balloon, and then deflating and removing the catheter. On August 30, 1994, the FDA approved Medtronic’s pre-market approval (PMA) application for the Evergreen Balloon Catheter, and on April 27, 1995, and April 18, 1996, the FDA approved Medtronic’s PMA supplements, which requested approval for revised labeling for the device.

In 1996, Charles Riegel underwent angioplasty to dilate his coronary artery. During the procedure, Riegel’s doctor ultimately inserted the Evergreen Balloon Catheter into Riegel’s artery and inflated the device several times, up to a pressure of ten atmospheres. On the final inflation, the Evergreen Balloon Catheter burst, and Riegel began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. Riegel survived, but suffered severe and permanent personal injuries and disabilities.

Medtronic claimed immunity based on the FDA’s pre-market approval of the device. The Supreme Court held that state law claims regarding medical devices are preempted under the Medical Device Amendments (MDA) where the device manufacturer complied with federal requirements. In the MDA, Congress intended to resolve the conflict between state regulations and federal statutes. However, the decision expanded the reach of the MDA and also applied its provisions to state tort claims.

i How to Fix the Tort System, Business Week, March 14, 2005.
1 FDA: Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, 65 Fed. Reg. 81082, 81103 (proposed Dec 22, 2000).


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