Complete Immunity Preemption

A “Get Out of Jail Free” Card for Corporations

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In the News

“In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation.”

"FDA Considers Changes to Medical Device Regulation"
Information Week, 8/9/10

“Less than a week after its recall of a pair of hip implants, DePuy Orthopaedics was hit with another series of lawsuits over the devices, this time alleging that the Johnson & Johnson (NYSE:JNJ) subsidiary knowingly sold defective products.”

"Lawsuits Continue to Pile Up for Johnson & Johnson’s DePuy Orthopedics Over its Hip Implant"
Mass Device, 9/1/10

“Hirschbeck, at 42, was then among the best umpires in professional baseball and unwilling to quit a job that paid more than $350,000 a year.

Dr. John Keggi offered a hip replacement that could get him back on the field by 2004, Hirschbeck says. That didn't happen.

The ceramic joint made by Wright Medical Group Inc. shattered, leading to an infection and four more surgeries that left Hirschbeck permanently sidelined.”

"Ex-baseball Ump Claims Botched Hip Surgery Ruined His Career"
Connecticut Post, 6/11/10

"The Supreme Court dealt a defeat to the pharmaceutical industry and the Bush administration Wednesday, ruling that federal approval of a prescription drug does not provide a shield against lawsuits from injured patients."

"Suprume Court Rules Patients can Sue Drug Makers"
LA Times, 3/5/09

"Influential members of Congress plan to introduce a bill soon that would supersede last year’s Supreme Court device ruling, their aides say. If that legislation became law, injured people or their survivors would have the same right to sue device makers that the Supreme Court on Wednesday gave to people claiming injury or death from unsafe drugs."

"Drug Ruling Puts Devices in Spotlight"
New York Times, 3/5/09

Read More In the News »

Read how complete immunity preemption hurts consumers like Diana Levine»

The United States Supreme Court and Congress are facing critical issues that—depending on how they are resolved—could provide negligent corporations complete immunity from lawsuits.

It’s called federal preemption, and it refers to situations in which federal regulation trumps state law. And, perhaps most surprising, Americans and many policymakers have never heard of it. When viewed through the context of unsafe products, preemption of state law means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans. The civil justice system offers corporations a powerful incentive to make their products safer. All people should have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations.

Background

The Facts—Complete Immunity Preemption

The Facts—Wyeth v. Levine

The Facts—Riegel v. Medtronic

Timeline of Complete Immunity Preemption—The Evolution of Unauthorized Agency Preemption

Diana Levine Testimony before the House Oversight and Government Reform Committee Hearing entitled: “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”

ResearchGet Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability

The Truth about Torts: Using Agency Preemption to Undercut Consumer Health and Safety, Center for Progressive Reform, Sept. 2007

The Truth about Torts: Regulatory Preemption at the National Highway Transportation Safety Administration, Center for Progressive Reform, July 2008

In Their Own Words

Quotes on Complete Immunity Preemption From the News Media

Quotes from Experts in Leading Medical Journals Highlights Dangers of Complete Immunity Preemption

Quotes from the Congressional Testimony of Dennis Quaid

Quotes from the Congressional Testimony of Leading Experts on FDA Complete Immunity Preemption

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