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The Medical Device Safety Act

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The Medical Device Safety Act 

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


In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturers of certain medical devices approved by the Food and Drug Administration (FDA)’s pre-market approval process are immune from liability, even when the devices are known to be defective. 

The Court cited the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act, saying it had established a federal regulatory process for ensuring the safety of medical devices.  As a result of the Riegel decision, thousands of cases of patients injured by defective medical devices are being dismissed.  This leaves consumers, insurance companies,
and the government stuck paying for a manufacturer’s defect.  

View more news videos at:


State tort suits provide an added layer of consumer safety by encouraging manufacturers make safe products.  The government doesn’t have all the necessary resources to see that all drugs and medical devices are safe, and relies on the manufacturers to provide accurate safety data. 

In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts.  This creates a disturbing double standard between prescription drugs and medical devices.  

See other individuals injured by defective medical devices:


Faces of Defective Medical Devics 

The Facts—Riegel v. Medtronic

The Facts—Wyeth v. Levine

The Facts—The History of Complete Immunity Preemption 

The Facts - Studis Offer Evidence of Flawed Device Oversight

Medical Device Safety Act—Myths v. Facts


Examinging the Sprint Fidelis Effect on Medicare Costs - This new report by BYU Professor H. Dennis Tolley says taxpayers are forced to py the bill for device manufacturer negligence

Get 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

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

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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