Studies Show FDA Lacks Rigorous Scientific Evidence to Approve Cardiovascular Devices

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For Immediate Release: January 4, 2010

Contact: Jennifer Fuson
202-965-3500, ext. 8369

Studies Show FDA Lacks Rigorous Scientific Evidence to Approve Cardiovascular Devices

Passage of Medical Device Safety Act Critical to Protect Patients

Washington, DC Recently released studies show the Food and Drug Administration (FDA) lacks stringent scientific standards to evaluate cardiovascular devices and underscores the need to pass the Medical Device Safety Act (MDSA), according to the American Association for Justice (AAJ).  Currently, device manufacturers have complete immunity from product liability if their devices prove unsafe or defective because of the Supreme Court decision in Riegel v. Medtronic.

Last week, the Journal of the American Medical Association (JAMA) released a report showing premarket approval of cardiovascular devices was based on small studies, about 300 patients on average, and two-thirds were approved with results from just one study. The article also said cardiovascular device approval lacks the same strength as the FDA’s drug approval process and may be prone to bias. 

As the JAMA article states, “The importance of FDA device approval is magnified as it preempts consumer lawsuits on device safety.” 

Another FDA-sponsored study published online in the American Journal of Therapeutics found about 40 percent of the heart and blood vessel studies they examined lacked precise targets for how safety would be measured. Studies also failed to fully account for what happened to all patients enrolled in the research.

“If device manufacturers are using flawed studies to gain FDA approval for potentially dangerous devices, then they need to be held accountable for the safety of their products,” said AAJ President Anthony Tarricone.  “Passage of the Medical Device Safety Act is critical for patient safety, especially when medical devices have not gone through rigorous premarket testing and post-market monitoring.”

The Medical Device Safety Act (HR. 1346 / S. 540) would restore the right of victims to seek justice when injured by faulty medical devices, including heart defibrillators, artificial valves, and prosthetic knees and hips.  This legislation would follow the Supreme Court’s decision in Wyeth v. Levine, which held that federal law does not preempt state-law claims with regard to drug warning labels.  MDSA would restore this right to medical device patients.

As the world's largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people 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. Visit

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