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Medical Device Safety Act and Medtronics Defibrillator


Testimony before US Senate about Medical Device Safety Act (MDSA) and Faulty Medical Devices

This week the U.S. Senate Health, Education, Labor and Pensions Committee heard testimony from Michael Mulvihill who experienced a life threatening and life changing event on a road trip just over two years ago. He told his story to convince Congress to pass the Medical Device Safety Act (MDSA). MDSA is legislation that would restore the rights of patients who have been harmed to hold medical device manufacturers accountable in court when their faulty medical devices malfunction.

In June 2007, while driving on I-70 in Ohio with his wife, to visit family, he saw a blue light flash before his eyes and felt his body shaking. As he struggled to safely drive his car to the shoulder, his wife called 911. He doesn’t remember how many times he was shocked – all he remembers is the excruciating pain and fear.

Medtronics Defibrillator Malfunctions and Failures

Medical Device Malfunction

Mr. Mulvihill’s Medtronics defibrillator had malfunctioned. He was later told by a Medtronic representative that he had been shocked 22 times in 53 minutes. Four months later Medtronic recalled the wire that connects the defibrillator to the heart after there were 665 failures and five reported deaths to the FDA. However, because of a Supreme Court ruling last year, Medtronic can not be held accountable for the failure of their medical device.

“I relied on this medical device to save my life. Instead, the trauma I experienced because the device was not safe cost me my career and crippled my lifestyle,” said Mulvihill. “Medical device companies should be held accountable for the safety of the products they produce and profit from. I am asking Congress to restore my right to seek justice for myself and medical device patients everywhere.”

How the MDSA Law Can Help Protect You

Earlier this year, Bridget Robb, a single mother, testified before the U.S. House Energy and Commerce’s Subcommittee on Health with a similar story in support of the MDSA.

Sponsored by Senator Edward Kennedy (D-MA), Representative Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), The Medical Device Safety Act MDSA would give victims the ability to hold the manufacturers of medical devices, such as heart defibrillators, prosthetic joints and pain pumps accountable for their faulty medical devices at the state court level.

You can read Michael Mulvihill’s entire testimony here (in PDF format).

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