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