Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking but thought he’d simply hit some road debris. But he soon realized his heart defibrillator was firing, sending electrical shocks through his body while he was driving on the interstate.
After managing to pull over, Michael was taken to the hospital. A representative from Medtronic, the maker of his defibrillator, confirmed the device had malfunctioned, giving him 22 shocks in just 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA).
Michael had been diagnosed with an irregular heartbeat, and was implanted with his defibrillator in 2006 to control his heart rhythm and pulse. But the device intended to save his life nearly killed him and the anxiety from the episode led him to take early retirement because his job required so much interstate travel.
Unfortunately, his nightmare continues. Michael cannot hold the manufacturer of his device accountable for their faulty product because a U.S. Supreme Court decision last year gave the company complete immunity.
Yesterday, Michael testified before the U.S. Senate Health, Education, Labor, and Pensions Committee, and asked Congress to pass the Medical Device Safety Act (MDSA), which would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices malfunction.
Michael also joined victims of faulty medical devices from eight states at a press conference where they shared their stories and the importance of this legislation. Mike and Joseph Collins of Georgetown, Texas were both implanted with a faulty device. Michele Meyer and Mark and Janis Baird of Minn., had children who died as a result of their devices malfunctioning. And Avery deGroh, of McHenry, Il., was only 3 when she received nine painful shocks from her faulty defibrillator.
MDSA was introduced in congress by Sen. Edward Kennedy (D-MA), Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), and currently has 101 co-sponsors in the House and 23 co-sponsors in the Senate. This important legislation is critical in ensuring the safety of those patients who rely on these devices.
Both the Senate HELP Committee, and the House Energy and Commerce Health Subcommittee have held hearings on the legislation. The next step is for the Committees and Congress to move the legislation forward, so people like Mulvihill, Mike and Joseph Collins, and Avery deGroh can seek justice.
5 Comments
JILL PAUL RN
Cecelia, great article. Michael Mulvihill received 22 shocks in 53 minutes - my husband received 37 shocks in about the same time frame. It was horrifying. The Medical Device Safety Act 2009 needs to be passed now to prevent many more innocent victims from being injured. This will not stifle medical innovation - it will only make medical manufacturers' more cautious when introducing new products and not rush to market only to increase their bottom line. This is what happened in the Sprint Fidelis case. Thank you.
Wayne Parsons
Great article. I hope consumers will appreciate what you are doing at AAJ, Cecelia. I know that I do.
Mike Bryant
This message needs to keep getting out. People must have justice, with the protections of a remedy and a recourse.
Jeanne Meyer
My granddaughter died in December of 2008 because of the faulty Medtronic Fidelis lead that was implanted. We are not interested in receiving a huge settlement like in so many lawsuits, only that medical device companies be responsible for their errors and allowing a defective lead to be sent to the FDA for approval, when they knew there was a problem with it. they did not tell the FDA about this problem and insisted on the FDA to approve it so it could go to market as soon as possible. Over 200,000 people have received this defective lead and what we are seeing right now with deaths and injuries is just the tip of the iceberg. Many more will be injured and die because of this. That is why the law has to be changed so that companies are more responsible when they create a device to be put into someone' body. We trust those companies, so do the doctors who implant them - they shouldn't be defective!
JILL PAUL RN
Jeanne, I'm with you. I'm so sorry about your Granddaughter - how tragic. We, too, only want to see the MDSA passed to protect others who might suffer as we have, due to Medical Manufacturer's not taking responsiblily for their products. I would love for you to sign the peition that is ongoing and tell your story to those who promise to read it ie Congress/Senate.
You can find the peition at: http://www.PetitionOnline.com/tftwj23/petition.html. Together, we can get this bill passed. We all need to work on the same page. Thank you.
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