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Billy Cunningham
Billy Cunningham
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We Need the Medical Device Safety Act Passed

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In the Spring I wrote a blog about the introduction of the Medical Device Safety Act of 2009. in the Senate. The bill was introduced in response to the U.S. Supreme Court’s ruling in Riegel v. Medtronic, 552. U.S. 2 (2008) where the Court ruled that a medical device manufacturer cannot be sued under state law by patients who claim to have been harmed by the device that received marketing approval from the FDA. I referenced an editorial from the New England Journal of Medicine encouraging Congress to swiftly pass the proposed act. After introduction, the bill was referred to committee but has not come out of committee.

I was curious about how treating physicians felt about the ruling in Riegel and the bill. I interviewed Dr. Fred Meyer, a Professor and the Chair of the Department of Orthopedics at the University of South Alabama in Mobile, Alabama. http://www.southalabama.edu/usahs/hsjoin.pl?docID=261 Dr. Meyer has implanted thousands of medical devices over his career. Orthopedic medical devices allow his patients to return to a more normal life after a serious injury or debilitating illness. He relies heavily on the manufacturer to design and manufacture devices that fit the needs of his patients. A great majority of times those devices do exactly what they were designed to do. When they fail, the consequences to his patients can be grave. If they fail because they were not designed correctly or due to a manufacturer’s error, Dr. Meyer believes, like the editors of the New England Journal ,that his patients should have access to the civil justice system to be compensated. He also told me that he has seen how the civil justice system provides a safety net to his patients from manufacturers who fail to provide devices that are manufactured to specified standards.

He reminded me of the Sulzer hip-replacement debacle. Sulzer designed a hip replacement which was presented to and after testing approved by the FDA. However, after implanting the hip replacement, several surgeons reported cases of early failure which led to an investigation. That investigation revealed the failure arose from an attempt to cut costs which resulted in leaving a residue of machining oils on the backside of the shell of the hip-replacement. This residue inhibited the bone growth necessary for bonding between the shell and pelvic bone. This in effect, caused the shell of the hip-replacement to loosen, scar tissue to form, and in some cases additional bone loss. Patients implanted with this defected product experienced pain in the groin and inner thigh, pain when rising from a seated position, and weight-bearing pain. Due to these severe symptoms, many needed revision surgery. The Sulzer hip-replacement implants were recalled and removed from the market.

Dr. Meyer cited this as a perfect example of how FDA approval does not guarantee the success of a device and how without the civil justice system his patients who suffered unnecessarily would have not been compensated due to a cost saving attempt by a manufacturer. He also told me the story of scheduling a surgery for wrist implant and being assured by the company representative that the device was exactly what he needed only to find out the device was sized wrong. Had Dr. Meyer proceeded with the surgery without recognizing the error, under the Riegel case and without the passage of the Medical Device Safety Act of 2009 or a similar act, that patient will be unable to be compensated because the FDA approved the device. Such a result cannot be the law of this country.

I urge everyone to contact their Congressmen and Senators to urge the passage of an act to protect the public from such injustice.

2 Comments

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  1. Helen Rodenbaugh says:
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    Thank you for urging your readers to contact their representative to urge the passage of a medical device safety act. I love my husband four horrible months after his device was implanted. His doctor’s comment to me was “I don’t know what happened”. I regret that we did not do the research before he agreed to the implant. They are not safe for everyong and their is no reversing a bad experience. I cannot forgive myself. Let the buyer beware!

  2. james says:
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    Im one of the many effected by this. I was nearly killed when my first defib implant caused a 100% clott in my vena cava. I have no blood deseases so this was caused by the lead. During open heart surgery to remove the clott they placed the lead directly to the heart so ther ewas no more risk of clotting again. Well this just happend to be a lead that fractured. When they replaced that one they had to run it back in to the vein because the risk of opening my chest back up was way to high. So now because of this I will be on blood thinners for the rest of my life. Not to mention they also caused a huge amount of damage from the original device.

    Thanks for your support! We need it.