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The House Energy and Commerce Subcommittee on Health began hearing testimony on the Medical Device Safety Act of 2009, which proposes the Supreme Court decision in Riegel v. Medtronic, Inc be overturned. The Reigel ruling prevents patients that were injured by certain federally approved medical devices from seeking compensation via state product liability suits – in other words, federal law trumps (preempts) state law in these cases. The House bill has been a catalyst in the legal community. The American Tort Reform Association, for example, claims the bill would be an economic stimulus for personal injury attorneys. The American Association for Justice, on the other hand, says the bill would restore victims’ rights.

The subcommittee’s hearing was just as divided. While the arguments within the subcommittee hearing were relatively tame, an argument broke out between Subcommittee Chairman Henry Waxman (Democrat) and Steve Buyer (Republican). Waxman argued the FDA’s ability to protect the American public has plummeted due to severe underfunding. Buyer claimed this was “bizarre logic.”

A former chief counsel of the Food and Drug Administration (FDA) testified at the hearing and argued ultimate authority should rest with the FDA and not a group of people that listen to lawyers “rant” at them. He further argues that making it easier for the companies to be sued would lead to limits in innovation because companies would be deterred from taking risks in developing new products. David Vladeck, who will become the Federal Trade Commission’s consumer protection chief next month, claims the Riegel decision gave consumers the “worst of both worlds” since the FDA cannot assure every medical device is safe and with Riegel, consumers can no longer rely on the tort system if they are injured.

Mr. Vladeck is dead-on with his comment. There have to be checks and balances on any system. It is no secret that the FDA (and most other federal oversight agencies) do not have adequate resources to police drug companies, medical device companies, automobile manufacturers, and much of the banking industry (Exhibit A being what has occurred in our economy over the past 12-24 months), just to name a few. While lawyers, especially trial lawyers, are not a favorite profession of most citizens, trial lawyers (of which I am a card-carrying member) are needed as an enforcement mechanism. The possibility of litigation is a deterrent, and it is also a means to hold those who place profits ahead of safety accountable.


  1. Gravatar for JILL PAUL RN

    Greg, thank you for your update on the MDSA 2009. It looks like discussions are heating up in Congress, and so they should. The 1976 pre-emption law on medical devices is totally antiquated and needs to be reformed in keeping with our sophisticated medical devices on the market today. David Vladeck is right when he says that there has to be checks and balances and not just a bottom line to consider ahead of safety. We know that the FDA has not been doing their job for years - the FDA has even admitted to this. They cannot possibly stay on top of the thousands of new medical devices on the market today - a very different situation from 1976. Therefore, we need to pass The Medical Device Safety Act S540/HR1346 to protect the innocent victims' who have been harmed by faulty devices and have no legal recourse.

    If you or a loved one has been injured by a faulty medical device, please sign and leave comments on the Medical Device Safety Act Petition which can be found at:

    I also encourage each and everyone of you to write/email your respective Congressmen/Women and Senators to enlist their support of this very important bill. Thank you.

  2. Gravatar for Greg Webb

    Ms. Paul,

    Thank you for your comments, and the link for the petition. Your comments are insightful and accurate. Let's hope for positive results in the future.

    Greg Webb

  3. Gravatar for JILL PAUL RN

    Greg, as a seasoned health professional I had never heard of pre-emption prior to Oct. 31st, '08. On that day, my husband's recalled Sprint Fidelis lead to his pacemaker/ICD fractured resulting in 37 horrendous, debilitating shocks. Fortunately I was home and witnessed the event barely able to call "911" myself all the while he was screaming "JUST KILL ME". When I touched his hand, I, too, was shocked. 2 surgeries later at a cost of $150,000, 1) to retrieve the fractured lead and replace the pacemaker/ICD, and 2) to extract a hematoma which had formed under his new pacemaker, we are still suffering from the psychological and physiological damages that this faulty medical device created. My husband is 100% pacemaker dependent having undergone 4 heart ablations to eradicate underlying Atrial Fibrillation and Flutter which he did not tolerate. If he had been home alone, I would have come home to find him dead on the floor with his pacemaker battery totally depleted. Or, if this had happened when he was driving his car, he not only would have killed himself, but, anyone else on the road around him. How does one ever recover from the horrors of that thought? Now, he has a new and improved pacemaker/ICD which, no doubt, has never been tested by the FDA. That's very comforting, isn't it? His original pacemaker/ICD was implanted at the prestigious Mayo Clinic in Phoenix in Sept. '06, where he would fly quarterly from California for a pacemaker check - the last being Sept. 3, '08. The longevity of a pacemaker/ICD should be 5-7 years - his lasted 2 years. That should certainly increase Medtronic's bottom line! Most lay people think that when a pacemaker battery needs to be changed, that we somehow open a lid and pop a new one in. Not so. The whole unit has to be changed at a cost of $45,000 just for the unit itself, not to mention hospital & surgery costs. I have the bills to prove it. His new lead to his ICD was $10,000 for which Medtronic offered to reimburse $600.00. These are facts - not fiction. This tells my story why I am such an advocate for the Medical Device Safety Act 2009. I'm sorry if I'm long winded on this, but I just want to prevent others' from suffering the consequences that we have had to suffer, due to a faulty medical device. I have been in contact with an Attorney in Washington who is willing to take the petition that Josephine McKee started after suffering 50+ shocks, to members of Congress, the Senate and to committee members on the Hill. I urge each and everyone of you to sign and post comments to this ongoing petition. No one should suffer in silence. The petition can be found at:

    Greg, thank you for allowing me to tell my story.

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