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Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer responsibility for defective medical devices. This law will overturn the holding in the U.S. Supreme Court case of Reigel v. Medtronic decided two years ago. Background on that case can be found at the author’s website.

Though the opposition claims that this law will give unsophisticated juries more authority than the FDA experts, the FDA has conceded for years that it does not have the wherewithall to monitor and control the medical product performances in the field. The FDA has relied on state court actions brought by injured consumers as a "complimentary review" of the medical devices it authorizes into the marketplace.

Following the Reigel decision, the FDA has had to rely on manufacturers to correct defects in their products, something that manufacturers are naturally reluctant to do. Contrary to the opposition’s view, profit most often motivates the actions of the manufacturers. The "initiative" and "inventiveness" that the opposition claims will be stifled by the law seldom overrules the profit motive in favor of safety innovations. This is particularly true when the manufacturer is made completely immune from responsibility to those hurt by its defective products.

We commend Congress for its work to correct the "black hole" that the Supreme Court created, and to return responsibility to those that place defective medical products into the medical marketplace and our bodies.

One Comment

  1. Gravatar for JILL PAUL RN

    Great article Todd. You summed it all up very eloquently. Michael Mulvihill, who testified yesterday, received 22 horrendous, inappropriate shocks in 53 minutes while driving his car with his wife onboard. This was the result of a Medtronic Sprint Fidelis lead fracture. My husband suffered 37 horrendous, inapproptiate shocks from his Sprint Fidelis lead fracture in about the same length of time. I witnessed this event and it was horrifying. Medtronic knew they had a serious problem with the Sprint Fidelis lead but chose to put profits ahead of patient safety. Medtronic should not receive the benefit of a judicial doctrine granting the company immunity when they knowingly put patients' at risk. The premarket approval process for Class III devices that are substantially equivalent to another deivce, do not have to undergo the premarket approval process. It is my understanding that this is essentially what happened with the Sprint Fidelis lead. Some say that decisions about the safety of medical devices should be left to the experts and scientists at the FDA who evaluate "new" products with the overall public good in mind. The Sprint Fidelis lead was not considered a "new" product and therefore, was never tested. Dr Maisel, a Cardiologist at Beth Israel Deaconess Medical Center and also chair of the FDA Circulatory System Devices Advisory Panel, testified yesterday to that fact. Yes, we need safe products and innovation in the Medical Device field but not at the expense of injured parties who have no legal rights in the civil justice system. Many voices speaking out in favor of The Medical Device Safety Act can be read at:

    I encourage each of you who have been injured, or, have a family member who has been injured by a faulty medical device, to sign this ongoing petition. I also encourage you to write/email your respective Congressmen/Women and Senators to solicit their support for this very important bill. There is still much opposition to overcome to restore our legal rights. Thank you.

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