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Medical Device Safety Act of 2009–Rebuilding the Status Quo

Lobbying efforts, particularly by injured victims and their counsel (as well as manufacturers of medical devices), are continuing for the Medical Device Safety Act of 2009. It’s no surprise that each side takes the position it takes—the victims hoping to pass the legislation to prevent more blanket immunity for manufacturers of devices that hurt or kill patients; and manufacturers hoping to reap the benefits of zero liability for some of their devices which cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Physicians are coming out in support of the Medical Device Safety Act. Typically, they support tort reform and anything to prevent or limit lawsuits against healthcare providers. However, in a New England Journal of Medicine Editorial of April 9, 2009, three physicians took a stand behind the proposed legislation.

The argument of victims and doctors is essentially this—for many years, medical device manufacturers have been liable for injuries caused by their products. No surprise there. However, last year the U.S. Supreme Court ruled in Riegel v. Medtronic that manufactuers can’t be sued under state law for devices that received marketing approval from the FDA. Before Riegel, manufacturers had clear incentive to warn about the possible dangers of their products. The result, of course, has been untold dismissal of lawsuits, leaving many victims without any recompense.

In their editorial, the physicians make clear that patient safety is enhanced by accountability. In light of the recent case of Wyeth v. Levine, which holds pharmaceutical manufacturers responsible for their products, it is clearly unfair for medical device manufactures to get off scot free. In this post-Enron world, the public is beginning to understand that safety is good, and corporate greed is not.

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