Michael Townes Watson


An article in this week’s New England Journal of Medicine, entitled “A Pivotal Medical-Device Case” raises an important issue about the fairness of our civil justice system. Here is the link to the article.

The article discusses the Supreme Court case, Riegel v. Medtronic. The issue raised by the article is not a new one, but the Defendant is asking the the United States Supreme Court to give broad and sweeping new protection to companies who manufacture defective and dangerous medical devices, even if those devices kill or seriously injure patients. In Riegel v. Medtronic, the patient was seriously injured because the balloon utilized in a coronary angioplasty surgery ruptured. The Plaintiff in the lawsuit claims that the balloon device was defective. The legal issue is now whether the injured patient is deprived of a legal remedy simply because the Food and Drug Administration had approved the device for use.

The history of medical device liability in this country is not generally known to the public. Some remember the Dalkon shield cases of the 1970’s, in which thousands of women either died or were seriously injured as a result of defective IUD devices. Following those cases, Congress gave the FDA authority to regulate the design and approval of medical devices. Yet, an injured patient has still retained the right to access to the justice system if injured by a defective product, even though the FDA has approved the product. The question before the Supreme Court in Riegel is whether the intent of Congress in granting such authority to the FDA, was to completely remove from the justice system the ability to adjudicate cases claiming that a medical device is defective. So, ask yourself if you would like for the FDA, with all of its political ramifications and lobbying influence, to determine whether an injured patient can have access to the justice system.

Recent news has pointed out the influence of pharmaceutical and medical companies, and their lobbyists, on the FDA approval process and on doctors’ decisions regarding drugs and medical devices. The Supreme Court is now considering whether that influence, with all of its attendant dangers, will deprive patients injured by medical devices of their day in court. Although this case has not received the coverage it deserves in the press, it is vitally important for the rights of injured patients.

Michael Townes Watson, author of America’s Tunnel Vision—How Insurance Companies’ Propaganda Is Corrupting Medicine and Law.

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Posted at 10:22 AM, Jan 03, 2008 in
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