You may not know it yet, and hopefully, you will never have to learn it. But from now on, if you are injured or killed as a result of a medical device that was FDA approved, but negligently manufactured, you will not be able to seek redress in state courts. Due to a principle called “preemption,” as in, federal law preempts state law in these circumstances, state laws regulating medical devices are trumped by the FDA’s authority to do so. So, if the FDA approved the device, the manufacturer is immunized from any state lawsuits seeking compensation for injury or death. If you would like to read the U.S. Supreme Court decision that deprived us of this right, the citation is Riegel v. Medtronic, 128 S.Ct. 999 (2008) .

You would think that physicians and hospitals all over the United States would be celebrating this decision, as it insulates the companies that make the medical devices they use from liability. But you would be wrong. In the July 3, 2008 issue of The New England Journal of Medicine, three of its top editor-physicians spoke out against the Riegel decision, and expressed their grave concerns about a similar case about to be decided by the U.S. Supreme Court, Wyeth v. Levine, 128 S.Ct. 1118 (2008) . If the Wyeth case is decided in favor of Wyeth, a drug manufacturer, drug companies may also be immunized against state lawsuits, if the drug in question was FDA approved when used by the injured individual.

Why are they concerned? Clearly because patient care and well-being are at the top of their list of priorities. As the authors point out, FDA approval is not a guarantee of any drug’s safety, due to limitations inherent in pre-approval studies of such drugs. As they also note, preemption of the right to bring such suits will result in a decrease in the safety of drugs and medical devices, and unjustly deprive injured patients of the ability to seek the legal redress to which they are entitled.

Should you be concerned about these trends? If you are not, may I suggest that you be very, very careful.

We’re here to listen.

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