posted by Todd Harvey at 9:05 AM
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posted by Todd Harvey at 7:35 PM
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Labels: Fair Labor Standards Act
posted by Todd Harvey at 7:08 PM
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On February 20, 2008, the Supreme Court decided that the Medical Device Amendments of 1976 (MDA) created a standard of safety oversight for medical devices that supersedes state or common law requirements. The case was Riegel v. Medtronic. In this case, Charles Riegel suffered serious injury when a balloon catheter burst during his angioplasty procedure. As a result of the device's failure, Riegel underwent emergency bypass surgery and was on cardiac life support. The suit filed against Medtronic claims that the device was defective and its labeling inadequate, a suit brought under New York common law.
According to the Court's decision, any medical device that has received approval by the Food and Drug Administration (FDA) cannot be held to any higher standard of strict liability, breach of implied warranty, and negligence relating to its "design, testing, inspection, distribution, labeling, marketing, and sale." The Court decided that the FDA requirements provided for "reasonable assurance of safety and effectiveness" of all medical devices.
Some doubt about the "reasonable assurance" provided by the FDA, is cast by the presence of dangerous and defective devices such as the pain pump and the Kugel Mesh Hernia Repair Patch.
This doubt it reinforced by a recent report from the Health and Human Services' Office of the Inspector General, entitled "The Food and Drug Administration's Oversight of Clinical Trials." This report found that the FDA's effectiveness was limited by a number of factors. First, the FDA lacked the data handling capability to track all the institutional review boards monitoring clinical trials and other key factors in the development and approval of new drugs. Second, the FDA's inspections are haphazard, and included inspections of less than 1 percent of clinical trial sites. Third, the FDA relies on voluntary compliance by pharmaceutical companies to correct regulatory deficiencies located during inspections. Finally, the report noted that FDA guidance and regulations are not consistent with current practices during clinical trials.
Note that the Medtronic ruling only applies to suits involving medical devices. Next term, the court will consider a case involving FDA-approved drugs, such as the Ortho Evra Birth Control Patch.
The Supreme Court ruling does not quite ban defective product lawsuits against manufacturers of medical devices, but it does make these suits more difficult to argue and to win because they have to be argued under federal law only, whereas many cases have been argued under state law in the past.
Because of this restriction, it is even more important that you get a qualified and experienced personal injury lawyer to represent you.
If you or someone you love has been injured by a defective medical device, please contact Burke, Harvey, and Frankowski, LLC today for a free initial consultation.
posted by Patti at 3:12 PM
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posted by BHF at 1:38 PM
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posted by BHF at 8:13 AM
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posted by BHF at 8:40 AM
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posted by BHF at 9:13 AM
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