In September, 2015, President Obama nominated Dr. Robert M. Califf to head the U.S. Food and Drug Administration (FDA). Califf already holds a powerful position within the FDA. He became the FDA’s Deputy Commissioner for Medical Products and Tobacco in February, 2015. But for some, Califf’s deep ties to the pharmaceutical industry are an … [Read more...]
Search Results for: Medtronic
Defibrillator Recall Advice
There are many manufacturers of Automated External Defibrillators (AEDs). Although the units must pass the same rigid FDA tests in order to be marketed to the public, when it comes to recalls, all units are not alike. AEDs are intended to treat adults and/or children in cardiopulmonary arrest; therefore, the first indication that an AED is faulty … [Read more...]
Medical Device Litigation 101
Medical Device Litigation History and Primer1976 through Reigel v. MedtronicGuest post provided by Denver personal injury attorney Beth KleinBackground of the ActThe Food & Drug Administration ("FDA") governs medical devices for use and sale in the United States. The FDA was given power over medical devices in the 1976 Medical Device Amendments to … [Read more...]
Supreme Court Grants Immunity to Medical Device Manufacturers
(Editorial Content)The Supreme Court finally gave medical device makers their one true wish - Immunity from Lawsuits. Companies that produce medical devices like breast implants and implantable defibrillators now have federal protection against lawsuits arising from deaths or injuries associated with their products as long as the product has been … [Read more...]
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