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Recent rulings of interest to you and your practice.
Recent happenings that may affect your practice.
The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act contain an express preemption provision, namely 21 U.S.C. ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the U.S. Supreme Court has held, in a case involving ' 360k(a), that traditional state law claims are permissible and are not preempted if the common law duties involved parallel the duties statutorily imposed in the federal law and do not impose higher standards.
New York Attorney General Andrew M. Cuomo recently spearheaded a statewide New York investigation into health insurers' use of physician-ranking programs. The investigation, which has made inquiries to insurers including United Healthcare, Aetna, CIGNA Healthcare, Empire Blue Cross Blue Shield, Preferred Care and HIP Health Plan of NewYork/GHI, has now produced a settlement with CIGNA. Although the investigation is specific to New York, the issues raised are national in scope and worth serious consideration, since health insurers nationwide are increasingly utilizing physician-ranking systems.
Your hospital and physicians have the opportunity to conduct a study on a new method for the early detection of a disease. They go through the necessary procedures of obtaining patients at risk for the disease, and those patients knowingly agree to participate in the program. However, there may be one problem with this scenario. According to a recent case out of New York, your hospital and physicians may have just established a hospital-patient and/or physician-patient relationship with each of the study participants, exposing all of them to the risk of multiple medical malpractice lawsuits.
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Epstein Becker & Green (New York): Steven Skwara and Robert Penezic join the health care and life sciences practice as partner and as senior counsel, respectively. Skwara was at Blue Cross and Blue Shield of Massachusetts, serving as associate general counsel and as director, fraud investigation and prevention. Penezic was at Broad and Cassel's Fort Lauderdale, FL, office. …
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Recent occurrences in this important area.