Drugs and Devices
December 21, 2007
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.
Is Ranking Physicians a Fair Practice?
December 21, 2007
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.
Hospital LIability for Medical Research Studies
December 21, 2007
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.
Case Notes
November 30, 2007
Highlights of the latest product liability cases from around the country.
Ancillary Businesses Losing Appeal
November 30, 2007
Law firms once dreamed of owning separate businesses to bring in new streams of revenue, and while some achieved that goal, the industry is now largely backing away from a strategy that provided little economic benefit.
Movers & Shakers
November 27, 2007
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. …
Verdicts
November 27, 2007
Recent ruings of importance to you and your practice.
Med Mal News
November 27, 2007
The latest information you need to know.
'Sorry Works' -- or Does It?
November 27, 2007
Sacred cows make great steaks, as one wit quipped. The usual way of doing things is being stood on its head and, in the realm of medical malpractice claims at least, is being replaced in many cases by fresh approaches and claim resolution templates. Specifically, historical norms of adversarial claim approaches are being supplanted by 'apology programs,' which receive increasing interest and publicity.
