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For medical device manufacturers, federal preemption can be a powerful defense to state tort claims. Although there is some split of authority, most federal courts of appeals that have addressed the issue have held that when a medical device reaches the market via the Food and Drug Administration's (FDA) rigorous "premarket approval" (PMA) process, many state common law claims are expressly preempted by the Medical Device Amendments (MDA) of 1976.
Liability claims against health care facilities, including hospitals and nursing homes, often include claims of negligent hiring, supervision and/or credentialing in addition to the "traditional" theories of medical malpractice litigation. For many years, state courts debated whether a hospital's alleged acts in credentialing physicians fell within the scope of the "treatment and care" of patients. While the majority of jurisdictions now appear to recognize private causes of action against a health care facility based upon alleged improper hiring, retention or credentialing of professional staff, there is no uniformly accepted standard of care nationwide. Accordingly, specialists and the occasional practitioner in this litigation field are equally well advised to monitor the developing common law of their jurisdiction in the litigation of cases presenting such claims.
Most medical malpractice attorneys deal primarily with individual clients and local medical providers and institutions. Sometimes, however, a case has broader reach, crossing state lines and encompassing claims by several plaintiffs. If the case is a class action lawsuit, a whole different set of rules and procedures come into play.
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State medical licensing boards and hospitals rely on many information sources when making licensing and credentialing decisions. One major source of information is the National Practitioner Data Bank (NPDB), a reporting system managed by the Health Resources and Services Administration (HRSA). Last month, the reliability of the information contained in the NPDB was called into question after reporting failures within the federal government itself were exposed by a report issued by the Office of the Inspector General (OIG). The OIG found that three Health and Human Services (HHS) agencies had failed to report as many as 474 medical malpractice cases that should have been reported to the NPDB over the course of several years.
The nation's second trial over health effects of the drug Vioxx got swamped in New Jersey last month, as a jury categorically rejected claims that failure to warn about the painkiller's risks caused a user's heart attack. The jury found, 8-1, that Merck & Co. properly alerted prescribing physicians to a link between Vioxx and an increased risk of cardiovascular events, and found unanimously that there were no consumer-fraud violations in the way Merck marketed Vioxx to physicians. As a result, the jury never reached the question of proximate causation of postal worker Frederick "Mike" Humeston's heart attack.