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The increased level of enforcement activity by the FDA has focused the attention of consumers and the plaintiffs' bar on the increased frequency with which physicians prescribe FDA-approved drugs and medical devices for unapproved uses. Plaintiffs' attorneys increasingly choose to name prescribing physicians in their products liability suits as co-defendants, pleading both medical malpractice and other associated tort claims against these physicians, and often premising such claims upon the decision to prescribe for a so-called "off-label" or unapproved use. Thus, the continuing expansion of off-label uses of drugs and devices has led to numerous potential legal minefields for the prescribing physicians.
A high-profile wrongful death case was recently decided for the second time in favor of a Miami couple whose child suffered severe brain damage during his birth at the U.S. Naval Hospital in Jacksonville, FL.
Measuring the extent of medical damages, for a medical malpractice claim as for any other type of negligence claim, is an important part of any case. Normally, when a defendant causes harm that sends a plaintiff to a hospital or doctor, three different measures may be relevant to determining the defendant's liability ' the amount the plaintiff herself has paid for medical care, the amount the plaintiff's health insurance has paid on her behalf, and the amount a health care provider has billed as its "usual and customary" charge.
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Who's doing what; who's going where.
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In last month's issue, the authors discussed the concept of "Never Events": things that should never occur absent negligence in hospitals or other health care settings. The discussion concludes herein.
In last month's issue, the author noted a systemic problem with the distribution of risk during drug clinical trials. Although clinical trial sponsors invariably carry insurance, their coverage may not pay for all of the damages suffered by trial participants. This can leave doctors and hospitals at risk.