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Scientific and legal issues in fenfluramine/dexfenfluramine litigation.

Fenfluramine and dexfenfluramine were popular and widely used antiobesity agents until they were withdrawn from the market in 1997. Even though early research appeared to demonstrate their safety, serious concerns were raised about these medications. Primary pulmonary hypertension (PPH) was a known side effect, but it was believed that the health benefits of weight loss compensated for the risk of PPH. With widespread use of these agents, 2 other conditions--valvular heart disease and neurotoxicity--were reported as potential side effects. In this paper, we review the evidence for these adverse events and whether the current data meet federal and Texas legal standards for admissibility. We discuss also the basis for health claims against physicians, and the scientific and legal challenges faced by both plaintiffs and defendants.

Anti-Obesity Agents↗

Drug-related problems and adverse drug events: negligence, litigation and prevention.

Since the inclusion of medical profession under Consumer Protection Act, Indian doctors are facing malpractice suits. The incidence of adverse events (AEs) is 3.4-3.7, of adverse drug events (ADEs) is 2.4-6.5 and of adverse drug reactions (ADRs) is 6.7 per 100 hospital admissions. The complications of drug-related problems (DRPs) include therapeutic failure (TF) in 23% and new medical problems (NMPs) in 10% and could lead to serious permanent disability and death in majority (42%). The incidence of negligence in serious ADEs and death is 34% and 51%, respectively. Proportion of preventable ADEs is 28-50%. Errors occur most often in prescribing (39-56%) and result in malpractice claims in 13-25% of cases. Rational prescribing, improved therapeutic knowledge through re-training and effective use of computers in prescribing could prevent errors and reduce economic consequences for patients, doctors and hospitals.

Drug Prescriptions↗

Chronic pain in a family of 6 in the context of litigation.

We describe a family of 6 (2 parents and 4 children), evaluated 6 and 8 years after a minor car accident for chronic pain. A near identical complex of multiple physical, constitutional, and psychological symptoms were shared by all family members, all of whom bore the diagnosis of fibromyalgia. The case was brought to court after nearly a decade of symptomatology and extensive use of the health care system. The minor compensation awarded was consumed ultimately by legal fees. Psychosocial/personality issues and iatrogenic and medico-legal contributions in the evolution and resolution of the legal claim are discussed.

Accidents, Traffic↗

Peril? Litigation!

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Abortion, Legal↗