Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.
نویسنده
چکیده
Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.
منابع مشابه
A shift on "pay for delay"--reopening doors for pharmaceutical competition?
by approved drugs is funded by the manufacturers — a situation that can lead to problems with the collection, analysis, and reporting of safety data.4 Finally, this alternative approach would be in keeping with a stronger, better-managed role for the FDA in monitoring drug side effects. A similar approach could also be used to create a fund for compensating patients injured by adverse events th...
متن کاملVariations in time of market exclusivity among top-selling prescription drugs in the United States.
Variations in Time ofMarket Exclusivity Among Top-Selling Prescription Drugs in theUnited States In the United States, effective market exclusivity for a prescription drug is the time between US Food and Drug Administration (FDA) approval and the availability of the first generic version. Market exclusivity incorporates the minimum regulatory exclusivity periods granted to all FDA-approved drug...
متن کاملEvaluation of Drug Prescription Pattern among General Dental Practitioners in Rasht, Iran
Introduction: Irrational drug prescription is a controversial issue around the world that inter-feres not only with the patient's life but also with the society and economy. Despite few studies, there is no enough data on the prescription habits of dental practitioners. So, we aimed at evaluating the same issue in Rasht, Iran. Materials and Methods: This cross-sectional re-trospective study r...
متن کاملDrug Safety Unscrambling Post - Approval Drug Safety Monitoring
Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...
متن کاملCongress is likely to approve generic drug user fees: action should spur faster FDA approvals.
$824 billion in the last decade. The cost savings benefit is obvious, and some even claim that generic products can be safer than their brand-name counterparts. Edith A. Rosato, RPh, Chief Executive Officer at the Academy of Managed Care Pharmacy, explains: “Generic drugs, by definition, are versions of brand-name drugs that have been available in the marketplace for many years. The longer a dr...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Duke law journal
دوره 60 5 شماره
صفحات -
تاریخ انتشار 2011