Risk, Responsibility, and Generic Drugs

ArticleinNew England Journal of Medicine 367(18):1679-81 · November 2012with12 Reads
DOI: 10.1056/NEJMp1208781 · Source: PubMed
  • [Show abstract] [Hide abstract] ABSTRACT: Can a product manufacturer be subject to liability for a competitor's product? American tort law has always said, "No." It does not matter if the products are identical. Companies are not to be their competitors' keepers. Nevertheless, over the past few years, three courts have overturned this fundamental of tort law, holding that a manufacturer of a brand-name prescription drug can be subject to liability even when a plaintiff alleges that he or she was harmed by a generic drug made by the brand-name manufacturer's competitor. Most courts, including four federal courts of appeal and dozens of federal district and state trial courts, have rejected this expansion of tort law. This debate has intensified since 2011, when the Supreme Court of the United States held that all duty to warn claims against manufacturers of generic drugs are preempted by federal drug. The personal injury bar is hoping that courts will give competitor liability theories a new look, particularly when courts find that there is no other path for users of generic drugs to sue. This Article explains the reasons courts should continue resisting any temptation to change state tort law to allow for competitor liability: (J) it is driven by a search for pockets for paying claims in violation of fundamental tort law principles; (2) the overwhelming majority of courts have continued rejecting competitor liability, even since the Supreme Court ruling; and (3) shifting liability to manufacturers of brand-name drugs could have significant adverse legal and health care consequences.
    Article · Mar 2013
  • [Show abstract] [Hide abstract] ABSTRACT: Background The official prescribing information document distributed with a prescription drug is a key source of safety information, but it may include excessive or insufficient details. Objectives To compare prescribing information approved by the US Food and Drug Administration with the UK, Canada and Australia to identify content differences in safety warnings. Methods For 20 top-selling prescription drugs, we used an automated natural language processing tool to calculate the number and severity of reported adverse drug reactions (ADRs). We fit hierarchical Poisson models and included fixed effects for other prescribing information characteristics. Separately, we analysed the appearance and content of ‘black box’ warnings. Results There was substantial variation in safety content of approved prescribing information. Canada had the highest median ADRs per drug (138 (IQR 86–234)) and the UK had the lowest (84 (IQR 51–111)). The number of ADRs reported was on average 50% higher in Canada compared with the USA (ratio of ADRs/document: 1.5, 95% CI 1.4 to 1.6, p<0.001). By contrast, there were on average 15% fewer ADRs listed in the UK compared with the USA (ratio of ADRs/document 0.85 (95% CI 0.78 to 0.93, p<0.001), and 21% fewer ADRs listed in Australia compared with the USS (ratio of ADRs/document 0.79, 95% CI 0.74 to 0.85, p<0.001). There were no variations in ADR severity. The presence and qualitative content of boxed warnings also showed substantial diversity. Conclusions International variations exist in the presentation of safety data in drug prescribing information, which may have important implications for patient safety. Better international coordination is necessary to enhance use of this information for patient decision-making.
    Article · Apr 2013
  • [Show abstract] [Hide abstract] ABSTRACT: When a patient in the United States fills a prescription, the likelihood that a generic drug will be dispensed is overwhelming—and increasing. Generic drugs account for more than 80% of prescriptions, but only 20% of total drug spending, because of their lower cost. The move to generics is estimated to have saved more than a trillion dollars in the last decade.1Although generic drugs are bioequivalent to their brand-name counterparts, important legal distinctions between the 2 categories have resulted from 3 Supreme Court decisions. The first, Wyeth v Levine, arose after a woman developed gangrene in her forearm caused by intra-arterial injection of Wyeth’s antiemetic Phenergan (promethazine); the patient was awarded $6.7 million in damages based on her claim that the drug’s label did not sufficiently warn about its risks. In 2009, the Court upheld the award, noting that brand-name manufacturers are primarily responsible for providing accurate safety warnings for the drugs they produce.2 The decision makes sense because premarket testing does not reveal the full range of a drug’s adverse effects, postmarket surveillance by the US Food and Drug Administration (FDA) is insufficient, and state tort liability incentivizes manufacturers to continue monitoring the safety of their products.
    Article · Aug 2013
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