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• W1576073089 abstract "There should be no question that adverse drug events are a significant issue. A recent report indicated that in 2005 there were 89,842 serious adverse drug-related events (1), and 15,107 of these adverse events were deaths (1). In 2002, adverse drug events were associated with more than 3 million hospital admissions and increased the US hospitalization bill by $17 billion (2). Non–hospitalization-related medication injuries cost $76.6 billion (2). Data show that 3% to 4% of medications are withdrawn for safety reasons (3). With facts such as these, it should be no surprise that adverse drug events are the most common iatrogenic cause of patient injury (4).Traditionally, patients have been able to pursue legal action if they were harmed by a medication side effect about which they were not adequately warned (5). In such circumstances, patients have been able to pursue a “failure-to-warn” claim against the medication's manufacturer and/or the health care provider who prescribed the medication.The pharmaceutical industry is currently pushing an agenda to essentially eliminate the ability of individuals to pursue fail-ure-to-warn claims against manufacturers, regardless of the adequacy of the warning provided. Despite the existence of serious questions about the integrity of industry raised by misconduct involving the medications Ketek, Neurontin, Paxil, OxyContin, Trasylol, Vioxx, and Zyprexa, industry asserts with a straight face that because it is regulated by the US Food and Drug Administration (FDA), federal law should bar an individual's ability to bring a failure-to-warn claim. The concern is that some courts have begun to buy this argument.Industry's argument is based on its contention that Congress intended the FDA to be solely responsible for policing and punishing manufacturer misconduct in the context of medication promotion, safety, and warnings. Recentjudicial opinions have raised the very real possibility that pharmaceutical manufacturers may now be immune from failure-to-warn lawsuits in many states. If the dominoes continue to fall, the American public will be prevented from pursuit of failure-to-warn claims against a manufacturer or will be allowed to pursue such claims only when and if the FDA has expressly determined that a manufacturer acted fraudulently." @default.
• W1576073089 created "2016-06-24" @default.
• W1576073089 creator A5045878868 @default.
• W1576073089 date "2008-01-01" @default.
• W1576073089 modified "2023-09-23" @default.
• W1576073089 title "Preemption, Tort Reform, and Pharmaceutical Claims, Part Two: Has the Food and Drug Administration Shown It Is Solely Responsible for the Protection of Patients? Can It Do So? Will It Do So?" @default.
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• W1576073089 doi "https://doi.org/10.1080/08998280.2008.11928368" @default.
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