Establishing a No-Fault Compensation System to Replace Failure-to-Warn Product Liability Claims Against Prescription Drug Manufacturers

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Establishing a No-Fault Compensation System to Replace Failure-to-Warn Product Liability Claims Against Prescription Drug Manufacturers

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Title: Establishing a No-Fault Compensation System to Replace Failure-to-Warn Product Liability Claims Against Prescription Drug Manufacturers
Author: Lauer, Abigail
Citation: Abigail Lauer, "Establishing a No-Fault Compensation System to Replace Failure-to-Warn Product Liability Claims Against Prescription Drug Manufacturers"(May 2, 2012).
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Abstract: In 1986, Congress passed the National Childhood Vaccine Injury Act, which established a no-fault compensation system to provide money to people who are injured by vaccines. The major impetus behind this Act was the soaring cost of tort litigation and damages awards imposed on vaccine manufacturers, which was causing many manufacturers to stop producing vaccines altogether. The resulting vaccine shortages threatened the public health of the country. In recent years, manufacturers of prescription drugs have paid large damages awards and legal fees that are akin to those costs borne by vaccine manufacturers in the 1970s and early 1980s. Pharmaceutical manufacturers can be liable for billions of dollars if patients who take a drug suffer an unexpected adverse event that was not discovered during clinical trials. The uncertainty about the extent of liability a manufacturer may face for a particular drug is causing many manufacturers to remove beneficial drugs from the market or to forego drug development altogether. As a result, Congress should establish a no-fault compensation system to replace failure-to-warn claims against prescription drug manufacturers. Such a scheme would significantly reduce the incredible costs that the current drug product liability system imposes on drug manufacturers. At the same time, patients who take a prescription drug and suffer a serious injury that was not foreseen by the drug manufacturer or the FDA will be compensated, so long as they can prove that the drug was the cause of their injury. The National Vaccine Injury Compensation Program is an excellent model that Congress can adapt to meet the needs of participants in the market for prescription drugs.
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Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:11940218
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