Abstract
When any type of product has been ordered to be removed from the marketplace by a governmental regulatory body, that action is a powerful indicator that the product has been determined to be unsafe for further use, thereby branding the product as defective and opening up the possibility of product liability litigation. When the product is a drug or medical device, it is especially serious since the possibility of personal injury (acute and/or chronic) or death may occur. Needless to say, in these situations, product injury litigation will almost surely follow. We review the definition and requisite claims needed to establish drug product liability, and the role that the medical literature, clinical trial data, and even experimental research data can play in product (drug)-injury litigation. We show how each of these resources played a significant role in two well-known cases: Fen-Phen and thimerosal. The ultimate goal of such knowledge is to make better informed decisions about drug safety.
Highlights
When any type of product has been ordered to be removed from the marketplace by a governmental regulatory body, that action is a powerful indicator that the product has been determined to be unsafe for further use, thereby branding the product as defective and opening up the possibility of product liability litigation
We review the definition and requisite claims needed to establish drug product liability, and the role that the medical literature, clinical trial data, and even experimental research data can play in product-injury litigation
Based on post-marketing surveillance reports sent to the Food and Drug Administration (FDA), usually in the form of MedWatch reports for drugs or reports using the vaccine adverse event reporting system (VAERS) for vaccines, the agency may impose one of three possible decisions on a manufacturer
Summary
Manufacturers and suppliers can incur liability through three types of product defects: 1) Design defects—resulting from inherent properties of the drug’s molecular structure, or improper preclinical or clinical development. This is probably the most common type of defect encountered in new drugs introduced to the market. 3) Marketing defects—resulting from improper marketing and claims made for specific drug products This category often involves injuries caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect, or to a failure to provide adequate instructions regarding the safe and appropriate use of the drug.
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