The Role of Medical Literature, Clinical Trials and Experimental Research in Drug Product-Injury Litigation: A Primer with Two Examples ()
Affiliation(s)
1Kitzen Pharmaceutical Consulting, Collegeville, USA.
2Temple University School of Medicine, Philadelphia, USA.
3NEMA Research, Inc., Naples, USA.
4University of Arizona College of Pharmacy, Tucson, USA.
5Temple University School of Pharmacy, Philadelphia,USA.
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.
Share and Cite:
Kitzen, J. , Pergolizzi Jr., J. , Taylor Jr., R. and Raffa, R. (2018) The Role of Medical Literature, Clinical Trials and Experimental Research in Drug Product-Injury Litigation: A Primer with Two Examples.
Pharmacology & Pharmacy,
9, 208-227. doi:
10.4236/pp.2018.96016.
Cited by
No relevant information.