Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 1 of 1
Full-Text Articles in Law
The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia
The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia
DePaul Journal of Health Care Law
Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.
What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …