Product liability cases brought against pharmaceutical and medical device manufacturers typically focus on failure-to-warn claims. But who decides whether the challenged warning is adequate? Judge or jury? In its decision in Banner v. Hoffmann-La Roche Inc., 383 N.J. Super. 364 (App. Div. 2006), New Jersey’s Appellate Division challenged the conventional wisdom that juries alone should decide whether a manufacturer’s warning is adequate by taking one such determination into its own hands.

The plaintiffs in Banner were a married couple whose child had been born with profound birth defects due to the mother’s prenatal use of the drug Accutane. The couple sued Accutane’s manufacturer, Roche, for damages. Accutane, a Food and Drug Administration-approved medication for the treatment of severe acne, is a known teratogen, or chemical known to cause birth defects. Roche, aware of this danger, established a comprehensive pregnancy prevention program to be completed by each potential woman patient of childbearing age, which included a pregnancy test and consent and survey enrollment form.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Advance® Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]