A drug manufacturer may be held liable for punitive damages on a theory of “implied malice,” a federal judge has ruled, where evidence suggests the manufacturer withheld information from the U.S. Food & Drug Administration that would have led to stronger warning labels.

In his 25-page opinion in Wolfe v. McNeil-PPC Inc. , Senior U.S. District Judge Jan E. DuBois said a jury must decide whether the manufacturer of Children’s Motrin withheld from the FDA reports of two instances in which patients developed Stevens-Johnson Syndrome, a rare and life-threatening condition affecting the skin in which cell death causes the epidermis to separate from the dermis.

This content has been archived.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 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]