Since the Food and Drug Administration set forth its pre-emption analysis in the preamble to its Jan. 24, 2006 drug-labeling rule, there has been a flood of judicial opinions analyzing the scope and applicability of the pre-emption defense in prescription drug litigation. The cases have been sharply divided, and the defense now appears likely to be a key issue that will be addressed in all cases going forward.

In a November 2006 article in Product Liability Law & Strategy, I found that a clear majority of courts that had considered the FDA preamble had affirmed the pre-emption defense. Since then, however, the sides have balanced out, as a number of courts have departed from the FDA’s analysis, as follows.

This content has been archived.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]