Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Product Liability Law & StrategyKickerFeaturesSectionsNewsLJN Newsletters

FDA's New Labeling Rule Asserts Federal Pre-emption of State Product Liability Claims

By Beth L. Kaufman and David Black

On Jan. 18, 2006, the U.S. Food and Drug Administration ('FDA') issued a final rule to revise the required format of prescription drug labels so as to enable physicians to find the information they need more readily. New features include a section called 'Highlights' and a Table of Contents. According to the FDA's press release, this is the first time in 25 years that the labeling requirements have undergone a major revision.

One of the most important parts of the new rule is an 11-page statement proclaiming that FDA labeling requirements should pre-empt most state product liability claims. Courts across the country will now have to decide how much deference to give the FDA's statement in determining whether certain state product liability claims against pharmaceutical companies, such as failure to warn claims, are barred because labeling approved by the FDA is deemed to have provided all the necessary warnings.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.

Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers Image

There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.

Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

Removing Restrictive Covenants In New York Image

In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?

Transfer Tax Implications on Real Property Leases Image

The real property transfer tax does not apply to all leases, and understanding the tax rules of the applicable jurisdiction can allow parties to plan ahead to avoid unnecessary tax liability.