On January 24, 2006, the U.S. Food and Drug Administration (FDA) issued a Final Rule entitled Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006). In the now-famous preamble to that Final Rule, the FDA stated its view that “… under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.”   The preamble contains a detailed explanation of why the FDA believes that allowing certain state tort law claims for failure to warn would conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal labeling requirements for pharmaceutical and biologic products.   The FDA explains that it makes labeling decisions based on “a comprehensive scientific evaluation of the products’s risks and benefits under the conditions of the use prescribed, recommended, or suggested in the labeling.”   The FDA further explains:
Continue Reading Vioxx Multidistrict Litigation Court Refuses to Give Deference to FDA’s Preemption Preamble

Any industry manufacturing or even using products with even trace levels of benzene should be aware of the growing trend among trial attorneys to bring benzene exposure claims. It may be nearing the time for companies to undertake aggressive efforts to reduce or eliminate potential exposure to these types of claims
Several recent blogosphere entries

Kean Miller is pleased to announce that 12 lawyers, formerly in the Admiralty & Maritime, Construction, and Energy practice areas with Lemle & Kelleher, LLP, have joined the firm in the New Orleans office.

“We are very excited to welcome these distinguished attorneys to our law firm. They are an outstanding resource for our clients. Our offices are located in Louisiana’s major port cities — New Orleans, Baton Rouge and Lake Charles — and this esteemed group brings over 150 years of combined experience in maritime issues, admiralty law, marine insurance, oil & gas, drilling and exploration, pipelines, construction, and energy law to our clients.” said Gary A. Bezet, managing partner of the 121-lawyer firm.
Continue Reading Kean Miller Adds 12 Attorneys in Admiralty & Maritime, Construction, and Energy Practice Groups – New Orleans Office Triples in Size

The U.S. Food and Drug Administration (FDA) announced on January 18, 2006 that it is issuing final regulations making a “major revision” to the format of prescription drug information. Among other things, the rule revises the current regulations to require that the prescribing information of new and recently approved products includes “Highlights” of the prescribing information and a table of contents for the full prescribing information. View the announcement. This new “Highlight” procedure is designed to make the product warnings and package inserts easier to read and understand, both by prescribing physicians and by patients.
Continue Reading Federal Preemption of State Pharmaceutical Product Liability Tort Law – The FDA Speaks Out

Per its website at http://www.laed.uscourts.gov, the United States District Court for the Eastern District of Louisiana has closed until further notice, and has suspended “all deadlines and delays in matters pending before this court…until ordered otherwise.”

In-house counsel who are employed in Louisiana but are not licensed to practice law here have until July 1, 2005 to file an application for limited licensure to practice under the Louisiana Supreme Court’s new In-House Counsel Rule.
Continue Reading Louisiana In-House Counsel Rule Deadline Approaching

Glenn M. Farnet recently won a significant products liability victory for Black & Decker (U.S.) Inc., in the United States Fifth Circuit Court of Appeals. While using a pneumatic brad nailer, the plaintiff was blinded in one eye after a nail ricocheted off of the work surface. The district court granted Black & Decker’s summary judgment motion on the ground that the plaintiff did not satisfy his burden of proving the “risk/utility” element of a defective design claim under the Louisiana Product Liability Act. The United States Fifth Circuit affirmed the ruling.
Continue Reading Products Liability Victory on Summary Judgment