Louisiana protects corporate directors and officers from liability to shareholders or others when they make decisions in good faith and reasonably believe that their decisions are in the best interest of the organization. This principal, called the “business judgment rule,” gives officers and directors the freedom to take risks and to make decisions without wondering
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
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
Reproduced with permission from Class Action Action Litigation Report, Vol. 6, No. 21, pp. 793-795 (Nov 11, 2005). Copyright 2005 by The Bureau of National Affairs, Inc. (800-372-1033). http://www.bna.com Katrina has already spawned a hurricane of lawsuits. These suits include: suits by individuals who claim they were injured by hazardous substances that leaked from storage facilities, refineries, or pipeline facilities; suits by individuals who claim that oilfield production and pipeline activities caused wetland damage that exacerbated the effects of hurricane Katrina; and suits by individuals who claim faulty levees caused the widespread flooding that followed in the days after Katrina made landfall. All of these suits have a common thread: each will require the courts to determine whether the damages sued upon resulted from nature’s fury or human blunder. Louisiana, like many other states, recognizes the general principle that an “act of God” can be a complete defense to liability for negligence and strict liability claims. Louisiana courts have generally used a consistent definition of the term “act of God,” but the application of that definition in the context of a specific event has not always been consistent or clear, particularly when the issue of contributing human fault is at play.
Continue Reading Nature’s Fury or Human Blunder? The ‘Act of God Defense’ in Louisiana
The past twenty years has seen a dramatic increase in the volume of mass tort and other forms of complex litigation. As the volume of litigation has grown, so too have the burdens on the judiciary and the litigants. To address this growing problem, it is imperative that modern adjudicatory tools be adopted to achieve the goal of securing the just, speedy, and inexpensive determination of every action. One such case management tool that has developed in the context of mass tort litigation – but that can be equally effective in other types of litigation – is the Lone Pine Order.
Continue Reading The Lone Pine Order As a Case Management Tool for Complex Litigation
For many years, Louisiana litigators have faced the often confusing issue of what to do when the court hands you an unfavorable interlocutory judgment. Do you file an application for a supervisory writ or do you file an appeal?
Continue Reading To Writ or Not to Writ?
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