Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
FDA's Failure-to-Warn Pre-emption
Nearly one year after the U.S. Food and Drug Administration issued a pre-emption on filing failure-to-warn actions over federally approved drugs, rulings across the nation show a clear division over the issue.
The FDA declared that it possessed the pre-emptive power in the preamble to new rules for drug labeling issued on June 30, 2006. The pre-emption attempts to ban plaintiffs from filing the lawsuits if the drug has FDA approval. Plaintiffs' attorneys call the FDA pre-emption camouflaged tort reform, while defense counsel argue that a qualified arm of the federal government should call the shots on drug safety ' not judges and juries.
While some courts have upheld the FDA's pre-emption, others have rejected it. (Because of the diversity of the parties involved in the suits, these state tort claims are being filed in federal as well as state courts.) In Pennsylvania, a failure-to-warn lawsuit over the suicide risk of Paxil' and the generic version of Paxil is now on appeal in the Third U.S. Circuit Court of Appeals after a trial court upheld the drug maker's pre-emption argument, despite a husband's claims that the drug company's failure to warn about suicide risks caused his wife to kill herself with a razor. Colacicco v. Apotex Inc., No 05-cv-5500 (E.D. Pa.). A similar case is on appeal in the Fifth Circuit, where pre-emption also was upheld despite a widow's claims that fuller warning about the possible side effects of the antidepressant Effexor' would have affected the doctor's decision to prescribe the drug to her husband, who committed suicide. Ackermann v. Wyeth Pharmaceuticals, No. 4:05CV84 (E.D. Texas).
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- 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
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
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.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
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.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.