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Supreme Court to Confront FDA Pre-emption and the Consequences of 'Overwarning'
In 2008, the U.S. Supreme Court will likely decide a key question that has driven FDA pre-emption debates over the past decade: whether ' as plaintiffs' counsel maintain ' warning labels for FDA-approved drugs and medical devices provide only 'minimum standards,' or whether ' as the FDA insists ' they provide a balanced judgment of the FDA, setting both a floor and a ceiling on safety warnings. This article reviews the legal issues facing the Court in a series of FDA pre-emption cases before it. It then discusses the central flaw in plaintiffs' 'minimum standards' argument, drawing on a series of recent scientific and medical developments that highlight how 'overwarnings' can have significant, real-world, adverse consequences with respect to public health.
FDA Pre-emption Issues Currently Facing the Supreme Court
In 2008, the Supreme Court is poised to issue two and perhaps three pre-emption decisions that will have long-lasting implications for the future of state tort litigation involving FDA-approved prescription drugs and medical devices. In Riegel v. Medtronic Inc., No. 06-179 (argued Dec. 4, 2007), the Court will decide whether plaintiffs may sue manufacturers of Class III medical devices under state tort law for product designs and labeling approved by the FDA through its rigorous PMA review process. In Warner-Lambert Co., LLC v. Kent, No. 06-1498 (cert. granted Sept. 25, 2007), the Court will decide whether its 2001 opinion in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) that fraud-on-the-FDA claims are pre-empted applies to plaintiffs' use of such claims to fall within exceptions to statutory bars to state tort or punitive damages claims relating to FDA-approved products. In Wyeth v. Levine, No. 06-1249 (pet. for cert. pending), the Court may address the most hotly contested issue of all ' whether and under what circumstances state tort law claims against prescription drug manufacturers impermissibly conflict with and are pre-empted by FDA approval of prescription drugs and their labeling.
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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.