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Key Pre-emption Ruling in Third Circuit
On April 8, 2008, the Third U.S. Circuit Court of Appeals issued a significant decision concerning the authority of federal regulatory agencies to pre-empt state tort claims, Colacicco v. Apotex Inc., No. 6-5148. The decision, authored by the former chief judge of the Third Circuit, holds that when the Food and Drug Administration (the 'FDA') publicly concludes that a specific warning is unnecessary for a prescription pharmaceutical, state tort law cannot supply a cause of action for failure to include the rejected warning in the product's labeling.
The plaintiffs in the two cases consolidated for appeal were the husband and daughter, respectively, of two adults who committed suicide after taking anti-depressant drugs known as selective serotonin reuptake inhibitors ('SSRIs'). The drugs in question were Zoloft', Paxil', and the generic drug containing the active ingredient in Paxil, paroxetine hydrochloride. The plaintiffs argued that, under state law, the manufacturers should have warned physicians of the association between these drugs and an increased risk of suicidal thoughts and behavior ('suicidality'). The FDA, however, had repeatedly rejected the scientific basis for the warning suggested by the plaintiffs. The defendants argued that the FDA's actions pre-empted the plaintiffs' state-law failure-to-warn claims.
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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.
Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers
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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.
When Is a Repair Structural or Nonstructural Under a Commercial Lease?
A common question that commercial landlords and tenants face is which of them is responsible for a repair to the subject premises. These disputes often center on whether the repair is "structural" or "nonstructural."