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November issue in PDF format
November issue in PDF format
November issue in PDF format
Addressing the Conflict: FDA vs. Torts
Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world.
Eli Lilly Joins Others in Limiting Sales to Canada
In October, Eli Lilly and Co. became the latest drug manufacturer to announce that it will begin limiting quantities of pharmaceutical products shipped to Canadian wholesalers.
News from the FDA
All the latest FDA news and information you need to know.
Fen-Phen Again
Nearly 83,000 Fen-Phen users, including those whose claims have already been approved, may have their payments delayed or denied due to a new scheme instituted by the trustees of the Wyeth Settlement Trust, according to a lawsuit filed Nov. 5 by New York City-based law firm Napoli, Kaiser, Bern & Associates. The suit was filed on behalf of several individuals who are awaiting payment of damages from the trust, formerly known as The American Home Products Settlement Trust.
The Off-Label Divide
Is it ever appropriate for a drug manufacturer to disseminate information about an off-label use of a drug? If so, when is it inappropriate? Is the dissemination of such information commercial speech protected by the First Amendment that cannot be proscribed by the FDA? Can manufacturers be held accountable for this speech by the FDA or in a products liability action?
Case Briefing
The latest rulings of importance to you and your practice.
Antitrust Goes Global
Billions of dollars in potential awards, a new map for antitrust litigation, and what many say is a likely spot on the Supreme Court docket; <i>Empagran v. F. Hoffman-LaRoche</i> has it all. What could it mean for U.S. pharmaceutical (and other) companies? "Corporations in this country and all over the world are really scared of this," says Paul Gallagher, a Washington D.C.-based Cohen, Milstein, Hausfeld &amp; Toll partner who serves as lead plaintiffs counsel in the case.

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  • The 'Sophisticated Insured' Defense
    A majority of courts consider the <i>contra proferentem</i> doctrine to be a pillar of insurance law. The doctrine requires ambiguous terms in an insurance policy to be construed against the insurer and in favor of coverage for the insured. A prominent rationale behind the doctrine is that insurance policies are usually standard-form contracts drafted entirely by insurers.
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  • Abandoned and Unused Cables: A Hidden Liability Under the 2002 National Electric Code
    In an effort to minimize the release of toxic gasses from cables in the event of fire, the 2002 version of the National Electric Code ("NEC"), promulgated by the National Fire Protection Association, sets forth new guidelines requiring that abandoned cables must be removed from buildings unless they are located in metal raceways or tagged "For Future Use." While the NEC is not, in itself, binding law, most jurisdictions in the United States adopt the NEC by reference in their state or local building and fire codes. Thus, noncompliance with the recent NEC guidelines will likely mean that a building is in violation of a building or fire code. If so, the building owner may also be in breach of agreements with tenants and lenders and may be jeopardizing its fire insurance coverage. Even in jurisdictions where the 2002 NEC has not been adopted, it may be argued that the guidelines represent the standard of reasonable care and could result in tort liability for the landlord if toxic gasses from abandoned cables are emitted in a fire. With these potential liabilities in mind, this article discusses: 1) how to address the abandoned wires and cables currently located within the risers, ceilings and other areas of properties, and 2) additional considerations in the placement and removal of telecommunications cables going forward.
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