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November issue in PDF format

November 11, 2003

November issue in PDF format

November 10, 2003

November issue in PDF format

November 10, 2003

Addressing the Conflict: FDA vs. Torts

November 10, 2003

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

November 10, 2003

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

November 10, 2003

All the latest FDA news and information you need to know.

Fen-Phen Again

November 10, 2003

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

November 10, 2003

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

November 10, 2003

The latest rulings of importance to you and your practice.

Antitrust Goes Global

November 10, 2003

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 & Toll partner who serves as lead plaintiffs counsel in the case.

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Supreme Court Hears Arguments In Corporate Trademark Infringement Remedy Calculation Case
The business-law issue of whether and when a corporate defendant is considered distinct from its affiliated entities emerged on December 11 at the U.S. Supreme Court, with the justices confronting whether a non-defendant’s affiliate’s revenue can be part of a judge’s calculation of the monetary remedy for the corporate defendant’s infringement of a trademark.
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Navigating AI Risks: Best Practices for Compliance and Security
The most forward-thinking companies embrace AI with complete confidence because they have created governance programs that serve as guardrails for this incredible new technology. Effective governance ensures AI consistently aligns with an organization’s best interests, safeguarding against potential risks while unlocking its full potential.
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What Will 2025 Bring for Legal Tech
It’s time for our annual poll of experts on what they expect 2025 to bring in legal tech, including generative AI (of course), e-discovery, and more.
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AIAs: A Look At the Future of AI-Related Contracts
AI’s rapid market proliferation and regulatory expansion mirrors privacy’s, and businesses should model their contractual AI compliance on the successes of privacy law’s DPA and BAA.
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The Death of SEO: How AI Is Impacting Search, PPC and Cookies
Traditional keyword strategies and ranking tactics are losing ground to a more dynamic approach in which optimizing for search now means optimizing for every platform and user interaction. This evolution is appropriately being called “Search Everywhere Optimization.” The redefined SEO reflects how AI is not just changing how people find information but also how businesses need to think about visibility in an increasingly connected digital ecosystem.
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