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?
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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; Empagran v. F. Hoffman-LaRoche 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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Expert testimony can be the linchpin that makes or breaks a case. But lawyers have had a tougher time getting that testimony admitted since 1993, when the U.S. Supreme Court decided in Daubert v. Merrell Dow Pharmaceuticals that scientific testimony must be not only relevant, but reliable. In 1999's Kumho Tire v. Carmichael, the Court extended that rule to all experts. This means that a lawyer preparing to qualify or challenge an expert at trial must answer a number of questions. What is the state of the case law under Daubert? How has the particular court or judge applied the rule? How have courts ruled on this type of expertise? Has this expert ever come before a judge?
No 'Magic Bullet,' Says Task Force The FDA's Counterfeit Drug Task Force issued its interim report on October 2. It contains potential options for a multi-pronged approach to combat counterfeit drugs. In recent years, the FDA has seen an increase in the number and sophistication of efforts to introduce counterfeit drugs. The FDA noted at the time the report was issued that the problem of counterfeit drugs is being treated separately from the problem of unapproved and potentially unsafe drugs that are being imported via the Internet and other unregulated international channels. Under current law, those drugs are purchased outside of U.S. and foreign consumer protection systems, so they are "buyer beware" products that have traveled outside of the regulatory protections of the legal U.S. drug distribution system.
The State of the Re-Importation Debate When Gov. Rod R. Blagojevich of Illinois announced in mid-September that his state was considering buying drugs from Canada for its employees and citizens, the debate over cross-border drug purchases via the Internet and by other means, got even hotter than it was before. The pharmaceutical industry is fighting a battle similar in scope to the music industry's Internet copyright infringement war, but because no suits have been brought against 80-year-old diabetics buying insulin from pharmacies in Montreal, national debate on the issue of the purchase of foreign drugs has gotten less press of late than the debate over music piracy.
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