In This Issue:
- Firm News:
DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards
- Main Article:
Customizing an International Arbitration Clause: Strategies for Success
- Practice Area Notes:
Bankruptcy and Restructuring Update; London Litigation Update; Trademark Litigation Update; and Life Sciences Litigation Update
Complete Appellate Victory for Swiss Re in Synthetic CDO Action; Sentencing Victory for Caviar King; and Major Arbitration Victory for Leading European Energy Company
- Noted with Interest:
The First Amendment and Off-Label Promotion: United States v. Caronia
- Excerpt from First Amendment and Off-Label Promotion: United States v. Caronia:
For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions” — the promotion of drugs for uses that have not received FDA approval — by pharmaceutical manufacturers and their representatives. Suing under 21 U.S.C. §§ 331(a) and 352(f), the “misbranding” provisions of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., the government has claimed that pharmaceutical manufacturers and their representatives may not engage in off-label marketing even though physicians are free to prescribe drugs for non-approved uses. The government has obtained massive settlements based on the threat of such charges, including an agreement last year by one company to pay a $500 million criminal fine and $198.5 million in forfeiture as part of a misdemeanor plea agreement for off label marketing of the prescription drug Depakote. See Press Release, U.S. Department of Justice, Abbott Laboratories Sentenced for Misbranding Drug (Oct. 2, 2012).
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Topics: Amazon, ANDA, Arbitration, Contract Drafting, Drug Manufacturers, Expert Witness, FDA, FDCA, First Amendment, FTC v Actavis, International Arbitration, Life Sciences, Misbranding, Off-Label Promotion, Off-Label Use, Pharmaceutical, Prescription Drugs, SCOTUS, Trademarks
Published In: Alternative Dispute Resolution (ADR) Updates, Bankruptcy Updates, Criminal Law Updates, International Trade Updates, Science, Computers & Technology Updates
DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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