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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