In a Westlaw Today article, Washington, D.C. attorneys analyzed a significant decision by the U.S. Court of Appeals for the First Circuit affirming two former medical device company executives’ convictions related to off-label promotion.
The article summarizes the key aspects of the First Circuit's decision and discusses the implications for government enforcement against medical products manufacturers moving forward.
The authors note the defendants are likely to seek further review from the U.S. Supreme Court, and it is unclear whether the Court would agree with the First Circuit's analysis.
The Supreme Court has recently been receptive to First Amendment arguments, and less deferential to agency regulation, especially when those regulations are not clearly rooted in the statutory text.
The article was authored by life sciences regulatory & compliance partners Kellie Combs and Joshua Oyster, partner and appellate and Supreme Court practice head Douglas Hallward-Driemeier and life sciences regulatory & compliance counsel Beth Weinman.
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