Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues

November 1, 2016By: Andrew J. Hull & Anne K. Walsh Download PDF

A problematic decision from the Ninth Circuit appears to impermissibly grant the FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. The court affirmed the felony conviction and 48-month imprisonment of Dr. Michael Stanley Kaplan, a Nevada urologist, for conspiracy to commit adulteration under the Federal Food, Drug, and Cosmetic Act (“FDC Act”). United States v. Kaplan, No. 15-10241, 2016 WL 4709870 (9th Cir. Sept. 9, 2016). We hope other courts recognize this decision for what it is, a bad set of facts that led to bad law.

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