United States v. Regenerative Sciences, LLC

878 F. Supp. 2d 248 (2012)

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United States v. Regenerative Sciences, LLC

United States District Court for the District of Columbia
878 F. Supp. 2d 248 (2012)

AR

Facts

Regenerative Sciences, LLC (defendant) was a doctor-formed company that created a procedure using stem cells for orthopedic healing. The procedure involved a doctor taking a tissue sample from a patient, putting that sample in a solution to grow new cells, shipping the solution to a laboratory, having a doctor at the lab inspect the solution, and then ultimately reinjecting the solution back into the patient. The Food and Drug Administration (FDA) sued, arguing that the procedure fell within the meaning of a drug under the Food, Drug, and Cosmetics Act. The FDA claimed that the procedure resulted in an adulterated and misbranded drug. Regenerative responded that they practiced medicine wholly within Colorado and that the procedure was not a drug subject to federal regulation.

Rule of Law

Issue

Holding and Reasoning (Collyer, J.)

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Casebooks

Bioethics
Food and Drug Law
Healthcare Law

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