The Off-Label Use of POM Wonderful: Using Section 43(a) to Eliminate Misleading Off-Label Drug Promotion

• Published in: Washington and Lee law review Vol. 75; no. 1; pp. 593 - 646
• Main Author: Hurley, Christopher A
• Format: Journal Article
• Language: English
• Published: Lexington Washington & Lee University, School of Law 01-01-2018
• Subjects: Advertising; Drugs; Enforcement; FDA approval; Federal regulation; First Amendment-US; Hit & run accidents; Jurisdiction; Lanham Act 1946-US; Litigation; Marketing; Medical equipment; Medical treatment; Pharmaceutical industry; Side effects; United States > US
• ISSN: 0043-0463; 1942-6658

On his way home from the hospital with his newborn son, a hit-and-run accident left Jeremy Lew with a severely injured spine. Lew underwent surgery, during which his doctor implanted a device approved by the Food and Drug Administration (FDA) between his cervical vertebrae. The treatment initially appeared successful, but Lew later began suffering from "unrelenting" pain, barely able to pick up his children. Although the FDA approved the device, the agency intended it for use only in the mid-to-lower spinal column. The off-label use of the medical device caused Lew unimaginable pain as a result of his nerve injury, and could have further caused sterility, infection, or urinary problems. Advocates of off-label medication use tout highly successful treatments that have saved lives even when approved treatments have failed. Typically, the FDA weighs a medication's benefits against potentially harmful side effects as part of its New Drug Application process, established by the Food, Drug, and Cosmetic Act.