Whistleblower Attorney Bob Thomas is once again leading a law school seminar on “Health Care Fraud and Abuse” at Boston University, with second and third year law students digging into the False Claims Act, the Anti-Kickback Act, Stark I and II, and “off-label” misbranding and adulteration under the Food Drug and Cosmetic Act (“FDCA”), as well as many of the strategic and practical questions that come up for attorneys practicing in this area. The course offers law students a view into this dynamic area of the law, where new case law is made every week, and where one can start to imagine a variety of different career options within the field.
Each week for the first half of the seminar, students are given a short writing assignment to answer a bothersome question that comes out of the reading – usually one that arises from one of Mr. Thomas’ qui tam cases. In addition, each student will do at least one class presentation on a subject matter area.
This past week, the seminar explored the misbranding and adulteration theories under the FDCA, and how those violations can fall within the ambit of the False Claims Act (with its treble damages and penalties enhancements). The Glaxo Cidra case served as a case study, with its $750 million settlement.
Another topic that was explored under the FDCA was the hot topic of compounding. As you may know, compounders for too long managed to dodge federal oversight by posing as mere pharmacies, until the sad saga of New England Compounding put an end to the obfuscation. Now, a new compounding law passed by Congress specifically requires compounders to register with the Food and Drug Administration and submit to its jurisdiction or formally seek a written waiver. Revealingly, in the months since the law was passed, the FDA has been on a tear visiting these sites, and finding quite a few violations that consumers would want to know about. Right on cue, a USAToday article just came out summarizing this history, as the once lightly regulated industry now gets used to complying with stricter federal oversight.
It’s enjoyable to be working in a field that is so highly relevant and fluid, something the law students appreciate quickly from the content of the seminar.