The Newest Twist in the State Regulation of Off-Label Marketing

By Zack Buck

The newest chapter in the legal drama involving Johnson & Johnson, Inc. (“J&J”) and its subsidiary Janssen Pharmaceutical, Inc. (and a subsidiary previously known as Ortho-McNeil-Janssen Pharmaceuticals, Inc.) (“Janssen”) was written late last month. Specifically at issue was whether or not the alleged off-label marketing of its blockbuster antipsychotic Risperdal violated state anti-fraud and consumer protection statutes. In late February, the South Carolina Supreme Court upheld a jury verdict finding for the state under the South Carolina Unfair Trade Practices Act (“SCUTPA”), but reduced the damages award from $327 million to $136 million. In a series of cases at the state level involving the marketing of Risperdal, this is the first time that a jury verdict against J&J/Janssen has been upheld by a state supreme court. Cases in Pennsylvania, Arkansas, West Virginia, and Louisiana have ended with verdicts for the pharmaceutical company.

I’ve been following these cases for years and have undertaken further analysis on the topic here. Of course, news headlines have been dominated by the startling penalty amounts states had sought—and, in some states, had been initially imposed. Most noteworthy, an Arkansas jury imposed a $1.2 billion fine before the Arkansas Supreme Court reversed the finding; in Louisiana, the fine was $330 million before its state supreme court did the same. Indeed, these litigated claims are in addition to settled claims—the largest of which were entered into by J&J with the federal government and various states for $2.2 billion in 2013.

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Introducing New Blogger Zack Buck

Isaac BuckIsaac D. (“Zack”) Buck is joining Bill of Health as a regular contributor.

Zack is an assistant professor at Mercer University School of Law in Macon, Georgia, where he teaches torts and various health law courses.  His scholarship focuses on how the enforcement of health care fraud and abuse laws impacts American quality of care.  In 2013, he was selected as a Health Law Scholar as part of the ASLME Health Law Scholars Workshop at Saint Louis University School of Law, and he has participated in the new scholars programs at both AALS and SEALS.

Before joining Mercer, Professor Buck was a visiting assistant professor at Seton Hall University School of Law in Newark, New Jersey, where he taught bioethics, mental health law, and health care fraud and abuse.  He also has served as a visiting professor at Hamline University School of Law in St. Paul, Minnesota, where he has taught health care fraud and abuse.  He formerly practiced law at Sidley Austin LLP in Chicago.  Zack holds a J.D. from the University of Pennsylvania Law School, where he served as an Arthur Littleton and ­­H. Clayton Louderback Legal Writing Instructor and an associate editor of the University of Pennsylvania Journal of International Law.  He also holds a Masters of Bioethics from the University of Pennsylvania School of Medicine Center for Bioethics and a B.A. with highest distinction from Miami University (OH).

Recent publications: