Off-Label Promotion Subject of Thomas M. Greene Presentation to ABA Antitrust Law Section
The ABA’s most recent presentation on off-label promotion featured Greene LLP attorney Thomas M. Greene. The panel, which was sponsored by the Health Care and Pharmaceuticals Committee of the ABA Section of Antitrust Law, was entitled “Off-Label Promotion of Pharmaceuticals: Application of the False Claims Act and Consumer Protection Acts to Promotional Strategies.” Audio of the presentation is available here for section members.
Mr. Greene led off the presentation with a discussion of the statutory and regulatory scheme governing the promotion of drugs. After introducing the Food, Drug and Cosmetics Act (FDCA) and the promotion regulations promulgated by the FDA, Mr. Greene went on to discuss the definition of “labeling” and how it relates to the statutory definition of “misbranding” – dissemination of misbranded drugs is a crime under the FDCA. Mr. Greene also discussed the safe harbor for promoting drugs off label through use of reprints of peer-reviewed journal articles and reference publications, and that the safe harbor still prohibits all false or misleading off-label promotion. Mr. Greene’s slides for the presentation are available here (slides 6 through 26).
Toward the end of the presentation, Mr. Greene referred to Neurontin as a compelling story of how the government and private health care organizations have fought back against false and misleading off-label promotion by the pharmaceutical industry. Greene LLP attorneys, including Mr. Greene, handled the very first False Claims Act case to pursue the theory that off-label promotion can cause false claims and can lead to False Claims Act liability. Filed in 1996, the case settled in 2004 for $430 million in civil fines and criminal penalties.
The story of Neurontin is ongoing, however, and is also a tale of how private health care organizations can seek to recover damages for fraudulently-induced off-label prescriptions. The District of Massachusetts is the home of a multi-district litigation concerning the marketing of Neurontin; Mr. Greene is the Chairman of the Plaintiffs Steering Committee in the MDL. One organization, Kaiser Foundation Health Plan, was selected by presiding judge Patti Saris as a bellwether trial. The jury in that trial returned a $47 million RICO verdict which was trebled to $142 million; the consumer protection act in that case, the California Unfair Competition Law, was tried to the judge, who returned a judgment of over $102 million. Efforts to certify a class of the remaining health care organizations has been briefed by Greene LLP attorneys for the First Circuit, with oral argument scheduled for February 6, 2013.
After successfully resolving the Neurontin False Claims Act case against Pfizer, Greene LLP attorneys have pursued other pharmaceutical companies under an off-label promotion theory of recovery. Greene LLP attorneys represented a relator in the Bristol-Myers Squibb case concerning the drug Abilify which settled in 2007 for $519 million, as well as the relators in the Detrol case against Pfizer, whose case was settled for $14.5 million in 2011 without government intervention.