Archive for February, 2011

Thomas M. Greene Leads Seminar on Off-Label Promotion at Johns Hopkins University

Wednesday, February 16th, 2011

On February 9, 2011, Greene LLP attorney Thomas M. Greene led a seminar hosted by the Center for Clinical Trials at the Bloomberg School of Public Health.  The seminar drew from Mr. Greene’s experience with Neurontin litigation.  Open to all students at Johns Hopkins University, the seminar was entitled “How Industry Distorted the Scientific Evidence and Turned ‘Snake Oil’ Into a $10 Billion Blockbuster: Lessons for Public Health.”

Mr. Greene was invited by Dr. Dickersin to illustrate to public health students how a pharmaceutical company can enjoy enormous success through marketing messages that are not based in scientific evidence.  “It’s important to show future public health professionals just how easy it is for a pharma company to perpetrate a fraud this expansive,” said Greene.  “That fraud took years of dedicated effort to expose.  The Neurontin litigation was a true example of collaboration between medical doctors and experienced litigators, to ensure that the medical literature, the evidence base physicians most rely on, remains untainted by fraudulent marketing messages.”

In 2010, Mr. Greene tried a RICO case against Pfizer that centered on fraudulent off-label promotion of the drug Neurontin, leading to a $47 million dollar verdict that was automatically trebled and a $102 million judgment under the California Unfair Competition Law.  Dr. Kay Dickersin’s research and testimony were essential to the RICO case.  She reviewed Pfizer’s clinical trial research reports and compared them to the medical journal articles that were supposed to describe the results of the research, revealing a systematic scheme to show efficacy for off-label uses by suppressing negative results and misrepresenting others as positive.  Dr. Dickersin published her research on Neurontin research and publication practices in the New England Journal of Medicine, as senior author of the article entitled Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use.

Experts like Dr. Dickersin and Dr. David Kessler, former Commissioner of the FDA, were crucial to the RICO case’s success – but the jury verdict also would not have been possible without the investigative lawyering spearheaded by Greene LLP attorneys over a fourteen year period.  For attendees of the Johns Hopkins seminar, Mr. Greene carefully described the off-label strategy of Pfizer and its predecessors and the methods by which the company converted its illegal strategy into billions in off-label sales.  Mr. Greene pointed out several poignant documents uncovered by his firm during discovery, including the email in which a Pfizer employee stated: “Gabapentin is the ‘snake oil’ of the twentieth century.  It has been reported to be successful in just about everything that they have studied.”

Mr. Greene was grateful for the opportunity to speak to Johns Hopkins students about Neurontin, but cautioned everyone who attended that if they were to experience off-label marketing practices in the future first-hand, those practices might not look exactly like the fraud he had illustrated.  “I wanted to be sure those students knew that they will have to be on guard,” said Greene.  “The Franklin False Claims Act case that I settled in 2004 was the first time that a pharmaceutical company was held accountable for off-label promotion.  Since then, it doesn’t seem to me like companies have stopped promoting their drugs off label; they’ve just gotten more clever about it.  Staying one step ahead is the challenge that faces attorneys and public health professionals in the future.”