Thomas M. Greene and Palko S. Goldman of Greene LLP Co-Author Case Study on Publication Strategy, Reporting Bias in Off-Label Promotion
In a partnership between law and medicine characteristic of Greene LLP, attorney Thomas M. Greene and physician Palko S. Goldman have co-authored an article about Pfizer’s strategy of promoting Neurontin for unapproved indications instead of seeking additional indications from the FDA. The article, published by the peer-reviewed journal Trials, is a case study in how a pharmaceutical company’s selective reporting of clinical trial results can affect medical literature. “No regulatory body vets the clinical trial evidence of a drug’s effectiveness for off-label uses,” said Dr. Goldman. “It is critically important for drug manufacturers to report results for off-label uses in the most unbiased manner possible,” he observed.
Experts in clinical trial methodology at the Johns Hopkins Bloomberg School of Public Health also co-authored the Trials article. Said Goldman, “the medical community recognizes that true and unbiased clinical trial results are vital to prescribing decisions.” The co-authors relied heavily on thousands of documents obtained through sixteen years of litigation spearheaded by attorney Thomas M. Greene, including those from an eight year False Claims Act case settled for $430 million in 2004 without government intervention. As Chairman of the Plaintiffs Steering Committee for the Neurontin Multi-District Litigation centered in Massachusetts, Greene has also pursued cases by private parties against Pfizer, including an ongoing appeal to the First Circuit Court of Appeals and a $142 million RICO verdict for Kaiser Foundation Health Plan.
“Physicians have played an integral role in the Neurontin litigation,” said Greene. “It takes a partnership between attorneys and physicians to piece together an off-label strategy like that of Neurontin, and that’s why someone like Dr. Goldman is so important.” Palko S. Goldman, who has worked with Greene for over six years, helped to lead discovery efforts in Neurontin litigation, in which he and several attorneys sorted through millions of pages of documents.
Involving doctors in all stages of litigation has been a hallmark of Greene LLP’s practice in pharmaceutical cases. “I firmly believe that having a physician intimately involved in the litigation process puts us at an advantage, against defendants but also as compared to other firms,” noted Greene. “We have succeeded where other firms have failed, in large part because Dr. Goldman has seen things that others missed.” Goldman’s presence at the firm, Greene added, is “one of the ways in which Greene LLP is uniquely qualified to handle a variety of cases against pharmaceutical companies.”
Greene LLP is a leader in pharmaceutical litigation, including the representation of qui tam whistleblowers in False Claims Act cases. Its attorneys have nearly twenty years of experience representing whistleblowers, with a track record of successes in health care industry cases. The five attorney firm has worked extensively in False Claims Act cases, and has also held pharmaceutical companies liable under other laws, including RICO and several state statutes.