Greene LLP Plays Critical Role in Ground-Breaking $142 Million Jury Verdict Against Pfizer
A federal jury sitting in Boston ordered drug-maker Pfizer, Inc. to pay $142 million in damages for the fraudulent marketing of the drug Neurontin to Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals. After a month-long trial, the jury of Massachusetts residents found that Pfizer, the world’s largest drug manufacturer, committed fraud in violation of the Racketeer Influenced and Corrupt Organizations (RICO) Act with its marketing of the drug Neurontin for various off-label uses that turned the antiepileptic drug into an unexpected blockbuster. The verdict represents the first RICO verdict against a pharmaceutical manufacturer.
Tom Greene, along with his Greene LLP colleagues, played a crucial role in uncovering Pfizer’s fraud. Their work included amassing a mountain of evidence demonstrating how Pfizer fraudulently marketed Neurontin. Greene LLP worked with internationally recognized experts, including the former head of the FDA, Dr. David Kessler, as well as the current head of the US Cochrane Group, Dr. Kay Dickersin, to show how Pfizer’s actions were fraudulent, unscientific and unethical. These experts testified that the rigorous, scientific evidence demonstrated that Neurontin was no more effective than a placebo for several specific off-label uses, including bipolar disorders, migraines, general neuropathic pain outside of the FDA-approved indication for postherpetic neuralgia (PHN), and that Neurontin had no greater efficacy for any indication at dosages above 1800 mg per day. Nearly all of this evidence came from Pfizer’s own research files. However, the jury found that Pfizer fraudulently concealed or distorted this evidence, while it aggressively marketed Neurontin in partnership with various medical marketing vendors. Dr. Dickersin’s testified: “What was published was not what happened.” During the ten-year period that Pfizer and Parke-Davis actively marketed Neurontin, off-label use skyrocketed, quickly dwarfing Neurontin’s use for its FDA-approved indications.
One of the central themes throughout the trial was the importance of evidence-based medicine. In the closing, Tom Greene argued:
The heart of evidence-based medicine is the evidence, but the soul of evidence-based medicine, the soul is the validity of that evidence. And when the validity of the evidence is corrupted by lies and misrepresentations, as was done in this case, then physicians can no longer trust and rely on the validity of the evidence.
After the verdict was returned, Greene said that the verdict represented a “triumph for evidence-based medicine over marketing-based medicine.”
For more information, please see Bloomberg’s article “Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud.” For more information about the selective publication of trials related to Neurontin, please see this article published in the New England Journal of Medicine in November 2009 and authored by Dr. Dickersin and several other researchers in the field of publication bias.
Tags: Drug Fraud