Case Tried by Greene LLP Leads to $95 Million in Damages for Fraudulent Off-Label Promotion of Neurontin, the “Snake Oil of the Twentieth Century”
On November 3, 2010, the federal district court in Massachusetts ordered Pfizer to pay Kaiser Foundation Health Plan and Kaiser Foundation Hospitals more than $95 million for violations of the California Unfair Competition Law in connection with its marketing and promotion of its epilepsy drug Neurontin. In her 146-page opinion, Judge Patti Saris found that “Pfizer fraudulently marketed Neurontin by showcasing positive information about Neurontin’s efficacy in the published literature, while suppressing negative evidence” and that “there is little or no scientifically accepted evidence that Neurontin is effective” for the treatment of bipolar disorder, various pain conditions, or migraine.
The Court’s ruling is the result of a five-week trial where Kaiser claimed it had been misled into paying for tens of millions of dollars of Neurontin prescription for off-label uses because Pfizer fraudulently overstated Neurontin’s effectiveness. Kaiser claimed that Pfizer suppressed clinical trial tests that showed that Neurontin was not effective for the treatment of neuropathic pain, bipolar disorder, migraine headaches, or in doses above its FDA-approved level. It also claimed that Pfizer had intentionally caused misleading articles about Neurontin to be published reputable medical journals, and that it had deceived Kaiser regarding medical research in its direct communications with Kaiser and its physicians.
In her findings, Judge Saris observed that one Pfizer employee termed Neurontin “the snake oil of the twentieth century” in reference to the drug’s claimed effectiveness for numerous off-label uses. Examining more than 20 clinical trials sponsored by Pfizer and two predecessors, the Court found that there was “little or no scientifically accepted evidence that Neurontin is effective for the treatment of bipolar disorder, neuropathic pain, nociceptive pain, migraine, or doses greater than 1800 mg/day.” The Court found that some of the negative studies were never published; others were published in obscure journals. In still other cases primary negative outcomes were suppressed while favorable secondary outcomes were reported.
The Court held that Pfizer had a duty to disclose scientific data demonstrating the lack of efficacy of Neurontin for off-label uses. Pfizer was required to provide this information because it was marketing the drug for unapproved uses by disclosing positive information about the drug while suppressing negative information in its possession. With respect to its failure to disclose the results of clinical trials on bipolar disorder, Judge Saris determined that Pfizer’s conduct was “particularly outrageous” because “there was not a scrap of evidence supporting efficacy” and that “there were actual negative side effects of depression.”
The case has significant effects for drug companies who market drugs that are used extensively off-label. The Court stated that “because it is legal for physicians to prescribe drugs off-label, it is imperative that they have accurate scientific information about the medication in the published medical literature. . . .[H]ealth care professionals practicing evidence-based medicine must rely on the integrity of the published literature to determine whether a pharmaceutical product is effective.” The Court found that intentional misrepresentations of medical research and intentional suppression of negative studies constituted “fraudulent business acts or practices” that would “likely deceive a reasonable health plan or reasonable physician.”
Judge Saris concluded that Pfizer conducted an extensive and long-term advertising campaign that was fraudulent and misleading. It implemented this campaign through its publication strategy, its sponsorship of continuing medical education programs, and direct communications to physicians and health plans such as Kaiser. As a result of this fraudulent campaign, Kaiser paid millions of dollars for ineffective medications for its members.
The Court held that Kaiser would not have purchased Neurontin for the off-label indications at issue had it known the truth regarding Neurontin’s efficacy. Accordingly, it ordered Pfizer to pay $65,418,419 in restitution. After adding interest as required by California law, the Court ordered Pfizer to pay Kaiser $95,286,518.
The case was tried in the United States District Court in Boston during February and March of this year. At the conclusion of the trial, a federal jury found that Pfizer’s conduct violated the Racketeer Influenced Corrupt Organizations Act (RICO) and awarded Kaiser $47,363,092 in damages. Under federal law, that amount will be trebled to $142,089,276. The claim under the California Unfair Competition Law, however, was reserved for decision by the trial court. Judge Saris’s November 3, 2010 order was her decision on the remaining statutory claim and her explanation as to why she reached her decision.
Neurontin was originally approved by the FDA in 1993 as an adjunctive therapy for the treatment of partial epilepsy seizures in adults. In the mid-1990s Neurontin’s original sponsor, Parke-Davis, recognized its use as an epilepsy treatment was limited and began to promote Neurontin for bipolar disorder, migraines, and other off-label uses. Pfizer acquired Parke-Davis in 1998. At that time, 87.5% of Neurontin was used for non-epilepsy indications. In 2004, a Pfizer subsidiary pled guilty to guilty to criminal violations of the Food Drug and Cosmetic Act due to the off-label marketing of Neurontin and settled a False Claims Act case brought by Greene LLP for $152,000,000. However, Judge Saris’s findings show that the fraudulent conduct continued well after Pfizer’s acquisition of Parke-Davis.
At the time of trial, Neurontin was still used predominantly for off-label purposes, most notably neuropathic pain. It is believed that this is the first time a federal court has ever ruled that a prescription drug is not effective for the primary uses for which it is prescribed. In reaching these conclusions, the Court based its opinion on the highest quality evidence, following the standards adopted by the FDA and the scientific community at large. Much of this evidence first became public during the March trial.
Regarding the Court’s findings, Thomas M. Greene, a lead trial lawyer for Kaiser, said: “This is a landmark ruling. Judge Saris has chronicled, in rich detail, exactly how Pfizer fraudulently promoted Neurontin through a systematic campaign of misrepresentations and omissions concerning the drug’s efficacy. This ruling also represents a validation of the scientific method for determining whether or not a drug is efficacious.”