In a May 13, 2009, order, U.S. District Court Judge Patti B. Saris denied the plaintiffs’ motion for class certification in a lawsuit alleging that Warner-Lambert and Pfizer (which acquired Warner Lambert in 2000) engaged in fraudulent off-label promotion of the drug Neurontin.1 Jim Rouhandeh and Ted Polubinski of Davis Polk & Wardwell, counsel for Pfizer, retained Cornerstone Research and Dr. Michael C. Keeley, a senior vice president of Cornerstone Research, to evaluate opinions offered by the plaintiffs’ retained economists on causation, injury, and damages.
The plaintiffs’ experts claimed damages exceeding $4.6 billion based in part on an econometric causation model that sought to relate “detailing” promotion, whether improper or not, to off-label prescriptions. The plaintiffs’ causation expert claimed that the model showed that detailing, the practice of pharmaceutical company representatives visiting doctors, caused virtually all prescriptions to be written for certain off-label indications and assumed that virtually all detailing was off-label. Dr. Keeley explained that detailing was not the only or even the primary factor causing patients to take Neurontin for off-label indications and that there was no basis for the assumption that virtually all detailing was off-label. Dr. Keeley noted that detailing could not be the only factor causing prescriptions to be written because many physicians had not been subject to any detailing. Dr. Keeley showed that plaintiffs’ econometric causation model was deeply flawed and produced results that had no scientific validity in part because it failed to consider factors other than promotion that contributed to physicians’ prescribing decisions. He demonstrated that the model results changed dramatically after correcting for some of these omissions and that the model no longer showed that promotion was the main factor causing off-label prescriptions to be written.
Judge Saris found that plaintiffs’ analysis “does not take into account any factors [other than promotion] that may have led doctors to prescribe Neurontin for off-label indications” and that the statistical findings of the plaintiffs’ expert were not “sufficient to certify any of the indication-specific Consumer subclasses.” Judge Saris further concluded that the plaintiffs’ analysis “does not suffice to defeat the predominance challenge” because “many doctors were not detailed, and even if they were, plaintiffs would have to demonstrate doctor-by-doctor that defendants’ fraudulent misrepresentations…caused the doctor to prescribe the medication.”
1 Judge Saris’s decision follows a decision by Judge Bernstein to decertify a class in a related case in Pennsylvania state court which was described in a March 5, 2009, Cornerstone Research Update.