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BOSTON - (Mealey's) The Massachusetts federal judge overseeing the Neurontin multidistrict litigation on Dec. 10 granted summary judgment against all but two class action plaintiffs after finding no direct evidence that Pfizer Inc.'s off-label marketing influenced prescribing physicians (In Re: Neurontin Marketing, Sales Practices, and Products Liability Litigation, MDL Docket No. 1629, No. 04-10981, D. Mass.).
A company, a health insurer, two union health and welfare funds and six individuals filed class complaints against Pfizer Inc. and predecessor Warner-Lambert Co., alleging that the off-label marketing of Neurontin violated the Racketeer Influenced and Corrupt Organizations Act (RICO) and the New Jersey Consumer Fraud Act, constituted common-law fraud and resulted in unjust enrichment.
The plaintiffs alleged that the defendants' off-label marketing of Neurontin for treatment of bipolar disorder, doses greater than 1,800 milligrams a day and treatment of neuropathic, chronic or nociceptive pain resulted in them paying for prescriptions for ineffective uses of the drug.
Judge Patti B. Saris found that only two plaintiffs -- Gary Varnam and Jan Frank Wityk -- showed evidence that their doctors received fraudulent material from Pfizer: "dear doctor" letters that contained misleading information about a medical journal article about Neurontin and omitted negative information from three other clinical trials. She said that evidence creates a triable issue of fact as to causation.
The remaining four individual plaintiffs produced no evidence that their doctors received or read misleading or fraudulent publications about Neurontin's off-label use, the judge said.
The third-party plaintiffs (TPP) also put forth no evidence as to which doctors, if any, were "tainted" by misleading information such as dear doctor letters or other marketing material, the judge said.
Judge Saris said an analysis by plaintiff expert Dr. Meredith Rosenthal of the correlation between Pfizer's promotional spending and increased Neurontin prescriptions "does not suffice to demonstrate the extent of harm caused by the fraud, as opposed to run-of-the-mill off-label detailing." She noted that the Second Circuit U.S. Court of Appeals recently rejected such "aggregate proof" in overturning a Zyprexa TPP RICO class certification.
"Because the Class TPP Plaintiffs have not directly relied on misrepresentations by defendants, and because they have presented no evidence as to how many or which physicians who prescribed Neurontin to their members relied on fraud, they cannot establish causation," the judge wrote.
[Editor's Note: Full coverage will be in the Dec. 16 issue of Mealey's Emerging Drugs & Devices. In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Document #28-101216-021Z. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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