Hagens Berman brought suit against Pfizer and its subsidiary, Parke-Davis, accusing the companies of a fraudulent scheme to market and sell the drug Neurontin for a variety of "off-label" uses for which it is not approved or medically efficacious.
Neurontin is approved for the adjust treatment of epilepsy. The suit alleges that in 1995, Parke-Davis decided that it did not want to undertake the clinical trials that FDA requires in order to approve new uses for the drug and instead created an illegal promotional campaign to get more patients to use Neurontin. More than 80% of the sales of Neurontin are for uses for which the drug has never been proven safe or effective.
The off-label promotion scheme remained hidden until a qui tam complaint filed by a previous Parke-Davis employee was fully unsealed by the United States District Court for the District of Massachusetts in May of 2002. Following the unsealing of the qui tam complaint, multiple federal class actions based upon the newly unsealed information were filed in various jurisdictions. These were consolidated in a federal MDL in front of Honorable Patti B. Saris, and HBSS was appointed Liaison Counsel as well as Co-Lead Counsel representing a class of consumers and third party payors who paid for prescriptions of Neurontin for conditions for which Neurontin was never FDA approved and is not effective.
After years of prolonged briefing and argument, the Court issued an initial ruling on class certification in August of 2007, denying Plaintiffs' motion, but requiring resubmission of papers. In March 2009, after resubmission of class certification briefing, Judge Saris issued a ruling denying class certification for all off-label indications still in the case. Class Plaintiffs moved for reconsideration seeking certification of a class of Neurontin purchasers for a single off-label indication: bipolar disorder. The motion is under advisement with the Court.
Briefing of summary judgment motions was complete in April, 2009.
In the meantime the Court has requested and been provided competing trial plans from Plaintiffs and Defendants and has indicated a decision on the scheduling of a potential bellwether trial involving third party payors will be forthcoming.
Parties moved to approve a $325 million class-wide settlement for third-party payers.
On Nov. 12, 2009, Judge Saris ordered the commencement of a bellwether trial involving Kaiser and specified that "the Court will issue special jury instructions on fact issues so that the findings will have preclusive effect on subsequent litigation." The trial is scheduled to begin on February 22, 2010 in Boston, Massachusetts and is expected to last for four weeks.