Portfolio Media, New York (May 13, 2008)--The government has weighed in on Pfizer Inc.'s bid to dismiss a whistleblower lawsuit filed by a former executive alleging that the company illegally marketed human growth hormone Genotropin.
Under the False Claims Act, a complaint need not allege that the defendants made a false statement but merely that they caused a third party to make a false statement to get a false claim paid, said the motion filed Monday in the U.S. District Court for the District of Massachusetts.
"A statement urging a physician to prescribe a drug for an unapproved, off-label use could well amount to a half-truth and satisfy the false statement requirement ... where, for example, the drug sales representative fails to mention that the evidence does not support the drug's efficacy for the use he or she is promoting or the FDA has specifically concluded that the drug is not safe or effective for that use," the complaint said.
The government also said Pfizer is seeking too rigid a pleading standard when it contends that the amended complaint fails because it doesn't make specific false claims or do so with sufficient particularity.
However, the motion said that the U.S. was submitting the brief only to put forward its position on how to interpret and apply certain aspects of the Medicaid Act and the FCA. The government was not taking a position on the sufficiency of the complaint.
The suit brought by Dr. Peter Rost was given new life in November when the U.S. Court of Appeals for the First Circuit said that while he didn't meet the proper pleading requirements in his qui tam lawsuit, he should have been given an opportunity to amend his complaint.
The U.S. District Court for the District of Massachusetts had tossed the qui tam case in September 2006 for lack of jurisdiction.
In the False Claims Act suit filed in June 2003, Rost, a former Pfizer marketing vice president, accused Pfizer and its unit Pharmacia Corp. of off-label marketing for Genotropin, which allegedly boosted the company's sales by as much as $50 million in 2002 alone.
Rost claimed many of those sales came at the expense of the government through Medicaid, which generally does not give reimbursements for off-label uses.
Rost based his case on information from Pfizer and Pharmacia's marketing methods, but the district court found that Rost's case was only speculation.
The circuit court agreed with the lower court, saying that Rost's original complaint did not meet the pleading requirements but he should have been given a chance to amend.
Rost did so in January.
Pfizer and Pharmacia promptly moved to dismiss the complaint again, saying the amended complaint largely repeated the allegations that were already held to be deficient.
The government's brief filed Monday was in response to wrangling over the pending dismissal motion. The judge in the case also just allowed the Washington Legal Center to file a motion in support of the defendants' dismissal bid.
Mark I. Labaton, a lawyer with Kreindler & Kreindler LLP and counsel for Rost, said that the government's brief supports their position and shows that the issues raised in the case are important from a public policy standpoint.
A lawyer for Pfizer didn't immediately respond to a request for comment Tuesday.
A hearing on the motion to dismiss is scheduled for Monday.
Rost's suit was unsealed in November 2005 after the U.S. decided not to intervene in the case. Rost, who began working for Pharmacia in 2001, based his claims on several alleged practices by the drug companies.
Rost was fired from Pfizer in December 2005 after his complaint was unsealed. His allegedly wrongful termination became the subject of a separate lawsuit filed the same month in the U.S. District Court for the Southern District of New York.
The suit also resulted in a criminal investigation conducted by the U.S. attorney's office in Massachusetts. In April 2007, the office announced that Pfizer would plead guilty and pay a fine for violating an anti-kickback statute through Genotropin-related payments to doctors.
Pfizer paid $34.7 million to resolve Genotropin-related investigations conducted by the Department of Health and Human Services, the Department of Justice and the FBI.
Genotropin is FDA-approved for the treatment of children with hormone-related growth failure or with Prader-Willi Syndrome, and adults with growth hormone deficiency.
Rost is represented in this matter by Kreindler & Kriendler LLP.
Pfizer is represented in this matter by Covington & Burling LLP.
The district case is USA v. Pfizer Inc. et al., case number 1:03-cv-11084, in the U.S. District Court for the District of Massachusetts.
--Additional reporting by Erin Marie Daly and Ron Zapata
