"PFIZER WHISTLEBLOWER CHALLENGES CLAIM DISMISSAL"

Health Law360:

PFIZER WHISTLEBLOWER CHALLENGES CLAIM DISMISSAL

"The DOJ said that the legal issues in the case could have a substantial impact on the scope of the False Claim Act’s jurisdictional bar and the pleading requirements for complaints, and said consultations between the affected agencies must take place in order to determine whether an amicus brief will be filed."

--A former marketing vice president at Pfizer Inc. is appealing the dismissal of his whistleblower lawsuit accusing the pharmaceutical giant of illegally marketing a successful biotechnology drug, human growth hormone Genotropin.

The appeal, filed by Dr. Peter Rost in the U.S. Court of Appeals for the First Circuit on March 15, challenges the decision of the U.S. District Court for the District of Massachusetts to toss the action last September for lack of jurisdiction.

Rost was in charge of worldwide marketing for Genotropin, a recombinant, or manmade, human-growth hormone. The U.S. Food and Drug Administration approved Genotropin to treat certain hormonal deficiencies in children and adults.

However, Pharmacia Corp., the Peapack, N.J.-based subsidiary Pfizer bought in 2003, began marketing and selling the drug for other uses, such as increasing growth in short children and delaying the aging process in adults.

Rost filed his lawsuit in June 2003, alleging violations of the False Claims Act by New York-based Pfizer and Pharmacia. According to Rost, who began working for Pharmacia in 2001, Pfizer’s off-label marketing for Genotropin boosted the company’s sales by as much as $50 million in 2002 alone.

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.

Pfizer filed a motion to dismiss Rost’s case on Aug. 30, arguing that his complaint lacked subject matter jurisdiction and failed to plead fraud with particularity.

Specifically, Pfizer said the court couldn’t entertain the suit because it was based on facts the company had already disclosed to the government.

U.S. District Judge Joseph Tauro agreed, finding that Rost’s complaint failed to identity an actual false claim that was submitted to the government for the reimbursement of an off-label prescription of Genotropin.

Tauro found that Rost simply speculated that Pfizer’s marketing activities caused physicians to prescribe Genotropin for off-label uses and that federal and state government health care programs reimbursed some of the prescriptions.

But Rost, who had vowed to appeal the September ruling, has refused to go down without a fight, and has renewed his claims that federal and state public health care programs paid not just one but many claims for improper off-label use of Genotropin sold as a result of Pharmacia’s illegal marketing campaign.

“Pfizer may dispute the number of claims submitted to governmental entities, the total amount of the claims or the proportion of claimants who took Genotropin for unapproved uses,” the appeal states. “They may even dispute whether Pfizer continued these practices after it acquired Pharmacia. But this much is certain: Pharmaceia turned Genotropin into a cash cow by illegally peddling a dangerous drug to make short kids tall and their grandparents young.”

The appeal argues that Pfizer is “well aware” that such claims were submitted because it keeps insurance claims information for the 30,000 Genotropin patients in its computer database.

Simultaneously with Rost’s filing, the U.S. Department of Justice on March 15 moved for a thirty day extension of time to file an amicus curiae brief in the case by April 26.

The DOJ said that the legal issues in the case could have a substantial impact on the scope of the False Claim Act’s jurisdictional bar and the pleading requirements for complaints, and said consultations between the affected agencies must take place in order to determine whether an amicus brief will be filed.

Rost, reached by e-mail on Wednesday, pointed out that he had overcome three of four hurdles in his lower court case, and the fourth hurdle was “essentially a technicality.”

“This particular [court] requested a specific false claim on a specific patient to be submitted,” Rost said. “That is a very tough hurdle to overcome, and quite frankly, if that would be applied to all false claims cases in the future, there will never be a drug company again convicted in the First Circuit."

Rost added that it would be illegal to obtain this information under the patient privacy protections as part of the Health Insurance Portability and Accountability Act of 1996, leading to “a catch-22 situation.”

“If the district court ruling is not overturned, the False Claims Act is all but dead as far as drug companies are concerned in the First Circuit,” he said. “There is also a bigger issue at stake here: With today's highly charged political climate within the Justice Department, what they actually do one month from now will say a lot about the government's interest in prosecuting big company fraud.”

Pfizer spokesperson Bryant Haskins said the company could not comment on pending litigation but noted that the district court "dismissed Rost's case in its entirety," adding that Pfizer is confident the appellate court will do the same. Attorneys representing Pfizer could not immediately be reached for comment.

Rost is represented in the matter by Kreindler & Kriendler LLP. Pfizer is represented by Covington & Burling LLP.

The appellate case is USA ex rel Dr. Peter Rost v. Pfizer, case number 06-2627, in the U.S. Court of Appeals for the First Circuit.

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 Erik Larson

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