Pfizer loses bid to dismiss US off-label whistleblower suit

By Nancy Faigen
Published Online: 07/10/2008

There is now another chapter to the whistleblower suit filed by a former Pfizer executive as it relates to alleged off-label promotion.

US District Judge Patti Saris in Boston refused to throw out completely a suit by Dr Peter Rost – a vice-president of marketing at Pfizer until he was dismissed in 2005 – that contends that Pharmacia (now Pfizer) violated the Federal False Claims Act by fraudulently promoting the human growth hormone, Genotropin (somatropin), for unapproved uses, such as treating short stature in children who did not have growth hormone deficiency and for combating ageing in adults.

The judge will allow Dr Rost to proceed with his allegations of false claims for paediatric uses, but not the other indication. She agrees with Pfizer's contention that allegations of false claims for adult anti-ageing use are deficient, according to the September 18th opinion filed.

"We are pleased that the court significantly limited the claims that Dr Rost can pursue against Pharmacia for its conduct that pre-dated Pfizer's acquisition in 2003," Pfizer said in a statement. The company further noted that the US Justice Department declined to pursue the false claims allegations years ago.

The suit has a long history. It was initially filed in June 2003, and accuses Pfizer's Pharmacia unit of wrongly accepting federal reimbursement for the unapproved uses. Dr Rost alleges that as a result of Pharmacia's practice hundreds and possibly thousands of false claims based on off-label prescriptions were reimbursed by federal Medicaid and other federal health care programmes in violation of the False Claims Act.

The Massachusetts district court dismissed the suit last November on grounds that it failed to specify details of the alleged fraud. A federal appeals court last year overturned the lower court's dismissal of the suit, allowing Dr Rost to file an amended complaint (Scrip Online, November 23rd, 2007).

The amended complaint, filed in January, contends that more than 200 false claims were submitted to both Medicaid and other federal programmes from citizens of Indiana, and covered short statue without growth hormone deficiency and for "small for date". The suit contends that neither of these is a "medically accepted indication" supported by citations in the drug compendia during the time period covered by the action.

In a motion to dismiss the amended complaint filed in February, Pfizer states that Dr Rost's "only significant ‘new' allegation consists of a list that purports to be claims data for Genotropin with ‘short stature' diagnosis codes for certain unnamed Indiana patients." Pfizer argues that this is plainly insufficient under what is known as Rule 9(b) of the False Claims Act, which demands that fraud claims have sufficient specificity. Pfizer further stated: "Because Rost does not plead the who, what, where, when and how of any alleged fraud, his allegations are insufficient as a matter of law under Rule 9(b)". There was also a footnote citing the fact that "Rost cannot escape Rule 9(b)'s requirements by alleging that subsequent discovery might unearth false claims ... the First Circuit held in Karvelas that a 'qui tam relator [whistleblower] may not present general allegations in lieu of the details of the actual false claims in the hope that details will emerge."

But in her September 18th opinion, Judge Saris said that "Dr Rost's amended complaint satisfies Rule 9(b)'s heightened pleading requirement".

The judge added that, for the time being, the Court will permit discovery only relating to the sales and marketing region that includes Indiana. "If the discovery shows that kickbacks were paid to the doctors who then made off-label prescriptions, and that this sales region was following national directives, the court will expand the scope of discovery nationwide," she stated. All fact discovery relating to the Indiana sales region shall be completed by February 15th, 2009, and this will be followed by the filing of expert reports and depositions. Judge Saris said that all motions for summary judgment shall be filed by June 15th, 2009.

Industry watchers have suggested that it is significant that Dr Rost has shown that it is possible to clear Rule 9(b) of the False Claims Act, and proceed toward discovery.

Source.