Pharmalot: "Peter Rost Wins A Big Round Against Pfizer"

From Pharmalot:

Last February, the controversial gadfly and former Pfizer exec cleared a hurdle in his ongoing whistleblower lawsuit against Pfizer. In a filing, Rost cited approximately 200 instances in Indiana in which Genotropin, a human growth hormone, was marketed by Pharmacia (which was bought by Pfizer) for unapproved uses, such as combating aging in adults and treating short stature in children.

Providing such detail was needed for the case to proceed. And the move signaled two potentially significant developments. One is the long-term implication for Pfizer, should Rost ultimately prevail. The other is that his efforts may serve as a template for other whistleblowers who are similarly stymied by federal judges seeking details that are, otherwise, very hard to come by.

Interestingly, the Department of Justice, which declined to join Rost’s case, filed a statement of interest that was favorable to Rost, citing concerns with overall interpretation of law. Essentially, the DOJ rebutted the key points Pfizer subsequently argued to get the case dismissed. At the time, we wrote the DOJ move may have increased the likelihood the case will proceed toward discovery.

We were correct. A federal judge in Boston denied Pfizer’s motion to dismiss and is allowing Rost to proceed with his allegations of false claims for pediatric uses (but not aging in adults). This is significant not only for Rost, but for others who file whistleblower lawsuits, because he showed that is possible to clear rule 9b of the False Claims Act (here is the ruling).

This refers to fraud claims with “sufficient specificity,” another way of saying a whistleblower must provide very specific info about false claims a drugmaker submitted to the government for payment. This may include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing, a level of detail that can be very hard to obtain, given patient privacy laws such as HIPAA.

“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,” wrote US District Court Judge Patti Saris.