(CN) - Although Pfizer admitted that fraudulent marketing produced 65 percent of all Bextra prescriptions, a health insurance provider cannot use statistics to accuse the drugmaker of a multimillion fraud, a federal judge ruled.
The Food and Drug Administration approved the anti-inflammatory drug Bextra as a treatment for arthritis and painful menstruation, but the drug was withdrawn from the market in 2005 after it was found to substantially increase the risk of heart attack.
Since Pfizer had also illegally marketed the drug as a pain reliever, the Justice Department fined
Pfizer $2.3 billion - the largest criminal fine ever imposed in the United States.
In 2008, Pfizer agreed
to pay an additional $894 million to settle 90 percent of Bextra-related actions with consumers and third-party providers.
Choosing to independently seek civil damages, however, Health Care Service Corp. opted out of this settlement.
The insurer says it paid more for Bextra than it would have otherwise paid for a traditional nonsteroidal anti-inflammatory drug.
"It was foreseeable by defendants and the intended consequence of their actions that doctors and pharmacists would prescribe Bextra for unsafe, ineffective, and unapproved uses," according to the second amended complaint. "Defendants' unlawful marketing conduct caused injury to plaintiff in the form of reimbursements."
Finding that the insurer's theory lacked specificity, however, U.S. District Judge Charles Breyer in San Francisco dismissed the case with prejudice.
"The mere fact that prescriptions were written does not prove causation," Breyer wrote. "As explained above, plaintiff must make specific allegations that individual physicians actually relied on these misrepresentations in writing the challenged prescriptions. As plaintiff has not alleged any first-party or third-party reliance, it has not shown that defendants proximately caused this injury under the RICO standard."
Pfizer has admitted that approximately 65 percent of Bextra prescriptions were the result of fraud, but this "figure pertains to all prescriptions of Bextra, not only to those paid for by plaintiff," Breyer wrote.
"Without more specific allegations of reliance by physicians whose prescriptions plaintiff reimbursed, there is no way to know if any of those prescriptions resulted from the deception," he added.
The court also found that the insurer's quantity-effect theory for causation "is unpersuasive because it requires too much speculation."
For the same reason, Breyer also rejected the claim that about overpaying for Bextra.
"Generalized proof of reliance by doctors cannot complete the causation chain," he wrote, quoting precedent.