Pfizer Hit With $1.3B Fine For Bextra Marketing

By Liz McKenzie

Law360, New York (October 16, 2009) -- A federal court has levied a record $1.3 billion criminal fine — the largest ever imposed in the U.S. — against Pfizer Inc. subsidiary Pharmacia & Upjohn Co. Inc. for fraudulently misbranding its anti-inflammatory drug Bextra.

Judge Douglas Woodlock of the U.S. District Court for the District of Massachusetts sentenced Pharmacia to pay a criminal fine of $1.195 billion and a criminal forfeiture of $105 million, a total of $1.3 billion, at a hearing Friday.

The U.S. Attorney’s Office of Massachusetts, which prosecuted the case on behalf of the U.S. government, says it is the largest criminal fine ever issued in the U.S. for any matter.

Pharmacia agreed to the plea bargain, accepting responsibility for the allegations, and prosecutors told the court that if the case had gone to trial, the government’s evidence would have proved most, if not all, the allegations.

“From in or about February 2002 through Bextra's removal from the market in April 2005, Pharmacia first through a co-promotion agreement with Pfizer, and then as a subsidiary of and with Pfizer, promoted the sale of Bextra for some of the very uses and dosages that the [U.S. Food and Drug Administration] had declined to approve — such as for general acute pain and surgical pain — and about which the FDA had raised specific safety concerns,” the U.S. Attorney's Office for the District of Massachusetts said in a statement about Friday’s fine.

The U.S. Attorney's Office said there was ample evidence that Pharmacia’s marketing team positioned Bextra for uses that had not been approved, and in some cases were explicitly denied, by the FDA.

It also claims Pharmacia used advisory boards, consultant meetings and even travel to lavish resorts to promote Bextra with physicians and medical prescribers to persuade them to prescribe the medicine for unapproved uses and dosages.

Pharmacia also created sham physician requests for medical information in order to send information relating to unapproved uses and dosages to physicians, it said.

It also doled out promotional samples promoting Bextra for use in unapproved conditions and controlled purportedly independent medical education to broadcast off-label uses for Bextra, including acute and surgical pain, the U.S. Attorney's Office said.

Furthermore, the Attorney’s Office said Pharmacia paid vendors to draft articles about using Bextra in unapproved conditions without properly disclosing its role in the practice.

Representatives from Pfizer could not immediately be reached Friday to comment.

In September, Pfizer agreed to pay an additional $1 billion, plus interest, settling civil allegations that it fraudulently promoted and marketed Bextra, and three other drugs; Geodon, an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug. The settlement also resolved allegations that it paid kickbacks for the off-label marketing to induce physicians to prescribe the drugs.

The settlement also contains a provision requiring Pfizer to comply with a “significantly expanded” corporate compliance program. Pfizer agreed to a separate $33 million settlement of off-label marketing claims with 42 states in September as well.

The settlement grows out of a group of nine qui tam lawsuits brought against Pfizer for off-label marketing.

In October 2008, Pfizer agreed to pay $894 million to settle the bulk of product liability, consumer fraud and state attorney general lawsuits filed against it over the drugs Celebrex and Bextra.

Those cases started piling up across the U.S. after a ruling by the FDA in February 2005 that the drugs led to an increased risk of heart damage.

Celebrex came on the market in 1999, and Bextra followed in 2001. Pfizer voluntarily removed Bextra from the market in 2005, while Celebrex remains on the market.

Pharmacia is represented in the matter by Ropes & Gray LLP.

The case is U.S. v. Pharmacia & Upjohn Co. Inc., case number 1:09-cr-10258, in the U.S. District Court for the District of Massachusetts.