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Drug Maker Pfizer to Pay Largest Criminal Fine Ever to Settle Allegations of Off Label Marketing

By September 10, 2009July 17th, 2019Drug Safety

Pharmaceutical company Pfizer Inc. will pay $2.3 billion to the federal and state governments over allegations that it illegally marketed several drugs for off-label uses, the New York Times reported Sept. 2. The fine settles both criminal and civil allegations against the giant manufacturer for illegal off-label marketing of Bextra (gabapintin), a painkiller that is now discontinued, as well as Zyvox, an antibiotic; Lyrica, a nerve pain medication; and and Geodon, an antipsychotic. Whistle-blowing former employees and government regulators accused Pfizer of pushing doctors to prescribe Bextra for levels of pain beyond its FDA approval and at higher doses than approved, even though risks of the drug increased with the dosage. Bextra was withdrawn in 2005 because of reports that it increased risk of heart attacks and potentially fatal skin disorders.
This is actually the fourth off-label marketing fine for Pfizer. Most recently, the company was accused of pushing Neurontin, a drug approved for treating epileptic seizures and nerve pain, for off-label use to treat psychiatric disorders from the depression and anxiety spectrums. One of the six whistle-blowers in the current case was a sales representative for Pfizer while it was settling the Neurontin allegations. He said managers told him and his colleagues to ignore the controversy and the companywide integrity agreement Pfizer signed, and continue to market Bextra for illegal uses. “The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” he told the newspaper.
Despite the huge size of the fine, the Times said, the $2.3 billion payment represents fewer than three weeks of Pfizer’s sales. This incongruity, as well as Pfizer’s history of recidivism when it comes to illegal marketing practices, left prosecutors, drug safety advocates and pharmaceutical liability attorneys feeling cynical. Almost every major drug maker has been accused of paying kickbacks to doctors or hurting federal health programs financially — in fact, Pfizer’s behavior in this most recent case allegedly cost Medicare and Medicaid millions of dollars. However, Pfizer general counsel Amy W. Schulman said consumers and regulators can still trust Pfizer because “the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner.”
As a dangerous drug lawyer, I believe every part of that statement except the last clause — “in an appropriate manner.” It is difficult to believe that the manufacturer is committed to appropriate drug marketing when it has now been fined four times for the same illegal marketing. Even though this fine set new records for its size, I do not believe that the company’s behavior will change until the fines get even higher — or affect its profits in another substantial and long-term way. If the former employee is right that sales are the most important consideration at Pfizer, regulators must take actions that hurt sales and profits before this company, and others engaged in the same practices, will ever truly change. Until then, consumers trying to protect themselves have little choice but to question their doctors closely about FDA approval for the drugs they are prescribed.

Unfortunately, some patients have undoubtedly already been hurt by illegal marketing of off-label drugs. For these patients, it’s too late for aggressive preventive enforcement efforts to help — but that doesn’t mean they have no options or rights. Carey, Danis & Lowe helps patients around the U.S. who were hurt by a defective or unreasonably dangerous medication, sue the drug makers who deceived them or sold them an unreasonably dangerous medication. In many cases, these patients are put in serious risk of death or permanent disability — and they have the high medical bills to show it. Our defective drug attorneys help patients claim all of the financial costs of the injury, including the costs of time off work and any future medical care, as well as compensation for their injuries, physical pain and emotional anguish.
If you or a loved one was hurt by a prescription drug, regardless of whether it was prescribed for off-label uses, the Lowe Law Firm would like to help. To learn more at a free consultation, please contact us online or call 1-877-678-3400 today.