In what is being called the largest prescription drug criminal fraud case in U.S. history, Pfizer will pay $2.3 billion in civil and criminal penalties to compensate taxpayers, patients and doctors across the United States for illegal drug marketing.
A government investigation revealed that Pfizer promoted the sale of Bextra – an anti-inflammatory drug that Pfizer pulled from the market in 2005 – for uses and dosages that the FDA specifically declined to approve due to safety concerns. Despite the lack of approval, Pfizer literally wined and dined physicians around the country to promote the “off-label” uses of its drug. As a result, Pfizer will pay a criminal fine of $1.3 billion.
In addition, Pfizer agreed to a $1 billion civil settlement to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications.
Massachusetts will receive $14.7 million, which will go back into the state’s Medicaid program.
The settlement comes just weeks before a controversial prescription drug-related murder case is scheduled to go to trial in Massachusetts. In 2007, Michael and Carolyn Riley of Hull, Massachusetts, were charged with first-degree murder in the death of their four-year-old daughter, whom allegedly died of a prescription drug overdose of Clonidine and other prescription drugs that were given to her by her parents. The Rileys have brought a medical malpractice claim against their daughter’s Boston doctor, who prescribed Clonidine for a use which was not approved by the FDA. That case is pending.
The Pfizer settlement and the upcoming trial of Michael and Carolyn Riley are a reminder of the damage that prescription drugs can cause when they are prescribed for uses which have not been approved. About 1.3 million people are harmed as a result of a medication error every year in the United States.
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