For many years, executives and sales representatives of pharmaceutical giant Pfizer engaged in a massive illegal scheme to promote four prescription drugs for unapproved uses and paid kickbacks to encourage health care providers to prescribe these and others medications.
During an intensive four-year investigation, Department of Justice (DOJ) lawyer Sara Bloom and her team of 25 agents, attorneys and analysts from across the federal government uncovered the full scope of Pfizer's misconduct. They poured over thousands of documents, interviewed hundreds of witnesses, followed tips from whistleblowers, traced the flow of money and fought an army of corporate lawyers.
The end result of their painstaking work was an agreement by Pfizer and its subsidiary, Pharmacia & Upjohn Company Inc., to pay $2.3 billion in fines and penalties to resolve civil and criminal charges¿the largest health care fraud settlement in history.
"This civil settlement and plea agreement represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient health," said Tony West, assistant attorney general in DOJ's Civil Division, when the settlement was announced last year.
Bloom, drawn to public service 15 years ago because she "wanted to make a difference," said the long investigation showed that the choice of "drugs that patients were being given was influenced by money and other things given to doctors." She called this "a deeply offensive notion" that corrupts the marketplace and could endanger patient health.
"I feel lucky to have a position where my job is to try to figure out what is the right thing to do and to try to maximize our impact in protecting government programs and their beneficiaries from fraud and corruption," Bloom said.
The Pfizer investigation focused on the company's illegal marketing of four prescription drugs: Bextra, a painkiller; Geodon, an antipsychotic medication; Zyvox, an antibiotic; and Lyrica, a medication to treat nerve pain.
It is unlawful for drug companies to promote uses of medications that have not been approved for safety and effectiveness by the Food and Drug Administration (FDA). Bextra, for example, was approved in 2001 to treat arthritis, but Pfizer touted the drug as a remedy for acute and surgical pain¿conditions for which it had neither been clinically tested nor received the FDA's blessing. Bextra was withdrawn from the market in 2005 because of serious risks of heart problems and stroke.
The Justice Department said the Pfizer sales staff created sham requests from physicians asking for information about unapproved uses of its drugs, and then sent mailings to the doctors making unsubstantiated claims about the medications. Officials also said Pfizer sent doctors on all-expense paid trips to resorts and paid kickbacks to influence their decision-making.
In addition, the company's false claims about its drugs resulted in it improperly receiving hundreds of millions of dollars in reimbursements from Medicaid and Medicare¿money that had to be returned to these programs as part of the settlement agreement.
Phillip Coyne, an agent with the inspector general's office at the Department of Health and Human Services (HHS), said Bloom was "the driving force behind investigating, developing, planning and building the case." He said she was "relentless," "committed to the pursuit of the truth," and a "tremendous advocate for taxpayers, Medicare and Medicaid beneficiaries and average Americans."
"Her ability to lead, build consensus and motivate people enabled her to overcome the largest obstacle, the sheer size of Pfizer's defense team and the company's seemingly unlimited resources, to support the case," Coyne said.
Jeremy Sternberg, an assistant U.S. attorney in Massachusetts, said Bloom did "a masterful job" coordinating the complex case and all of its moving parts and people.
"She genuinely cares about public health and safety and is committed to prosecuting cases that will ensure that," said Sternberg. "She is tireless, bright and talented."