A former Abbott Laboratories sales rep filed a federal lawsuit against the company, accusing it of illegally promoting its cholesterol drug TriCor for uses not approved by regulators, including the prevention of cardiac health risks in patients with diabetes.
The suit was filed in September 2009 in U.S. District Court in the Eastern District of Pennsylvania by Amy Bergman. It was filed under the False Claims Act on behalf of the federal government, 22 states and Washington, D.C.
It was previously confidential under laws designed to protect whistleblowers who come forward with information about alleged health care fraud, but it was unsealed in August after federal and state governments declined to intervene.
In her suit, Amy Bergman charges Abbott improperly promoted TriCor as a first-line treatment for treating or preventing cardiac health risks in diabetic patients and as a combination treatment with other statins. Moreover, the drugmaker allegedly paid kickbacks to physicians to increase TriCor prescribing. Bergman, who worked for Abbott from 1999 through 2008, claims she was “trained, directed, incentivized, and encouraged” to engage in off-label promotion. She also contends Abbott instructed reps to withhold or misrepresent pertinent clinical information.
“These misrepresentations regarding TriCor were an integral component of Abbott’s scheme to illegally increase sales of TriCor because clinical studies of TriCor did not support its efficacy and/or safety for the off label and medically unnecessary uses Abbott instructed its sales representatives promote,” the suit charges. “In fact, TriCor’s legitimate medical use and market share had been limited because TriCor lacked positive outcomes data in (existing) clinical studies.”
The suit charges that as a result of off-label promotion, prescription claims were submitted to and reimbursed by Medicare, Medicaid, and other health programs funded by the federal and state governments from 2000 to 2008.
Drug makers are barred from actively promoting drugs for uses not approved by the Food and Drug Administration, though doctors have the discretion to prescribe drugs for so-called off-label uses.
TriCor is a prescription pill that was approved by the FDA in 1998 for use in reducing amounts of fatty substances in the blood like cholesterol and triglycerides and increasing high-density lipoprotein, or HDL. The drug accounted for $987 million in U.S. sales in 2011, though it is scheduled to face generic competition this year, Abbott said in a securities filing.
A spokesman for North Chicago-based Abbott said the allegations are without merit, noting that the federal government has declined to intervene in the case.
According to a memorandum posted on the U.S. Justice Department’s website, when the government opts not to join in the whistle-blower’s case, it “usually, but not always, results in the dismissal” of the suit.
The lawsuit comes on the heels of an agreement Abbott reached in May to pay $1.6 billion to settle federal and state claims that it illegally marketed the anti-seizure medication Depakote for off-label uses.
As part of the agreement, Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters.
The company pleaded guilty to misbranding, a misdemeanor under the Food, Drug and Cosmetic Act. Abbott also agreed to a five-year probationary period in which the company must report any probable violations of the law to the probation office, according to the Justice Department.