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Abbott Labs and AbbVie Inc. Hit with $25M in Penalties for Misbranding and Kickbacks

In October of 2018, the U.S. Department of Justice announced it had reached a settlement with Abbott Labs and its subsidiary AbbVie Inc. overcharges the companies had engaged in illegal promotion practices related to its drug TriCor. 

The settlement put to rest allegations that between 2006 and 2008 the companies had engaged in a conscious, deliberate scheme to induce physicians to write illegal “off-label” prescriptions for the drug, using improper incentives, such as gift baskets, gift cards, and other emoluments. The companies also hired physicians and other healthcare providers to consult and speak at industry events designed to induce prescribers to adopt off-label uses for Tri-Cor and reward them for doing so.  

TriCor is a drug the U.S. Food and Drug Administration had approved for treating patients with high levels of triglycerides. Yet, Abbott promoted the drug for:

  • Treatment, prevention, and reduction of cardiovascular events and cardiac health risks
  • Enhancement of the efficacy of statin drugs
  • Targeted treatment of diabetic patients, which included the preventing or reduction of cardiac health risks 

With its off-label promotion, Abbott had grossly overstepped legal limits and the boundaries of decency. Promising patients with compromised health that your drug will reduce their risk of a heart attack is reprehensible. Imagine how those patients, given new-found confidence that they could handle physical exertion or emotional stress, might have jeopardized their health. If but one patient suffered a cardiac event because of Abbott’s pay-for-play scheme, a $25 million settlement is far too light a penalty. This is an egregious example of Big Pharm putting profits before people in a cynical plot to enhance revenue.

The action against Abbott Labs and AbbVie Inc. began as a qui tam lawsuit in the Eastern District of Pennsylvania. Qui tam refers to the situation where a private citizen acts as a proxy for the U.S. government, suing as the plaintiff in a lawsuit under the federal False Claims Act when the government has been the victim of fraud. In this case, Abbott’s malfeasance caused false claims to be made under government healthcare programs. 

The whistleblower who brought the case, Amy Bergman, who had worked as a sales representative for Abbott, was entitled to share in the U.S. government’s recovery, which amounted to $23.2 million. Although the USDOJ did not disclose the amount of the bounty Ms. Bergman collected, the FCA allows whistleblowers to receive 15 to 25 percent of the government’s recovery. This would give her an estimated payday of $3.46 million to $5.8 million, which is a substantial sum for merely doing the right thing by revealing a threat to the health of one’s fellow citizens.

“The employee who, in the public interest, has the personal courage to challenge illegality is a kind of public hero.”