Abbott, AbbVie Pay $25M Over Off-Label Promos, Kickbacks
Abbott Laboratories and AbbVie Inc. will fork over $25 million to end a whistleblower’s False Claims Act case alleging off-label promotion of triglyceride drug TriCor and unlawful kickbacks in the form of gift baskets and gift cards, the U.S. Department of Justice said Friday.
The payout ends a nine-year case brought by former Abbott sales representative Amy Bergman, who will get a $6.5 million slice of the settlement. The deal — which stems from allegedly improper billing of Medicare, Medicaid and Tricare — is fairly sizable for an FCA case that the government declined to join.
“We are happy this matter is finally concluded. It was a hard-fought, nonintervened case,” Marc Raspanti, a name partner at Pietragallo Gordon Alfano Bosick & Raspanti LLP and counsel for Bergman, told Law360.
Friday’s settlement resolves a case originally filed in 2009 and it covers conduct from 2006 through 2008. During that time, TriCor was approved to treat conditions related to elevated triglyceride levels, but Abbott promoted it for unapproved uses related to cardiac health risks, the DOJ said.
In addition, Abbott used kickbacks in the form of meals, gift baskets and gift certificates to encourage doctors to write prescriptions for TriCor and it improperly encouraged or rewarded prescribers with paid consulting and speaking arrangements, according to the DOJ.
Abbott now focuses on diagnostics, medical devices and brand-name generic drugs. AbbVie was spun off from Abbott several years ago and specializes in traditional brand-name drugs, including the immunosuppressant Humira, the world’s best-selling drug.
“This settlement resolves disputed issues involving sales and marketing practices that occurred over a decade ago,” AbbVie said in a statement. “There has been no finding of liability or determination of any wrongdoing.”
Abbott litigated the case for years, arguing at times, to no avail that Bergman’s allegations were too vague. In a 2014 ruling, a Pennsylvania federal judge said Bergman had supplied “myriad details of Abbott’s marketing statements that contradict its FDA-approved label.”
In 2012, Abbott inked a $1.5 billion criminal and civil settlement that centered on kickbacks and off-label promotion of anti-seizure drug Depakote. This year, AbbVie found itself mired in a noteworthy fraud case alleging “classic” kickbacks in the form of money and meals as well as “sophisticated” kickbacks in the form of marketing assistance for physician practices.