In an Order entered on January 31, 2014, District Judge Darnell Jones, II found the whistleblower Complaint filed by former Abbott employee, Amy Bergman, under Federal and State False Claims Acts, alleged sufficient facts regarding kickbacks to physicians and improper off-label marketing of the blockbuster drug TriCor.
Abbott Laboratories, a pharmaceutical company that has already pleaded guilty and paid over $1.5 billion to U.S. federal and state authorities after multiple separate investigations into alleged illegal marketing and false claims regarding several of its prescription drugs and those of its subsidiaries, was unsuccessful in its attempt to dismiss this similar case regarding its blockbuster drug TriCor. TriCor is a fibrate that was approved by the FDA for use in certain limited circumstances in patients with elevated triglycerides or a particular type of cholesterol imbalance. The Relator in the current case, a former salesperson for Abbott, filed a whistleblower lawsuit alleging Abbott marketed TriCor to doctors in a deceptive manner for medically unnecessary and unapproved uses, resulting in hundreds of millions of dollars in inappropriate prescription costs paid by Medicare and Medicaid. The lawsuit also alleges that Abbott paid kickbacks and other improper incentives to high volume prescribers and other physicians in order to encourage or reward them for prescribing TriCor.
In denying the Motion to Dismiss, Judge Jones observed that the Amended Complaint “provides myriad details of Abbott’s marketing statements that contradict its FDA-approved label. Specifically, relator alleges that there were no clinical data supporting the use of TriCor as a first-line therapy for diabetics to treat cardiovascular morbidity and mortality, which was an off-label use. Nevertheless, Abbott directed its representatives to respond strategically to these kinds of objections from physicians and to provide studies of a different, albeit similar, drug to support the off-label claims Abbott was making about TriCor.” Judge Jones went on to state, “These marketing activities, if they in fact occurred as Relator alleges, flout the provision on the FDA-approved package insert for TriCor which notes that the drug’s effects on cardiovascular morbidity and mortality have not been established.”
Annual sales of TriCor increased dramatically in the United States during the time period that the illegal marketing activities alleged in the Amended Complaint occurred — from approximately $403 million in 2002, to approximately $1.3 billion in 2008.
The lawsuit seeks to benefit the United States government and a number of states by having Abbott repay Medicare and Medicaid the hundreds of millions of dollars in prescription costs paid as a result of the deceptive off-label marketing and kickbacks. Federal law provides protection and compensation to employee whistleblowers that bring evidence of false claims to the government. The lawsuit was filed by attorneys at Nicholson & Eastin, LLP and the Kelley/Uustal law firm.
Lead Attorney Robert Nicholson commented that, “Judge Jones engaged in a very thoughtful and thorough analysis of the allegations and the law, and appropriately denied Abbott’s Motion to Dismiss the Amended Complaint. As detailed in the case filings, Abbott has a documented history of improper off-label marketing, with multiple prior settlements with the Government regarding other drugs. We view the decision as a significant victory for the Relator in her effort to expose Abbott’s conduct regarding TriCor, and we are confident that this case will resolve in favor of the United States and the Relator.”
The case is pending before the Honorable C. Darnell Jones, II, in the United States District Court for the Eastern District of Pennsylvania under Case No. 09-4264
For more information, or a copy of the Amended Complaint, contact Robert Nicholson, at Nicholson & Easton, LLP, Robert@NicholsonEastin.com or (954) 634-4400.