The qui tam suit alleges that the three pharma companies allegedly deceived the Food and Drug Administration (FDA) to receive approval for biliary stents, which the companies then illegally marketed its off-label use as vascular stents. These vascular stents were incorrectly placed in senior patients to treat vascular disease without FDA approval. The suit further claims that, also without FDA approval, the device makers made false statements to the FDA that the stents were intended for cancer patients with biliary blockages, and were marketed to doctors as vascular stents.
According to a news report by The American Lawyer, the companies have also been accused of paying illegal kickbacks by discounting purchasing contracts to healthcare providers who chose to use the biliary stents as unapproved vascular stents.
Whistleblower Kevin Colquitt, a former sales rep and manager for Guidant (which is part of Boston Scientific and Abbott Laboratories), claimed millions of people underwent these procedures, and Medicare and Medicaid paid untold millions of dollars in claims unnecessarily—as well as harming many older patients. Mr Colquitt is now a lawyer at Baron & Budd LLP. AARP lawyers Kelly Bagby (who has a background in fraud investigation) and Stacy Canan are joining Colquitt's counsel; Bagby said she "considered Colquitt's case to raise serious safety concerns for AARP members.…"
In December 2009, the Justice Department decided not to intervene in Colquitt's case, but at the beginning of October 2010, DOJ lawyers filed a notice of interest, which asserted responses to some of the defense arguments for dismissing Colquitt's case, and they may still intervene in the qui tam lawsuit.
Getting back to AARP: Ed Silverman, the founding editor of Pharmalot and a prize-winning journalist who has covered the pharmaceutical industry for the past 15 years, said that "By injecting itself into the equation, AARP is clearly arguing that alleged health care fraud—including off-label marketing—has become a pressing societal problem," and that the advocacy group is sending a clear message to pharmaceutical companies who illegally market their drugs and devices off-label. "Not only employees, lawyers and prosecutors are willing to force the issue," he added.
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"We are concerned about Medicare fraud and activity by criminals seeking to defraud seniors—and we want to ramp up our local community resources to educate seniors and people with Medicare about how that can help us stop it," said CMS Administrator Donald Berwick, M.D.
Recently, the Obama administration has warned that, due to confusion over the provisions of the Patient Protection and Affordable Care Act, fraudsters are taking advantage of the Act to prey on seniors, whose Medicare beneficiary numbers are the key to billing scams that drain resources from the federal health program. And now seniors are fighting back—some in the form of qui tam whistleblower lawsuits.