No, AARP did not file a lawsuit. But the age-old advocacy group has signed on as co-counsel in an existing whistleblower lawsuit that was filed against Abbott Laboratories, Johnson & Johnson and Boston Scientific for allegedly off-label marketing of metal biliary stents. The suit was filed in 2006 by Kevin Colquitt, a former sales rep and manager for Guidant, which was bought by Abbott.
In his suit, Colquitt charged the stents were incorrectly placed in older patients to treat vascular disease, but were not approved by the FDA for that purpose. The suit also contends the device makers made false statements to the FDA that the stents were intended for cancer patients with biliary blockages, and were marketed to docs as vascular stents, also without FDA approval (read the lawsuit here).
Consequently, Colquitt claimed millions of people underwent procedures, and Medicare and Medicaid paid untold millions of dollars in claims unnecessarily. And that's why AARP decided to enter the picture. "Fraud is draining billions from the health care system, which in turn hurts older persons,” says Kelly Bagby, an AARP Foundation senior attorney, who is joining the litigation as co-counsel, in a statement.
By injecting itself into the equation AARP is clearly arguing that alleged health care fraud - including off-label marekting - has become a pressing societal problem. Of course, a seat at the table in a federal courtroom may not hold any wider significance immediately. But it does send a signal to drug and device makers that not only employees, lawyers and prosecutors are willing to force the issue.
We should note that the US Department of Justice recently filed a brief with the court to counter some of the arguments made by the device makers. The purpose, however, was not to side with Colquitt - the Justice Department was clear that such a step was not being taken - but to disagree with the interpretations of the False Claims Act offered by the companies (here is the brief).
pic thx to katerha on flickr