Attorneys with AARP Foundation Litigation have joined as co-counsel in a lawsuit under the federal False Claims Act that challenges the off-label marketing and use of stents for purposes not approved by the FDA. The lawsuit alleges that the practice not only put patients in danger, but also defrauded Medicaid and Medicare programs by billions of dollars.
The Claims Underlying the Litigation
Kevin Colquitt alleges that when he was a medical device executive, his former employer, Guidant (now Abbott Labs), and other device manufacturers Boston Scientific Cordis, and Johnson & Johnson directed staff to urge health providers to use biliary stents in patients needing vascular stents, and to train providers to submit false claims to Medicare and Medicaid for payment. He also alleges that his former employer provided illegal kickbacks to health providers as inducement for using the biliary stents, and that it filed false statements and certifications with the FDA when seeking approval for those stents.
The actions of the device companies also put patients' health at risk. Biliary stents are intended for short-tem use to ease pain for people suffering certain gastrointestinal cancers, while vascular stents are generally permanent implants. Biliary stents have a lower regulatory approval threshold than vascular stents. In other words, biliary stents can be rushed to market more quickly because they undergo less extensive testing due, in part, to the fact that they are not expected to last as long as vascular stents.
The difference is so serious that in 2008, the FDA issued a Special Communication warning physicians that it was concerned about the high incidence of off-label use of biliary stents and stating that the agency did not believe these devices can safely be used in the vascular system. The agency reported problems with nearly 200,000 stents inserted for off-label use, including dislodgement and problems with deployment. The FDA documented that patients with the unapproved devices suffered aneurysms, air embolisms, strikes, internal bleeding, arterial dissections and even death.
Colquitt filed a whistle-blower lawsuit alleging that his employer had profited by hundreds of millions of dollars in fraudulent health care payments and endangered the lives and safety of thousands of patients. The lawsuit seeks to reimburse federal and state governments for fraudulent claims paid, as well as to provide a strong deterrence to other medical device and pharmaceutical manufacturers.
What's at Stake
Over the past five years, the Department of Justice has resolved several similar cases alleging that medical device manufacturers were causing false claims to be submitted to government health insurance programs, resulting in settlement funds for victims and changed corporate practices. For cash-strapped federal and state health care programs, the cases are critically important. Medicare and Medicaid have paid billions in reimbursement claims for procedures using unapproved devices.
U.S. ex rel. Colquitt v. Abbott Labs is currently before a federal court in Texas. AARP Foundation Litigation attorneys are co-counseling the case with attorneys from the law firms of Baron & Budd (where Colquitt is now an attorney) and Stein, Mitchell & Muse.