Whistleblower accuses EP ablation device makers of kickbacks
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The lawsuits, originally filed in 2007 and 2008 in the southern district of Texas, were made public July 10. The U.S. Department of Justice has until Aug. 21 to decide whether to participate in the lawsuits, which were filed by a former employee of Natick, Mass.-based Boston Scientific.
The whistleblower -- whose identity is protected -- alleges that manufacturers have struggled to sell their surgical ablation products because the devices have not been approved by the FDA for specific use in the treatment of atrial fibrillation.
As a result, the lawsuit claims that the companies initiated a nationwide sales campaign, including illegal kickbacks and other improper means, to entice physicians and hospitals to use the products for off-label purposes.
In fact, in a recent report from the Agency for Healthcare Research and Quality (AHRQ) about the uncertainty associated with using radiofrequency catheter ablation to treat atrial fibrillation, the agency acknowledged that "physicians often use other catheters that have not been approved by the FDA for atrial fibrillation."
"Defendants have promoted their products to hospitals by highlighting the high spread between Medicare reimbursement for procedures performed with defendants' products and the relatively low cost of those procedures," the lawsuit states.
Among other allegations, the whistleblower contends that the companies offered discounts to hospitals to ‘lock-in' market share, and agreements also allowed them "to confiscate all competitors' products and equipment ... to ensure that the hospitals will only use defendants' products."