BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices

Regulatory NewsRegulatory News | 15 May 2019 |  By 

CareFusion, a subsidiary of Becton Dickinson (BD), agreed to a $3.3 million settlement to resolve allegations of civil fraud under the False Claims Act over purchases and sales of unapproved devices.

The case was brought on by the US Department of Justice (DOJ) and alleged that providers who used CareFusion devices in medical procedures submitted false claims to federal insurance programs, such as Medicare. The devices allegedly lacked US Food and Drug Administration (FDA) approvals or clearances.

The firm also admitted to buying and selling the unapproved or cleared devices, according to the DOJ. CareFusion relied on another manufacturer’s claims that they qualified for preamendment status exemption to market the devices in the US. But the manufacturer reportedly lacked enough evidence to support such claims.

“BD fully complies with all laws and regulations for the medical products the company manufactures, markets and distributes,” a BD spokesperson told Focus on behalf of its CareFusion subsidiary. “It is important to note that CareFusion received confirmation and assurance from the products’ manufacturer that these products were legally available for sale in the US prior to the manufacturer recalling them. BD chose to settle the matter to avoid the time and expense of further litigation.”

Most of the $3.3 million settlement will go to the US government ($2.8 million) and the remaining amount, totaling approximately $478,460, will be separately paid to adversely affected states.

“When companies sell devices without proper authorization, they may be putting patients’ health at risk,” FDA’s Center for Devices and Radiological Health Director Jeffrey Shuren said in reaction to the settlement. He added that FDA “will continue to investigate and bring to justice companies that attempt to subvert the regulatory functions of the FDA, which are intended to protect the public health.”

The latest agreement follows CareFusion’s long string of DOJ settlements and judgements dating back to 2013 and amounting to more than about $85 million to resolve allegations.



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