December 6, 2021

Volume XI, Number 340

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December 06, 2021

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December 03, 2021

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Running Out of Juice: Battery Issues in Cardiac Devices Prompt St. Jude Medical to Settle with U.S. Government for $27 Million

July 20, 2021. No one wants to think of their physical heart, much less the device implanted to keep their heart beating regularly, as a ticking time bomb. St. Jude Medical allegedly sold defective heart devices with the knowledge that lithium clusters could form on the batteries of these devices, causing the batteries to prematurely drain (premature battery depletion or PBD).

St. Jude Medical manufactures implantable defibrillators, devices which detect and correct irregular heartbeat with a small electrical impulse. The device manufacturer allegedly failed to report two serious injuries and one death due to lithium clusters causing devices to lose power and malfunction—in 2014. By October 2016, after thousands of devices had been implanted in patients, St. Jude became subject to an FDA Class 1 Recall, which encompasses “‘violative’ products [that] ‘will cause serious adverse health consequences, including death.’” As these devices were implanted into patients insured by federal healthcare programs, St. Jude allegedly violated the False Claims Act.

A whistleblower filed suit on behalf of the US government.  They are entitled to receive 15-25% of the government’s recovery.

Concealing information about the safety of a product not only potentially harms the patients who need these medical devices to live and work, but also erodes public trust in the medical device industry.  Knowingly selling defective devices additionally defrauds the government and the American public, as claims under federal healthcare programs are paid with taxpayer dollars.  To uphold public health and welfare, the Department of Justice needs whistleblowers to report fraud involving defective medical devices.  Medical device manufacturers need not break a few hearts to turn a profit.

© 2021 by Tycko & Zavareei LLPNational Law Review, Volume XI, Number 201
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About this Author

Jonathan K. Tycko leads the Whistleblower Practice Group of Tycko & Zavareei LLP

In recent years, the laws of the United States have undergone a whistleblower revolution. Federal and state governments now offer substantial monetary awards to individuals who come forward with information about fraud on government programs, tax fraud, securities fraud, and fraud involving the banking industry. Whistleblowers also now have important legal protections, designed to prevent retaliation and blacklisting.

The law firm of Tycko & Zavareei LLP works on the cutting edge of this whistleblower revolution, taking on even the most complex and confidential whistleblower...

202-973-0900
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