St Jude Hospital Scandal

The news about the St Jude hospital scandal is a topic to discuss, as what charges have been going against St Jude Hospital?

There was a false claim act in the St Jude hospital between 2014 and 2016, but the news was still going on till 2021. 

The government alleged that St. Jude failed to disclose adverse severe health events in specific models of its Fortify, Fortify Assura, and Unify devices. 

People are curious to know about the charges and investigation of St Jude hospital. Is the case still going on? 

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This article will include everything you need to know about the hospital scandal, and please continue reading. 

St Jude Hospital Scandal

The medical device manufacturer, which Abbott acquired in January 2017, allegedly sold the defective devices to healthcare facilities.

Abbott to Acquire St. Jude Medical for $25 Billion
Abbott to Acquire St. Jude Medical for $25 Billion. (Source: The New York Times)

The facilities then implanted the devices into patients insured by federal healthcare programs, which were illegal, and used in patients at risk of cardiac arrest due to an irregular heartbeat.

After the scandal started between 2014 and 2017, Acting U.S. Attorney Jonathan F. Lenzner annouched, “Medical device manufacturers must be truthful with the Food and Drug Administration, and the U.S. government will not pay for unsafe devices and risk injury or death,” 

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Selling Defective Heart Devices, Allegations And Charges

On July 8, 2021, St. Jude Medical agreed to pay $27 million to settle False Claims Act charges of knowingly selling a defective heart device to healthcare facilities. Abbott Laboratories acquired St. Jude in early 2017.

St. Jude Medical Pays $27 Million for Allegedly Selling Defective Heart Devices
St. Jude Medical Pays $27 Million for Allegedly Selling Defective Heart Devices. (Source: Diagnostic and Interventional Cardiology)

After investigations were done for almost three or four years, St Jude finally agreed to pay, and the case was settled down.

The heart devices were implanted in the patient’s chests and activated when the device detected an irregular heartbeat. The devices send an electrical pulse to the heart to restore its regular rhythm.

St. Jude knew by 2013 that lithium clusters had formed on the devices’ batteries, which caused some of the batteries to fall and suffer a premature power drain.

 The clusters can move after formation, typically due to the device’s movement. In most instances, these clusters are harmless.

However, suppose the clusters form a bridge between the cathode and the anode surfaces of the battery or other parts of the ICD or CRT-D. 

In that case, the hospital can conduct electric current leading to a battery shortage, which can prematurely drain the battery of power, also known as Premature Battery Depletion.

It was only possible to determine whether a lithium cluster had bridged the anode and cathode surfaces after first exploding the device.

St. Jude’s continued to distribute the devices. On October 10, 2016, St. Jude issued a medical advisory caused by the battery shorts. The FDA ruled that this was a Class I product recall.

They stopped selling the devices, and when they stopped doing and selling the stuff, thousands of defective devices remained implanted in patients.

So, between 2014 and 2017, one of the patients who received one of the defective devices initiated the False Claims Act suit.

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