Stockert 3T HCD-Related Infections: A Potential World Epidemic

 
Category: 
Defective Medical Devices

The Stockert 3T Heater-Cooler System (3T HCD), manufactured by LivaNova PLC (a merger between Sorin with Cyberonics, Inc.), approved by FDA in 2006, is a class II device, designed to provide temperature-controlled water to patients who have undergone cardiothoracic surgeries, as well as, other medical and surgical procedures. The goal is to warm or cool the patient in order to optimize medical care and improve patient outcomes.

The Modus-Operandi- The Pathway linked to the spread

Infections from nontuberculous mycobacteria called NTM infections have been associated with the HCDs. The symptoms of this infection can take months or years to show. The symptoms include fever, cough, shortness of breath, night sweats, muscle aches, weight loss, etc. Research studies have linked M. chimaera infections to 3T HCDs. Investigations have revealed evidence showing that the LivaNova manufacturing site for 3T HCDs, in Germany, was the likely source of contamination for devices manufactured prior to September 2014. (Post 2014, LivaNova implemented changes to their manufacturing processes to reduce the risk of M. chimaera contamination of 3T HCDs).

Alarming Facts

According to Centers for Disease Control and Prevention (CDC), the point-source contamination situation made over 600,000 patients, who had undergone heart surgery since 2012, susceptible to M. chimaera infections. The CDC also confirmed that 28 heart surgery patients in U.S. were infected with the bacteria. Using the mid-2016 data, Pennsylvania's Department of Health confirmed 21 cases of M. chimaera infections related to the machines as well as six related deaths.

FDA Intervenes

FDA started receiving adverse event reports related to infections by 2010. These reached 32 by 2015. Further investigation indicated that German manufacturer Sorin’s Stockert 3T HCD was most commonly used in the U.S. when these events were reported. In June 2015, safety warnings were also announced regarding the risks associated with the use of the heater-cooler device which was then followed by a recall from the market by the manufacturer and FDA.

The FDA announced another safety warning in 2016 targeted specifically to infections associated with the use of the Stockert 3T heater-cooler device based on M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.

Neither an MDL nor any Settlements for this Mass-Tort

In early 2016, LivaNova was slammed with a class action lawsuit in Pennsylvania; multiple class action and individual lawsuits are now filed in federal and state courts across the country including Iowa and Michigan. Lawsuits accuse the company of failing to warn about the potential risks associated with the device, defective product manufacturing, negligence, and misrepresenting the risks.

Plaintiffs of the federally filed Stockert 3T HCD lawsuits filed a motion to transfer pretrial discovery and proceedings of 15 Stockert 3T Heater-Cooler product liability lawsuits pending in five districts in a multidistrict litigation to U.S. District Judge Bruce H. Hendricks, U.S. District Court for the District of South Carolina, Greenville Division. However, this motion was denied on April 5, 2017, stating that the cases could continue to be handled through informal coordination.

Civil lawsuits have also been filed against hospitals and health care providers for being negligent and for the role they played in exposing patients to the deadly bacteria during open-heart surgeries by not following the cleaning and sterilization protocols recommended by the manufacturer. Pennsylvania’s York Hospital is one such hospital facing many lawsuits.

As of the date of this article, there have been no large group settlements involving the Stockert 3T heater-cooler device and its potential link to surgical infections. Despite the late realization that Stockert 3T infections could lead to a world epidemic, the company continues to defend each of the claims made against it.

Need for Control

This outbreak, if not controlled could blow up into a pandemic. Steps have to be taken immediately to assess the gravity of the situation to evaluate any potential exposure including details that would conclusively help in determining when the contamination occurred along with the purchase, usage status, and installation details. Hospitals are strongly encouraged to notify patients who had cardiopulmonary surgeries within the last four years. If any of these patients subsequently developed related symptoms, they are advised to immediately consult their physicians. A prompt, efficient, and precise action plan is required to avert the consequences of this possible outbreak.

This article was submitted by Neural IT. Neural IT provides cost-effective and timely medical record reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email them at [email protected] or call +1-844-NIT-TEAM (648-8326).

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