Last year, reports surfaced that millions of Americans who’ve undergone open heart surgery might be at risk of a rare bacterial infection due to contaminated blood heating and cooling surgical devices.
Now, with lawsuits from those affected popping up around the country, a federal panel has ordered that the majority of cases be moved into a centralized court to better serve the interests of the parties and allow more efficient handling.
The 3T Heater-Cooler MDL Process
The transfer order was issued on February 1st by the Judicial Panel on Multidistrict Litigation, a seven judge panel first created in 1968 that combines similar cases into one district for faster and more efficient handling of trial preparation.
This serves to streamline the legal process for both the injured patients and the defending companies, leading to faster verdicts or settlements. Also, it allows different plaintiffs to share valuable evidence that may be used in their cases.
In these cases, patients are alleging that negligence on the part of the makers of the Storin 3T Heater-Cooler systems used during their surgeries led to non-tuberculous mycobacterium (NTM) infections such as M. chimaera, M. abscessus, and M. fortuitum.
These infections in the chest cavity can be deadly if not treated quickly, and at the very least may require hospitalization, frequent testing and antibiotic use.
New Heater-Cooler Infection MDL Set in PA
The panel took into consideration the fact that 40 federal lawsuits have already been filed around the country in 21 different districts, as well as 33 lawsuits in 8 different state courts. And, the litigation is expected to continue growing.
Ultimately, they decided that consolidating all federal 3T Heater-Cooler infection cases to the Middle District of Pennsylvania under the direction of Federal District Judge John E. Jones III.
The case will be formally known as MDL 2816, In Re: Sorin 3T Heater-Cooler System Products Liability Litigation. Court records indicate there are now over 50 cases pending in the MDL venue.
Judge Jones and the MDL court will be responsible for coordinating all evidence gathering and pre-trial preparation by the parties. Then, the court will schedule a handful of bellwether cases to test the outcomes for future trials or help facilitate settlement.
Infection Risks for Heart Surgery Patients
Surgical heater-cooler devices have been used for decades to maintain an optimum internal temperature in those undergoing heart surgeries. It’s estimated they are used in most of the 250,000 heart procedures each year.
In 2013, doctors first noticed a link between patients who’d undergone heart surgeries and later developed M. chimaera infections, even though their procedures were performed in different facilities.
Then, in 2015, European based LivaNova/Sorin, who makes the 3T Heater Cooler used in at least 60 percent of all heart surgeries, found out their devices had been contaminated with bacteria from the manufacturing plant.
At the time, LivaNova didn’t recall the dangerous machines, but simply gave hospital staff instructions on how to try to clean them.
The FDA labeled this a recall and issued warnings for consumers about the infection risks from heart surgery heaters, but most of the affected devices remained in use in hospitals around the country.
A year later, the Centers for Disease Control got involved, warning patients of the infection risks. They followed up with a report estimating 90 percent of hospital surgical heaters might be affected by the dangerous bacteria.
Infections May Surface Years After Surgery
Patients who’ve undergone open-heart or open chest wall surgeries in the past five years are at risk of developing strains of a rare infection called non-tuberculous mycobacterium (NTM). These may go by the names M. chimaera, M. abscessus, or M. fortuitum.
NTM infections might develop in as little as 2 weeks after surgery, or can take up to 4 years to surface. They can be treated with antibiotics if they are caught in time, but can turn fatal if left untreated.
Aside from the dangers of the infection itself, patients who’ve been exposed through surgery must continue to monitor for the symptoms for years afterward. These include:
If you or a loved one have been diagnosed with internal infection after undergoing a heart surgery, it is important to learn your legal options to join this litigation. You may be entitled to substantial compensation.
Contact DrugNews today for more information on the surgical heater-cooler warnings and litigation news, or to speak directly with a lawyer about your case.
Mycobacterium chimaera in Heater–Cooler Units in Denmark Related to Isolates from the United States and United Kingdom. CDC. (March 2017). Retrieved from wwwnc.cdc.gov
JPML Transfer Order. MDL 2816, In Re: Sorin 3T Heater-Cooler System Products Liability Litigation. (February 1, 2018). Retrieved from www.jpml.uscourts.gov
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