A number of plaintiffs are opposing recent efforts by the makers of the Sorin 3T Heater-Cooler to centralize and consolidate all federal infection lawsuits over the heart surgery device, indicating that there are compelling factual and legal reasons not to transfer all cases to one U.S. District Judge for coordinated pretrial proceedings.
Dozens of product liability lawsuits have been filed in U.S. District Courts nationwide, each raising similar allegations that contaminated heater-cooler systems commonly used during open heart surgery caused individuals to develop nontuberculous mycobacterium (NTM) infections, which may surface months or even years after the procedure.
Given similar questions of fact and law raised in the cases, the manufacturers filed a motion to centralize the heater-cooler litigation last month, asking the U.S. Judicial Panel on Multidistrict Litigation to transfer all cases to one judge to avoid duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, several plaintiffs point to substantial differences in the injuries, and wide disparities between how far along some cases are in the litigation process, arguing that centralization would unjustly delay and prejudice Plaintiffs who most desperately need the earliest possible trial dates.
The 3T Heater-Cooler is a device commonly found in operating rooms nationwide, and is used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain systems distributed to hospitals may be contaminated with bacteria, which is then released in a mist that may enter the sterile surgical site.
The bacteria may cause difficult to treat internal infections, which typically do not surface until months, or even years after exposure. As a result of the risk, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated 3T Heater-Cooler, recommending continued medical monitoring.
According to allegations raised in complaints filed in courts nationwide in recent months, the manufacturers Sorin Group and Livanova knew or should have known about the infection risks, yet withheld information from consumers and the medical community. The lawsuits also claim the manufacturers released a defective device onto the market by not preventing the contamination, which appears to have taken place inside the manufacturing facilities where the devices were made.
While the manufacturers have pushed for the litigation to be centralized before one judge in the U.S. District Court for the District of South Carolina, various different responses filed by plaintiffs argue that centralization is not appropriate, or that South Carolina is not the most appropriate venue. Some responses also argue that the most serious cases, involving the “signature” M. chimaera infections should be broken out into a separate MDL if centralized proceedings are established.
“[T]he M. chimaera cases are unique and must be treated as such to avoid undue prejudice to the M. chimaera Plaintiffs,” according to arguments presented in an opposition brief (PDF) filed on November 28. “The M. chimaera cases are the only ones in which the source of the bacteria that caused the Plaintiff’s infection is known (the M. chimaera bacteria was imported from Sorin’s factory in Germany). The M. chimaera cases are also unique because M. chimaera victims have a disturbingly high 50% mortality rate. Time is of the essence for every M. chimaera victim lucky enough to still be alive.”
Mixed in with many of the infection lawsuits and some wrongful death lawsuits are also a number of heart surgery class action claims, seeking medical monitoring for individuals exposed to the bacteria, but not diagnosed with any injury. Sorting through the different classes of injuries would unduly delay pretrial proceedings, and other opposition briefs also note that many of the benefits associated with a multidistrict litigtion (MDL) can be achieved based on informal coordination efforts.
The JPML rejected a previous attempt to consolidate the 3T Heater-Cooler lawsuits in April 2017, finding that there were too few cases pending at that time. However, that motion was filed by a single plaintiff, and the manufacturers opposed centralization in the earlier filing. They now bring this new request, pointing out that the litigation has grown substantially since that time.
3T Heater-Cooler Infection Risks
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
It is expected that the JPML will consider oral arguments on the motion during an upcoming hearing session in January 2018.