On February 1, 2018, lawsuits filed in federal district courts around the country against Sorin Group USA, Inc., Sorin Deutschland GmbH, and LivaNova PLC began the process of being transferred to Harrisbug, Pennsylvania for coordinated proceedings in an MDL, or multidistrict litigation. Multidistrict litigation is often utilized to streamline complex cases where many plaintiffs have been injured by a drug, medical device, consumer product, or incident (such as the BP oil spill, hotel fires, airline crashes, etc.). The Sorin heater-cooler bacteria lawsuits stem from infections allegedly caused by the Sorin Stöckert 3T Heater-Cooler device, a machine that helps regulate a patient’s body temperature during cardiothoracic surgery.
The First Attempt at Coordination Denied in Early 2017
In March 2017, the Judicial Panel on Multidistrict Litigation held a hearing on the first effort to coordinate then-pending Sorin cases into an MDL. The Judicial Panel on Multidistrict Litigation is the group of federal court judges that determine whether multidistrict coordination is necessary.
In the first petition, a group of plaintiffs asked that the cases be re-assigned to a federal judge in South Carolina. The initial request for coordination included fifteen individual lawsuits filed in South Carolina as well as North Carolina, Iowa, South Dakota, and Pennsylvania. The Defendants vigorously opposed the establishment of an MDL initially. They argued that there were too few cases pending, that the parties were already informally coordinating with success, and that the cases were too dissimilar to benefit from coordinated discovery – especially since the Defendants contended that discovery would be focused on the actions of the hospitals and surgeons with regard to their use of the heater-cooler devices in individual surgeries rather than more generic issues focused on the presence of a general defect in the heater-cooler products that were sold around the world.
The Judicial Panel denied the request for coordination in an April 5, 2017 order. The Panel found that the individual federal lawsuits pending around the country were already moving at an acceptable pace and the judges assigned to the fewer than 20 individual lawsuits could coordinate informally and still achieve the desired efficiencies regarding discovery and prosecution of the cases.
It is speculated that the Judicial Panel denied this initial request for coordination due to the relatively small number of cases pending at the time as well as the fact that some of the cases had been pending for quite some time and were quite advanced in pretrial proceedings. In most instances where the Judicial Panel has granted an MDL and ordered national coordination, there are at least 50 lawsuits pending, and most MDLs involve thousands of individual lawsuits.
Following denial of the MDL petition in April, plaintiffs’ lawyers around the country continued to work together to engage in informal cooperation and the sharing of resources in the hopes of achieving some of the same efficiencies that can be achieved through MDL proceedings without experiencing the delays that are also, unfortunately, part of the MDL process. In the months that followed, additional individual lawsuits were filed in state and federal courts and trial preparation continued in the filed cases.
New Cases Lead to a Second Petition – and a JPML Change of Heart
In a surprising turn of events in November 2017, the Defendants filed a motion to establish an MDL and coordinate the litigation. It is unusual for the Judicial Panel to grant such a motion when they have already denied coordination, but second requests are often made. In its petition, Sorin and LivaNova noted that it was facing 40 individual lawsuits at that time, including the 26 that were pending at the time of the initial request for coordination plus additional personal injury and wrongful death cases filed involving heater-cooler-induced mycobacterium infections in Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Minnesota, New York, and Tennessee. Some plaintiffs filed briefs opposing the manufacturers’ coordination request due to concerns that the establishment of an MDL might delay cases that had been pending for several years and were approaching trial dates, while others supported the renewed request. The Judicial Panel heard arguments for and against the motion in late January of 2018.
On February 1, 2018, the Judicial Panel issued an order granting the Defendants’ request. This order established MDL No. 2816, known as In Re: Sorin 3T Heater-Cooler System Products Liability Litigation (No. II), and transferred all pending federal court cases to Judge John E. Jones, III, a federal court judge in Scranton, Pennsylvania. Judge Jones was already presiding over other Stöckert 3T cases, including the Whipkey case which should be the first heater-cooler case to be tried before a jury in 2019. Judge Jones recently held an introductory phone conference with the attorneys involved in the 40 filed cases and is expected to hold some preliminary hearings in the coming weeks.
In addition to the federal court cases, there are also several cases concurrently pending in state court venues, primarily in Pennsylvania, Iowa, and California. Many of these cases involve local defendants, including the hospitals. Most of the federal court cases are solely focused on product liability claims against the heater-cooler manufacturers and do not include claims against the hospitals, as it is believed that the hospital and surgical personnel acted appropriately with regard to use and attempts to clean the heater-cooler device given the information that they were provided by the manufacturers as well as the challenges in being able to properly decontaminate the heater-cooler system due to its inherent design defects.
Nontuberculous Mycobacterium (NTM) Infections
Currently, most of the pending cases involve patients who developed M. chimera mycobacterium infections after undergoing a surgical procedure (usually a heart or transplant surgery) where a Stöckert 3T heater-cooler device was utilized. It is estimated that several hundred thousand patients may have undergone procedures and potentially been exposed to contaminated water that circulates through this medical device.
Over the past 12 months, many hospitals have written to patients to alert them to this potential exposure, although not all hospitals have yet to do so. It is believed that Sorin has the majority of the market share for heater-cooler device sales in the United States, which is why so many patients were potentially exposed. The good news is that the actual number of patients that have been diagnosed with confirmed mycobacterium infections suspected to have been caused by contaminated aerosolized water coming from the Stöckert 3T heater-cooler devices is relatively small.
While the reported governmental investigations have focused on the M. chimera mycobacterium, other forms of non-tuberculous mycobacterium infections have been reported in the FDA’s MAUDE database as coming from the Stöckert 3T heater-cooler devices. These other non-tuberculous mycobacterium infections include but are not limited to, the following: M. abscessus, M. chelonae, M. fortuitum, M. gordonae, M. intracellulare, and M. kansasii.
In the coming months as the state court and MDL proceedings move into the expert witness discovery phase, more efforts will be focused on identifying the precise species that are non-tuberculous mycobacterium that can be scientifically and legally linked to use of the Sorin 3T heater-cooler devices.
One dozen children contracted the rare bacterial infection mycobacterium abscessus following pediatric-heart surgery at Children’s Hospital in New Orleans. The rash of heater-cooler infection cases prompted swift action from the hospital.
The culprit is a heater-cooler machine, specifically the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T. The machine is used to control patients’ body temperatures. It cools the patient when their heart is stopped and warms them when it is started again.
Both the Centers for Disease Control and Prevention (CDC) in Atlanta and the U.S. Food & Drug Administration (FDA) in Silver Spring, Md., have warned the public about the problem associated with heater-cooler devices.
CDC Issues Health Alert for Heater-Cooler Infection
The CDC issued a health alert, and the FDA is conducting an investigating. “Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever,” the CDC states on its Web site. “This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.”
“Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming / cooling blankets through closed circuits,” the FDA states on its Web site. “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.”
The 12 tiny patients at Children’s Hospital are not experiencing life-threatening infections, their doctor said.
“Our patients are responding to treatment,” Dr. John Heaton, chief medical officer, told WWL-TV in a story titled “12 children treated for serious infection after heart surgery at Children’s Hospital.” He stated that “No one is in imminent danger at this point that we can tell.”
The children contracted the infection just as the FDA described. A design flaw in the Stöckert 3T causes the water in its tanks to develop a common bacteria. This bacteria is naturally found in dirt and dust and also in municipal water systems. The bacteria then is vented into the air and inhaled.
“It’s a bug that’s a normal contaminant…but it’s not harmful if you drink it in low quantities,” Dr. Heaton said.
Patient Surveillance Prime Heater-Cooler Infection Prevention Tactic for Hospitals
Children’s Hospital initially noticed four patients with redness and wetness around their chest incisions, prompting emergency rounds to find out whether other patients’ incisions were infected.
“We were able to jump on this pretty quickly,” Dr. Heaton told The New Orleans Advocate in a story titled “Children’s Hospital in New Orleans says 12 patients contracted rare infection after recent heart surgeries.” “We surveil our patients pretty intensely, and when we had several patients present (symptoms) within a 72-hour period, that set off a red flag right away.”
The surgeries took place this summer. In August, the hospital sent out a letter to the families of 55 patients. Those contacted were potentially at risk of a heater-cooler infection.
“We regret that any of our patients could possibly be affected by this infection,” Dr. Heaton wrote in the letter. “Our thoughts are with those involved, and we apologize for any anxiety caused by this communication. Our response team has also consulted other hospitals that have dealt with the same issue in the past for guidance and information regarding lessons learned and best practices for treatment.”
Heater-Cooler Infection Cited as Huge Problem in Surgical Suites
Infection in surgical suites is a huge problem. Once started, it very often requires the closure of hospitals or portions of hospitals to eradicate the problem. Most hospitals have a high vigilance level for infection control because the cost to a hospital, both short-term and long-term, is astronomical.
Surgical-site infections, or SSIs, are responsible for between 14 and 17 percent of all infections acquired in hospitals, according to the Journal of Preventative Medicine and Hygiene. SSIs are divided into three categories: superficial infections, deep incisional infections and infections involving organs or body spaces. The latter two account for an approximate 50 percent of all SSIs in the United States.
“Factors causing surgical site infection are multifarious,” the Journal states. “The rate of surgical wound infections is strongly influenced by operating theatre quality, too. A safe and salubrious operating theatre is an environment in which all sources of pollution and any micro-environmental alterations are kept strictly under control. This can be achieved only through careful planning, maintenance and periodic checks, as well as proper ongoing training for staff.”
Children’s Hospital has set up an around-the-clock hotline at (504) 896-2920 and took the Stöckert 3T out of service.
Almost half a million pacemakers implanted in patients with heart disease have been recalled because of a scary and shocking scenario: The life-saving devices could be tampered with remotely by computer hackers – pacemaker hacking is becoming a possibility.
The U.S. Food and Drug Administration released a safety alert in August of 2017 about potential pacemaker hacking, stating the potential for personal harm. The safety alert, titled “Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication – Firmware Update to Address Cybersecurity Vulnerabilities,” immediately grabbed headlines.
Pacemaker Hacking Fears Stoked by FDA
“White hat hackers have previously pointed out the risks with connected medical devices,” according to an article in Fortune titled “465,000 Pacemakers Recalled on Hacking Fears.” “In its announcement, the FDA noted that this vulnerability could allow third parties to rapidly drain the pacemaker’s battery or adjust the operation of the device.”
Josh Corman, director of the Atlantic Council’s Cyber Statecraft Initiative, which focuses on the public impact of cybersecurity vulnerabilities, said the threats involving such medical devices are real.
“Corman says people should not have a crisis of confidence that imperils future medical breakthroughs, despite the reality that nothing is unhackable,” CNN Money reports in an article titled “Over half a million hackable pacemakers can now be fixed.” “Instead, he says, it’s important to determine what connectivity is actually needed, and balance it with acceptable risks.”
The fix actually is easy and takes no more than three minutes, although it will require everyone affected to make an appointment with his or her doctor. The corrective action is a firmware update.
“The FDA and Abbott do NOT recommend prophylactic removal and replacement of affected devices,” the FDA states in the safety alert. “Print or digitally store the programmed device settings and the diagnostic data in case of loss during the update.
After the update, confirm that the device maintains its functionality, is not in backup mode, and that the programmed parameters have not changed.”
The FDA stated that no injuries have been reported yet but made clear the danger of that happening in the future.
“Many medical devices – including St. Jude Medical’s implantable cardiac pacemakers – contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits,” the safety alert states. “As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”
Pacemaker Hacking Scenarios Explained
The scary and shocking scenario might play out like this: A computer hacker gains access to an implanted pacemaker and changes its programmed data, resulting in improper pacing – making the heart beat too fast or too slow – depleting the battery in the process. While the FDA’s safety alert is limited to pacemakers, there is no reason bad actors are unable to gain access to other devices connected to the Internet. The firmware of these devices forms the basis of their operating systems.
Included in the recall list are the Accent DR RF, Accent MRI, Accent SR RF, Allure Quadra RF, Allure RF, Anthem RF, Assurity, Assurity MRI and Quadra Allure MP RF.
“All industries need to be constantly vigilant against unauthorized access,” Robert Ford, Abbott’s executive vice president of medical devices, said in a press release titled “Abbott Issues New Updates for Implanted Cardiac Devices.” “This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”
The topic of hacking and health care is not a new one. In 2013, former Vice President Dick Cheney revealed on CBS’ 60 Minutes he disabled a feature on his defibrillator that enabled it to be connected to Wi-Fi out of fear of being assassinated by terrorists. Also in 2013, the FDA and the Industrial Control Systems Cyber Emergency Response Team, which works to reduce the risks surrounding 16 critical-infrastructure sectors in the United States, came out with dual studies not only on pacemakers and defibrillators but on drug-infusion pumps, patient monitors and ventilators, as well – all containing passwords. A blog later published the findings.
“Pacemaker programmers do not authenticate to pacemaker devices,” the blog, titled “Understanding Pacemaker Systems Cybersecurity,” states. “Any pacemaker programmer can reprogram any pacemaker from the same manufacturer. This shows one of the areas where patient care influenced cybersecurity posture.”
Patients and physicians are urged to contact Abbott’s customer hotline for technical support. The number is 800‐722‐3774 and patients can call with questions regarding the firmware update. They additionally are urged to report any adverse events via the FDA’s MedWatch Online Voluntary Reporting Form.
Medtronic, one of the world’s largest medical-device makers, already has been the focus of high-profile litigation that resulted in an $8.45 million settlement. The Dublin, Ireland, company whose operational headquarters are in Fridley, Minnesota, is now the focus of more high-profile litigation involving thousands of Medtronic Infuse cases that could result in $300 million in payouts.
All of the cases surround the Infuse Bone Graft product. Infuse Bone Graft, when used correctly, is surgically implanted in an area of the body where bone growth is lacking. It consists of a naturally occurring protein carried via a sponge, which releases the protein in stages so it can be absorbed properly.
“Using Infuse Bone Graft eliminates the need for a second surgery to harvest, or remove surgically, bone from your body (“autogenous” bone) for placement at the surgery site,” the Medtronic Web site states. “Autogenous bone harvest has the risk of pain, complications, longer surgical time, and more anesthesia.”
Problems with Medtronic Infuse Bone Graft Explained
Problem is, Infuse Bone Graft has not been used correctly, according to the plethora of plaintiffs who have suffered debilitating and permanent injuries as a result. In some cases, patients said they were unaware they were going to receive the product.
Medtronic’s Headquarters in Fridley, Minnesota. By Group29 – Own photo, CC BY-SA 3.0, Wikipedia.
“Many of the injured patients allege in their lawsuits that they found out about the use of Infuse only after their surgery ended with complications,” reports the StarTribune in an article titled “Medtronic says it’s close to resolving Infuse lawsuits.” “Some say Medtronic sales reps were present in the operating rooms during their surgeries.”
That allegation was the root of the problem in the first case, where two men being treated at the University of California Los Angeles said their doctors were getting kickbacks from Medtronic.
“Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed,” the StarTribune reports in another article titled “Patients who received Medtronic’s Infuse product to get $8.45 million in settlements.” “They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.”
In addition to the sponge, there is another carrier for Infuse Bone Graft – the LT-Cage Device. Small, hollow and thimble-like, it is used for spinal fusion.
“Today there is a clinically studied, proven alternative to taking bone graft from the patient,” according to Medtronic. “A potential advantage to having spinal-fusion surgery using the Infuse Bone Graft and LT-Cage Device is that it removes the need to collect bone from your hip.”
Weiss and Lew both experienced extra spinal bone growth that led to nerve damage. Weiss had lumbar surgery, while Lew’s condition prompted Wang to insert the LT-Cage Device into Lew’s neck even though the U.S. Food & Drug Administration warned that could cause nerve damage.
“The following is a list of potential adverse events which may occur with oral maxillofacial surgery using the INFUSE® Bone Graft:” reads a document on the FDA’s Web site. “Some of these adverse events may have been previously reported in the adverse events table below or have been reported to the manufacturer.”
Off-Label Use of Medtronic Infuse Bone Graft Exacerbates Problems
“Ectopic and/or exuberant bone formation” is listed as a risk in addition to nerve damage. Other potential adverse events include allergic reaction, death, fetal-development complications, itching, scar formation, tissue damage and antibodies to certain types of collagen.
Such off-label use of a medical device is acceptable, according to the FDA. In response to the question of whether the FDA requires and Institutional Review Board to approve off-label use, the agency states, “No, when a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Note: Although not required by FDA, an IRB may still decide on its own initiative to review such use.”
The $8.45 million settlement was split between Weiss and Lew. Their doctor, Jeffrey Wang, is believed to have received $300,000 in consulting fees, grants and royalties from Medtronic beginning in 2000, and at one point appeared as an endorser on the company’s Web site.
“Substantially all” of the thousands of other cases that stem from the product’s misuse have reached agreements, says Mark Reilly, managing editor of the Minneapolis / St. Paul Business Journal, in an article titled “Medtronic could soon settle thousands of Infuse lawsuits.”
Reilly notes that Medtronic will pay $22 million to 950 plaintiffs, already paid $85 million to settle a shareholder lawsuit and paid another $40 million to the U.S. Department of Justice.
“In all the settlements, Medtronic denied wrongdoing,” Reilly says.
The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that were manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. This discovery was made during a routine monitoring procedure. The cytotoxicity can cause chronic infections, long-term hospitalization due to revision surgeries, paralysis, and death. On April 20th, Zimmer Biomet released an urgent Medical Device Removal notification to all of its customers to seek medical treatment to quarantine the devices.
Though not the same device, this is what a spinal fusion stimulator can look like.
Spinal Fusion Stimulator Failed Cytotoxicity Tests
“A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body,” said the FDA. “A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.” The FDA has labelled this as a Class 1 recall which is the most serious classification of recall. This severity of classification is only reserved for products that could be linked to serious complications or death.
These devices are used during spinal fusion surgery. They increase the possibility of permanently connecting two or more bones of the spine together. They are implanted in patients backs and provide constant electrical stimulation to the surgical site. This assists in fusing the vertebrae bones.
Zimmer Biomet will apparently schedule a time for removal of the quarantined devices from medical facilities by one of their sales representatives. Surgeons who extract these devices should conduct normal clinical monitoring for 3-6 months postoperatively for implanted patients. Hopefully the spinal fusion simulators were recalled in time to avoid adverse health effects in patients. However, with 100,000 of these devices already implanted in patients, that may not be the case.
The Stockert 3T Heater-Cooler, manufactured by LivaNova, has been linked to cases of mycobacterium chimaera, a type of non-tuberculosis mycobacteria (NTM), due to water contamination. The Stockert system is commonly used in medical practice. The machine supplies temperature controlled water to external heat exchangers or warming/cooling blankets on patients who are undergoing cardiothoracic surgery. They aid in circulating the blood and keeping organs at the temperature best suited to the type of surgery being performed. The water is provided to the blankets through closed circuits, and therefore has no physical contact with patients. However, the contaminated water is released through the exhaust vent of the machine, causing the bacteria to be transmitted to the patient.
In April 2016, a European study was published that detected a link between M. chimaera clinical samples from several infected cardiothoracic patients, samples from the heater-cooler devices used during said patient’s procedures, and environmental samples from the manufacturer’s facility. The contamination is believed to have occurred during the manufacturing of the product, specifically in models assembled prior to September 2014.
Mycobacterium Chimaera Spread by 3T Heater-Cooler Devices
Mycobacterium chimaera is responsible for the NTM infections that have occurred in patients who have come into contact with the Stockert Heater-Cooler system during cardiac surgery. While NTM infections caused by the 3T heater-cooler are rare, M. chimaera can cause serious illness or even death. The bacteria is not transmitted easily, however those with weakened immune systems are particularly susceptible to infection. Furthermore, the infection may not present symptoms for months, or even years, making it difficult to detect in patients. The symptoms of NTM infections include night sweats, muscle aches, weight loss, fatigue, and unexplained fever.
Safety Communication Issued by FDA over Heater-Cooler Infection Concerns
In October of 2015, the FDA issued a safety communication regarding the link between NTM infections and heater-cooler devices. The statement discussed the contamination of the device and aimed to provide recommendations to minimize the risk of infections in patients. The FDA then issued a Warning Letter to LivaNova PLC for its Stӧckert 3T Heater-Cooler System. This was a result of issues with the device that were discovered upon inspections conducted at facilities in Munchen, Germany and Arvada, Colorado. Due to the risks posed by these violations, the 3T devices manufactured in Munchen were placed under import alert. This restricted the availability of the 3T devices to facilities where the device is medically necessary. Since issuing the statement, the FDA has continually worked to investigate risk factors and causes of transmissions of bacteria through heater-cooler devices. As new information surfaces, the FDA will continue to update safety recommendations for patients and healthcare facilities.
The Center for Disease Control issued a letter for open-chest cardiac surgery patients to bring to their healthcare providers. The letter explained the details of the infection these patients had been exposed to from use of the heater-cooler device. It listed the symptoms of NTM infections and alerted health care providers to be aware of potential risks. They also outlined a course of action if a patient is suspected of having an NTM infection. The CDC recommends obtaining an acid fast bacilli (AFB) culture to identify the organism. This will determine whether M. chimera is present. The letter concluded stating that healthcare providers should contact the CDC with any questions regarding the infection.