Carbon monoxide (CO) poisoning causes more than 20,000 emergency room visits and 400 deaths each year in the U.S., according to the Centers for Disease Control and Prevention. It is a colorless, odorless, tasteless gas, making it difficult to detect and therefore difficult to prove as the culprit in countless CO poisoning cases. Many injuries and deaths can be avoided if proper precautions are taken, such as installing CO detectors and designing products to minimize the risk of CO exposure. Despite CO’s deadly effects, it seems the government has done little to recognize the issue as a serious one, while the automobile and manufacturing industries have barely acted to fix the problem at all.
Sources and Effects of CO Poisoning
The matter of CO poisoning warrants greater attention and awareness, especially after being responsible for so many deaths, like the deaths of Rodney Eric Todd and his seven children. They were all killed from accidental CO poisoning. The carbon monoxide was leaking from a gas generator inside the house that ran out of fuel but was still turned on. While this sounds like an improbable way for eight people to die, CO is known as the silent killer. Perhaps if there were clearer warnings about the dangers of keeping gas generators inside, Todd’s family would still be alive.
Carbon monoxide is a byproduct of many different products such as fuel-burning cars, household appliances, and business operations making CO poisoning possible from many different sources. The estimated annual societal cost of this poisoning is about 1.3 billion dollars based on the medical expenses and lost wages of those affected. Since the compound is commonplace, greater awareness of its effects would decrease the social burden and inadvertent deaths.
Oftentimes it can be difficult to recognize CO poisoning for its flu-like symptoms. Doctors are susceptible to misdiagnosing and improperly treating patients. Symptoms can include headache, dizziness, chest pain, vomiting, and confusion, and even loss of consciousness. One of the most commonly reported conditions is brain damage, caused by the deprivation of oxygen to the tissue and brain as CO binds to hemoglobin in the blood and spreads through the body. There is no cure for CO-related brain injuries, however there are several ways to treat patients. Treatments include cognitive and vocational rehabilitation and hyperbaric oxygen therapy, which is breathing pure oxygen in a chamber with higher-than-normal air pressure. The latter is typically used for severe cases of CO poisoning; it replaces the CO in your bloodstream faster than simply breathing fresh air. The severity of the symptoms depends on the duration of exposure, level of CO, and height and weight of the individual.
CO Poisoning Cases Are Complicated
Hyperbaric oxygen chambers like this one are sometimes used to treat victims of severe carbon monoxide poisoning.
The wide range of CO sources and the many variables that can affect CO poisoning provides a challenge to the plaintiffs in these cases because they need to prove the source of the CO, establish the cause of harmful exposure, and demonstrate the medical connection between the exposure and injuries. To gather this evidence, many types of expert analyses may be necessary, such as physicians, engineers, medical experts, and a variety of others. A different set of experts are needed to substantiate the effects CO has on the body, including cardiologists, neurologists, toxicologists, and others. Proving damages from CO poisoning is expensive for plaintiffs and results in some difficult obstacles. Another pitfall of these cases are negligence claims based on failure to install a CO detector alarm in the first place. These alarms are an easy way to prevent injury from CO. Unfortunately, CO alarms are only mandated in private domiciles by twenty-seven states via state statute and only five states require them in school buildings. More state laws requiring installation of CO alarms would help to reduce the number of CO poisoning cases.
The type of defendant also changes the way CO poisoning cases are handled. Defendants can range from property owners to hotels and restaurants to appliance repair providers. In the case of property owners, it is vital that they complete preventative maintenance and inspections to determine possible hazards before they occur. If they do not do this, it can constitute a breach of applicable duty of care. There are also various codes that apply in different situations, such as International Fire Codes, International Building Codes, and International Mechanical Codes, as well as standards such as the American National Standards. All of these codes add different layers to defending CO poisoning cases.
Determining the amount of CO in the air that is permissible can also be a contentious issue that often impedes litigation. Governmental agencies and associations have differing opinions. For example, the Occupational Safety Health Administration sets the exposure limit for the workplace at fifty parts per million as a time-weighted-average over an eight-hour period. The recommended exposure limit from the National Institute for Occupational Safety and Health is thirty-five parts per million as a time-weighted average over an eight-hour period. In living spaces, the permissible exposure limit is nine parts per million with the desired level to be zero according to the American Society of Heating, Refrigerating, and Air Conditioning Engineers. These varying numbers suggests that the amount of CO in the air can vary on a case-by-case basis, although the ideal rate is zero parts per million.
Proliferation of Keyless Ignitions in Automobile Industry Presents New Challenges
There are separate challenges presented by keyless ignition cases, which are an excellent example of the automobile industry’s lack of recognition on the issue of CO poisoning. While push-to-start features and smart keys are a technological advantage, they can lead to cars being unintentionally left on after the driver leaves the vehicle. The longer the car is left on, the more harmful exhaust full of CO is released, which can then travel from the garage into the house and harm unsuspecting families, especially if the car is left on overnight. These cars are designed to start when the key fob is nearby, however the fob can be taken away and the car will remain on. While this is a safety problem, automakers have failed to publicize this problem and will continue to promote these cars because the National Highway Traffic Safety Administration is not acting.
All of the above-mentioned complications of CO poisoning result in costly and complex litigation. Each case entails a unique set of requirements and must be approached with individual manner. More accidental deaths will continue to happen, and they will require more persistent advocates to get the attention and care their cases require unless awareness of CO poisoning is more widely spread.
One trillion dollars. That’s how much the country spent on the opioid epidemic between 2001 and 2017, according to a report released by the nonprofit institute Altarum, a consulting group focused on improving public health.
The cost of the crisis trickles both up and down and impacts corporations, governments and insurance companies, as well as families, local businesses and neighborhoods.
“The greatest cost comes from lost earnings and productivity from overdose deaths – estimated at $800,000 per person based on an average age of 41 among overdose victims,” the report states. “This figure is largely made up of lost wages of workers and productivity losses of employers, but it also weighs on government in the form of lost tax revenue. It has increased in recent years as the epidemic has transitioned away from older people to younger ones and from prescription opioids to illicit drugs.”
Opioid Epidemic Results in High Costs to Society
More than 42,000 deaths were caused by opioid overdoses in 2016, according to the U.S. surgeon general’s office. In 2010, the death toll was 21,000. The startling spike spurred the office to take action, with Dr. Jerome Adams issuing an advisory: “Be prepared. Get naloxone. Save a life.” Naloxone is an easily administered nasal spray that quickly reverses the deadly symptoms of an overdose.
“Health care costs related to the opioid crisis reached $215.7 billion from 2001 to 2017,” the report states. “This stemmed largely from emergency room visits to treat and stabilize patients after an overdose, any associated ambulance and Naloxone use required, and related indirect health care costs associated with the increased risk of other diseases or complications.”
And the costs have nowhere to go but up.
“An additional $500 billion is estimated through 2020 if current conditions persist,” the report states.
Governing magazine, a nonpartisan news outfit, reports that Middletown, Ohio, spent $1 million-plus on ambulance dispatches for overdoses between October 2016 and October 2017. It also reports that Pennsylvania will spend $5 million this year on naloxone alone. In Nebraska, the epidemic costs $465 per resident. In West Virginia, it costs $4,793 per resident. The state has one of the highest rates of opioid overdoses in the country.
“The costs build up slowly over time, so you almost don’t even notice it,” Nashville lawyer Mark Chalos told the magazine in an article titled “How Much Is the Opioid Crisis Costing Governments?” “But when our people really started to dig into the budgets, they realized the costs are more significant.”
Geographic Factors in Opioid Epidemic
The American Enterprise Institute, a public-policy think tank, conducted a study on “The Geographic Variation in the Cost of the Opioid Crisis” and found the costs of the opioid epidemic are disproportionate at state and local levels, as exemplified by the Nebraska / West Virginia comparison.
“The types of costs attributable to opioid abuse – health care costs, criminal justice costs, and lost productivity, for example – are fairly well understood, as is the economic impact of the crisis at the national level,” the study states. “However, the economic burden of the opioid epidemic is unevenly distributed across the country, with many communities especially hard hit. As federal, state, and local policymakers and stakeholders seek to curb the epidemic, it is vitally important that they know how these costs are distributed.”
VSL – Value of a Statistical Life – A New Way to Measure Cost of Opioid Epidemic
Enter the White House’s Council of Economic Advisers, or CEA. The federal agency compiled a paper in November 2017 that used a metric called the Value of a Statistical Life, or VSL, to gain insight into the costs of the opioid epidemic. The VSL essentially puts a price tag on one’s willingness to lower his or her death risk. It is helpful for shaping policies and programs that reduce fatalities.
“CEA finds that previous estimates of the economic cost of the opioid crisis greatly understate it by undervaluing the most important component of the loss – fatalities resulting from overdoses,” states the executive summary of the paper, titled “The Underestimated Cost of the Opioid Crisis.” “CEA estimates that in 2015, the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP that year. This is over six times larger than the most recently estimated economic cost of the epidemic.”
The paper states that though this is the first of its kind to be published, it will not be the last.
“A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it,” it concludes. “CEA will conduct further economic analysis of actual and proposed demand- and supply-side interventions; consider the impact of public programs such as Medicare and Medicaid; and explore the important role of medical innovation in combatting the crisis.”
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.
The next hearing session of the United States Judicial Panel on Multidistrict Litigation is scheduled for November 30, 2017 in St. Louis, Missouri. Eight matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters include trending issues such as Equifax’s massive 2017 data breach and the national opioid litigation against Big Pharma manufacturers and distributors. Ten matters will be considered for centralization without the parties making oral arguments.
What is the United States Judicial Panel on Multidistrict Litigation?
Multidistrict litigation is a mechanism for increasing efficiency in the federal court system. Created through an Act of Congress in 1968, 28 U.S.C. 1407, the law allows for the transfer of civil actions involving common questions of fact to one federal district court for coordinated or consolidated pretrial proceedings. To transfer a case, the Judicial Panel on Multidistrict Litigation must determine that the transfer will (1) be for the convenience of parties and witnesses; and (2) promote the just and efficient conduct of the related lawsuits. The efficiency in transferring cases to on federal court, or “centralization,” is accomplished through avoidance of discovery duplication, prevention of inconsistent pretrial rulings, and conserving resources of the parties, their attorneys, and the judiciary. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which Judge will handle the centralized proceedings.
The Judicial Panel on Multidistrict Litigation consists of seven sitting federal judges appointed to serve on the panel by the Chief Justice of the United States Supreme Court. Appointment is reflective of a judge being held in high esteem on the bench. The current Chair of the panel is Judge Sarah S. Vance from the Eastern District of Louisiana.
Currently, there are Multidistrict Litigation matters pending in disaster cases involving the September 11 terrorist attacks, the Deepwater Horizon oil spill; intellectual property; employment cases; securities litigation; and several others. Multidistrict Litigation is most frequent in cases involving products liability, antitrust, or marketing and sales practices. To date in 2017, Multidistrict Litigation has been formed in 9 products liability matters; 4 marketing and sales practice matters; and 2 antitrust matters.
Matters Set for Oral Argument
The following matters are scheduled for oral argument during the hearing session:
- MDL No. 2777 – In re: Michael Stapleton Associates, Ltd., Fair Labor Standards Act (FLSA) and Wage Hour Litigation
- MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation
- MDL No. 2801 – In re: Capacitors Antitrust Litigation (No. III)
- MDL No. 2802 – In re: Epipen (Epinephrine Injection, USP) Employee Retirement Income Security Act (ERISA) Litigation
- MDL No. 2804 – In re: National Prescription Opiate Litigation
- MDL No. 2806 – In re: McGregor-Mayweather Boxing Match Pay-Per-View Litigation
- MDL No. 2807 – In re: Sonic Corp. Customer Data Security Breach Litigation
- MDL No. 2808 – In re: Anthony Spencer Green, Sr. Litigation
Notable Motions to Transfer
MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation. This matter involves over 300 cases filed against the consumer credit agency, alleging violations of state and federal laws for the company’s purported failure to use adequate safeguards to protect consumers. The alleged failures resulted in unauthorized individuals gaining access to Equifax, Inc.’s data network storing the private information of 143 million consumers. The Plaintiffs suing Equifax, Inc. moved for consolidation when only 22 cases were pending and noted numbers were likely to rise quickly given the amount of victims; by the morning of the hearing, over 300 cases had been filed. Equifax, Inc. acknowledged the data breach in September 2017; records accessed included names, Social Security numbers, birth dates and, in some cases, driver’s license numbers.
MDL No. 2804 – In re: National Prescription Opiate Litigation. Counsel representing several Plaintiffs filed for consolidation of the actions of state, county, and municipal governments and other agencies against opiate manufacturers Purdue Pharma, Teva/Cephalon, Janssen, Endo, Actavis, and Mallinckrodt and distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc. The lawsuits allege negligence as well as violations of public nuisance laws, state consumer protection statutes, and the Federal Racketeer Influenced and Corrupt Practices Act, 18 U.S.C. §§1961, et seq. Plaintiffs allege opioid manufacturers and distributors misrepresented the risk of addiction associated with opioid use to regulators, doctors, and patients and failed to report suspiciously large orders of their drugs, actions which allegedly contributed to the current nationwide opioid epidemic.
The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley, led by veteran pharmaceutical and medical device lawyers Brenda Fulmer and C. Calvin Warriner, III, recently filed several more lawsuits against the manufacturers of Xarelto. The law firm has filed dozens of personal injury and wrongful death lawsuits against Bayer and Janssen Pharmaceuticals alleging that Xarelto is defective and has caused numerous serious and some fatal bleeding injuries to patients.
Searcy Denney Files Xarelto Lawsuits
One of the newly-filed lawsuits involves a Dade County, Florida resident who began taking Xarelto after being diagnosed with atrial fibrillation after failing aspirin therapy. The patient was placed on Xarelto in 2014. One of the allegations in the national Xarelto litigation effort is that prescribing doctors should have been warned by Xarelto’s manufacturers that this particular blood thinner should not be considered as first-line therapy in light of the reported increased incidence of bleeding injuries, the lack of an antidote to reverse the anti-clotting effects of Xarelto (which is available for Coumadin and Pradaxa), and the inability to determine which patients might be particularly susceptible to a bleeding episode while on Xarelto. This patient developed an acute upper GI bleed, the most common injury associated with Xarelto, after taking the drug for about a year. The patient developed significant hematuria (blood in urine), severe abdominal pain, and coffee-ground stool (a classic sign of bleeding in the gastrointestinal tract). The patient developed severe anemia which led to respiratory failure and significant abdominal bleeding which caused the bladder to rupture.
Searcy Denney’s pharmaceutical lawyers also filed a recent lawsuit on behalf of a Delray Beach, Florida patient who developed a GI bleed and bleeding in his brain after taking Xarelto for three years. This patient was prescribed Xarelto in 2012, shortly after this drug was approved by the FDA. At the time, there was a lot of hype over Xarelto and its ease of use over Coumadin, which requires regular blood monitoring of INR levels and dietary and medication restrictions. Patients were assured that Xarelto had the same safety profile as Coumadin, yet it would be easier to use and be less of a hassle, which was very compelling to young patients with busy lives. Unfortunately, since then, Xarelto has become one of the drugs with the highest number of adverse events reported to the FDA. In the pending Xarelto MDL litigation, the plaintiffs contend that Xarelto patients face a far greater risk of developing bleeding injuries than patients who ingest Coumadin and that representations in Xarelto’s warning label and marketing materials to the contrary were false.
The third recent lawsuit filing by our Mass Tort Unit involves a wrongful death claim on behalf of the surviving family members of a Pompano, Florida man who died in Broward County earlier this year due to an intracranial hemorrhage after ingesting Xarelto for a few months. Prior to starting Xarelto in 2016, the patient had taken Plavix and aspirin for several years for his atrial fibrillation. The primary use of Xarelto is in patients with this common heart arrhythmia who are at risk of developing blood clots and ischemic strokes from pooling of blood in the heart. Anticoagulant drugs (like Coumadin, warfarin, Xarelto, Pradaxa, and Eliquis) thin the blood and make patients less likely to develop blood clot-related injuries, including ischemic strokes where a clot blocks blood flow in the brain. Xarelto, however, has a propensity to cause hemorrhagic strokes, where there is bleeding in the brain (rather than a blockage).
Xarelto Lawsuits Consolidated into MDL
These individual lawsuits will become a part of MDL No. 2592, which are coordinated legal proceedings for Xarelto pending in New Orleans. Currently, there are more 18,000 individual lawsuits pending in these multi-district litigation proceedings. These cases include both personal injury and wrongful death claims, and most involve allegations that use of Xarelto led to the development of bleeding injuries in the GI tract or brain. Bleeding injuries have been reported after just a single dose of Xarelto. Judge Eldon Fallon is presiding over the national litigation and has extensive experience with supervising complex pharmaceutical cases. There are also nearly 1,500 cases pending in state court in Pennsylvania.
The third bellwether trial against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer Corporation began on August 7, 2017, at a federal courthouse in the Southern District of Mississippi in Jackson. This case involves Dora Mingo, a 69-year-old retired schoolteacher from Summit, Mississippi who developed deep vein thrombosis (a “DVT”) in January of 2015, after undergoing hip implant surgery earlier that month. She developed by the DVT while she was on the blood thinner Lovenox following her hip surgery, so a hospital doctor prescribed Xarelto 15 mg to be taken twice a day for 21 days and then a 20-mg dose to be taken daily after that. After taking Xarelto for only a few weeks, Ms. Mingo’s blood work showed significant abnormalities in her hemoglobin and hematocrit levels, and she was instructed to go to the ER immediately. At the hospital, she was diagnosed with severe anemia and testing showed that she had an acute upper GI bleed for which she received blood transfusions and underwent a procedure to clip a bleeding ulcer. She was hospitalized for two days for the Xarelto-induced bleed and associated anemia.
The Xarelto defendants sought to dismiss her lawsuit and prevent the jury trial from proceeding in July and contended that Ms. Mingo was unable to prove that Xarelto was defective under Mississippi’s product liability law which requires that the plaintiff prove that the product was unreasonably dangerous to consumer and that she was injured by the drug. Further, Bayer and Janssen contended that Ms. Mingo’s case should be dismissed as they do not believe that she can fulfill her burden to prove that the Xarelto that she ingested failed to function as expected and that there was a feasible alternative medication available that she could have taken and avoided the risk of developing the upper GI bleed and anemia. In the Xarelto MDL litigation, the plaintiffs contend that there are safer alternative blood thinners available, including Coumadin or warfarin (which have been prescribed for decades) as well as other modern blood thinners, including Eliquis (which has a different dosing regimen) and Pradaxa (which reportedly now has an antidote available). The plaintiffs have also argued that manufacturers should warn that patients be given a blood test (known as an anti-Factor Xa assay, which is being used in Europe to identify high-risk patients) prior to use of the newer blood thinners to confirm that the patient will tolerate the drug.
The biggest challenge in meeting the plaintiff’s burden of proof is that the FDA has not determined that Xarelto is unreasonably dangerous (and, in fact, has promoted the safety of the drug). The plaintiff also has a burden in proving that the risk of a GI bleed is higher with Xarelto than with the other blood thinners, as the studies on this issue are conflicting and all blood thinners can cause GI bleeding events. The FDA originally approved Xarelto (also known as rivaroxaban) in 2011 for blood clot and stroke prevention in patients with atrial fibrillation and those who have undergone orthopedic surgeries.
Request for Summary Judgment from Defendants Denied
On July 21, 2017, Judge Fallon denied the defendants’ request for a summary judgment dismissing the lawsuit under Mississippi’s product liability statute, finding that there were disputed fact issues that prevented the claims from being dismissed prior to trial. It is likely that these same issues will be raised during the course of the trial after evidence and testimony on the existence of a product defect is presented to the Mississippi federal court jury. Additional motions to dismiss the case on the basis of federal court preemption and claims that federal law prevented Xarelto’s manufacturers from enhancing the safety warnings for the blood thinner have also been denied by the MDL judge. Judge Fallon also considered and rejected motions from both parties to exclude their opponents’ expert opinions on the risks associated with other anti-coagulants, unapproved dosing and monitoring regimens, and whether Ms. Mingo’s injuries were caused by her short-term use of Xarelto.
Judge Fallon is expected to preside over a fourth Xarelto bellwether trial, the Henry case, in Texas federal court later this year. The first two MDL bellwether trials were tried before juries in New Orleans and both resulted in verdicts in favor of the drug’s manufacturers. Appeals are pending regarding these trial losses by the plaintiffs.
The law firm of Searcy Denney, with offices in West Palm Beach and Tallahassee, represents more than 50 clients in their mass tort product liability lawsuits against the manufacturers of Xarelto. The firm has a dedicated Mass Tort Unit that focuses solely on drug and medical device claims. The timeframe for filing of lawsuit over a defective drug can be short, so please do not delay in contacting a lawyer if you or a loved one have suffered a gastrointestinal bleed, bleeding in the brain, or other injury associated with the use of Xarelto.
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.