The next hearing session of the United States Judicial Panel on Multidistrict Litigation (“JPML”) is scheduled for January 31, 2019 in Miami, Florida. Six matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters set for this session include such hot topics as the massive Marriott data breach and litigation over Valsartan products contaminated with NDMA, a probable human carcinogen.
2018 JPML Year in Review
2018 saw a continuation of the pattern of decreasing motions for consolidation. Only 56 motions for centralization were filed in 2018, the lowest number in at least nine years and less than half of the 121 motions filed in 2009. However, the JPML centralized 28 of these new requests, an increase over the past two years. More actions were involved in those granted motions to centralize, the most in more than nine years. So, while requests to centralize are down, those actions that are centralized involve more lawsuits than in the recent past. MDLs continue to be dominated by products liability and antitrust cases. However, four new intellectual property MDLs were created in 2018.
Matters Set for January 2019 Oral Argument
The following matters are scheduled for oral argument during this first hearing session of the year:
• MDL No. 2875 – In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation
• MDL No. 2876 – In Re: Enhanced Recovery Company, LLC, Fair Debt Collection Practices Act (FDCPA) Litigation
• MDL No. 2877 – In Re: Air Crash at Durango, Mexico, on July 31, 2018
• MDL No. 2878– In Re: Ranbaxy Generic Drug Application Antitrust Litigation
• MDL No. 2879 – In Re: Marriott International, Inc., Customer Data Security Breach Litigation
• MDL No. 2880 – In Re: H&R Block Employee Antitrust Litigation
Notable Motions to Transfer
MDL No. 2875 – In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation. A class action plaintiff filed for transfer of at least fifteen consumer class action lawsuits and two individual lawsuits arising out of use of the generic drug Valsartan. The lawsuits were filed against manufacturers, distributors, and marketers of Valsartan – a prescription drug used primarily to treat high blood pressure and heart failure – following a July 2018 FDA announcement regarding voluntary recalls of several products containing the active ingredient valsartan after the products were found to contain NDMA, a probable human carcinogen. The moving plaintiff requested transfer to the District of New Jersey, where many of the actions are currently located and which serves to house the headquarters of at least three named defendants.
The main dispute over centralization between the parties in this case appears to be whether consumer class actions seeking solely economic damages and product liability cases requesting personal injury damages should be consolidated. Several of the defendants have opposed the transfer motion; while most defendants agree to transfer of the consumer class actions if the JPML feels it is warranted, they seek denial for the transfer of any individual personal injury claims.
MDL No. 2879 – In Re: Marriott International, Inc., Customer Data Security Breach Litigation. Data breach litigation continues trending in MDL requests for 2019; here, two motions for consolidation and transfer of litigation have been filed over the Marriott International, Inc. and Starwood Hotels & Resorts Worldwide, LLC data breach. The ten lawsuits that had been filed as of December 3, 2018 at the time of filing the motion to transfer has now grown to over 35 lawsuits. Plaintiffs allege Marriott failed to protect its customers’ private information, resulting in four years of hacker access to the reservation system of its hotel chains. Marriott disclosed the data breach on November 30, 2018, acknowledging that the names, addresses, credit card numbers, phone numbers, passport numbers, travel locations, and arrival and departure dates were exposed for up to 500 million customers. The two initial motions both requested transfer and consolidation to the District of Maryland, where Marriott headquarters are located, one alternatively suggesting the District of Massachusetts. Several briefs have subsequently been filed suggesting transfer to Florida, Connecticut, and New York.
MDL No. 2880 – In Re: H&R Block Employee Antitrust Litigation. This request to transfer and consolidate putative class action lawsuits centers around allegations that H&R Block violated the Sherman Antitrust Act by engaging in conspiracies not to compete for employees and to suppress employee wages. The lawsuits were filed on the heels of a July 2018 letter from 11 state attorneys general to eight national fast food franchisers requesting information about similar “no-poach” agreements in franchise contracts. The state attorneys general cited concern for such agreements limiting the abilities of fast-food and other low wage workers to seek raises and promotions in announcing the request for information. The current lawsuits allege that H&R Block has a policy in its own stores and require its franchisees to execute “no-poach” agreements, resulting in average wages of $10.86 per hour for H&R Block seasonal tax preparers as opposed to an industry hourly wage average of $22.67. H&R Block has opposed the transfer, citing only two jurisdictions where lawsuits have been filed as well as an arbitration agreement that it anticipates will remove at least two of the pending lawsuits.
For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves. Product Quest Manufacturing, a Florida company that manufactures the product, recommends consumers stop using it immediately and either discard or return the spray to the place of purchase.
On August 8, 2018, the U.S. Food and Drug Administration (“FDA”) announced a voluntary recall of the CVS Health 12 Hour Sinus Relief Nasal Mist. Product Quest Manufacturing found a specific lot of their spray was contaminated with bacteria Pseudomonas aeruginosa. According to Product Quest, “repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised.”
The recalled products can be identified by locating the side panel. The side panels are coded with “Lot 173089J” and “EXP 09/19.” 16,896 units are involved in the recall. The units were sold nationwide.
What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is the most common strain of the Pseudomonas infection to cause problems in humans. Infections with this type of bacteria are generally treated with antibiotics, although the Centers for Disease Control and Prevention notes that some strains – mostly in healthcare facilities – can be multidrug-resistant. Pseudomonas aeruginosa infections associated with healthcare facilities often cause bloodstream infections, pneumonia, urinary tract infections, and surgical wound infections. Exposure to Pseudomonas aeruginosa is seen in hot tubs and swimming pools. These mild exposures in normally healthy people result in ear infections or skin rashes. Symptoms can also mimic the common cold or flu and include sinus pain and pressure, fever and chills, body aches, light-headedness, rapid pulse and breathing, nausea and vomiting, diarrhea, or decreased urination.
Regulation of Over-the-Counter Medications
As an over-the-counter, or nonprescription, medication the CVS Health 12 Hour Sinus Relief Nasal Mist is sold directly to consumers without a prescription. In 1951, the Durham-Humphrey Amendment to the Federal Food, Drug and Cosmetic Act of 1938 established a legal framework for prescription and non-prescription drugs. The Amendment also authorized the FDA to make this prescription/over-the-counter distinction. The FDA states that medications designated as over-the-counter are generally safe and effective when used as directed. However, just because the FDA presumes over-the-counter drugs are safe does not mean they are free of defects. Being vigilant requires reading warning labels, taking medications as directed and watching for recalls such as this one for the CVS 12 Hour Sinus Relief Nasal Mist.
The FDA announcement directs consumers who have been injured by the nasal mist to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail or by fax.
If you become ill or are injured by an over-the-counter medication, seek the assistance of a physician or health care provider.
In an age where data is widely available and almost everything is stored online, data breaches are becoming more common, and the outcomes of cases involving data breaches are unpredictable. Data involved in a breach can range from financial data, such as credit card numbers, to health data, such as treatments and medical history. Based on previous settlements reached, stolen health data typically has the most extensive damages due to the incredibly personal nature of the data, while stolen credit card data has the least damages. It is a lot easier to cancel and replace a credit card than it is to replace identifying information such as a Social Security number. When there is a breach of identifying information, continued alertness is necessary to prevent identity theft, adding to the costs.
The Type of Data in a Data Breach Matters
There are two cases that illustrate the disparity between settlements involving different types of data. An infamous hacker who goes by the name “Cumbajohnny” was responsible for hacking both T.J Maxx and Heartland Payment Systems. Data for approximately 130 million credit and debit cards was stolen from Heartland, and more than 45 million credit card5s were affected from the T.J Maxx breach. However, the Heartland settlement was $500,000, despite involving the breach of three times the amount of data. The T.J Maxx settlement was valued at $6.1 million. The court’s value was based on the type of data breached; Cumbajohnny and his cohort stole identification information from at least 450,000 customers of T.J Maxx, including Social Security and driver’s license numbers. Although the nominal value of credit card information was larger for Heartland, considering the threat of identity theft, the real value of the 455,000 people affected from T.J Maxx was much greater. In fact, eighty-six percent of the T.J Maxx settlement was from the much smaller number of identifying information stolen, and the other fourteen percent is attributed to the 45 million stolen card records.
Although identifying information is valuable in settlements, medical records often add the most value to a data breach settlement because they contain deeply personal information. For example, the breach of Advocate Health Care included unencrypted medical records, affecting 4.03 million patients. The case settled for $5.55 million, remaining the largest HIPAA settlement to date. This case exemplifies the need to keep up with the swiftly-evolving digital landscape to protect clients’ information. It may also demonstrate legislative attention to particularly personal and sensitive data. Due to the variation and uniqueness of each data breach case, it is important to evaluate the types of compromised data.
Identify Theft Also Important Factor
Generally, cases with elements identity theft will be stronger because it is difficult to prove standing without it. Some jurisdictions require the plaintiff to have suffered from identity theft to have standing. It can be difficult to prove that the hacker had malicious intention and/or sold the data they stole, and until they do sell it, some jurisdictions will not give the class standing. For large data breach cases, such as the T.J Maxx settlement, the plaintiff’s attorneys must be prepared to litigate the case under the standing rules of the federal court in any district because many cases filed all over the country can be consolidated into one federal district court for multidistrict litigation.
The value of data breach cases does not only include the monetary value of the breach. Protection against future losses, such as improved digital security and credit monitoring, are important to preventing identity theft and ensuring the affected company isn’t breached again. It can be beneficial to the plaintiff if the company at fault had a previous breach and did not take proper measures to increase their security.
What Happened After the Breach?
Before initiating a case, it is valuable to research what a company has already done after experiencing a breach. Oftentimes, the company will offer one-year free credit-monitoring for customers who experience ongoing credit risk. While credit-monitoring is helpful for preventing a breach, some companies may only monitor one of the three credit bureaus (Equifax, Experian, and TransUnion) to keep costs low, leaving customers vulnerable to fraudulent activity that shows up on other bureau’s credit reports.
Researching if the company bulked up its security after a breach is also useful. It can be difficult to find exactly what the company did in the aftermath because the discovery may not be accessible. Cybersecurity blogs can come in handy to get technical details of how the hacker was able to get into the company’s system in the first place and learn what, if anything, the company did to improve security. If there is a lot of room for security or credit-monitoring improvement, the value of the settlement may be greater, however the court can enforce this by either raising the dollar value of the settlement or mandating the company increases security. For example, after the Target data breach, which affected 41 million customers, the settlement required Target to employ a chief officer who manages security, to actively monitor its systems for security events, provide security training to its employees for five years, and perform routine security assessments. The case settled for $18.5 million, but the injunctive relief was much greater.
Third Party Vendors Can Play Role
Determining if the company or a third-party vendor is at fault for the breach can be challenging. The company experiencing the data breach often claims they have the most up-to-date security systems, however discovery usually reveals gaps that the hackers used to get in and out with the data. If a third-party could be responsible, it would be best to establish the relationship between the company and the vendor as soon as possible and determine if the vendor is primarily responsible for the breach.
An example where the vendor was unmistakably at fault is the case of the Stanford Hospital data breach. The hospital’s business associate (BA), Multi-Specialty Collection Services, LLC, posted 20,000 patients’ emergency room records, including hospital account numbers, billing charges, and emergency room admission and discharge dates, to a student homework website asking how to graph the patients’ data. Stanford Hospital properly encrypted the records before sending them to the vendor, but they were still responsible for paying the administration costs of the $4 million settlement. The hospital also agreed to train its vendors on how to most effectively protect patient data. Since vendors are typically smaller entities, they likely have fewer resources, and this could affect the settlement amount.
The U.S. Food and Drug Administration’s (FDA) slow and retroactive response to toxic chemicals found in cosmetics is being called into question. In the past year, there have been more protests urging the FDA to ban lead acetate, a compound found in hair dyes. It was banned in Canada and Europe nearly a decade ago for causing toxic levels of lead to build up in the blood, so what is taking the U.S. so long? Part of the reason why harmful chemicals aren’t banned from cosmetic products faster is that the FDA can only regulate products if it receives “reliable information,” as stated in the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Public protests, such as the petitions against lead acetate, are the beginning of the process that incites the FDA to begin research of the chemical, but this research can take years to complete. It is the responsibility of the FDA to find evidence that a certain product is harmful when used as intended because the manufacturer of the product is not required to submit their data. The research necessary to find such evidence takes time to complete. In the meantime, these dangerous chemicals will already have continued to harm many people.
Cosmetic Industry Also at Fault
The FDA’s response to toxic chemicals in cosmetics is not the only issue; there is no regulation of chemicals before the cosmetic products go to market. A company does not have to perform particular tests on products containing new chemicals, nor is it mandatory for the companies to publicize safety data they collect. Lack of accountability has allowed cosmetic manufacturers to use chemicals in everyday items, such as shampoo and toothpaste. Some cosmetics can contain formaldehyde, a byproduct of some preservatives put into cosmetics. The chemical is commonly used as a preservative for dead animal parts, such as the frog you may have dissected in science class. Formaldehyde was declared a human carcinogen by the National Toxicology Program at the Department of Human Health and Services in 2011 because it can cause cancers of the nasal cavity, myeloid leukemia, and rare cancers. About one fifth of cosmetics contain formaldehyde, a scarily high percentage.
Preventative Measures Are Ready For Congressional Passage
Henri de Toulouse-Lautrec’s “Woman at her toilette”
Consumers should not have to worry about using cosmetics which may have toxic effects on their bodies. One preventive measure the U.S. could enact is to ban chemicals based on preliminary toxicity data rather than the exhaustive data and research that is required. The Personal Care Products Safety Act is a piece of legislation recently introduced in Congress by Senator Dianne Feinstein which may help solve the problem. If passed, the bill will give the FDA the authority to take products off of store shelves immediately after receiving any reports of customers experiencing bad reactions. This will help close the gap between initial complaints and the years it takes the FDA to gather information before banning the chemical. Furthermore, the bill includes the mandate that manufacturers register their facilities and pay a fee to the FDA. The money will be used to determine the safety of at least five cosmetic ingredients a year. This preventative measure will help eliminate the inefficient process of removing harmful products from store shelves after they have gone to market.
While passage of this bill would be an excellent start to solving the problem, the FDA must enforce more thorough regulation of cosmetic products all around. Unfortunately, the laws on regulation of cosmetics do not require FDA approval before being put on the market, apart from color additives. The administration advises the manufacturers to consult available toxicological test data and perform any additional tests necessary to ensure the safety of the product. However the FDA has no legal jurisdiction to ban a product unless a law has been broken, such as the misbranding of a product. Implementing stricter regulations on companies will bring more peace of mind to consumers who should not have to worry about the toxicity of their cosmetics in the first place.
The next hearing session of the United States Judicial Panel on Multidistrict Litigation (“JPML”) is scheduled for March 29, 2018 in Atlanta, Georgia. Ten matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings, covering a variety of hot topics. The hearing session will cover two data breach matters, a bitcoin exchange issue, and two patent litigation consolidation requests.
Overview of January 2018 Hearing Session
Following the January 25, 2018 hearing session in Miami, Florida, the JPML issued transfer orders centralizing cases and creating new Multidistrict Litigation (“MDL”) in seven out of the thirteen new petitions:
- MDL No. 2809 – In Re: Onglyza (Sexagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation (Transferred to the Honorable Karen K. Caldwell, Eastern District of Kentucky)
- MDL No. 2814 – In Re: Ford Motor Co. DPS6 Powershift Transmission Products Liability Litigation (Transferred to the Honorable André Birotte, Jr., Central District of California)
- MDL No. 2816 – In Re: Sorin Heater-Cooler System Products Liability Litigation (No. II) (Transferred to the Honorable John E. Jones, III, Middle District of Pennsylvania)
- MDL No. 2817 – In Re: Dealer Management Systems Antitrust Litigation (Transferred to the Honorable Amy J. St. Eve, Northern District of Illinois)
- MDL No. 2818 – In Re: General Motors Air Conditioning Marketing and Sales Practices Litigation (Transferred to the Honorable Matthew F. Leitman, Eastern District of Michigan)
- MDL No. 2819 – In Re: Restasis (Cyclosporine Opthalmic Emulsion) Antitrust Litigation (Transferred to the Honorable Nina Gershon, Eastern District of New York)
- MDL No. 2820 – In Re: Dicamba Herbicides Litigation (Transferred to the Honorable Stephen N. Limbaugh, Jr., Eastern District of Missouri)
Matters Set for Oral Argument
The following matters are scheduled for oral argument during the March 29 hearing session:
- MDL No. 2822 – In Re: First Databank Prescription Information Litigation
- MDL No. 2824 – In Re: Gold King Mine Release in San Juan City, Colorado, on August 5, 2015
- MDL No. 2825 – In Re: Alteryx, Inc., Customer Data Security Breach Litigation
- MDL No. 2826 – In Re: Uber Technologies, Inc., Data Security Breach Litigation
- MDL No. 2827 – In Re: Apple Inc. Device Performance Litigation
The former Bitcoin exchange called Mt. Gox is the subject of a pending consolidation motion.
- MDL No. 2828 – In Re: Intel Corp. CPU Marketing Sales Practices and Products Liability Litigation
- MDL No. 2829 – In Re: Mt. Gox Bitcoin Exchange Litigation
- MDL No. 2830 – In Re: Uniloc USA, Inc., and Uniloc Luxembourg, S.A., HPE Portfolio Patent Litigation
- MDL No. 2831 – In Re: AM Retail Group, Inc., Fair Labor Standards Act (FLSA) and Wage and Hour Litigation
- MDL No. 2832 – In Re: Liquid Toppings Dispensing System (‘447) Patent Litigation
Notable Motions to Transfer
MDL No. 2827 – In Re: Apple Inc. Device Performance Litigation. A class action plaintiff in the Northern District of California filed for transfer of actions across the country against Apple, Inc. The petition for transfer states that the actions sought to be consolidated and coordinated all deal with Apple “throttling” the performance of older model iPhones following the release of the iOS 10.2.1 operating system. The “throttling” allegedly involved automatically slowing down iPhone system performance to use less energy and conserve battery when the OS detected a battery that was not working well. The lawsuits allege that Apple failed to inform consumers that it was purposefully slowing down its devices, or to provide a promised fix to the problem; ultimately, the lawsuits claim consumers were denied the opportunity to make an informed decision about whether to buy a new iPhone or a much less expensive replacement battery.
MDL No. 2832 – In Re: Liquid Toppings Dispensing System (‘447) Patent Litigation. One of two proposed patent litigation MDLs set for argument during this session, this matter involves defendants’ request to transfer over twelve actions involving competing franchises that offer frozen treats and flavored, shaved ice from specially-designed trucks to one MDL. Kona Ice, Inc. advertises that its trucks are “entertainment vehicles” whose best feature is the “Flavorwave,” a row of self-service taps that dispense flavors that go over shaved ice. Kona Ice, Inc. filed several lawsuits in September 2017 against franchisees of Tikiz Franchising, LLC alleging infringement of its patent related to the design of the Kona Ice truck.
MDL No. 2826 – In Re: Uber Technologies, Inc., Data Security Breach Litigation. Data breach litigation continues trending in MDL requests; here, two plaintiffs move for transfer of litigation over the Uber Technologies, Inc. data breach to the Northern District of California. As of the day prior to the March hearing session, the proposed MDL had 21 associated actions – at least twelve of which are putative class action lawsuits. Plaintiffs allege that Uber and other defendants violated state consumer protection statutes, breached express and implied contracts as well as its fiduciary duties and covenants of duty to act in good faith and fair dealing by failing to protect the private information of its 57 million customers and drivers. Even more egregious are allegations that Uber engaged in efforts to hide the breach and failed to reveal it to the public until 2017.
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.