3M Combat Arms Earplugs May Have Caused Hearing Loss
The Judicial Panel on Multidistrict Litigation (JPML) issued a Transfer Order on April 3, 2019 centralizing lawsuits against 3M relating to allegations of issues regarding the design, testing, sale, and marketing of the dual-ended Combat Arms Earplugs, Version 2. The newly created Multidistrict Litigation (MDL) will be overseen in the Northern District of Florida by Judge M. Casey Rodgers, a federal judge with prior experience handling a large-scale MDL.
In July 2018, 3M announced a $9.1 million payment to resolve allegations that it knowingly sold its dual-ended Combat Arms Earplugs, Version 2 to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device. On the heels of this announcement, individual service members suffering from problems including hearing loss and tinnitus began filing lawsuits alleging their hearing injuries resulted from use of the earplugs.
JPML Coordination of 3M Combat Arms Earplugs Hearing Loss Lawsuits
In early 2019, Plaintiffs requested coordinated pretrial proceedings, otherwise known as the formation of an MDL, over the eight lawsuits filed at the time on the basis that the lawsuits all made similar allegations of wrongdoing against 3M. Less than four months later and on the date the JPML entered the Transfer Order, the Court noted it was aware of 635 related lawsuits (in addition to the original eight) filed in 33 different courts. The JPML granted the Transfer Order after finding the lawsuits “involve common factual questions arising out of allegations that defendants’ Combat Arms earplugs were defective, causing plaintiffs to develop hearing loss and/or tinnitus…[c]entralization will eliminate duplicative discovery; prevent inconsistent rulings on Daubert issues and other pretrial matters; and conserve the resources of the parties, their counsel, and the judiciary.”
Barring objections, all of the related lawsuits – and future lawsuits filed by Combat Arms Earplugs, Version 2 users – will be transferred to the Northern District of Florida. The JPML reviewed suggestions to transfer the cases to other locations including the District of Minnesota – the location of 3M’s corporate headquarters, the Western District of Missouri, the District of Columbia, the Middle District of Georgia, and the Southern District of Florida, among others. It ultimately chose the Northern District of Florida as “a forum with the necessary judicial resources and expertise to manage this litigation efficiently and in a manner convenient for the parties and witnesses.” It is important to note that any lawsuits that are not resolved through settlement, bellwether trial, or motion practice during pretrial proceedings will be transferred back for plaintiffs to have individual trials at the conclusion of the MDL.
JPML Appoints the Honorable M. Casey Rodgers to Preside Over 3M Combat Arms Hearing Loss Cases
The JPML transferred this new MDL to Judge M. Casey Rodgers. The panel noted that Judge Rodgers is “an able jurist with experience in presiding over a large products liability MDL.” Judge Rodgers was previously appointed to oversee MDL No. 2734, In Re: Abilify (Aripiprazole) Products Liability Litigation in October 2016. The Abilify MDL held over 2,000 lawsuits at its height. This MDL arose from lawsuits alleging the drug, an atypical anti-psychotic medication prescribed to treat a variety of mental disorders, can cause impulse control problems in users. A confidential settlement was announced in February 26, 2019, beginning the process of winding down MDL No. 2734.
Judge Rodgers became a United States Magistrate Judge in May 2002. On November 21, 2003, President George W. Bush appointed her to a position as United States District Judge for the Northern District of Florida. She served as Chief United States District Judge for the Northern District from June 2011 to June 2018.
On March 28, 2019, the United States Judicial Panel on Multidistrict Litigation will hear arguments from attorneys representing individual service members across the country and attorneys from 3M Company regarding whether claims against 3M for hearing loss injuries stemming from use of the earplugs during active duty should be consolidated for pretrial proceedings. In these lawsuits, service members claim the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. Additionally, the lawsuits claim 3M misrepresented the effectiveness of its hearing protection devices to the military during the proposal process when seeking to procure a government contract to be the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.
Background of 3M Combat Arms™ Earplug Litigation
Military service members in training, standard military operations, and especially those in combat, are often exposed to high intensity noise of various types. Between 2003 and 2015, Aero Technologies and 3M Company (who acquired Aero Technologies in 2008) sold millions of the Combat Arms™ earplugs to the military for use by service members in active combat and otherwise. The earplugs are non-liner, or selective attenuation earplugs; this means there are two sides to give soldiers two options for hearing reduction in one product. When worn on the olive-colored side, or the “closed” position, the earplugs were intended to block noise like a traditional earplug. When worn on the yellow side, the “open” position, the earplugs were intended to block or significantly reduce loud noises while allowing the user to hear lower level noises, like communications from commanding officers.
In May 2016, Moldex-Metric, Inc. filed a qui tam lawsuit against 3M Company alleging violations of the False Claims Act for representations it made to the United States about the hearing protection afforded by the Combat Arms™ earplugs. The qui tam action followed lawsuits both 3M and Moldex-Metric, Inc. had previously filed against each other; news reports indicate 3M sued Moldex-Metric, Inc. for earplug patent infringement and Moldex-Metric, Inc. countersued for fraud and failure of 3M’s earplugs to pass safety tests, in violation of its contracts with the military.
A qui tam lawsuit is a lawsuit brought by a private citizen – here, a competitor earplug manufacturer – that alleges false statements in the performance of contract with the government or in violation of government regulation. In other words, the lawsuits allege fraud on the government. Here, Moldex-Metric, Inc. alleged Aero Technologies designed the Combat Arms™ earplugs in a manner that was too short for correct insertion, resulting in loosening without recognition by the person wearing them – and that Aero Technologies knew about the product defect as early as 2000. The lawsuit maintained Aero Technologies/3M did not disclose this defect to the United States. Notably, according to the U.S. Department of Veterans Affairs (VA), tinnitus and hearing loss are the two most common health conditions among military veterans. The qui tam lawsuit cited sources quantifying VA service member hearing loss treatment at over $1 billion per year.
In a qui tam lawsuit, the government has the option to join the private citizen as a plaintiff in the lawsuit or to opt out and have the private citizen pursue the fraud claims on his or her own. In July 2018, the United States joined as a party and publicly announced a settlement with 3M. As part of the settlement, 3M paid $9.1 million to the United States “to resolve allegations that it knowingly sold the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device.” The settlement resolved claims the U.S. government had against 3M; it did not resolve any claims of individual service members for injuries suffered as a result of 3M’s alleged false statements.
Following the announcement of the settlements and primarily starting in January 2019, individual service members who used the Combat Arms™ earplugs as instructed and suffered noise-induced hearing loss during their time in service began filing individual lawsuits against 3M. As of February 14, 2019, service members have filed over 150 lawsuits in various state and federal courts.
The United States Judicial Panel on Multidistrict Litigation and the Case for Consolidation of 3M Combat Arms™ Earplug Lawsuits
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. 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.
Attorneys representing one of the service member plaintiffs filed a motion seeking transfer of claims by U.S. military personnel and other wearers of the Combat Arms™ earplugs who suffered hearing-related injuries for coordinated proceedings on January 25, 2009. 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. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which judge will handle the centralized proceedings. General opinion is in favor of consolidation, given the similarity of all of the claims asserted and the number of claims filed – as well as the scores of lawsuits expected to be filed in the future. The real question may be which judge is appointed to oversee centralization – suggestions have included judges in the District of Minnesota (where 3M headquarters is located), the Eastern District of Louisiana, and the Western District of Missouri.
Searcy, Denney, Scarola, Barnhart & Shipley, P.A. is currently investigating and handling cases of service members who suffered hearing loss and tinnitus injuries arising from use of the 3M Combat Arms™ earplugs. If you have any questions about these cases, please give us a call.
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.
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.”
“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.”