the 3M Company is a renowned manufacturer based in Minnesota. The company has been in the news since May 2016 over claims that it sold the government combat earplugs for U.S. troops on the front lines yet the products were defective. 3M produced two versions of these earplugs; the dual-ended version and the single-ended version, and allegedly supplied the government with the dual-ended version without revealing that the product had some defects. The faulty earplugs were known as the Dual-Ended Combat Arms Earplugs, Version 2 (CAEv2) and until they were discontinued, they were part of 3M’s Military Combat Safety Gear line and standard issue equipment for the armed services.
The earplugs were primarily designed to protect the wearer’s hearing using two basic functions; when worn one way the user would get better noise protection from sounds such as explosions or gunfire and when inserted in the opposite direction, the user would be able to hear sounds such a speech at a reasonable volume. And despite the fact that this designed seemed promising, it was later discovered that the earplugs’ stem was too short, preventing it from reaching deep into the ear. This defect could cause the earplug to gradually and subtly loosen thus letting destructive sounds to enter the ear canal, possibly damaging the wearer’s hearing. This one of the reason claims of hearing loss and tinnitus among US troops and veterans have risen steeply.
About the Faulty 3M Earplugs
t he Dual-Ended Combat Arms Earplugs were originally created by Aearo Technologies, Inc., which 3M Co. later acquired in 2008. 3M chose to retain the employees at Aero that created and tested the earplugs. Aearo was cognizant of the earplug’s defect as early as 2000 even before they won the military contract 2003 and became the exclusive supplier of attenuation earplugs to the military. They had performed tests on the earplugs and identified that they had defects that reduced the earplugs’ effectiveness in noise cancellation and providing hearing protection. But even with this, they never disclosed these defects to the U.S. government or the military.
The government alleged that 3M and Aearo Technologies were cognizant of the fact that the earplugs were too short for proper insertion into the wearer’s ears. The United States alleged that 3M did not reveal this design defect to the military even as the contract was being finalized. The complaint indicated that the earplugs would loosen in the wearer’s ear without the knowledge of the wearer, thereby allowing damaging sounds to travel around outside of the earplug and enter the ear canal.
The faulty CAEv2 earplugs were designed for armed forces in Afghanistan and Iraq in order to provide protection from hearing loss from 2003-2015. When marketing the devices, the manufacturers told soldiers they could flip the plug for enhanced protection around explosions or gunfire. They allegedly assured that these dual-ended earplugs could offer numerous safety options to protect them. The earplugs could block sound just like traditional earplugs when worn in the “blocked” or “closed” mode. When flipped to the “unblocked” or “open” mode, which is the yellow end, the plugs would greatly reduce intense impulse sounds such as explosions and gunfire in the battlefield. In addition, the open position would not block low volume noises such as communication from comrades or approaching combatants. 3M alleged that the dual-ended earplugs would allow the military to perform necessary duties on the battlefield with the assurance that they are protected from hearing damage.
3M Misled the Government and the Military
Moldex-Metric, Inc., a competitor of 3M Company, initiated a whistleblower lawsuit against 3M under the False Claims Act, in May 2016. In the lawsuit, Moldex-Metric claims that 3M and its predecessor corporation made false statements to the government and failed to disclose the design defects regarding its dual-ended Combat Arms earplugs. The U.S. Department of Justice then joined the lawsuit. As stated in the lawsuit, the earplugs have likely caused tinnitus and hearing loss to thousands of soldiers in addition to exposing millions to the risk.
When replying to a government-issued RFP, Aero Technologies was required to certify that the dual-ended Combat Arms earplugs complied with military standards. This means that they had to certify that the earplugs would protect the wearer’s hearing from impulse sounds produced by explosions and military firearms while allowing the user to hear quieter sounds such as speech and spoken commands. The earplugs were supposed to have an acceptable noise reduction rating (NRR) and be free from all defects. Instructions on proper use and handling would also be provided. To meet these standards, the company was supposed to test the products and include the NRR on the product label. Aero chose to hire its own employees to conduct the testing instead of hiring an independent firm. Testing personnel recruited 10 test subjects in January 2000 and some of those were employees at Aero. They earplugs were tested under three conditions:
- Hearing ability without the earplugs inserted
- Hearing ability with the yellow open side inserted
- Hearing ability with the dark closed side inserted
After testing only eight of the subjects, the testing on the closed position was stopped, violating testing protocol. The results showed an average NRR of 10.9 when the expected NRR was 22. There was a variation in the results with some subjects getting better results and others experiencing worse results since the earplugs were too short to properly fit in some subjects. However, testing on the open position continued on all ten subjects. The outcome was an NRR of -2, showing that the earplugs did not block sound but instead amplified it. According to the lawsuit filed by Moldex-Metric, 3M changed the NRR to “0” and claimed that the results would benefit the military. They touted that the soldiers would be protected from extreme sounds while being able to hear softer sounds such as approaching enemy combatants and spoken commands.
Meanwhile, an investigation was carried out by testing personnel to find out why the earplugs were not working well in the closed position. They discovered that the earplug’s stem was too short and could not be inserted deeply enough into the ear canal. They also found out that the basal edge of the thirds flange of the open end folded backward when the closed end was inserted. Once the application pressure was released, the flanges on the yellow side returned to their original shape, which resulted in the earplug loosening enough to reduce its effectiveness. The problem was experienced in both closed and open ends since the sides are shaped the same way.
As such, users had to fold back the flanges on the opposite side before inserting the earplug into the ear in order to get the desired NRR results. When Aero learned of this in February 2000, the company retested the closed position of the earplugs using modified fitting instructions. This involved folding back the flanges on the yellow side to allow for deeper insertion into the ear, which significantly improved the NRR rating to 22, compared to the first test results of 10.9 NRR.
The open end of the earplugs was not retested because 3M allegedly wanted the low NRR already achieved in order to prove to the military that they could hear quieter sound while wearing the earplugs. And while manual manipulation prior to insertion allowed the earplugs to achieve 22 NRR, 3M never included the instructions in the packaging. Users were only told to insert the earplugs normally without any extra instructions. This means that the way the earplugs were being used by the soldiers significantly increased the risk of the device loosening during use. Yet, Aero/3M falsely overstated the amount of hearing protection that the device provided. Therefore, the company misled the military by packaging and marketing the devices with a labeled 22 NRR.
3M $9.1 Million Settlement with U.S. Government for False Statements
According to the announcement made on July 26, 2018, by the Department of Justice, 3M Company agreed to pay $9.1 million based on the allegations that they knowingly supplied defective military earplugs to the armed forces. The qui tam lawsuit indicts the company for selling these earplugs without warning the military of the potential design faults which could result in hearing loss and tinnitus.
As a way of setting an example, the Department of Justice required 3M to pay this amount to ensure that companies pay for the damages they have caused when they engage in fraudulent activities. The dual-ended Combat Arms earplugs were found to be less effective in protecting the soldiers and therefore the liable company had to compensate for the consequences. The False Claims Act allows private parties to provide evidence of fraudulent activities against the U.S. government and sue on behalf of the government. In this case, Moldex-Metric was a whistleblower and for that reason, the company received $1.9 million of the $9.1 million settlement for their role in the case.
The damages that 3M was required to pay the U.S government comprise the monetary damages directly related to the cost of the earplugs in addition to a significant amount of ongoing medical expenses to help veterans suffering from tinnitus or hearing loss as a result of the faulty earplugs. The settlement was ultimately the result of a joint effort by the Army Criminal Investigation Command, the District of South Carolina Attorney’s Office, the Defense Criminal Investigative Service, and the Civil Division of the Department of Justice.
While 3M settled the case with the government, the company did not admit to any liability as stated in the lawsuit. However, the US government still insisted that 3M knew of the defective design but never revealed it to military officials when their contract was being finalized. 3M discontinued the product and stated that the settlement as a chance for the company to move forward past a long legal process and not as an admission of wrongdoing.
Tinnitus & Hearing Loss Among Veterans and US Troops
According to the Veterans Benefits Administration’s Annual Benefits Report of 2016, hearing loss and tinnitus are the VA’s two most prevalent disabilities related to military service, with 1,084,069 and 1,610,911 cases yearly. Also, they are the most compensated disabilities with the Veteran Benefits Administration reporting that the occurrence of hearing injury amongst service members is growing 13% -18% annually. The Department of Defense even went ahead to establish a Hearing Center of Excellence in 2012 and declared hearing loss an epidemic.
3M’s Dual-Ended Combat Arms earplugs have instigated serious hearing loss among service members, which compromises the ear and the connection between the brain and the ear. This health condition is a leading medical issue for military personnel. This health condition can be both an overwhelming long-term and permanent condition. Given that hearing loss is untreatable, it can be a devastating long-term and permanent condition. An individual’s hearing may begin to fade away gradually and the individual may have difficulty hearing others clearly and may often require them to speak up or repeat what they said. An individual may as well experience ringing in the ears and sensitivity to sound. Hearing loss can be categorized by different levels as follows:
- Moderate hearing loss- when the other person in a conversation has to continuously repeat themselves.
- Mild hearing loss- when it’s difficult for the affected individuals to catch every word in a conversation.
- Severe hearing loss- when a hearing aid must be used in almost every instance in order to have a conversation.
- Profound hearing loss- when one is continuously asking others to speak up because he/she can’t hear normal speech. A cochlear implant or hearing aid is needed to hear.
This is a health condition characterized as continuous or sporadic ringing in the ears and tends to vary in volume levels. Tinnitus is one of the most common disabilities among U.S. troops and veterans because of their exposure to extremely damaging levels of sound like explosions, aircraft, gunfire, machinery, and other similar sounds. The Dual-Ended Arms earplugs provided by 3M were expected to offer utmost protection from such damaging noises but their ineffectiveness exposed service men and women to tinnitus. Many veterans affected by tinnitus find that this condition can have a lifetime impact such as difficulty concentrating and sleeping, with the condition being permanent in most cases. Tinnitus can cause annoying sounds that only the sufferer can hear, including hissing, ringing, buzzing, clicking, whistling, and roaring.
Being one of the most common health conditions in America, Tinnitus affects millions of people. Most veterans experience their tinnitus as a result of the hearing loss. The two main types of tinnitus are:
- Objective tinnitus: This is when the sufferer and other individuals around him/her can hear the sounds. This is typically caused by somatic systems and blood flow issues but is less common.
- Subjective tinnitus: This when the sounds can only be heard by the sufferer. It’s caused by auditory and neurological reactions to hearing loss. It is the most common type of tinnitus.
Troops and Veterans at High Risk of Hearing Damage
According to the Centers for Disease Control and Prevention (CDC), veterans are 30% more likely to suffer from serious hearing problems when compared to nonveterans. The likelihood of suffering from the condition increases four times for veterans serving the country after the year 2001. Most of the hearing problems develop as a result of exposure to loud noises, including roadside bombs, machinery, blasts, heavy equipment, and gunfire. Exposure to destructive loud noises may occur during training, on the battlefield, or while performing general duties. Such issues can also contribute to hearing impairment, especially if the sufferer cannot afford adequate gearing protection.
While hearing loss is a serious disability in itself, studies suggest that it can also lead to other problems. A study shows that 59% of tinnitus sufferers had depression while 79%. In another study, it was discovered that post-deployment hearing conditions usually occur together with traumatic brain injury, depression, and post-traumatic stress disorder (PTSD). Another study shows that hearing loss can affect the sufferers’ quality of life. Researchers also report that in addition to reducing the quality of life, hearing loss was also a risk factor for distress. More reviews and research shows that old people will have more limited lives and may be forced to limit their living space to only nearby areas.
Noise-induced hearing loss can occur abruptly or even take years to be apparent based on the intensity of a sound and the length of exposure. A sound less than 75 decibels is typically deemed safe. But firearms and firecrackers produce 150 decibels, which is twice than what is considered safe. And while there is no cure for noise-induced hearing loss, the problem is manageable with surgery and hearing aids. The US government made hearing protection obligatory for the military in order to prevent hearing impairments related to their work.
Filing a 3M Hearing Loss Lawsuit
3M chose not to disclose the downsides of their earplugs but simply continued to profit off of them at the expense of the health of our soldiers. Despite the fact that 3M has agreed to pay a settlement to the U.S Department, it is imperative to note that this settlement was arrived at in a whistleblower case under the False Claims Act. This means that the money was meant to compensate the government for the cost of purchasing allegedly defective earplugs. It does not benefit veterans and service members who’ve suffered hearing loss or tinnitus in their line of duty while using the faulty dual-ended earplugs.
Conversely, the affected military personnel may file individual lawsuits to seek compensation for pain and suffering, personal injuries, medical bills, loss of enjoyment of life, loss of the ability to work, loss of consortium, loss of future earning capacity, and lost wages. It may also be possible to recover punitive damages that are meant to punish the company that engaged in fraudulent and egregious conduct.
There’s more to the cost of hearing loss. The condition can also be linked to depression, anxiety, and earning potential. The VA spends more than $2 billion annually in disability benefits related to hearing complications. Hearing aids can cost thousands with cochlear implants being more costly. If you were issued with the defectively designed 3M CAEv2 earplugs and are currently suffering from tinnitus or hearing loss, you may be entitled to any damages incurred.
Military service members and veterans who have suffered hearing damage from defective 3M dual-ended combat arms earplugs may file lawsuits alleging that 3M:
- Manufactured defective earplugs
- Knew from the start that the earplugs were defective and could pose a risk of hearing loss for users
- Knowingly supplied the faulty devices to the military even though they had design defects
- Failed to disclose the defects to the US government and the military
- Put users at risk for hearing damage without them being aware
To qualify to file a mass tort lawsuit against 3M, you must:
- Have served as a soldier in the U.S. military deployed to Afghanistan or Iraq between 2003 and 2015
- Have been issued with dual-ended earplugs during military service
- Have been diagnosed with tinnitus or hearing loss
Consumer Alert Now helps military personnel and veterans from all over the United States to get help from seasoned defective earplugs attorneys. Our quest is to keep people safe from potentially dangerous products and help them receive the compensation they deserve due to the negligence of another party. We can connect you to attorneys who are currently investigating 3M Combat Arms earplugs cases. You’ll speak with one of the attorneys we work with to discuss your case and understand your legal rights and options. It doesn’t cost you anything to get in touch with a lawyer and if you don’t want to take any legal action yet, you’re under no obligation to enter a formal agreement. Call our defective medical device attorney at (800) 511-0747 or reach us online to get started. If you’re unsure about the brand of earplugs that you were issued, we can help with that.