With all its defects, the 3M Combat Arms version 2 Earplugs (CAEv2) were never recalled, either voluntarily or by order of the Food & Drug Administration (FDA).
When a manufacturer has good reason to believe that its product presents a risk of injury or otherwise threatens the public’s health or well-being, it usually issues a voluntary recall of the product. Most commonly, recalls are tied to safety concerns about manufacturing defects.
The problem with issuing a recall is that this course of action can negatively impact the manufacturer’s stock. Furthermore, recalls can evolve into dropping sales of the manufacturer’s other products, as customers become aware of the dangers presented from the recalled product. For a company like 3M, which manufactures and sells a broad range of products, a drop in trust could prove damaging across product lines.
The Food & Drug Administration (FDA) can issue a recall order under 21 CFR 810 if a manufacturer fails to voluntarily recall a dangerous product. Earplugs are considered medical devices and fall under the FDA domain, despite the fact that they do not need to be FDA approved.
There is little public information or public statements about 3M’s decision to discontinue its CAEv2 line—or the timing for this decision as it related to the legal problems that lay ahead for the manufacturer.
It is known, however, that 3M discontinued the CAEv2 in 2015, approximately one year before the government’s filing legal action against 3M in response to a whistleblower exposing the earplugs’ defects and the manufacturer’s fraudulent activities surrounding the marketing and sales of the devices to the government.
CBS News ran coverage of the lawsuit in which the government sued 3M for its CAEv2 products, which military personnel had been using on the battlefield and in training from 2003-2015.
3M issued the following statement:
“3M has great respect for the brave men and women who protect us around the world. We have a long history of serving the U.S. military, and we continue to sell products, including safety products, to help our troops and support their missions.”
The pleasant sentiment and $9.1 million settlement missed one thing: an admission of wrongdoing on behalf of 3M. 3M’s statement is as follows:
“We deny this product was defectively designed and will defend against the allegations in these lawsuits through the legal process.”
In an attempt to explain why it would agree to settle on the matter, rather than stick to their convictions of honesty and transparency in the trial, 3M offered this statement:
“Settling the investigation into this discontinued product at this point allows the matter to no longer be a distraction to the business and frees former and current 3M employees from having to go through the inconvenience of a protracted investigation and litigation. We take great pride in our products and this resolution is not an admission of liability, but simply a decision to move forward with our mission to provide high-quality personal safety equipment products to our customers.”
The Department of Justice has not indicated which earplugs the military currently uses.
The fact that 3M has discontinued the CAEv2 does not affect its liability for injuries resulting from the use of the hearing protection devices. Countless veterans have likely sustained hearing loss due to their use of these supposed hearing protection devices. Thousands have already filed their lawsuits to recover compensation for their injuries.