As the coronavirus wreaks its unprecedented havoc across the country, it continues to expose serious deficiencies in adequate pandemic response preparation at both the state and federal levels. Stockpiles and supply chains related to N95 respirator masks and other personal protective equipment (PPE)—including surgical masks and isolation gowns—continue to fall well short of the monumental task, especially in the hardest-hit areas like New York City, forcing nurses, doctors, hospitals, governors, and even the CDC to come up with strategies to optimize the supply of PPE.
In recent weeks, with the situation escalating seemingly by the hour, and with President Trump often mentioning and occasionally “invoking” (albeit vaguely) the Defense Production Act—and the federal government’s attendant power to order private companies to manufacture critical equipment and goods in the face of a national emergency—many have been asking why it’s taken so long to get a massive N95 mask-production push in motion.
A recent Washington Post article provides an explanation, and here in the land of “I’ll see you in court” and the home of a bottomless trove of lawyer jokes, it might not come as much of a surprise: 3M was concerned that repurposing the industrial masks that make up most of its production (and which are intended for use at construction sites and other non-healthcare settings) for use by doctors, nurses, and other medical personnel could leave the company exposed to liability. In other words, 3M was afraid they’d get sued if the masks didn’t sufficiently protect health care workers from coronavirus infection.
It’s an interesting (and somewhat) novel issue within the realm of “product liability,” the rules governing a manufacturer’s potential legal responsibility for harm allegedly caused by one of its products. A company like 3M could typically avoid liability in a situation where someone used one of its products in a way that the company never intended. But when the company is churning out respirator masks for immediate use in response to a national health crisis, there’s not much space for the company to argue a lack of awareness of how these masks will be used. On the other hand, 3M soon found itself with little-to-no say in a government-mandated repurposing of its product from industrial to medical use (just a few hours after 3M’s concerns were made public, according to the Post, President Trump issued a formal order directing 3M to produce respirator masks for health care workers.)
Such a unique situation begs for a unique approach, as James Baker points out in a New York Times op-ed, discussing the need to account for all potential roadblocks to an all-hands-on-deck manufacturing response to the PPE supply shortfall:
What about [manufacturer] liability? The first answer is to make equipment that works. The second answer is Title 42, giving the secretary of health and human services authority to determine that the coronavirus pandemic “constitutes a public health emergency,” recommend use of “covered countermeasures” to fight the pandemic and in doing so grant broad protection from liability under both state and federal law, except in the case of “willful misconduct.” There are other solutions as well, like special legislation, indemnification clauses to contracts, the government contract defense and, if all else fails, waivers.
Indeed, in mid-March, almost two months after the first coronavirus case was reported in the U.S., according to the Post, “Congress passed and President Trump signed emergency legislation that included the protection against lawsuits that 3M sought, settling a longrunning political battle over liability when industrial masks are used in health emergencies.” Protection from liability in connection with future health-related emergencies was part of the recent $2 trillion economic stimulus package, all of which helped to (belatedly) open the manufacturing floodgates and provide critical help to the health care workers who are on the front lines of the coronavirus response.