Inside America’s mask crunch: A slow government reaction and an industry wary of liability

On March 5, as the deadly coronavirus was racing through the United States, Vice President Mike Pence paid a visit to the Minnesota headquarters of 3M, the manufacturing giant that produces protective respiratory masks.

Pence, who leads the White House's coronavirus task force, praised the company during a public roundtable for deciding at the outset of the crisis "to go to full capacity" and ramp up production of high-grade N95 masks.

With its factories in South Dakota and Nebraska cranked up and running around the clock, 3M was on pace to double its global output to nearly 100 million a month, according to the company.

But in a private meeting shortly before Pence spoke publicly, company leaders had warned the vice president 3M had a problem, according to people familiar with the session, who spoke on the condition of anonymity to describe the closed-door discussion.

Chief Executive Michael Roman said he was concerned that repurposing the company's industrial masks, which made up a bulk of its production, for use by doctors and nurses could leave the company vulnerable to lawsuits. The lack of a liability waiver from Congress - a protection the industry has sought for years - would hinder full distribution of the gear, he said.

While all N95 masks, also known as respirators, filter at least 95 percent of airborne particles, masks for construction and medical use vary in design and fit, and are subject to different regulations.

The liability issue, which set off a scramble by Pence's aides, was one of a number of roadblocks that delayed the distribution of a basic protective item desperately needed to stem the spread of the virus.

The confluence of a slow initial response by the Trump administration, its wariness of compelling the industry to produce gear and a long-running debate about granting manufacturers legal protection in a health emergency contributed to a critical shortage of masks to front-line workers, according to an examination by The Washington Post of the early weeks of the crisis.

The dearth of masks for medical workers in the United States, despite weeks of warnings as the virus ravaged parts of China and Italy, has become symbolic of the nation's wider failure to properly prepare for the pandemic.

The first coronavirus case in the U.S. was reported Jan. 21 in the state of Washington. By early February, the federal government had declared a public health emergency. But it took nearly a month, until March 2, for the Food and Drug Administration to issue an emergency order giving manufacturers formal blessing to begin repurposing industrial masks for health care workers, a necessary step to getting construction masks into hospitals.

It was another two weeks before Congress passed and President Donald Trump signed emergency legislation that included the protection against lawsuits that 3M sought, settling a long-running political battle over liability when industrial masks are used in health emergencies.

The liability waiver - which was then extended to future health emergencies in the $2 trillion stimulus package - helped open the floodgates. 3M is on track to distribute at least 31 million masks to health care workers this month, up from five million a month it was providing earlier this year, according to the company and White House officials.

On March 21, the federal government awarded manufacturers contracts to produce about 600 million N95 masks over the next 18 months to supplement the private sector's supply.

By then, the virus had been spreading in the United States for two months, and the need for masks was so dire that some doctors in Seattle and New York were reusing them or making their own from craft supplies.

"It is a basic role of government to provide defense, in this case against a public contagion. But they have not met the test," said Rhonda Medows, a doctor in hard-hit Seattle, who serves as an executive with one of the region's largest medical centers.

The need to dramatically ramp up U.S. production and distribution of masks should have been apparent early on in the crisis, former disaster preparedness officials said. For years, public health advocates had warned that the U.S. national stockpile of medical supplies was woefully inadequate. Domestic mask makers had repeatedly tried to sound the alarm about the country's overreliance on foreign-made masks - a problem that became acute when China shut down its factories as the virus swept through that country.

Katie Miller, a spokeswoman for Pence, said the vice president worked intently on procuring more masks from the moment Trump tapped him to lead coronavirus response in late February.

"We were trying to do this in any way that we could, as fast as we could, understanding the urgency of the issue," she said.

The Department of Health and Human Services said in a statement that it had been working with American manufacturers since January to respond to the outbreak.

"HHS has been transparent that more supplies are needed," the department said in a statement.

Some critics said the industry itself could have done more. Despite the emergency order from the FDA and another declaration intended to give companies protection from lawsuits, it was only after the passage of the legislation in mid-March that 3M, one of the country’s biggest mask manufacturers, substantially increased its distribution of industrial masks for health care customers.

Roman, the company's CEO, said in a March 22 statement that the new law helped "ensure that all N95 disposable respirators can be used in health-care settings, and has enabled us to increase distribution to those workers beginning this weekend."

3M declined to comment on Roman's private remarks in his meeting with Pence. In a statement, the company said it did not delay shipments, adding it shipped more than 1.35 million industrial masks to health care customers in the two weeks before the law was signed. But the company acknowledged the volume increased after it secured liability protection.

"Don't talk to your lawyers if you're making masks or gowns or ventilators," said Arthur Caplan, a professor of bioethics at New York University School of Medicine. "See where the need is and get moving as fast as you can."

In the past week, 3M said it delivered 10 million N95 respirators to health care facilities across the country. The company is now manufacturing 35 million N95 masks a month in the U.S., more than 90 percent of which are designated for health care workers, it said, and expects to be up to 50 million a month in June. 3M did not respond to questions about the mix of medical versus industrial masks it is now producing.

Still, the need is outstripping supply, industry officials and health care experts said.

So far, the Trump administration has refused to use one major tool at its disposal, the Defense Production Act, to force companies to produce and distribute masks, part of a pattern of showing deference to private industry in fighting the outbreak.

Instead, the president has praised companies that have volunteered to help produce masks. On Sunday, Trump outraged many doctors and nurses by questioning whether they need as many masks as they have requested, even suggesting without evidence that some were being squandered or "going out the back door."

"We're delivering millions and millions of different products and all we do is hear that, 'Can you get some more?' " he told reporters on Sunday, citing the case of a New York hospital whose mask usage has spiked. "I don't think it's hoarding; I think it's maybe worse than hoarding."

A global crunch

For two decades, experts on pandemics have cited the need for mass stockpiles of protective equipment and rapid production to replace quickly diminished supplies as key steps to contain outbreaks.

"What was done in the U.S. in early January - in those precious weeks - would have been critical," said Christopher Kirchhoff, a former Pentagon and White House national security aide who worked on the Ebola mobilization and later put together a "lessons learned" report about the experience.

In response to the mask shortage, volunteers around the country have stepped forward to try to fill the gap. Members of sewing circles are stitching masks at home. The clothing manufacturer Hanes has said it will shift underwear production lines to make gear. Americans have scoured work sites and storage closets to find unused masks to donate - including Washington National Cathedral, which located 5,000 unused respirators in a church crypt.

But some experts said those efforts, while heartening, may be too haphazard to make a dent in the problem. Health care workers have said they continue to suffer shortages on the front-lines - a problem dramatically illustrated by guidance from the Centers on Disease Control and Prevention last month advising workers to use bandannas to cover their faces as a last resort.

In a normal year, the U.S. health care system uses about 25 million medical N95s, according to Premier Inc., an organization that helps hospitals purchase supplies. Many of the masks are disposable and meant to be used once.

HHS has estimated that the United States could need as many as 3.5 billion N95 masks during a pandemic.

A 2016 planning document prepared by the National Security Council called on the White House to prioritize procuring protective equipment in case of a pandemic. The planning guide, first reported by Politico, drew on the expertise of multiple agencies. It was developed by a White House medical preparedness task force established by President Barack Obama but disbanded by the Trump administration in 2018. White House officials have said the task force's functions were folded into another office.

At the time, the issue was hypothetical. Now, nations around the world are grappling with the sheer scope of the need. Massive quantities of the filtered masks are sought now not just in the United States, but simultaneously in nearly every nation of the world.

The need has spiked just as countries have closed borders and worked to stockpile their own supplies.

"The pressure is just so intense because of the global nature of this," said Khatereh Calleja, president of the Healthcare Supply Chain Association.

Despite known worries about possible pandemics, manufacturers said one reason for the shortage has been a decision by many hospitals to adopt just-in-time purchasing of items like masks as a cost-savings mechanism.

"Manufacturers don't carry inventory and if you do, you are less competitive," said Charles Johnson, president of the International Safety Equipment Association, a trade group that represents mask-makers. "They produce what they need to satisfy orders. That's what has happened to global manufacturing."

American manufacturers have also been warning for years that more and more production of medical supplies, including masks, has been relocated overseas, including to China. That has reduced costs for American health care companies, but has made the supply chain more vulnerable to global pandemics.

China, which experienced the world's first coronavirus outbreak, was quick to stop exporting masks its own doctors and nurses needed at home, making stockpiling more difficult in recent months, U.S. health care executives say.

An analysis by the Associated Press last month found that there had been no shipments of medical grade N95 masks from China since Feb. 19 and only 13 shipments of nonmedical N95 masks, which was about half as many that had arrived in the same period a year earlier.

To satisfy demand in the case of emergencies like the coronavirus pandemic, the federal government in 1999 established the Strategic National Stockpile, a last-resort cache of drugs and supplies intended to be tapped only in moments of crisis.

But the national stockpile was significantly depleted during the H1N1 influenza outbreak of 2009, when 85 million N95 respirators were distributed from the cache and was never significantly replenished despite repeated warnings and requests from health care and industry groups.

Federal officials said in March that the stockpile contained about 12 million N95 respirators and 30 million surgical masks, a tiny percentage of what is now needed by health care workers and emergency responders.

The Trump administration has begun distributing the meager supplies but with so much more demand than supply, many states have received only a fraction of their requests.

By this week, the stockpile was nearly exhausted.

In a statement, HHS said Secretary Alex Azar pushed for more funding for the stockpile and began transferring supplies to Washington state, site of the nation’s first outbreak, on March 1.

The agency noted, however, that "health care supply chains are private sector driven."

Some experts said mask production and distribution could be accelerated if Trump used the Defense Production Act, a 1950 law that gives the commander in chief the power to marshal resources in time of war and order industrial manufacturers to produce specific items.

"The administration has considerable power in this regard," said Nicole Lurie, who served as a top HHS official in the Obama administration.

Trump did invoke the act last week to compel General Motors to manufacture ventilators to help handle the surge of coronavirus patients, but he has otherwise resisted bipartisan calls to embrace it more fully.

"We are, as you know, using the act, but we use it only when necessary," he told reporters on Thursday. "We use it as leverage. We generally don't have to use it to accomplish what we want to accomplish."

Seeking legal cover

3M, which dominates the mask market in the United States, produces most of its respirators for industrial use. Even after boosting production, only five million out of 35 million of its masks a month were going to health care workers before the law passed last month, Pence said at a White House briefing.

Other manufacturers include Moldex, based in Culver City, California, which produces eight million a month, also largely industrial, and Honeywell and Owens & Minor, which declined to disclose their production figures.

The manufacturing lines that make medical and industrial models are generally regulated by two different agencies, so converting them from making one product to the other is not straightforward, according to Dan Glucksman, a spokesman for the International Safety Equipment Association. Some retooling would be required, as medical N95 masks include an extra material that makes them splash-proof, he said.

Over the years, 3M executives have warned about rising costs due to liability lawsuits, including those related to the use of industrial and medical protective equipment. The company has faced lawsuits from people who allege they were exposed to pollutants such as asbestos, coal dust and hazardous chemicals, according to a review of 3M financial reports.

For more than a decade, mask manufacturers have sought extra legislation to protect themselves from lawsuits over the use of their industrial masks in health emergencies, arguing that such a waiver was necessary to ensure supply during a crisis.

Industrial respirators meet most of the performance standards of medical masks, but are not tested for fluid penetration, according to the FDA.

During the 2006 avian flu outbreak, six companies wrote in a letter to then-President George W. Bush that without legislation, "the ability for American manufacturers to address emergency preparedness or have surge production capacity is and will be severely constrained."

Opponents of such a measure have said such a blanket protection could leave the U.S. government - and by extension, American taxpayers - on the hook if health care workers file lawsuits after becoming sick while wearing industrial masks distributed during a pandemic.

The trial lawyers lobbying organization, the American Association for Justice, has spent years working with consumer advocates and others to block attempts by 3M and other manufacturers to secure waivers from lawsuits, officials there said, adding that court actions have historically been an important check on unsafe equipment.

The liability issue was still unresolved when Azar declared a public health emergency on Feb. 4.

It took another month for the FDA to address the shortage of medical N95 masks, issuing an emergency authorization on March 2 that legalized the sale of many types of industrial masks for health care workers.

Agency officials did not say what caused the delay or respond directly to a question about whether they regretted not moving faster. In a statement, the FDA said it began creating "a more streamlined access to market" for some protective masks in 2018.

On March 10 - five days after Pence visited 3M - Azar went further, using his authority under a law adopted during the avian flu outbreak to declare that manufacturers, distributors and other parties would be immune from federal and state lawsuits if they distributed products in accordance with the FDA emergency action. Instead the federal government would assume the liability risk.

But manufacturers wanted the protections to be reinforced in new legislation.

"Whether or not the agency chooses to issue that order, it had to be tested in a court of law," Johnson said. "Without clear cut legislative action that allows the government to take on that liability . . . our members would still face our day in court."

Jonathan Moreno, a professor of medical ethics and health policy at University of Pennsylvania, said a pandemic was the wrong time for companies to dwell on their liability concerns.

The dire medical need "was very clear in early March," he said. "You didn't have to be a fancy epidemiologist or Dr. [Anthony] Fauci to know what was coming."

[Anthony Fauci was ready for this, even if America was not]

The liability language that the industry was seeking was included in an early draft of the first coronavirus relief act that Trump signed into law on March 6, but House Democrats cut the language, according to people familiar with the negotiations, who requested anonymity to discuss sensitive matters.

Rep. Frank Pallone Jr., D-N.J., who opposed including the provision in that bill, said what industry wanted amounted to “an indefinite, blanket liability.”

Democrats agreed to include key liability protections that the industry was seeking in the second coronavirus-related legislation, passed on March 18. It explicitly covered many industrial masks used to combat coronavirus until October 2024.

Pallone said he agreed with that approach because it was a "targeted liability waiver" with an end date.

On March 19, the day after the bill was signed into law, Pence described the measure as having opened the floodgates.

"Following the signing of last night's bill, all of those masks now have liability protection and the companies can sell industrial masks to hospitals," he said during the White House's daily coronavirus briefing.

Standing beside him, Trump echoed that view. "They had a big problem with liability," he said, in an apparent reference to 3M.

Roman, the company's CEO, also cast the law as a game-changer.

"As I write this, more than 500,000 respirators are on the way from our South Dakota plant to two of the more critically impacted areas, New York and Seattle, with arrivals expected starting tomorrow. We are also ready to expedite additional shipments across the country," he said in a statement.

Later in the month, the industry got even more cover when Senate Republicans included liability protection as part of the $2 trillion stimulus package, over the objections of some Democrats, who had said such a move would give away too much.

"Let me be very clear that this provides immunity for respirator manufacturers from this point forward," Sen. Mazie Hirono, D-Hawaii, said during a floor debate over the measure in mid-March.

The final bill - which waived manufacturer liability for more types of industrial masks used during the coronavirus crisis, as well as future public-health emergencies - was signed into law Friday by Trump.

- - -

Beth Reinhard contributed to this report.