A1 0 ez m2 the washington post.friday, april 3 , 2020
the coronavirus pandemic
and a long-running debate about
granting manufacturers l egal pro-
tection in a h ealth e mergency con-
tributed to a critical shortage of
masks to front-line workers, ac-
cording to an examination by The
Washington Post of the early
weeks of the crisis.
on Thursday evening, h ours af-
ter this report published online,
Trump announced he had invoked
the Korean War-era Defense Pro-
duction Act to compel 3m to pro-
vide more N 95 masks for use by
medical workers in the United
States, a sharp turnabout in the
administration’s posture toward
the company.
Trump later tweeted: “We hit
3m hard today after seeing what
they were doing with their masks.
‘P Act’ all the way. Big surprise to
many in government as to what
they were doing - will have a big
price t o pay!”
The dearth of masks for medi-
cal 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 p andemic.
The first coronavirus case in the
United S tates was r eported Jan. 2 1
in the state of Washington. By
early february, t he federal govern-
ment had declared a p ublic health
emergency. But it took nearly a
month, until march 2, f or the food
and Drug Administration to issue
an emergency order giving manu-
facturers formal blessing to begin
repurposing industrial m asks for
health-care workers, a necessary
step t o getting construction masks
into hospitals.
It was another two weeks be-
fore Congress passed and Presi-
dent Trump signed emergency
legislation that included the pro-
tection 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 tril-
lion stimulus package — helped
open the f loodgates. 3 m is on t rack
to distribute at least 31 million
masks to health-care workers this
month, up from 5 million a month
it was providing earlier this year,
according to the company and
White House officials.
on march 21, the federal gov-
ernment awarded manufacturers
contracts to produce about
600 million N95 masks over the
next 18 months to supplement the
private sector’s s upply.
By then, the virus had been
spreading in the United States for
two months, and the need for
masks was so dire that some doc-
tors in Seattle and New York were
reusing them or making t heir o wn
from craft supplies.
“It is a b asic role o f government
to provide defense, in this case
against a public contagion. But
they have not met the test,” said
rhonda medows, a d octor in hard-
hit S eattle, who serves as an execu-
tive with o ne of the region’s largest
medical centers.
The need to dramatically ramp
up U.S. production and distribu-
tion of masks should have been
apparent early on in the crisis,
former d isaster preparedness o ffi-
cials said. for years, public health
advocates had warned that the
U.S. national stockpile of medical
supplies w as woefully i nadequate.
Domestic mask makers had re-
peatedly tried to sound the alarm
about the country’s overreliance
on foreign-made masks — a prob-
lem that became acute when Chi-
na shut down its factories as the
virus swept through t hat 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 the
coronavirus response in late feb-
ruary.
“ We w ere trying to do this in any
way that we could, as fast as we
could, understanding the urgency
of t he issue,” s he said.
The Department of Health and
Human Services said in a state-
ment 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 state-
ment.
Some critics said the industry
itself could have done more. De-
spite the emergency order from
the fDA and another declaration
intended to give companies pro-
tection from lawsuits, it was only
after the passage of the legislation
in mid-march that 3m, one of the
country’s biggest mask manufac-
turers, substantially increased its
distribution of industrial masks
for h ealth-care customers.
roman, the company’s CEo,
said in a march 22 statement that
masks from a
the new law helped “ensure that
all N95 disposable respirators can
be u sed i n healthcare s ettings, and
has enabled us to increase distri-
bution t o those workers b eginning
this weekend.”
3m declined to comment on
roman’s private remarks in his
meeting with Pence. In a state-
ment, the company said it did not
delay shipments, adding that it
shipped more than 1.35 million
industrial masks to health-care
customers in the two weeks before
the law was signed. But the com-
pany acknowledged the volume
increased after it secured liability
protection.
“Don’t talk to your lawyers if
you’re making masks or gowns or
ventilators,” s aid Arthur Caplan, a
professor o f bioethics at New York
University School of medicine.
“See where the need is and get
moving as fast as you c an.”
In the past week, 3m said it
delivered 10 million N95 respira-
tors to health-care facilities across
the country. The company is now
manufacturing 35 million N
masks a month in the United
States, 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 ques-
tions about the mix of medical
versus industrial masks it is now
producing.
Still, the need is outstripping
supply, industry officials and
health-care experts s aid.
Until Thursday, the Trump ad-
ministration had refused to use
one major tool at its disposal, the
Defense Production Act, to force
companies t o produce and distrib-
ute masks, part of a pattern of
showing deference to private in-
dustry in fighting t he outbreak.
Instead, the president had
praised companies that had vol-
unteered to help produce masks.
on Sunday, Trump outraged many
doctors a nd nurses by q uestioning
whether they need as many masks
as they have requested, even sug-
gesting without evidence that
some were being squandered or
“going o ut the back door.”
“We’re delivering millions and
millions of different products and
all we do is hear that, ‘Can you get
some more?’ ” h e told r eporters on
Sunday, citing the case of a New
York hospital where mask usage
has spiked. “I don’t think it’s
hoarding; I t hink i t’s maybe worse
than hoarding.”a global crunch
for two decades, experts on
pandemics have cited t he need for
mass stockpiles of protective
equipment and rapid production
to replace q uickly d iminished sup-
plies as key steps to contain out-
breaks.
“What was done in the U.S. in
early January — in those precious
weeks — would have b een critical,”
said Christopher m. 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 experi-
ence.
In response to the mask short-
age, volunteers around the coun-
try have stepped forward to try to
fill the gap. members of sewing
circles are stitching masks at
home. H anes has said it will shift
underwear production lines to
make gear. Americans have
scoured work sites and storage
closets to find unused masks todonate — including Washington
National Cathedral, which l ocated
5,00 0 unused respirators in a
church crypt.
But some experts said those ef-
forts, 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 b andannas to cover their faces
as a last resort.
In a normal year, the U.S.
health-care system uses about
25 million medical N95s, accord-
ing to Premier, an organization
that helps hospitals purchase sup-
plies. many of the masks are dis-
posable 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 p lanning d ocument p re-
pared by the National Security
Council called on t he 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 devel-
oped by a White House medical
preparedness task force estab-
lished by P resident B arack o bama
but disbanded by the Trump ad-
ministration in 2018. W hite H ouse
officials have said the task force’s
functions were folded into anoth-
er office. A t the t ime, t he i ssue was
hypothetical. Now, nations
around the world are grappling
with the sheer scope of the need.
massive quantities o f the f iltration
masks are sought now not just in
the U nited States, but also i n near-
ly every nation of t he world.
The need has spiked just as
countries h ave closed borders and
worked to stockpile their own sup-
plies.
“The pressure is just so intense
because of the global nature of
this,” s aid Khatereh Calleja, presi-
dent of the Healthcare Supply
Chain A ssociation.
Despite known worries about
possible pandemics, manufactur-
ers said one reason for the short-
age has been a decision by many
hospitals to adopt just-in-time
purchasing of items s uch a s masks
as a cost-saving mechanism.
“manufacturers don’t carry in-
ventory, and if you do, you are less
competitive,” said Charles John-
son, president o f the International
Safety Equipment Association, a
trade g roup that r epresents mask-
makers. “They produce what theyneed to satisfy orders. T hat’s what
has happened to global manufac-
turing.”
American manufacturers have
also been warning for years that
more and more production of
medical supplies, including
masks, has been relocated over-
seas, including to China. That has
reduced costs for American
health-care companies but has
made the supply chain more vul-
nerable to global pandemics.
China, which experienced the
world’s first coronavirus out-
break, w as quick to stop exporting
masks its own doctors and nurses
needed at home, making stockpil-
ing more difficult in recent
months, U. S. health-care execu-
tives say.
An analysis by the Associated
Press last month found that there
had b een no s hipments of m edical
grade N95 m asks f rom China s ince
feb. 19 and only 13 shipments of
nonmedical N 95 masks, which
was about half as many that had
arrived in the same period a year
earlier.
To s atisfy demand i n the case of
emergencies like the coronavirus
pandemic, the federal govern-
ment in 1999 established the Stra-
tegic National Stockpile, a last-re-
sort cache of drugs and supplies
intended to be tapped only in mo-
ments o f 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 re-
plenished despite repeated warn-
ings 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 n ow n eeded.
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, The Post r eport-
ed Wednesday.
In a s tatement, H HS said Secre-
tary Alex Azar pushed for more
funding for the stockpile and be-
gan t ransferring supplies t o Wash-
ington state, site of the nation’s
first outbreak, o n march 1.
The agency noted, however,
that “ health care supply chains are
private sector driven.”
Some experts said mask pro-
duction and distribution could
have been accelerated if Trump
had more quickly embraced theDefense Production Act, a 1950
law that gives the commander in
chief the power to marshal re-
sources in time of war and order
industrial manufacturers to pro-
duce specific items.
“The administration has con-
siderable 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. o n Thursday, he u sed t he
act to force six c ompanies to facili-
tate the supply of materials for
ventilators, along with ordering
3m t o provide more masks.
“We are, as you know, using the
act, but we use it only w hen neces-
sary,” he told reporters last week.
“We use it as leverage. We g eneral-
ly don’t have to use it to accom-
plish what we want to accom-
plish.”seeking legal cover
3m, which dominates the mask
market in the United States, pro-
duces most of its respirators for
industrial use. E ven a fter boosting
production, only 5 million out of
35 million of i ts m asks produced 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, Ca-
lif., which produces 8 million a
month, also l argely industrial, a nd
Honeywell and owens & minor,
which declined to disclose their
production figures.
The manufacturing lines that
make medical and i ndustrial mod-
els 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 re-
quired, as medical N95 masks in-
clude a n extra material t hat 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 u se of i ndustri-
al and medical protective equip-
ment. T he c ompany h as faced law-
suits from people who allege they
were exposed t o pollutants s uch 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 emer-
gencies, arguing that such a waiv-
er was necessary to ensure supply
during a crisis.
Industrial respirators meet
most of the performance stan-
dards of medical masks but are
not tested for fluid penetration,
according to the f DA.
During the 2006 avian flu out-
break, six companies wrote in a
letter to then-President George W.
Bush that without legislation, “the
ability for American manufactur-
ers to address emergency pre-
paredness or have surge produc-
tion capacity is and will be severe-
ly constrained.”
opponents of such a measure
have said such a blanket protec-
tion could leave the U.S. govern-
ment — and by extension, Ameri-
can taxpayers — on the hook if
health-care workers file lawsuitsafter b ecoming sick while w earing
industrial masks distributed dur-
ing a pandemic.
The trial lawyers lobbying o rga-
nization, the American Associa-
tion for Justice, has spent years
working w ith consumer advocates
and others to block attempts by
3m and other manufacturers to
secure waivers from lawsuits, offi-
cials there said, adding that court
actions have historically been an
important check on unsafe equip-
ment.
The liability issue was still unre-
solved when Azar declared a pub-
lic 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 i ndustrial 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 mov-
ing faster. In a s tatement, the fDA
said it began creating “ a more
streamlined access to market” for
some protective m asks in 2 018.
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 manufac-
turers, distributors and other par-
ties would be immune from feder-
al and state lawsuits if they distrib-
uted products in accordance with
the fDA emergency action. In-
stead, the federal government
would assume the liability r isk.
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 o n that l iabili-
ty... o ur members would still face
our d ay i n court.”
Jonathan moreno, a professor
of medical ethics and health policy
at the 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 S.]
fauci to know what was coming,”
referring to the head of the Na-
tional Institute of Allergy and In-
fectious Diseases.
The liability language that the
industry was seeking was includ-
ed in an early draft of the first
coronavirus relief act that Trump
signed into law on march 6, but
House Democrats cut the lan-
guage, according to people famil-
iar with the negotiations, who
spoke on t he c ondition of a nonym-
ity to discuss t he sensitive matter.
Democrats agreed to include
key liability protections that the
industry was seeking in the sec-
ond coronavirus-related bill,
passed on march 18. It explicitly
covered many industrial masks
used to combat coronavirus until
october 2024.
Pallone said h e agreed with that
approach because i t was a “ target-
ed 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 t o hospitals,” he said d uring
the White House’s daily coronavi-
rus b riefing.
Standing beside him, Trump
echoed that view. “They had a big
problem with liability,” he said, in
an apparent r eference to 3m.
roman, the company’s CEo,
also cast the law as a game-chang-
er.
“A s I write this, more than
500,000 respirators are on t he w ay
from our South Dakota plant to
two of the more critically impact-
ed areas, New York and Seattle,
with arrivals expected starting to-
morrow. We a re also r eady t o expe-
dite additional shipments across
the country,” he said in a state-
ment.
Later in the month, the indus-
try got even more cover when Sen-
ate republicans included liability
protection as part of the $ 2 trillion
stimulus package, over the objec-
tions of s ome Democrats, who had
said such a move would give away
too m uch.
The final bill — which waived
manufacturer liability for more
types of industrial masks used
during the coronavirus crisis, as
well as future public-health emer-
gencies — was signed into law by
Trump on friday.
[email protected]
[email protected]
[email protected]beth reinhard contributed to this
report.Liability fears held up mask producers’ response to virus
Jim lo scalzo/ePa-eFe/shutterstock
Pat Roth sews face masks to be donated to the George Washington University Hospital in Washington. Health-care workers are grappling
with shortages of personal protective equipment amid the coronavirus pandemic, and many have resorted to homemade masks.Glen stubbe/star tribune/associated Press
Deborah Birx, the White House coronavirus response coordinator,
holds a N95 mask as she and Vice President Pence visit the firm 3 m.