In September 2018, the Trump administration received detailed plans for a new machine designed to churn out millions of protective respirator masks at high speed during a pandemic.
But HHS did not proceed with making the machine.
The project was one of two N95 mask ventures — totaling $9.8 million — that the federal government embarked on over the past five years to better prepare for pandemics.
The other involves the development of reusable masks to replace the single-use variety currently so scarce that medical professionals are using theirs over and over. Expert panels have advised the government for at least 14 years that reusable masks were vital.
That effort, like the quick mask machine, has not led to a single new mask for the government’s response.
“The Halyard contract was part of an explicit strategy to ensure we could surge mask production in the next crisis,” said Nicole Lurie, who was the HHS assistant secretary for preparedness and response under Barack Obama. “Now we’re dealing with the consequences of not having that capability.”
Halyard said Thursday in a statement that its work on the government contract was completed in September 2018. A spokeswoman declined to give additional details.
An HHS spokesperson, who spoke on the condition of anonymity, told The Washington Post that although Halyard’s plans were feasible, no funding was available to build the machine.
HHS’s Biomedical Advanced Research and Development Authority, or BARDA, the department that solicited the Halyard design, had a budget of nearly $1.5 billion for 2020, according to an HHS report.
Amid the current crisis, the design remains under consideration, according to the spokesperson, who said, “Implementing this design along with use of more proven mask manufacturing techniques are being considered by a supply chain task force to reduce N95 shortages.”
In an interview with CNBC last week, Edward A. Pesicka, chief executive of Halyard’s parent company, Owens & Minor, said his company had already stepped up production of masks and other protective gear to its maximum.
“We are in the process of actually expanding capacity, but that’s going to take probably five to six months to make sure that you have the capability to expand that capacity,” Pesicka said.
He did not mention the firm’s work for the government on a high-speed machine.
Pesicka did not respond to an email requesting comment.
Making masks quickly
The Obama administration and medical firm Halyard Health of Alpharetta, Ga., announced the project to develop a rapid pandemic mask production line in December 2015.
In May 2018, another firm, Owens & Minor of Mechanicsville, Va., bought Halyard’s surgical clothing business to operate as a division named O&M Halyard.
On the government side, the fast-mask project was an initiative of BARDA, a part of HHS that is responsible for creating countermeasures against pandemics, biochemical attacks and other threats.
Halyard promised in its 2015 statement to design a “one-of-a-kind, high-speed machine” to help federal health planners solve a production problem that had bedeviled them for years.
Officials had long assumed that a public health emergency would one day create a huge demand for the respirator masks known as N95s. But the difficulty of predicting when a pandemic or other crisis would strike meant stockpiled masks could pass their expiration dates while sitting on shelves.
Halyard said its new machine would provide a just-in-time inventory alternative and avoid waste by enabling rapid and plentiful production when a crisis hit.
“Pandemic preparedness in the United States is imperative to protecting health and saving lives, and respirator manufacturing capacity remains a critical gap in that preparedness,” Robin Robinson, then the director of BARDA, said in a statement at the time.
HHS officials said in a strategy document that they hoped the machine would produce at least 1.5 million masks per day — 10 times the output manufacturers were each then telling the government they could do.
Asked whether the machine in its design could have accomplished the 1.5 million daily rate, Halyard said in a statement that it submitted a plan “to meet the requested specifications.” The HHS spokesperson said, “The project successfully demonstrated the feasibility of the approach and developed an initial design of a high-speed mask manufacturing line.”
No details of progress in the Halyard mask project appear to have been publicly reported by the government.However, in May 2017, HHS signed off on a $3.3 million payment to Halyard as part of the machine project, according to federal contracting records.
A Halyard employee involved in the project told The Post that the firm delivered the design to the government on time in 2018 and within the government’s $5 million budget. Outside contractors and engineering firms were brought in, according to the manager, who spoke on the condition of anonymity because he was not authorized to talk publicly about the work.
Brief mentions in HHS budget requests to Congress for 2020 and 2021 noted the department was “supporting efforts at Halyard Health to develop high-speed manufacturing for surge production” of N95 masks.
But in an emailed statement from O&M Halyard, the company said: “Owens & Minor Halyard’s obligations under that contract were completed with delivery of a final design package to BARDA in September 2018.”
The HHS spokesperson said references to the Halyard collaboration appeared in recent budgets because BARDA “requested funding to build the prototype” but did not get enough money for it.
As of Friday evening, the spokesperson had not answered a question about whether the shortfall reflected a congressional decision or was a consequence of shifting priorities within HHS.
When the pandemic mask project launched in 2015, Halyard was facing legal action over some of its protective medical gear.
A group of hospitals and clinics roughly a year earlier had sued the firm and its former parent company, paper and medical giant Kimberly-Clark, alleging fraud in the marketing of surgical gowns.
Among other disclosures during the class-action lawsuit in Los Angeles, one Kimberly-Clark employee was found to have said in an email that the process used to seal the seams on the gowns was “crap,” court filings show.
Company executives rejected that characterization of the production process in their testimony and maintained that the gowns were of high quality.
The lawsuit was filed by a then relatively unknown attorney: Michael Avenatti.
Avenatti would go on to find fame representing adult-film actress Stormy Daniels in high-profile legal fights against President Trump. Avenatti now is in a New York jail, awaiting sentencing after his February conviction for trying to extort sportswear firm Nike.
At the surgical gown trial in the spring of 2017, a jury found that Kimberly-Clark and Halyard had misrepresented the safety of its MicroCool-branded surgical gowns. The verdict is on appeal at the U.S. Court of Appeals for the 9th Circuit.
In its appeal, Halyard says among other arguments that none of the clinics that sued had suffered any injuries from its gowns. The firm says that tens of millions of gowns have been sold without any reported infections.
Stephen Devereaux, an attorney for Halyard in the case, said in an email, “The company does not comment on pending litigation.”
The jury awarded $454 million in total damages, which Judge Dolly M. Gee reduced to about $25 million. Kimberly-Clark and Halyard are in an ongoing legal dispute about who should pay the damages, court records show.
The HHS spokesperson said Halyard made the department aware of the case before the mask machine contract was signed.
Soon after Owens & Minor bought Halyard’s surgical clothing business in 2018, the surviving firm renamed itself Avanos Medical. Avanos remains based in Alpharetta but now focuses on technical medical devices.
Avanos, not O&M Halyard, has responsibility for the surgical gown litigation, according to representatives of both companies.
Raul Damas, an Avanos spokesman, said of the mask-making project that “that program and capability went to Owens & Minor when Halyard sold its surgical business to them” and that Avanos had “no visibility” on the project after that.
Lee Burnes, who was a Halyard vice president for research and development in 2015, when the mask project was announced, said the company had pursued it for the chance to “demonstrate our expertise and help make a difference.”
This week, Burnes, now a senior vice president at Avanos, declined to comment on the design venture. “I am no longer part of Halyard and it has been a couple of years,” he said in an email.
Making a reusable mask
While funding Halyard’s mask effort, HHS’s BARDA also backed development of an N95 mask that could be used by medical personnel more than once without risk of contamination or infection.
In September 2017, the Trump administration contracted with Applied Research Associates of Albuquerque to create a prototype of a “next-generation respirator,” as the masks are called, that could be sanitized and reused during public health emergencies.
Medical personnel tackling the coronavirus outbreak have said that because of shortages, they have had no choice but to reuse their conventional N95 masks, a practice that manufacturers warn could diminish the masks’ effectiveness.
Applied Research Associates has been awarded $4.8 million for the project so far, according to public contract records, and received an extension in May to work beyond its 15-month prototype development phase.
But that 2019 deal came too late for the coronavirus outbreak.
“Unfortunately, if the pandemic would have happened next year, we’d have been in much better shape,” said Brian Heimbuch, principal investigator on the project for Applied Research Associates. “It’s still in progress. It looks promising.”
It’s been 14 years since experts assembled by the Institute of Medicine warned of the need for a reusable mask. The Committee on the Development of Reusable Facemasks for Use During an Influenza Pandemic took up the issue in January 2006 as part of a federally funded study, delivering its recommendations in a few months.
Health officials and manufacturers, the panel said, should collaborate closely to create materials for an N95 mask that could be used again and again.
“Given the potential duration of a pandemic, even stepped-up production and stockpiling of disposable medical masks and N95 respirators may not be sufficient to meet demand,” the committee warned.
It noted a government estimate that medical personnel would need 90 million N95s during a six-week pandemic. The same estimate would be cited nine years later by Halyard Health as evidence that its high-speed mask machine was needed.
In 2009, another panel, this time inside the government, also urged development of masks that could be used more than once to meet demand in a crisis.
Working under the name Project B.R.E.A.T.H.E. — Better Respiratory Equipment using Advanced Technologies for Healthcare Employees — the group assigned the highest priority rating to its recommendation on reusability.
Lewis J. Radonovich Jr., who was then a senior health official at the Department of Veterans Affairs, led the panel. Now a senior researcher at the Centers for Disease Control and Prevention, he did not respond to a request for comment.
Howard Cohen, a professor of occupational safety at the University of New Haven who also was a member of the committee, said its work unfortunately had proved prescient.
“It is sad, because we really did see this coming,” Cohen said. “We saw the shortfall. And there were a bunch of things that potentially could have been done and weren’t.”