There better be some serious consequences for this company

Five years ago, the U.S. Department of Health and Human Services tried to plug a crucial hole in its preparations for a global pandemic, signing a $13.8 million contract with a Pennsylvania manufacturer to create a low-cost, portable, easy-to-use ventilator that could be stockpiled for emergencies.

This past September, with the design of the new Trilogy Evo Universal finally cleared by the Food and Drug Administration, HHS ordered 10,000 of the ventilators for the Strategic National Stockpile at a cost of $3,280 each.

But as the pandemic continues to spread across the globe, there is still not a single Trilogy Evo Universal in the stockpile.

Instead last summer, soon after the FDA’s approval, the Pennsylvania company that designed the device — a subsidiary of the Dutch appliance and technology giant Royal Philips N.V. — began selling two higher-priced commercial versions of the same ventilator around the world.

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Last Friday, President Donald Trump invoked the Defense Production Act to compel General Motors to begin mass-producing another company’s ventilator under a federal contract. But neither Trump nor other senior officials made any mention of the Trilogy Evo Universal. Nor did HHS officials explain why they did not force Philips to accelerate delivery of these ventilators earlier this year, when it became clear that the virus was overwhelming medical facilities around the world.

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An HHS spokeswoman told ProPublica that Philips had agreed to make the Trilogy Evo Universal ventilator “as soon as possible.” However, a Philips spokesman said the company has no plan to even begin production anytime this year.

  Pro Publica

Who's their friend in Congress? The White House? HHS?

Neither HHS nor Philips would provide a copy of their contract, citing proprietary technical information that would have to be redacted under a Freedom of Information Act request. But from public documents and interviews with current and former government officials, it appears that HHS has at times been remarkably deferential to Philips — and never more so than in the current pandemic.

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[T]he contract HHS signed in September 2019 gave Philips almost a year before it had to produce a single Trilogy Evo Universal, and two more years to fulfill the order of 10,000 ventilators.

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On the same day in July that the FDA cleared the stockpile version of the ventilator, it granted the application of Philips’ U.S. subsidiary, Respironics, to sell commercial versions of the Trilogy Evo. Philips quickly began shipping the commercial models overseas from its Murrysville, Pennsylvania, factory.

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Philips is negotiating with a White House team led by Trump’s son-in-law, Jared Kushner, to build 43,000 more complex and expensive hospital ventilators for Americans stricken by the virus.

Does Jared have stock in the company?

Some experts said the nature of the current crisis — in which the federal government is scrambling to set up field hospitals in New York’s Central Park and the Jacob K. Javits Convention Center — underscores the urgent need for simpler, lower-cost ventilators. The story of the Trilogy Evo Universal, described here for the first time, also raises questions about the government’s reliance on public-private partnerships that public health officials have used to piece together important parts of their disaster safety net.

“That’s the problem of leaving any kind of disaster preparedness up to the market and market forces — it will never work,” said Dr. John Hick, an emergency medicine specialist in Minnesota who has advised HHS on pandemic preparedness since 2002. “The market is not going to give priority to a relatively no-frills but dependable ventilator that’s not expensive.”

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Steve Klink, the company’s Amsterdam-based spokesman, said Philips was within its rights under the HHS contract to prioritize the commercial versions of the Trilogy Evo. An HHS spokeswoman — who insisted she could not be identified by name, despite speaking for the agency — did not disagree.

“Keep in mind that companies are always free to develop other products based on technology developed in collaboration with the government,” she said in a statement to ProPublica. “This approach often reduces development costs and ensures the product the government needs is available for many years.”

But not the year when it's desperately needed.

Just last month, HHS gave a very different impression to Congress, hailing the Trilogy Evo it funded as a breakthrough in its campaign for pandemic preparedness.

“This game-changing device, considered a pipedream just a few years ago, is now available at affordable prices to improve stockpiling and deployment” in an emergency, the agency told Congress in a budget document delivered on Feb 10.

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Had government officials insisted that Philips first produce the ventilators that taxpayers paid to design, the government could conceivably be distributing all 10,000 to hospitals now.

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Klink, the company spokesman, said Philips was only committed to meeting the original contract deadline of 10,000 ventilators by September 2022.