Case 1:25-cv-11916-BEM Document 291 Filed 03/16/26

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Milhoan, 50 Dr. James Pagano, Dr. Raymond Pollak, 52 -appear to lack any expertise or professional qualifications related to vaccines or immunization as required by ACIP’s Charter. See ACIP Membership Roster, supra note 16. An additional three of the current ACIP members Dr. Retsef Levi, 53 Dr. Robert Malone, 54 and Dr. Catherine Stein 55_though they have

50 Dr. Milhoan “is a pediatric cardiologist and former U.S. Air Force flight surgeon,” who “holds a Ph.D. in the mechanisms of myocardial inflammation.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Milhoan has any relevant vaccine-related experience or expertise.
51 Dr. Pagano “is a board-certified emergency medicine physician with more than 40 years of clinical experience.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Pagano has any relevant vaccine-related experience or expertise.
52 Dr. Pollak “is a surgeon, transplant immunobiologist, and transplant specialist who has published more than 120 peer-reviewed works and served as principal investigator on NIH transplant biology grants and numerous drug trials.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Pollak has any relevant vaccine-related experience or expertise.

53 Defendants describe Dr. Levi, Professor of Operations Management at the MIT Sloan School of Management, as “a leading expert in healthcare analytics, supply chain and manufacturing analytics, risk management, and biologics and vaccine safety” and note that he has “collaborated with industry stakeholders and public health agencies to develop decision-support models to evaluate biologics and vaccine safety” and co-authored studies examining the association between mRNA COVID-19 vaccines and risks of cardiovascular disease, mortality, and adverse pregnancy outcomes.” ACIP Membership Roster, supra note 16. However, based on the current record, he has published only two papers discussing vaccines, and both of those were published mere months before his appointment. Retsef Levi, et al., Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer- BioNTech or mRNA-1273 among Adults Living in Florida, MedRxiv (Apr. 29, 2025), https://www.medrxiv.org/content/10.1101/2025.04.25.25326460v1 [https://perma.cc/NGN8-SARX] (cited at Compl. ¶77(g) n.53); Josh Guetzkow, et al., Observed-to-Expected Fetal Losses Following mRNA COVID-19 Vaccination in Early Pregnancy, MedRxiv (June 20, 2025), https://www.medrxiv.org/content/10.1101/2025.06.18.25329352v1.full- text [https://perma.cc/EKL3-ELMS] (cited at Compl. ¶ 77(g) n.53). Publishing two papers on a topic, while no doubt relevant to ACIP, likely does not rise to the level of “expertise” called for under ACIP governing documents. See Expertise, Black’s Law Dictionary (12th ed. 2024) (defining “expertise” as “[s]kill or knowledge in a particular subject; specialized experience that gives rise to a facility that comparatively few people possess”).
54 Defendants describe Dr. Malone, an adjunct professor at Pennington Biomedical Research Center, Louisiana State University, as “a vaccinologist, scientist, and biochemist known for his early contributions to mRNA vaccine technology” whose “expertise spans molecular biology, immunology, and vaccine development.” ACIP Membership Roster, supra note 16. The only evidence in the record of his experience related to vaccines is that he was involved in early research on mRNA technology in the 1980s and 1990s. See id. Even crediting that experience, the Court cannot conclude that this experience, thirty plus years ago, constitutes the requisite expertise necessary for ACIP today. Further, the scope of his role in that research is disputed, see Davey Alba, The Latest Covid Misinformation Star Says Не Invented the Vaccines, N.Y. Times (Apr. 3, 2022), https://www.nytimes.com/2022/04/03/technology/robert-malone-covid.html (cited at Compl. ¶ 77(h) n.59), which the Court need not resolve at this juncture.

55 Dr. Stein is a professor at Case Western Reserve University and “an epidemiologist with more than two decades of research experience on tuberculosis and infectious diseases and 115 peer reviewed publications.” ACIP Membership Roster, supra note 16. However, there is no evidence in the record that her experience and expertise relate to vaccines, vaccination, vaccine safety, or vaccine policy as to be relevant to ACIP’s function.

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The first case of severe mpox (formerly monkeypox) has been identified in New York City, according to an advisory issued by the NYC Health Department.

One resident has tested positive for mpox clade I, one of the two main genetic groups (clades) of the mpox virus, which causes the illness.

“Clade I causes more severe symptoms and can be life-threatening,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital. “It spreads via direct contact or sex, and kissing, and very close respiratory droplets, but not over longer distances by respiratory spread.”

MPOX STRAIN SURFACES IN US WITHOUT INTERNATIONAL TRAVEL, RAISING FEARS OF WIDER OUTBREAK

Clade II was the strain that caused a 2022 global outbreak, according to the Centers for Disease Control and Prevention. Survival rates for this type are more than 99.9%.

Clade I, which was responsible for the 2024 outbreak in the DRC and Africa, is known to cause more severe illness and deaths. 

The New York City patient recently traveled out of the country, the advisory states. “This appears to have come here from travel and has not spread locally,” Siegel noted.

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There is no known local transmission of mpox clade I in New York City and the risk remains low for local residents, according to NYC Health Commissioner Dr. Alister Martin.

“The NYC Health Department recommends that New Yorkers who are at risk for mpox receive and complete the two-dose vaccine series that works to prevent mpox,” he said in a statement.

To help prevent transmission, the CDC recommends vaccination for men who are gay, bisexual or have sex with men, are age 18 or older, and have other specific risks. Those who plan to travel to areas where clade I mpox is spreading should also seek the vaccine.

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People who may have been in close contact with an infected person should get the vaccine within 14 days.

As with other viral infections, those who are immunocompromised or very young are at the greatest risk of severe infection.

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Vaccination can help reduce the chances of infection and also makes symptoms less severe, according to experts. The two-dose JYNNEOS vaccine is the most common type of protection. Those who have had mpox do not need to be vaccinated.

Mpox symptoms include a sometimes painful, blistery rash on various parts of the body, fever, chills, exhaustion, muscle aches, headache, swollen lymph nodes and respiratory symptoms, according to the CDC. These symptoms usually emerge one to three weeks after exposure.

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In rare cases, mpox can lead to eye infections, severe rash, painful skin lesions and neurological problems.

Treatment for mpox involves supportive care to manage symptoms. In severe cases, patients may receive TPOXX (tecovirimat), an antiviral medication used to treat infections caused by viruses related to smallpox, including mpox, Siegel noted.

A woman seeking emergency care for severe abdominal pain recently shared her frustration on social media with the long wait times at a Canadian hospital.

Amanda Gushue, 37, first visited her primary care physician — who sent her to the emergency department (ED) with a swollen appendix.

After waiting for two hours in triage, she was sent to the waiting room — where she was shocked to see that it could be anywhere from five to 15 hours before she could see a doctor or nurse.  

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She ultimately waited another 10 to 12 hours before she was seen.

“There were probably about 150 seats, and they were all full,” Gushue, a resident of Cape Breton, Nova Scotia, told Fox News Digital. “This is what we deal with when we go to the hospital on a regular basis — you’re looking at spending a full day there.”

Gushue shared that one elderly woman came in with a head wound, “bleeding profusely,” and had to wait for two hours before she was seen.

Gushue said she attributes the long wait times to a scarcity of doctors. “We have tons of nurses, but no doctors.”

Even after she was admitted, Gushue claimed she received sub-par care and was not given sufficient privacy.

DANGEROUS TIKTOK TREND LEAVES BOY BADLY BURNED AS DOCTORS ISSUE WARNING

Canada has a universal healthcare system that is funded through taxes, according to the government’s website.

Eligible residents of a province or territory can apply for public health insurance to access free healthcare services, the website states.

“I would rather pay for my healthcare at this point and get treated fairly,” Gushue said.

“The healthcare system is overworked right now, and these doctors are probably exhausted,” she said, expressing her point of view. “They’re working around the clock, and then after a 16- or 17-hour shift, you get a cranky doctor.”

Gushue was ultimately admitted. She had her appendix removed recently. 

She is now recovering and said she “feels great.”

“I would rather pay for my healthcare at this point and get treated fairly.”

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In 2024-2025, there were more than 16.1 million unscheduled emergency department visits in Canada’s hospitals, an increase from about 15.5 million the year before, according to the Canadian Institute for Health Information (CIHI).

Among those patients who were admitted into the hospital from the emergency department, nine out of 10 of the ED visits were completed within 48.5 hours, the above source stated. For those who were not admitted, nine out of 10 were completed within around eight hours.

Median wait times vary widely by province, CIHI stated.

Some of the main factors contributing to the extended wait times include staff and bed shortages, hospital flow issues (due to lack of primary care access), and overcrowding that leads to system stress, according to the Canadian Medical Association.

Dr. Warren Thirsk, an emergency room doctor in Edmonton, recently shared with the Calgary Journal that he sometimes sees more than 100 people in the waiting room of his hospital, which only has 30 chairs.

“People who can stand, stand. Some are on the ground, and we’re hoping they’re alive,” he said. “And you walk by this carnage, and then you start your day.”

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The doctor added that some patients wait all night to receive care. “What used to be a mass casualty event is now the new norm,” he said, per the report.

Another ED physician, Dr. Michael Howlett, who is president of the Canadian Association of Emergency Physicians, also shared his concerns about the situation.

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“I’ve worked in emergency departments since 1987, and it’s by far the worst it’s ever been. It’s not even close,” he told CityNews, a Canadian news outlet. 

“We’ve got people dying in waiting rooms because we don’t have a place to put them,” he went on. “People [are] being resuscitated on an ambulance stretcher or a floor. Those things have happened.”

In January, Alberta’s minister of hospitals announced an investigation into the death of a 44-year-old man who died after waiting nearly eight hours in an Edmonton emergency department with chest pain, according to local reports. 

A system review has since been completed by Acute Care Alberta, identifying emergency department overcrowding and triage challenges. The review issued multiple recommendations to prevent similar incidents, though a formal investigation into the death remains ongoing.

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The government also announced new triage liaison physician roles in major hospitals, as physicians report continued overcrowding and capacity issues.

Fox News Digital reached out to Nova Scotia Health and Canada Health requesting comment.