In March last year, Steve Cicala took his wife, Susan, to the emergency room at Clara Maass Medical Center in New Jersey to treat a worsening cough and fever, unaware that she had COVID-19.
As her breathing and blood pressure deteriorated, she received azithromycin and hydroxychloroquine and placed a ventilator. Eleven days after being admitted to the same hospital where she worked for years as a nurse, Susan had a cardiac arrest and died at the age of 60.
Steve Cicala is now the first person known to pursue a COVID-19 claim with a decade-old US government fund that has up to $ 30 billion that can be used to compensate for serious injuries or deaths caused by treatments or vaccines in the fight against the pandemic.
COVID-19 presents the first serious test of the Countermeasure Injury Compensation Program (CICP) overseen by the Department of Health and Human Services (HHS). The program has so far denied compensation in 90% of cases registered before the pandemic, mainly for vaccines against the H1N1 flu.
Cicala’s complaint has not been reported previously.
He could receive about $ 367,000 from the virtually untapped fund if he could show the treatment that caused his wife’s death. He is not alleging negligence against the hospital, which is largely protected from liability under an emergency health law.
“There is nothing to bring her back,” said Cicala, “but obviously with our two children and now two grandchildren, if there was anything we could do to help them, it would be great.”
Cicala, 58, said she believes the hospital offers the best care possible. Clara Maass declined to comment.
A MORTAL COMBINATION
The government does not publish specifications for claims to the fund, the amount of payments or why the claims were denied. HHS declined to comment.
A revelation of the Freedom of Information Act brought by a law professor and seen by Reuters shows 48 complaints made this year and were pending until February 16, for serious injuries and deaths from vaccines, fans and drugs – figures that were not previously reported .
All of these claims were related to COVID-19.
To encourage efforts to save lives during a declared public health emergency, healthcare providers and pharmaceutical companies can be protected from nearly all lawsuits, and claims for serious injury or death are submitted to the CICP.
This legal protection extends to the COVID-19 vaccines from Moderna Inc, Pfizer Inc and partner BioNTech SE, and Johnson & Johnson, as well as approved drugs, which briefly included the anti-malarial drug hydroxychloroquine touted by former President Donald Trump.
US regulators revoked the emergency authorization for hydroxychloroquine after studies suggested it was not effective and could pose cardiac risks for some patients.
Electrocardiogram records show that Susan Cicala’s heart rhythms were interrupted by hydroxychloroquine and azithromycin, according to her husband’s lawyer, Jonathan Levitt, of Frier Levitt.
“These two in combination are known to be deadly now,” said Levitt. “And it was also put on a respirator, which, as you know, also poses some substantial dangers.”
Cicala’s is one of about a dozen claims that Levitt has filed with the fund. He said he has more than 200 clients planning to seek compensation for deaths allegedly caused by unsuccessful COVID-19 treatments.
“Our cases are mainly about hydroxychloroquine,” said Levitt, who receives a portion of the successful claims, although he declined to say how much.
Lawsuits in the United States over some drugs reached billions of dollars and protection against liability was seen as the key to vaccine development at breakneck speed during a pandemic.
However, critics said the compensation fund pays relatively small amounts for serious injuries and lacks transparency.
In its 10-year history, the fund has paid $ 6 million for 29 vaccine injury claims, according to disclosures obtained by Peter Meyers, a professor at George Washington University Law School and a specialist in vaccine injuries, and seen by Reuters. Most of them were for the neurological disorder Guillain-Barré syndrome caused by the H1N1 flu vaccine.
The Centers for Disease Control and Prevention (CDC) in the United States estimates that about 123 million people have received the H1N1 vaccine.
Of the 48 coronavirus-related claims received by the fund, 21 involved COVID-19 vaccines, including three deaths, according to FOIA information obtained by Meyers.
The CDC said it had received reports of deaths among people who received the COVID-19 vaccines, but there is no evidence to link the shots to the deaths.
Based on information from Meyers’ FOIA, it appears that less than 25 claims were filed in 2020, and it was unclear whether these were related to COVID-19.
By the end of January, more than 25 million people in the United States had received at least one dose of the coronavirus vaccine. Meyers said the number of complaints about the vaccine suggests that the vaccines are extremely safe.
Still, he said the program’s lack of transparency could undermine support for protecting pharmaceutical companies from lawsuits and medicines and vaccines authorized for emergency use.
“It is important to be open to gain the confidence of the American public and to contain the hesitation of the vaccine,” he said. (This story corrects paragraph 21 to show that Peter Meyers is a professor at George Washington University Law School instead of Georgetown Law)
Reporting by Tom Hals in Wilmington, Delaware; Editing by Noeleen Walder and Bill Berkrot