A non-disclosure agreement (NDA) an Ohio hospital insisted a COVID-19 patient’s husband and daughters sign before she could be given the drug ivermectin was ruled invalid by Franklin County Court of Common Pleas Judge Carl A. Aveni, on October 6.
After returning to Ohio from a family trip, Brenda Downs, 64, contracted COVID-19, and within days deteriorated to the point she was admitted to OhioHealth in Columbus. Despite a federally recommended treatment that included remdesivir, Downs’ condition worsened. On the same day she was put on a ventilator, her family requested doctors at OhioHealth administer ivermectin, an anti-malarial drug that had shown some success in combatting COVID-19.
The hospital initially refused, saying ivermectin had not been approved by the U.S. Food and Drug Administration (FDA) for use against COVID-19. The family sued the hospital to administer the drug or allow an outside physician to do so.
$100,000 Penalty NDA
OhioHealth relented, but only after insisting the hospital and the Downs family conclude an NDA. That agreement, a copy of which was obtained by Health Care News, states:
“Mr. Downs has been fully apprised and informed of OhioHealth’s position that the administration of Ivermectin to Mrs. Downs in these circumstances is unlikely to provide her with a medical benefit, is an off-label use not approved for emergency or other use and that he voluntarily consents to proceed with the treatment described in Paragraph 1 as a compassionate use, with full knowledge of OhioHealth’s position; and
“Mr. Downs has voluntarily agreed to proceed with the treatment described in paragraph 1 because he believes, based on his independent research, that it has the realistic probability of benefit equal to or greater than standard care and that the risks of using such treatment are reasonable compared to the risks associated with not proceeding with the same.”
The NDA states that “upon proof by OhioHealth of such breach, OhioHealth shall be entitled to recover liquidated damages, without proof of actual damages, in the amount of one hundred thousand dollars ($100,000.00) from the Downs’ Releasors, who shall be jointly and severally liable for the same, except that the Downs lawyers and law firms shall not have liability unless that lawyer or that law firm is proven to be the violator.”
Under pressure from the hospital and desperate to save Downs’ life, the family signed the confidentiality agreement on August 18, 2021. But Franklin County Court of Common Pleas Judge Mark Serrott insisted the NDA be signed by the family’s attorney, Ralph Lorigo, who refused. Even after Downs’ husband obtained a new attorney, the ivermectin was never administered. Downs died on September 2, 2021.
Dueling Lawsuits
Wanting to tell their story without each member being held liable for the $100,000 fine, on October 22, 2022, the Downs family asked the Franklin County court to declare the agreement void, arguing, among other things, the hospital never intended to administer the ivermectin or allow it to be given by a third party, and that it was signed under duress. OhioHealth countersued, saying the suit was frivolous, and demanded the family be held responsible for the hospital’s legal fees.
Cara Bookman, one of Downs’ daughters who signed the confidentiality agreement, said in an email to Health Care News, “We did not sue for malpractice or wrongful death and our current case was filed under seal.”
“The reason we did not seek an against medical advice discharge of my mother was due to her unstable condition,” said Bookman. “The doctors told us she would most likely die in transport, and we agreed with that assessment at the time.”
As for the hospital not administering ivermectin, Bookman said, “Someone from OhioHealth lied to the judge and told him my mother was doing significantly better, and due to this lie, the judge did not force the hospital to uphold their agreement.”
Why Secrecy?
“The hospital’s behavior is both outrageous and hard to believe,” said Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons. “An NDA with a $100,000 fine might be appropriate to protect against disclosure of proprietary information, causing financial loss.
“But what is the hospital afraid of?” asked Orient. “That people might find out that an outside physician saved the life of a patient they refused to help? That they allowed an ‘off-label’ use of a long-approved drug—which is routine and extremely common in almost all other circumstances? That a dying patient went on to die after getting ivermectin instead of not getting it? That a family had to sue them to get a drug billions of people have received, often over the counter? That they are a dictatorial institution without regard for patients’ views or common compassion?”
Marilyn Singleton, M.D., J.D., a California-based physician, notes that the decision of the U.S. Court of Appeals for the Fifth Circuit, in Apter et al. v. Department of Health & Human Services et al., centering on whether the FDA interferes with doctors’ ability to prescribe ivermectin for COVID-19, is instructive.
“The court criticized FDA’s ‘you are not a horse’ campaign and emphasized that the FDA is not a physician,” said Singleton. “Nor is the hospital. The patient and her physician had the right to try the ivermectin. This reeks of a power play rather than a patient safety concern. The lawsuit by the hospital is not only cruel, it telegraphs that the hospital was wrong in fighting the patient and now it is doubling down.”
Bonner Russell Cohen, Ph. D. (bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.
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