At least 14 lawsuits are ongoing in the State of New York alone to compel hospitals in that state to administer ivermectin to severely ill COVID-19 patients. A total of 60 lawsuits involving demands for ivermectin as a treatment for COVID-19 have been handled by one law firm alone. TrialSite has followed many of these lawsuits, including an interview with the partner of a leading law firm leading the legal charge—the Law Office of Ralph Lorigo. While federal regulators don’t recommend off-label use of the U.S. Food and Drug Administration (FDA) approved antiparasitic drug, that doesn’t translate to a legal ban on physicians doing so. Traditionally, physicians had the discretion to take an off-label drug and, if in their best professional judgment and assuming appropriate disclosure and approval by the patient, prescribe off-label to address a particular problem. However, with a concerted effort to tarnish the name of this drug used by billions primarily in low-and middle-income countries (LMICs) over the last four decades—with very few safety issues—a concerted peer pressure to stop doctors and pharmacies from prescribing also leads to hospitals refusing to use the drug even if patient families request so.
Recently David Robinson, the state health reporter for Lohud, part of the USA TODAY Network in New York, showcased some of the lawsuits associated with this unfolding situation. Robinson reports that in most cases, desperate families seek to find anything that may save the life of their loved ones.
In these cases, the hospitals’ protocols have failed, and the patients are left in isolation and “kept alive by breathing machines while in medically induced comas,” reports Robinson. The patients’ families seek action and are forced to hire law firms such as Lorigo’s to compel the use of ivermectin.TrialSite reported that earlier in the year, judges seemed to be more open to taking the patient/plaintiffs side, but over the past few months, a significant change, coinciding with a massive seemingly orchestrated anti-ivermectin media campaign, has led to judges ruling against the patients’ families in most situations.
While the families of patients fall into desperate straits seeking any remedy to save their loved ones, Robinson reports hospital administrations and their physician employees counter that by stating the lawsuits cross an unacceptable line raising “far-reaching ethical and medical ramifications of judges overruling health officials on the safety and efficacy of drugs.”
While the FDA issued repeated warnings about self-medication, the Centers for Disease Control and Prevention (CDC) shared a report by the American Association of Poison Control Centers (APPCC) indicating urgent action involving a three-fold increase in calls to poison control centers. The takeaway: with mounting off-label ivermectin prescriptions, there were many calls associated with overdose or toxicity concerns. TrialSite investigations debunked that story involving mass levels of ivermectin-based calls to poison control centers. TrialSite obtained data from the AAPCC that while ivermectin prescriptions driven by off-label for COVID-19 skyrocketed over 2,000%, there was a three-fold increase in calls to AAPCC concerning the drug. However, after analyzing the data, it became apparent the vast majority of calls (99%) were not serious. One percent (or 11 calls) were deemed serious, but it wasn’t clear what the outcome of those actions were. There were no reported deaths in association with the AAPCC data. TrialSite did report claims from the health department of New Mexico that an overdose death was associated with ivermectin; however, the individuals were already severely ill with COVID-19. No conclusive proof was offered—only the statement that the drug was associated with the death.
The Lohud piece included an interview with Ralph Lorigo, the Buffalo-area attorney, who reports he has now represented 60 cases involving actions to compel hospitals to administer ivermectin across 25 states.
Lorigo shared, “Some of the 60 cases ended with judges ordering hospitals to administer the drug.” Apparently, in several of the cases, the ivermectin purportedly worked, and patients went home. TrialSite has reported more denials than victories of late, and apparently, Lorigo didn’t share with Lohud just how many denials were involved with the 60 or so cases.
Call to Action: Follow the link to the Lohud article for a full read on one point of view on the growing numbers of ivermectin-based lawsuits.