Healthcare worker sues health system for suppressing VAERS reporting

A physician assistant is suing Rochester Regional Health for violating federal law by intentionally suppressing reports of adverse events resulting from the COVID-19 vaccines.

Under 42 U.S.C. § 300aa-25, medical providers and health systems that provide COVID-19 vaccines must report any adverse events from a vaccine to the Vaccine Adverse Event Reporting System (VAERS). The Centers for Disease Control and Prevention (CDC) administers VAERS and is supposed to use the system to monitor vaccine safety. Healthcare workers who submit reports to VAERS are not required to verify a causal link between the vaccination and an adverse event.

In addition to being legally required to report to VAERS, providers are also contractually bound to do so. Any provider wanting to administer COVID-19 vaccinations must sign a contract with the CDC in which the provider agrees to “report moderate and severe adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS).” The provider must also ensure staff understand and comply with the agreement provisions, including VAERS reporting.

Once an adverse event is reported to VAERS, the patient can use the report to claim compensation for the injury from the Countermeasures Injury Compensation Program (CICP), administered by the Health Resources and Services Administration (HRSA). Since the federal government has shielded drugmakers from liability for damage caused by their products, the CICP is the only option vaccine victims have for financial relief.

Adverse events go unreported at RRH/UMMC

When the COVID-19 vaccines were rolled out in December 2020, Deb Conrad was a physician assistant (PA) working at United Memorial Medical Center (UMMC), which is part of the Rochester Regional Health (RRH) system. She served as director of Advanced Practice Providers (APPs) and was a member of the medical executive committee. Recognized for her stellar work and dedication, Conrad was recommended for a seat on the New York State Society of PA’s Board for Professional Medical Conduct.

Shortly after RRH began administering COVID-19 vaccinations, Conrad began to notice adverse events in patients directly following the injections. Some of these reactions included breakthrough infections and deaths. However, Conrad saw that not only were these adverse events going unreported to VAERS, but RRH had not educated or trained staff on VAERS reporting.

Conrad began reporting these events to VAERS on her own after she would clock out of her shifts. She teamed up with Dr. Danielle Notebaert, UMMC’s lead ER physician, who identified ER patients suffering from potential adverse events from the vaccine. By May 2021, Conrad had reported over 160 adverse events to VAERS. She contacted the hospital’s administrators about the legal requirement to report adverse events and volunteered to be the reporter.

VAERS reporting violated the hospital’s ‘approach to the vaccine’

According to a lawsuit Conrad filed last year, UMMC leadership appeared uninterested in reporting to VAERS. In an internal email on May 6, 2021, hospital administrators discussed a skin-related side effect from the COVID-19 vaccines but did not share this with hospital staff. They also dismissed VAERS reports of side effects, saying they were few compared with the number of overall vaccinations and therefore did not matter.

RRH and UMMC leadership told Conrad to “dial it back” and report only adverse events for her own patients.

“From what our risk team is telling us, really you can only be reporting on the patients that you are providing direct care for and so you cannot, and I know you’ve been volunteering and trying to be helpful, but we need you to try to kind of dial it back and focus on the patients that you are directly responsible for,” UMMC’s Chief Medical Officer Dr. Tara Gellasch told Conrad in a meeting in May 2021.

Conrad said she was only submitting reports to VAERS because no one else was doing it. The hospital responded:

“The approach has been that this is the responsibility of the individual provider who believes they have identified a potential adverse event and that has been our approach . . . You can’t control, and I know this is frustrating, but you can’t control whether someone else is putting the report in . . . and we do need to follow how the system is approaching this currently,” she was told.

When Conrad persisted, she was accused of being “anti-vaxxy”:

I don’t want us to go down any kind of rabbit hole here but the thing I think we need to be clear about and I am just going to be frank with you …in reading the few emails you sent me and reading the email that went out to the providers, it does come across a bit…uh very vaccine...ugh I won’t say very but it comes out quite, it comes out quite almost anti-vaxxy, right, and you know, clearly as an organization, as a health system, right and as … an organization that is working on following CDC guidelines and following the guidance of the department of health, we are very much advocating for patients to receive the vaccine. And we are very much working on the…effort to work to try and reduce vaccine hesitancy… We want people to understand that on the whole this is a very safe vaccine and that the science supports that. 

Conrad was then instructed to “tow [sic] the company line”:

Yes, just like other vaccines, there are folks that are going to be negatively impacted but, on the whole, we have seen a tremendous benefit to the vaccine … you and I are not individual providers, we’re employee providers and we do on some level need to kind of .. for lack of a better way of saying it, we tow the company line. That is part of our responsibility is to be supporting the mission of the organization.  

RRH told Conrad they were auditing her VAERS reports because reporting adverse events was contrary to the hospital’s “approach to the vaccine.”

Since she was forbidden from reporting adverse events for other patients, Conrad began sending the reports to hospital leadership so they could ensure their submissions to VAERS. However, not only did the hospital refuse to do so, but on at least one occasion Conrad found that evidence of vaccination had been removed from a death certificate to conceal the vaccine’s possible role.

Fired without due process

In September 2021, Dr. Gellasch and UMMC President Dr. Peter Janes met with Conrad and claimed there were “complaints” from patients or patients’ families about her VAERS reporting. They threatened to report her to the New York State Society for Physician Assistants (NYSSPA) for “spreading misinformation about the vaccines.”

Conrad went public about the illegal suppression of VAERS reports. Days later, she was fired from her job. To make an example of her, the hospital humiliated her in front of her colleagues. As she was charting her patients, she was suddenly surrounded by hospital staff, escorted to her workstation to retrieve her personal belongings, and then escorted out of the hospital while closely monitored by HR employees.

Violations of the False Claims Act

In May 2023, Conrad sued RRH and UMMC for violating the False Claims Act, a federal law against knowingly defrauding the government. Her legal team at Warner Mendenhall Law Group is arguing that the knowing suppression of VAERS reports and falsification of records violates RHH/UMMC’s contract with the CDC, in which they falsely claimed they would report adverse events to VAERS. Conrad, who now works as an advanced practice provider director at GoldCare, is suing for damages including backpay and civil penalties for thousands of False Claims Act violations.

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