Screenshot of Erin Blau from CDC website

Epidemiologist Erin Blau gives a presentation at a CDC conference about the Location Vaccination public health investigation. | Screenshot from CDC website

Dozens of people have come forward to file lawsuits in a public health case that recently resulted in a $5,000 agreed order against a central Kentucky physician, following multiple infections associated with his wife’s traveling vaccine business.

At least five lawsuits have been filed in Montgomery Circuit Court by people from various cities who say they were injured after getting vaccinations from Location Vaccination of Mount Sterling, Ky.

“To me, this is just a straight-up negligence case,” said Ira Kilburn, a Salt Lick, Ky., attorney representing 40 plaintiffs. “It had nothing to do with the vaccines themselves.”

The business, owned and operated by Fairshinda Sabounchi McLaughlin under the medical license of her husband, Dr. Paul E. McLaughlin, would travel around the region, including to Louisville, other parts of Kentucky and neighboring states, vaccinating workers at different companies against flu and other illnesses, such as hepatitis A, pneumonia and tetanus, according to state health officials.

An attorney at O’Bryan, Brown & Toner, the law firm that’s representing the couple in legal proceedings, declined to comment on the lawsuits, but the couple argues in court documents that such cases must be dismissed on procedural grounds to be handled by an alternative to the traditional legal system.

The vaccinations were given by Fairshinda Sabounchi McLaughlin and at least two other untrained representatives of the business, according to a letter written by the state’s public health commissioner, Dr. Jeffrey Howard, and resulted in a media alert earlier this year about adverse reactions that some workers were having.

“For vaccines, it’s not uncommon for someone to experience a minor site reaction to the extent where there might be some redness, but this was really more than that,” said Erin Blau, an epidemiologist with the U.S. Centers for Disease Control and Prevention who’s assigned to the Kentucky Department for Public Health.

“This was severe redness, tenderness, pain, development of a nodule and (some of) these individuals were experiencing like an abscess-like reaction and that’s not something that should be expected after a vaccination and definitely should catch any clinician’s eye,” Blau added.

More than 100 people across three states, Kentucky, Indiana and Ohio, experienced symptoms of infection, with more than 25 testing positive for non-tuberculous mycobacterium, said Blau, who gave a presentation at a conference this year about her part in the investigation of the case.

“The infections people experienced during this outbreak were unacceptable and serve as a reminder that we can and must do more to prevent the mishandling of one of the most important inventions in modern history — vaccines,” Blau said on the CDC’s website.

“… We had to be creative and persistent in our efforts to understand how the outbreak happened and make sure affected people and their doctors had the information they needed.”

The bacteria could not be isolated in samples taken from the business or vaccines that were collected, but some people tested positive for it, Blau said. She also said this “very clearly was not a vaccine issue and it was very much limited to this one business … There was something once the vaccine was handled by this business that allowed for contamination.”

During site visits and interviews, Blau said she learned of questionable hand hygiene practices, inadequate temperature monitoring, and vaccines reportedly being drawn up well in advance of administration.

“While use of a multidose vial is standard, vaccine should only be drawn up immediately before administration, so to collect vaccine that was already drawn up into syringes, this seemed highly unusual,” she said during her presentation.

Montgomery County Courthouse

Montgomery County Courthouse | Photo by Darla Carter

In lawsuits filed in Montgomery Circuit Court, workers from Mount Sterling and elsewhere assert that they were injured as a result of actions by the McLaughlins. The suit mentions the vaccinations as well as follow-up treatment.

The lawsuit filed for Kilburn’s clients — who got vaccinated around Oct. 3, 2018 — asserts that Paul E. McLaughlin provided medical treatment, advice and care to the plaintiffs individually and through his wife after adverse reactions to the vaccinations started to occur.

It also accuses the doctor of failing “to properly diagnose and treat the (plaintiffs’) conditions resulting in future extensive treatment, emergent treatment, and surgery to remove abscesses and lumps” from the plaintiffs’ bodies.

The lawsuit also says that before administering the vaccinations to the 40 plaintiffs, the McLaughlins “had been put on notice” that people were having adverse reactions but continued to give vaccinations “without warning of the prior adverse reactions.”

Earlier this month, Dr. Paul E. McLaughlin entered into an agreed order with the Kentucky Board of Medical Licensure, requiring him to pay a fine of $5,000 and be on probation for five years.

The doctor also must complete at least five hours of continuing education on a subject related to vaccine administration, according to the order, and develop a written policy regarding the storage and administration of vaccines and protocols for follow up in the event of adverse vaccination reactions.

But his Louisville lawyer, Tracy S. Prewitt, stresses that the agreed order does not represent an admission of guilt, pointing to a portion of the order that says, “The licensee denies that he delegated his professional or medical responsibilities or that he inappropriately responded to the vaccination reactions when he became aware of them.”

She also noted in an emailed statement: “Dr. McLaughlin has been a valued member of the medical community for many years and has always provided careful, conscientious care to his patients. His care has never been questioned in the past.

“While some patients reported reactions to vaccines administered by Location Vaccination, a separate entity, there has been no determination that these reactions were anything other than well-recognized side-effects associated with most vaccines. The Kentucky Board of Medical Licensure has not restricted Dr. McLaughlin’s medical license. This Agreed Order simply sets out the unproven accusations of others. Dr. McLaughlin has denied all issues related to quality of care.”

The statement on behalf of Dr. McLaughlin contrasts with language in the agreed order that stipulates: “On June 20, 2019, the licensee appeared before the Inquiry Panel, which opined that the licensee’s blanket delegation of his professional and medical responsibilities to an unqualified and unlicensed person without sufficient oversight, and his failure to evaluate, treat and report the patients with adverse vaccinations reactions appropriately, constitutes a failure to conform to prevailing medical practices in the Commonwealth of Kentucky and contributed to a public health crisis.”

In her conference presentation, Blau said that when McLaughlin’s wife was asked about her training during the investigation, “she initially answers with nursing.”

Blau added: “It takes multiple follow-up questions to uncover that this background in nursing is no license, degree or certification. No, it’s far less; it’s that she was trained by a nurse once years ago.”

But Prewitt noted in an email that “Kentucky law generally does not require individuals who administer vaccines to maintain licensure through any local, state, or federal agency.”

Prewitt declined to comment on the lawsuits, and fellow attorney Benjamin J. Weigel, who’s filed some of the defense documents for the McLaughlins in the Montgomery County lawsuits, didn’t respond to a request for comment.

Central kentucky map

Mount Sterling is in central Kentucky, near Lexington and Winchester. | MapQuest

However, the McLaughlins argue in court documents that claims filed in Montgomery Circuit Court should be dismissed on a procedural basis, namely that such claims must be handled first by the National Vaccine Injury Compensation Program and the U.S. Court of Federal Claims.

Location Vaccination came to the attention of the general public when the Kentucky Department for Public Health issued a news release Feb. 1, 2019, saying that it was investigating multiple infections associated with vaccinations that had been given by Location Vaccination since Sept. 1, 2018.

The news release noted that infections were unlikely to get better on their own and symptoms could develop a few days to more than 12 weeks after vaccination.

The release also quoted Kentucky Public Health Commissioner Jeffrey Howard as saying that “if you received vaccine from this provider, we strongly encourage you to consider getting another round to ensure you are fully immunized and not at risk for contracting illness.”

Court documents show that Howard wrote a letter to Michael Rodman, the Kentucky Board of Medical Licensure’s executive director, on Jan. 4, 2019, expressing concerns about Location Vaccination.

Howard’s letter noted that Mrs. McLaughlin had called in prescriptions for patients under her husband’s name without office visits or testing and that there were some reports from patients that Mrs. McLaughlin had offered to cover treatment costs related to the vaccinations.

During an on-site interview Dec. 12, 2018, the Kentucky Department for Public Health “spoke with Mrs. McLaughlin and documented that she admitted to calling in antibiotics and steroids for a number of employees experiencing reactions and that she’s even called in antibiotics and steroids to employees who had not experienced a reaction,” Howard’s letter said.

“When asked why she called in antibiotics for employees without symptoms, she said it made them feel better,” his letter said. “Mrs. McLaughlin stated that her husband, Dr. McLaughlin, was upset when he later found out that she called in antibiotics and steroids for an asymptomatic employee.”

Howard also noted that the prescribing of antibiotics without appropriate testing and cultures was in direct contradiction to a statewide health alert that had been sent to providers on Dec. 19, 2018, and that Dr. McLaughlin had read.

“Inappropriate prescribing could lead to serious outcomes, particularly in light of the steroid prescriptions that have been reported by several patients,” Howard’s letter said. In the case of non-tuberculous mycobacterium infections, he wrote, “this could lead to disseminated mycobacterium infection which could be fatal in the case of individuals with immune disorders.”

The letter also said that “antibiotic therapy, particularly monotherapy without knowledge of susceptibility information for the specific mycobacterium can result in the development of resistance, prolonging and complicating treatment, and potentially leading to additional adverse consequences for the patient.”

This article has been updated to correct the year of an on-site interview mentioned in this story.