J.B. was depressed after losing her brother to COVID-19. Her menstrual cycle was out of whack, and while she assumed that was from stress and grief, her husband worried it might be something else and wanted her to see her nurse practitioner about the bleeding.
At the time, Dr. Ryan Cole ran one of the laboratories used by women’s health practices in the Boise area. That’s where J.B.’s nurse practitioner sent a biopsy taken from her body on July 6, 2021.
Cole gave a diagnosis: a rare and aggressive form of endometrial cancer.
“I felt like I died already” upon hearing the diagnosis, J.B. told the Idaho Capital Sun in an interview. “You know, you know. It was scary,” she said, beginning to cry. “Oh, sorry. I don’t want to even, like, remember it.”
The Sun agreed to use only J.B.’s initials to protect her medical privacy.
It wasn’t until after she underwent major surgery that J.B. learned she didn’t have cancer after all.
On Wednesday, J.B. filed a medical malpractice lawsuit in Ada County that accuses Cole of negligence and other harms. The Sun contacted Cole and his representatives by email and phone Thursday, but they could not be reached for comment.
What she didn’t know at the time of her cancer diagnosis was that Cole, a local pathologist, had just begun to make a name for himself based on a stance against COVID-19 vaccines, including false claims that they cause cancer.
There is no evidence that COVID-19 vaccines can raise, or lower, a person’s risk of cancer. There is evidence that they lower a person’s risk of severe illness, death and chronic health issues after a COVID-19 infection.
“I have seen a 10- to 20-fold increase of uterine cancer in the last six months in my laboratory,” Cole said at a meeting of America’s Frontline Doctors in San Antonio, Texas, about two weeks after he misdiagnosed J.B. with cancer of the uterine lining. “In the last six months. When did we start shots? January? How much solid-tumor cancer increase are we going to see over the next several years? Probably a lot.”
Cole became medical director of America’s Frontline Doctors – an organization that opposes COVID-19 vaccines – in July 2021, the month he gave that presentation, according to his resume. Cole has yet to publicly share data to back up his claim.
‘Internal trauma and a lot of pain’
After the diagnosis from Cole, J.B.’s nurse practitioner read it and immediately referred her to physicians who specialize in cancer and gynecologic cancers.
The surgeon removed her reproductive organs and surrounding abdominal tissue.
“I can’t even imagine receiving that kind of a diagnosis from someone, and then spending that period of time wondering – or knowing, or believing – that you had a very serious cancer,” said Eric Rossman of Rossman Law Group, one of two Boise law firms representing J.B. and her husband in the case. “And then just to find out, after that radical, extensive procedure, that there’s really no cancer whatsoever.”
According to the lawsuit, J.B. consulted with a St. Luke’s Health System gynecologic oncologist on July 20, 2021.
“At that time and relying on Dr. Cole’s pathology report, Dr. Perez discussed various treatment options with (J.B.) including chemotherapy, radiation therapy and surgery,” the lawsuit says.
She chose surgery and, on July 26, 2021, the doctor performed surgery to remove her uterus, remove both of her ovaries and fallopian tubes, and tissue and lymph nodes in her abdomen, the lawsuit says.
Three pathologists at the hospital examined the organs and tissue as they were removed and saw no cancer. The surgeon asked to get the biopsy tissue samples back from Cole’s laboratory; in early August, three of the hospital’s pathologists determined that biopsy, too, showed no sign of cancer, the lawsuit says.
J.B. and her husband were told by the surgeon’s office on Aug. 30, 2021, “that the final pathology on the tissue samples showed that (she) never had cancer,” the lawsuit says. “The erroneous diagnosis of cancer caused (her) to undergo an unnecessary surgery and the resultant pain and suffering from such surgery. The erroneous cancer diagnosis caused (the couple) substantial emotional trauma in believing that (she) had cancer and then in being told that she did not have cancer.”
It took J.B. at least six weeks to heal from the immediate physical impact of surgery, they said. Their bedroom is on the second floor of their home, so J.B. essentially lived on the second floor because it was too painful to walk up and down stairs, she said.
She had “internal trauma and a lot of pain,” her husband said.
There are lingering effects, the couple said. They have “good insurance” but still had large out-of-pocket costs from the surgery, her husband said. And because of the misdiagnosis, her medical records flagged her as a “cancer survivor.” That altered how doctors approached things like breast cancer screenings – ordering a biopsy to confirm that a benign spot on her mammogram wasn’t cancer, for example, her husband said.
The lawsuit accuses Cole of negligence, calling his conduct “reckless and outrageous … constituting an extreme deviation from reasonable standards of conduct” with “an understanding of, or disregard for, its likely consequences.”
The lawsuit also alleges Cole Diagnostics is liable for Cole’s actions.
It accuses Dr. Ryan Cole and Cole Diagnostics of negligent infliction of emotional distress – specifically, “severe mental suffering” that caused J.B. to have “severe and chronic insomnia, anxiety, fear of doctors and severe headaches” and her husband to have insomnia and anxiety.
J.B. and her husband seek damages and compensation. The amount would be determined in court, but it’s more than $25,000 for each of the three counts, according to the lawsuit. They also seek economic damages, such as payment for medical bills that resulted from the misdiagnosis.
Not just another case of a patient suing their doctor
Cole is a pathologist who specializes in skin diseases.
A presentation by Cole in spring 2021 inside the Idaho Capitol minimized the risks of COVID-19 and argued against public health guidance. The presentation racked up millions of views on social media and streaming video platforms.
After that, Cole rose to prominence in a movement that denied the safety and effectiveness of COVID-19 vaccines and other public health measures.
Cole also received a political appointment in mid-2021 to serve as the only physician on the board of Central District Health, Idaho’s largest regional public health department.
He owned and directed Cole Diagnostics laboratory in Garden City for about 20 years. But due to blowback from his public statements on COVID-19, Cole had to “sell it off,” he said in a January interview published to video streaming platform Rumble.
“So, at the end of the day, I just had to, you know, sell it off,” Cole said in the interview. “And I’m still doing the autopsy consultation. I still have access to, you know, some equipment that I held in reserve so I can still help people. But now it’s a shadow of what it was, you know, on a daily basis.”
Reporting by the Idaho Capital Sun last year revealed accusations by several of Cole’s former employees that he operated his laboratory in a “reckless” manner. The Sun reported that Cole Diagnostics pulled in large amounts of money from COVID-19 test revenues and federal and state grants associated with the pandemic.
The Washington Medical Commission in January charged Cole with violating professional standards when he treated COVID-19 patients through telehealth and spoke at events about COVID-19 and vaccines.
In a response filed last month, Cole denied all of the charges and argued that Washington’s medical licensing authorities were trying to stifle his First Amendment rights to freedom of speech.
Multiple patients were misdiagnosed by Cole: records and interviews
The Sun reported last year on complaints that Cole misdiagnosed two women with cancer or precancer of their reproductive organs. The Sun did not publish details that could be used to identify the women, to protect their medical privacy.
J.B. read that report by the Sun. She said to her husband, “The other patient of Dr. Cole that (had) a complaint, it sounds like me. It just has the age (as) 60-something, and during the time I was only 50.”
She assumed it was an error – that the woman in the complaint was her.
But it wasn’t an error. Instead, J.B. is the second woman to have undergone major surgery after getting erroneous test results from Cole, and the third woman the Sun has identified who received a misdiagnosis related to gynecologic cancer.
The patient whose medical care is described in Cole’s Washington Medical Commission complaint file is a 64-year-old woman whose description is not similar to J.B.
According to the records in Cole’s case file, that patient also had major surgery – removing reproductive organs and abdominal tissue – on July 19, 2021. Cole examined a biopsy taken from the woman’s body on June 30, 2021, and diagnosed her with endometrial cancer.
Pathologists from St. Luke’s Health System and Stanford University determined there was no evidence of cancer in the woman’s uterus or in the biopsy tissue that Cole had examined.
The Washington Medical Commission sent Cole a letter on March 30, 2022, asking him to respond to the allegation by April 20, 2022.
The commission’s records show Cole failed to respond by the deadline and didn’t respond to two emails, three phone calls and a certified letter.
Cole and his lawyer responded by email to the Washington Medical Commission on July 28, 2022.
The response made several arguments in defense of his diagnosis:
- The health care provider gave him a small amount of tissue to examine from the biopsy and he “suggested that further pathology be conducted due to the size of the tissue sample.”
- His report “clearly stated that the clinician should read the microscopic description, wherein I suggested genetic testing.”
- While his own report recommended further evaluation, Cole criticized Stanford pathologists’ use of the words “may be” as a less definitive assessment. “They hedge diagnostically, which gives no meaning or direction to the clinician or patient,” he wrote.
- Pathology groups can “vary slightly in the criteria they use for determining the line between metaplasia (not cancer) and carcinoma (cancer).”
- Cole’s diagnosis was confirmed by a pathologist who worked for his laboratory.
- Even in hindsight, the tissue looked “highly suspicious for cancer” based on his examination, he said. “If this were my mother or my wife, I would have wanted them to have a hysterectomy,” he wrote.
Why no second opinion before invasive surgery?
The complaints about Cole’s diagnoses indicate that both patients had symptoms and abnormal test results that prompted their health care providers to order the biopsies Cole used to diagnose the patients.
Was surgery the most prudent way to treat these patients? Why didn’t anyone get a second opinion?
Rossman said, in his client’s case, “if you look at this Cole Diagnostics original pathology report, there’s just really no ambiguity.”
There is nothing in the report that would ordinarily raise questions or doubts about the diagnosis, he said.
“Obviously, there were a lot of second, third, fourth and fifth opinions after the surgery, and they were unable to find any cancerous cells,” Rossman said. “But preoperatively? No. Because this was such an unequivocal diagnosis in Dr. Cole’s report. There really was no reason for (the surgeon) to question that.”
The cancer J.B. thought she had is an aggressive type of cancer. She didn’t want to wait to get treatment, she said. Health care providers worked to get her in for surgery as soon as possible, she said.
“Coming from a Third World country, you know, I didn’t expect to have a big mistake like this in U.S.,” said J.B., who immigrated to the U.S. from the Philippines. “We look up to the system and technology here. (To) have that kind of mistake, it’s so unbelievable. … It’s beyond my imagination. I thought everything here is precise, consistent and handled with care.”
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