Years ago, when rheumatologist Leonard Sigal, MD, was undertaking research on Lyme disease and treating patients with the condition at the Robert Wood Johnson Medical School, in New Brunswick, New Jersey, a regular stream of abuse and threats became the usual background noise of his work. He didn’t get used to it, but it never stopped.
“I was accused of incredibly heinous crimes,” Sigal told Medscape Medical News. “I was accused of lying, cheating, of doing things to make money that were against the public interest and against the interest of patients in general.”
It’s an experience many doctors who treat Lyme disease have endured, so much so that some infectious disease doctors aren’t comfortable treating patients with Lyme disease, according to Timothy Flanigan, MD, a professor of infectious disease at Brown University, Providence, Rhode Island..
But it wasn’t until Sigal left academia in 2003 that he realized the toll all that background abuse had been taking on him.
“It was a breath of fresh air,” he said. “I didn’t have to go into clinic and argue with people. I didn’t have to read articles in the newspaper that made no sense whatsoever. I didn’t have to hear through second and third parties how such and such was saying horrible things about me. I didn’t have to fight anymore. When I was in industry and working on stuff that had nothing to do with Lyme disease, I realized what a relief it was not to have that burden.”
So the last thing Sigal expected after all these years was to find himself named in a lawsuit alleging that he was part of a conspiracy to deny patients of what they claimed was appropriate treatment for Lyme disease. Yet, that’s exactly what happened in November 2017, when a group of 24 patients with Lyme disease, led by Texas resident Lisa Torrey, filed a lawsuit against the Infectious Diseases Society of America (IDSA), eight insurance companies, and seven of the doctors involved in producing the IDSA guidelines on Lyme disease diagnosis and management. Sigal himself had not even participated in writing the guidelines. He simply reviewed them, made a few grammatical suggestions, and said they looked good. Yet, over the next 4 years, he and his fellow defendants rode an emotional rollercoaster of seemingly endless motions, amendments, and other legal developments, waiting to find out whether they would owe millions of dollars for simply summarizing — or just reviewing — the available medical literature on Lyme disease.
“There were times I was on the verge of real anger. I was frustrated. There were times I was frightened, and, occasionally, I would just think of it as being silly. But when I thought of it as being silly, I had to remember I was being sued in Texas, because who knows what’s going to happen,” Sigal said. “It’s not as though I was being sued in a jurisdiction where anybody knew about Lyme disease. There are examples of physicians who are convicted of doing things they didn’t do because they were sued in the wrong jurisdiction.”
Several individuals who spoke with Medscape Medical News on condition of anonymity said that the district court where the suit was filed is notorious for being especially friendly to plaintiffs. But in legal rulings issued on September 1 and September 20, 2021, a federal judge in Texas dismissed all the patient group’s claims. The plaintiffs filed an appeal on October 19. It’s unclear whether that has any reasonable chance of success.
“One of the things this court case does is validate the fact that our [guidelines] process is a legitimate process and there isn’t outside influence from insurance companies or pharma firms,” Daniel McQuillen, MD, president of IDSA, told Medscape Medical News. “We don’t really want anything other than to be vindicated, which we were, 100%.”
But that vindication came with a cost, both emotional and financial. Although IDSA’s insurance covered many of its legal costs, “it’s not a trivial expense,” McQuillen said. “We’re left with a baseless lawsuit with no facts that went on for 4 years, and our [medical] society basically bore all that expense, which isn’t really particularly fair.”
The lawsuit alleged that the IDSA, the seven named physicians, and the insurance companies had “engaged in a decades-long conspiracy to deny the existence and prevent treatment of chronic Lyme disease.” The patient group claimed that the doctors knew that many patients with Lyme disease do not respond to short-term antibiotic treatment and instead need “long-term antibiotic treatment until the symptoms are resolved,” an assertion not supported by the scientific evidence.
What many patients call “chronic Lyme disease” is termed post-treatment Lyme disease syndrome (PTDLS), a constellation of symptoms that include pain, fatigue, and cognitive difficulties that some people experience after a 2–4 course of antibiotics for Lyme disease. It took years of patient advocacy before the Centers for Disease Control and Prevention recognized PTLDS as a condition, but awareness of it has been increasing, said Flanigan, who was not involved in the lawsuit but treats patients with Lyme disease and PTLDS.
“Long haulers and sequelae of COVID have really opened the eyes of many practitioners that these long-term inflammatory conditions are real and very challenging to treat, and we need to work with patients to help them improve their health,” Flanagan said. “It’s a sad commentary on our society that the difficulty in treating patients with post-treatment Lyme disease syndrome, or what is commonly referred to by patients as chronic Lyme, ends up in a lawsuit in court.” He said he’s glad the lawsuit was dismissed but added that “there’s a crying need for additional high-quality, evidence-based research to help patients who are suffering from post-treatment Lyme disease syndrome.”
Patients fought for broader recognition of their condition, and some of them organized. They came up with their own ideas of what was causing their symptoms to persist. One that especially took hold was that infection from Borrelia burgdorferi , the bacteria that causes Lyme disease, persists after initial antibiotic treatment, causing so-called chronic Lyme disease. The cause of PTLDS is still under investigation, and the evidence does not support the idea of a persistent bacterial infection. Multiple studies from the National Institutes of Health have shown that long-term use of antibiotics does not benefit patients who continue to experience symptoms after initial treatment. Several studies have shown that severe adverse effects can result from extended intravenous antibiotic treatment, including death.
Nevertheless, the plaintiffs in the lawsuit argued that the insurance companies “enlisted the help of doctors who were researching Lyme disease — the IDSA panelists — and paid them large fees to develop arbitrary guidelines for testing Lyme disease,” thereby enabling the insurance companies to deny coverage for long-term antibiotic treatment to patients.
“The assertions were just preposterous,” McQuillen said.
In addition to the conspiracy charge, the plaintiffs brought additional accusations to the lawsuit over the years, including racketeering and claims that the guidelines contain false representations regarding Lyme disease testing and treatment. The plaintiffs claimed that the guidelines didn’t acknowledge that treatment can fail and included false information about how to test for Lyme disease. In reality, however, the guidelines do acknowledge that not all patients respond to the recommended 2- to 4-week course of antibiotics and that some diagnoses should be made clinically rather than on the basis of testing.
Regardless, guidelines are not stipulations. They’re a summation of the medical and scientific findings on Lyme disease based on careful review of hundreds of studies.
“They make really clear that adherence to the guidelines [is] voluntary. They aren’t a standard of care from which deviation of care is a problem,” McQuillen said. “You take those guidelines and apply it to the patient in front of you, and you see what fits best for that patient, because not every patient is going to fit into guidelines.”
Further, the authors say that IDSA vets their recommendations for any potential conflicts of interest in accordance with the organization’s guidelines practices.
“The point of the guidelines is to have people on the committee who don’t care what the guidelines are as long as we have good patient care,” McQuillen said.
Choosing to Fight
Malpractice insurance does not cover this kind of lawsuit, because the doctors named in it did not personally treat any of the patients who filed it. Thus, the doctors were at risk of losing thousands, or millions, of dollars in legal fees, even if they ultimately prevail. Several of the physicians’ academic and healthcare institutions stepped in to cover some fees, and IDSA covered the rest in a joint defense.
“The IDSA provided me a lawyer at no cost to me, and I felt protected by them,” Sigal said. “They took care of me and made sure I was safe, and I am grateful to them for that.”
McQuillen said the expenses exceeded what the organization’s umbrella insurance covered. The physicians had invested their time and effort into the guidelines without any financial compensation.
“They’ve basically put a lot of sweat equity into producing guidelines” that follow the organization’s practices and ethics, McQuillen said. “To leave them out on an island by themselves is just not the right thing to do. We wouldn’t do that for any of our members who did something on behalf of our society.”
IDSA could have chosen to settle the lawsuit, as the insurance companies did.
“None of us on the board felt that that was the right thing to do, because we believe in the process, and the science is right, and you shouldn’t be able to try to change that by having a lawsuit that’s baseless,” McQuillen said.
Several of the doctors named in the suit spoke with Medscape Medical News off the record about the exhaustion, frustration, and general suffering the suit has caused them over the past several years, including ongoing harassment that targeted their families and often became quite personal. But none of those who spoke with Medscape Medical News expressed any wish that IDSA had chosen the faster, cheaper, easier route of settling.
“I love the organization for having done this rather than caving and paying,” Sigal said. “They showed real moral character, real integrity in fighting this suit, because they had done nothing wrong.”
Fighting the suit was about more than standing by the science, though. It’s essential to ensure physicians continue to conduct research and write clinical guidelines, even about ambiguous or controversial topics, said Raymond J. Dattwyler, MD, a professor of microbiology, immunology, and medicine at the New York Medical College, New York City, who wrote the treatment part of the guidelines and was named in the suit.
“I was really surprised that someone would sue for scientific guidelines, because guidelines are common across medicine, and they’re just a roadmap to help practicing physicians understand how to handle evaluation or treatment of any number of particular problems,” Dattwyler told Medscape Medical News. But he wasn’t surprised that IDSA chose to fight the accusations, “because the principle involved is so compelling,” he said. “It’s really standing up for all medical societies, and it’s very important to have guidelines. For the health and welfare of the American public, you need to have good information readily available to the practicing physicians.”
If the patient group had won in a settlement, it could potentially have led to less rigorous guidelines from other medical organizations, which would have had an adverse effect on public health, Dattwyler said. Such a chilling effect could reverberate far beyond the management of Lyme disease.
“One of the problems with our legal system is anybody can sue anybody, but it costs so much to defend yourself,” Dattwyler said. “This lawsuit costs millions, so that’s chilling. That’s going to inhibit guidelines, and it’s not only guidelines for infectious disease but it’s guidelines for cancer, guidelines for allergic diseases, guidelines for any number of things.”
To an extent, the threats and harassment that patient groups have directed toward different doctors have already had a chilling effect.
“For the people who gave of their time in good faith to generate these guidelines to get harassed everywhere, all the time, sometimes at home, sometimes at their place of work, it’s just unfair,” McQuillen said. “It also might discourage people from working in research to try to figure out better diagnostics or get a vaccine that actually works. Even if you really find it incredibly interesting, if laying over you is the threat that someone is going to sue you baselessly, and you’re going to have to put the time and effort into defending that, not to mention the money, I can’t see how that would be considered a positive that would encourage you to do it. In some ways, attacking people that are trying to help may drive them away from trying to help.
“At the same time, professional disagreements among practitioners — including a small minority who do treat patients with lengthy courses of antibiotics — can ultimately harm patient care, Flanigan said.
“There’s a lot of energy being expended fighting among different care providers, and often the individual needs of the patients seem to be not addressed,” Flanigan said. “The discord between different approaches often seems more important than spending time with the individual patient and trying to find a tailored approach to treatment which can benefit the patient best.”
At the same time, Sigal said he believes most of the clinicians who use non–evidence-based treatments for their patients do so because they genuinely believe it’s the right thing to do.
“I think they’re motivated by the same concerns that I have, and that is, I need to do what’s best for my patient,” Sigal said. Ultimately, the evidence should lead the way, he said. “The only arbiter we possibly have in deciding these things is the medical scientific literature,” Sigal said, “and if you can’t subscribe to that, then this way lies madness.”
Tara Haelle is a Dallas-based science and medical journalist.