The Danger Within Us

by Jeanne Lenzer

  With the FDA ignoring him, Fegan was determined to get his story out to the press. By late 2010, my colleague, Shannon Brownlee, and I had written three articles about the device industry in which Fegan’s case appeared, including my original article in The BMJ and two popular articles in Discover and Reader’s Digest.100, 312, 313 They included what I thought was one of the most shocking points of the case: Cyberonics never collected death statistics for any of the five studies the company submitted to the FDA to prove the safety of the VNS device. And even more shocking to me: the FDA said it was satisfied that the device was safe based on the studies provided by Cyberonics.

  Fegan sent the articles out to everyone he could think of. More politicians. More journalists. More FDA officials. He struggled to get the word out for more than a year after the articles about the VNS device were published. But by 2012, it was clear that the articles had changed absolutely nothing. There was no public outcry. No calls for a congressional investigation. No action taken at the FDA.

  In August of 2012, Fegan wrote to Dr. Jeffrey E. Shuren, the director of the Center for Device Evaluation and Research, a division of the FDA:

  Dear Dr. Shuren,

  I would like to share my near death experience with you. On July 2 2006, I had what I thought was a bad run of atonic seizures. My parents just happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neurologist and EMS.

  My last memory of that morning was being inside of the ambulance the next thing I knew I was in the ICU.

  The Vagus Nerve Stimulator was stopping my heart (asystole) every 3 minutes during the 30 second stimulation cycles. If my parents hadn’t happened to stop by that day I would have died and my death would have probably just been written off as a fatal seizure or SUDEP. No one would have ever suspected it was the VNS that killed me.…

  Dennis Fegan

  But none of his entreaties was met with any action. Still, Fegan had one last spark of hope. One of the officials Fegan had contacted was William H. Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. A cardiologist and an assistant professor of medicine at Harvard Medical School, Maisel had long been a strong advocate for improved safety standards for implanted medical devices. He founded the Medical Device Safety Institute before he moved to the FDA. Maisel had responded to Fegan personally and promised that he would oversee an investigation into the VNS device.314

  Then, suddenly, Maisel stopped responding.

  Fegan was now in free fall. He was sure the device was still killing people with epilepsy—people no one seemed to care about. He felt as if he were screaming, yet the world had gone deaf. His thoughts were getting scary. He began to see signs that the Secret Service was on his doorstep in retaliation for his making threats against the FDA. The CIA was after him, too.

  On September 11, 2012, Fegan sent a volley of e-mails to Maisel. He demanded that the agency remove all VNS devices from the market. When he didn’t get an immediate response, he exploded:

  Do you know who I am Bill?…Order every one of those GODDAMN VNS devices shut off NOW. Don’t FUCK AROUND. Order every one of those GODDAMN devices off right this FUCKING minute before it kills one more innocent epileptic. If it doesn’t happen NOW you will not only be having the law to deal with, your poor ass will have to deal with me.

  NOW GODDAMN IT.

  Dennis Fegan

  Maisel’s failure to respond to Fegan may have been related to an incident two months earlier, in late July, when Maisel was arrested in a sting operation for soliciting a prostitute.315 FDA leadership declined to take action against Maisel, saying that the arrest had nothing to do with his work at the FDA. Under the circumstances, Maisel, previously outspoken about device safety, wasn’t sticking his head above the parapet. He was lucky to have a job.

  Frustrated, Fegan sent other e-mails, equally threatening and equally out of character for him—at least for the old Dennis Fegan, whom his friends and family had always known.

  Two days after sending his e-mails to Maisel, Fegan was whisked off to the psych ward at the Corpus Christi Medical Center. Neighbors had called the police because he was yelling and throwing lawn chairs in the street. When the police arrived, he told them he was building a barricade. Preparing for war. The CIA or the FDA, maybe both, were after him. He calmed down after a day or two at the Corpus Christi hospital and returned to what seemed a normal life.

  But less than a year later, Fegan’s big breakdown occurred.

  Officer Ernesto Coronado was one of the first police officers to arrive at the home of Fegan’s parents on August 25, 2013. Fegan and his sister were standing in front of the house when Coronado arrived. Fegan was obviously angry, and his movements appeared erratic. The officers tried to calm him and figure out what was upsetting him, but he was having none of it. Faced with an angry six-foot-three-inch, 240-pound man, Coronado and his colleague called for backup. Within minutes, two additional officers arrived. Four police cars were then parked in front of the house, their blue and red lights whirling, attracting the attention of neighbors.

  At one point, Fegan threw a bottle, and it shattered on the sidewalk. At another point, he grabbed his sister’s neck from behind. Fegan would later say it was “just a hug.”

  Unable to calm Fegan, one of the officers gave a small, almost imperceptible hand signal, and all four cops leaped into action. As Coronado would later write in his report, the officers “escorted [Fegan] to the ground.”316 Coronado was cut as he fell on shards of broken glass from the bottle Fegan had thrown. Still bleeding, Coronado and the other officers hog-tied Fegan. They put him facedown on the ground, bending his knees so his feet pointed up in the air. They cuffed his ankles and tied his ankle cuffs to his wrists, which were also cuffed behind his back. Then they dragged him off to one of the police vehicles. Fegan yelled and struggled as they put him in the car belly down across the backseat.

  When police brought Fegan back to the psychiatric ward of the Corpus Christi hospital, Carlos Estrada, a psychiatrist, marked the admitting complaint with a description of Fegan as exhibiting “strange behavior.” He wrote, “The patient is a 54-year-old white, single disabled male, who lives alone in Corpus Christi, Texas…the patient reports that he suffers from severe, uncontrolled temporal lobe epilepsy.”

  Estrada outlined what Fegan told him: that he had a VNS device implanted in 2000 that caused him to pass out when his heart stopped and that he had “started to investigate if the device was safe” by contacting Cyberonics as well as the FDA and other patients through the VNS message board. Fegan told Estrada that the device caused many deaths, and he wanted the device removed from the market. He said he couldn’t sue the company for the harm he suffered because the Supreme Court ruled that as long as the FDA approved the device, the manufacturer was immune from lawsuits.

  The psychiatrist faithfully noted each of Fegan’s statements in his chart, revealing that Fegan was surprisingly lucid.

  Estrada said that, while in the psychiatric unit, Fegan started “calling, writing, and e-mailing” FDA officials William Maisel and Jeffrey Shuren and that Fegan had become “obsessed” with the issue. Based on information provided by Fegan, his family, and one of Fegan’s e-mails, Estrada wrote that Fegan was frustrated with the lack of action at the FDA and “made threatening e-mails using coarse language.” Estrada quoted one of Fegan’s e-mails (delicately changing “fuck” to “f***” in his notes): ‘I don’t see any signs of action yet…so get your f***ing ass in gear. I am not f***ng around here. You don’t know me and you sure as f**k don’t want to know me…’”

  Fegan told Estrada that Homeland Security contacted him after his last e-mail, on September 11, 2012, and told him he was “going to be receiving a letter to ‘cease and desist,’ otherwise he would be prosecuted by the Federal Government.”

  Fegan rapidly improved during his stay in the psychiatric unit and was released from the hospital fou
r days later, coherent and normal. But the episode left its mark. He felt humiliated, like a man who had tumbled far from the days when he was a professional paramedic calming and treating patients in crisis. Somehow his life seemed to have gone terribly, terribly wrong. He wasn’t that violent, out-of-control man who’d been dragged from his parents’ lawn by police.

  These two episodes represented the first times Fegan had ever needed psychiatric care. He’d never been on psychiatric medication or had psychiatric problems in the past, yet he had suffered psychosis, a distinct condition in which an individual can’t distinguish reality from unreality. Psychosis is a feature of schizophrenia, which causes some patients to hallucinate and see or hear things that don’t exist. Schizophrenia usually begins early in life, typically in a patient’s late teens or early twenties. A psychotic episode that begins late in life (Fegan was fifty-four) suggests a medical or organic problem rather than a psychiatric disorder. Metabolic disorders, toxic illnesses, severe infections involving the bloodstream or brain, dementia, and Alzheimer’s disease are just a few of the medical problems that can cause psychoses. But Fegan wasn’t demented or seriously ill. In between the two episodes he was normal. Nor was he schizophrenic.

  There were reasons to suspect an organic basis for his breaks with reality. When he was hospitalized with multiple episodes of asystole, his brain was deprived of oxygen—a condition called hypoxia—which could have caused some injury to the brain. Larry Johnson, the ER doctor who cared for Fegan, said, “It wouldn’t be surprising if he did have some degree of hypoxic brain damage.”

  Repeated episodes of oxygen deprivation may have set up Fegan for his unraveling those many years later, even though he was lucid in between, because stressors sometimes “unmask” underlying disorders. There are many parallels in medicine. For example, if someone has a so-called lytic lesion, an eaten-out area of bone caused by a cyst or cancer, he or she might walk around for years without any awareness of the problem—until a very slight trauma occurs and the bone shatters, unmasking the underlying cancer. So although Fegan’s first psychotic break didn’t occur until years after he was hospitalized with asystole, it could be that aggravating factors had unmasked underlying insults to his brain. And Fegan suffered a thousand small cuts—and several big ones—after he was hospitalized. Underlying hypoxic brain injury, combined with his original head injury at the age of seven, his temporal lobe seizures and seizure medicines, the chronic stress of his battle over the VNS device, and, finally, the ultimate and crushing blow of the Supreme Court ruling may have formed the substrate for Fegan’s eruption.

  For Fegan, it was as if he’d been fighting his way out of a thick tangle of spiderwebs, and the more he fought and struggled, the more entangled and hopeless he became. When he opened the letter from attorney Jay Winckler telling him that he couldn’t sue Cyberonics because of the US Supreme Court ruling on preemption,317 Fegan had already felt the earth shift beneath his feet. A Reagan-loving Texan, he believed in freewheeling capitalist enterprise, unfettered by government constraints. But the same lack of constraints on business, when applied to the healthcare industry, had caused him to live with a dangerous medical device in his neck, one that couldn’t (and can’t) be removed. Fegan’s experiences upended some of his earlier beliefs. He still distrusts government, but he can also imagine it as a potential force for good—one that can provide genuine protections for citizens if it can be disentangled from the powerful arm of industry.

  For Fegan, the medical-industrial complex isn’t an abstraction. It’s Cyberonics; it’s the FDA; it’s hospitals, doctors, insurers, medical researchers—and all of these failed him.

  * * *

  One final story from Fegan’s medical history sums up in a small, sad way just how dysfunctional our American healthcare system can be.

  Back in 2006, during Fegan’s hospitalization, an X-ray had suggested that the lead wire from his VNS device appeared to have migrated dangerously into his jugular vein. Fegan was told of the finding but was reassured by his doctors that it was just a mistake—the lead was not in his jugular vein. Years later, his new neurologist, JoAnne Sullivan, decided to get a definitive reading on the VNS lead wire and ordered an ultrasound. The new test, performed on January 10, 2011, confirmed the original reading: the wire was indeed inside Fegan’s jugular vein. The finding was so worrying that the radiologist, Cameron Gates, took the unusual step of contacting Sullivan by phone about the result and documenting in his note that: “The above findings and impression were discussed with [Sullivan] at 11:00 a.m. on 1/10/11. She expressed understanding of the findings during our conversation.” Radiologists may read hundreds of imaging studies in a week. The overwhelming majority never trigger a phone call. But, said Gates, radiologists are required to call the referring doctor for potentially life- or limb-threatening circumstances in which further action or diagnostic testing must be taken to avert possible catastrophe. However, rather than alerting Fegan to a problem and calling in a specialist to evaluate him further, Sullivan simply ordered a repeat ultrasound—five months later, in June of 2011. This time a different radiologist confirmed the earlier finding. Once again, Sullivan failed to inform Fegan and instead ordered a third ultrasound, which was performed in October and which resulted in yet another radiologist reporting exactly the same finding that the three previous radiologists had reported: the VNS wire was in fact in Fegan’s left jugular vein.

  Fegan says that during an office visit with Sullivan, he noticed that she looked worried while she read one of the reports. He asked if something was wrong. She told him that the report indicated that the lead wires “weren’t where they should be,” he said, but that it was simply a “logical mistake” because of all the scarring in the area. Fegan says she reassured him that the leads were on the vagus nerve.

  With Fegan’s permission, in late 2015, fifteen years after he was implanted with the VNS device, I sent copies of his ultrasounds to Stephen Baker, a nationally recognized radiologist, and asked him to comment on the location of the leads. Baker became the fifth doctor to confirm that not only was the wire clearly in Fegan’s jugular vein—but a clot was also attached to the tip of the wire. With that reading, I told Fegan that the original radiology reading from 2006 had not been an error, and the others weren’t, either. Part of the VNS device was indeed in his jugular vein.

  At first Fegan refused to believe it. He liked Sullivan, and she had told him the finding was just a mistake. When told the reading had been confirmed and was no mistake, he still rejected the idea, saying, “But I would have bled to death if it was in my jugular vein.”

  What Fegan didn’t realize was that lead wires can penetrate surrounding tissues. Lead-wire problems were well known to Cyberonics and the FDA, and the agency issued three recall notices for them in 2007, indicating that they were prone to “breakage, corrosion, and dissolution.” This could cause them to penetrate surrounding tissues and trigger intense inflammatory reactions with progressive scarring, problems so severe that some surgeons routinely declined to remove the wires, saying it was too dangerous to do so. In one report, a surgeon attempting to remove the wires wrote that not only had a lead wire broken, the patient’s vagus nerve had also “disintegrated.”

  Although the clot in Fegan’s jugular vein may never break loose, he knows that if it does, it could pass from his jugular into the right side of his heart and out to his lungs, where it could cause a potentially fatal pulmonary embolus. If the wire were to erode into the carotid artery, which lies adjacent to the jugular vein and vagus nerve, and if a clot broke off inside the carotid artery, it could migrate to the brain, causing a stroke.

  But Sullivan remained mum about the findings, never telling Fegan of the danger still lurking in his body from the device he’d had turned off years ago—the device a surgeon said was too dangerous to remove completely. Sullivan told Fegan there was nothing more she could do for him. Her dismissal of him puzzled Fegan, but he decided he’d simply have to find yet anothe
r neurologist.

  Shortly after Sullivan last saw Fegan, between August of 2013 and December of 2014, she was paid more than two thousand dollars as a speaker for Cyberonics. She was just one of many physician recipients of the company’s largesse. Cyberonics spread its love around liberally: records show that during that time period the company paid $2.71 million to 3,456 doctors to promote the VNS device.

  No matter where Fegan turned, he was likely to bump into strands of the spiderweb of interlocking economic connections that make up the medical-industrial complex. No wonder that when he went looking for help he couldn’t find it.

  * * *

  Industry largesse, subverting and quietly seducing players across all sectors of the medical-industrial complex, has contributed not only to the rise of corporatized medicine and research but also to a deepening divide among doctors and policy makers about how healthcare and medical research should be organized. Some, like Dr. Eugene Braunwald, embrace academic-industry ties as a way to speed discovery and improve care, while others, like Bernard Lown and Jerome Hoffman, say that leaving healthcare to profiteers raises prices and betrays the trust between patient and doctor.

  Braunwald’s career exemplifies some of the effects of the transformation of medical research under the pressures of profit seeking. Braunwald had begun his career as a salaried doctor working at the National Institutes of Health, where he made breakthrough discoveries that have withstood the test of time. His extensive contributions in four key areas of cardiology—congestive heart failure, valvular disease, heart attacks, and hypertrophic cardiomyopathy—all came during this period. He wasn’t taking out patents or running a research empire with industry funding. He was a salaried academic, driven by what drives all good scientists—intense curiosity and a desire to solve problems. And while he enjoyed public recognition, professional honors, and a good income, he was not on the fast track to grand riches.