Following a unified trial of a claim by a student participant in an experimental study conducted by the SUNY at Buffalo, the Court found the State of New York negligent, including a failure to properly and adequately screen the claimant for the study and for using a prescription medical device without a physician's order and without a physician evaluating claimant. The Court awarded claimant $2,159,000, including $659,000 for future lost wages, $500,000 for past pain and suffering and $1,000,000 for future pain and suffering. As such a structured judgment is required pursuant to CPLR 5041(e).
|Claimant short name:||HUEGEL|
|Footnote (claimant name) :|
|Defendant(s):||STATE OF NEW YORK, STATE UNIVERSITY OF NEW YORK AT BUFFALO|
|Footnote (defendant name) :|
|Judge:||J. DAVID SAMPSON|
|Claimant's attorney:||BROWN CHIARI, LLP
BY: Timothy M. Hudson, Esq.
Brian Hogan, Esq.
|Defendant's attorney:||HON. LETITIA JAMES
New York State Attorney General
BY: Darren Longo, Esq.
Assistant Attorney General
|Third-party defendant's attorney:|
|Signature date:||May 12, 2020|
|See also (multicaptioned case)|
On May 11, 2015, claimant Andrew C. Huegel was approved to participate as a volunteer study subject in an experimental study conducted by the State University of New York at Buffalo (SUNY or SUNY Buffalo) Department of Exercise and Nutrition Sciences. The subject study, entitled "Impact of Work; Rest Ratio and Fitness on Performance and Recovery" (the "study") was led by principal investigator David Paul Hostler, III, Ph.D., a professor and chair of SUNY's Department of Exercise and Nutrition Sciences. As a student participant in the SUNY Buffalo study, claimant was provided with and directed to ingest a CorTemp capsule, a device that once ingested would monitor his core temperature throughout the study experiment and was to pass through his digestive system and out of his body in two to three days. Soon after ingesting the capsule, claimant began to experience severe abdominal pain. The abdominal pain persisted and about ten days later, claimant was examined by one of SUNY Buffalo's investigators, who advised him that his pain was unrelated to the capsule and assured him that the capsule had passed from his body. However, claimant's symptoms worsened and ultimately led to emergency surgery that located and removed the embedded capsule and with it, a section of his small intestine where the capsule had become embedded and encapsulated.
On August 6, 2015, a notice of intention to file a claim was served upon the Attorney General of the State of New York. A claim was filed on July 29, 2016, alleging that the claim accrued between May 4, 2015 and June 23, 2015. On July 25, 2016, the State of New York filed its answer denying the allegations in the claim.
A unified trial of all issues was conducted in Buffalo, New York between September 23, 2019 and September 27, 2019. During the trial, testimony was provided by claimant; one of the SUNY investigators, Lindsey Ray; claimant's treating surgeon, Jeffrey P. Steinig, M.D., and the SUNY principal investigator of the study, Prof. David Paul Hostler III, Ph.D. In addition, testimony was provided by an FDA medical device regulation and labeling expert, David L. West, Ph.D., MPH and an expert in internal medicine and gastroenterology, Jay Luther, M.D. Finally, in lieu of testimony, the parties stipulated into evidence the report and the work life expectancy and lost wage tables prepared by claimant's expert economist, Ronald R. Reiber, Ph.D. Following the trial, the parties requested and were given until January 31, 2020 to submit post-trial memoranda. On March 16, 2020, prior to the completion of the Court's decision, all courts in New York State were closed due to the COVID-19 pandemic, which resulted in the delay of issuance of this decision.
TESTIMONY OF CLAIMANT
Andrew Huegel testified that he is presently 25 years old and is employed in the family business, Buffalo and Orchard Park Topsoil. He stated that this business was started by his father, Alan Huegel, who recently died. Upon his father's death, claimant testified that his brother took over the operation of the business (TT:8-11)(1) . Claimant testified that he graduated from West Seneca West High School, where he participated in football and wrestling all four years. As a result of his participation in these sports, he became active in weight lifting and bodybuilding. Claimant testified that his social life then evolved around physical activity and exercise. He enjoyed it to the extent that he chose exercise science as a major when he attended SUNY Buffalo (TT:13-16).
Claimant testified that during his freshman year at SUNY Buffalo, he lived at home and commuted to campus. He did well academically, obtaining a 3.6 to 3.8 GPA each semester and graduating with a 3.7 GPA (TT: 18-20). He testified that he first became aware of the study during his sophomore year in an introductory to exercise science class. Participation in the study was promoted by Deena Campbell (Campbell), who advised claimant's class that participants in the study would be paid $250 and that it involved taking a stress test and EKGs. Claimant testified that he met with Campbell after class and was provided with a study packet and was directed where to go to be interviewed. At this interview, he stated that he initialed and signed the study document (Exhibit 2) to become a participant and that Campbell read the whole packet to him, including the information in the paragraph regarding the core temperature capsule. Claimant testified that she advised him that he would need to swallow a pill or capsule, that it would be in him for two to three days and would then pass through his intestinal tract. Claimant testified that Campbell told him that 40,000 people had previously ingested the pill without any problem, which removed any concern that he had. He testified that he understood from reviewing the study packet documents that there was a physician involved with the study. Claimant testified that he was not given any information indicating that if the capsule was retained in his body that surgery would be necessary to remove it, adding that Campbell told him that it could be lodged but it had never happened. Claimant testified that if he had he been told that surgery would be necessary if he was unable to pass the capsule, he would not have participated in the study as he stated that was too big of a risk (TT: 22-29).
Claimant identified the health questionnaire that he completed and the consent form that he executed (Exhibit 3). During the process of his meeting with Campbell, claimant testified that he met Dr. Hostler, who asked him a couple of questions about his use of an inhaler and then told him that he was cleared to participate in the study. Claimant was directed to the family history page of the health questionnaire and stated that during the screening process no questions were asked by Campbell or Dr. Hostler that related to his family health history. He testified that during this meeting, Crohn's disease was not discussed and he had at that time never heard of it. Claimant testified that his entire time with Dr. Hostler lasted only about five minutes (TT: 29-33).
Claimant testified that his next visit was four days later on April 14, 2015 when he started his participation in the study and performed some tests. On May 11, 2015, following claimant's completion of additional testing, he was given a CorTemp capsule to take home and ingest that evening. He testified that he was told to take the capsule at 10:00 p.m., drink plenty of water and return to SUNY Buffalo the following day to complete his testing. Claimant testified that shortly after taking the capsule that evening, he began to experience abdominal pain. He testified that he began sending text messages to Campbell to keep her informed and he identified Exhibit 32 as the series of texts between them beginning on May 11, 2015. He also identified Exhibit 19 as reflecting the observations recorded by Campbell during his participation in the study. Claimant testified that Campbell was the only person who he was involved with during his participation in the study (TT: 35-41).
Claimant completed the physical tests for the study on May 12, 2015 and later that evening began to experience a sharp pain in his lower abdomen. On May 13, 2015, Claimant testified that he went in to provide a blood sample and told Campbell what he was feeling. He stated that Campbell told him not to worry and that the pain would last no more than three days. In response, claimant told Campbell that he would like to speak to Dr. Hostler and get his advice but was told that he was not available. Claimant testified that he later saw Dr. Hostler in the hallway following a class and told him that he was experiencing a sharp stabbing pain in his lower abdomen that he associated with the CorTemp capsule. He testified that in response, Dr. Hostler chuckled and told him not to worry, that this pill has never stuck in anyone before, and recommended that he eat plenty of fiber and it will pass (TT: 41-43).
Claimant was next referred to the text message on May 13, 2015 (Exhibit 32), which indicated that he was to stop in to see Campbell between 8:00 and 10:00 a.m. to see if the pill was out. Claimant testified that Campbell placed a beeper against his body and if it registered a temperature, the pill was still in him. He stated that it was at this time that he withdrew from the study as Campbell had given him another CorTemp capsule that he was to swallow and he did not want to take another pill unless he knew with certainty that the first pill was out of his body. Campbell utilized the beeper device and then told him that the pill was out. Claimant testified that he began to experience the same abdominal pain with vomiting that evening. He testified that he sent a text to Campbell to advise her of his recurring complaints.
Claimant testified that the next text message was two days later on May 15, 2015. He stated that Campbell asked how he was feeling and he replied that he was a feeling a lot better. Claimant testified that during this time period he had completed final exams and was about to begin the gross anatomy course, a mandatory requirement to continue in his major. Claimant testified that the text messages from Campbell on May 15 and 16, 2015 continued to emphasize that the pill would pass out of him naturally. Claimant identified his text to Campbell on May 16, 2015, where he stated that he was experiencing stomach pains all day and was unable to go to the bathroom. He stated that in response, Campbell told him that he might have the flu (TT: 45-51).
Claimant testified that he had only two conversations with Dr. Hostler, the first while he was completing the study questionnaire and the second was the brief encounter in the hallway. He testified that at no time after he reported his symptoms to Campbell did anyone involved in the study recommend that he see a doctor or seek medical attention. Claimant confirmed a text from Lindsay Ray on May 13, 2015 in which she related to him that Dr. Hostler had been informed of his condition and felt that his vomiting was most likely a bug. Claimant testified that during this time period he believed that Dr. Hostler was a physician and this statement reassured him that there would not be an issue with the pill (TT: 52- 56).
Claimant confirmed the content of a text message with Campbell on May 17, 2015 in which he related that the previous night was the worst that he had felt, that his stomach pain intensified, that he went to the Mercy Ambulatory Center (MAC Center) because he was dehydrated from vomiting and that he was still not able to go to the bathroom. He testified that the MAC Center re-hydrated him, provided painkillers and nausea medicine (TT: 56-59).
Claimant testified that on May 18, 2015, Campbell sent a text inquiring how he was feeling and he responded that he was not feeling comfortable since no one could tell him what was the cause of his problem. On May 20, 2015, claimant testified that he received a text from Campbell to confirm that he was coming in at 9:00 a.m. on May 21, 2015 so that she could check to see if the pill was still inside him. In that same text, claimant stated that Campbell asked that he return the second CorTemp capsule since he would not be participating in the second part of the study. Claimant confirmed that on May 21, 2015, Campbell utilized the beeper and told him that it did not register his temperature, so the pill must have passed.
On May 25, 2015, claimant confirmed in a text that he was again experiencing symptoms and wanted Campbell to retest him to determine whether the pill had passed out of him. Claimant testified that it was during this time period that the gross anatomy class started, which required that he attend class and labs five days a week for six hours each day. He testified that passing this course was a prerequisite in order to enter the exercise science program major. Claimant testified that throughout this time period, he could eat very little as he continued to experience abdominal pain, vomiting and diarrhea. He testified that he had to withdraw from the gross anatomy class and could not pursue his chosen major (TT: 59-67).
Claimant identified the next text on June 2, 2015, testifying that at no time between May 25 and June 2, 2015 did Campbell or anyone involved in the study attempt to contact him. He testified that he went to see his primary physician, Dr. Novelli, and explained the study and what he had been experiencing and was referred by him to a GI specialist. Claimant testified that the purpose of the June 2, 2015 text was to obtain from Campbell a copy of the study packet. He confirmed that the symptoms he related to Campbell at that time were accurate. He testified that in response, Campbell emailed him the packet and he printed a copy for Dr. Novelli. When claimant next saw Dr. Novelli, he wanted claimant to get a CT scan and he expected that the CT scan would show that the pill was out of his body. Claimant testified that on June 4, 2015, following the CT scan, he received a call from Dr. Novelli, who told him to go the Buffalo General emergency room immediately and not attend his gross anatomy class. He testified that his mother drove him to the emergency room, where he explained what had occurred, including the results of the recent CT scan. Claimant stated that they confirmed what he had already been told by Dr. Novelli that the pill was still inside him. He testified that the emergency room staff told him that it was in the end part of his large intestine and that it would pass. They provided him an enema and sent him home (TT: 67-77).
Claimant testified that three days later on June 7, 2015, he received a text from Campbell asking how he was feeling and he related that he was still vomiting but feeling pretty good. He testified that when he explained to Dr. Novelli what had happened to him at Buffalo General, he wanted claimant to come in and see him again. Claimant testified that when he saw Dr. Novelli on June 9, 2015, he told him that he thought that claimant needed emergency surgery. He testified that it was then that he sent a text to Campbell to inform her that the pill was stuck in his small intestine and that he required surgery. He testified that he told Campbell that he had been provided with false information in that the pill still remained in his body (TT: 77-80).
Claimant testified that Dr. Novelli told him that he anticipated that a colonoscopy would be performed to remove the pill. He testified that when he was told that it was emergency surgery, he became very upset, scared and believed his life would never be the same. At Mercy Hospital, claimant met Dr. Steinig, who performed the surgery. He recalled that Dr. Steinig explained that he would need an exploratory intestinal resection and described the risks involved. Claimant described that he was in a lot of pain following this surgery and remained at Mercy Hospital for about five days (TT: 264-275). Claimant described the area of the surgical incision and that he was upset by its appearance and the condition of his mangled belly button. He testified that Dr. Steinig told him that its appearance would not improve, which was devastating to him. When he returned home, claimant testified that his typical day was spent on the couch watching TV and playing video games. He stated that the scar from the incision continued to ooze and drain during this time period. Claimant identified a photo of him taken prior to ingesting the pill (Exhibit 46) and a photo taken following surgery (Exhibit 45), stating that his weight dropped from 180 to 140 lbs. after ingesting the capsule. Claimant testified that he noted that the incision started to leak fluid and he then saw Dr. Steinig's assistant, Dr. Mitchell, who told him that the incision was infected. Dr. Mitchell told him that he would need surgery to clear out the infection. He testified that the second surgery also took place at Mercy Hospital about July 4, 2015 (TT: 277-287). Claimant testified that the surgery was performed and a device known as a wound vac was attached to him that was to reduce the potential for infection. He identified photo Exhibit 38 as depicting the wound vac device. Claimant stated that he experienced pain while home after the second surgery. He testified that it was at this time that he began experiencing internal pain that he would later learn was Crohn's disease. During this time period, he continued to remain home and largely sat on the couch. Once August came, claimant testified that SUNY Buffalo allowed him to medically withdraw and would let him continue with the junior class without having passed gross anatomy. Claimant testified that when he began classes, Dr. Hostler taught one of his classes and at no time did he speak to him or ask how he was doing (TT: 289-297).
Claimant testified that he first met Dr. Trubish after his first surgery at Mercy Hospital. He stated that she was recommended to him to deal with the Crohn's disease. Claimant testified that he told Dr. Trubish that he wanted medication that would have the least impact upon his life and she initially prescribed Asacol. He testified that he was concerned about the numerous side effects with the stronger medications and that given his young age, he would eventually experience one of the side effects. Claimant testified that gained most of his weight back, but as he did the scar became larger and began to bulge. Claimant identified photo Exhibit 43 as displaying what Dr. Steinig described as a herniation with a bubble on top of it. He described the scar as three inches by three inches. He testified that Dr. Steinig was concerned and scheduled a CT scan (TT: 297-303). Claimant testified that Dr. Steinig explained to him that he had a hernia and that the area covering it was very thin and could create an emergency life-threatening situation. Claimant testified that he spoke with Dr. Trubish about this surgery and how it would affect his Crohn's disease and she told him that he could not have the surgery with active Crohn's disease. She recommended that claimant see Dr. Butler, a colorectal surgeon. Claimant testified that he met with Dr. Butler and that he told him that in that Asacol was not working to control his Crohn's disease, he would need to try Humira and as a result, he started Humira in April 2018 (TT: 304-307).
Claimant testified that Dr. Trubish indicated to him that she has seen significant improvement since he was prescribed Humira and that his Crohn's disease is now in remission so that he may safely pursue the hernia surgery. He stated that Dr. Trubish has recommended Dr. Armstrong to perform this surgery. He testified that his abdominal pain has subsided with the use of Humira, and that prior to his participation in the study, he did not experience any abdominal pain. Claimant testified that he began to experience the abdominal pain associated with Crohn's disease following the surgery to remove the pill. He testified that he met with Dr. Armstrong, who encouraged him to schedule the hernia surgery as quickly as possible because every day is a risk with the scar and there is a risk that the hernia surgery may reactivate the Crohn's disease. In the interim, claimant testified that he is very protective of his abdomen fearing that something could catch on the scar and cause his intestines to come out. He wears an abdominal binder to provide more protection but he testified that he has to always be careful and avoid certain activities that would strain his abdominal muscles. Claimant testified that as a result, he cannot participate in activities he previously enjoyed, including power lifting, football, snowboarding, wrestling or boxing (TT: 307-313).
Claimant testified that he eventually graduated from SUNY Buffalo in 2017 and is presently employed at Buffalo & Orchard Park Topsoil and with TrainSMART Buffalo. He stated that he works at the topsoil business full-time dependent upon the season performing manual labor and earns $15 per hour. Claimant stated that he stays at the location where they sell topsoil, stone and mulch and operates a loader the majority of the time, avoiding the heavy manual labor work that he was previously able to perform. He stated that he was unemployed in the winter months and then identified Exhibit 61, a document from the New York State Department of Unemployment Insurance detailing his 2018 unemployment benefits (TT: 320-325). Claimant testified that he has worked for TrainSMART Buffalo for the past two and one-half years. He stated that he did an internship with them his last semester of the exercise science program and has worked for them ever since. Claimant described the business as a personal studio training facility that focuses on an older clientele and individuals rehabbing injuries. He stated that he works there six hours per week and identified Exhibit 61 and the 1099 form issued to him for what he earned in 2018 at TrainSMART Buffalo (TT: 325- 327).
Claimant testified that his participation in the SUNY Buffalo study impacted his ability to get into the physical therapy program at SUNY Buffalo because he was unable to complete the gross anatomy course due to the surgery and subsequent medical treatment. He stated that he has not considered returning to school because of his need for hernia surgery. Claimant also testified that as a result of his participation in the study, he experienced depression and Dr. Steinig has recommended that he participate in counseling. He stated that he went to Western New York Psychotherapy but did not find it very helpful (TT: 327-330).
On cross-examination, claimant was shown Exhibit 2, the study consent form and identified his signature dated April 10, 2015 and testified that Campbell read it to him and they discussed it as they went along. Claimant was next shown Exhibit 3, the health questionnaire and identified his handwriting on that form. He testified that on April 10, 2015, when he filled out and signed this form he did not know that he or his mother had Crohn's disease. Claimant testified that when he went to the MAC Center, it was not on the advice of anyone at SUNY Buffalo. He stated that the MAC Center took an x-ray and told him that there was a pill in him, that it would pass and sent him home. Claimant testified that he first saw Dr. Novelli about three weeks after ingesting the pill and he ordered a CT scan and after reviewing the results, told him to go to the Buffalo General emergency room. He stated that Buffalo General took an x-ray, told him that the pill was in his sigmoid colon, gave him an enema and said it would pass out of his body that evening. Claimant testified that up to this point in time, no medical provider had discussed Crohn's disease or any inflammatory bowel disease. He stated that the first time that he learned that he had Crohn's disease was after the abdominal surgery to remove the pill (TT: 331-338). Claimant testified that he had three colonoscopies, two open surgeries and a third surgery has been recommended to correct the hernia. He stated that he is currently planning to have the hernia surgery in February 2020. Claimant testified that he is currently on Humira and takes an injection every other week. He stated that he believes that he is suffering from depression but is not presently receiving any treatment or medication (TT: 338-342).
TESTIMONY OF LINDSEY RAY
Lindsey Ray (f.k.a. Lindsay Russo) testified that she is employed by SUNY Buffalo and that in 2015 she was a research technician employed in the lab of the Center for Research and Education in Special Environments. She left this position on February 13, 2019. While a research technician in the lab, her immediate supervisor was Dr. David Hostler, who she stated was the principal investigator. Ray testified that she previously worked with Dr. Hostler in a similar capacity at the University of Pittsburgh (TT: 140- 142).
Ray testified that in April 2015, claimant was a participant in a study conducted at SUNY Buffalo referred to as the two-cylinder study. She stated that the purpose of the study was to look at the physiological effects of firefighters using a three-cylinder oxygen pack versus the standard two-cylinder pack. The two-cylinder study had two aspects to it, one utilizing live firefighters and the second, a laboratory component utilizing student participants. Ray testified that the live portion of the study was conducted at the University of Pittsburgh at a firefighter training facility and the participant portion was conducted at SUNY Buffalo. Ray stated that she and Dr. Hostler were both involved in the entire two-cylinder study. She testified that Deena Campbell was a post-doctorate student who was working with them on the two-cylinder study but Campbell was not involved in planning the study. Ray confirmed that the Campbell referred to in claimant's testimony was, in fact, Deena Campbell (TT: 143-145).
Ray testified that the study at the University of Pittsburgh was affiliated with the Department of Emergency Medicine in the University of Pittsburgh Medical College (UPMC). Ray testified that Dr. Cliff Callaway, Dr. Rittenberger and Dr. Suyama were physician investigators at the UPMC. She also confirmed that Dr. Reis, a cardiologist was also involved in the study at the University of Pittsburgh. Ray testified that none of the physicians took part in the study conducted at SUNY Buffalo. She stated that these physicians were constantly part of the lab study at the University of Pittsburgh and were involved in screening participants and checking to make certain that they met the required health parameters. Ray testified that the physicians were also present at the live burns conducted with the firefighters and would review the results of any electrocardiograms or EKGs conducted of the participants (TT: 146-149).
Ray testified that the FEMA grant for this study was awarded to Dr. Hostler and when he took the chair position at SUNY Buffalo, he worked with the University of Pittsburgh to get the grant transferred to SUNY Buffalo so that he could continue to work on it. Ray testified that she, Campbell and Dr. Hostler all screened participants for the study at SUNY Buffalo. She testified that the screening involved going through a brief medical history, obtaining baseline vital signs of blood pressure, heart rate and respiratory rate, and then a VO2 max test to obtain the maximum oxygen consumption. Ray testified that these results were evaluated by the three of them with no one else involved. She also stated that they were in the process of starting to collaborate with physicians at SUNY Buffalo but none to her knowledge participated (TT: 149-157).
Ray testified that she was familiar with a medical device known as the CorTemp capsule, which she described as a small pill the size of a vitamin that is ingested and has a serial number that you can program and it emits a signal so that you can read the individual's core temperature once ingested. She stated that the CorTemp capsule was utilized in the study at both universities. Ray testified that she was not aware that the CorTemp device was a Class II prescription device and thought it was just an over-the-counter medical device. She stated that it was ordered by herself, Campbell and Dr. Hostler while at SUNY Buffalo and at no time was a physician involved in approving or ordering these devices. Ray testified that it was possible that a physician was involved in ordering them at the University of Pittsburgh (TT: 157-160).
Ray testified that the medical questionnaire and consent form were originally discussed while in Pittsburgh and then formally drafted and submitted to the SUNY Buffalo Institutional Review Board (IRB). She stated that the incident was brought to the IRB and after discussion with them, modifications were made to the consent form (TT: 160-165). She then identified the consent form for the two-cylinder study (Exhibit 2) as the one utilized with claimant and was directed to the risks section on page 5 of the consent form, which referred to the CorTemp device utilized in the study. Ray testified that she included this section and that it was language utilized in previous studies that she cut and pasted into the consent form. Ray testified that she did not know who had classified the risk of the capsule becoming lodged as a rare risk. She did not have a role in drafting the section, stating that no one will be allowed to participate if you have a history of digestion problems such as diverticulitis, previous abdominal surgery or if the study physician feels it places you at risk. She stated that the study physician phase would have referred to the physicians at the University of Pittsburgh who were involved and that there was no study physician involved at SUNY Buffalo (TT: 165-171).
Ray testified that she was not aware that if a foreign object became lodged in the bowels that there was a risk that surgery might be required to remove it. She agreed that a risk of surgery was something a student participant would want to know. Ray identified Exhibit 3 as the health questionnaire utilized in the two-cylinder study. She stated that the CRESE laboratory had a form health questionnaire that she edited for use in the two-cylinder study and did not consult with any physician. Ray stated that this health questionnaire was utilized in studies that did not incorporate the use of the CorTemp device and agreed that it also was not created or tailored to the specific risks of the two-cylinder study. She also agreed that some of the information in the health questionnaire did not relate to or involve risks that would occur in the two-cylinder study (TT: 172-180).
Ray testified that she had not previously seen the CorTemp form (Exhibit 5), which listed the uses, contraindications and warnings on the CorTemp device label. She stated that she had read the contraindications and the warnings sections prior to its use with claimant but had never read the intended use section before. Ray testified that she was not aware that it could only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with its use. She stated that with current studies at SUNY Buffalo, Dr. Hostler has a physician available on call, a practice that was not in place during the two-cylinder study. Ray agreed that the specific contraindications listed for the CorTemp device were not included in the health questionnaire. She testified that the questionnaire now used at SUNY Buffalo includes a listing of all of the specific contraindications for the CorTemp device and this was not implemented until after claimant's incident (TT: 181-186).
Ray testified that on April 10, 2015, the day claimant completed the health questionnaire, she, Campbell and Dr. Hostler were present and that there was no physician. She stated that the VO2 max test would have been administered to claimant on that date. Ray testified that his second visit was to establish a strength baseline and would involve strength testing and if they had not yet worn the firefighting equipment, they would take it home to wear that evening. Ray then explained that each study participant would then be engaged in the full laboratory portion of the study, which consisted of either performing the activity with the two-cylinder tank or the three-cylinder tank. She stated that each study participant would take a core temperature pill, put on the firefighter protective gear and then go into a heated environmental chamber where they would then perform exercises. The participants would then exit the chamber and perform the strength exercises again to see how they performed. They would then be provided with a blood pressure monitor, an ECG monitor and an actograph wristwatch to take home for the evening and return them the following morning. Ray testified that the CorTemp capsule was utilized to capture data of the participant's core body temperature during the activity to make certain they maintained a safe core temperature during the exercises (TT: 187-192).
Ray identified Exhibit 20, which was the data collection form dated May 13, 2015 for the laboratory tests involving claimant. She stated that claimant would have participated on May 12, 2015 and would have ingested the CorTemp capsule on May 11, 2015. Ray testified that prior to claimant, they had study participants who would carry the capsule in their body for 24 to 48 hours and she was unaware of anyone carrying the capsule more than 48 hours other than claimant.
On May 13, 2015, Ray testified that she spoke to claimant and he told her that he did not feel well and had vomited the prior evening. She also testified that claimant expressed concern about the CorTemp capsule. Ray stated that she did not speak with any medical provider about claimant's symptoms. She then identified a series of emails between her and Dr. Hostler (Exhibit 22). These emails indicated that within 30 minutes of speaking with claimant, Ray composed a series of emails to Dr. Hostler which advised him that claimant had vomited between 8:00 p.m. and 2:00 a.m. and was experiencing terrible stomach cramps and pain and that claimant was constipated. Ray admitted that these symptoms were consistent with a gastrointestinal complaint. She also confirmed that she related to Dr. Hostler that claimant was concerned about the CoreTemp capsule and that she had scanned him and determined that it was still inside his body. Ray testified that claimant told her that his mother experienced frequent stomach issues but that he did not know why. She testified that she did not have any concerns at that time that his symptoms were connected to the CorTemp capsule (TT: 195-206).
Ray testified that she provided Dr. Hostler with claimant's telephone number and when he could be reached as she thought that he might want to meet with claimant due to the stomach issues he was experiencing. Ray testified that Dr. Hostler responded to her email and asked whether she had taken claimant's temperature, which she had and it was normal. She testified that Dr. Hostler told her to tell claimant that the CorTemp pill could not make him sick and that she should check with claimant the next day. Dr. Hostler did not believe there was anything to worry about. Ray testified that she saw claimant the following day and he was more concerned and still not feeling well. She testified that she told claimant that Dr. Hostler thought he had a bug, but she was not aware that claimant believed that Dr. Hostler was a physician. Ray testified that she did not recall speaking with claimant after that date. She stated that she had learned from Dr. Hostler that the pill remained in claimant and that he was hospitalized but she did not reach out to claimant.(2)
On cross-examination, Ray testified that prior to the issue with claimant retaining the CorTemp capsule, she was not aware of any similar issue involving other study participants at the University of Pittsburgh or SUNY Buffalo. She testified that to order the CorTemp capsules, she would contact the sales representative for CorTemp, Lee Carbonella, and place an order. Ray testified that the CorTemp capsules were then shipped to her via UPS (TT: 225-226).
TESTIMONY OF DAVID PAUL HOSTLER III
Dr. David Paul Hostler III (Hostler) testified that in the spring of 2015, he was the principal investigator of a FEMA funded study that sought to look at the effects of twin cylinders on firefighters. He stated that there were two components to the study, a field study conducted at the University of Pittsburgh and a laboratory study conducted at SUNY Buffalo. Hostler testified that the funding for the study was received in the fall of 2012 or early 2013 (Exhibit 8). He confirmed that the laboratory portion of the study was the portion that claimant was a study participant. Hostler testified that the grant application set forth a screening visit protocol that was to be followed (Exhibit 8, Section 4.3.a) and that after providing an informed consent, subjects were to complete a survey of demographics, medical history and physical activity, and receive a physical exam by a study physician.
Hostler confirmed that when the study was implemented at SUNY Buffalo, there was no physical exam conducted by a study physician. He confirmed that the application also detailed what was to be performed in the physical examination, including a physician review of the inclusion and exclusion criteria, a blood sample separating plasma and serum, and an initial EKG. Hostler admitted that none of these procedures were followed at SUNY Buffalo and with claimant specifically. He also admitted that at no time did he ever inform FEMA that he had discontinued the EKG screening practice (TT: 351-358). Hostler testified that he believed the IRB was aware that there were no physicians involved in the screening of prospective study participants. He stated that he, Ray and Campbell were the only investigators on the study and then claimed that the determination not to utilize a physician at SUNY Buffalo was made by the IRB (TT: 360-364).
Hostler admitted that there were three physicians involved with the portion of the two-cylinder study conducted at the University of Pittsburgh. He agreed that as principal investigator, he had the overall responsibility for the conduct of the two-cylinder study both at the University of Pittsburgh and SUNY Buffalo (TT: 365-367). Hostler then testified that he did not include physicians in the two-cylinder study at SUNY Buffalo and that they were included in the study at the University of Pittsburgh only as collaborators, stating that the physicians had an intellectual interest in the work he was doing.
Hostler was then shown the FEMA grant submitted by him that identified two physicians who were to devote time and for which allocations were made to perform subject project screenings and provide medical oversight at the live firefighter portion of the study. He also identified a third physician who was responsible for reading exercise stress tests and to oversee the analysis and interpretation of the EKGs and VP studies (TT: 369-374). Hostler admitted that Dr. John Leddy, a clinical associate professor of orthopedics at SUNY Buffalo was listed by him in the grant to FEMA as being available to provide medical support and screening of study subjects. He also admitted that Mary Carey, a nurse and member of the faculty at SUNY Buffalo was to be involved in the study to read EKGs, even though screening EKGs were never conducted by him in the study. Hostler testified that $799,209 of the original $997,000 FEMA grant (Exhibit 12) was transferred to SUNY Buffalo (TT: 379-386).
Hostler testified that he reviewed the health questionnaire completed by claimant (Exhibit 3). He stated that the purpose of the health questionnaire was to look for exclusion criteria (TT: 390-393). Hostler testified that exclusion criteria for the study included cardiovascular disease, respiratory disease, bowel disease and medications that blended thermo regulation and that this criteria was written down in the IRB protocol. He agreed that in the section regarding abdominal symptoms that claimant had advised that he belched and had gas and that there was no follow-up. Hostler admitted that any follow-up questions from the responses in the health questionnaire with a study prospect would have come from him. He testified that he also never inquired further regarding claimant's family medical history. Hostler stated that he was aware that a retained foreign body presented a risk of surgery to individuals and that it was something a study participant would want to know (TT: 399-404).
Hostler was questioned about the informed consent form and stated that the phrasing that it was a rare risk for the capsule to become lodged in the intestines was arrived at the University of Pittsburgh IRB and that the company that manufactured the CorTemp capsule told him that in 40,000 applications they had never seen a capsule become lodged in the intestines. Hostler testified that he reviewed claimant's health questionnaire and approved him for participation in the study. He stated that he did not believe that the CorTemp capsule was a prescription medical device and stated that he had used it approximately 1,000 times. He testified that the device comes individually packaged in a small plastic Ziploc bag with a label and he did not recall if he had read the label. Hostler was then shown the label (Exhibit 5) that contained the intended uses, contraindications and warnings for the device. He then stated that he was not aware that the label indicated that the CorTemp capsule can only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestible thermometer. It was his belief that they had purchased the CorTemp capsules used in the study once he was at SUNY Buffalo and that the purchase was probably made by Ray or Campbell. Hostler admitted that claimant was not clinically evaluated by a physician for the listed contraindications (TT: 405-412).
Hostler testified that he first became aware that claimant was having a problem after ingesting the CorTemp capsule a day or two after his study visit. He was then referred to the email chain (Exhibit 22) and stated that the first time he was advised of this issue with claimant was on May 13, 2015. Hostler testified that he was advised at that time that claimant had vomited between 8:00 p.m. and 2:00 a.m. the previous evening and had terrible stomach cramps and pain. He agreed that these were abdominal or gastrointestinal symptoms. He also agreed that claimant being constipated was also a gastrointestinal symptom. Hostler testified that he wanted to know whether claimant still had the pill inside him as he was experiencing gastrointestinal symptoms. He stated that he was not concerned at this time that the CorTemp capsule was making claimant sick and instructed Ray to state that to claimant. Hostler testified that he did not call claimant but did see him in the lab the following day and spoke to him. Hostler agreed that it was accurate that claimant continued to contact his lab in the weeks following his ingestion of the CorTemp capsule seeking assistance (TT: 412-418).
Hostler testified that he was advised by Campbell that claimant had excreted the pill and that this turned out to be a false positive. He stated that he was aware that claimant had been having symptoms since May 13, 2015 and did not recall why he told Campbell to begin constructing a time line on June 3, 2015. He testified that he made the entries on the time line for June 4, 2015 and two of the June 9, 2015 entries. Hostler testified that he did not know why they neglected to include on the time line the email entry for May 13, 2015 that claimant was experiencing frequent stomach issues (Exhibit 22). He also testified that he did not know how the entry on the time line for Crohn's disease came about and admitted that the email chain did not mention anything about claimant having Crohn's disease (Exhibit 23). Hostler testified that he only became aware after claimant's surgery that he had been diagnosed with Crohn's disease.
Hostler agreed that claimant spoke to him on May 14, 2015, and that he reported to his investigators that he continued to have nausea, diarrhea, vomiting and cramps over the next few days. He stated that at no time did claimant deny him any access to his health information or to his primary physician. Hostler also stated that on May 16, 2015, it was confirmed after claimant went to the emergency room that the pill remained in his body and that on May 18, 2015, Campbell spoke to claimant and told him that the pill would pass through his GI tract. He agreed that it was on May 26, 2015 that Campbell obtained the false positive reading. Hostler testified that between May 14 and May 26, 2015, he was not concerned that claimant had retained the CorTemp capsule from the symptoms he described. He added that at no time was he concerned enough to report it to Dr. Leddy or to the IRB. Hostler testified that on June 4, 2015 he spoke to the IRB (TT: 419-429). He testified that he never met with claimant after May 18, 2015 up to and including the time of his surgery and did not notify the IRB that claimant had retained the CorTemp capsule until June 4, 2015. Hostler stated that at no time did he reach out to any member of claimant's family.
Hostler agreed that Exhibit 34 accurately depicted his conversation with HQ, the manufacturer of the CorTemp capsule and that he had blamed claimant for not disclosing that he and his mother had Crohn's disease. Hostler testified that on June 9, 2015, the date of claimant's surgery, he sent an email to Dr. Ron Moscati, the IRB medical director, asking him to call as he had an issue regarding a study subject and admitted that this was the first time that he had called Dr. Moscati about claimant (TT: 432-438).
TESTIMONY OF JEFFREY P. STEINIG, M.D.
Dr. Jeffrey P. Steinig is a physician licensed to practice in New York with a specialty in general and vascular surgery. He testified that he was contacted by claimant's primary physician, Dr. Novelli, who advised that he had a patient with a bowel obstruction who had swallowed a smart pill and had been seen in the emergency room at Buffalo General and sent home. Dr. Steinig testified that he agreed to meet claimant at Mercy Hospital later that day. Dr. Steinig testified that a CT scan demonstrated the presence of a foreign body in the distal terminal ileum with obstructive symptoms. He stated that claimant was in obvious discomfort with nausea and vomiting, which he interpreted as symptoms of obstruction. Dr. Steinig testified that he observed claimant and found a distended abdomen, tenderness in both lower quadrants, and an elevated white blood cell count. He concluded that claimant was in need of emergency surgery for a small bowel obstruction, adding that if not handled in this way, his bowel could perforate and lead to sepsis and possible death.
Dr. Steinig testified that after examining claimant, there was no option other than immediate surgery and he stated that he performed an exploratory laparotomy and a resection of his terminal ilium and cecum with an ileocolonic anastomosis (TT: 229-232). He testified that when he began the surgery, he did not know that claimant had Crohn's disease. Dr. Steinig identified photo Exhibit 42 as depicting the operative specimen and testified that a pathologist later determined from this specimen that claimant had Crohn's disease. He then pointed on this photo exhibit to where the pill was located. Dr. Steinig testified that it is a general rule and surgical principal that operations are to be avoided except under five circumstances, one of which is obstruction. He testified that operations are avoided because people who have had an operation for Crohn's disease will require another at some point in their life and as a result, they try to remove as little bowel or intestine as possible in the event that the patient becomes highly symptomatic in the future and requires extensive bowel resection. Dr. Steinig stated that medical management is the preferred treatment approach for Crohn's disease and involves the use of anti-inflammatory medicines to blunt the immune response, which include steroids and intravenous or oral medicines (TT: 235-239).
Dr. Steinig testified that had claimant been seen by him two weeks earlier, assuming that he was not then obstructed, he could have performed a small bowel follow-through with a series of x-rays to locate the blockage, which he indicated is also the best test for diagnosing Crohn's disease. He stated that he most likely would have found Crohn's disease and then referred claimant to a gastroenterologist. Dr. Steinig testified that the gastroenterologist with expertise in the medical management of Crohn's disease would decide whether to perform an endoscopic evaluation or colonoscopy in order to remove the pill without surgery. He also stated that through medical management, they would have been able to attempt to help claimant expel the pill with the use of drugs and thereby avoid surgery.
It was Dr. Steinig's opinion that the presence of the pill caused the inflammation and contributed to the development of the abscess on claimant's bowel wall that was present when he performed the surgery. He stated that the presence of this abscess also increased the complication rates for wound infection, hernia formation and recurrent abscess (TT: 239-244). Dr. Steinig also opined that if claimant had been medically managed, with the alternatives available there was a substantial possibility that claimant could have passed the capsule on his own without surgical intervention. He testified that he continued to treat claimant following the surgery and claimant developed an infection at the wound site that was treated by his colleague, Dr. Mitchell, which required that claimant undergo debridement surgery to remove the dead tissue. Dr. Steinig opined that the abscess was a substantial factor in causing the infection. He stated that in order to treat the wound infection, they utilized a wound vac which is a medicated sponge that is placed into the wound and covered with a plastic seal (Exhibit 58). Dr. Steinig testified that claimant also developed hernias. He identified photo Exhibit 40 as depicting the scar tissue from the incisional hernia that was left following removal of the wound vac. Dr. Steinig testified that if you were to make a hole where the scar exists, claimant's intestine would be right there as he no longer has any muscle tissue layer. He testified that he explained to claimant that this needed to be remedied surgically as it can otherwise create a life threatening situation if the intestine were to strangulate within the hernia. However, Dr. Steinig stated that this surgery would have to await getting claimant's Crohn's disease under control. He added that if his intestine was to strangulate, this too would require emergency surgery. Dr. Steinig opined that the cause of the hernia and infection was not claimant's underlying Crohn's disease but that both arose from the need for the emergency surgery to address the obstruction (TT: 244-250).
Dr. Steinig described the procedure for the hernia surgery that claimant will require, which is known as a component separation hernia repair that also involves the use of mesh. He stated that claimant will need to be hospitalized for three to five days and will then have a recovery period of a couple of months and will require that he not engage in any physical activity. Dr. Steinig testified that any hernia repair can reoccur and a repeat procedure may need to be performed. He opined that both the hernia and the presence of Crohn's disease make it a distinct possibility that claimant will undergo future abdominal surgery. Dr. Steinig testified that claimant's abdominal wall will be permanently altered so he will have decreased mobility, decreased range of motion and decreased strength. He also opined that claimant will have a 10 to 15 year decreased work life expectancy. Dr. Steinig also testified that the scar tissue and umbilical will almost certainly need to be removed and that he will not have a normal appearing naval (TT: 250-256).
On cross-examination, Dr. Steinig testified that when he removed the pill, he had to resect the terminal ileum because the tissue was so diseased from Crohn's disease. He stated that it was as he performed the exploratory laparotomy that he diagnosed the presence of Crohn's disease. Dr. Steinig testified that the CT scan taken two days prior to surgery showed the obstruction. He stated that the inflammation was a combination of the presence of the capsule and the Crohn's disease. Dr. Steinig testified that when he stated that the capsule contributed to the abscess, he meant that the capsule contributed to the inflammatory response that was already occurring and made everything worse. He added that the claimant had subclinical Crohn's disease and it was the existence of the obstruction that he was being treated for at the Buffalo General emergency room. Dr. Steinig testified that the obstruction occurred before he presented himself at the MAC Center for the CT scan, but he did not know exactly when the obstruction occurred. Dr. Steinig clarified that claimant would experience a 10 to 15 year reduction in work life capacity for manual labor but that there would be no reduction for non-manual labor (TT: 257-262).
TESTIMONY OF DAVID L. WEST, PhD.
Dr. David L. West testified that he holds a doctoral degree in environmental health with a minor in epidemiology. He stated that after receiving his bachelor degree in mechanical engineering, he was an officer in the U.S. Public Health Service, where he served for 26 years.(3) During his service, Dr. West testified that he was assigned to the National Cancer Institute, the National Institute for Occupational Safety and Health (NIOSH), and his last assignment was with the FDA. At the FDA, he was first the Associate Director and then Deputy Director of the Office of Device Evaluation, which regulates the marketing of medical devices and the regulation of clinical trials of investigational devices. During this time period, Dr. West testified that this office regulated the introduction of medical devices into the U.S. market. He testified that he exercised the final review and signature authority for all Class III device trials requiring pre-market approval and all clinical studies regulated by the FDA. Finally, he stated that he had final review and signature authority for all complex, controversial and precedent setting decisions for 510 (K) applications for Class II medical devices (TT: 85-91).
Dr. West testified about the three classes of medical devices categorized and regulated by the FDA and their review process. He then explained why the FDA reviews the labeling that accompanies a medical device, stating that the labeling tells the doctor or health care professional how the device is to be utilized and cautionary language that includes contraindications, warnings and precautions so that it is used safely and effectively (TT: 92-96). Dr. West testified that the FDA has no authority to regulate the practice of medicine, however, medical devices that are labeled for use only on the order of a physician bear a prescription legend and they may only be utilized by a licensed practitioner with sufficient training and experience to know how to use the device. He stated that it is the FDA position that a Class II device that is for prescription use may be sold to and used by people licenced by the states as licensed practitioners, i.e., limited to a physician or dentist (TT: 96-100).
Dr. West identified Exhibit 5 as the labeling provided with the CorTemp device. He testified that the intended use listed on the label states that it could only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestible thermometer. He stated that FDA labels are written in language that can be understood by a physician and with instructions that can be followed by a physician with medical training (TT: 100-108). Dr. West testified that contraindications are conditions of the patient that are known and represent risks to the patient that would not be outweighed by the benefits to be derived from using the device. He added that these conditions are serious and the physician is to carefully consider them. Dr. West testified that the FDA does not envision non-physicians using prescription medical devices (TT: 109-111).
Dr. West testified that he had read the clinical protocol for the study at the University of Pennsylvania at Pittsburgh and that the physicians were to be there to screen patients and to monitor the patients so that the appropriate patients were getting into the study and were to be present for ongoing monitoring during the study (TT: 113-117). Dr. West testified that when the study was transferred from Pittsburgh to SUNY Buffalo, he did not see any protocol similar to what he reviewed for the University of Pittsburgh study. As to documents relating to oversight or screening by physicians, Dr. West testified that he saw an informed consent document on SUNY Buffalo letterhead and that it was stamped as reviewed and approved by their IRB. He stated that IRBs are comprised of medical professionals and laymen and are to reflect the standards of conduct of a local community and the expertise of the medical people on the board and that it is their function to look at the study plan, protocol and most importantly, ensure that the informed consent complies with the protocol. He testified that his review of the consent form indicated that physician oversight was to be employed at SUNY Buffalo, specifically referencing to Exhibit 2. In his review of the documents, Dr. West saw one document that said that Dr. Leddy would be available but he did not see anything indicating that Dr. Leddy was actually assigned to the study. He stated that neither the investigator nor the co-investigator of the SUNY Buffalo study were physicians, that claimant was never screened by a physician and that the CorTemp device was not given to him by a physician. Dr. West characterized its use as an off-label use by a non-physician and that by doing so, he opined that its use without having claimant evaluated by a physician was a departure from good and acceptable standards of care. He also stated that it was reasonable to conclude that the IRB believed that there was a physician involved. Dr. West opined that the use of the CorTemp device in this manner by non-physicians was not consistent with the FDA approved labeling for the CorTemp capsule (TT: 118-125).
On cross-examination, Dr. West testified that the CorTemp device came with FDA cleared labeling with indications for use, warnings and precautions and an owner's manual instructing the user on how to use it. He added that a medical device with a prescription label comes with instructions that will enable a licensed practitioner to know how to use it safely and effectively. He testified that the intended use of this device was for use by a physician and that HQ, the company that manufactured the device was to sell it only to physicians or institutions in which physicians operate or work. He clarified his earlier testimony concerning whether there was a violation of good and accepted standards of care stating that the CorTemp device was not used in accordance with labeling by a physician. As to whether there was a violation of good and accepted standards of care, Dr. West testified that this is a medical judgment and he is not a physician (TT: 127-131).
On redirect examination, Dr. West stated that the question asked on cross examination about standards of care refers to the practice of medicine and has nothing to do with an academic research study that is not administering care to a patient. He testified that dispensing a CorTemp capsule to claimant without a physician being involved was not consistent with the FDA's expectation of how the product would move through commerce and how it would be used in health care facilities. Dr. West testified that this device was marketed with a label requiring that it be administered by a physician and that it did not happen in this instance.
TESTIMONY OF JAY LUTHER, M.D.
Dr. Jay Luther is a physician specializing in gastroenterology and a clinical physician and member of the faculty of Massachusetts General Hospital (Mass General) and Harvard Medical School in Boston, Massachusetts. Dr. Luther, who testified as an expert witness on behalf of claimant, has been involved in a study at Mass General since 2011 investigating inflammatory bowel diseases, including Crohn's disease and ulcerative colitis to understand certain characteristics of these diseases, why patients develop them, and certain therapeutic options and why they work in some and do not work in others. He stated that he spends between 25% and 40% of his practice treating patients with inflammatory bowel disease and is a member of a group specializing in gastroenterology that form the Crohn's and Colitis Center at Mass General. In his capacity at Mass General, Dr. Luther has been involved in five to ten clinical studies that have utilized various endoscopic devices (Exhibit 62: 7-17).(4)
Dr. Luther testified that the CorTemp capsule utilized in the SUNY Buffalo study is a wireless endoscopic device whose intended use is for a one-time measurement of core body temperature in patients who need continuous monitoring. He testified that it may be used only on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestable thermometer probe. Dr. Luther added that the clinical evaluation of the patient is to make certain that the patient is "safe and stable for ingestion of this sensor" and that the evaluation includes an interview of the patient and potentially, a physical examination. In his work as a clinical researcher, Dr. Luther testified that he has previously conducted numerous clinical evaluations of patients in connection with study participation. He testified that a clinical evaluation must focus upon contraindications as "you don't want to unnecessarily put somebody at risk for a complication or harm when it could have been avoidable by just appropriate identification of already known contraindications" (Exh. 62: 17-21).
Dr. Luther testified that the claimant's record indicated that at no time was he clinically evaluated by a physician prior to his participation in the study (Exh. 62: 21-22). Dr. Luther testified that the health questionaire completed by claimant (Exhibit 3) had a comprehensive review of potential symptoms that could be associated with inflammatory bowel diseases (IBD). He stated that the two most common symptoms seen in patients who come in with newly diagnosed IBD include abdominal pain and nausea or vomiting. In addition, Dr. Luther testified that belching or gas and frequency of bowel movements are also symptoms commonly associated with IBD, and that claimant marked "yes" to both of these symptoms on his health questionnaire. Dr. Luther saw no indication in the record that there was any follow-up by the SUNY Buffalo investigators concerning these positive responses. He also testified that the health questionnaire was deficient in that it did not seek information as to whether the prospective study subject had any IBD, including Crohn's disease. It was also Dr. Luther's opinion that the health questionnaire did not adequately address the specific contraindications of the CorTemp capsule (Exh. 62: 25-28).
It was Dr. Luther's opinion that the primary risk posed to claimant from a gastrointestinal standpoint was the potential for retention of the capsule. Although the CorTemp product literature indicates a one to two percent retention rate, he has found that individuals with a disorder of the small intestine such as Crohn's disease exhibit a much higher retention rate. In the section of the SUNY consent form relating to risks, he testified that the risk they cite from the frequency of capsule retention is less than he would have included. In addition, Dr. Luther testified that the consent language was deficient in that it did not mention that surgery was a risk from ingesting the device. He stated that it was important to include the risk of surgery so that participants fully understand the risks of their participation in research and if they have not been informed properly of either the benefits or the risks, "you really haven't done your job in terms of making sure that the participant really wants to be involved." As such, it was Dr. Luther's opinion that the study departed from a good and accepted standard of care by failing to disclose the risk of surgery from ingesting the capsule (Exh. 62: 32-37).
Dr. Luther testified that the claimant's record indicated that claimant ingested the CorTemp capsule on a Tuesday evening and had developed pain, nausea and vomiting by Wednesday evening. Dr. Luther stated that the record indicated that claimant then reached out to the SUNY study coordinator but no one in the study put claimant in contact with a physician or other licensed medical provider. In addition, he testified that there was no record of any attempts by investigators connected with the SUNY study to provide claimant with any information concerning the CorTemp device and how it might be contributing to his symptoms (Exh. 62: 42).
Dr. Luther testified that the SUNY health questionnaire requested that the study participant include the name of his primary care physician, the purpose of which he stated is to ensure that the participant does not have any medical issues that would impact his enrollment in the study and in the event that anything happened during his participation, they would know the name of a physician to contact. The claimant's health questionnaire identified Dr. Novelli as his primary care physician. Dr. Luther testified that claimant's records with Dr. Novelli indicated in a note dating to December 2013 that claimant's mother had Crohn's disease. He testified that this was a high risk factor that should have been highlighted and investigated further to determine if claimant was a suitable candidate for the study. Dr. Luther testified that the basis for this opinion was that there is a genetic component to Crohn's disease and ulcerative colitis which leads to a higher risk of developing the disease if you have a first-degree relative who has the disease. He testified that he saw no evidence that anyone involved in the study contacted Dr. Novelli (Exh. 62: 43-46).
Dr. Luther opined that SUNY's failure to have a physician clinically assess claimant created an unreasonable risk of harm. Further, it was his opinion that SUNY's failure to administer an adequate screening process prior to permitting claimant to ingest the CorTemp capsule caused claimant to suffer harm. In Dr. Luther's opinion, it was also unreasonable that the SUNY study did not have an established protocol or procedure in place to address a study subject who, like claimant, retained a capsule after ingesting it (Exh. 62: 46-48).
Dr. Luther testified that he was familiar with the emergency surgical procedure performed by Dr. Steinig, which he stated was an open laparotomy to remove the CorTemp capsule from claimant's small intestine. He testified that during this procedure, claimant's ileocecal valve was removed, which is significant for two reasons: one, it is common postoperatively for patients to develop diarrhea as the ileocecal valve is important in helping absorption of bile acids and if not absorbed, this can irritate the colon and cause diarrhea. Second, patients can develop an overgrowth of intestinal bacteria from the small intestine that can lead to bloating, abdominal discomfort and diarrhea. Dr. Luther testified that in addition to removal of the ileocecal valve during this surgery, 13 cm. of his small intestine was also removed. He stated that from their examination of the tissue, full-thickness inflammation was viewed that was consistent with and "a hallmark" to diagnose the existence of Crohn's disease (Exh. 62: 50-54).
Dr. Luther testified that after ingesting the CorTemp capsule, claimant exhibited symptoms that he had retained the capsule in his bowel. He testified that claimant related these symptoms in his text messages to a member of the SUNY study staff, Campbell, including abdominal pain, nausea, vomiting and weight loss. Dr. Luther testified that there was nothing in the claimant's record to indicate that Campbell or any other investigator in the SUNY study advised claimant to seek medical attention (Exh. 62: 54-55).
Dr. Luther testified that in his treatment of patients with Crohn's disease, it is his objective to medically manage the disease with medical therapies and without resorting to surgery. He testified that the reason they attempt to avoid surgery is that a patient with Crohn's disease who has surgery is then more likely to require another surgery and if you remove a section of the bowel during surgery, this will affect the patient's ability to absorb certain nutrients that can adversely affect their health going forward. Dr. Luther testified that following claimant's surgery, the removal of the bowel did not result in remission of the Crohn's disease and that he continued to experience its recurrence. He testified that claimant's medical records indicate that he recently went into remission after being prescribed a biologic medicine known as Humira (Exh. 62: 63-66).
Dr. Luther testified that when claimant presented to Mercy Hospital on June 9, 2015, the surgery performed by Dr. Steinig was emergency surgery as claimant by then had a full bowel obstruction. He explained that this was a medical emergency because even the continued ingestion of air or saliva could cause pressure at the site of the full obstruction that risked perforation, the consequence of which is that bacteria from the bowel would leak into the abdomen and could lead to organ damage. It was Dr. Luther's opinion that non-surgical therapies were no longer viable due to the fact that claimant came to Mercy Hospital about one month post-ingestion with a severe illness and now had a full obstruction. It was Dr. Luther's opinion that the SUNY was negligent in that they failed to investigate claimant during the screening process given the characteristics in claimant's family history and his symptoms of bloating and gas. Furthermore, he opined that they were also negligent in that the consent form did not lay out the potential for retention of the capsule, all of which contributed to claimant's obstruction and the need for the emergency surgery. Finally, it was Dr. Luther's opinion that this surgery was necessitated not because of the underlying Crohn's disease but as a result of the obstruction (Exh. 62: 66-74).
Dr. Luther also opined that because claimant had to be treated with emergency surgery, this deprived him of the opportunity to have his Crohn's disease treated non-surgically and medically managed. He emphasized that the goal in treating patients with Crohn's disease is to delay surgery to the extent that is possible and that by the time claimant presented at Mercy Hospital, medical management was no longer a safe option. Dr. Luther also testified that as a result of this surgery, claimant developed complications, including infection which required a wound vac placement and an incisional hernia. He testified that the presence of Crohn's disease does not affect a patient's ability to recover from surgeries and that the need to address the infection with a second surgery and the future surgery to correct the hernias were direct results of the emergency surgery to address the obstruction (Exh. 62: 75-78).
On cross-examination, Dr. Luther stated that he was not sure if claimant ever advised the SUNY study staff that his mother had Crohn's disease and that there was nothing in the Mercy Hospital record indicating he advised that his mother had Crohn's disease. Dr. Luther agreed that claimant was released with a differential diagnosis of bowel obstruction, colitis, diverticulitis and gastroenteritis. He agreed that the Buffalo General Hospital record indicated that the capsule had passed the ileocecal valve into the sigmoid colon and that claimant's mother had an unknown type of colitis. Dr. Luther testified that the surgical records indicated that the capsule was located in the terminal ileum, which is before the sigmoid colon. He did not believe that the capsule had moved to this location from the sigmoid colon and that the report misinterpreted the image (Exh. 62: 81-88).
Dr. Luther was then asked what was the purpose of the emergency surgery and he responded that it was to relieve the obstruction and remove the capsule. He testified that the obstruction was due, in part, to the presence of the capsule in the ileum. Dr. Luther testified that the surgeon removed part of claimant's ileum because of the Crohn's disease and because the capsule was lodged in his ileum. He stated that in his opinion, the pill had been there for so long that it had caused a complete obstruction with severe inflammatory changes of the surrounding tissue with a high risk of perforation that was evidenced by the fact that tissue outside the colon, namely, the peritoneum had also become inflamed. Dr. Luther testified that the capsule did not cause the inflammation in the distal ileum but that the inflammation caused the pill to lodge where it did (Exh. 62: 88-92). He also opined that claimant was suffering some inflammation that was acute and some that had been longstanding, which was why he believed that part of the intestine had to be removed. Dr. Luther stated that they could have performed a colonoscopy to remove the capsule had it been addressed two weeks earlier (Exh. 62: 92-94).
Dr. Luther testified that one out of every two to as many as three out of every four Crohn's patients will require surgery at some point in their lifetime. He also testified that of those patients who have one surgery, twenty-five percent will require a second surgery within five years and one-third of those patients will require a third surgery. Dr. Luther testified that had claimant been diagnosed with Crohn's disease earlier, he would have moderate Crohn's disease instead of the severe Crohn's that he presented with at the time of the emergency surgery (Exh. 62: 94-96).
With respect to a question concerning the health questionnaire, Dr. Luther testified that claimant's response that he was experiencing belching and gas was significant, especially in a younger patient since one of the things he sees in his clinical practice is abdominal bloating, belching and gas. He stated that its presence could be caused by something as simple as diet or it could be a sign of inflammation within the gastrointestinal tract. Dr. Luther further testified that when he sees patients exhibiting this symptom, he will ask them how long it has been going on and whether they think there is an association with eating or if not, if anything else brings on this symptom and then he will do an examination (Exh. 62: 96-98).
Dr. Luther testified that because claimant had a family history of Crohn's disease, there was an increased risk that he would also have Crohn's and if in fact, he did, claimant would be at risk for retaining the CorTemp capsule. He stated that the studies that have looked at the likelihood for retention in patients, a lot who end up retaining the capsule are patients with Crohn's disease. Dr. Luther's opinion was that if it was known that claimant had Crohn's disease, he would have suggested against him participating in the SUNY study. Further, he opined that if it was known that claimant's mother had Crohn's disease, he would have flagged him for a more in-depth evaluation by a licensed clinical care provider (Exh. 62: 98-101).
On redirect examination, Dr. Luther stated that it is unsafe to use a prescription device without a doctor's approval as it is the physician's duty to evaluate its use in a patient in order to minimize risk and harm to the patient. He agreed that the safe use of the CorTemp capsule as a prescription device required an individual clinical assessment of claimant and it was a deviation from the standard of care to utilize a controlled medical device without one (Exh. 62: 102-104). Dr. Luther stated that in his clinical practice he has developed algorithms and protocols to address retention of endoscopic capsules because their likelihood is not insignificant and the consequences of retention are also not insignificant. He testified that he did not see anything in the study documentation that indicated that they had similarly developed procedures to address a study participant with a retained capsule. Dr. Luther also clarified that the reason that he diagnosed claimant with severe Crohn's disease was because he presented for surgery with obstruction.
Dr. Luther also had the opportunity to review the medical records of Dr. Novelli, which he stated indicate that on January 19, 2015, Dr. Novelli performed a physical examination of claimant prior to his participation in the study. This examination included a complete abdominal examination and Dr. Novelli indicated at that time that claimant showed no presence of Crohn's disease (Exh. 62: 105-112). Dr. Luther again opined that SUNY's negligence denied claimant the substantial possibility that his underlying Crohn's disease could have been medically managed without surgery and managed in that fashion for years (Exh. 62: 114-115).
LAW AND ANALYSIS
The claim alleges that the negligence of SUNY consisted of its failure to properly and adequately screen claimant for this experimental study; to have him screened by a physician either prior to his participation or during the course of his participation in the study; to perform proper tests prior to or during his participation in the study; to refer claimant to a physician at any time after SUNY was advised of his severe abdominal pain; to provide proper and adequate medical care to claimant; to use proper, adequate and safe equipment in the study; that they made false and/or misleading representations to claimant regarding the equipment and personnel involved in the study; and they utilized personnel who lacked the proper education and training to conduct this experimental study. The Court of Appeals has held that "[t]he threshold question in any negligence action is . . . [whether the] defendant owe[s] a legally recognized duty of care to [the] plaintiff" [Davis v South Nassau Communities Hosp., 26 NY3d 563 , citing Hamilton v Beretta U.S.A. Corp., 96 NY2d 222, 232 ). A critical consideration in determining whether a duty exists is whether "the defendant's relationship with either the tortfeasor or the plaintiff places the defendant in the best position to protect against the risk of harm" [Davis, supra at 572, citing Hamilton, supra at 233). The claimant must not only demonstrate that the defendant owed a legal duty to claimant, but that this duty was breached and was a proximate cause of his injuries [Pulka v Edelman, 40 NY2d 781, 782 (1976)].
It has previously been held that the determinative factor to establish whether a duty exists involving a college or university is whether it possessed a sufficient degree of control over the subject event, and thus was under a duty to take reasonable precautions for the safety of the participants (Hores v Sargent, 230 AD2d 712 [2d Dept 1996]). In the present claim, the claimant was an enrolled undergraduate student at SUNY Buffalo who volunteered to participate in an experimental study conducted by SUNY and was thereafter screened, interviewed and accepted into the study by the defendant's principal administrator, Dr. Hostler, who is also a professor and chair of SUNY Buffalo's Department of Exercise and Nutrition Sciences. As such, I find as a matter of law that SUNY exercised a sufficient degree of control that it was in the best position to determine what reasonable precautions should be taken for the safety of participants in the study and therefore, a duty of care exists requiring that SUNY take reasonable precautions for the safety of all study participants, including claimant.
Whether claimant has established by a preponderance of the evidence that SUNY was negligent by failing to take reasonable precautions for the safety of the claimant as a participant in the two cylinder study is a factual question. In arriving at this factual determination, the Court finds the following facts significant. Dr. Hostler and Ray testified that this study had two components, one which was conducted earlier at the University of Pittsburgh with the Department of Emergency Medicine in the University of Pittsburgh Medical School. In that portion of the study, Ray identified three licensed physicians with the University of Pittsburgh who were investigators in the study, as well as a fourth physician investigator who was a cardiologist. These physicians participated in the screening of study participants and were involved with the participants during the testing phase of the study. Ray testified that none of these physicians participated in the participant portion of the study conducted at SUNY Buffalo. It was established that the study application protocols submitted by Dr. Hostler to the SUNY Buffalo IRB stated that a physical examination of each participant would be conducted by a physician. The study protocol also detailed specifically what would be performed by the physician during the physical examination of the participant, including a physician review of the inclusion and exclusion criteria, taking a blood sample and performing an initial EKG. However, the testimony clearly established that no physician was involved in the screening of prospective study participants or in monitoring them during the testing phase. Dr. Hostler admitted during his testimony that none of these procedures were followed by him in the study in which claimant was a participant. In addition, although Dr. Hostler listed in the submission to the SUNY Buffalo IRB that a physician, Dr. John Leddy and a nurse, Mary Carey were to participate, neither was involved in the SUNY study or with claimant's screening or participation. Dr. Hostler also admitted that screening EKGs were never conducted of any participants in the SUNY Buffalo study. The Court also finds that the testimony at trial established that the CorTemp capsule or pill that was utilized for this study at the University of Pittsburgh and SUNY Buffalo was to be ingested by the study participants and is a Class II prescription device. It is uncontroverted that the label for this medical device approved by the FDA states that it is only to be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestible thermometer. Dr. West and Dr. Luther, whose testimony the Court finds credible, both testified that the CorTemp capsule may be used only on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of an ingestable thermometer probe. At no time was the claimant clinically evaluated by a physician before being provided with the CorTemp capsule and instructed to ingest it as a participant in the study.
Accordingly, I find that claimant has established by a preponderance of the credible evidence that a prescription medical device was used without a physician's order and without a physician evaluating the contraindications and warnings with respect to including claimant in this study. Dr. Hostler, who is not a physician, testified that he had used the CorTemp capsule about 1,000 times but he could not recall whether he had ever read the label for the device and claimed that he did not know it was a prescription device. Upon observing Dr. Hostler testify and his demeanor while doing so, I found his testimony was less than credible and at certain times his demeanor demonstrated that his responses were not believable. Specifically, I find that Dr. Hostler was not credible in his testimony that he was not aware that the CorTemp capsule was a prescription device and I find that he not only knew that it could be used only on the order of a physician but he also knew from the protocols submitted to the IRB that a physician was to be involved in the screening process of study participants and to continue to monitor those participants during the course of the study.
As such, I find that SUNY was negligent in failing to properly and adequately screen the claimant for this experimental study and in failing to have claimant screened by a physician either prior to or during the course of his participation in the study. In determining that SUNY was negligent, the Court also finds that SUNY's negligence was a proximate cause of claimant's injuries, i.e., that Dr. Hostler's issuance of this prescription medical device without a physician's approval and without the participation of a physician to evaluate claimant during the screening process and monitor him during the study was a proximate cause of the CorTemp capsule embedding in claimant's intestine and his resulting injuries.
I also find that the informed consent form included with the SUNY Buffalo study packet documents stated that it was a rare risk for the capsule to become lodged in the intestines but did not state that there was a risk of surgery. Ray testified that she was not aware that if a foreign object became lodged in the intestine it might require surgery to remove and she agreed that the risk of surgery was something that a student participant would want to know before agreeing to participate in the study. Dr. Hostler testified that he was aware that if the capsule were to embed in the intestine that it would require surgery and agreed that this was something that a study participant would want to know. The claimant, whose testimony I found credible, testified that had he been made aware that if the CorTemp capsule lodged in his intestine that there was a risk of surgery, he would not have participated in the study.
Dr. Hostler testified that he reviewed claimant's health questionnaire and it was he who approved claimant for participation in the study. He testified that he did no follow-up on claimant's indications of belching and gas or inquire into his family medical history. The health questionnaire also requested the name of claimant's primary physician, Dr. Novelli. Dr. Hostler testified that at no time prior to admitting claimant into the study or at any time during claimant's participation did he contact Dr. Novelli. The claimant's expert gastroenterologist, Dr. Luther, whose testimony I found credible testified that there are two purposes for having the primary physician listed on a study health questionnaire, namely, to ensure that the participant does not have any medical issues that would impact his participation and to be able to contact the primary physician in the event there is a need during the study. Dr. Luther testified that had a call been placed to Dr. Novelli, they would have learned that claimant's mother had Crohn's disease. This, he explained, was a high risk factor that should have been investigated further to determine if claimant was a suitable candidate for the study. The basis for Dr. Luther's conclusion was that there is a genetic component to Crohn's disease and ulcerative colitis that leads to a higher risk of developing the disease if you have a first-degree relative with it. As such, it was Dr. Luther's opinion that SUNY's failure to have a physician clinically assess claimant created an unreasonable risk of harm and their failure to do so and claimant's subsequent ingestion of the CorTemp capsule was the proximate cause of his later injury. It was Dr. Luther's opinion that SUNY Buffalo failed to investigate claimant sufficiently during the screening process given the characteristics in his medical history and his reported symptoms of belching and gas.
Dr. Luther also testified that it was unreasonable that the SUNY Buffalo study had no protocol or procedure in place to deal with a study participant who, like claimant, retained the CorTemp capsule. He testified that soon after claimant ingested the capsule, he displayed symptoms indicating that he had retained the capsule in his bowel, including abdominal pain, nausea, vomiting and weight loss. From the testimony of Dr. Hostler, Ray and the emails between claimant and Ray and Campbell, I find that at no time did any SUNY employee advise claimant to seek medical attention. I find based upon Dr. Luther's opinion that had claimant been treated by a physician earlier that he would not have required the emergency surgery with Dr. Steinig. Dr. Luther agreed with Dr. Steinig's testimony that when claimant presented at Mercy Hospital on June 9, 2015, that he required emergency surgery as claimant had a complete bowel obstruction.
Dr. Luther also testified that in the treatment of patients with Crohn's disease the objective is to medically manage the disease with surgical intervention being a last resort. It was his opinion that non-surgical therapies to dislodge the CorTemp capsule were not viable due to the fact that claimant came to the hospital about one month after ingesting the capsule and by then there was a complete obstruction with severe inflammatory changes of the surrounding tissue. It was Dr. Luther's opinion that the surgery performed by Dr. Steinig was necessitated by the obstruction caused by the CorTemp capsule and not by any underlying Crohn's disease. Dr. Luther opined that because claimant had to be treated with emergency surgery, this deprived claimant of the opportunity to have his Crohn's disease medically managed for years without the need for surgery. I also find that as a result of the surgery performed by Dr. Steinig, the claimant required a second surgery when an infection developed which also required the installation of a wound vac. I further find that claimant will require a third surgery to correct hernias that developed from the previous surgeries which as of the time of trial could not yet be operated on safely until claimant's Crohn's disease was under control.
I find from the testimony at trial that the SUNY Buffalo investigators were aware of claimant's symptoms of abdominal pain as early as May 13, 2015, that he had become constipated as early as May 16, 2015, and that his abdominal pain had intensified as early as May 17, 2015. As such, I find that SUNY was negligent in failing to properly screen claimant in accordance with the IRB protocols and procedures prior to and during his participation in the study; that SUNY failed to refer claimant to a physician at any time after the SUNY Buffalo investigators had been advised of claimant's severe abdominal pain and other symptoms. I also find that SUNY was negligent in that the SUNY Buffalo investigators made false and/or misleading representations to claimant regarding the qualifications of the investigators involved in the study, of the safety and efficacy of the CorTemp capsule used in this study and with claimant, in particular; and that SUNY was negligent in failing to have a physician involved in the screening process and in monitoring the participants during the study and that SUNY's failures as stated above were a proximate cause of claimant's injuries and resulting surgeries.
Upon consideration of all of the testimony and exhibits presented at trial, I find that at the time of SUNY's negligence in April and May 2015 that the claimant was 22 years old and that during this time period he reported his symptoms to the SUNY Buffalo investigators, which included extreme abdominal pain, a loss of appetite, vomiting what food he was able to eat, diarrhea, dehydration from vomiting, and constipation. I find that at the time claimant ingested the CorTemp capsule that he had asymptomatic subclinical Crohn's disease and that the defendant's negligence deprived claimant of the opportunity to have his Crohn's disease medically managed and the ability to remove the capsule with a non-surgical alternative such as a colonoscopy. I also find that as a result of the defendant's negligence that the defendant is also liable for the resulting surgery caused by the embedded capsule which required that claimant first undergo an emergency bowel resection to address the complete blockage and which required the removal of a portion of his small intestine and the ileocecal valve. I further find that the defendant is liable for the claimant's second surgery to address the infection which was a direct result of the first surgery and which also required the installation of a wound vac. The proof at trial also established that the claimant will require a third surgery in the future to address the hernias in his abdomen and necessitating the use of biological mesh that I find to be a direct result of the previous two surgeries. During the course of the trial, photographic evidence was presented depicting the appearance of claimant's abdomen and based upon this evidence and the testimony relating to it I find that claimant's scars from the surgeries have caused permanent disfigurement. I also find that as a direct result of SUNY's negligence that the future treatment and medical management of what had been asymptomatic Crohn's disease that the ability to medically manage his symptoms has been complicated by the necessity of the emergency bowel surgery and the removal of a portion of his small intestine and the ileocecal valve and that this may require future surgery that might otherwise have been medically managed without the need for surgery. Finally, I find that claimant had a work life expectancy to age 67 when he would reach full Social Security eligibility age and this would be in the year 2060 (Exhibit 63). Based upon the testimony of Dr. Steinig, whose testimony I found credible, he opined that the hernias in his abdomen will reduce his work life expectancy about 15 years.
Based upon the foregoing, I award damages of six hundred fifty-nine thousand ($659,000) dollars for future lost wages, the sum of five hundred thousand ($500,000) dollars for past pain and suffering from May 11, 2016 to the date of trial, and the sum of one million ($1,000,000) dollars for future pain and suffering for claimant's life expectancy of approximately 50 years. In addition, to the extent that claimant has paid a filing fee, this too may be recovered in accordance with Court of Claims Act § 11-a (2).
In that the amount of future damages awarded exceeds $250,000, a structured judgment is required pursuant to CPLR 5041(e). Accordingly, the Clerk of the Court is directed to stay the entry of judgment in accordance with this decision until a hearing is held pursuant to CPLR Article 50-B. The Court will contact the parties in order to schedule a hearing. For the purposes of CPLR Article 50-B, the Court encourages the parties to agree upon the attorneys fee calculation and discount rate to be applied and to formulate a structured settlement of their own (CPLR 5041[f]). In the event the parties fail to reach agreement, each party shall submit a proposed order directing judgment in writing conforming to the requirements of CPLR Article 50-B within 120 days of the date this Decision is electronically issued to the parties in accordance with the Administrative Orders of the Office of Court Administration during the court shutdown due to the COVID-19 pandemic.
As to any objections upon which this Court reserved decision during the course of the trial and as to any motions made at trial upon which the Court previously reserved or which remain undecided, all are hereby denied.
May 12, 2020
Buffalo, New York
J. DAVID SAMPSON
Judge of the Court of Claims
1. References to the trial transcript will be by page number with the designation "TT:1-4".
2. Ray identified Exhibit 23, an email exchange with Campbell on June 3, 2015. She testified that she and Campbell had been asked by Dr. Hostler to create a chronology or time line of the events surrounding claimant. Ray testified that she believed that it was Dr. Hostler who first contacted the IRB about the claimant's incident (TT: 207- 217). She testified that Campbell had incorrectly advised claimant that he had passed the capsule through a bowel movement and that she spoke with Campbell and it was her belief that the false reading was because the battery in the pill must have died (TT: 221-223).
3. Dr. West testified that the U.S. Public Health Service is part of the Department of Health and Human Services and its largest components include the National Institutes of Health (NIH), the Centers for Disease Control (CDC) and Prevention and the Federal Drug Administration (FDA) (TT: 87-88).
4. The testimony of Jay Luther, M.D., was taken on September 18, 2019, prior to the trial by videotape. A video and written transcript of his trial testimony was received into evidence without objection as Exhibit 62. References to the transcript will be by page number in the following format, "Exhibit 62: 1-3".