United States District Court, D. Massachusetts
ENOCH O'D. WOODHOUSE II, Plaintiff,
UNITED STATES OF AMERICA, Defendant.
FINDINGS OF FACT AND RULINGS OF LAW
JUDITH GAIL DEIN, Magistrate Judge.
This malpractice action, brought under the Federal Tort Claims Act, arises out of the medical treatment the plaintiff received at the Department of Veterans Affairs Medical Center in Jamaica Plain, Massachusetts, on July 13, 2007. Specifically, the plaintiff challenges the manner in which an esophagogastroendoscopy ("EGD" or "endoscopy") was performed, and the sufficiency of the information he was provided prior to consenting to the procedure. A jury-waived trial was held before this court on October 6, 7 and 8, 2014. The court heard testimony from the plaintiff, Enoch Woodhouse II; his wife Stella Sealy Woodhouse; his treating physician at Massachusetts General Hospital, Christopher R. Morse, MD, Internal Medicine, Gastroenterology; and three treating physicians from the VA Medical Center in Jamaica Plain: Sharmeel Wasan, MD, Fellow in Gastroenterology; Satish Singh, MD, Staff Gastroenterologist; and Marcos C. Pedrosa, MD, Chief of Endoscopy. The plaintiff's primary care physician, Carl Dettman, MD, testified by deposition. The parties submitted proposed findings of fact and rulings of law on December 17 and 22, 2014. The court has been provided with transcripts of the trial proceedings. After careful consideration of the transcripts, exhibits, and the parties' submissions, this court makes the following findings of fact and rulings of law. Judgment shall enter in favor of the defendant for the reasons detailed herein.
II. FINDINGS OF FACT
1. The plaintiff, Enoch Woodhouse, was born in 1927 in Boston, Massachusetts. He enlisted in the army at age 17 during World War II, and was a member of the Tuskegee Airmen, a group with which he is still involved. After being discharged from the army, Mr. Woodhouse attended Yale on the GI Bill, and graduated in the class of 1952. He attended Boston University and Yale law schools, and received his JD degree. (I:76-78).
2. After law school, the plaintiff was appointed as a United States Diplomatic Courier with the State Department, and later served as a JAG officer for the Air Force before starting his own law practice in Boston. (I:77-79). There is no question that Mr. Woodhouse has served his country honorably and proudly and, as his counsel argued, that he had earned the right to quality healthcare services. (See III:91).
3. Mr. Woodhouse developed dysphagia, i.e., difficulty in swallowing. On March 18, 2002, he was seen as an outpatient at the VA Medical Center in Jamaica Plain, where he complained that he had been having difficulty swallowing pills and solid food for the past two years. (Ex. 1 at 327; I:81-82). At that time, he had no complaints about weight loss. (Ex. 1 at 327).
4. On April 3, 2002, he underwent a barium swallow and upper GI exam at the VA Medical Center. The test showed a "small Zenker's diverticulum, and no relaxation phase of the cricopharayngeal [muscle] and [a] small hiatal hernia, no other mechanical abnormalities." (Ex. 1 at 322).
5. A Zenker's diverticulum is an outpouching, or defect, of the posterior wall of the esophagus. It forms posterior to and above the cricopharyngeus muscle (the "CP muscle") when a hypertonic, or tense, CP muscle partially obstructs the flow of food down the esophagus during swallowing. When the food hits the obstruction, it finds a point of weakness above that obstruction and creates a pouch, which is the Zenker's diverticulum. (I:24-25). As in case of Mr. Woodhouse, a Zenker's diverticulum in and of itself can be asymptomatic. It may become problematic, however, if it causes regurgitation or aspiration, or if it causes halitosis. (I:25; II:103-04).
6. In 2002, Mr. Woodhouse and his doctor agreed to a conservative course of treatment for his swallowing difficulties. Mr. Woodhouse was to manage his condition by breaking up his pills, chewing his food well, drinking a lot of fluid while eating, and monitoring his progression. (Ex. 1 at 322).
7. Mr. Woodhouse continued to have difficulty swallowing. In 2004, he was seen by his primary care doctor at the VA Medical Center, Dr. Carl Dettman. (Ex. 1 at 297). In March 2004, he reported to Dr. Dettman that he was "concerned" because "others have commented on his [weight] loss" and attributed his weight loss to difficulty chewing due to new false upper teeth. (Ex. 1 at 307). His records showed a slow weight loss over the last 1½ years "most likely due to dentition." (Id.). By October 2004, his weight had declined from 138 in March to 131- pounds. (Ex. 1 at 297, 307). His weight remained stable through about June 2007. (See Ex. 1 at 278).
8. On May 17, 2007, Mr. Woodhouse was seen by Dr. Dettman complaining that over the "last couple of months" he had had difficulty swallowing solids, which were getting stuck in his throat, and in swallowing pills. (Ex. 1 at 278-79). His weight was recorded at 134 pounds. (Ex. 1 at 279). While the plaintiff attributed his difficulty to his Zenker's diverticulum, the doctor questioned whether this was the cause. (Ex. 1 at 279).
9. Dr. Dettman ordered another barium swallow and upper GI, which was performed on June 4, 2007. (Ex. 1 at 278). The exams disclosed no changes since 2002. There was still a small Zenker's and non-relaxation of the CP muscle. (Ex. 1 at 278). Dr. Dettman wrote that he "doubt[ed] Zenker's is cause of swallowing problems, " but since the patient was "very symptomatic" and Mrs. Woodhouse, a nutritionist, was "very concerned about weight loss, and malnutrition relating to swallowing difficulty, " he ordered further review by a gastroenterologist. (Ex. 1 at 278). Dr. Dettman discussed the test results with Mr. and Mrs. Woodhouse on June 5, 2007. (Ex. 1 at 278).
10. I find that while the medical records do not support a finding of significant weight loss from 2004 through 2007, Mr. and Mrs. Woodhouse consistently reported in 2007 that Mr. Woodhouse was losing a lot of weight, and that they were concerned that he would become malnourished. The doctors at the VA Medical Center took the Woodhouses' concerns seriously.
The Recommended Procedure
11. On June 26, 2007, Mr. Woodhouse had a gastroenterology consult with Dr. Raj Goyal at the VA Medical Center. (Ex. 1 at 274). Dr. Goyal is a pre-eminent expert in his field of the esophagus and esophageal diseases. (II:65-66). The plaintiff has raised no objection to the care provided by Dr. Goyal.
12. Mr. Woodhouse complained to Dr. Goyal that he had been suffering from dysphagia for many years, which he described as being localized to the throat and limited mostly to solids. (Ex. 1 at 274). According to Mr. Woodhouse (although not supported by the medical records), he had lost over 15 pounds over 5 years due to poor food intake. (Ex. 1 at 274). Dr. Goyal noted that there had been a "recent barium swallow for worsened symptoms (but no further weight loss)" which revealed no change - there was still a small Zenker's and non-relaxation of the CP muscle. (Ex. 1 at 274). Dr. Goyal recommended an upper endoscopy ("EGD") with empiric dilation of the upper esophageal sphincter. (Ex. 1 at 276). According to Dr. Goyal's notes "[t]he assessment and plan were discussed with the patient who appears to understand." (Ex. 1 at 276).
13. An upper endoscopy (EGD) is performed using a scope that is passed down the esophagus into the stomach and into the first portion of the duodenum, or the area of the bowel after the stomach, in order to look for any abnormalities. (I:27).
14. The EGD is done to assist in identifying the cause of dysphagia. In the case of a patient such as Mr. Woodhouse, i.e., an older patient who was complaining of a worsening condition and weight loss, I find that it is common and within the standard of care to use the EGD to rule out cancer. (II:52, 68-69, 118). While cancer may be identified through a barium swallow, an endoscopy may help to reveal lesions that are not evident in a barium swallow. (I:65).
15. An EGD may also result in a limited dilation of the sphincter simply due to the passage of a scope through the constricted area. (III:54-55). This might result in some relief to the patient, although it would be very temporary. (III:12).
16. A dilation is a procedure using a balloon or series of dilators (long tubes of varying increasing sizes) that are passed down the esophagus over the obstruction in order to stretch out a stricture that is causing the narrowing of the esophagus. (I:27-28, 70). Generally, a scope is passed through the narrowed area to assess it, and a guide wire is then left behind. The scope is taken out and then, using the guide wire, either a series of dilators that are tapered and rigid, or a balloon that will have a central channel that could be threaded over the wire, is inserted to stretch out the area. (II:71). The guide wire helps insure that the dilators are placed down the esophagus and not diverted into the diverticulum, so it is not prudent to dilate a patient with a Zenker's diverticulum without some sort of guidance or tract. (II:71). However, the existence of a Zenker's diverticulum does not render an endoscopy inappropriate treatment. (See I:65-66).
17. With an "empiric dilation, " a dilation is performed to treat whatever is causing the symptoms, without knowing what in actuality is causing the symptoms. (II:69-70).
18. The dilation is intended to provide temporary relief by stretching the non-relaxing CP muscle. (I:28-29). At some point following a dilation, the muscle will re-contract back. (I:28). There is a study, however, albeit involving only a limited number of patients, that shows "that endoscopic dilation can be an effective treatment for patients with oropharyngeal dysphagia because of a CP bar" and that the temporary relief provided can last as long as a period of years, even if the patient has a Zenker's diverticulum. (I:70-72, III:33-34, 42-43).
19. As a general statement, a dilation will not treat a Zenker's diverticulum, and the pouch will still exist. (I:28-29; II:121; III:67).
20. The plaintiff's expert, Dr. Morse, initially questioned the decision to attempt to perform the endoscopy and dilation on a patient with a known Zenker's diverticulum and negative barium swallow on the basis that the risk of cancer was low. Instead, he testified that Mr. Woodhouse should have been sent to surgery initially, with an endoscopy performed in connection with the surgery. (See II:34-35, 59). However, Dr. Morse subsequently testified that the EGD and dilation may have been an appropriate initial course of treatment. (I:6566, ("I don't know that the initial decision was incorrect or correct. That's a physician's judgment call.")). The plaintiff has made it clear that he is not challenging the initial decision to perform the endoscopy and dilation. (I:66; III:91-92). Rather, the issue is whether, as detailed below, the VA doctors should have continued attempts to insert the scope after having difficulty with the procedure. (I:66).
21. To the extent that it is an open issue, I find that it was within the acceptable standard of care for the VA doctors to have attempted to perform an endoscopy and dilation without first proceeding to surgery. As an initial matter, Mr. Woodhouse's Zenker's diverticulum was both small and asymptomatic, so there is evidence that there was no need to treat it surgically in 2007. (II:104; III:43). Moreover, an endoscopy is a much less invasive procedure, and does not require general anesthesia so it has less potential dangers for the patient. (II:120; III:33-34, 43-44). It is recommended by doctors that you start with the least invasive and less risky procedures before moving on to more invasive procedures. (II:120; III:16-17, 43-44). The results of the endoscopy, along with other tests such as a functional test, would provide information to determine if surgery was warranted. (II:46).
The Procedure at the VA Medical Center
22. As detailed above, Dr. Goyal recommended that Mr. Woodhouse undergo an upper endoscopy with an empiric dilation of the upper esophageal sphincter. (Ex. 1 at 276). Mr. Woodhouse underwent the procedure at the VA Medical Center in Jamaica Plain on July 13, 2007. (Ex. 1 at 272-73). He was 80 years old at the time.
23. Approximately 15 minutes before the start of the procedure, Mr. Woodhouse met with Dr. Sharmeel Wasan. (II:15, 17). Dr. Wasan had completed a three year Residency in internal medicine, worked as a hospitalist at Brigham and Women's Hospital for a year, and was starting as a Gastroenterology Fellow, a three year program. (II:23-25). She had just started at the VA Medical Center on July 1, 2007. (II:25-26). She had been taught how to obtain an informed consent. (II:27-28).
24. Dr. Wasan had no independent memory of obtaining consent from Mr. Woodhouse. I find, however, that Dr. Wasan followed her usual procedure in the case of Mr. Woodhouse. I also find that since Dr. Wasan was new to the VA, it is likely that she would have been even more careful to follow appropriate procedure, especially since, as was standard procedure, she was being overseen by the attending physician, Dr Singh. (See II:17-18).
25. It was Dr. Wasan's practice to explain the scheduled procedure, but not the alternatives to the procedure. (II:18). While the plaintiff argues that Dr. Wasan should have explained the alternative of surgery to Mr. Woodhouse, I find that the plaintiff has not established that it was Dr. Wasan's role to explain alternative procedures, especially since she was not responsible for determining the appropriate course of treatment. Rather, the record establishes that Dr. Dettman discussed the test results with Mr. and Mrs. Woodhouse on June 5, 2007. (Ex. 1 at 278). Mr. Woodhouse s condition was then assessed by Dr. Goyal, who determined the appropriate course of treatment. (Ex. 1 at 276). Moreover, according to Dr. Goyal's notes, he reviewed his "assessment and plan" with Mr. Woodhouse who understood them. (See Ex. 1 at 276). The plaintiff has not challenged Dr. Goyal's treatment of him. I find that the plaintiff has failed to establish that Dr. Wasan was responsible for advising him of alternative treatment options and/or that Dr. Goyal did not fully explain the available treatment options.
26. In connection with obtaining consent for the endoscopy and dilation procedure, it was Dr. Wasan's practice to explain that there were risks, including, without limitation, "risks of bleeding, infection and even a small tear or a perforation that can require an emergency surgery. These risks are very rare but they do exist." (II:29). In addition, it was Dr. Wasan's practice to tell a patient with a medical history of a Zenker's diverticulum that "because you have Zenker's diverticulum, there is a slightly increased risk of having a tear that can cause a surgery." (II:29-30). Dr. Wasan's practice would have been to have the patient sign a consent form. (II:30). The form Mr. Woodhouse signed expressly provided: "[p]otential complications include perforation (a hole in the esophagus, stomach or small intestine[)], bleeding requiring transfusion, infection, drug reaction, the need for surgery, or death." (Ex. 1 at 36).
27. I find, therefore, that Mr. Woodhouse was informed, both orally and in writing, that there was a risk of perforation during the EGD and that his Zenker's diverticulum increased the risks. (II:29; Ex. 1 at 36).
28. The risk of perforation during a routine upper endoscopy is less than one percent, although as the condition becomes more and more advanced, the risk becomes higher. (III:13). The risk of perforation for a patient with Zenker's diverticulum is somewhere between three and five percent. (II:37).
29. Mr. Woodhouse testified that if he been advised that there was a risk of bleeding requiring a transfusion, or a possibility of a drug reaction, a possible need for surgery, or that the procedure could result in death, he "never" would have agreed to the procedure. (I:86). I find, however, that Mr. Woodhouse was appropriately advised and that he did consent to the procedure freely and voluntarily. In fact, as detailed below, he subsequently agreed to a much more invasive, surgical procedure, which was performed by Dr. Morse with similar warnings.
30. Dr. Satish Singh was assigned to perform the EGD on Mr. Woodhouse. (II:64-65). Dr. Singh graduated from Boston University medical school in 1987. He completed a three year residency at University of Rochester, Strong Memorial Hospital. He did a GI Fellowship at Yale University, Yale New Haven Hospital, and he is board certified in gastroenterology. (II:57-58). Prior to the day in question, Dr. Singh had performed hundreds of EGDs. (II:59-60).
31. Dr. Singh reviewed portions of Mr. Woodhouse's medical records prior to the procedure, including Dr. Goyal's notes. (II:42-43). He was aware that Mr. Woodhouse had a Zenker's diverticulum. (II:46). As ordered, by Dr. Goyal, Dr. Singh planned on doing an upper endoscopy and, if appropriate, an esophageal dilation. (II:43). The endoscopy would determine whether the dilation, which as detailed above included the passing of a wire into the stomach, could be performed, and whether there were other causes of the dysphagia. (II:44-45). The fact that Mr. Woodhouse had a Zenker's diverticulum put Dr. Singh "at high alert" and he knew that he should be "very careful" when introducing the scope. (II:46).
32. Mr. Woodhouse was consciously sedated, which meant that he could still interact with the doctor. (II:133). Under conscious sedation, the patient responds to both verbal stimuli and to touch. (III:10).
33. Dr. Singh first attempted to pass the 180 adult endoscope. (II:46). Normally, a physician puts the endoscope down the patient's throat right on the sphincter and asks the patient to swallow. With gentle pressure the endoscope can then be advanced into the esophagus. (II:134). This is a standard procedure which plaintiff's expert agrees has a very small risk of perforation. (I:44). Dr. Singh attempted this procedure three to five times, but was unsuccessful. (II:47). I find that Dr. Singh did not push the scope into the esophagus because of his concerns about the Zenker's diverticulum. (II:78-79). I also find ...