The opinion of the court was delivered by: Richard F. Cebull Senior U.S. District Judge
FINDINGS OF FACT, CONCLUSIONS OF LAW, AND ORDER
This matter came before the Court for trial without a jury on April 22 through 24, 2013. Plaintiffs Harold and Kathy Holtshouser were represented by Daniel B. Bidegaray. Defendant United States of America was represented by Assistant United States Attorney, Timothy J. Cavan.*fn1
Witnesses were sworn and testified, and certain exhibits were offered and received into evidence. From the evidence presented, the Court makes the following:
1. This is a negligence action brought by the plaintiffs pursuant to the Federal Tort Claims Act (FTCA), 28 U.S.C. § 2671, et seq. (Dkt. 1). Plaintiffs seek to recover damages from the United States based on medication filled and dispensed to Harold Holtshouser (Holtshouser) by the Department of Veterans Affairs (VA). Id.
2. Plaintiffs allege that the VA pharmacy negligently filled and dispensed prescriptions for a drug known as Metoclopramide, which caused an abnormal movement disorder, tardive dyskinesia. Plaintiffs also allege that it aggravated Holtshouser's Parkinson's symptoms. (Final Pretrial Order (FPTO) Nature of Action).
3. At the time this action was filed, Plaintiffs were residents of the State of Montana, and lived in the City of Livingston, Park County, Montana. (Dkt. 1, p. 2).
4. Plaintiffs Harold and Kathy Holtshouser submitted an administrative tort claim with the VA on May 11, 2010. The claim form listed both Harold and Kathy Holtshouser as claimants. The Court determined that the administrative tort claim form was sufficient for both claimants.
5. Harold Holtshouser was born on February 9, 1922. (FPTO, Agreed Fact (b)). He is a veteran of the U.S. Navy, and is eligible for VA healthcare benefits. Holtshouser obtained his primary medical care from the VA at the VA Bozeman Community Based Outpatient Clinic and the VA Medical Center in Fort Harrison, Montana.
6. During the time period from 2001 through 2008, Holtshouser received his primary medical care at a VA community outpatient clinic in Bozeman. His primary care provider during that period was a nurse practitioner, Shaunna Kersten.
7. The VA pharmacy filled prescriptions and dispensed Metoclopramide to Holtshouser at various times between May 15, 2001 and May 20, 2008.
8. Holtshouser suffered from a number of complicated medical conditions. Since 1975, he has had a 100% VA disability for chronic anxiety and depression. (Ex. 74, p. 34, Bates #255*fn2 ). Also, in addition to regularly being treated for a multitude of acute medical problems, he also suffered from a number of other chronic medical conditions, including Type II diabetes, hyperlipidemia, coronary artery disease with a history of myocardial infarction and angina, chronic low back pain with three prior lumbar surgeries, history of cor pulmonale, degenerative arthritis, mild dimentia, severe diabetic neuropathy, renal insufficiency, gastroeophageal reflux disease with diabetic gastroparesis, hypothyroidism, spinal stenosis, and a history of asbestosis. (Ex. 74, p. 95, #316).
9. Holtshouser also required many medications for his health problems, and was generally taking more than 20 medications on a daily basis during that time period. (See e.g., Ex. 74, p. 1017-18, #1238-39).
10. Prior to 2001, Holtshouser had a 20-25 year history of acid reflux symptoms. (Ex. 74, p. 854, #1075; p. 889, #1110). In 2001, however, his reflux symptoms became particularly severe. In fact, from April 2001 until October 2001, Holtshouser received and/or sought medical care from the VA or private health care providers for his reflux symptoms on 16 occasions. (Ex. 62, p. 1-9; Ex. 74, p. 849-895, #1070-1116).
11. In April 2001, he reported to the VA that he felt burning from his mouth to his stomach. (Ex. 74, p. 850, #1071). By May 3, 2001, he complained that his acid reflux symptoms had become "really bad." (Ex. 74, p. 853, #1074). He was nauseous, and had acid burning up to his throat and burning his lips. (Ex. 74, p. 854, #1075). Consequently, a esophagogastroduodenoscopy (EGD) was ordered to evaluate his upper gastrointestinal tract, which was scheduled with the VA surgical department on May 11, 2001. Nevertheless, he returned to the VA on May 8, 2001, and reported that he had constant burning and acid coming up into his mouth and burning his lips, and he felt he could not "take it" until his appointment. (Ex. 74, p. 863, #1084).
12. Holtshouser's EGD was performed on May 11, 2001, which did not reveal the cause of his symptoms. (Ex. 74, p. 868, #1089). Since first line therapies for acid reflux, such as H2 Blockers and PPI inhibitors, had not been effective in relieving his condition, the VA surgeon recommended that Holtshouser be put on Carafate and Reglan. (Ex. 74, p. 868, #1089). Reglan is the brand name for Metoclopramide, which is the medication at issue in this case. VA pharmacy records indicate that a prescription for Metoclopramide was issued by VA surgeon Michael Evans on May 15, 2001. (Ex. 74, p. 3610, #3835). The prescription was for 10mg, one tablet four times a day before meals and at bedtime. (Ex. 74, p. 4093, #5898).
13. It appears that Holtshouser did not immediately start the medication, and his severe reflux symptoms persisted. On May 17, 2001, he presented to the emergency room at the Livingston Memorial Hospital with complaints of continuing upper abdominal distress. (Ex. 67, p. 91). The emergency room physician noted that Holtshouser had not been on Reglan. Therefore, he also prescribed Reglan, 10mg before meals and at bedtime, and directed him to follow-up at the VA. (Ex. 67, p. 91).
14. When Holtshouser's severe reflux symptoms did not resolve (Ex. 74, p. 885-891, #1106-1112), he was referred by the VA to a private gastroenterologist, Timothy Johnson, M.D. Holtshouser saw Dr. Johnson on July 12, 2001, and advised Dr. Johnson that he had experienced some improvement on Metoclopramide. (Ex. 62, p. 9). Dr. Johnson, therefore, continued to prescribe Metoclopramide. (Ex. 62, p. 8). Dr. Johnson also performed a repeat EGD and colonoscopy on September 5, 2001, which was again largely unremarkable. (Ex. 62, p. 5-6).
15. While Dr. Johnson ultimately discontinued Holtshouser's Metoclopramide prescription, he also concluded that diabetic gastroparesis was contributing significantly to his reflux and regurgitation symptoms. (Ex. 62, p. 2, 7, 8). When he was unable to manage his symptoms from the condition, however, Dr. Johnson simply referred Holtshouser back to his primary care provider at the VA on September 21, 2001. (Ex. 62, p. 2).
16. Holtshouser was seen back at the VA by NP Kersten on October 2, 2002. He reported that his reflux symptoms were actually worse overall. He could not find anything to eat, he experienced burning all of the time, and had developed a hoarse voice. Like Dr. Johnson, NP Kersten believed that his symptoms were related to diabetic gastroparesis. (Ex. 74, p. 896, #1117). It is undisputed that Metoclopramide was an appropriate medication to treat diabetic gastroparesis and/or gastroesophageal reflux disease (GERD) in the time period from 2001 through 2008.
17. Due to the severity of Holtshouser's reflux complaints, and NP Kersten's conclusion that his symptoms were the result of diabetic gastroparesis, she continued Holtshouser's prescription for Metoclopramide. (Ex. 74, p. 895-96, #1116-17). The medication was ultimately effective in relieving Holtshouser's reflux symptoms. Holtshouser spent the winter of 2001 in Arizona, and did not complain of any reflux symptoms during his several visits to the VA in Prescott, Arizona. (Ex. 74, p. 3759-82, #5488-5511). He returned to the VA clinic in Bozeman on March 21, 2002, and reported at that time that his reflux symptoms were stable. (Ex. 74, p. 902, #1123).
18. Holtshouser's reflux symptoms remained stable during the periods he was on Metoclopramide for the next 6 years. His first prescription expired on May 9, 2002, and he was thereafter off the medication for one year, from May 2002 until May 2003. (Ex. 74, p. 3610, #3835). By May 2003, however, Holtshouser contacted the VA and again complained of "really bad acid reflux" to the extent that it was again burning his lips. (Ex. 74, p. 980, #1201). It was noted that the surgical department had previously recommended Carafate and Reglan for the condition. (Ex. 74, p. 980, #1201). NP Kersten recommended that these medications be renewed on a trial basis for one month. (Ex. 74, p. 982, #1203). Holtshouser's reflux was to be evaluated in a follow-up appointment in two weeks. (Ex. 74, p. 982, #1203).
19. Holtshouser returned for a follow-up on June 12, 2003, and reported that his reflux was better. (Ex. 74, p. 986, #1207). He was thereafter left on the medication until December 2004, during which time he had minimal complaints of acid reflux. (Ex. 74, p. 986-1165, #1207-1386).
20. Holtshouser was again off of the medication for approximately two years from December 2004 to November 2006. (Ex. 74, p. 3610, #3835). The medication was restarted in November 2006. While the circumstances of the second renewal are not clear from the record, NP Kersten testified that it was necessarily at the request of the patient. That is, in order for a medication to be renewed, there must be a request by the patient. (Kersten Dep. 174:2-29). Thereafter, Holtshouser's reflux remained under good control, without significant complaints.
21. In all, Holtshouser was prescribed the medication during three different periods from 2001 to 2008: May 2001 to June 2002; May 2003 to January 2005; and November 2006 to May 2008. (Ex. 74, p. 3610, #3835; p. 4093-4105, #5898-5910).
22. All of the Metoclopramide prescriptions were accurately filled and dispensed by the VA pharmacy, according to the prescriptions issued by VA health care providers licensed to prescribe the medication. (Testimony of Lori Fitzgerald).
23. The VA pharmacy is largely a mail-out operation. There is a pharmacy located at the Fort Harrison VA Medical Center, but it only dispenses medications for inpatient use at the medical center, or for veterans who obtain their prescriptions on-site. Prescriptions for all other VA patients around the state are mailed to the patient. (Testimony of Lori Fitzgerald).
24. Once a prescription is issued by a physician, it is entered into the VA electronic system. A VA pharmacist will review the prescription and request that it be filled at a centralized VA dispensary in Kansas. The medication is then mailed by the ...