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Flores v. United States

United States District Court, S.D. California

June 30, 2017

MARIA FLORES, by and through her guardian, Josie Clark, Plaintiff,
v.
THE UNITED STATES OF AMERICA, Defendant.

          FINDINGS OF FACT AND CONCLUSIONS OF LAW FOLLOWING BENCH TRIAL

          Hon. Gonzalo P. Curiel United States District Judge

         Maria Flores, by and through her guardian Josie Clark (“Plaintiff”), brings this action against Defendant United States of America (“Defendant” or “the Government”) for injuries sustained due to an “overdose” of rivastigmine, (also known as the “Exelon Patch, ” “the Patch, ” or “Exelon”) a transdermal medication, that occurred at the San Ysidro Health Center (“SYHC” or “the Center”) located in San Diego County. Pl.'s Trial Brief, Dkt. No. 36 at 1-2. Plaintiff asserts that the nursing staff at SYHC committed medical negligence when they applied an Exelon Patch to Flores without removing a prior patch, thereby causing the “overdose.” Id. The Court held a bench trial on June 5- 7, 2017.[1] Alvin M. Gomez appeared on behalf of Plaintiff and Steve B. Chu and Glen Dorgan appeared on behalf of Defendant. Having carefully reviewed the evidence and the arguments of the parties, as presented at trial, and in their written submissions, the Court makes the following findings of fact and conclusions of law pursuant to Rule 52 of the Federal Rules of Civil Procedure.

         FINDINGS OF FACT

         A. The Parties

         The San Ysidro Health Center is an adult daycare center for patients who require assistance with basic activities of daily living. The Center takes care of participants Monday through Friday from approximately 8:00 am to 5:00 pm and, depending on enrollment, can have up to one hundred individuals in attendance on a weekly basis. SYHC employs a number of registered nurses, social workers, and other individuals who together form a care team to watch over the Center's participants.

         Maria Flores, born January 8, 1934, was living with her daughters, Josie Clark and Leticia Reynoso (“daughters”), prior to her enrollment at San Ysidro Health Center. Plaintiff moved in with her daughters, who alternated handling her care, in 2012 because she could no longer take care of herself. She was experiencing memory problems and would get confused easily. It was difficult for her to follow a conversation. While living with her daughters, Flores began wandering out of the house, into the street. To prevent any harm resulting from such behavior, the daughters placed deadbolts on their homes to ensure their mother would not leave when she was not being watched over.

         Sometime between the late summer and fall of 2013, the daughters decided to enroll their mother in a caregiver program. They looked at three different centers before deciding on SYHC. They settled on SYHC because it had Spanish-speaking staff, as Plaintiff only spoke Spanish, had activities for the enrollees, and was close to Reynoso's place of work. Soon thereafter, Flores was accepted into the SYHC program. Flores attended the program Monday through Friday for at least four hours per day. A bus went to the homes of the daughters to retrieve Flores in the morning and afternoon, as she was no longer driving in 2013.

         B. Flores' Medical Background

         Dr. Michael Lobatz, an expert in neurology, testified that the first mention of Alzheimer's in Flores' medical records appeared on April 29, 2011. Flores had visited her primary care physician, Dr. Sharna Shachar, with her son who told the doctor that his mother had short-term memory loss, was sleeping more, was getting frustrated and forgetful, and had become slightly paranoid and accusatory. Dr. Shachar diagnosed Flores with dementia and prescribed her donepezil to ameliorate the symptoms.

         About two years later, Flores saw Dr. Roberto Gratianne, a neurologist, on February 18, 2013. Joint Exhibit 17-024. Dr. Gratianne's medical records indicate that Flores presented herself to him for an evaluation of her memory loss. At that time, she had a history of progressive dementia that had started back in 2008 and that had been diagnosed in 2010. She required constant supervision and help with self-care. Dr. Gratianne's contemporaneous records also indicate that Flores was exhibiting behavioral problems as she thought her son was her husband. In fact and according to Dr. Lobatz, Flores' primary care physician, Dr. Shachar, had prescribed Flores an antipsychiatric tranquilizer, called risperdal, at around the time she began to see Dr. Gratianne.

         Dr. Lobatz testified that Dr. Gratianne performed a standard cognitive evaluation of Flores called the Mini Mental Status Examination (“MMSE”). The MMSE has a total score of 30 points. Achieving 26 points or greater would be expected for a normally educated individual. Twenty to 26 points would be indicative of mild cognitive changes and 10 to 20 points would be indicative of moderate changes. Below 10 points indicates a severe condition. The MMSE, however, does not test behavioral symptoms. Dr. Lobatz testified that in individual with mild memory loss, but very bad behavior associated with cognitive degeneration, would have a severe, not a mild case.

         Flores scored a 13 out of 30 on the MMSE administered by Dr. Gratianne on February 18, 2013. She scored a 12 out of 30 on the MMSE administered by Dr. Gratianne on April 24, 2013. Dr. Lobatz testified that the results of the April examination alone, and not including any behavioral symptoms, indicated that Flores had significant moderate dementia approaching severe. A third MMSE was administered to Flores by Dr. Gratianne in July 2013. She scored an 11 out of 30 on that test. According to Dr. Lobatz, that the July score was similar to the April score validated the abnormalities recorded by the April MMSE.

         Dr. Gratianne diagnosed Flores with Alzheimer's at her February 2013 appointment. He subsequently examined her in April 2013, June 2013, July 2013, August 2013, November 2013, and on January 4, 2014. According to Dr. Gratianne's November 2013 records, Flores was not doing well. She had worsening balance, gait and mental status. She was also having occasional hallucinations. According to Dr. Gratinanne's January 4, 2014 records, Flores arrived in a wheelchair and needed total care and constant supervision at that time.

         SYHC also assessed Flores at the time of her enrollment. Dr. Lobatz testified that SYHC performed a somewhat similar test called the SLUMS (St. Louis University Mental Status Examination). Dr. Lobatz testified that the SLUMS is more sensitive to milder forms of early dementia, but that once an individual has more severe symptoms, the SLUMS and MMSE start approaching one another in terms of their sensitivity. On average, Dr. Lobatz testified, a SLUMS score is about 4.5 points less than a MMSE score. Staff at SYHC performed a SLUMS on Flores on September 25, 2013. Joint Exhibit 15-140. She scored 4 out of 30 points on the examination, which, Dr. Lobatz testified, is roughly equivalent to a score of 8.5 on the MMSE.

         Given her MMSE and SLUMS scores, Dr. Lobatz testified that as of September 2013, Flores was at the 8-to-10 level of the MMSE. Dr. Lobatz testified that in September 2013 Flores' Alzheimer's disease was very severe.

         C. The Exelon Patch

         On November 21, 2013, Dr. Roberto Gratianne prescribed Flores Exelon, or rivastigmine, at a dosage of 4.6 mg/24 hours to aid with her Alzheimer's symptoms. Joint Exhibit 7-001.[2] According to SYHC's records, Flores began taking Exelon on December 5, 2013. Joint Exhibit 4-002.

         Dr. Lobatz testified that Exelon ameliorates Alzheimer's symptoms by enhancing short term memory. Acetylcholine is a neurotransmitter that is correlated with short term memory. The more acetylcholine present in the brain, the better one's memory. Dr. Lobatz testified that as acetylcholine levels drop in Alzheimer's disease, memory worsens gradually. Accordingly, Dr. Lobatz testified, one strategy for treating Alzheimer's disease is to prescribe a medication that increases the acetylcholine level within the brain. Acetylcholine is broken down by an enzyme that naturally occurs in the brain called cholinesterase. As such, to increase acetylcholine levels to help memory, doctors prescribe cholinesterase inhibitors, which prevent the acetyl cholinesterase enzyme from breaking down acetylcholine. Rivastigmine is a cholinesterase inhibitor. The drug was first developed as an oral medication and later developed as a transdermal patch.

         Dr. Lobatz testified that the Exelon Patch is dosed initially at 4.6 mg per 24 hours. When an Alzheimer patient begins therapy, he or she starts at the lowest possible dose, which is 4.6 mg per 24 hours. If the individual is tolerating the medication, the effective dose is increased to 9.5 mg per 24 hours. Dr. Lobatz testified that there was nothing in Flores' medical records prior to January 7, 2014 to indicate that Flores was not tolerating the medication.

         Dr. Richard Clark, an expert in toxicology, testified that the Exelon Patch is similar to a small Band-Aid that has a reservoir of the drug impregnated within it. The drug diffuses into the skin surface and then into the fat level right below the skin. As the drug diffuses into the fat, it is slowly absorbed by the blood vessels travelling through the skin, which then distribute the drug throughout the body. The Patch dispenses the drug throughout the 24 hours that it is applied.

         D. Date of Incident

         SYHC's medical records indicate that, as of January 7, 2014, Flores was taking two oral medications per day: Namenda for her dementia and Citalopram, an antidepressant. Those records also indicate that Flores was contemporaneously receiving rivastigmine through the Exelon Patch once per day. SYHC was responsible for applying the Patch and administering her other medications, Monday through Friday. Over the weekends, the daughters would administer their mother's medication, including the transdermal Exelon Patch.

         On Tuesday, January 7, 2014, Flores arrived at the Center. Flores used a walker at the Center to assist her with ambulating. Registered nurses Alejandro Florez, Shirley Roman, and Claudia Gonzalez were all present at SYHC that morning. Absent from the roster was Yessica Toscano, the individual who dispenses medication to the Center's participants on a daily basis. Because Toscano was not working that day, the other floor nurses, Florez, Roman, and Gonzalez, were responsible for performing Toscano's duties. According to Flores' Medication Administration Record, Flores received the Exelon Patch at 10:00 am each morning. Joint Exhibit 15-074.

         The floor nurses had trouble locating the bottle containing Flores' Citalopram medication on the morning of January 7, 2014. As a result, Gonzalez called Clark at 10:21 am to report that staff could not find Flores' medication and that the daughters needed to bring some. Joint Trial Exhibit 19-001. A few minutes afterwards, at 10:28 am, Clark called Reynoso, her sister, about the missing medication.

         Following the report about Flores' medication, Reynoso headed to the Center and arrived late morning, before noon. Reynoso recalls that she arrived at the Center before noon because she was late to go on a lunch date with her husband, which they had scheduled around noon. When she arrived at the facility, the staff told her that they had already found Flores' medication and already administered it to her.[3] While at the Center, Reynoso observed that her mom was “restrained” in a seated position and that she did not have her walker. Seeing her mother in this state upset Reynoso. She found another walker somewhere in the facility, unbuckled her mom, and watched her for a while. Sometime thereafter she left to have lunch with her husband at IHOP.

         Roman had administered Flores' medication that day. Roman first gave Flores her Namenda. Next, she turned to Flores' transdermal medication. Roman consulted Flores' Medical Administrative Record, Joint Exhibit 15-074, to determine where Gonzalez had administered Flores' Exelon Patch the previous day. As Roman tried to administer the medication to Flores' back, Flores tried to hit Roman with her elbows. She had become agitated after taking the Namenda. Roman did not visualize Flores' skin before removing and placing the new Exelon Patch. Instead, she used her hands to feel for the previous day's patch. Roman testified that she removed a patch from Flores' right upper back. She placed the old patch on her glove and noticed that there was a long white hair on it. She testified that she specifically recalls removing a patch because she felt bad because she thought she had pulled a hair from Flores' head.

         Roman testified at her deposition that she administered Flores her medications soon after 11:00 am. At trial, however, Roman testified that she gave Flores her medication closer to 1:00 pm than 12:00 pm. She stated that only fifteen or so minutes had passed between the time that she administered Flores her medication and the time that Flores began vomiting, which was between 1:00 pm and 1:15 pm, approximately. Roman states that she recalls that the vomiting began fifteen minutes after she administered Flores' medication because she had specifically thought that Flores must have been throwing up the oral medication. The Court, however, finds that Roman's deposition testimony is more credible than her trial testimony given that it was taken closer in time to the incident - that is, on February 19, 2016, more than fifteen months prior to her trial testimony - and because it coincides with the testimony provided by Reynoso, which indicated that Flores had received her medication prior to noon. Accordingly, the Court finds that Flores received her prescribed dose of Exelon at approximately 11:00 am.

         Sometime thereafter, at around 1:00 pm, Flores became nauseous and began to vomit. Before 1:00 pm, Gonzalez had noticed that Flores appeared pale, cold, and clammy. Around 1:00 pm, Gonzalez realized that Flores was not well. Gonzalez observed Flores sitting in a chair with vomit in her lap. Gonzalez instructed a Certified Nursing Assistant (CNA) to get the vital machine to check Flores. Once the CNA returned with the vital machine, Gonzalez began to measure her signs. Gonzalez observed that Flores was conscious but that she had begun to slouch on the side of her chair. She noticed that Flores was sweating and that she had stopped vomiting. When Gonzalez could not pick up a pulse anymore, she asked the CNA to call “Code Blue.”

         According to the Comprehensive Report of the Paramedics, they received a call at 1:20 pm for a patient in cardiac arrest and they arrived at 1:23 pm. Joint Exhibit 9. Upon arrival at the Center, the paramedics found Flores laying on the floor on her back. The paramedics reported that Flores was nonresponsive, cold, pale and dry. Flores was PEA, meaning she had pulseless electrical activity. She was also suffering from bradycardia, a slow heart rate, as her heart was beating at 30 bpm (beats per minute). The paramedics proceeded to perform CPR. Flores remained PEA until she was intubated. Dr. Barnard testified that Flores had, indeed, experienced cardiac arrest given that she required resuscitation to regain her vital signs.

         Once Flores was intubated, her heart rate increased from 30 bpm to 132 bpm. The patient remained intubated and unresponsive en route to the hospital. Both of Flores' daughters, along with Flores' granddaughter Yolanda Clark, were onsite while the paramedics were present. They had arrived after 9-1-1 was called. Josie Clark testified that when she arrived at the Center she observed vomit everywhere and that her mother was on her back.

         Flores was taken to Sharp Chula Vista Hospital for treatment. Joint Exhibit 13-259 - 13-511. While at the hospital and after discussing Flores' DNR (Do Not Resuscitate) status, the daughters decided to remove their mother's breathing tube, believing that she would die. Joint Exhibit 13-260. Flores' other children were present at her bedside because the daughters had called to inform them of their mother's state. Hospital staff removed Flores' breathing tubes. Flores started gasping and made an unexpected recovery. Dr. Robert Clark, the Government's expert in toxicology, reviewed the ...


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