[Cite as Ellahi v. Ohio Dept. of Mental Retardation & Dev. Disabilities, 2012-Ohio-1243.]




                                                         Court of Claims of Ohio
                                                                                        The Ohio Judicial Center
                                                                                65 South Front Street, Third Floor
                                                                                           Columbus, OH 43215
                                                                                 614.387.9800 or 1.800.824.8263
                                                                                            www.cco.state.oh.us



FRANKIE ELLAHI, Admx.

        Plaintiff

        v.

OHIO DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL
DISABILITIES

        Defendant

Case No. 2009-08268

Judge Joseph T. Clark

DECISION

        {¶1} Plaintiff, Frankie Ellahi, administrator of the estate of Michael Hornung,
brought this action alleging wrongful death and medical negligence. The case was tried
to the court on the issues of both liability and damages.
        {¶2} Plaintiff’s decedent1 was a resident at the Montgomery Developmental
Center (MDC) from September 23, 2002 until his death on October 17, 2008.
Defendant owns and operates MDC, a facility that provides residential care and
treatment for the mentally disabled.
        {¶3} Michael was born in 1983 to parents who were mentally retarded. Tests
showed that Michael had an IQ of 40, meaning that he was substantially mentally
retarded as well. Plaintiff, Michael’s grandmother, was granted custody of Michael and
raised him until he was 18 years old. In addition to mental retardation, Michael suffered
from behavioral disorders which caused him to act aggressively at times.                                       At


        1
         Michael Hornung shall be referred to as “Michael” throughout this decision.
Case No. 2009-08268                             -2-                                     DECISION

approximately age 18, Michael was placed in a supported living program through the
Butler County Board of Mental Retardation and Developmental Disabilities (MRDD).
During the time that Michael was residing in a group home, he was sexually abused by
a home health aide.          Michael was traumatized by the abuse: he became more
aggressive and began harming himself which led to his hospitalization on several
occasions. In 2002, Michael was placed at MDC.
       {¶4} Michael continued to exhibit signs of aggression at MDC, striking out both at
staff and at other residents.        Michael also tried to escape from MDC on multiple
occasions.     Beginning in 2003, Michael began treating with Dr. Sanders, the staff
psychiatrist at MDC.2 Dr. Sanders examined each patient at MDC at least once per
year. Dr. Sanders also conducted quarterly medication reviews with MDC staff during
which time each patient’s medication regimen was evaluated. MDC patients did not
attend the medication reviews.
       {¶5} Dr. Sanders was Michael’s psychiatrist at MDC from 2003 to 2008. During
that time, Dr. Sanders diagnosed Michael with moderate mental retardation, disruptive
behavior disorder, and “rule out post traumatic stress disorder.” Dr. Sanders prescribed
olanzapine, also known as Zyprexa, a drug which is FDA-approved to treat
schizophrenia and other psychotic disorders.              The FDA-recommended dosage of
olanzapine is 20 milligrams per day.
       {¶6} As of October 17, 2008, Dr. Sanders had prescribed the following
psychiatric medication to treat Michael’s condition: 40 milligrams of olanzapine, 20
milligrams of Haldol, and 1500 milligrams of Depakote per day.
       {¶7} On the morning of October 17, 2008, Michael was found unresponsive in his
bed. CPR was initiated but was not successful. An autopsy was performed by the


       2
        The parties stipulate that Dr. Sanders was an employee of defendant as those terms are used in
R.C. 2743.02 and 109.36(A)(1)(b).
Case No. 2009-08268                        -3-                                DECISION

Montgomery County Coroner’s office.        The cause of death was stated as: “gastric
material aspiration due to olanzapine intoxication.”
       {¶8} Plaintiff asserts that defendant was negligent when it prescribed olanzapine
in a manner that was “off-label,” meaning that it was prescribed in a dosage that
exceeded the FDA recommend dosage, and that olanzapine was not specifically
recommended to treat Michael’s condition. Plaintiff further asserts that defendant was
negligent when Dr. Sanders failed to develop a proper care plan for Michael to prevent
olanzapine intoxication, including the failure to monitor Michael for signs of such
intoxication. Plaintiff also asserts that defendant’s nursing staff was negligent when it
failed to perform 15-minute bed checks on Michael as required per its own policy.
       {¶9} Defendant admits that its staff failed to “bed check” Michael on the morning
of October 17, 2008, from 12:00 a.m. to 2:00 a.m. However, defendant contends that
neither the administration of olanzapine to Michael nor its failure to check on him for two
hours proximately caused his death.
       {¶10} “To maintain a wrongful death action on a theory of negligence, a plaintiff
must show (1) the existence of a duty owing to plaintiff’s decedent, (2) a breach of that
duty, and (3) proximate causation between the breach of duty and the death.” Littleton
v. Good Samaritan Hosp. & Health Ctr., 39 Ohio St.3d 86, 92 (1988), citing Bennison v.
Stillpass Transit Co., 5 Ohio St.2d 122 (1966), paragraph one of the syllabus.
       {¶11} In order to establish medical malpractice, it must be shown by a
preponderance of evidence that the injury complained of was caused by the doing of
some particular thing or things that a physician or surgeon of ordinary skill, care and
diligence would not have done under like or similar conditions or circumstances, or by
the failure or omission to do some particular thing or things that such a physician or
surgeon would have done under like or similar conditions and circumstances, and that
the injury complained of was the direct and proximate result of such doing or failing to
Case No. 2009-08268                        -4-                                DECISION

do some one or more of such particular things. Bruni v. Tatsumi, 46 Ohio St.2d 127
(1976), paragraph one of the syllabus.
       {¶12} It is well-established that “[t]he coroner’s factual determinations concerning
the manner, mode and cause of death, as expressed in the coroner’s report and the
death certificate, create a nonbinding rebuttable presumption concerning such facts in
the absence of competent, credible evidence to the contrary. (R.C. 313.19, construed.)”
Vargo v. Travelers Ins. Co., 34 Ohio St.3d 27 (1987), paragraph one of the syllabus.
      {¶13} Kent Harshbarger, M.D., J.D., deputy coroner for Montgomery County,
testified that he performed the autopsy on Michael and opined that the cause of death
was gastric material aspiration due to olanzapine intoxication.          Dr. Harshbarger
explained that normally, if an individual vomits in his sleep, he wakes up. However, Dr.
Harshbarger opined that Michael did not wake up because the sedating effect of the
medication that he was taking prevented him from doing so. Thus, Michael aspirated
gastric material into his lungs and then died. Dr. Harshbarger explained that when he
performed the autopsy, he obtained blood samples from both the femoral artery and the
liver, and that the samples showed that Michael had a “toxic” level of olanzapine in his
bloodstream. Dr. Harshbarger also stated that plaintiff may have suffered a seizure
before his death, but that there was no way to state with certainty from an autopsy
whether a seizure occurred.
      {¶14} On cross-examination, Dr. Harshbarger testified that he does not prescribe
medications in his practice; that this case was the first time that he had cited olanzapine
intoxication as a cause of death; and that he had to consult medical literature to make a
finding that the level of olanzapine found in Michael’s bloodstream was toxic.         Dr.
Harshbarger noted that in his search of the literature, he found that some individuals
who had much higher levels of olanzapine in their blood than Michael did had survived.
However, Dr. Harshbarger also stated that the level of olanzapine in Michael’s
bloodstream was hundreds of times higher than therapeutic levels.
Case No. 2009-08268                        -5-                               DECISION

      {¶15} Plaintiff testified that she visited Michael one time at MDC during his 6
years of residency there, and that she did not visit him more frequently due to her ill
health and inability to afford transportation to and from MDC. According to plaintiff, she
did, however, speak to Michael two to three times per week over the telephone. Plaintiff
testified that at times during her telephone conversations with Michael she felt that he
was “over-medicated” because he mumbled his words.
      {¶16} Robin Lindsly and Rae Jean Williams, both of whom were aunts of Michael,
testified that they also spoke to Michael on occasion when plaintiff called him. Williams
also testified that at times Michael sounded “groggy” to her.
      {¶17} Debra Leger testified that she worked the 2:15 to 10:45 p.m. shift 5 days
per week as a Therapeutic Program Worker (TPW) at MDC, that she was Michael’s
primary care giver, and that Michael was like “family” to her. Leger described Michael
as higher functioning than some of the other residents, that he liked music, that he liked
to help with cleaning and other chores, that he got along well with the other residents
and that he liked the staff. Leger acknowledged that Michael had impulsive behavior
and would sometimes hit people. Leger stated that she never witnessed Michael being
“overly tired” unless he was ill. According to Leger, during the week before Michael’s
death, he was his normal, “happy-go-lucky” self.        Leger described the evening of
Michael’s death as follows: that he helped with dinner, then took a shower, then at
approximately 7 or 7:30 p.m. he went to his room to listen to music. Leger stated that
she checked on him at 10:15 p.m. before she left for home and that he was sleeping at
that time. Leger stated that when she was informed of Michael’s death the following
day, she was “shocked.”
      {¶18} Stephanie Johnson testified that she had been a TPW at MDC since 2005;
that Michael was more independent than other residents; that during the week before he
died, Michael was in a happy mood; and that during her last check of his room before
Case No. 2009-08268                         -6-                                DECISION

she left work on October 17, 2008, Michael was in his bed masturbating. Johnson
stated that when she learned that Michael had died she was “dumbfounded.”
       {¶19} Richard Sanders, M.D., testified that he has been both licensed to practice
medicine in Ohio and board-certified in general psychiatry since 1994. Dr. Sanders
explained that MDC cares for patients with an IQ of less than 50 who have behavior
problems that make them unmanageable in other places. Per his contract, Dr. Sanders
worked at MDC approximately two days per week. Dr. Sanders explained that the
TPWs work directly with the residents, and that they make direct, anecdotal
observations that are recorded on a shift summary basis. Dr. Sanders noted that MDC
also employs nurses and a full-time primary care physician.
       {¶20} With regard to medications, Dr. Sanders stated that when a patient arrives
at MDC, he initially examines the list of medications that a patient is taking and begins a
process of elimination to see whether the medications and their dosage levels are
effective and appropriate. Dr. Sanders explained that he performs an annual psychiatric
evaluation for each patient at least one time per year, during which time he observes
the patient, interviews the patient if he is verbal, and talks to the direct care workers to
obtain their impressions of the patient. Dr. Sanders testified that when Michael was
admitted to MDC, he was taking a variety of medications including olanzapine, Haldol,
and Depakote. Dr. Sanders tried to vary the dosages and types of medications for
Michael, but he was eventually placed on tranquilizers to try to improve his behavior.
       {¶21} Dr. Sanders explained that with MRDD patients, making a firm diagnosis of
their condition is difficult.   Dr. Sanders diagnosed Michael with “disruptive behavior
disorder, unspecified.”     Dr. Sanders added that once a patient is diagnosed, a
psychiatrist then tries to find medications to help with that disorder. When Michael
arrived at MDC, he was taking 30 milligrams per day of olanzapine. From December
2003 to May 2007, Michael was prescribed 40 milligrams per day of olanzapine. In May
2007, Dr. Sanders lowered Michael’s dosage of olanzapine to 20 milligrams per day
Case No. 2009-08268                          -7-                                 DECISION

because Michael was suffering from tremor. Dr. Sanders explained that he had hoped
to replace olanzapine with Seroquel, another anti-psychotic drug. However, after two
and a half months, the tremor did not improve, and Michael broke his toe in a fit of rage.
Dr. Sanders reasoned that a reduction in olanzapine resulted in more agitation, so he
then prescribed olanzapine at 40 milligrams per day from July 2007 through October
2008.
        {¶22} Dr. Sanders described “off-label” as prescribing medications for indications
not specified in the Physicians’ Desk Reference, which is approved by the FDA. Dr.
Sanders stated that it is within the standard of care to prescribe drugs off-label when
nothing else is working for the patient. Dr. Sanders added that there was no medication
that was FDA approved to specifically treat aggression in a mentally retarded adult with
disruptive behavior disorder.
        {¶23} According to Dr. Sanders’ notes, in 2007 during his annual exam, Michael
was angry during his interview, asking questions such as “[w]ho are you and what are
you doing?” In his 2008 interview, Dr. Sanders testified that Michael gave perfunctory
responses to his questions, but Dr. Sanders added that he did not perceive Michael to
be overly-tired or overly-medicated.
        {¶24} On cross-examination, Dr. Sanders testified that 20 milligrams per day is
the recommended dose of olanzapine; that side effects of olanzapine include
drowsiness and sedation; that Haldol can also cause drowsiness and sedation; that
Michael was on more than one anti-psychotic drug; and that Dr. Sanders was
dissatisfied with the efficacy of Michael’s medications.
        {¶25} Plaintiff’s expert, Robert P. Granacher, Jr., M.D., M.B.A., testified that he is
board certified in general, geriatric, and forensic psychiatry, neuropsychiatry, and
clinical psychopharmacology. Dr. Granacher stated that he prescribes anti-psychotic
medication such as olanzapine and Haldol, and anti-epilepsy drugs such as Depakote.
Case No. 2009-08268                       -8-                               DECISION

       {¶26} Dr. Granacher testified that in comparing Michael’s annual exam from 2007
to 2008, Michael had become much “quieter.” According to Dr. Granacher, Michael did
not talk as much, was not as alert, and seemed more sedated and lethargic in 2008.
Dr. Granacher’s basis for this conclusion was that Dr. Sanders used the term “minimally
responsive” when he described Michael in the 2008 evaluation.
       {¶27} Dr. Granacher explained that olanzapine is prescribed to treat two types of
psychosis: bipolar illness and schizophrenia. However, Michael was not diagnosed with
either disorder. Dr. Granacher stated that the risk of aspiration increases with anti-
psychotic drugs because they affect the ability to swallow and cough, and they also
increase the risk of seizures.
       {¶28} Dr. Granacher opined that one of three things happened to Michael: 1) that
excess sedation which was caused by the medications that he was prescribed produced
obstructive sleep apnea, resulting in the loss of Michael’s airway; 2) that Michael’s
peptic ulcer disease was aggravated by the high doses of medication, which in turn
caused him to vomit, aspirate his vomit and die of respiratory failure; or 3) that the
drugs that he was prescribed caused a cardiac arrhythmia, which resulted in ventricular
tachycardia, which led to Michael vomiting and then aspirating vomit into his lungs. In
Dr. Granacher’s opinion, Michael was too sedated to wake up when he vomited due to
olanzapine intoxication. Dr. Granacher explained that medical literature states that a
toxic blood level of olanzapine is above 160 nanograms per milliliter, and that the
coroner found that Michael had 440 nanograms per milliliter in one area of his body and
280 nanograms per milliliter in another area. Dr. Granacher described the lethal blood
level of olanzapine as between 240 and 5000 nanograms per milliliter.
       {¶29} Dr. Granacher opined that Dr. Sanders’ prescription of 40 milligrams of
olanzapine, 20 milligrams of Haldol, and 1500 milligrams of Depakote per day was not
within the standard of care. Dr. Granacher explained that it is within the standard of
care to prescribe a drug off-label but that the dosage level of twice the recommended
Case No. 2009-08268                          -9-                                  DECISION

dosage was not within the standard of care.          Dr. Granacher further stated that Dr.
Sanders did not meet the standard of care when he prescribed excessive doses of
drugs in a medically incompetent patient. Dr. Granacher stated that it is “obvious” that
the excessive dosage of medication caused Michael to be unable to protect his airway.
Dr. Granacher further stated that the clinical signs of olanzapine intoxication were the
variances in Michael’s appearance between the 2007 annual review and the 2008
annual review. However, Dr. Granacher noted that an individual can be intoxicated
from olanzapine without showing any signs or symptoms.
       {¶30} Dr. Granacher stated that Dr. Sanders should have sent Michael for further
medical testing, including seeing a sleep specialist. Dr. Granacher also stated that Dr.
Sanders should have sent Michael’s blood for testing to see if there were excessive
levels of olanzapine. On cross-examination, Dr. Granacher stated that this was the first
case in which he had testified regarding a death caused by olanzapine.
       {¶31} Defendant’s expert, Heath Jolliff, D.O., testified that he was board-certified
in emergency medicine and medical toxicology. Dr. Jolliff is employed by the Adena
Medical Center in Chillicothe, Ohio and by the Central Ohio Poison Center at Children’s
Hospital in Columbus, Ohio. Dr. Jolliff also maintains a full-time medical toxicology
practice where he treats patients in various hospitals in Columbus. Dr. Jolliff stated that
he prescribes medications such as olanzapine and Haldol.
       {¶32} In regard to his work for this case, Dr. Jolliff stated that he performed a
literature search regarding toxicity of olanzapine and found 51 articles about it
worldwide. Dr. Jolliff stated that he found a case study of an individual who had died
solely of olanzapine overdose and that the level of olanzapine in that individual’s
bloodstream was twice the level that was found in Michael’s bloodstream.
       {¶33} Dr. Jolliff opined that Michael did not die as the result of olanzapine toxicity.
Dr. Jolliff stated that when a patient is suffering from toxicity from a drug, the patient will
show an elevated level of that drug in the bloodstream as well as signs or symptoms of
Case No. 2009-08268                        - 10 -                              DECISION

impairment. Upon review of Michael’s documented daily activities in the week before
his death, Dr. Jolliff noted that the TPW notes did not show any evidence of lethargy or
sedation.   Dr. Jolliff also opined that Dr. Sanders’ use of the off-label dosage of
olanzapine was within the standard of care for a patient such as Michael. Dr. Jolliff
noted that there have been studies with individuals who have been prescribed 80
milligrams of olanzapine per day, and that he has treated patients who had been
prescribed higher daily doses of olanzapine than Michael had been prescribed. Dr.
Jolliff further opined that olanzapine did not contribute to Michael’s death but rather that
the proximate cause of his death was gastric content aspiration. Dr. Jolliff also opined
that the medical literature does not support the theory that olanzapine toxicity was a
proximate cause of Michael’s death.       Dr. Jolliff explained that post-mortem levels of
drugs in the bloodstream are always higher than ante-mortem levels. Dr. Jolliff opined
that the high level of olanzapine that was identified in Michael’s bloodstream was the
result of post-mortem redistribution, which he described as a phenomenon whereby a
medication that has been prescribed to a patient over a long period of time begins to
store itself in areas of the body, and that upon death, those drugs “leak” into the
bloodstream, resulting in a toxic medication level.           Dr. Jolliff added that the
administration of CPR can also increase the level of medication found in the
bloodstream. Dr. Jolliff opined that the more probable explanation for Michael’s death
was that he suffered a seizure, which led to aspiration.
       {¶34} On cross-examination, Dr. Jolliff stated that he was not qualified to opine
on the psychiatric standard of care; his opinions relate solely to the cause of Michael’s
death. However, he added that he is qualified to testify as an expert with regard to drug
dosing. Dr. Jolliff agreed that sedation can be a reason for not waking up once a
person starts to vomit.
       {¶35} The court allowed the record to be held open for plaintiff to submit the
testimony of Stephen R. Payne, M.D., as a rebuttal witness with regard to whether
Case No. 2009-08268                           - 11 -                                  DECISION

Michael had suffered a seizure shortly before his death.3 Dr. Payne testified that he is a
primary care internist who cares for adult patients. Dr. Payne opined that he did not
believe that Michael suffered a seizure shortly before his death because there was no
physical evidence, such as lacerations of the tongue from biting, consistent with a
seizure. Dr. Payne further stated that Michael was also taking what he considered to be
a therapeutic dose of anti-convulsant medication at the time of his death. Lastly, the
very high level of olanzapine that was found in Michael’s bloodstream and his liver
during the autopsy caused Dr. Payne to believe that the chance of Michael suffering
from a seizure that caused aspiration was unlikely.
      {¶36} On cross-examination, Dr. Payne stated that any patient of his who has
seizures is referred by him to a neurologist to treat seizures, and that he does not
prescribe olanzapine, Haldol, or Depakote in his practice.
      {¶37} Upon review of the evidence, the court finds that plaintiff has failed to prove
that defendant breached the standard of care. Plaintiff’s expert, Dr. Granacher, was not
particularly persuasive to the court. Specifically, Dr. Granacher’s testimony that Michael
was lethargic, sedated, and minimally responsive in a general sense is not supported by
the evidence. Although Dr. Sanders used the phrase “minimally responsive” to describe
Michael’s responses to his questions during his 2008 annual review, the court finds that
Michael led an active life immediately prior to his death. Indeed, the court finds that the
testimony of the TPWs, who interacted with Michael on a daily basis, was credible as to
Michael’s activity level prior to his death. The greater weight of the evidence shows that
Michael was able to help perform chores and that he had been active in the days prior
to his death, in stark contrast to Dr. Granacher’s depiction of him as being sedated and
showing objective signs of olanzapine intoxication.



      3
       Upon review of the deposition of Dr. Payne, all objections contained therein are OVERRULED.
Case No. 2009-08268                          - 12 -                               DECISION

         {¶38} Furthermore, the court finds that Dr. Sanders met the standard of care
when he prescribed olanzapine “off-label.” The court finds that Dr. Sanders evaluated
Michael’s medication regimen during quarterly reviews after carefully balancing the risk
of his aggressive behavior and the side effects of the medications. The medical records
show that Michael was prescribed a static dose of olanzapine, 40 milligrams per day,
from July 2007 through October 2008, and that the 40 milligram dosage improved his
violent behavior.    The greater weight of the evidence shows that Michael tolerated
olanzapine well and that he did not show objective signs or symptoms of olanzapine
intoxication. It is difficult for the court to believe that the prescription of a static dose of
olanzapine for approximately 15 months proximately caused Michael’s death. The court
finds that Dr. Jolliff’s opinion that Michael’s death was most likely caused by a seizure
was more credible than Dr. Granacher’s testimony regarding the cause of Michael’s
death.     Moreover, the court finds that Dr. Payne’s testimony was not particularly
persuasive.     Therefore, the court cannot find that either Dr. Sanders or any of
defendant’s other employees failed to meet the standard of care in this case.
         {¶39} Defendant admits that its staff failed to “bed check” Michael on the evening
of October 17, 2008 from 12:00 a.m. to 2:00 a.m., which was a violation of its policy to
check on patients every 15 minutes.            However, failure to comply with internal
regulations in itself does not constitute negligence. Williams v. Ohio Dept. of Rehab. &
Corr., 67 Ohio Misc.2d 1, 3 (Ct. of Cl.1993). Plaintiff has not proven to the court that
defendant’s failure to check on Michael during that time period was a breach of the
standard of care. The court further finds that defendant’s failure to perform 15-minute
bed checks was not a proximate cause of Michael’s death. For the foregoing reasons,
the court finds that plaintiff has failed to prove any of her claims by a preponderance of
the evidence and, accordingly, judgment shall be rendered in favor of defendant.
Case No. 2009-08268                       - 13 -                                 DECISION




                                              Court of Claims of Ohio
                                                                        The Ohio Judicial Center
                                                                65 South Front Street, Third Floor
                                                                           Columbus, OH 43215
                                                                 614.387.9800 or 1.800.824.8263
                                                                            www.cco.state.oh.us



FRANKIE ELLAHI, Admx.

      Plaintiff

      v.

OHIO DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL
DISABILITIES

      Defendant

Case No. 2009-08268

Judge Joseph T. Clark

JUDGMENT ENTRY

       {¶40} This case was tried to the court on the issues of liability and damages. The
court has considered the evidence and, for the reasons set forth in the decision filed
concurrently herewith, judgment is rendered in favor of defendant. Court costs are
assessed against plaintiff. The clerk shall serve upon all parties notice of this judgment
and its date of entry upon the journal.



                                          _____________________________________
                                          JOSEPH T. CLARK
                                          Judge
Case No. 2009-08268               - 14 -                      DECISION

cc:


Eric A. Walker                       Eric P. Allen
Assistant Attorney General           2200 Kroger Building
150 East Gay Street, 18th Floor      1014 Vine Street
Columbus, Ohio 43215-3130            Cincinnati, Ohio 45202

HTS/dms
Filed January 13, 2012
To S.C. reporter March 23, 2012
