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Koon v. Walden

Court of Appeals of Missouri, Eastern District, First Division

October 24, 2017

BRIAN KOON and MICHELLE KOON, Respondents,
v.
HENRY D. WALDEN, MD and SAINT LOUIS UNIVERSITY, Appellants.

         Appeal from the Circuit Court of the City of St. Louis Hon. Michael W. Noble

          ROBERT G. DOWD, JR., PRESIDING JUDGE.

         Dr. Henry Walden and St. Louis University (collectively "Defendants") appeal from the multi-million dollar judgment entered after a jury trial on claims that they had overprescribed opioids to Brian Koon and caused him to become addicted, resulting in damages to him and his wife (collectively "Plaintiffs"). On appeal, Defendants challenge the denial of a mistrial during voir dire, the admission of certain evidence, the punitive damage instruction and the submissibility of all of the claims against them. We affirm.

         The evidence at trial showed the following. Opioids-drugs such as oxycodone, oxycontin and hydrocodone-are a class of prescription pain relievers derived from synthetic versions of opium. All opioids have a similar effect on the brain. Opioids work by binding to receptors in the brain that control the perception of pain. They do so in generally the same way that heroin does and produce the same euphoric effects. There are serious risks associated with opioids, including tolerance, dependency, addiction, life-threatening respiratory depression, overdose and death.[1] As patients take opioids, they develop tolerance and need more and more medication over time in order to achieve the same level of pain relief. Opioids change a patient's brain to make the body physically and psychologically dependent on the medication. All patients who use opioids for long enough will become tolerant and dependent, and some will become addicted. Addiction is a disease characterized by habituation, craving and preoccupation with obtaining and taking the drug.

         Opioids are dangerous, and most are categorized as Schedule II drugs by the Drug Enforcement Administration, the classification for the most potent legal drugs and the ones that have the potential to do the most harm. Opioids should only be prescribed for severe enough pain that is not adequately relieved by alternative non-narcotic treatment. Opioid therapy should begin at the lowest effective dose of immediate-release opioids and go up slowly if needed. Opioids should be stopped as soon as possible.

         The standard of care requires doctors to conduct a risk assessment with the patient before prescribing opioids, in which they discuss the risks versus the benefits of giving opioids to the particular patient for the particular pain. The risks and benefits should be re-assessed at an office visit each time the dose of an opioid is increased. Once a patient is taking opioids, he or she should be monitored regularly, meaning regular contact to assess pain levels and functioning and to check for side effects and behaviors that would suggest the patient is becoming addicted. The risk assessments and the results of monitoring a patient should be documented in the medical records.

         Doctors must also keep track of the amount of opioids-number of pills and dose-that the patient is taking. The standard of care requires all healthcare providers to have a medication management system in place to make sure patients do not receive too many opioids. The maximum daily dose recommended for a patient with non-cancer pain is between 90 and 120 milligrams MED.[2] Though this upper limit is not contained in any textbook, law or label, it has been the standard for many years to help primary care doctors recognize when it is time to refer a patient elsewhere. If a patient's pain is not adequately controlled by around 100 milligrams MED of opioids, then he or she should be referred to a pain management specialist because by 200 milligrams MED, the risk of addiction, abuse and dying increases sharply. One study from 2009 found that 1 in 32 patients who escalated to taking above 200 milligrams MED died from opioid related overdose. A group of physicians recommended in 2012 that the Food and Drug Administration require labels on opioids that would set a maximum daily dose of 100 milligrams MED for a maximum length of 90 days and that would explain that long-term opioid use had not been proven safe and effective for chronic non-cancer pain.

         Warning signs that a patient is dependent or addicted to opioids include patterns of early refills, asking for higher doses, taking multiple doses at once and exhibiting a loss of control over the ability to take the medication as prescribed. Patients who become addicted to opioids cannot themselves articulate the effect the increased doses of medication are having on their lives and will continue taking medicine despite those adverse effects. If a doctor suspects the patient is addicted, he should cease opioids and help the patient wean off of them.

         The risks associated with opioids were generally agreed upon by all the doctors who testified at trial, both those who testified as experts for plaintiffs and defendants and the defendants themselves. The risks were well known to anyone prescribing these drugs, including Dr. Walden and SL U.Similarly, there was no real dispute at trial that healthcare providers should weigh the risks and benefits of opioids, should prescribe the lowest effective dose for the shortest amount of time and only when other modalities of treatment are ineffective, should monitor their patients carefully and assess them for signs of dependency and addiction.

         Dr. Walden had been Brian Koon's primary care physician since 2001. Koon experienced intermittent lower back pain, which became more regular in 2008 after he threw his back out and fell while drying off from a shower. A visit to the chiropractor did not resolve all of the pain, so Koon went to see Dr. Walden on February 21, 2008 complaining of significant back pain. The pain was restricting his ability to do certain jobs at work. After examining him, Dr. Walden ordered x-rays and told Koon to continue using a muscle relaxer and ibuprofen as needed. The x-rays were normal. About a week later, Koon called Dr. Walden's office complaining that he still had "discomfort" in back, which the ibuprofen was helping on "some days." He asked the doctor to prescribe pain medication. Dr. Walden wrote a prescription for 30 pills of hydrocodone[3] with one refill, to be taken as needed every six hours. There is a notation in the medical record that he discussed the prescription with Koon, but Dr. Walden could not recall the details of that conversation. He agreed that a physician must weigh the risks and benefits of prescribing an opioid each time the patient is started or continued on the drug. This is something he admitted he should have done with Koon and believed he had done with Koon, but could not recall the specific times he did so and had no documentation of the details of any such discussion, except for one, discussed below.

         On March 31, 2008, Koon called Dr. Walden's office and requested a refill of the hydrocodone, explaining that he was taking double the amount of pills directed by his prescription. Dr. Walden prescribed more. On April 1, 2008, Dr. Walden saw Koon in his office, noting that he continued to have "back discomfort" and continued worsening of the pain, especially at the end of the work day, which was helped by taking two to three hydrocodone pills. Dr. Walden prescribed more pills and ordered an MRL Koon called Dr. Walden's office a couple of weeks later asking for the results of the MRI and again reporting "having to take more than the prescribed dose" of hydrocodone for it to work. Dr. Walden increased the dose of hydrocodone. Dr. Walden also referred Koon to an orthopedic surgeon, who said the MRI did not show a need for surgery and referred Koon to physical therapy. Koon saw another surgeon that he sought out himself for a second opinion, and that surgeon reached the same conclusions, but referred Koon to a pain management doctor. She treated Koon with spinal steroid injections from time to time.

         On July 8, 2008, Koon left a message with Dr. Walden's office stating that he increased the amount of hydrocodone he was taking and then tried to decrease it but "felt very bad, shaky, nose running, sweating, weak, yawning and moody." When he took the medicine, he felt better within an hour. Koon said he "needs help." Dr. Walden did not call Koon back or ask him to come in for an office visit; he just authorized another refill without speaking to Koon. On August 19, 2008, Dr. Walden saw Koon in his office. His notes indicate that Koon was doing better with back pain, receiving injection therapy and taking hydrocodone six times a day with "plans to wean back in one week." Dr. Walden noted that Koon desired to return to full work duty. Dr. Walden indicated the plan was for Koon to continue the hydrocodone but cut himself back on how often or how many pills he took. Dr. Walden did not change the hydrocodone prescription.

         On February 10, 2009, another SLU doctor saw Koon for an office visit and recommended switching from hydrocodone to another type of opioid called oxycontin, which is the long-acting version of oxycodone ("contin" meaning "continuous"). He prescribed that to Koon and told him to follow up with Dr. Walden. A week later, when Koon went to see Dr. Walden, it was noted that Koon continued to have pain, but was tolerating the oxycontin well with no adverse effects. Koon reported that the oxycontin was wearing off quicker than he would like and had not eliminated the pain. Dr. Walden continued to prescribe the hydrocodone in addition to the oxycontin. Dr. Walden knew that oxycontin in combination with other opioids can increase the risk of respiratory depression.

         On August 20, 2009, Koon saw Dr. Walden and reported continued back pain, some relief from the hydrocodone and oxycontin, though it did not seem as potent as it once was, and said he tolerated the medicine well. At this visit-a year and half after starting him on opioids-Dr. Walden notes that they discussed the possible adverse effects and risk of dependence and both agreed that the benefits clearly outweighed the risks. By October of 2009, Dr. Walden had added immediate-release oxycodone to the hydrocodone and oxycontin already being prescribed to Koon. He continued to prescribe all three opioids at the same time in increasing amounts during 2010 and 2011. Koon was also taking sleeping medication and sedatives at the same time as the opioids, which exposed him to a higher risk of life-threatening respiratory depression.

         At Koon's request, Dr. Walden sent him to another pain management doctor in April of 2012, who diagnosed opioid dependence, recommended treating that, gave Koon injections and referred him to a psychiatrist. On May 24, 2012, Koon and his wife went to Dr. Walden's office after she called to discuss weaning off the opioids. Koon was in tears asking the doctor to get him off the medication and telling him that the pills were running his life. Koon said he told Dr. Walden about the fact that the pain management doctor said he was on too much medication and would not take over his treatment because of the amount of drugs he was on. Dr. Walden noted at that visit that Koon was tolerating the medicine well, denied noncompliance and had no new adverse effects.

         In July of 2012, the pharmacy called Dr. Walden concerned about the large amount of opioids in the prescription Koon was trying to fill; Koon's wife also called the same day saying she had tried hiding the medicine from Koon, but he found it and took it all. Dr. Walden stated that this is when he and the other providers involved began trying to taper down one of Koon's drugs, the immediate-release oxycodone. In August of 2012, the pharmacy refused to fill Koon's prescriptions, so his wife called Dr. Walden and he wrote a new prescription. Before she could pick it up, Koon's withdrawal symptoms got worse and his wife admitted him to a rehab facility. After completing the rehab program, Koon had several surgeries on his lower back. Koon was diagnosed as having severe opioid use disorder, which is similar to a diagnosis of addiction.

         Koon and his wife testified that they regularly had to call Dr. Walden's office for early refills because Koon would run out early and have withdrawal symptoms. The prescription would be refilled-and sometimes the dose increased---without Dr. Walden talking to either of them. Sometimes, Dr. Walden would prescribe morphine to fill the gaps in prescriptions that could not be refilled early. Koon admitted he asked for these increased doses and early refills and wanted treatment for his back pain so he could keep working and provide for his wife and young daughter. At first, he said, the opioids helped him be able to work, but eventually the effects of the opioids interfered with work more than the pain had. The medications also interfered with his relationship with his daughter and his wife. His focus became solely his pain medications. The drugs ran his life: they were all that mattered to him, and everything revolved around the opioids. He had no control over it. Dr. Walden agreed that Koon exhibited a lack of control over his medications toward the end of his course of treatment with Dr. Walden, though he still claimed to believe only that Koon was dependent on the drugs and could not say that he was addicted.

         The parties stipulated to the amounts Koon was prescribed between February 2008 and August 2012. In 2008, Koon's average daily dose of opioids was 49.67 milligrams MED. The following year, it was up to 208 milligrams MED on average per day. In 2010, Dr. Walden more than doubled that to an average daily dose of 545.59 milligrams MED. In 2011, he doubled it again, reaching 1, 173.37 milligrams MED per day. By 2012, Koon was prescribed, on average, 1, 555.94 milligrams MED a day. Koon went from a prescription for six pills a day to almost forty pills of opioids a day between the three prescriptions.

         Plaintiffs' expert described these doses as "excessive, " "colossal, " "reckless, " "extraordinary" and "astronomical" and said they exposed Koon to a very high risk of injury, including addiction. This is the very pattern of prescribing that state licensure boards and the DEA are trying to protect patients from because it "exposes a patient to a very high risk of dying for backache." In his opinion, there was "no legitimate medical purpose" for Dr. Walden to prescribe Koon opioids in these amounts and for this length of time. In fact, he opined, a patient with low back pain should never be treated with chronic opioid therapy by a primary care doctor. Moreover, Dr. Walden did not conduct a risk and benefit assessment that met the standard of care in this case, nor was there any system in place to adequately monitored Koon's use of opioids in accordance with the standard of care. The expert testified that these deviations from the standards of care for treating a patient with opioids caused or contributed to Koon's injuries.

         SLU admitted Dr. Walden was its employee and had prescribed all of Koon's opioids in the course of that employment. SLU also acknowledged that Koon was its patient and that it agreed to treat him, through its physicians. SLU does not monitor the amount of opioids that are prescribed to its patients. SLU's representative at trial said SLU saw no reason to monitor opioids any differently than other medications. A one-page policy from 1998 is the only standard SLU has in place for prescribing controlled substances, and it merely specifies what needs to be on the prescriptions and how records thereof must be maintained. SLU was aware of the risks associated with opioids and agreed that its physicians should conduct risk-benefit analysis, monitor patients and assess them for signs of addiction. SLU's representative agreed that a dose in excess of 1, 500 milligrams MED was an "unusually high amount."

         The jury was instructed that they must assess a percentage of fault to Defendants if they believed Dr. Walden and SLU either (a) failed to weigh the risks and benefits of prescribing opioids to Koon, (b) overprescribed opioids to Koon, (c) failed to monitor Koon's opioid treatment or (d) failed to assess him for dependency or addiction. The jury also had to find that this conduct was negligent-in that Defendants failed to use the degree of skill and learning ordinarily used under similar circumstance by members of Defendants' profession-and that this negligence caused or contributed to cause Plaintiffs' damages. The jury was instructed that they could find Defendants liable for punitive damages if they determined that Defendants knew or should have known that this conduct created a high degree of probability of injury and thereby showed complete indifference to or conscious disregard for the safety of others. They were also instructed to assess a percentage of fault to Koon if they believed he either failed to provide information to Dr. Walden, failed to weigh the risks and benefits, failed to follow Dr. Walden's instructions for opioid use or failed to follow instructions for weaning off the medications.

         The jury returned a verdict in Plaintiffs' favor on their claims for compensatory damages, assessing 67% of the fault to Defendants and 33% to Koon. Judgment was entered, awarding Koon $938, 000 and his wife $804, 000 in compensatory damages. Judgment was also entered on the jury's verdict finding Defendants liable for punitive damages in the amount of $15, 000, 000. This appeal follows.

         Admission of Opioid Epidemic Evidence

         Defendants claim the trial court erred in admitting evidence of and allowing repeated references to a nationwide "opioid epidemic." They argue this evidence was irrelevant and highly prejudicial because its only purpose was to mislead the jury to believe that they should hold Defendants accountable for the epidemic. They contend that allowing this evidence resulted in a verdict that held Defendants responsible for harm to non-parties caused by other non-parties in unrelated situations. We disagree.

         Evidence must be both logically and legally relevant to be admissible. Crow v. Crawford & Company, 259 S.W.3d 104, 122 (Mo. App. E.D. 2008). "Evidence is logically relevant if it tends to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence, or if it tends to corroborate evidence which itself is relevant and bears on the principal issue of the case." Cox v. Kansas City Chiefs Football Club, Inc. 473 S.W.3d 107, 116 (Mo. banc 2015). "Logical relevance has a very low threshold." Id. at 130. Determining legal relevance requires the trial court to balance the probative value of the proffered evidence against its prejudicial effect on the jury. Id. at 122.

         Although only relevant evidence is admissible, the trial court is accorded "considerable discretion" when making the "subjective determination of relevancy." Ziolkowski v. Heartland Regional Medical Center, 317 S.W.3d 212, 216 (Mo. App. W.D. 2010). Thus, we give great deference to the trial court's evidentiary rulings, presume that the ruling is correct and will reverse only if the court clearly abused its discretion. Williams v. Trans States Airlines, Inc., 281 S.W.3d 854, 872 (Mo. App. E.D. 2009). If reasonable persons could disagree about the propriety of the action taken by the trial court, then it cannot be said that the trial court abused its discretion. Id. Rather, an abuse of discretion occurs when the ruling is "clearly against the logic of the circumstances then before the court and is so arbitrary and unreasonable as to shock the sense of justice and indicate a lack of careful consideration." Id. Only if there is "a substantial or glaring injustice" will we disturb a trial court's ruling on the admission of evidence. Carlson v. Saint Louis University, 495 S.W.3d 777, 779 (Mo. App. E.D. 2016).

         Defendants claim that evidence about the opioid epidemic was "persistently injected" throughout the trial, including during opening statement and closing argument. In its brief, Defendants cite "examples" of the offending evidence, suggesting there is other evidence about the opioid epidemic in the record they have not bothered to cite, but that warrant reversal. We can only review the admissibility of the evidence for which the appellant actually provides a citation to the transcript. Block Financial Corporation v. America Online, Inc., 148 S.W.3d 878, 890 (Mo. App. W.D. 2004) (court has no diity to search transcript where appellant does not identify specific testimony or other objectionable evidence and does not cite to transcript or legal file where evidence was admitted; point is not preserved for appellate review, even when reply brief attempted to correct problem). Thus, here we will review only the evidence for which Defendants have provided a citation to the transcript.

         Defendants first cite to testimony by Plaintiffs' expert, Dr. Paul Genecin. On direct examination, Dr. Genecin discussed the well-known risks associated with prescribing opioids, and then he was asked:

Q: Okay. Doctor, is there a recognized problem with overprescribing of opioid narcotics?
A: Yes. There's been a marked increase of prescription of opioid narcotics, and that's been going on for the past 15 to 16-

         Defendants objected that references to the opioid epidemic were irrelevant and prejudicial. The court overruled the objection, finding that although there was "some prejudice" from this evidence, the probative value outweighed the prejudice. Dr. Genecin went on to testify that the topic of prescription opioid use and misuse had been well covered in the popular media and in medical publications.

         The next challenged testimony is that of SLU's corporate representative, Dr. Robert Heaney, the CEO of SLUCare. Defendants set out in the brief the following particular exchange:

Q: Okay. St. Louis University and SLUCare and Dr. Walden and you have known about this problem, this epidemic, for some time now, correct?
A: We would have known about the increasing problem with opioids, yes.

         They cite to several other pages of the transcript on which Dr. Heaney testified, which include the following testimony. Dr. Heaney said the problem of opioid misuse and abuse had gone on for a while and had been increasing. He agreed that an article counsel presented to him stated that opioid consumption had increased by 300% between 1999 and 2010, that since 2002, deaths from prescription drugs had surpassed those from cocaine and heroin combined and the rate of overdose deaths had increased 19% per year from 2000 to 2006. Dr. Heaney testified that, at a corporate level, SLU was not aware of studies finding that 1 in 550 of patients receiving opioids for chronic non-cancer pain had died of overdose within a median of 2.6 years from their first prescription, but he said some of SLU's physicians may have been aware of it. He did not know whether SLU was, at a corporate level, aware of the study finding that 1 in 32 patients who escalated to opioid doses greater than 200 milligrams MED had died from opioid-related overdose, but he was sure some SLU physicians were aware of it. Dr. Heaney insisted that even based on what was known at the time of trial, SLU would not change the way it monitors the use of opioids, Although no death should be minimized, Dr. Heaney pointed out that 31 of the 32 patients in the above study "did okay and needed those medications." He also acknowledged that the greater the dose of opioid, the greater the potential for problems and the greater the need for monitoring.

         Defendants next point to the testimony of their own expert, Dr. Erik Gunderson, [4] who said on cross-examination that "we're in the midst of a prescription opioid epidemic in our ...


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