Joseph L. Fink III, BSPharm, JD, DSC (HON)

A patient who allegedly had consumed a mixture of 3 prescription medications met his demise, and the judge dismissed the widow’s lawsuit against the chain pharmacy. Was that the correct decision, and what was the proper role of the widow’s expert witness pharmacist?

A worker at a factory in a Midwestern state had completed his usual night shift and returned home at 7:30 am. He met his wife in the driveway and they spoke for about an hour. At that time, the wife noticed nothing unusual about his communication or conduct. She left for her place of employment, and her husband entered the house. He died at approximately 3 pm while sleeping. The cause of death was identified as alprazolam, fentanyl, and oxycodone intoxication.

Prior to his death, a pharmacist at a national pharmacy chain had dispensed fentanyl patches to him pursuant to a prescription issued by his treating physician. The widow filed a wrongful death lawsuit against both the pharmacy chain and the prescriber.

The crux of the argument advanced regarding the pharmacy chain was that the pharmacist employed by the chain responsible for the transaction “violated the standard of care to be expected of a reasonably competent pharmacist under the circumstances by filling the prescription knowing that [the husband] worked in a high-heat environment and that he had succumbed to an increased level of fentanyl due to heat exposure at work.”

The surviving spouse had lined up a pharmacist to testify as an expert witness about how a high-temperature working environment could potentiate the effects of the fentanyl. The trial court judge limited the testimony and prevented the witness from testifying that the patient had “succumbed to an increased level of fentanyl due to heat exposure.”

An expert witness is typically brought in during a trial to explain the issues at hand in an understandable fashion to allow the jurors to make an informed decision. Usually, the expert witness is asked to indicate whether another pharmacist with similar education, experience, and skill who is operating under similar circumstances would reasonably reach the same conclusion or take the same action as the actual pharmacist under review did. Either side, or both, can proffer an expert witness, but the judge must deem the individual’s background acceptable for him or her to participate.

The attorney for the pharmacy chain made a motion to dismiss the lawsuit by asking for a summary judgment. A summary judgment motion asks the trial court judge to decide and declare that there is no genuine dispute regarding any material fact at issue in the lawsuit and that the party making the motion is entitled to judgment. The trial court judge granted the motion and dismissed the lawsuit. The surviving spouse filed an appeal with the relevant state court of appeals, arguing that the decision of the trial court judge was erroneous.

The court of appeals judges agreed with the trial court and upheld the dismissal of the lawsuit.

The appellate court judges pointed out that the plaintiff/spouse presented no evidence regarding her husband’s working conditions on the day of his death. Despite that, the plaintiff had presented during pretrial proceedings the deposition of the pharmacy expert witness that contained his expert opinions regarding the relationship between the fatality and working conditions.

The attorney for the surviving spouse did not challenge the trial court’s decision to limit the testimony of the expert witness when the appeal was filed. The appellate judges pointed out that the trial court had “prohibited him from testifying that [the husband] had succumbed to an increased level of fentanyl due to heat exposure.”

Further, the trial court additionally specified that the proffered expert witness “could not discuss the factual circumstances surrounding his use of the patch while at work” because he did not know specific details regarding the deceased husband’s job.

When the trial court judge was considering the motion for dismissal made by the defendant pharmacy chain, the plaintiff/spouse submitted 2 affidavits from the proposed pharmacy expert supporting her position that the summary judgment should not be granted and the case should not be dismissed. The trial court judge did not accept the 2 additional submissions by the pharmacist expert witness in support of the position of the plaintiff/spouse, and that decision by the presiding officer in the court below was not challenged on appeal.

The appellate judges concluded that though the widow “argues that the record contains substantial evidence that creates a genuine issue of material fact as to the pharmacy’s liability,” they did not concur.

The judges stated that “we have thoroughly examined the record, and we conclude that there are no admissible facts to support [the widow’s] claim that the cause of death was tied to a duty [the chain pharmacy] had breached by filling [the husband’s] prescription for fentanyl patches.”

They affirmed the trial court’s “grant of summary judgment for the [pharmacy chain].”

, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

Articles

Trial court judge places limits on testimony of widow’s pharmacy expert witness and dismisses lawsuit.

Wrongful Death Case Is Tied to Additive Effects of Multiple Drugs

By the time of his death in 2011, Dr. Jack Kevorkian was said to have assisted in the suicides of at least 130 patients. In part because of his advocacy, physician-assisted suicide became a heated topic of discussion in the 1990s.

Five states—Oregon, Washington, Vermont, Colorado, and California&mdash;and the District of Columbia now have Death With Dignity acts that allow adults with a prognosis of no more than 6 months to live to choose to end their lives. Montana allows an “end-of-life option” via a ruling of the state’s supreme court in 2009.

 The intent of such laws is to help terminally ill patients avoid undue pain and suffering and allow them more autonomy in decisions concerning their end-of-life care. Participating individuals must be mentally competent, able to voluntarily request and obtain the necessary prescription, and self-administer the medication.

 Most participants are younger than 65, have received a diagnosis of terminal cancer, and are in hospice care.

 All health care providers involved in the process are legally protected from charges of assisted suicide, homicide, and elder abuse.

Death with dignity is a controversial issue. Thirty-seven states have laws expressly prohibiting physician-assisted suicide,

 and physician opponents say that actively participating in the death of a patient violates the Hippocratic Oath, which instructs doctors to “do no harm.” Health care systems with religious affiliations also oppose death with dignity, claiming that death is a “sacred part of life’s journey” that should neither be hastened nor delayed.

 Furthermore, there is concern that such laws open the door to potential abuse.

 The determination of a patient’s prognosis can be arbitrary, and physicians are not held accountable for the life-ending drugs that they prescribe. This lack of accountability may lead to patients being pressured by physicians or family members into committing suicide or using physician-assisted suicide to avoid exorbitant medical bills.

In response, because an individual’s decision to die with dignity is viewed as strictly voluntary, health care providers, hospitals, and physician groups may opt out without the risk of penalty.

Advocates of death with dignity argue that the practice is uncommon; a physician may encounter the situation only once or twice in a career. Further, since the passage of the Oregon law in 1997, fewer than 2000 prescriptions for lethal drugs have been written in Oregon, and just 65% have been used. This is a pattern that is consistent year after year (FIGURE 1).

 Moreover, choosing to die is not an instantaneous decision. For example, Oregon law requires patients to make 2 oral requests to their physician at least 15 days apart, followed by a written request signed in the presence of 2 witnesses. The attending physician must then confirm the patient’s diagnosis and prognosis with a consulting physician. If either provider believes that the patient’s judgment is impaired by a psychiatric or psychological disorder, then a referral for a psychological evaluation must be made. If all requirements are met, then the physician must inform the patient of all reasonable alternatives to death with dignity. If the patient confirms their decision, the medication must be dispensed directly to the patient by the physician or via a written prescription delivered to a pharmacist either by the physician or through the mail. The patient may rescind the request at any time.

 Such conditions ensure that the physician’s and the patient’s judgments are neither hastened nor coerced.

Prescriptions for the high doses of oral barbiturates that are typically used in physician-assisted suicide may end up in the hands of a community pharmacist.

 This raises important considerations for the pharmacist, including patient-counseling issues, legal requirements, moral and ethical concerns, and consequences for refusing to dispense the medication. The American Society of Health-System Pharmacists released a statement in 1999 regarding pharmacists’ participation in death with dignity. The statement indicates that it is the duty of a pharmacist to provide patient-specific care and to respect the autonomy of the patient but that it also is the right of the pharmacist to choose not to participate in “morally, religiously, or ethically troubling therapies.”

End-of-life care presents a great opportunity for pharmacists to exercise their expertise. Physicians and pharmacists must contemplate the implications of death with dignity laws on their personal beliefs and future practice to provide empathy, understanding, and the best possible care to their patients.

Source: Oregon Health Authority Public Health Division, Center for Health Statistics. February 2017.

Erin N. Deja is a fourth-year PharmD student at the University of Kentucky College of Pharmacy.

Joseph L. Fink III is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

Davey M. Kevorkian speaks after his release from prison. 

website. nytimes.com/2007/06/04/us/04kevorkian.html. Published June 4, 2007. Accessed June 6, 2017.

LeBlanc J, Struve A, Mendoza L, Levy M. Difficult choices for healthcare providers as California legalizes assisted suicide. Lexology website. lexology.com/library/detail.aspx?g=ad4f41bd-ce90-48da-bce2-345bc3fcfcfa. Published October 10, 2016. Accessed June 6, 2017.

Oregon Death with Dignity Act. Ore Stat §127.800.

Oregon Health Authority, Public Health Division, Center for Health Statistics. Oregon Death with Dignity Act. Data summary 2016. Oregon state website. public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Documents/year19.pdf. Published February 10, 2017. Accessed June 6, 2017.

Gray K. Bill legalizing assisted suicide gets new life in Lansing. 

website. freep.com/story/news/politics/2016/08/13/bill-legalizing-assisted-suicide-gets-new-life-lansing/88537468. Published August 13, 2016. Accessed June 6, 2017.

Judge refuses to suspend California’s assisted death law. Modern Healthcare website. modernhealthcare.com/article/20160827/NEWS/160829934. Published August 27, 2016. Accessed June 6, 2017.

ASHP statement on pharmacist’s decision-making on assisted suicide. 

Five states&mdash;Oregon, Washington, Vermont, Colorado, and California&mdash;and the District of Columbia now have Death With Dignity acts.