Is a Sovereign Immunity Defense Available in a Lawsuit Against a University Hospital?

Pharmacy Times, November 2017 Cough, Cold, & Flu, Volume 83, Issue 11

Can a participant in a clinical research study conducted at a public university academic health center maintain a lawsuit against the institution for damages suffered when she attempted suicide, allegedly because of the combination of medications administered as part of the study?

ISSUE OF THE CASE

Can a participant in a clinical research study conducted at a public university academic health center maintain a lawsuit against the institution for damages suffered when she attempted suicide, allegedly because of the combination of medications administered as part of the study?

FACTS OF THE CASE

The female patient in a southern state volunteered to participate in a clinical trial of smoking cessation medication. The research project was designed to examine the effectiveness of using varenicline (Chantix) while simultaneously using bupropion (Zyban). At the time of enrollment, the patient told a research staff member that she was taking bupropion for depression. Further, she told the participant screener that she previously had experienced an adverse reaction to varenicline.

During the research study, the patient was prescribed varenicline and a placebo for bupropion. The medications were prescribed by a psychiatrist employed by the health center, and they were dis- pensed at the university’s pharmacy. The patient took the medications as directed and several weeks later attempted to commit suicide. Both medications bore FDA-approved warnings about possible adverse effects, such as agitation, depression, and suicidal ideation.

She attempted suicide by consuming a large quantity of morphine prescribed for her late husband prior to his death. She spent several weeks in the intensive care unit, where she suffered tissue destruction due to lack of movement while in a coma. That was followed by several months of renal dialysis and permanent nerve and kidney damage.

She filed a lawsuit against the public university health center, alleging negligence in screening her for participation in the study, as well as for its staff members’ prescribing and dispensing the medication to her when her history of depression should have ruled that out. The academic health center argued to the trial court judge that as a governmental institution, it had sovereign immunity and could not be sued. The trial court judge did not agree and denied that motion to dismiss the claim. The health center appealed to the state court of appeals.

THE COURT’S RULING

The appellate court looked at the wording of the state statute governing sovereign immunity of state government entities, along with past court opinions, and ruled that the institution had waived its sovereign immunity. The case could proceed to trial.

THE REASONING

The appellate court reviewed the statutory context of sovereign immunity in the state, concluding that “governmental institutions are entitled to immunity from suit for personal injuries, unless immunity has been waived.” Reviewing closely the wording of the relevant statute, the court identified a provision specifying that immunity is waived when the personal injury was “caused by a condition or use of tangible personal property if the governmental unit would, were it a private person, be liable to the claimant” under standard state law.

The academic health center argued that there had been no waiver of governmental immunity because the suit was based on the center’s “personnel negligently exercising professional judgment and misusing information in approving the patient’s participation in the study.” From the institution’s perspective, it was all error of judgment and decision making not involving “tangible personal property.”

The court of appeals judges did not agree. The 3 judicial officers cited a number of prior cases as precedent for the proposition that “either dispensing or administering a drug is a use of tangible personal property” for purposes of evaluating whether sovereign immunity has been waived. They found that the word use means to “put or bring into action or service; to employ for or apply to a given purpose.” Applying that definition, the court concluded that the academic health center and its personnel, physicians, and pharmacists had put the drug into service and employed it for a given purpose when they authorized and gave the patient the medication for the purpose of quitting smoking and conducting its study.

Sovereign immunity derives from the Middle Ages in England. Kings were seen as lawgivers appointed by God and therefore were then immune to the indignity of lawsuits filed against them by their subjects.

Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, 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.

Reference

  • Pugh GW. Historical approach to the doctrine of sovereign immunity. Louisiana Law Review. 1953;13(3). digitalcommons.law.lsu.edu/cgi/viewcontent.cgi?article=2013&context=lalrev. Accessed September 8, 2017.