Healthy volunteer died after routine bronchoscopy (2,3)
In 1996, Nicole Wan, a 19-year-old student from the University of Rochester, New York, responded to an invitation to provide her lung cells for laboratory lung cancer research. A few hours after completing the bronchoscopy procedure, she suffered from a heart attack and died two days later despite successful resuscitation.
Her post-mortem report indicated that she died of acute lidocaine toxicity. Lidocaine is a local anaesthetic that was sprayed down the throat to numb the airways during routine bronchoscopy. The report suggested that she had ‘likely received more than four times the maximum dosage’ (Doris, 1996) used in previous research.
The case led to a multi-million dollar lawsuit against the university by Nicole Wan’s family. Further investigations into the study by the State Department of Health reported the following safety issues:
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‘The operator had little regard for dosage (of lidocaine), was unaware of the maximal allowable quantity and was unable to indicate the exact amount used.’
The research protocol for this study did not specify the maximum amount of lidocaine that could be administered. As Nicole Wan experienced a lot of discomfort during her procedure, the topical anaesthetic was given liberally to relieve her pain so that the operators could proceed with cell collection.
This serious adverse event (SAE) could have been prevented if the operators of the procedure (two physicians and two technical support staff) had all received clearer instructions through the research protocol, or a Standard Operating Procedure (SOP).
There should also be an awareness that the procedure might need to stop if a subject was already showing signs of unusual discomfort.
‘There was no evidence in the medical record that a physician or nurse assessed Wan's medical condition at the time she left the bronchoscopy unit.’
Although severe reactions to lidocaine usually manifest very rapidly (within minutes of administration), the way in which lidocaine was administered in this study – as an aerosolised spray – delayed the onset of Nicole Wan’s symptoms. She was sent home after 90 minutes of observation post-bronchoscopy and developed symptoms shortly after she left. The SAE might have been picked up earlier if there was better monitoring and recording of her condition.
(Quoted from: Doris, 1996) (3)
No further bronchoscopies were conducted for the study after this incident, although the researchers proceeded with laboratory analyses of the collected cells. The lawsuit was eventually settled out-of-court.
Read more about the case: ‘Experimental Ethics: The Nicole Wan Case’ (Doris, 1996).
Student dies at Rochester in MIT-based study [Internet]. MIT News. 1996 [cited 2019 Jan 29]. Available from: http://news.mit.edu/1996/wandeath-0410
Doris ME. Experimental Ethics: The Nicole Wan Case. The Boston Phoenix [Internet]. 1996 Oct [cited 2019 Jan 29]; Available from: http://www.academia.edu/6964816/Experimental_Ethics_The_Nicole_Wan_Case
Doris ME. Experimental Ethics: The Nicole Wan Case. The Boston Phoenix [Internet]. 1996 Oct [cited 2019 Jan 29]; Available from: http://www.academia.edu/6964816/Experimental_Ethics_The_Nicole_Wan_Case