One of Switzerland’s best known and largest facilities, University Hospital Zurich, has had its reputation besmirched in an unfolding scandal in which its own Board has filed criminal complaints for involuntary manslaughter and grievous bodily harm, marking a major development in an investigation involving at least 11 deaths and 13 cases linked to medical devices.
The “Oberholzer report”, published earlier this month, found that between 2016 and 2020, there were about 4 500 operations at the hospital’s Clinic for Cardiac Surgery, and that within this window, the mortality rate surpassed statistical expectations by a shocking margin of 68 to 74 deaths, reports SiwssInfo.
In a report led by former federal judge Niklaus Oberholzer into these statistics, it was revealed that the clinic’s then director, Italian professor Francesco Maisano, had punted the use of a device he had helped to develop and from which he is alleged to have benefited financially.
The so-called Cardioband is a heart valve prosthesis developed by a company in which Maisano had a stake, and whose use may be linked to the excess of deaths.
According to the report, the root causes lie in comprehensive management failure. Maisano was appointed hastily in 2014 and without sufficient examination of his qualifications and conflicts of interest, it said. In addition, hospital management at the time neglected its duty of supervision and recognised warning signals too late.
Maisano was let go in 2020 and is now head physician at the San Raffaele Hospital in Milan.
The Swiss Observer reports that “this is no longer just an internal administrative failure; it is a full-scale criminal investigation into the heart of Switzerland’s most prestigious medical institution”.
While the hospital previously admitted to “serious errors”, these formal complaints indicate a dramatic shift toward accountability, and suggest a department where the margin for error was consistently breached.
Investigators, added the Observer, “are now tasked with determining whether these deaths were the tragic result of complex medicine or the criminal consequence of negligence and systemic malpractice”.
“The Zurich public prosecutor is dismantling the wall of silence that often surrounds medical institutions, investigating not just clinical errors, but the potential for forgery of documents. This aggressive legal posture sends a clear message: the sanctity of the operating room does not grant immunity from the Swiss penal code.”
In the meantime, the Clinic for Cardiac Surgery is under new management, which says it has since instituted stricter compliance rules, a register for vested interests and a planned whistleblowing system.
CEO Monika Jänicke expressed gratitude to an informant, a former heart surgeon from the clinic, who had initiated the investigations.
“It deserves our respect,” Jänicke said of the whistleblower. She declined to comment on the fact that the whistleblower had lost his job in this case.
That is a matter of the past, said Jänicke, who became CEO of the hospital only later, in 2023.
See more from MedicalBrief archives:
Women have less chance of surviving cardiac arrest – Swiss study
SAHPRA moves to regulate medical devices
Deaths and lawsuits expose flaws in FDA’s medical device oversight
