In December 2018, Bjork decided to reopen a previously discontinued investigation into three cases. Additional written evidence was obtained and more interviews were held with individuals in Sweden, Belgium, Britain, the United States and Spain, Bjork said in a statement.
“It has become clear to me that the operations were carried out in conflict with science and proven experience,” he added.
Macchiarini was fired from Sweden’s prestigious Karolinska Institute in March 2016 for breaching medical ethics after being accused of falsifying his resume and misrepresenting his work.
When Macchiarini’s first windpipe transplant was reported in the medical journal Lancet in 2008, it was hailed as a breakthrough in regenerative medicine. Macchiarini’s new airway — partly made using stem cells from the patient — was thought to herald a new era where new organs could be made in the laboratory.
Despite an independent commission in Sweden that found numerous problems in Macchiarini’s work, the Lancet has so far declined to retract the study.
Bjork said the operation had caused the victims “serious physical injuries and great suffering,” and “have been carried out with absolutely no legal basis.”
“I have made the assessment that the three operations are therefore to be considered as aggravated assault,” Bjork said. “It is the former surgeon at Karolinska University Hospital who alone should bear the criminal responsibility.”
Macchiarini earlier had disputed the accusations, saying they were false.
Of the 20 patients Macchiarini operated on to provide them with an artificial windpipe — from countries including Spain, Russian, Iceland, Britain and the U.S. — only three are still alive. Critics say Macchiarini skirted medical ethics to carry out dangerous procedures with no proven benefit and that he fabricated descriptions of this patients’ conditions.
Bjork declined to explain why he believes the operations were carried out with no legal basis. These details and explanations will first be made at the main hearing, he said, adding no date for that was set yet at the District Court in Solna, in northern Stockholm.
Last year, an Italian court sentenced Macchiarini to 16 months in prison for forging documents and abuse of office.
Olsen reported from Copenhagen, Denmark. Maria Cheng in London contributed to this report.
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