The question that can free or convict Macchiarini

Facts: The trial against Macchiarini

In the fall of 2020, the surgeon Paolo Macchiarini was charged with aggravated assault of three of his patients, two men and one woman, who were transplanted with synthetic trachea in 2011–2012.

In his lawsuit, the prosecutor writes that the interventions were “completely contrary to science and proven experience” and that it violated the law as “it did not constitute any form of medical care or approved research study”. According to the prosecutor, the acts must be assessed as serious, among other things, as they caused “severe bodily harm and very severe suffering”.

Alternatively, the prosecutor demands that the surgeon be sentenced for causing bodily harm, a serious crime.

On June 16, Paolo Macchiarini was sentenced by Solna district court to a suspended sentence for causing bodily harm, a serious crime, against one of his patients. He was acquitted in the other two cases.

Causing bodily harm has a lower penalty value than assault and in this case is judged not to reach up to a year in prison. In order to be convicted of assault, there must be intent, which was completely lacking in Macchiarini’s case, the district court considered.

Source: The Prosecutor’s Office, Solna District Court

In June last year, Paolo Macchiarini was given a suspended sentence for causing bodily harm, but was acquitted of crimes against two of three patients who had his synthetic trachea operated on at Karolinska University Hospital.

Despite the fact that, according to the district court, the procedures did not comply with the requirement of science and proven experience, Macchiarini was considered to have acted in a needy, criminal sense, due to the patients’ condition. The first two transplants were therefore justified.

However, given the severe complications that followed, the surgeon should never have performed the third operation, the court held.

When the case is now taken up in the Court of Appeal, the so-called emergency clause comes into focus. What counts as an emergency, and how do you weigh the benefit against the risk?

Assessed as difficult in healthcare

According to Lena Wahlberg, docent and researcher in general jurisprudence with a special focus on medical law at Lund University, the law is not straightforward when it comes to healthcare.

— It is usually required that the danger must be imminent. How should it be perceived in a disease context? The illness is there, but death is not imminent, so is the situation urgent enough? she says.

Another aspect involves weighing the operation method against the situation.

“In an emergency situation where it’s about breaking a glass window, picking up a phone and making a call, saving a life obviously weighs more heavily, so the assessment is often simpler there,” she says.

— In healthcare, the interests at stake are much more difficult to assess, where one may be about extending life by a few years, while the other is to have a good and dignified end of life without having to undergo 80 operations.

According to the district court, Macchiarini’s transplants were not a matter of research, as the prosecutors wanted it to be. The fact that, despite the weak scientific basis, the surgeon was given the right to act in an emergency could still have consequences if the verdict stands, Lena Wahlberg believes.

— The court expressed it as the method “cannot easily have been regarded as doomed to fail”, and that is, of course, a very weak requirement for knowledge. That interpretation of the emergency provision can be argued to water down the requirement for science and proven experience, she says.

Both sides have appealed

After the verdict in the Solna district court, both sides chose to appeal the verdict.

According to the prosecutors, none of the three patients was so close to dying that the unproven procedures were necessary. They claim that the procedures were completely contrary to science and that the surgeon should therefore be sentenced to prison for serious assault, alternatively serious bodily harm in all three cases.

– I understand that what they are really looking for is to say that this has not been healthcare at all, and if it is not, you are not allowed to cut people in any way, says Lena Wahlberg.

Paolo Macchiarini, for his part, believes that he did nothing criminal. After the district court verdict, Macchiarini’s lawyer Björn Hurtig said that on the whole they were satisfied with the outcome. Now they want the surgeon to be acquitted entirely.

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