Facts

In February 2002, K.A. was diagnosed with malignant colorectal cancer. She was treated at the Triemli City Hospital in Zurich, where she underwent preoperative radiation therapy and was simultaneously administered the active ingredient 5-fluorouracil (5-FU) via infusion. During the therapy, her condition deteriorated, and on March 18, 2002, K.A. died as a result of the therapy. Her husband F.A. filed a criminal complaint for negligent homicide.

The criminal proceedings were initially discontinued, but were resumed on appeal by F.A. Eventually, the case reached the Federal Supreme Court.

Considerations

The Federal Supreme Court examined whether the physicians had violated their duty of care in the treatment of K.A. In particular, the question was whether the administration of the drug 5-FU in a higher than approved dosage (so-called "off-label use") was permissible.

The court concluded that the "off-label use" is generally permissible, provided that the general duty of care under the Therapeutic Products Act is observed. The physicians must comply with the recognized rules of medical and pharmaceutical science.

In the present case, the court affirmed that the treatment with the higher dosage corresponded to the medical…