[Does a physician have to inform the patient about the rare risk of priapism before administering an anticoagulant?]

Unfallchirurg. 2018 Aug;121(8):674-676. doi: 10.1007/s00113-018-0521-8.
[Article in German]

Abstract

There are no pharmaceuticals without side effects. Primary care physicians and especially hospital staff have to ask themselves every time they are administering medication whether they should inform the patient about possible risks and alternative treatment options. The "bizarre" side effects which can occur even from taking routine medication are illustrated by a legal case decided by the District Court of Hannover: After surgery a patient developed an anticoagulant-induced priapism. The surgery itself was not subject of the court case but the patient sued the hospital for neglecting to inform him about the possible risk of priapism and about the alternative treatment with rivaroxaban, which both parties agreed had not happened. The District Court now had to decide whether the hospital is duty bound provide patients with such detailed information in order to obtain informed consent. The Hannover Court, and also later the Court of Appeal in Celle, answered this question in the negative; however, the decision shows that it is not sufficient for the treating physician to refer the patient to the patient information leaflet. Instead the physician is legally bound to personally and orally inform the patient about the risks and possible side effects, even when they are rare but typically associated with the prescribed medication.

Keywords: Alternative treatment; Heparins; Informed consent; Medical malpractice claim; Rivaroxaban.

Publication types

  • Case Reports
  • Review

MeSH terms

  • Anticoagulants* / adverse effects
  • Drug-Related Side Effects and Adverse Reactions*
  • Germany
  • Humans
  • Informed Consent* / legislation & jurisprudence
  • Jurisprudence
  • Male
  • Physicians* / legislation & jurisprudence
  • Priapism* / chemically induced

Substances

  • Anticoagulants