A fine of 10,000 euros, including 5,000 suspended, was requested Friday, March 25 in Gap against a surgeon accused of having operated, between 2015 and 2017 without having ensured their “informed consent», some 126 patients using a non-compliant technique in France.
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The Public Prosecutor of Gap, Florent Crouhy, estimated that the interventions of this spine specialist practitioner, tried since Wednesday before the Gap criminal court, should have been part of the Jardé law, which governs research. biomedical. For the magistrate, the surgeon was guilty of having used a method “innovative” without “the approval of the competent authoritynor thefree, informed or express consentof his patients.
A “non-compliant” method
A former surgeon in the orthopedic and traumatology department of the Gap hospital, Gilles Norotte operated on his patients using percutaneous disc cementoplasty: a methodnot consistent with the data of surgical science– but practiced abroad – consisting of injecting acrylic cement into the empty spaces of damaged spinal discs. During his trial, Gilles Norotte explained that he acted within the framework of “routine careto justify why he did not submit this “single injection» to the Jardé legislation, which imposes in particular a protocol including the informed consent of the patient and the approval of a committee for the protection of persons (CPP).
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The surgeon recalled that the injection of cement, of which he underlined the immediate analgesic effect, was used “in common practice to solidify spinal fractures” and since “over sixty-five” for “maintain the intervertebral spaces“. He also clarified that he had resorted to this surgical practice for the sole purpose of “ease the painof his patients and theiravoid, given their age, heavier surgery“. Believing that Gilles Norotte simply “adapted a proven technique“, colleagues and peers of the surgeon called to the bar regretted the”gap» existing between the current regulations and the «speed of biomedical advances“.
For their part, witnesses called by the prosecution argued that by injecting its patients with the acrylic cement elsewhere than “directly in the bone“, for which he was approved, the practitioner has actually indulged in “an innovative surgical procedurelikely to fall into the realm of biomedical research. “The technique is not prohibited. But under the law, it is not a common treatment and he had to respect a prospective protocol which has not been put in place.“Said Anne Dupont, chief warrant officer of the Office center for the fight against damage to the environment and public health (OCLAESP) who led the investigation.
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At the opening of the debates, Gilles Norotte castigated “an unfair situation», «shamefully instrumentalized” by a “pseudo-whistleblower” – in reference to the former head of department who denounced his method according to him “ethically wrong– and lamented the “media tsunami“which also”tarnished the image of the Gap hospital“. The decision was reserved. Gilles Norotte faces up to three years in prison and a fine of 45,000 euros.
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