A prominent Bernese orthopedic surgeon is currently on trial at the Regional Court Bern-Mittelland, facing serious charges of grievous bodily harm. The case revolves around a faulty spinal implant he allegedly used on seven patients, despite prior knowledge of its failures in animal testing. The prosecution is seeking a two-year suspended prison sentence.
Key Takeaways
- A surgeon is on trial in Bern for allegedly using faulty spinal implants.
- Seven patients received the implant, which reportedly failed in animal tests.
- The prosecution claims patients were not fully informed about risks or the surgeon's ties to the manufacturer.
- The defense argues the surgeon had no decision-making power in the implant's development and properly informed patients.
- The surgeon did not inform his patients about the implant's international recall in 2014.
Implant's Troubled History and Surgeon's Involvement
The core of the legal battle centers on a specific spinal implant. This device, developed by a British company named Ranier, was intended for patients suffering from back pain. The surgeon, a recognized expert in his field, led the scientific advisory board for Ranier from 2007 to 2015.
During his tenure, the implant underwent testing on baboons. These animal trials yielded problematic results. An expert testified in court that the prosthesis did not function effectively in the animal subjects.
Fact: Animal Test Results
During baboon trials, the spinal implant reportedly failed to function as intended. The US Food and Drug Administration (FDA) expressed concerns about these outcomes.
The US Food and Drug Administration (FDA) conveyed its apprehension to the company regarding these findings. The FDA required Ranier to demonstrate that similar issues would not arise in human patients before granting approval. Despite these concerns, the company proceeded with human trials.
"The prosthesis did not function at all with the monkeys," an expert stated during the court proceedings, highlighting the implant's poor performance in animal tests.
Allegations of Patient Exploitation
Stephan Kinzl, the lawyer representing the affected patients, argued in court that the patients were effectively reduced to "test animals." He emphasized that the FDA quickly identified potential problems, a foresight that proved accurate as similar issues later emerged in human subjects.
The defense, however, countered these claims. The surgeon's lawyer contended that the results from animal studies are not directly transferable to humans. She stated that such tests primarily serve to observe material behavior. The decision to use the implant in humans, she argued, rested with the manufacturing company, not with the surgeon as a researcher.
Background: The 'Implant Files' Investigation
This case gained public attention in 2018 as part of the global 'Implant Files' investigation. This journalistic collaboration uncovered significant systemic flaws in the regulation and oversight of medical devices worldwide.
Financial Ties and Disclosure Concerns
A significant point of contention in the trial is the surgeon's alleged financial relationship with Ranier. The prosecution asserts that the surgeon received approximately 100,000 Swiss francs from the company between 2009 and 2015. They also suggest he had prospects of profit sharing through stock options.
The defense strongly refutes any financial motive. The surgeon's lawyer stated that he received no substantial compensation for his work with Ranier. She also denied the prosecution's claim regarding stock options, asserting that a financial motive cannot be attributed to her client.
- Prosecution's View: The surgeon received 100,000 CHF and held stock options, indicating a financial interest.
- Defense's View: No high compensation was received, and stock options are unproven, negating a financial motive.
Patient Information and Consent
Patients who received the implant testified that they were unaware of several critical facts before their surgeries. They reported not knowing about the lack of long-term data for the implant, the surgeon's affiliation with the manufacturer, or the concerning results from the animal tests.
The prosecution described this as a "deception of consent." They highlighted that patient records regarding pre-operative information were "very sparse." Patients uniformly stated that specific complications were not explained to them, and the surgeon reportedly emphasized only the implant's benefits, calling it a "good product." He also allegedly failed to disclose his role in co-developing the product.
Key Statistic: Patient Claims
All seven patients who testified stated they were not informed about specific complications or the surgeon's ties to the manufacturer.
The defense maintains that the surgeon obtained valid consent from every patient. His lawyer argued that he provided "comprehensive, individualized, and understandable information about the risks." She further stated that any alleged harm, such as the artificial disc disintegrating, stemmed from the implant's design, not the surgical procedure itself. Thus, she argued, the manufacturer, not the surgeon, bears responsibility, and the charge of grievous bodily harm is not applicable.
The Recall and Silence
In 2014, Ranier internationally withdrew the implant from the market due to an increasing number of reported complications. However, the Bernese surgeon did not inform his patients about this recall.
When the manufacturing company sent a letter urging him to check on his patients, he reportedly marked "No!" on the form. This meant many patients learned about the faulty implant they carried through media reports in 2018, four years after the recall.
Ethical vs. Legal Duty
The trial explores the complex line between a surgeon's ethical obligation to patients and their legal responsibilities after a procedure is completed.
The prosecution charges the surgeon not only with grievous bodily harm but also with abandoning his patients. Clinical Director Mazda Farshad, an expert witness from the Balgrist University Hospital in Zurich, testified that informing patients about a recall is an "ethical duty."
The defense argued that a doctor's legal responsibility to patients concludes once treatment and follow-up checks are complete. A recall, they stated, does not create a new legal obligation. The surgeon, according to his lawyer, could also reasonably expect patients to contact him if they experienced problems.
"The patients did not know they were being used as white mice," stated patient lawyer Stephan Kinzl, highlighting the alleged lack of transparency.
The patient's lawyer, Stephan Kinzl, emphasized that patients had a right to be warned. He argued that given his special role as a company advisor, the accused surgeon should have known about the potential for harm to humans, not just animals.
Verdict Anticipated
The defense is seeking a full acquittal for the surgeon, arguing that all accusations are "untrue, unproven, or based on assumptions." They also demanded 862,000 Swiss francs in damages and 56,000 Swiss francs in moral compensation, citing a "media hunt" that harmed their client's reputation and career.
Kinzl, the patient's lawyer, countered that the scandal only came to light because the media fulfilled its watchdog role. He noted the surgeon himself appeared on television when the affair became public.
The accused surgeon, who had previously refused to testify, spoke at the very end of the trial. He expressed his apologies to all patients, stating, "I never wanted to harm anyone." He also described the accusation of financial gain as unbearable. The verdict in this high-profile case is expected on February 16.