A jury found that neurosurgeon Robert Replogle, MD, did not have to disclose his connection with spinal device company Spineology before receiving a patient's consent to a spinal fusion using one of the company's implants.
What you need to know:
1. In late 2010, Dr. Replogle performed a minimally invasive fusion of the L5-S1 vertebrae on a patient with two prior procedures that did not relieve her pain – first a spinal decompression and then a multilevel fusion. He used a unilateral pedicle screws and an OptiMesh graft, developed by Spineology. At the time, he had a consulting agreement with the company and $110,000 worth of its stock, which he failed to disclose to the patient.
2. The patient complained of pain in a follow-up appointment, which Dr. Replogle observed to be normal after the fusion. The patient later saw a separate neurosurgeon who performed a revision procedure to remove most of the OptiMesh implant, which he found to be problematic.
3. The patient filed suit against Spineology in 2013, which she later settled before trial. She filed a separate suit against Dr. Replogle in 2014, alleging that he deviated from the standard of care.
4. In 2008, the American Association of Neurological Surgeons and Congress of Neurological Surgeons released guidelines in relation to physician financial ties and informed consent. Dr. Replogle's team argued he was unaware of the guidelines at the time.
5. In 2018, the jury sided with Dr. Replogle, stating that he was not negligent in obtaining the patient's informed consent or his surgical technique.
6. More recently, the district court denied the patient's motion for a new trial.