Legal Ethics/LACK OF CONSENT
QUESTION: Dear Dr. Friedman, thank you for making this blog available. My question is reference to my cousin, who had a spinal fusion surgery performed at a leading teaching facility. We learned that the surgeon, not only failed to disclose his financial interests in the manufacturer that provided the devices used, but one of the devices had an "absolute contraindication" not to implant the device in his cervical spine. The FDA also had issued a prior notice warning of "Life-threatening complications" from use of one the other devices also in the neck. Nevertheless the surgeon implanted these devices together which resulted in many of the exact complications that were published in the FDA notice as well as peer-reviewed clinical studies. While my cousin consented to a single-level cervical fusion, he never provided consent to have a multi-level cervical fusion using devices either never cleared for use in combination or a device that was labeled contraindicated for such use. I'm told that such conduct would open the surgeon and facility to medical battery for lack of consent (vs lack of "Informed" consent.) Could you clarify?
The issue of informed consent really depends on whether the state in which the healthcare occurred has specific statutes defining what is necessary. From an ethics standpoint, informed consent is not signing a paper. Informed consent is the provider telling the patient the relevant risks and benefits of the procedure to allow the patient to make the best choice for his or her self. From an ethics standpoint, it is problematic for a provider not to inform a patient that there is a financial interest in providing a certain modality because the patient cannot make an informed decision without that knowledge. From the facts you describe, it could be a medical battery depending on the laws in that state. A medical battery is an unwanted and/or unconsented medical procedure. Violations of Black Box Warnings or FDA Bulletins could be the basis of a cause of action.
I hope this information was helpful. Please feel free to follow up should you have further questions.
Paul D. Friedman, M.A., Ph.D., J.D.
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QUESTION: Thank you Dr.Friendman. The state is California. While there was no "BLack box" FDA warning, the absolute labeled contraindication states, this device is, ". . . not intended to be implanted into the cervical spine [emphasis added] . . ." Nevertheless, the surgeon implanted the device without informing my cousin. Additional facts are that the very same device was approved by the FDA 30 months later, but with changes to its design that directly removed very risk of failure that occurred with my cousin. I'm advised that such conduct may actually be criminal in nature and could merit a criminal investigation. If the same manufacturer that had a financial relationship to the surgeon and to the implanted devices were also present during the operative procedure and delivered the device the day of the operative procedure without my cousin ever being informed of its use, does it then also open the manufacturer to liability as well since they provided the device with knowledge that its use was contraindicated in the procedure that led to the injuries suffered by my cousin.
It depends on the knowledge base of the manufacturer. Often, a representative of the manufacturer is actually present in the operating suite without the patient's knowledge which, in my opinion, is an ethical violation. Black Box Warnings apply more to pharmaceuticals but FDA Bulletins are compelling regarding the applicable standard of care and possible medical battery cases regarding hardware. I suggest your cousin seek legal counsel as soon as possible and keep in mind that the statute of limitations in California is one year in this case.
Paul D. Friedman, M.A., Ph.D., J.D.