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Expanding informed consent: What should orthopedic surgeons disclose topatients?
Mandating orthopedic surgeons to disclose consulting agreements and royaltypayments to patients will depend on court’s interpretation of risk.
At first glance, the informed consent doctrine is simple and easy to comprehend. A surgeon is required to advise patients of the risks, benefits and alternatives to a surgical procedure. Over the course of the last several decades, patients have sought to expand this basic doctrine. As legal case law shows, patients’ advocates can be creative in the application of the informed consent doctrine.
 B. Sonny Bal |
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In a case titled Truman v. Thomas, a physician recommended that a woman undergo a pap smear. She refused, and later developed cervical cancer. She sued the physician on the grounds that he had an obligation to advise her of the risks that she confronted by reason of her refusal. The court upheld her claim, and the Truman case has since been referred to as the doctrine of “informed refusal.”
Performance disclosure
In 1996, the Wisconsin Supreme Court in Johnson v. Kokemoor appeared to extend the doctrine of informed consent to include the requirement that a surgeon disclose his/her performance compared to that of other surgeons.
As one law scholar stated, “This is the first case in the country to suggest that a doctor may have an obligation to disclose his own level of experience regarding a particular procedure before obtaining true informed consent.” While the Johnson decision appears to be unreasonably harsh, the facts showed that the defendant surgeon had provided misleading information about his experience that undoubtedly influenced the court in its decision.
The court did not, however, limit its decision to misleading statements, but concluded broadly: “When different physicians have substantially different success rates, whether surgery is performed by one rather than another represents a choice … and requires disclosure under Wisconsin law.”
Personal disclosures
In another case, Hidding v. Williams, the doctrine of informed consent was further expanded. The court required that a surgeon disclose his history of alcoholism. The Johnson and Hidding decisions suggest that courts may consider factors other than the risks of surgery, even including personal and professional characteristics of the treating doctor as part of the informed consent process.
The courts have also construed the informed consent doctrine to include the disclosure of a surgeon’s HIV status. In a case dealing with this matter, Scoles v. Mercy Health Corporation of Southeastern Pennsylvania, Scoles was an orthopedic surgeon who became HIV-positive. The hospital where he practiced learned of this, and conditioned his clinical privileges on his agreement to inform his patients of the HIV-positive status prior to any invasive procedure. Scoles brought a suit against the hospital based on the Americans with Disabilities Act; the court ruled that the hospital had reasonably decided that the doctor should be required to disclose his HIV status prior to surgery.
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Inadequate informed consent
In one of the most unusual informed consent cases, Arato v. Avedon, the court rejected the plaintiff’s claim that there had been inadequate informed consent. The case involved a terminal cancer patient who underwent radiation and chemotherapy after pancreatic cancer was diagnosed. The oncologist disclosed that there were “serious” and “great” risks of recurrence, whereupon the condition would be incurable. What the oncologist failed to disclose was that the inherently high mortality rate associated with pancreatic cancer left little, if any chance that radiation and chemotherapy would be successful.
The patient’s estate sued, claiming that the bleak truth was that Arato had faced certain death regardless of treatment. It alleged that had the patient known of this, he would have forgone treatment and focused on his family and business affairs. Instead, he underwent radiation and chemotherapy that contributed to the failure of his contracting business as well as real estate and tax losses following his death. The jury found for the defendant physician, and the California Supreme Court upheld the verdict.
Financial disclosures
Given the variations reflected in case law on the informed consent doctrine, as well as recent developments in the orthopedic industry, the question arises whether or not courts will eventually require orthopedic surgeons to disclose financial relationships with industry as part of the informed consent process. The answer may lie in understanding and recognizing those risks that require disclosure, according to courts.
The courts require that surgeons disclose inherent risks and material risks. Inherent risks are defined as those risks or complications that occur no matter how flawlessly a procedure is performed. Material risks are defined as those risks that bear upon a patient’s decision to undergo a surgical procedure. For example, certain complications of foot and ankle surgery may be more material to a ballerina than to an average patient; certain risks of hand surgery may be more material to a concert pianist than the average patient; and certain complications of shoulder surgery may be more material to a professional baseball pitcher than to the average patient. Materiality thus plays a critical role in the informed consent process, and surgeons should understand this concept thoroughly in advising elective surgery.
Cause-and-effect relationship
It is easy to conceive that an orthopedic surgeon’s close financial relationship with a device manufacturer is something that a patient would consider material if the surgeon chose to use that manufacturer’s product as the surgical implant. While it is foreseeable that patients would consider disclosure of such relationships material to their decision, there may be one overwhelming obstacle that would prevent and discourage lawsuits premised on the failure to disclose this information.
The informed consent doctrine requires that the patient demonstrate a cause-and-effect relationship between the failure to disclose a material fact and the patient’s adverse outcome. This is a tough hurdle to cross.
In the context of the informed consent doctrine, this means that if the information had been disclosed, the patient would have declined elective surgery, thereby preventing the undesirable outcome. It appears reasonably unlikely that a patient who brings a claim asserting that the surgeon should have disclosed his/her financial relationship with a manufacturer would refuse to undergo a procedure such a total hip or knee replacement.
In order to prove harm, such a plaintiff would have to show that the orthopedic implant was inferior to another manufacturer’s implant, and that had a different design of implant been used, the outcome would have been different. While this is a daunting task, readers should be aware that the informed consent doctrine remains dynamic in its interpretation by courts; reasonable prudence today would dictate that the orthopedic surgeon should consider erring on the side of disclosure of any industry relationships that relate to the planned surgical intervention.
For more information:
- B. Sonny Bal, MD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
- Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.