Should Informed Consent Include Even the Rarest of Complications?

A U.S. District Court judge has dismissed a malpractice case against a surgeon and the Mayo Clinic in which a patient who went blind after 11-hour spine surgery complained that he wasn't adequately warned of the risks associated with the procedure.

Even if the surgeon, Paul Huddleston, MD, knew that rare cases of post-op blindness were associated with spine surgery, the surgeon didn't have to include every risk he was aware of in informed consent discussions, said Judge Joan N. Erickson in her ruling dismissing the case on July 9. "Because he was aware of an 'association' between [post-op blindness] and prolonged prone spine surgery is unpersuasive because knowledge of the association does not establish that the risk was significant."

In 2006, Manley Stowell of Birch Run, Mich., opted for elective surgery for spinal fusion and to have hardware and a broken screw from a previous surgery removed from his spine. Before the procedure, Dr. Huddleston discussed the risks of the spine surgery including the risk of stroke, which he said could affect vision. Mr. Stowell verbally agreed to the procedure but did not sign an informed consent form, according to court documents.

During the procedure, Mr. Stowell was in the prone position for 11 hours and lost 3,500 cubic centimeters of blood. When he woke up in recovery, he was blind in both eyes. An ophthalmologist at the Mayo Clinic diagnosed posterior ischemic optic neuropathy (PION), according to court documents.

Although a known complication in long spine surgery procedures, PION is very rare. One study presented at the trial reported just 4 cases of PION out of 14,102 spine surgeries performed over 20 years.

In January 2009, Mr. Stowell sued Dr. Huddleston and the Mayo Clinic in federal court in Minnesota. He claimed that the surgeon was negligent because he didn't tell Mr. Stowell about the risk of blindness or about non-surgical options to help alleviate his back pain.

Mr. Stowell told the court that if he had known there was a risk of blindness he wouldn't have consented to the program. However, the judge dismissed the case, citing Minnesota case law that says a physician has a duty to disclose risks that have a "serious probability" of occurring, according to court documents. A doctor doesn't need to disclose every risk, "no matter how remote," wrote the judge.

"We believe the court's decision is sound," said Bryan Anderson, a spokesman for the Mayo Clinic. "Mayo physicians take the informed consent process very seriously and discuss the appropriate risks and complications with all of our patients."

An attorney for Mr. Stowell did not respond to a request for a comment.

Kent Steinriede

More breaking news