On December 8, 2011 the Supreme Court of Ohio issued an opinion laying out when expert testimony is needed in a medical claim based on lack of informed consent.  The case is White v. Leimbach, 2011-Ohio-6238.

Dr. Warren Leimbach, a neurosurgeon, successfully operated on Robert White for acute back pain caused by a herniated disc.  Several months later, White fell and re-injured his back.  After consulting Leimbach again, and getting a second opinion a second time from Dr. Michael Miner, White agreed to have Dr. Leimbach perform a second discectomy surgery. The second surgery left White in acute, ongoing pain. 

White and his wife filed suit against Leimbach alleging he had failed to get White’s informed consent before performing the second discectomy. White claimed that Dr. Leimbach failed to inform him that a second surgery posed a greater risk of a bad outcome, and had he known that he would not have consented to the second surgery. 

At trial, it was established that risks of the second procedure were nerve damage and chronic pain.  Dr. Miner testified both as a fact witness and as an expert witness for Dr. Leimbach.  He testified that based on his review of the medical records nerve damage—one of the risks of the procedure—had not materialized, and that he saw no evidence that the surgery had worsened White’s pain. The trial court granted a directed verdict in favor of Dr. Leimbach, finding there was no proof of the second element—that the undisclosed risks actually materialized and caused injury.  The Tenth District Court of Appeals reversed. 

Lack of informed consent is a quirky little tort. In Ohio, it is a medical claim, with all that entails.  It was once a battery—an intentional tort involving unagreed to bodily contact. But over time, it came to be part of the satellite of medical claims, and is generally now recognized as a negligence action.  

 The Supreme Court of Ohio set forth the elements of the common law tort of lack of informed consent in 1985 in Nickell v. Gonzales, (1985), 17 Ohio St.3d 136, 477 N.E.2d 1145. Those elements are

(a) The physician fails to disclose to the patient and discuss the material risks and dangers inherently and potentially involved with respect to the proposed therapy, if any;

(b) the unrevealed risks and dangers which should have been disclosed by the physician actually materialize and are the proximate cause of the injury to the patient; and

(c) a reasonable person in the position of the patient would have decided against the therapy had the material risks and dangers inherent and incidental to treatment been disclosed to him or her prior to the therapy.

In the White case the Court further explained Nickell.  What hadn’t been clear in Nickell is when the plaintiff needed expert testimony to prove his or her claim. In the 7-0 decision (Justice Pfeifer concurred in judgment only, which I’ll discuss further) written by Justice O’Donnell, the Court held that  there are two parts to the first Nickell element: the material risks and dangers and the significance of those risks and dangers, and that expert medical testimony is required to establish both aspects of that first element.  Expert testimony is also required to establish the second element, namely, that the undisclosed risks actually materialized and harmed the patient.   But the Court held that expert testimony was not required to establish the third element–what a reasonable person in the patient’s position would have done had that information been given to the patient.

All the justices on the court agreed that there was a failure of proof on the required second element–that the undisclosed risks actually materialized–and reinstated the trial court’s directed verdict in favor of Dr. Leimbach.

Justice Pfeifer wrote an interesting separate concurrence, disagreeing with the other justices on the need for expert testimony on the first element—failure to disclose the material risks of the surgery.  He agrees that the first element has two aspects to it–the need to establish the risks of the procedure and then whether that risk was material to the patient’s decision. He would require expert testimony on the first prong, but not the second.  He thinks juries, unaided by expert testimony, are able to determine whether the undisclosed information was material to the patient’s decision.    

 In 1994, when I was on the First District Court of Appeals, I came to pretty much the same conclusion in Valerius v. Freeman et al., (Oct. 19, 1994), Hamilton App. No. C-930658, unreported, 1994 WL 570289 as Justice Pfeifer in the White case.

There is one important holding in White that was barely discussed at all. It has been an open question whether a patient bringing an informed consent claim needs expert testimony on the third and final element of the claim- whether  a reasonable person in the position of the patient would have decided against the therapy had the material risks been disclosed to the patient before the treatment.  All seven justices agreed that expert testimony is not required for this element.  That should help plaintiffs in these kinds of cases. And incidentally, that is an objective, not a subjective test—would a reasonable person in the patient’s position—not that particular patient—have declined the treatment given the undisclosed risks.

Case Syllabus

The tort of lack of informed consent is a medical claim, and therefore expert medical testimony is required to establish both the material risks and dangers inherently and potentially involved with a medical procedure and that an undisclosed risk or danger actually materialized and proximately caused injury to the patient, but is not necessary to establish what a reasonable person in the position of a patient would have done had the material risks and dangers been disclosed prior to therapy because that is a separate issue for jury consideration. ( Nickell v. Gonzalez (1985), 17 Ohio St.3d 136, 17 OBR 281, 477 N.E.2d 1145, followed and explained.)

0 Responses to Merit Decision: The Necessity of Expert Testimony in an Informed Consent Claim. White v. Leimbach.

Judge Bettman’s anyalysis of White v. Leimbach is on point. However there is one other matter that needs to be addressed. Ohio has an “Informed consent” statute, ORC 2317.54. If a patient signs a written consent form, and it meets the three requirements of the statute, then the consent is presumed valid and effective so as to bar any claims based on the theory of informed consent. I just tried a case here in Cincinnati on the basis of informed consent. A women, age 19 at the time, became pregnant with her first child. Mom is a pregestational diabetic and these women tend to have larger babys. Third trimester ultrasounds suggested this was a very large baby, probably exceeding 10 pounds. The standard is that if the baby may be over 10 pounds, then mom should be advised of the risks and benefits of C-section v. vaginal delivery. Mom was never given the option, and during birth, the baby became “stuck” (shoulder dystocia), causing a tearing of the 3rd and 4th cervical nerve roots, also known as a brachial plexus injury, leaving the child with permenant dysfunction of his right arm. The defense raised the informed consent statute as a bar. The trial judge struggled to reconcile the statute with the common law (Nickell), and finally instructed the jury on both theories. We argued the written consent form did not meet the requirements of the statute in that it was signed by mom before there was any concern about a macrosomic infant, and further, none of the risks of shoulder dystocia were on the form. We did present expert testimony as to the first two elements of Nickell. When we focused on the third element of Nickell, the trial judge was NOT even going to allow the plaintiff to testify as to what she would have done had she been given the option of C-section in that the standard is what a reasonable person would have done. I showed the trial judge the Nickell decision wherein the Supreme Court stated that the testimony of the plaintiff, while relevent, was not the standard, and then the judge allowed me to question plaintiff as to what she would have done had she been so advised. The jury found that indeed the written consent form did not comply with the statute, and further held that the defendant physician had not provided informed consent, and returned with a verdict in favor of our client for $1.14m. The case is now over.

Reply

Judge Bettman’s anyalysis of White v. Leimbach is on point. However there is one other matter that needs to be addressed. Ohio has an “Informed consent” statute, ORC 2317.54. If a patient signs a written consent form, and it meets the three requirements of the statute, then the consent is presumed valid and effective so as to bar any claims based on the theory of informed consent. I just tried a case here in Cincinnati on the basis of informed consent. A women, age 19 at the time, became pregnant with her first child. Mom is a pregestational diabetic and these women tend to have larger babys. Third trimester ultrasounds suggested this was a very large baby, probably exceeding 10 pounds. The standard is that if the baby may be over 10 pounds, then mom should be advised of the risks and benefits of C-section v. vaginal delivery. Mom was never given the option, and during birth, the baby became “stuck” (shoulder dystocia), causing a tearing of the 3rd and 4th cervical nerve roots, also known as a brachial plexus injury, leaving the child with permenant dysfunction of his right arm. The defense raised the informed consent statute as a bar. The trial judge struggled to reconcile the statute with the common law (Nickell), and finally instructed the jury on both theories. We argued the written consent form did not meet the requirements of the statute in that it was signed by mom before there was any concern about a macrosomic infant, and further, none of the risks of shoulder dystocia were on the form. We did present expert testimony as to the first two elements of Nickell. When we focused on the third element of Nickell, the trial judge was NOT even going to allow the plaintiff to testify as to what she would have done had she been given the option of C-section in that the standard is what a reasonable person would have done. I showed the trial judge the Nickell decision wherein the Supreme Court stated that the testimony of the plaintiff, while relevent, was not the standard, and then the judge allowed me to question plaintiff as to what she would have done had she been so advised. The jury found that indeed the written consent form did not comply with the statute, and further held that the defendant physician had not provided informed consent, and returned with a verdict in favor of our client for $1.14m. The case is now over.

Reply

It seems to me what Justice Pfeiffer was saying is that the first element is not that much different from the third: if a person can testify as to what he or she would have decided to encounter in terms of risk given the potential magnitude of the risk and gravity of the harm, and that is also an objective test, viz., what others – including the jurors – would find on that issue, then what is a “material” risk that must be disclosed is also within the purview of the patient/plaintiff, as well as the lay jurors. What the majority seems to be saying is that an expert must disclose the details: what are the known risks and complications, what is the relative incidence of such complications, and what are the medical ramifications of such. Without that information, the jury cannot deem the patient was, in fact, even denied a necessary opportunity to make an informed decision about what transpired. I tend to agree with both points of view, and do not really see this as an earth shattering decision; I cannot imagine trying such a claim without having had an expert establish those things as a matter of both law and persuasion.

Reply

It seems to me what Justice Pfeiffer was saying is that the first element is not that much different from the third: if a person can testify as to what he or she would have decided to encounter in terms of risk given the potential magnitude of the risk and gravity of the harm, and that is also an objective test, viz., what others – including the jurors – would find on that issue, then what is a “material” risk that must be disclosed is also within the purview of the patient/plaintiff, as well as the lay jurors. What the majority seems to be saying is that an expert must disclose the details: what are the known risks and complications, what is the relative incidence of such complications, and what are the medical ramifications of such. Without that information, the jury cannot deem the patient was, in fact, even denied a necessary opportunity to make an informed decision about what transpired. I tend to agree with both points of view, and do not really see this as an earth shattering decision; I cannot imagine trying such a claim without having had an expert establish those things as a matter of both law and persuasion.

Reply

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