Informed Consent Becoming More Difficult?

We hold that the trial court erred by excluding expert testimony regarding undisclosed medical risks that had not materialized.” (White v. Beeks, filed May 18, 2015)

In Tennessee, informed consent depends on what a reasonable patient would need to know in order to make a reasonable decision in regards to medical treatment. The patient must be told his diagnosis or the nature of the ailment, the reasons for the proposed treatment or procedure, the risks involved and the prospects for success, and alternative methods of treatment along with the risks and benefits of such treatment. The patient must also be told if the treatment is considered experimental.

The informed consent standard used in Tennessee is the “objective patient” standard and this is the same standard used in the 1992 Code of Medical Ethics used by the American Medical Association. Only the practitioner is competent to explain the goals, risks, and hoped for benefits for the particular patient. This process should not be delegated to another person.

The recent decision in Ike White v. David Beeks, M.D., has threatened to turn this consent process on its head, especially if it were to be adopted in other states.

Ike White, a 19 year old, had chronic back pain related to a fall down a flight of stairs, injuries suffered while lifting a 200 pound car transmission, and injuries incurred in a three-wheeler accident.

In May 2006, Dr. David Beeks operated on Mr. White’s lower back; the discs were fused to stabilize the spine. To help with the stabilization, a bone grafting product, InFuse, was used. InFuse is a human-engineered protein which stimulates bone growth. This new bone is supposed to help in the fusion process.

Although Mr. White’s pain improved after the operation, it recurred about six weeks later. Radiographs confirmed that new bone had formed at the spinal stabilization sight.

On July 6, 2007, a health care liability suit was filed against Dr. Beeks. The suit alleged that the InFuse caused the new bone growth which put pressure on the nerves in the back. Mr. White later testified that Dr. Beeks had never discussed the risks associated with the InFuse, and, in fact, had never used the word “InFuse”. Mr. White claimed that alternatives to InFuse were not discussed nor was the risk of not using InFuse to help with the fusion.

Mr. White’s medical expert, Dr. Melvin Law, testified that “Dr. Beeks should have described the relative advantages of InFuse, the complications associated with its use, the potential to increase the chances for a successful fusion when using InFuse versus not, and the manner in which InFuse would be used” (White v. Beeks)

It was Plaintiff’s theory that this pressure on the nerves was the cause of the back pain. It was alleged that the InFuse had been negligently placed. It was also alleged that Dr. Beeks did not get an informed consent since all of the possible complications of InFuse had not been discussed.

During the trial, the Court granted a motion which limited the Plaintiff’s expert’s testimony to only the risks of InFuse that allegedly occurred and caused Mr. White’s pain.

The jury ruled that the injury was not related to the InFuse since there was undisputed testimony that new bone formation had never been shown to result in neurologic injury for this type of case. Even if InFuse had been the cause of the new bone growth, the pain was not due to this bone deposition.

On appeal, Plaintiff argued that the trial court erred by not allowing Dr. Law’s testimony relating to risks that had not occurred in this case. Mr. White claimed he would never have consented for the procedure if all of the significant risks had been disclosed; including the new bone formation.

The Appellate court agreed with the trial court but on further appeal, the Tennessee Supreme Court agreed with the Plaintiff. The Tennessee Supreme Court wrote, “[A] physician would be liable to a patient for injuries resulting from a procedure, ‘regardless of whether such injuries resulted from negligence or otherwise’ when informed consent had not been obtained.” (White v. Beeks)

So it came down to an issue of informed consent and it did not matter if the complication (injury) suffered had been discussed in the consent process. If all material complications had not been presented to the patient, then the jury should make a decision as to whether the consent process was adequate or not. Since the trial court did not allow the plaintiff’s expert to opine on what he felt were complications not discussed in the consent process, then the jury could not have made an informed decision on the adequacy of the process.

The Tennessee Supreme Court ruled that this error, more probably than not, infuenced the jury’s verdict. As such, the plaintiff was awarded a new trial.

The bottom line is that the physician in Tennessee (and any other state that follows this ruling) must make a “full disclosure” of any facts necessary for a patient’s “intelligent” consent for a proposed treatment. Obviously, the term “full disclosure” is open for interpretation. With this holding, it will be difficult, if not impossible for the clinician to go over every “material” complication associated with a procedure, especially if medical devices are to be used.

It is possible that I may be reading too much into this decision. It seems unlikely that the Court intended that every conceivable risk be discussed with the patient. Perhaps just the risks that a reasonable physician would discuss in the process of getting informed consent are required. But what risks would be relevant for that particular patient in coming to an informed consent? What we do know from this decision is that even if the injury suffered was discussed in the informed consent process, it may not not be enough to win on the informed consent cause of action.

It will take time for the Court to clarify this holding. In the meantime, plaintiff attorneys in Tennessee, and perhaps other states, are likely to include an “informed consent” theory in future medical malpractice cases.

Dr. Weiman’s website is www.medicalmalpracticeandthelaw.com

Dr. Weiman is the author of two books: Medical Malpractice and Fundamental Issues In Health Care Law

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