Ike J. WHITE III v. David A. BEEKS, M.D.
Supreme Court of Tennessee, AT KNOXVILLE.
November 3, 2014 Session Filed May 18, 2015
As Revised on Denial of Rehearing Aug. 26, 2015
460 S.W.3d 517
Richard A. Smith and Stacy Lynn Archer, Chattanooga, Tennessee, for the appellee, David A. Beeks, M.D.
OPINION
SHARON G. LEE, C.J., delivered the opinion of the Court, in which CORNELIA A. CLARK, GARY R. WADE, JEFFREY S. BIVINS, and HOLLY KIRBY, JJ., joined.
I.
Ike J. White III, aged nineteen, had suffered from back pain for over a year. His pain affected his mobility and sleep, and he was unable to work or continue his education. In January 2006, Mr. White sought treatment from Dr. David A. Beeks, an orthopedic surgeon then practicing in Cleveland, Tennessee. In May 2006, after conservative treatment was unsuccessful, Dr. Beeks operated on Mr. White‘s lower back, fusing select discs and joints to stabilize the spine by using the bone-grafting product, InFuse.1 Mr. White‘s back pain initially improved. Approximately six weeks after surgery, however, Mr. White again reported significant lower back pain. Subsequent tests indicated that ectopic or abnormally placed bone had formed at the site of the surgery.
On July 13, 2007, Mr. White filed a health care liability suit against Dr. Beeks in the Bradley County Circuit Court.2 In an amended complaint, Mr. White alleged that Dr. Beeks had failed to obtain Mr. White‘s informed consent to the surgery by not advising Mr. White of his intention to use InFuse, the manner in which it would be used, or the risks associated with its use. Mr. White‘s informed consent claim was centered on the theory that Dr. Beeks’ use of InFuse caused the ectopic bone growth, which, in turn, caused pressure to be placed on a nerve in Mr. White‘s back. This pressure on the nerve was alleged to be causing Mr. White‘s continued back pain.
A jury trial was conducted over four days in August 2012. Mr. White testified that he had suffered back pain stemming from three separate incidents.3 Mr. White testified that he had trouble walking, touching his toes, and sleeping more than four hours a night because of his pain. In addition, Mr. White was unable to work or continue his education. Mr. White took over-the-counter pain medications and used heating pads and ice packs to reduce his pain. After the pain became too much to bear, Mr. White went to the emergency room in January 2006. That same month, he sought treatment from Dr. Beeks, who examined Mr. White, reviewed his x-rays, and recommended physical therapy.
Mr. White testified that physical therapy did nothing to ease his pain, which included a sensation like a “lightning bolt shooting down [his] leg.” When he visited Dr. Beeks for a follow-up appointment on February 3, 2006, Mr. White ranked his pain a 10 out of 10,4 and he told Dr. Beeks that physical therapy was not helping his ongoing pain. As a result, Dr. Beeks ordered an MRI of the lumbar spine, which showed a degenerative disc with herniation. Dr. Beeks reviewed the results with Mr. White and told him he had a herniated disc pushing on one of his nerve roots. Dr. Beeks recommended that Mr. White undergo a surgical fusion because surgery was the only viable option at that point.5
Surgery was scheduled, but Mr. White cancelled it to get a second opinion. Dr. Beeks referred Mr. White to Dr. Stephen Dreskin for pain management and to discuss nonsurgical treatment. Mr. White testified that he had rated his pain level “an 8 or a 9 out of 10” when he met with Dr. Dreskin, who subsequently gave him an epidural steroid injection in his back. Because this injection made him feel worse, Mr. White did not schedule a second epidural steroid injection. Dr. Dreskin recommended surgery to address Mr. White‘s ongoing pain.
Mr. White returned to Dr. Beeks’ office, and they again discussed surgery. As Mr.
According to Mr. White, his back pain improved after surgery, but soon the pain returned, including “a real sharp drilling kind of pain every time [he] put any pressure on [his] right leg, [and a] fuzzy lightning bolt kind of feeling... down [his] right leg.” Subsequent tests indicated that ectopic bone had formed at the site of the surgery. Mr. White elected not to undergo additional surgery to remove the bone growth.
Dr. Law testified that Dr. Beeks failed to provide the information required by the standard of care in order to obtain Mr. White‘s informed consent to the surgery. He explained that Dr. Beeks was obliged to discuss the rationale for the surgery and the alternative treatments or alternative types of surgery, which included simple decompression without fusion or other types of fusion procedures. Dr. Law opined that Dr. Beeks should have explained to Mr. White that he had the option of deciding whether to use InFuse during surgery. In addition, Dr. Law said that Dr. Beeks should have described the relative advantages of InFuse, the complications associated with its use, the potential to increase the chance for a successful fusion when using InFuse versus not, and the manner in which InFuse would be used. Further, Dr. Law stated that Dr. Beeks should have explained the risks of performing a fusion, as opposed to a simpler type of decompression procedure. Notably, Dr. Law testified that Dr. Beeks should have disclosed to Mr. White that the main risks of using InFuse were nerve pain, irritation, and ectopic bone growth. Consistent with the trial court‘s pretrial order, Dr. Law did not testify as to any other risks, including fluid collection or cystic lesions. Dr. Law admitted that he does not discuss every possible “theoretical complication with a patient” in order to obtain informed consent. In Dr. Law‘s opinion, the use of InFuse caused ectopic bone growth at the site of the fusion, and the bone growth precipitated Mr. White‘s compressive radiculopathy, which caused pain.
Dr. Beeks testified that he discusses with his patients the risks associated with medical procedures because he could not expect the typical patient to know of such risks and “the patients need to make an informed decision of whether they want to have a procedure.” Dr. Beeks stated that he had given Mr. White enough information so that he could make an informed decision. Dr. Beeks covered with Mr. White the risk of death, the possibility of an infection, and the potential for paralysis or increased weakness. The surgical consent form, signed by Dr. Beeks and Mr. White, stated that Dr. Beeks had “fully
Though he never specifically mentioned InFuse to Mr. White, Dr. Beeks testified that he “would have mentioned that [he was] going to use alternative bone-graft products to supplement so that [he] didn‘t have to go to [Mr. White‘s] iliac crest.” Dr. Beeks indicated that he decided not to get into technical specifics because he “wanted to keep th[e] discussion as straightforward as possible; and, mostly... wanted [Mr. White] to know what his potential outcomes were.” Dr. Beeks did not believe Mr. White needed “to know the specifics of the metallurgy of the screws or the difference in the hundreds of different types of bone-grafting options... available.” As a result, Dr. Beeks focused his discussion with Mr. White on the general risks that could result from the surgery, such as the risk of nonunion, the potential for hardware issues, the possibility of not healing, and the chance of neurological injury. At the time of the surgery, Dr. Beeks was aware InFuse could cause ectopic bone growth but that it did not result in any neurological injury.
Dr. Beeks’ expert medical witness, Dr. Christopher Kauffman, testified that Dr. Beeks had complied with the standard of care for a surgeon in obtaining Mr. White‘s informed consent for the surgery. According to Dr. Kauffman, informed consent requires telling patients “the things that... could [a]ffect their ability to get better and get back to work or their overall health status.” Dr. Kauffman indicated that Dr. Beeks had to review the options available to Mr. White and recommend the procedure that would be most successful in alleviating Mr. White‘s pain without significant complications. Dr. Beeks had to tell Mr. White about the relevant risks, such as the possibility of an infection or death, and the risks associated with the recommended type of posterior lumbar interbody fusion procedure.
In Dr. Kauffman‘s opinion, based upon the leading study on InFuse in 2006 — the year the surgery was performed — there were more benefits to using InFuse than risks, as compared to using a regular bone graft procedure. InFuse was associated with an increased incidence of ectopic bone growth; however, the ectopic bone growth had not been shown to cause neurological problems and, thus, could not be properly labeled a “risk” of the procedure. Thus, Dr. Kauffman stated that it was not clear whether the ectopic bone growth actually caused harm to Mr. White, especially because his presurgical pain mirrored his postsurgical pain. In addition, Dr. Kauffman testified that Mr. White was a cigarette smoker6 and that smoking hindered the healing process after a spinal fusion. Dr. Kauffman concluded that he could not say with certainty whether the ectopic bone growth was causing neurological problems, or if prior nerve aggravation and the bone‘s failure to fuse correctly because of continued smoking were the real sources of Mr. White‘s ongoing pain.
The jury returned a verdict in favor of Dr. Beeks, and Mr. White appealed, arguing that he was entitled to a new trial because the trial court had erred by excluding Dr. Law‘s testimony concerning the undisclosed risks that did not occur. A divided panel of the Court of Appeals affirmed the trial court‘s judgment. White, 2013 WL 6451764, at *9. The majority opinion held that the trial court did
We granted Mr. White‘s application for permission to appeal to decide whether the exclusion of expert testimony regarding undisclosed risks that had not materialized constituted an abuse of discretion, and if so, whether the error more probably than not influenced the jury‘s verdict.
II.
The doctrine of informed consent attempts to reconcile the tension between a physician‘s desire to do what he or she feels is best for a patient and the patient‘s right to personal autonomy and self-determination over his or her own body. See generally W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 32 (5th ed. 1984); Ben A. Rich, Medical Paternalism v. Respect for Patient Autonomy: The More Things Change the More They Remain the Same, 10 Mich. St. U.J. Med. & L. 87 (2006). Implicit in this notion of self-determination is the importance of receiving a patient‘s consent for any procedure and the preservation of the patient‘s right to make decisions about his or her medical care. Keeton, supra, at 190. Informed consent developed from the theory of battery, which created a cause of action for a “nonconsensual, intentional, and offensive touching of another without lawful justification.” Black‘s Law Dictionary 182 (10th ed. 2014); see Schloendorff v. Soc‘y of N.Y. Hosp., 211 N.Y. 125, 105 N.E. 92, 93 (1914) (“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient‘s consent commits an assault, for which he is liable in damages.“).
Courts established the basic principles of informed consent in the early 1900s, recognizing that a patient could bring a cause of action against a medical practitioner for performing an unauthorized medical procedure. See, e.g., Pratt v. Davis, 224 Ill. 300, 79 N.E. 562, 565 (1906); Mohr v. Williams, 95 Minn. 261, 104 N.W. 12, 16 (1905). Soon after, this principle was extended to necessitate consent for medical procedures, requiring that a physician‘s treatment not exceed the patient‘s wishes, regardless of what the physician, in his or her professional judgment, felt was best. See Rolater v. Strain, 39 Okla. 572, 137 P. 96, 99 (1913).
In Salgo v. Leland Stanford Jr. Univ. Bd. of Trs., 154 Cal. App. 2d 560, 317 P.2d 170, 181 (1957), the doctrine of informed consent, as it is known today, was first articulated. In Salgo, the California Court of Appeals examined not only the patient‘s consent, or lack thereof, but also the underlying medical information upon which the patient‘s decision was based. The court held that a physician should make a “full disclosure” of any facts necessary for a patient‘s “intelligent” consent to a proposed treatment, but a physician should also take into account the patient‘s mental and emotional state to decide how much and what information constituted full disclosure for informed consent. Id. Thus, Salgo planted the seed of informed consent and signaled the beginning of a slow shift away from a strict battery theory to a more context-sensitive informed consent theory.
In Tennessee, the doctrine of informed consent has evolved in much the same manner. This Court first recognized the medical battery cause of action in Butler v. Molinski, 198 Tenn. 124, 277 S.W.2d 448, 451-52 (1955) (distinguishing between actions for negligent malpractice and those premised upon the unauthorized performance of an operation). Fourteen years later, the Court explained in Ray v. Scheibert, 224 Tenn. 99, 450 S.W.2d 578, 581 (1969) that a medical battery action would result when a “plaintiff did not effectively consent — therefore, did not consent at all — to the operation which the defendant performed.” (emphasis added). On remand in Ray, the Court of Appeals stated that when no “informed or knowledgeable” consent for a procedure was obtained (and no exception was applicable), a physician would be liable to a patient for injuries resulting from the procedure, “regardless of whether such injuries resulted from negligence or otherwise.” Ray v. Scheibert, 484 S.W.2d 63, 71 (Tenn. Ct. App. 1972).
In 1974, the Court of Appeals first stated the legal standard for an informed consent action. Longmire v. Hoey, 512 S.W.2d 307, 309 (Tenn. Ct. App. 1974). In Longmire, the intermediate appellate court held that in an informed consent claim, the plaintiff had the burden to show that either the surgical procedure was not actually authorized or the physician withheld material information regarding the risks involved, thus preventing the patient from making an intelligent choice when giving consent. Id. at 310. The Longmire court further clarified that in cases where the physician withheld material information, “the withheld information must be of such nature as to vitiate any verbal or written consent given.” Id. Nevertheless, the court acknowledged that it would be humanly impossible to disclose every aspect and risk of a surgery and that such disclosure would likely prevent a layperson from forming a rational decision. Id. Thirteen years later, this Court again considered informed consent and, in a narrow holding, determined that a physician‘s deviation from the standard of care would constitute a battery, because “the doctrine of battery [is] applicable to cases involving [treatment] performed without informed or knowledgeable consent.” Cardwell v. Bechtol, 724 S.W.2d 739, 750 (Tenn. 1987) (quoting Ray, 484 S.W.2d at 71) (emphasis and internal quotation marks omitted).
In 1998, the Court reaffirmed the Cardwell framework in Shadrick v. Coker, 963 S.W.2d 726, 732 (Tenn. 1998), reiterating, “the doctrine of lack of informed consent is based upon the tort of battery.” The Court held that a health care provider would be liable for injuries resulting from a procedure performed without informed consent, regardless of whether those injuries resulted from negligence. Id. Later the same year, however, the Court, for the first time, severed the theories of medical battery and informed consent. Blanchard v. Kellum, 975 S.W.2d 522, 524 (Tenn. 1998). The Court stated,
Under the Blanchard analysis, Mr. White‘s action is not a case of medical battery because he authorized Dr. Beeks to perform the spinal fusion. Mr. White, however, claims that Dr. Beeks did not give him the “full story” as to all the risks involved with the use of InFuse. Dr. Beeks claims that he adequately informed Mr. White of the risks and, in any case, the harm he suffered was not caused by the procedure. Accordingly, this claim falls squarely in the realm of informed consent.
Because this is an informed consent case,
by evidence as required by
§ 29-26-115(b) 7 that the defendant did not supply appropriate information to the patient in obtaining informed consent (to the procedure out of which plaintiff‘s claim allegedly arose) in accordance with the recognized standard of acceptable professional practice in the profession and in the specialty, if any, that the defendant practices in the community in which the defendant practices and in similar communities.
III.
A.
Decisions regarding the admission or exclusion of evidence are generally entrusted to the sound discretion of the trial court. Mercer v. Vanderbilt Univ., Inc., 134 S.W.3d 121, 131 (Tenn. 2004) (citing Otis v. Cambridge Mut. Fire Ins. Co., 850 S.W.2d 439, 442 (Tenn. 1992)); see also Smartt v. NHC Healthcare/McMinnville, LLC, No. M2007-02026-COA-R3-CV, 2009 WL 482475, at *13 (Tenn. Ct. App. Feb. 24, 2009) (holding that the trial court did not abuse its discretion in admitting evidence to prove an element of the medical malpractice claim after applying the balancing test of
We review a trial court‘s decision to admit or exclude evidence under an abuse of discretion standard. Otis, 850 S.W.2d at 442. A trial court abuses its discretion by applying an incorrect legal standard or reaching an illogical or unreasonable decision that causes an injustice to the complaining party. Gonsewski v. Gonsewski, 350 S.W.3d 99, 105 (Tenn. 2011); Brown v. Crown Equip. Corp., 181 S.W.3d 268, 273 (Tenn. 2005); State v. Gilliland, 22 S.W.3d 266, 270 (Tenn. 2000); State v. Shirley, 6 S.W.3d 243, 247 (Tenn. 1999). In reviewing the trial court‘s exercise of discretion, we presume that the trial court‘s decision is correct and review the evidence in a light most favorable to upholding the decision. Lovlace v. Copley, 418 S.W.3d 1, 16-17 (Tenn. 2013) (quoting Gonsewski, 350 S.W.3d at 105). Discretionary decisions, however, require a conscientious judgment, consistent with the facts, that takes into account the applicable law. Lee Med. Inc. v. Beecher, 312 S.W.3d 515, 524 (Tenn. 2010).
Relevant evidence, however, may be excluded “if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence.”
In his pretrial deposition, Dr. Law testified that the patient should be told of the following risks associated with InFuse: ectopic bone growth and different types of possible responses in the patient, specifically cystic lesions behind the spine, radiculitis, and fluid collection. According to Dr. Law, both cystic lesions and fluid collection would have necessitated additional procedures and/or surgery. Based on the pretrial order, Dr. Law testified at trial only to the risks of ectopic bone growth and “inflammatory reactions, that can cause continued nerve pain.” He was not allowed to testify about any other risks, including details of the specific inflammatory reactions, or additional procedures that these risks might have required.
A prudent person needs to be informed of all “perils bearing significance” in order to give informed consent. See Ashe, 9 S.W.3d at 122 (quoting Canterbury, 464 F.2d at 791) (internal quotation mark omitted). “Perils bearing significance” necessarily include those perils that caused harm and those that did not. The fact that a risk did not materialize does not make it less of a risk. At the time a patient is making a decision whether to undergo a medical procedure, he needs to know prospectively the risks he is facing — not just those risks that in hindsight materialized and caused him harm. The fact that a risk did not materialize during or after surgery is not a determining factor in whether it should have been disclosed to a patient before surgery. Accordingly, the jury should have been allowed to hear Dr. Law‘s complete testimony about the risks of InFuse, as this evidence would have been relevant under
Even though the evidence is relevant under
B.
Having concluded the trial court erred in excluding the evidence, we must now determine whether the error was harmful and warrants reversal. An erroneous exclusion of evidence is harmful “when considering the whole record, error involving a substantial right more probably than not affected the judgment or would result in prejudice to the judicial process.” See In re Estate of Smallman, 398 S.W.3d 134, 152 (Tenn. 2013) (quoting State v. Gomez, 367 S.W.3d 237, 249 (Tenn. 2012)) (internal quotation marks omitted); see also
The jury was required to determine what information Dr. Beeks was obligated to disclose to Mr. White in accordance with the recognized standard of care, whether Dr. Beeks deviated from the standard of care by not disclosing adequate information to Mr. White, and whether a reasonable person in Mr. White‘s position, adequately informed of the risks inherent in the use of InFuse, would have consented to its use. See Ashe, 9 S.W.3d at 123. In making this determination, the jury could have considered “the plaintiff‘s idiosyncrasies, fears, age, medical condition, and religious beliefs.” Id. at 124 (citing Fain v. Smith, 479 So. 2d 1150, 1155 (Ala. 1985); Bernard v. Char, 903 P.2d 667, 674 (Haw. 1995); Backlund v. Univ. of Wash., 137 Wash. 2d 651, 975 P.2d 950 (1999)). The jury was also instructed to consider the presence or absence of alternative procedures/treatments, the potential risks and benefits of those procedures, and the impact on Mr. White‘s health if InFuse had not been used.9
I‘ve had one case of ectopic bone growth. I‘ve had, oh, probably [ten] cases of a cystic lesion that forms behind the, in the patient‘s spinal canal. It‘s an inflammatory response. I‘ve had probably a [fifteen] percent, [fifteen] to [twenty] percent incidences] of patients developing inflammation postoperative—I would say, I would lump them all into [fifteen] to a [twenty] percent complication rate where patients either developed postoperative radiculitis or they developed a postoperative fluid collection where I had to take them back to surgery to draw the fluid off, or they have developed a cystic situation which I‘ve actually had to take them back to surgery for.
At trial, however, Dr. Law was precluded from testifying about the risks of InFuse that had not materialized. Consequently, he was not allowed to tell the jury about the risks of cystic lesions, fluid collection, or any other risks associated with InFuse that did not materialize. Thus, when asked at trial what risks were associated with InFuse, Dr. Law stated only the following: “[T]he main risk is inflammatory reactions, that can cause continued nerve pain. It can cause nerve irritation!,] and also the ectopic bone growth certainly is a complication that should be explained to the patient.”
After a careful review of the record, we hold that Mr. White was deprived of key evidence that was critical to his ability to prove his informed consent claim. This was a close case. The expert witnesses on behalf of Mr. White and Dr. Beeks offered differing opinions as to whether Dr. Beeks disclosed to Mr. White adequate information about the risks associated with spinal fusion surgery and the use of InFuse. Unlike Dr. Law, however, Dr. Beeks and his expert, Dr. Kauffman, were not precluded from offering substantial testimony against Mr. White‘s informed consent claim. Had Dr. Law‘s testimony not been limited, the jury would have heard expert proof demonstrating that Dr. Beeks failed to disclose to Mr. White that the use of InFuse was associated with a number of risks, in addition to ectopic bone growth and inflammation, that not only might have caused Mr. White continued back pain, but might have necessitated further invasive procedures. Given the issues in dispute, this would have had a significant effect on the jury‘s determination of whether Dr. Beeks obtained Mr. White‘s informed consent before using InFuse and whether a prudent person in Mr. White‘s position, adequately informed, would have consented to its use. The effect of the trial court‘s ruling was that the jury did not have the opportunity to hear relevant, admissible evidence supporting Mr. White‘s informed consent claim. Cf. White v. Vanderbilt, 21 S.W.3d 215, 229-30 (Tenn. Ct. App. 1999) (finding that the erroneous exclusion of an expert‘s deposition was not harmless, as it prevented the plaintiffs, in a close case, from introducing relevant evidence to support their medical malpractice claim); Brown v. Daly, 968 S.W.2d 814, 817-18 (Tenn. Ct. App. 1997) (finding that the erroneous exclusion of a party‘s proffered statement on the basis that it was hearsay was not harmless, as exclusion of
We hold that the erroneous exclusion of Dr. Law‘s testimony, more probably than not, affected the outcome of the trial. See Smallman, 398 S.W.3d at 152. Accordingly, the error was not harmless, and Mr. White is entitled to a new trial on his informed consent claim.
Conclusion
We hold that the trial court erred by excluding expert testimony regarding undisclosed medical risks that had not materialized. This error, more probably than not, affected the jury‘s verdict. Therefore, the judgments of the trial court and the Court of Appeals are reversed, and the case is remanded to the trial court for a new trial on the issue of informed consent consistent with the holdings in this opinion. Costs of this appeal are assessed to David A. Beeks, M.D., for which execution may issue if necessary.
CITY OF MEMPHIS v. SHELBY COUNTY, Tennessee
Court of Appeals of Tennessee, AT JACKSON.
November 13, 2014 Session Filed February 20, 2015
Application for Permission to Appeal Denied by Supreme Court August 14, 2015.
Notes
A physician has a duty to give a patient certain information before treating the patient; the information the physician must disclose is that information about the treatment involved and its attendant risks to enable the patient to make an intelligent decision about whether to undergo the treatment. The information that must be provided to the patient is that information that would be provided by physicians in the specialty in the community in which the physician practices or in similar communities.
In this case, plaintiff has the burden of proving:
- What a reasonable medical practitioner in the same or similar community would have disclosed to the patient about InFuse and the risks of it;
- That the defendant departed from the standard; and
- That a reasonable patient in plaintiff‘s position would have refused the treatment with InFuse if properly advised of the risks.
In determining how a reasonable patient would have acted under the circumstances, you should consider the testimony of the plaintiff, the plaintiff‘s idiosyncrasies, fears, age, medical condition, and religious beliefs, the presence or absence of alternative procedures/treatments and the potential risks and benefits thereof, and the impact of not using InFuse on plaintiff‘s health.