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Patsy Mitchell v. Dr. James Ensor
Citation: Not availableDocket: W2001-01683-COA-R3-CV
Court: Court of Appeals of Tennessee; September 17, 2002; Tennessee; State Appellate Court
Original Court Document: View Document
A medical malpractice lawsuit was filed by Patsy Mitchell against Dr. James Ensor and Memphis Internal Medicine, alleging failure to obtain informed consent before administering a testosterone injection for diminished libido. The plaintiffs contended that Dr. Ensor deviated from the standard of care by improperly administering the 2cc Depo-Testosterone injection, which is typically used in male hormone replacement therapy. Specific allegations included: 1. Administering hormone therapy without proper qualification and failing to refer the patient to a qualified physician. 2. Not conducting necessary diagnostic tests, such as blood tests to assess androgen levels, prior to treatment. 3. Pursuing a treatment plan that could be harmful to the patient. 4. Prescribing an excessive dosage of Depo-Testosterone. 5. Ignoring manufacturer guidelines for administering the drug. 6. Using Depo-Testosterone in an unapproved manner by the FDA for female patients. 7. Failing to adequately inform the patient about the risks, benefits, and alternatives of hormone replacement therapy, particularly the serious risks associated with administering male hormones to female patients. The circuit court ruled in favor of Dr. Ensor and the medical group, and the Court of Appeals affirmed the judgment, remanding the case for further proceedings. Defendants’ negligence in administering Depo-Testosterone to Patsy Mitchell has resulted in significant physical and psychological harm, including permanent disfigurement, hirsutism, clitoromegaly, painful intercourse, and ongoing psychological injuries. The defendants, Dr. Ensor and Memphis Internal Medicine, admitted to treating Mrs. Mitchell’s asexual disposition with a 2cc injection of Depo-Testosterone, yet denied any negligence, claiming their actions conformed to medical standards and were based on their best judgment. They acknowledged discussing Mrs. Mitchell’s diminished libido prior to the injection. Mrs. Mitchell, a middle-aged woman with limited education and a history of medical issues, sought treatment from Dr. Ensor starting in 1995, during which he was her primary caregiver for various ailments, including menopausal complications. Medical records indicate she had previously experienced adverse reactions to hormone therapies. On January 5, 1998, during a visit for abdominal bloating, Dr. Ensor scheduled further tests after examining her. Disputes arose regarding the events leading to the Depo-Testosterone injection. Mr. Mitchell claimed he presented a list of health complaints, highlighting “sex,” and asked Dr. Ensor for help, to which Dr. Ensor allegedly responded affirmatively. An injection was administered without adequate discussion of its purpose or side effects, particularly clitoromegaly. Conversely, Dr. Ensor’s account indicated Mr. Mitchell expressed concerns about his wife’s asexuality, suggesting a different context for the injection's administration. Dr. Ensor questioned Mrs. Mitchell about her husband’s concerns regarding her diminished libido before agreeing to treatment. He believed she had overheard the conversation with her husband. In support of this, the plaintiffs’ Complaint stated that Dr. Ensor asked Mrs. Mitchell about her hormone levels, to which she mentioned her diminished libido, leading to Dr. Ensor offering a solution. Dr. Ensor claimed he informed her about her husband’s worries regarding her asexuality, and testified that Mrs. Mitchell acknowledged understanding these concerns. However, he admitted he did not provide a comprehensive warning about potential side effects of Depo-Testosterone, including clitoromegaly, focusing instead on pedal edema, hair loss, and acne. Following a 2cc injection of Depo-Testosterone, Mrs. Mitchell experienced no side effects for about a month. In February 1998, she felt a "stinging" sensation during intimacy, leading to the discovery of her enlarged clitoris, which alarmed both her and her husband. They contacted Dr. Ensor’s office for information about the drug, but neither the manufacturer's package insert nor the Physicians Desk Reference listed clitoromegaly as a known side effect. Despite her discomfort, Mrs. Mitchell did not seek immediate medical attention and did not inform Dr. Ensor or other physicians she visited about her condition from February to April 1998. It wasn't until May 12, 1998, that she consulted Dr. Floyd Shrader, her former general physician, who confirmed her clitoral enlargement measured about two inches in length, identifying it as clitoral hypertrophy. Dr. Shrader opined that Mrs. Mitchell's condition resulted directly from the testosterone injection she received. Following this diagnosis, the plaintiffs did not seek additional medical advice. On January 4, 1999, Patsy and Steve Mitchell filed a medical malpractice lawsuit against Dr. Ensor, Memphis Internal Medicine, and Jane Doe, claiming malpractice related to the Depo-Testosterone injection and the failure to obtain informed consent. Mr. Mitchell additionally claimed loss of consortium due to the impact on his wife's services and companionship. A trial began on April 2, 2001, during which defendants moved for a directed verdict, which was denied. After closing arguments, the plaintiffs requested a jury instruction on informed consent, which was also denied. The jury ultimately ruled in favor of the defendants on the negligence claim regarding the drug's prescription and administration. Following the verdict, the trial court denied the plaintiffs' motion for a new trial. The Mitchells appealed, raising issues regarding the court's refusal to instruct on informed consent, the admissibility of Dr. Ensor's testimony, the defense expert's testimony regarding alternative causes, and whether the verdict was against the evidence's weight. The trial court's denial of the informed consent instruction was based on perceived legal uncertainties and doubts about the relevance of the risks involved. Plaintiffs’ counsel proposed a special instruction on informed consent and medical negligence after the court rejected a general informed consent charge. They argued that the instruction was necessary to address Dr. Ensor’s alleged breach of the standard of care. The court, however, found no merit in distinguishing between lack of informed consent and medical negligence, denying the instruction. The proposed instruction outlined the physician's duty to obtain patient consent, whether express or implied, and emphasized the requirement to disclose relevant information for informed decision-making. It specifically noted Dr. Ensor's failure to adequately inform Patsy Mitchell about the administration of a 400 mg. Depo-Testosterone shot and its potential masculinizing side effects. If it were determined that a reasonable person in Mitchell's position would not have consented if properly informed, and that the injection caused her injuries, then Dr. Ensor could be found negligent. The court’s decision to deny the instruction hinged on whether the proposed jury instruction accurately represented the law. The trial judge expressed skepticism that the case involved informed consent. The plaintiffs' instruction was deemed a correct statement of the law regarding medical malpractice based on informed consent principles, as outlined in T.C.A. 29-26-118. This statute requires evidence showing that the defendant failed to provide adequate information for informed consent according to accepted professional standards. The distinction between lack of informed consent and medical battery was reinforced by the Tennessee Supreme Court in Ashe v. Radiation Oncology Assocs., where a lack of informed consent claim arises when a patient is aware of a procedure but not its associated risks. Tennessee courts consistently uphold this distinction, indicating that a physician's failure to inform about risks is foundational for a lack of informed consent claim. In Tennessee, an objective standard is applied to assess causation in medical malpractice informed consent cases, requiring consideration from the perspective of a reasonable patient regarding whether they would have consented to a procedure if adequately informed of significant risks. The trial court refused to instruct the jury on informed consent for two reasons: 1) the doctrine does not apply to therapeutic treatments, as established in Cary v. Arrowsmith, and 2) there was insufficient proof that defendants needed to inform the plaintiff of risks associated with their injury. In Cary, the court ruled that negligence claims related to therapeutic drug administration do not fall under informed consent but rather traditional malpractice actions. The court emphasized that treating physicians must obtain informed consent for medical treatments but are not required to get consent for each aspect of treatment. The court disagreed with the defendants’ view that informed consent only applies to surgical procedures, noting that expanding the doctrine to include therapeutic drugs would undermine its foundational principles. Mrs. Mitchell’s primary claim revolves around a lack of informed consent. The Tennessee Supreme Court differentiates between lack of informed consent and medical battery, as clarified in Ashe v. Radiation Oncology Assocs. In this context, medical battery occurs when a doctor performs an unauthorized procedure, such as operating on the wrong body part or conducting a procedure the patient was unaware of. In contrast, a lack of informed consent arises when a patient is aware of the procedure but not informed about its associated risks. The court indicated that the precedential case Cary v. Arrowsmith does not govern this situation, as it limits informed consent doctrine to scenarios where the treatment involves multiple distinct components. However, subsequent cases in Tennessee suggest that informed consent is applicable to both surgical and medication-related procedures. The law mandates that healthcare providers must furnish patients with sufficient information about treatment options, allowing for an informed decision. The trial court’s refusal to instruct the jury on informed consent was based on insufficient evidence to justify such a charge. Liability may ensue if a healthcare provider proceeds with treatment without the patient’s informed consent, irrespective of negligence. In Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998), the court clarified that health care providers are not obliged to detail every aspect of treatment or all possible risks to secure informed consent. It emphasized that full disclosure of every potential complication could overwhelm patients and hinder rational decision-making. Providers are generally not required to disclose risks deemed non-material, such as unlikely, obvious, or already known risks, or when a patient's condition makes such discussions impractical or harmful. In the case at hand, the evidence indicated that clitoral enlargement had never been documented as a side effect of testosterone injections. Expert testimonies revealed that this risk was exceedingly rare and did not necessitate specific warnings. One expert, Dr. Shrader, acknowledged the unlikelihood of such an occurrence and confirmed that the standard of care involves discussing likely risks, not every rare possibility. He indicated that while patients should be informed about potential male characteristics from hormone treatment, it was unnecessary to mention every rare effect. The court upheld the trial court's decision to deny the plaintiffs’ request regarding the lack of informed consent. Additionally, the plaintiffs contested the admissibility of Dr. Ensor's testimony regarding the standard of care, arguing it lacked a reasonable degree of medical certainty. The court addressed this issue as part of their review. Plaintiffs argue that the trial court incorrectly re-opened direct examination after their motion to strike, allowing defendants to establish Dr. Ensor's testimony based on a reasonable degree of medical certainty. They claim Dr. Ensor's testimony regarding the standard of care and his breach was based on external expertise rather than solely his treatment of Mrs. Mitchell, asserting he was testifying as an expert rather than a treating physician, which necessitates the use of the phrase "to a reasonable degree of medical certainty." However, the court finds that the plaintiffs' concern is not about Dr. Ensor’s qualifications to testify on the standard of care but rather about the absence of this specific phrase in his testimony. The court agrees that while expert opinions in medical malpractice cases cannot rely on mere possibility or speculation, the specific language regarding a "reasonable degree of medical certainty" is not a requisite for admissibility. Citing precedent from two workers' compensation cases, the court emphasizes that the absence of this phrase does not preclude recovery if sufficient evidence supports causation. In the referenced cases, courts upheld findings of causation based on the overall evidence, even in the absence of the "magic words." The trial court granted the defendant's motion for partial summary judgment based on Dr. Megibow's failure to use the phrase "to a reasonable degree of medical certainty" regarding the cause of the plaintiff's psychological injury. The trial court found that Dr. Megibow's testimony did not meet the required standard, despite his affirmative response to a question about the truth of his statements. On appeal, the panel determined the trial court erred, noting that Tennessee law does not mandate the use of specific phrases for the admissibility of expert testimony. Citing dissenting opinions from past cases, the panel argued that while adherence to statutory language (T.C.A. 29-26-115) is advisable, it should not be so rigidly enforced that it obstructs legitimate claims. The court emphasized that expert opinions should be evaluated based on their substance rather than the exact wording used. Furthermore, the panel referenced prior rulings affirming that admissibility, qualifications, relevancy, and competency of expert testimony are within the trial court's discretion and can only be overturned on appeal for abuse of that discretion. Consequently, the panel found no abuse of discretion in the trial court's decisions regarding Dr. Ensor's testimony and the reopening of direct examination. The appeal regarding the defense expert, Dr. Sanford, testifying on alternative causes of the plaintiff’s condition was also addressed without finding an abuse of discretion. Plaintiffs contend that Dr. Sanford's testimony was speculative and did not meet the standard of reasonable medical certainty required by Tennessee law. They argue that: (1) Dr. Sanford's opinions lacked a scientific basis and did not assist the trier of fact as mandated by Tennessee Rule of Evidence 702, particularly as he could not identify the actual cause of Mrs. Mitchell’s condition; (2) the trial judge misinterpreted Dr. Sanford’s testimony regarding alternate causes, believing it was intended to educate the jury rather than persuade them of a specific cause; and (3) the judge's limiting instruction failed to mitigate the prejudice caused by admitting Dr. Sanford's testimony. Plaintiffs assert that mere possibilities of causation, rather than probabilities, do not qualify as admissible expert opinion, referencing Tennessee case law. In response, the court disagrees with plaintiffs' claims of speculation, noting that Dr. Sanford’s opinions were not presented to establish causation but to provide context and potential explanations for the condition. The judge found that Dr. Sanford's testimony aimed to inform the jury about scientific ideas regarding the condition, rather than to assert definitive causation, and his responses at trial supported this interpretation. Dr. Sanford did not attribute Mrs. Mitchell’s clitoral enlargement to any of the alternate causes he mentioned, including late onset congenital adrenal hyperplasia, ovarian androgen overproduction, or an ovarian tumor. Although he discussed these conditions, he refrained from linking them specifically to her case. The plaintiffs argued that Dr. Sanford's testimony was inadmissible speculation, referencing case law, particularly Lindsey v. Miami Development Corp., where the Tennessee Supreme Court ruled testimony speculative when an expert could not provide a reasonable basis for their opinion regarding causation. The plaintiffs also cited Primm v. Wickes Lumber Co. and Reel v. Crawley, where expert testimony was deemed inadmissible due to vague causation explanations. In contrast, Dr. Sanford was neither asked nor did he provide an opinion linking Mrs. Mitchell’s condition to the alternate causes, differentiating his testimony from those in the cited cases and thereby not crossing the threshold of inadmissible speculation. This distinction parallels the consideration in Sakler v. Anesthesiology Assocs., a medical malpractice case regarding causation and negligence. Following a jury trial that resulted in a verdict for the defendant, the Saklers appealed, arguing that the trial court erred by allowing a defense expert to provide a medical opinion based on speculation rather than reasonable medical probability. The defense expert indicated multiple potential causes for vocal cord paralysis, asserting that any of these could be responsible, which the plaintiffs contended was insufficient as expert testimony should rely on reasonable medical probability. The court upheld the trial court's ruling, affirming the admissibility of the expert testimony. It concluded that defendants in medical malpractice cases can introduce expert testimony framed in terms of "possibility" to counter a plaintiff's expert testimony expressed in "reasonable medical probability." The court referenced the First Circuit's decision in Wilder v. Eberhart, which emphasized that while proximate causation must be established by expert testimony, defendants need only provide credible evidence to challenge the plaintiff's claims, rather than disproving causation. The ruling clarified that defendants could present other possible causes without needing to establish them with certainty, thus preventing the unfair burden that would arise if a defendant were required to prove an alternative cause to rebut the plaintiff's case. This principle maintains that the burden remains on the plaintiff to establish that their injury was more likely than not caused by the defendant's negligence. Defendant’s experts cannot testify on causation if they cannot identify one specific cause, among possible causes A, B, C, or D, that more likely than not led to the plaintiff’s injury. Their testimony is only admissible to counter the plaintiff's claims, per the precedent set in Wilder and supported by the Kentucky Court of Appeals in Sakler. The jury's verdict is evaluated against the standard that there must be material evidence supporting it, following the guidelines from Barnes v. Goodyear Tire and Crabtree Masonry Co. This includes taking the strongest view of evidence favoring the verdict, assuming the truth of supporting evidence, allowing reasonable inferences, and disregarding countering evidence. The appellate court found sufficient material evidence to uphold the jury’s verdict and affirmed the trial court’s judgment, remanding the case for further proceedings. Costs of the appeal are assigned to the appellants, Patsy Mitchell and Steve Mitchell, and their surety.