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Pharmacist not qualified to give causation testimony in medically complex HCLA case.

Where plaintiff’s pharmacist expert was deemed incompetent to offer necessary causation testimony against the pharmacy defendants in an HCLA suit based on his inability to rule out possible causes of death in a complex medical case, summary judgment for those defendants was affirmed.

In Kidd v. Dickerson, No. M2018-01133-COA-R3-CV (Tenn. Ct. App. Oct. 5, 2020), plaintiff was the daughter of a patient who died after a stroke. The patient had multiple health issues at the end of her life, and the proper diagnosis and medication prescribed for blood clots was in contention in this HCLA suit.

On September 30, 2014, the patient, who was 82 years old, went to Family Health Group (“FHG”) with pain and swelling. She was seen by Dr. Ball and diagnosed with a blood clot. She returned on October 7 and was seen by Dr. Farmer, who also diagnosed a blood clot and prescribed a blood-thinning medicine called Pradaxa, which the patient had filled that day by the pharmacy defendants. The patient returned to FHG on October 13 for a follow-up appointment and saw Dr. Ball again, then returned on October 20 and was seen by a nurse practitioner, who found that the patient was “ill appearing,” that she had an “irregularly irregular” cardiovascular rhythm, and that she should be referred to a cardiologist that week.

The next day, the patient fainted and went to the emergency room, where she was admitted to the hospital. On October 24 she was diagnosed with a stage IV stomach tumor as well as a mass in her liver. An MRI showed that she had had multiple strokes, and she was also diagnosed with “healthcare associated pneumonia.” She was transferred to a nursing home, where she was “non-communicative and non-responsive” until her death on November 21.

The patient’s daughter (plaintiff) filed a healthcare liability suit against the pharmacy defendants, Dr. Farmer, Dr. Ball, and FHG. After several motions were filed and litigated, the trial court ultimately granted summary judgment to the pharmacy defendants; granted summary judgment to the “Defendant Doctors on the issue of whether their negligence caused Ms. Grimes’ death, on Plaintiff’s informed consent claim, and on Plaintiff’s claim that the doctors’ negligence hastened Ms. Grimes’ death;” granted summary judgment to Dr. Farmer on all claims; and “denied summary judgment to the Defendant Doctors on the issues of whether Dr. Ball failed to supervise [the nurse practitioner] and whether Dr. Ball and [FHG] caused Ms. Grimes’ injury and suffering.” This appeal followed.

Pharmacy Defendants

In its lengthy analysis, the Court of Appeals first affirmed summary judgment for plaintiff’s claims against the pharmacy defendants based on their alleged failure to give the patient appropriate warnings about the Pradaxa drug. Causation in an HCLA case must be proven by expert testimony, and it “must be shown to a reasonable degree of medical certainty.” (internal citation omitted). While plaintiff relied on the affidavits of two expert witnesses, one of those witnesses testified only to the doctors’ actions, so her cause of action against the pharmacy defendants was supported only by the affidavit of Mr. Lander, a “licensed and clinically active pharmacist.” The trial court ruled that “Mr. Lander’s opinion [regarding the patient’s cause of death] was a medical diagnosis which he was not qualified to make,” and that plaintiff had thus failed to present competent causation testimony as to the pharmacy defendants. The Court of Appeals agreed.

While the Court noted that pharmacists’ opinions have been deemed competent in some HCLA cases, it ruled that the trial court did not err in excluding the pharmacist expert’s opinion here. Mr. Landers opined that the patient died due to a “delayed diagnosis of an apparent acute gastrointestinal bleed,” and that the pharmacy defendants “directly caused the symptoms that led to the death of [the patient].” Based on the facts of this case and the multiple health issues that potentially led to the patient’s death, the Court of Appeals found that “to state that the Pharmacy Defendants’ negligence was the ‘but for’ cause of [the patient’s] injuries necessarily required Mr. Landers to ‘rule out’ her other conditions to determine that her injuries would not have occurred without the Pharmacy Defendants’ failure to give timely and adequate warnings.” The Court stated:

Mr. Lander’s affidavit provides no information as to how his education and experience as a pharmacist makes him competent to opine as to the cause of a patient’s stroke or to rule out other possible causes for her death. …[W]e decline to assume that a pharmacist has the education and experience to offer opinions on this particular issue. In short, this is a complex case wherein [the patient] was found to have a multitude of issues all bearing down on her in the weeks prior to her death. Mr. Lander, however, has not shown via his affidavit that he is competent to express an opinion as to the cause of [the patient’s] death in light of this complex medical situation.

Summary judgment for the pharmacy defendants was thus affirmed.

Informed Consent Claim Against Doctors

After analyzing evidentiary issues, the Court of Appeals looked at plaintiff’s allegation that the defendant doctors’ failed to properly obtain the patient’s informed consent before prescribing Pradaxa. Like all HCLA claims, an informed consent claim requires a plaintiff to prove causation by expert testimony, and the standard for causation in this type of claim “is whether a reasonable person in the patient’s position would have consented to the procedure or treatment in question if adequately informed of all significant perils.” (internal citation omitted).

Here, both parties “agreed that the decision to prescribe Pradaxa and the amount prescribed were within the recognized standard of acceptable professional practice as well as that a reasonable person in [the patient’s] position would take Pradaxa as prescribed because of the severe risk of clotting.” Plaintiff, though, argued that the doctors failed to give the patient “any or adequate information to allow [her] to formulate an intelligent and informed decision[.]” While there was a disagreement regarding what the doctors told the patient about the drug, the Court ruled that these disputed facts were not material. Plaintiff’s own expert testified that “a reasonable person would not refuse to receive a blood thinner if they were aware of the risk of embolism due to a blood clot,” that the doctor was reasonable in prescribing it, and that “a reasonable person would go forward with taking that medication because of the risk of clotting to her life.” Because plaintiff failed to present evidence that “even if given adequate information concerning the risks, a reasonable person would have chosen a different course of treatment,” summary judgment on the informed consent claim was affirmed. (internal citation omitted).

Other Claims Against Doctors

Plaintiff alleged in her complaint that defendant doctors’ negligence caused the death, hastened the death, and caused pain and suffering to the patient. Regarding the allegation that the doctors’ negligence caused the patient’s death, the Court of Appeals pointed out that plaintiff’s own expert “testified that he was not offering an opinion that [the patient’s] death was caused by the negligence of the Defendant Doctors.” Because plaintiff offered no evidence to create a factual dispute on this claim, the Court of Appeals affirmed the grant of partial summary judgment as to this allegation.

Plaintiff’s expert, however, did testify that defendant doctors’ actions “may have hastened [the patient’s] death,” but the Court of Appeals ruled that the undisputed facts supported summary judgment for defendants on this claim as well. Plaintiff failed to properly respond to certain of defendants’ statements of undisputed facts, which resulted in them being deemed admitted. One of those facts was that the patient “more likely than not would have died sooner than she did had she not received Pradaxa or had it been discontinued sooner than it was,” and that “the use of Pradaxa did not hasten her death, but more probably than not prolonged her life.” Further, plaintiff’s expert stated that he would defer to an oncologist regarding “whether the Pradaxa-caused bleeing issues hastened [the patient’s] death,” and the only oncologist involved in this case had stated that her death was not hastened by her use of Pradaxa. Based on these facts, summary judgment on the hastening of death claim was affirmed.

Next, the Court looked at the claim that the Dr. Ball and FHG caused the patient pain and suffering. Plaintiff presented no admissible evidence that the patient reported symptoms that would indicate internal bleeding in either her October 13 visit or October 17 phone call. Instead, the first mention was at her visit with the nurse practitioner on October 20. Because there was no evidence that Dr. Ball or FHG had reason to know of any “red flag” symptoms before October 20, the Court determined that there was insufficient evidence to support a pain and suffering claim for any actions before that date.

The Court noted, however, that the time period from October 20 until the patient was stabilized in the hospital was a different story, and it concluded that the pain and suffering claim regarding this time period should be allowed to continue. Defendants argued that any breach of the standard of care during this period was attributable only to the nurse practitioner. The Court agreed that plaintiff could not hold Dr. Ball and FHG liable under a negligent supervision theory, as there was no proof that the nurse practitioner was unfit for her job or that defendants were aware of such unfitness,  and it therefore reversed the trial court’s decision to allow this claim. The Court pointed out, however, that plaintiff’s complaint also raised the issue of respondeat superior. The Court reasoned that “[t]he trial court’s reliance on [plaintiff’s expert’s] testimony that the doctors were ‘ultimately responsible’ for the negligence of their employed nurse practitioner appears to fall more within a claim of vicarious liability premised on respondeat superior than a claim for negligent supervision.” Accordingly, the Court stated that this respondeat superior claim could be further litigated in the trial court.

Summary Judgment for Dr. Farmer

The Court of Appeals briefly affirmed the trial court’s grant of summary judgment as to all claims against Dr. Farmer. The Court pointed out that plaintiff’s expert had “no criticism of Dr. Farmer’s decision to prescribe Pradaxa,” and that Dr. Farmer had not been involved with the patient’s care after the initial October 7th visit. Further, Dr. Farmer was not the supervising physician for the nurse practitioner at issue.

This case addressed many issues, but an important takeaway is the lengthy analysis regarding when a pharmacist is qualified to testify as to causation in an HCLA case.

NOTE:  This was case argued in the Court of Appeals on May 7, 2019.  The opinion was released on October 5, 2020, some 18 months later.  Footnote 1 notes, however, that the opinion was not assigned to Judge Stafford until September 5, 2020.  Thus, Judge Stafford cranked out this opinion one month after the case was assigned to him.

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