McCorkle v. Gravois

Citations: 152 So. 3d 944; 2013 La.App. 1 Cir. 2009; 2014 La. App. LEXIS 1516; 2014 WL 3671577Docket: No. 2013 CA 2009

Court: Louisiana Court of Appeal; June 6, 2014; Louisiana; State Appellate Court

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Plaintiffs appealed a trial court judgment that granted summary judgment to Dr. Wayne Gravois, dismissing their wrongful death and survival action for alleged medical malpractice related to the prescription of Lunesta to Harvey MeCorkle. MeCorkle, who visited Dr. Gravois on January 13, 2010, for insomnia and stress, received educational materials and samples of Lunesta, with instructions to call if he experienced any issues. On January 17, 2010, MeCorkle was found deceased from a self-inflicted gunshot wound. A medical review panel found Dr. Gravois's prescription was appropriate and met the standard of care. Plaintiffs claimed Dr. Gravois failed to consider MeCorkle's history of depression and did not provide necessary safety instructions regarding Lunesta, contributing to MeCorkle's suicide. Dr. Gravois filed a summary judgment motion, arguing that the plaintiffs lacked expert testimony to establish a breach of the standard of care, as even their expert supported his actions. The trial court affirmed the summary judgment, concluding that no genuine issues of material fact existed.

Plaintiffs failed to prove the applicable standard of care in their case against Dr. Gravois regarding MeCorkle's death, relying on the Physicians’ Desk Reference (PDR) and package inserts for their claims. Plaintiffs argued that the Lunesta package insert establishes the standard of care, which requires physicians to instruct patients to read the Medication Guide. They contended Dr. Gravois violated this standard by providing only general instructions, contributing to MeCorkle's death. The trial court ruled that plaintiffs lacked an expert witness to testify on the standard of care, leading to the granting of Dr. Gravois's motion for summary judgment and dismissal of the claims with prejudice. Plaintiffs appealed, asserting the trial court erred by requiring an expert to establish causation regarding Lunesta’s role in MeCorkle’s death and ruling on an issue not properly before the court. The legal standards for summary judgment were outlined, emphasizing the mover's burden to demonstrate the absence of factual support for essential elements of the opposing claim, and clarifying that the court's role is to identify genuine triable issues rather than weigh evidence.

Summary:

Summary judgments are favored, but factual inferences must be drawn in favor of the opposing party, with all doubts resolved in their favor. Appellate courts review evidence de novo under the same criteria as trial courts when assessing summary judgment appropriateness. In a medical malpractice case, plaintiffs argue that expert medical testimony is not always necessary to establish the standard of care, citing the Lunesta package insert as sufficient for physicians' obligations. The Louisiana Supreme Court generally requires such expert testimony unless negligence is evident to a layperson or if the physician admits to a breach of the standard of care. Instances where expert testimony may not be needed include clear cases of negligence, the physician's own testimony regarding the standard of care, or violations of statutes/bylaws. In the current case, Dr. Gravois provided Lunesta samples to MeCorkle without the package insert but advised him to contact the clinic for any issues. MeCorkle experienced vivid dreams and concentration issues after using Lunesta but did not report these to Dr. Gravois. Ultimately, MeCorkle fatally shot himself after taking the medication for the fourth night.

Dr. Gravois's motion for summary judgment was supported by a medical review panel's opinion, which found no evidence that he failed to meet the applicable standard of care. He also presented deposition testimony from Dr. Matthew Abraham, a board-certified sleep medicine physician. Initially, Dr. Abraham had asserted in an affidavit that patients prescribed Lunesta should receive detailed instructions on monitoring for unusual thoughts or behaviors. However, during his deposition, he acknowledged that he did not recall writing those specific instructions and typically provides less detailed guidance, suggesting patients should contact his office for any medication-related issues. Dr. Abraham contrasted his instructions with those in the Lunesta package insert, admitting that he gives significantly less information and does not discuss suicide with patients taking Lunesta. He stated that the standard of care does not derive from the package insert but rather from ensuring patients can communicate any medication changes. Consequently, he opined that if Dr. Gravois instructed the patient to report any problems, he did not breach the standard of care. Despite Dr. Abraham's retraction of his earlier affidavit, plaintiffs argued against the summary judgment, claiming they could establish a breach of standard of care based on the Lunesta package insert and related PDR, which warn that worsening depression and suicidal thoughts may occur in primarily depressed patients using sedative/hypnotics. The precautions section of the product information emphasizes the importance of patient instructions regarding the use of Lunesta, including taking it immediately before bed, avoiding alcohol, consulting a physician with a history of mental health issues, and advising women on pregnancy and nursing.

The Medication Guide for Lunesta outlines serious side effects, including sleepwalking, abnormal thoughts, aggressive behavior, confusion, hallucinations, worsening depression, and suicidal tendencies. Plaintiffs argue that Dr. Gravois breached the standard of care by failing to instruct MeCorkle to read this guide, contributing to MeCorkle's death. Federal regulations mandate that drug manufacturers include detailed labeling information, covering contraindications, warnings, and precautions, which informs the medical community about drug risks. The PDR provides similar information and both have been utilized in medical malpractice cases to establish the standard of care. While these documents can support claims of negligence, the application of their contents in legal determinations can be complex, as seen in various cited cases. Plaintiffs reference multiple legal precedents to argue for their use in establishing the standard of care in this case.

In Terrebonne, the court addressed a unique case in Louisiana where a plaintiff relied exclusively on a manufacturer’s specific warning to establish the standard of care. The plaintiff opposed a defendant physician's motion for summary judgment by referencing the drug's package insert, which specified administration during particular times in a menstrual cycle, arguing that the physician’s deviation from these instructions constituted prima facie evidence of negligence. The court highlighted that, per the Louisiana Supreme Court's ruling in Pfiffner, expert testimony is not always required to establish the standard of care when a lay jury can recognize negligence. The court also referenced the Minnesota Supreme Court's decision in Mulder v. Parke Davis, which found that a physician’s failure to follow dosage recommendations from a manufacturer could necessitate an explanation for the deviation, especially when warnings indicated serious risks. Additionally, the court noted that the Mississippi Supreme Court in Thompson v. Carter recognized information in package inserts as prima facie proof of proper drug use. Ultimately, while the court acknowledged that existing jurisprudence supports using such evidence to demonstrate negligence, it refrained from definitively stating that a manufacturer’s warning alone could establish the standard of care. The court concluded that the question of whether plaintiffs could use this evidence as prima facie proof of the physician's negligence remained unresolved, making summary judgment inappropriate.

In the case of Foumet, a physician was accused of negligence for prescribing a medication contraindicated for a patient with a specific medical history while failing to disclose associated risks. The Physician's Desk Reference (PDR) explicitly stated the contraindication, yet the physician claimed it was standard practice to prescribe the drug regardless. The physician appealed a trial court ruling favoring the plaintiff, arguing that the court erred by relying solely on the PDR's contraindications. The Fifth Circuit Court of Appeal upheld the trial court's decision, emphasizing the authority of the PDR as a reliable medical source. 

Furthermore, the appellate court rejected the physician's claim regarding the plaintiff's lack of informed consent, highlighting the Informed Consent Doctrine, which mandates that patients be informed about their condition, proposed treatments, associated risks, and alternatives. The court noted that the physician's assertion about negligible risk contradicted the PDR warnings, reinforcing the PDR's reliability.

In a related case, Christiana, the Fifth Circuit reversed a summary judgment in favor of a hospital, citing that physician affidavits failed to address specific manufacturer contraindications regarding a medical stapler. The court found that deviation from manufacturer warnings could constitute negligence, even without expert testimony, given that such evidence could sufficiently establish a prima facie case of negligence. Together, the cases of Foumet, Terrebonne, and Christiana illustrate that clear contraindications or warnings in medical product documentation can inform a lay jury about the standard of care, leading to inferences of negligence when healthcare providers act contrary to these guidelines.

In Deroche v. Tanenbaum, the Fourth Circuit Court of Appeal upheld a summary judgment in favor of a physician, concluding that a manufacturer’s labeling and package insert alone cannot establish the medical standard of care under La. R.S. 9:2794. The plaintiffs alleged that the physician deviated from the manufacturer's instructions regarding Fleet Phospho-Soda preparation, but failed to provide expert medical testimony to substantiate their claim. The court emphasized that without expert testimony, the plaintiffs could not demonstrate a breach of the standard of care, leading to the dismissal of their case.

Similarly, in Robin v. Hebert, the Third Circuit also ruled that reliance on product labeling without expert testimony was inadequate to establish the standard of care in a case involving complex medical issues, resulting in the dismissal of the claims against a cardiologist. 

In the current case involving Lunesta, the court noted that the package insert contained general warnings regarding depression in patients but lacked specific contraindications or clear directives on administration that would differ from the physician’s actions. As a result, the plaintiffs could not meet their burden of proving the applicable standard of care or establishing negligence without expert testimony. The court referenced the New Jersey Supreme Court's caution that package inserts are not designed to set medical standards and that physicians often rely on their own experience over manufacturer information, reinforcing the necessity of expert testimony in such cases.

Expert testimony is essential to interpret package inserts and the Physician's Desk Reference (PDR), as these documents are intended for medical professionals rather than the general public. The court asserts that package inserts and PDR references alone do not establish the standard of care for physicians, and a physician's failure to follow PDR warnings does not automatically imply negligence. Relying solely on the PDR could mislead juries and undermine the necessity of expert testimony, potentially positioning drug manufacturers as arbiters of medical practice and placing undue liability on physicians. 

In this case, the trial court's judgment granting Dr. Gravois's motion for summary judgment and dismissing claims against him is affirmed. Plaintiffs did not adequately argue that Dr. Gravois breached the standard of care in prescribing Lunesta, focusing instead on his failure to provide specific instructions from the package insert. No expert testified that prescribing Lunesta constituted a breach of care. The trial court emphasized that a breach must be proven through expert testimony, which the plaintiffs lacked. Although plaintiffs contested the trial court's decision regarding their ability to establish the standard of care, the court found no error in its judgment since no expert supported their claims regarding the package insert as the standard of care for prescribing physicians. The conclusion affirms that the trial court's findings on both the standard of care and breach thereof were sound, and the issue of causation remains unaddressed due to the focus on the standard of care.

In Fournet v. Route-Graham, the appellate court emphasized that an expert opinion contradicting the Physician's Desk Reference (PDR) warnings did not justify disregarding the PDR’s reliability. In Terrebonne v. Floyd, the court found unresolved issues regarding whether a manufacturer’s specific warnings could serve as prima facie evidence of negligence, making summary judgment inappropriate. The appeal focused on whether the plaintiffs could prove the standard of care concerning Dr. Gravois's prescription of Lunesta, particularly through the Lunesta package insert and PDR references. Dr. Gravois testified he instructed the patient, McCorkle, to contact the clinic with any medication issues, although he did not definitively tell McCorkle to stop taking the medication if problems arose. Despite expert physicians suggesting Lunesta likely contributed to McCorkle’s suicide, the panel concluded that Dr. Gravois did not breach the standard of care in prescribing the medication. Regulatory requirements dictate that newer drugs must include "Boxed Warnings" for serious risks, which differ in structure from older drugs’ labeling. The summary highlights that while package inserts provide some evidence of the standard of care, they are not definitive, as shown in Thompson, where the burden could shift to the physician to justify deviations from recommended use. Additionally, a "contraindication" indicates that a drug should not be prescribed under certain patient conditions.

The court referenced the case of Terrebonne as a precedent showing that other courts recognize the Physicians' Desk Reference (PDR) as an authoritative source in medical malpractice cases. Specifically, it cited LW v. Delta Clinic, where the use of the PDR and drug labeling was approved for establishing the standard of care and prima facie negligence. In LW, the defendant physician acknowledged the PDR's acceptance in the medical field and used it in testimony, yet the plaintiff alleged malpractice due to the injection of a drug at a higher concentration than the PDR specified. The court found conflicting evidence regarding the compliance with the PDR, leading to a reversal of summary judgment.

Additionally, in Ekendahl v. Louisiana Medical Mutual Insurance Company, the Second Circuit ruled that a manufacturer's warning is merely evidence, not definitive proof, of the standard of care. The trial court's decision to credit expert testimony over the manufacturer's recommendations was upheld, emphasizing the necessity of expert testimony to establish standards of care and breaches, barring obvious negligence. Furthermore, the New Jersey Supreme Court determined that package inserts and PDR references do not alone establish the standard of care; they may be considered alongside expert testimony in a malpractice case.