Opinion
Court of Appeals Case No. 21A-CT-298
07-13-2021
John OSSIM, Kristen Ossim, Appellants-Plaintiffs, v. John Thomas CUMMINGS, Jr., MD d/b/a Community Neurosurgery, Community Physician Network, Inc., and Community Hospitals of Indiana, Inc., Appellees-Defendants.
Attorney for Appellant: Robert T. Dassow, Tyler J. Zipes, Hovde Dassow & Deets, LLC, Indianapolis, Indiana Attorneys for Appellee: Robert G. Zeigler, Erin E. Meyers, Zeigler Cohen & Koch, Indianapolis, Indiana
Attorney for Appellant: Robert T. Dassow, Tyler J. Zipes, Hovde Dassow & Deets, LLC, Indianapolis, Indiana
Attorneys for Appellee: Robert G. Zeigler, Erin E. Meyers, Zeigler Cohen & Koch, Indianapolis, Indiana
MEMORANDUM DECISION
Bailey, Judge.
Case Summary
[1] John Ossim ("John") and his spouse (collectively, the "Ossims") appeal the entry of summary judgment in favor of John Thomas Cummings, Jr., MD d/b/a Community Neurosurgery ("Dr. Cummings"); Community Physician Network, Inc.; and Community Hospitals of Indiana, Inc. (collectively, the "Defendants") on their claims of medical malpractice related to the surgical implantation of a medical device. On appeal, the Ossims abandon their claim that the Defendants failed to obtain informed consent, focusing instead on a claim of failure to warn. Concluding that the Ossims have not demonstrated that a claim of failure to warn is available under the circumstances, we affirm.
Facts and Procedural History
[2] The Ossims filed a proposed complaint with the Indiana Department of Insurance, alleging that the Defendants were liable for medical malpractice. A medical review panel (the "Panel") issued a unanimous opinion in favor of the Defendants. The Ossims then pursued their case in the Marion County Superior Court.
[3] The Defendants moved for summary judgment, designating the opinion of the Panel. The Defendants argued that, because the Panel unanimously opined in their favor, they were entitled to summary judgment "[u]nless [the Ossims] provide[d] an expert opinion to the contrary[.]" App. Vol. 2 at 4. The Ossims filed a response and a cross-motion for partial summary judgment. The Ossims declined to designate expert testimony, arguing that doing so was unnecessary.
[4] The designated evidence favorable to the Ossims indicates that, in 2012, John underwent back surgery. During the surgery, Dr. Cummings used the Xclose Tissue Repair System from Anulex Technologies, Inc. ("Xclose") to repair John's annulus, implanting two devices. About one year before the surgery, the U.S. Food and Drug Administration (the "FDA") issued a warning letter stating that (1) the Xclose device was not approved for annulus repairs, (2) there were potential risks associated with using the Xclose device for such repairs, and (3) the FDA considered the use to be "investigational." App. Vol. 2 at 124.
[5] There is designated evidence indicating that, prior to surgery, Dr. Cummings told the Ossims that he would not be implanting a medical device, and at no point prior to implantation were the Ossims informed of the content of the FDA letter. After surgery, John experienced worsened pain. Imaging was ordered, and the Ossims learned of the use of Xclose devices. John was diagnosed with device expulsion and recurrent herniation. John ultimately underwent a second back surgery that involved removal of the Xclose devices.
[6] The Ossims argued that the designated evidence established that the Defendants breached the applicable standard of care by "(1) failing to take reasonable steps to notify [the Ossims] of the FDA's Warning [Letter] before or after John's surgery; and/or (2) failing to obtain ‘informed consent,’ i.e. disclose all material information to [the Ossims] before John's surgery." App. Vol. 2 at 64 (emphases removed). Following a hearing, the trial court resolved the pending motions in favor of the Defendants, granting them summary judgment.
The transcript of the hearing was not provided on appeal.
[7] The Ossims now appeal.
Discussion and Decision
[8] "When reviewing a summary judgment decision, our well-settled standard is the same as it is for the trial court[.]" Stafford v. Szymanowski , 31 N.E.3d 959, 961 (Ind. 2015). That is, summary judgment is appropriate only if "the designated evidentiary matter shows that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Ind. Trial Rule 56(C). "We construe all evidence in favor of and resolve all doubts as to the existence of a material issue in favor of the non-moving party." Stafford , 31 N.E.3d at 961. Moreover, we review questions of law de novo and "will reverse if the law has been incorrectly applied to the facts." Markey v. Est. of Markey , 38 N.E.3d 1003, 1006 (Ind. 2015) (quoting Woodruff v. Ind. Fam. & Soc. Servs. Admin. , 964 N.E.2d 784, 790 (Ind. 2012) ). "Otherwise, we will affirm a grant of summary judgment upon any theory supported by evidence in the record." Woodruff , 964 N.E.2d at 790.
[9] In summary judgment proceedings, the non-movant is "not required to come forward with contrary evidence until the party seeking summary judgment demonstrates the absence of a genuine issue of material fact." Stafford , 31 N.E.3d at 961 (quoting Kennedy v. Murphy , 659 N.E.2d 506, 508 (Ind. 1995) ). Notably, in medical malpractice cases like the instant case, in which a medical review panel has issued a unanimous opinion in favor of the provider, the panel opinion "is ordinarily sufficient to establish prima facie evidence negating the existence of a genuine issue of material fact entitling the [provider] to summary judgment." Id. "[I]n such situations, the burden shifts to the plaintiff[.]" Id. With limited exception, the plaintiff must designate expert testimony to show a genuine issue of material fact and avoid summary judgment. See id. ; cf. Glock v. Kennedy , 133 N.E.3d 768, 778-780 (Ind. Ct. App. 2019) (collecting cases and discussing the general requirement that the plaintiff designate expert testimony).
[10] In a medical malpractice action "based on ordinary negligence, the plaintiff must establish (1) a duty on the part of the defendant physician in relation to the plaintiff, (2) failure of the physician to meet the requisite standard of care, and (3) an injury to the plaintiff resulting from that failure." Spar v. Cha , 907 N.E.2d 974, 979 (Ind. 2009). Separate from a theory of ordinary negligence, there is a "distinct theory of liability" known as the doctrine of informed consent, where a claim is "premised on the physician's duty to disclose to the patient material facts relevant to the patient's decision about treatment." Id.
[11] Even if a provider has obtained informed consent, the provider may later be liable for negligently failing to disclose adequate information after treatment. See Harris v. Raymond , 715 N.E.2d 388, 394 (Ind. 1999) ("[I]t is essential that the health care provider disclose material facts to the patient at appropriate times during the course of the patient's treatment so that the patient may make informed decisions about health care issues."). A claim based on inadequate post-procedure disclosure is sometimes referred to as the failure to warn. See id.
[12] On appeal, the Ossims abandon the doctrine of informed consent. They focus on a claim of failure to warn. The Ossims contend that, independent of a claim of informed consent, Indiana law permits recovery where a provider fails to make " ‘reasonable efforts’ to inform the patient of FDA ‘safety alerts’ issued regarding the device." Br. of Appellant at 9-10 (quoting Harris , 715 N.E.2d at 394, 395 ). They argue that this claim is available for inadequate disclosure "before and after the procedure." Id. at 9. According to the Ossims, "[b]ecause the uncontroverted [designated] evidence demonstrates [that the Defendants] made no such efforts" to disclose the contents of the FDA letter, the Ossims are entitled to partial summary judgment on a claim of failure to warn. Id. at 17.
Indeed, the Ossims specify that they "do not raise ... the issue of ‘informed consent’ on appeal." Br. of Appellant at 9 n.3. The Ossims may have abandoned the issue of informed consent due to caselaw on the subject stating that, "except in those cases where deviation from the standard of care is a matter commonly known by lay persons, expert medical testimony is necessary to establish whether a physician has or has not complied with the standard of a reasonably prudent physician." Culbertson v. Mernitz , 602 N.E.2d 98, 104 (Ind. 1992). But see Glock , 133 N.E.3d at 778-80 (collecting cases and noting that our Supreme Court "has seemingly drifted away from the majority holding in Culbertson ..., although it has never been overruled").
[13] In arguing that a claim of failure to warn is available, the Ossims rely on our Supreme Court's decision in Harris and its subsequent decision in Cox v. Paul , 828 N.E.2d 907 (Ind. 2005). In both cases, the Court discussed the claim of failure to warn in the context of medical devices. Critically, those cases involved non-disclosure of safety information that emerged after surgical implantation. See Harris , 715 N.E.2d at 394 (involving a safety alert and a recall that the FDA issued several years after surgical implantation); Cox , 828 N.E.2d at 909-10 (involving similar circumstances). Indeed, in identifying a duty in Harris , the Court addressed the prospect of "significant new information pertaining to the safety of medical devices" that "becomes available " after implantation. Harris , 715 N.E.2d at 395 (emphases added); see also id. at 394 (determining that a provider has a duty "to warn ... patients about manufacturer and FDA safety alerts that pertain to medical devices the physician ... previously inserted or implanted in [a] patient[ ]" (emphasis added)). Moreover, in Cox , the entire discussion falls under the heading "Liability for Failure to Notify Patient of Newly Discovered Risks [.]" Cox , 828 N.E.2d at 911 (emphasis added).
[14] Here, unlike in Harris and Cox , the pertinent safety information was available at the time of implantation. In arguing that these cases nonetheless contemplate a failure-to-warn claim based on inadequate pre-procedure disclosure, the Ossims direct us to language in Harris stating that a provider has a duty to warn "both current and former patients." 715 N.E.2d at 395. The Ossims suggest that the use of the word "current" means that, independent of the doctrine of informed consent, a provider has a duty to warn "current" patients prior to implantation.
[15] We disagree with the Ossims’ expansive reading of the word "current." As earlier discussed, Harris involved the emergence of safety information after implantation. In using the word "current," our Supreme Court was explaining that a provider has a post-surgical duty to warn not only current patients—i.e. those currently under the provider's care—but also those who have severed ties with the provider. See id. (determining that a provider had a duty to warn a patient who moved to Arizona, declining to "distinguish[ ] between a current patient who perhaps has not seen the provider for quite some time and a former patient who has intentionally severed all ties with the provider"). When read in context, the word "current" cannot be fairly read to show our Supreme Court's identification of a pre-surgical duty to warn that is separate from the well-established duty associated with the doctrine of informed consent. Ultimately, Harris and Cox are distinguishable and do not support reversing the trial court.
We therefore disagree with the Ossims’ assertion that reversal is warranted because the trial court purportedly "declined to follow Harris and Cox " on related, non-dispositive issues. Br. of Appellant at 15.
[16] All in all, the Ossims have failed to direct us to Indiana law recognizing a claim of failure to warn based on information available at the time of the procedure, i.e. , information that could be disclosed when a provider seeks informed consent. Moreover, apart from urging expansive readings of Harris and Cox , the Ossims do not cogently argue that, outside the bounds of informed consent, a duty to warn applies. Because the Ossims abandoned the issue of informed consent and have not demonstrated that any other claim is available under the circumstances, we affirm summary judgment in favor of the Defendants.
Notably, the Ossims do not explore the relationship between informed consent and a failure to warn. They also do not provide a standard—or analysis directed thereunder—regarding identification of the alleged duty.
Having resolved the appeal on the grounds set forth above, we need not address the parties’ arguments regarding the necessity vel non of expert testimony to support a claim of failure to warn.
[17] Affirmed.
May, J., and Robb, J., concur.