Howard v. Replogle

• Decision Date: 15 October 2019
• Docket Number: DA 19-0102
• Citation: 397 Mont. 379,2019 MT 244,450 P.3d 866
• Parties: Kathy HOWARD, Plaintiff and Appellant, and Cross-Appellee, v. Robert Edward REPLOGLE, M.D., Defendant, Appellee, and Cross-Appellant.
• Court: Montana Supreme Court

397 Mont. 379

450 P.3d 866

2019 MT 244

Kathy HOWARD, Plaintiff and Appellant, and Cross-Appellee,

v.Robert Edward REPLOGLE, M.D., Defendant, Appellee, and Cross-Appellant.

DA 19-0102

Supreme Court of Montana.

Submitted on Briefs: August 28, 2019

Decided: October 15, 2019

For Appellant: James G. Edmiston, Tanis M. Holm, Edmiston & Colton, Billings, Montana, Steven J. Harman, Steve Harman Law, PLLC, Billings, Montana

For Appellee: Gary Kalkstein, Travis Dye, Kalkstein & Dye, P.C., Missoula, Montana

Justice Ingrid Gustafson delivered the Opinion of the Court.

¶1 Plaintiff, Appellant, and Cross-Appellee Kathy Howard (Howard) appeals the Order Denying Plaintiff’s Renewed Motion for Judgment as a Matter of Law/Motion for New Trial issued by the Thirteenth Judicial District Court, Yellowstone County, on January 17, 2019. Defendant, Appellee, and Cross-Appellant Robert Edward Replogle, M.D. (Dr. Replogle) cross-appeals the District Court's October 25, 2018 Order Denying Defendant's Motion to Exclude Plaintiff’s Damages for Future Medical Expenses and Loss of Ability to Enjoy Life.

¶2 We affirm, addressing the following dispositive issues:

1. Did the District Court err by denying Howard's Motion for Judgment as a Matter of Law?

2. Did the District Court err by denying Howard's Motion for New Trial?

FACTUAL AND PROCEDURAL BACKGROUND

¶3 In approximately 2000, Howard was injured in a car accident. A short time later, she slipped and fell down a set of stairs. After dealing with back pain from these incidents for years, Howard was referred to Dr. Replogle in 2008. Dr. Replogle is a board-certified neurosurgeon and a member of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), who was practicing in Billings at the time of Howard's referral. In late 2008, Dr. Replogle performed a decompression procedure on Howard's spine, but Howard did not find relief. After the decompression procedure was not as effective as hoped, Dr. Replogle performed a multilevel fusion of Howard’s spine in early 2009 using PEEK grafts and a bone substitute. This fusion provided some pain relief to Howard for several months.

¶4 In late 2009, Howard was again experiencing back pain. In early 2010, Dr. Replogle recommended that Howard undergo a minimally invasive fusion of her L5-S1 vertebrae. Dr. Replogle recommended that this fusion be performed using unilateral pedicle screws and an OptiMesh graft. OptiMesh is a medical device designed, manufactured, and marketed by Spineology, Inc. OptiMesh is an "expandable bone graft

synthetic containment device," or essentially a mesh bag which is inserted into the disc space and then filled with bone graft material to fuse the vertebrae. Spineology invented OptiMesh to be used in interbody fusions. Due to FDA regulations, however, Spineology was not allowed to market OptiMesh for interbody fusions. The FDA-approved marketing language for OptiMesh stated that "OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft ) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates." The FDA does not regulate the use of the device, however, and spinal surgeons have been using OptiMesh "off-label" for interbody fusions in the United States and Europe since approximately 2003.

¶5 Dr. Replogle first used OptiMesh in a minimally-invasive interbody fusion in 2007. In 2008, Dr. Replogle bought $110,000 worth of Spineology stock and also entered into a consulting agreement with Spineology. Prior to Howard's surgery, Dr. Replogle had used OptiMesh in approximately 30 procedures. Before surgery, Dr. Replogle discussed the risks of the procedure with Howard as part of the informed consent process. Howard signed two consent forms stating that she understood the risks and wanted to proceed with the surgery. During the informed consent process, Dr. Replogle did not inform Howard of either his Spineology stock or his Spineology consulting agreement.

¶6 On March 11, 2010, Dr. Replogle performed the minimally invasive L5-S1 fusion procedure using OptiMesh. At a follow-up appointment after the surgery, Howard complained of pain, but Dr. Replogle observed no indications of abnormalities which required immediate intervention. Dr. Replogle observed Howard’s complaints to be normal following a spinal fusion

procedure. At Howard's last appointment with Dr. Replogle, on June 17, 2010, he informed Howard that further reconstructive spine surgery would not provide a benefit and referred her to a pain clinic. Howard did not follow up on this referral.

¶7 Howard continued to experience pain and was eventually referred to Dr. Judson Cook, a board-certified neurosurgeon who was then practicing in Cheyenne, Wyoming. In 2012, Dr. Cook performed a revision surgery and discovered problems with the OptiMesh fusion. Dr. Cook removed as much of the OptiMesh as he could when he performed the revision surgery.

¶8 In 2013, Howard filed suit against Spineology. In 2014, Howard filed a separate suit against Dr. Replogle and Northern Rockies Neurosurgeons. In 2016, Howard dismissed her claims against Northern Rockies Neurosurgeons and moved to consolidate the remaining claims against Spineology and Dr. Replogle. On July 31, 2018, Dr. Replogle filed a motion in limine seeking, in relevant part, to exclude evidence that Dr. Replogle owned shares of Spineology stock and preclude Howard from arguing that Dr. Replogle used OptiMesh for personal financial gain. In her brief opposing Dr. Replogle's motion, Howard argued that the "jury should be allowed to hear this relevant evidence and decide for itself whether this presented an ethical conflict of interest which should have been disclosed by Dr. Replogle to Plaintiff or not." At a hearing on the motion, Howard similarly argued that the issue of informed consent was a "battle of experts," involving a "disputed issue of fact" which made the matter "an issue for the jury to decide[.]" The District Court denied Dr. Replogle's motion in limine on this issue. Before trial, Howard settled with Spineology, leaving only her claims against Dr. Replogle pending. Howard contended that Dr. Replogle did not obtain her informed consent for the March 2010 procedure because he did not disclose his financial interest in Spineology to her, and that Dr. Replogle departed from the standard of care in performing the procedure.

¶9 The matter went to trial beginning on October 29, 2018. Dr. Allan Hamilton, Howard's expert witness, testified that Dr. Replogle did not meet the standard of care for obtaining informed consent when he did not disclose his financial ties to Spineology. Dr. Hamilton based his opinion on a set of guidelines issued by the AANS and CNS in 2008 regarding when a doctor should disclose his or her financial interest to a patient. Dr. Hamilton did not disclose the existence of these guidelines at his deposition before trial, but Howard did disclose them in a supplemental expert witness disclosure approximately two weeks before trial. Dr. Replogle moved to exclude the guidelines due to their untimely disclosure, but the District Court declined to exclude them, and Dr. Hamilton was allowed to testify about them at trial. Dr. Replogle, called as part of the Plaintiff's case-in-chief, testified that he did not disclose his Spineology interest to Howard. After the close of Howard's case-in-chief, she moved for judgment as a matter of law regarding the informed consent issue. The District Court denied the motion.

¶10 Trial continued, and Dr. Replogle's expert witness, Dr. Michael Levy, testified that Dr. Replogle was not required to disclose his financial ties to Spineology to obtain Howard's informed consent for the L5-S1 fusion procedure. Both Dr. Levy and Dr. Replogle further testified that they were not aware of the AANS and CNS guidelines. At the close of all evidence in the case, Howard again moved for judgment as a matter of law regarding her informed consent claim. The District Court again denied Howard's motion.

¶11 On November 2, 2018, the jury returned a verdict in favor of Dr. Replogle, finding that he was not negligent in either obtaining Howard's informed consent or the way he performed surgery. Howard then filed her renewed motion for judgment as a matter of law and motion for a new trial on December 5, 2018. After the matter was briefed, the District Court denied Howard's motions in its January 22, 2019 Order Denying Plaintiff's Renewed Motion for Judgment as a Matter of Law/Motion for New Trial. This appeal followed.

STANDARD OF REVIEW

¶12 We review a district court's M. R. Civ. P. 50 decision denying judgment as a matter of law de novo. Johnson v. Costco Wholesale , 2007 MT 43, ¶ 18, 336 Mont. 105, 152 P.3d 727. A district court should grant judgment as a matter of law only when there is a complete lack of any evidence which would justify submitting an issue to the jury, considering all evidence and any legitimate inferences that might be drawn from it in a light most favorable to the party opposing the motion. Wagner v. MSE Tech. Applications, Inc. , 2016 MT 215, ¶ 15, 384 Mont. 436, 383 P.3d 727 (citing Deonier & Assocs. v. Paul Revere Life Ins. Co. , 2004 MT 297, ¶ 18, 323 Mont. 387, 101 P.3d 742 ).

¶13 Where the basis of a motion for a new trial is insufficiency of the evidence, we review a district court's ruling de novo, determining whether there was substantial evidence to support the verdict. Giambra v. Kelsey , 2007 MT 158, ¶ 27, 338 Mont. 19, 162 P.3d 134 (citing Renville v. Taylor , 2000 MT 217, ¶ 14, 301 Mont. 99, 7 P.3d 400 ).

DISCUSSION

¶14 1. Did the District Court err by denying Howard’s Motion for Judgment as a Matter of Law?

¶15 "[T]he existence of a legal duty presents a question of law to be determined by the court." Dick Irvin, Inc. v. State , 2013 MT 272, ¶ 17, 372 Mont. 58, 310 P.3d 524 (citing State v....