Abstract
Robotic surgery presents challenges to surgeons and hospitals in the defense of medical and hospital malpractice lawsuits. The practitioner’s awareness of potential legal pitfalls is essential for establishing a practice in which robotic surgery plays a central role. This chapter explores the various legal theories that may be asserted by patients against surgeons and hospitals and provides advice for confronting and avoiding legal liability.
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References
Darringer v Intuitive Surgical, Inc., 2015 WL 4623935 (N.D. Cal.). (Products liability and negligence action against the manufacturer of a da Vinci robotic platform; plaintiff sustained injuries after undergoing a laparoscopic left pyeloplasty using a da Vinci robot.)
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Cobb v Dallas Fort Worth Medical Center-Grand Prairie, 48 S.W.3d 820 (Ct. App., Waco, Tex. 2001). (Pedicular hardware was inserted into plaintiff for treatment of an internal disc disruption in her lower back; several days after the surgery, the surgeon discovered that the screws used to install the pedicular hardware were made for a child patient and were not safe for use in a patient of plaintiff’s weight and size; plaintiffs alleged that the transpedicular hardware and screws were the wrong size and non-FDA-approved; hospital’s motion for summary judgment was denied as to the negligence claim and granted as to the strict liability claim.)
New York Pattern Jury Instruction 2:10 (2015).
New York Pattern Jury Instruction 2:150 (2015).
New York Pattern Jury Instruction 2:70 (2015).
Rivera v Kleinman, 16 N.Y.3d 757, 944 N.E.2d 1119, 919 N.Y.S.2d 480 (2011). (A surgeon operated on an infant's dislocated right and left hips; the surgeries were performed 2 weeks apart and entailed cutting and repositioning the bones that join at the hip and fixing them with a plate with side screws and a hip screw; plaintiff claimed that the surgeon improperly positioned the screw implanted in the infant’s left hip; that screw broke through the infant’s skin and was taken out during emergency surgery; the surgeon’s motion and the hospital’s cross motion seeking summary judgment were granted.)
Rex v Univ of Cincinnati College of Medicine, 2013 WL 6095889 (Ct. App., 10th Dist., Franklin Co., Ohio). (A surgeon performed a robotic wide excision radical prostatectomy; such surgery typically lasts for about 2 to 3 hours and the patient normally returns home the next day and can return to work in a little over 1 week; plaintiff’s surgery lasted for approximately 7 hours and plaintiff unexpectedly lost a massive amount of blood, About 2.3 liters; plaintiff was subsequently diagnosed with ischemic optic neuropathy; plaintiff failed to prove the surgeon’s preoperative and surgical treatment fell below the standard of care or that any alleged negligence proximately caused plaintiff’s eye injury.)
Espalin v Children’s Medical Center of Dallas, 27 S.W.3d 675 (Ct. App., Dallas, Tex. 2000). (After undergoing surgery to repair a coarctation of the aorta and a patent ductus arteriosus, an infant sustained paraplegia of her lower extremities; plaintiffs claimed that a cooling blanket supplied by the hospital did not work.)
Silvestrini v Intuitive Surgical, Inc., 2012 WL 380283 (ED La 2012). (During performance of a robotic transaxillary total thyroidectomy, the robot malfunctioned; neither the surgeon nor any other hospital staff member was able to repair it; the patient was under general anesthesia with the robot “inserted” in her neck when the malfunction occurred; the patient’s thyroid was removed using a traditional, non-robot-aided procedure; that technique required opening the patient’s neck with a long surgical cut; plaintiff claimed she now had an “extensive, unattractive scar” on her neck that would require significant plastic surgery, and that remaining remnants of her thyroid would need to be surgically removed.)
Rolon-Alvarado v Municipality of San Juan, 1 F.3d 74 (1st Cir. 1993). (An endotracheal tube, reinserted in the immediate aftermath of surgery, snapped; when a physician attempted to replace the broken tube, the patient went into cardiorespiratory arrest and died; defendant's motion for judgment as a matter of law was granted after plaintiff rested at trial.)
See, e.g., Mirabella v Mount Sinai Hosp., 43 A.D.3d 751, 842 N.Y.S.2d 17 (1st Dep’t 2007). (Plaintiff suffered a leak of bowel contents into her abdomen during bariatric surgery; during the operation, the surgeon did not seem to have any problems with the disposable surgical staplers he used; he visually observed that staples were in place, and he performed a leak test using saline irrigation with blue dye that confirmed no leaking; the surgeon observed that the staples were “closed and firm” on the anti-mesenteric side of the bowel, but there were no staples on the mesenteric side, as there should have been; the surgeon concluded that there was a “misfiring of the stapler”; the surgeon testified that such misfirings, while not common, were known to occur and were a matter of concern.)
Goldfarb v St. Charles Hosp. & Rehabilitation Center, 2 A.D.3d 579, 769 N.Y.S.2d 575 (2d Dep’t 2003). (While conducting a laparoscopy, a surgeon inserted into plaintiff's abdomen a trocar; the surgeon then noticed heavy internal bleeding, converted the procedure to a laparotomy, and stopped the bleeding, using sutures and clips; a general surgeon, who was brought into the operating room, inspected the operative site, identified a punctured artery as the source of the bleeding, and recommended consulting a vascular surgeon, was granted summary judgment; plaintiffs' theory, that the general surgeon was aware of a defect in the trocar prior to plaintiff's surgery and nonetheless allowed that type of trocar to be used in surgical procedures performed in the hospital, was speculative.)
Silvestrini v Intuitive Surgical, Inc., supra, at note 11.
See, e.g., Morrison v Altman, 278 A.D.2d 135, 718 N.Y.S.2d 319 (1st Dep’t 2000). (Defendants doctor’s and hospital’s motions for summary judgment were denied; issues of fact existed as to how and when an infectious agent was introduced, whether defendant doctor committed malpractice in administering a lumbar epidural steroid injection by taking 17 minutes to perform the procedure and using the same needle in more than one location, and whether defendant hospital’s nurse committed malpractice by failing to prepare proper records, obtain a full history, properly examine plaintiff, and properly evaluate the injection site.)
Siebe v University of Cincinnati, 117 Ohio Misc.2d 46, 766 N.E.2d 1070 (Court of Claims, Ohio 2001). (Defendant violated its own policy because a central venous line was not installed under the direction of an anesthesiologist; it was the standard of care at defendant hospital to have an attending anesthesiologist perform or supervise installation of a central venous line; it was against defendant's hospital policy to have a resident supervise placement of a central venous line by a trainee nurse anesthetist; misplacement of the central venous line and the lack of follow-up care by defendant proximately caused a hydrothorax to develop in the patient’s chest cavity.)
Wolicki-Gables v Arrow Intern., Inc., 641 F.Supp.2d 1270 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011). (A surgeon implanted into a patient with back pain and physical limitations an Arrow pump system; summary judgment was granted to defendant sales representative, who was present at the initial implantation procedure; the sales representative’s role was limited to carrying “back up” products in their sterile packages to have available for the surgeon’s use, if necessary, and to observing preparation of the products; the sales representative did not “scrub in” for the procedure and did not enter the sterile field; he did not come into contact with the pump, which never left the sterile field.)
Hill v Searle Laboratories, a Div of Searle Pharmaceuticals, Inc., 884 F.2d 1064 (8th Cir. 1989). (A copper intrauterine device perforated plaintiff’s uterus and was partially embedded in her small bowel.)
Talley v Danek Medical, Inc., 7 F.Supp.2d 725 (E.D. Va. 1998), aff’d, 179 F.3d 154 (4th Cir. 1999).
Talley v Danek Medical, Inc., supra, at note 20.
See, e.g., Svoboda v Our Lady of Lourdes Memorial Hosp., Inc., 31 A.D.3d 877, 817 N.Y.S.2d 772 (3rd Dep’t 2006). (Plaintiff underwent right knee replacement surgery; a continuous passive motion machine was used as part of his postoperative care at the hospital; after being discharged, plaintiff discovered an ulcer on his right calf; hospital’s motion for summary judgment was denied.)
O’Brien v Intuitive Surgical, Inc., 2011 WL 3040479 (N.D. Ill.). (Plaintiff alleged that a da Vinci surgical robot manufactured by defendant was defectively designed and malfunctioned during plaintiff’s pancreatectomy and islet cell transplant surgery; the complaint was dismissed; plaintiff did not allege that the malfunction directly caused a bodily rupture or injury or that the malfunction caused a delay in the surgery's completion and that the delay led to plaintiff’s injuries.)
Balding v Tarter, 2013 WL 4711723 (4th Dist., Ill.). (A urologist performed a laparoscopic robot-assisted radical prostatectomy; the complaint against the urologist was dismissed; plaintiff’s expert urologist was unable to say that had plaintiff undergone an open procedure, as opposed to the robotic procedure, he would not have sustained his median nerve injury; to the extent that a longer surgery may increase the risk of that complication, the expert stated it was “hard to say how much increase” there would be if the operation had lasted only 90 minutes; plaintiff’s treating plastic surgeon stated that compression injuries to the median nerve could occur at any point in time after 2 hours, and if plaintiff’s surgery had taken 2 hours, “he could have” had the same result.)
Mohler v St. Luke’s Medical Center, LP, 2008 WL 5384214 (Ct. App., Div 1, Dep’t B, Ariz.). (A patient’s small intestine was perforated during a laparoscopic robotically-assisted surgery to remove the patient’s gallbladder; the procedure was the first robotically-assisted surgery of any kind that the surgeon performed; an issue of fact on proximate causation existed as to whether the perforation occurred at the start of the procedure or through use of robotic equipment; there was evidence that trocars used with the robotic equipment were different from regular trocars used in laparoscopic procedures and that the trocars were an integral part of robotically-assisted procedures.)
Intuitivesurgical.com, Important Surgical Risks. Accessed 1 Sep 2015.
Commonwealth of Massachusetts Board of Registration in Medicine, Quality and Patient Safety Division, Advisory on Robot-Assisted Surgery, March 2013.
Lee Char SJ, Hills NK, Lo B, Kirkwood KS. Informed consent for innovative surgery: a survey of patients and surgeons. Surgery. 2013;153:473–80.
Ripley v Lanzer, 152 Wash.App. 296, 215 P.3d 1020 (2009). (Medical malpractice action; during an arthroscopic medical meniscectomy surgery, a scalpel blade detached from its handle and lodged in the patient’s knee joint; plaintiff’s corporate negligence claim against defendant hospital was dismissed because plaintiff failed to adduce expert medical evidence to establish the standard of care.)
Cobb v Dallas Fort Worth Medical Center-Grand Prairie, supra, at note 4.
Ripley v Lanzer, supra, at note 29.
Kenneson v Johnson & Johnson, Inc., 2015 WL 1867768 (D. Conn.). (Action against a hospital alleging negligence and violation of the Connecticut Unfair Trade Practices Act, arising out of surgery involving implantation of a “Prolene Mesh.”)
Schelling v Humphrey, 123 Ohio St.3d 387, 916 N.E.2d 1029 (2009).
Newbold-Ferguson v AMISUB (North Ridge Hospital), Inc., 85 So.3d 502 (4th Dist., Fla. 2012).
Raschel v Rish, 110 A.D.2d 1067, 488 N.Y.S.2d 923 (4th Dep’t 1985). (Plaintiff raised issues of fact relating to the hospital’s breach of its duty to investigate the competency of defendant plastic surgeon before renewing his staff privileges; defendant physician had been sued at least three times for malpractice for surgery and for silicone injections.)
Taylor v Intuitive Surgical, Inc., 188 Wash.App. 776, 355 P.3d 309 (Wash. 2015), review granted, 9 Feb 2016.
See, e.g., American College of Obstetricians and Gynecologists, Society of Gynecologic Surgeons, Committee Opinion, Robotic Surgery in Gynecology, Number 628, March 2015.
See, e.g., The Society of American Gastrointestinal and Endoscopic Surgeons and the Minimally Invasive Robotic Association, A Consensus Document on Robotic Surgery, November, 2007.
American Urological Association, Standard Operating Practices (SOPs) for Urologic Robotic Surgery.
Mohler v St. Luke’s Medical Center, supra, at note 25.
Vaccaro v St. Vincent’s Medical Center, 71 A.D.3d 1000, 898 N.Y.S.2d 163 (2d Dep’t 2010). (Plaintiffs claimed that a hospital negligently permitted a surgeon to utilize a Met–RX procedure in performance of a posterior foraminotomy decompression; the hospital’s neurosurgery expert noted that the Met–RX procedure was FDA-approved and the decision to use it was “within the sole province of the operating surgeon”; plaintiffs raised a triable issue of fact through the surgeon’s deposition testimony that the hospital permitted him to use the system, but never inquired into his background and training with the procedure, and that he had used the system in cervical spine surgery only once or twice before; plaintiffs’ neurosurgery and anesthesiology experts opined that the hospital failed to undertake due diligence in determining whether the surgeon had the requisite training and experience to utilize the procedure in cervical spinal surgery.)
Pedraza v Silverman, 2013 WL 2633596 (4th Dist., Div 1, Cal. 2013). (Medical malpractice action by a patient who underwent a robotically assisted laparoscopic surgery.)
Pedraza v Silverman, supra, at note 42.
Mohler v St. Luke’s Medical Center, LP, supra, at note 25.
Inouye v Black, 238 Cal.App.2d 31, 47 Cal.Rptr. 313 (3rd Dist., 1965). (Plaintiff underwent surgery performed by defendant neurosurgeon; defendant wired vertebrae together using two pieces of stainless steel wire; two years later, plaintiff learned that the wire had broken into relatively small fragments, an event not expected by defendant; at the close of plaintiff's case, defendant's counsel made a nonsuit motion which the trial court granted.)
New York Pattern Jury Instruction 2:120 (2015).
Goldfarb v Teitelbaum, 149 A.D.2d 566, 540 N.Y.S.2d 263 (2d Dep’t 1989). (Plaintiff claimed that defendant dentist inserted an allegedly defective mandibular prosthesis into her mouth; complaint dismissed.)
North Miami General Hosp., Inc. v Goldberg, 520 So.2d 650 (3rd Dist., Fla. 1988). (When plaintiff awoke from a routine operation, she had sustained burns at the places on her body where an electrosurgical grounding pad had been used during the surgery; the trial court erroneously submitted a strict liability issue to the jury.)
Rolon-Alvarado v Municipality of San Juan, supra, at note 12.
Cheshire v Southampton Hospital Assoc., 53 Misc.2d 355, 278 N.Y.S.2d 531 (Sup. Suffolk 1967). (Plaintiff alleged that surgical insertion of an intramedullary pin was warranted as properly manufactured and free of defects; the pin broke despite the surgeon’s alleged statement that the pin would not break and was as strong as, if not stronger than, the original bone; surgeon’s motion to dismiss the complaint was denied.)
Budding v SSM Healthcare System, 19 S.W.3d 678 (Sup. Mo. 2000). (Action for strict product liability arising from allegedly defectively designed Vitek Proplast Teflon temporomandibular joint implants; jury verdict for hospital affirmed.)
Von Downum v Synthes, 908 F.Supp.2d 1179 (N.D. Okla. 2012). (Plaintiff underwent a lumbar interbody fusion with the placement of medical devices; plaintiff alleged that the medical device implants were defective and had to be replaced; plaintiff was unable to state a cognizable claim for strict liability against the hospital.)
Goldfarb v Teitelbaum, supra, at note 47.
North Miami General Hosp., Inc. v Goldberg, supra, at note 48.
Liberty Mut. Fire Ins. Co. v Sharp Electronics Corp., 2011 WL 2632986 (M.D. Pa.), adopted in part and rejected in part, 2011 WL 2632880. (Plaintiffs claimed that a restaurant fire began in a cash register because of an electrical defect.)
Mracek v Bryn Mawr Hosp., 363 Fed.Appx. 925 (3rd Cir. 2010).
Mracek v Bryn Mawr Hosp., supra, at note 56.
Sita v Danek Medical, Inc., 43 F.Supp.2d 245 (E.D.N.Y. 1999). (Action against the maker of a surgical screw system used by an orthopedic surgeon in spinal surgery performed upon plaintiff; plaintiff's “failure to warn” claim, whether sounding in negligence or strict liability, was barred under the informed intermediary doctrine.).
Martin v Hacker, 83 N.Y.2d 1, 628 N.E.2d 1308, 607 N.Y.S.2d 598 (1993). (A patient became severely depressed after ingesting medications manufactured by defendant and prescribed by a physician to treat the patient’s hypertension; the depression allegedly led to the patient’s suicide; the manufacturer’s warning regarding the adverse reaction of drug-induced depression resulting in suicide was adequate as a matter of law.)
Henson v Wright Medical Technology, Inc., 2013 WL 1296388 (N.D.N.Y. 2013). (During hip replacement surgery, the surgical team implanted defendants’ Wright ProFemur Total Hip System; about 8 years later, the system broke, requiring emergency surgery for a total hip replacement; the court could not determine the adequacy of the warnings on defendants’ motion to dismiss; defendants failed to prove that the learned intermediary doctrine bars plaintiff's claim of failure to warn.)
Rounds v Genzyme Corp., 440 Fed.Appx. 753 (11th Cir. 2011). (Plaintiff underwent an autologous chrondrocyte implantation involving defendant manufacturer’s Carticel, which was a biologic product comprised of autologous cultured chondrocytes used to repair articular cartilage injuries; plaintiff’s negligence claim against the manufacturer was dismissed; the manufacturer’s package insert expressly and clearly warned the surgeon about how to identify Carticel patients and about the risk of the exact injury of which plaintiff complained.)
Parkinson v Guidant Corp., 315 F.Supp.2d 741 (W.D. Pa. 2004). (A guidewire manufactured by defendant fractured during the course of an angioplasty procedure; defendant provided physicians who utilize its guidewire with a list of instructions and a warning relating to the use of the guidewire; the physician who performed plaintiff's procedure testified that he was familiar with those warnings prior to performing the procedure on plaintiff and that, as an interventional cardiologist, he was familiar with the concept of tip separation; defendants were entitled to summary judgment on plaintiffs' negligent failure to warn claim.)
Smith v Johnson & Johnson, Inc., 483 Fed.Appx. 909 (5th Cir. 2012). (Plaintiffs' product liability claims arose from manufacturers’ alleged failure to warn of risks associated with the use of Mersilene mesh as part of an abdominal sarcoplexy; the surgeon was aware of the potential dangers in using Mersilene mesh and chose to use the mesh in plaintiff’s surgery despite those risks; defendants were granted summary judgment.)
Sita v Danek Medical, Inc., supra, at note 58.
Rounds v Genzyme Corp., supra, at note 61.
Taylor v Intuitive Surgical, Inc., supra, at note 36.
Tortorelli v Mercy Health Center, Inc., 242 P.3d 549 (Court of Civil Appeals, Okla. 2010). (A surgeon removed a bone tumor from plaintiff's tibia; during the surgery, an allograft bone putty was used; defendant hospital’s motion for summary judgment was granted.)
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Adams, M.B., Dopf, G.W. (2018). Legal Aspects of Setting Up a Robotic Program. In: Fong, Y., Woo, Y., Hyung, W., Lau, C., Strong, V. (eds) The SAGES Atlas of Robotic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-319-91045-1_4
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