In the realm of medicine, which is inherently defined by uncertainty, telesurgery is particularly ambiguous. Telesurgery poses numerous questions about responsibility. Who should be held responsible if this new and innovative medical technique involving operative robots proves harmful and injurious? How should these situations be analyzed? How can injured parties proceed and recover? What happens when only one manufacturer exists?
On January 15, 2010, the United States Court of Appeals for the Third Circuit tackled the question of liability within the world of telesurgery. The court affirmed the grant of summary judgment in favor of defendant manufacturers in Mracek v. Bryn Mawr Hospital. (1) Roland C. Mracek ("Mracek") underwent a prostatectomy (2) at Bryn Mawr Hospital, during which the operative robot "da Vinci[TM]," ("da Vinci") manufactured by Intuitive Surgical, Inc. ("Intuitive"), stopped working) Following the robot's malfunction and subsequent manual operation, Mracek suffered serious side effects, including erectile dysfunction. (4) Mracek then proceeded to sue both Bryn Mawr Hospital and Intuitive for damages pursuant to multiple theories: strict products liability, negligence, breach of warranty, and strict malfunction liability. (5) The lower court granted summary judgment in favor of the defendant manufacturer reasoning that Mracek failed to establish causation between the injury he suffered and the robot's alleged malfunction. (6)
This Note will evaluate the repercussions of such a holding and its creation of a seemingly impossible standard of causation for plaintiffs to overcome. Part II discusses the technology, its evolution and ever-changing uses, and benefits of telesurgery. Part III focuses on the formation of a robotic surgical equipment monopoly. Part IV describes the problems posed by such a monopoly in pursuing products liability causes of action. Part V delves deeper into the implications the Mracek case has on these products' liability scenarios, focusing on the monopoly of robotic technology and its relative obstacles, specifically as it relates to obtaining expert witnesses. Part VI concludes this Note by opining policy and legal recommendations.
WHAT IS TELESURGERY?
DEVELOPMENT OF TELESURGERY
Telesurgery, also referred to as cybersurgery, is most commonly defined as a surgical technique which allows for a surgeon to operate on a patient remotely, either from a different location or at a close proximity, through a telecommunications channel attached to a robotic operating machine. (7) For purposes of this Note, telesurgery will solely refer to the above definition to avoid any confusion. This definition represents the term's current use with respect to remote surgery, (8) and is in sync with the definition at issue in the Mracek case. (9) Moreover, telesurgery and cybersurgery will be used interchangeably throughout this article, both referring to the same field of remote, robotic surgery.
Cybersurgery stems from telemedicine, a broader field of medicine with varying definitions across domestic jurisdictions. (10) Each of these variations consistently involve the same focus: "the movement of health information via electronic or telecommunicative means and the provision of medical services via electronic or telecommunicative means without direct face-to-face interaction between the healthcare professional and the patient." (11) Such medicine stems from a desire for quality care in medicine through accessibility. (12)
That same push for quality care, through both accessibility and efficiency, has been a dominating force in the development of telesurgery. For example, the Department of Defense ("DOD") was attracted to telesurgery and hoped to develop a process to set up robotic instruments in the field to perform operations from a remote location if need be. (13) Subsequently, a medic could set up robotic tools in a remote war-zone while a surgeon in a domestic hospital performs a life-saving procedure on a soldier. (14) As preposterous as this idea and scenario may seem at first glance, the historical development of telesurgery indicates that the DOD's aspirations are not that far-fetched.
The world's first successful attempt at cybersurgery was on September 7, 2001 when Dr. Jacques Marescaux utilized a computer in New York City to manipulate a robot in Strasbourg, France to remove a patient's gallbladder during Operation Lindbergh. (15) Dr. Marescaux was not in a hospital; he was located in an ordinary building. Meanwhile, his patient and the robot were in a hospital in Strasbourg accompanied by two other doctors prepared to intervene if necessary. (16)
Dr. Marescaux used Computer Motion's ZEUS[R] Robotic Surgical System ("ZEUS"), a voice-activated robotic system composed of three robotic arms operated by the surgeon from a remote console. (17) Two of the arms hold the requisite surgical instruments and are manipulated by a joystick on the surgeon's remote console; (18) the third arm operates the camera and is voice controlled. (19) A high-speed fiberoptic service links the surgeon to the robotic system, which is located just a few feet away from the operating table. (20)
The setup of Operation Lindbergh was as follows: the doctor in New York worked at the robot control station, with a computer transmitting his commands. Using a headset, he talked to the team in France while viewing the patient on a video screen in New York. All the equipment (including computers, videoconferencing equipment, and audio equipment in both New York and France, as well as the robot, the camera, and the robot command station) was connected so that the robot responded to the surgeon's commands in real time with no significant delay in the transmission of sounds or images. (21) The use of technological advancements in the field of medicine is an evolving phenomenon. In 1988, laparoscopic surgery was introduced, which utilizes camera equipment to perform the operation. (22) In 1996, the first computer-assisted surgery occurred. (23) Computer-assisted surgery places a "computer interface between the surgeon and the patient." (24) This interface then reviews the surgeon's actions in order to: repeat the actions, guarantee its safety, and then transmit these actions to a remote device that actually performs the surgical operation. (25)
Operation Lindbergh represents the first time technology reduced the time delay over a long distance transmission, thus making truly remote surgery possible. (26) Specific distance parameters aside, a surgeon in a robotic procedure would be empowered to operate without direct contact with the patient through a camera that transmits the image over a telecommunication channel to a removed receiver. (27) This receiver then sends the image to another computer that generates an image of the internal body tissues of the patient on a monitor for the surgeon's reference. (28)
Initially, this remote manipulation tactic was performed with a cable, averaging a few meters in length, attached to the equipment, thus requiring the equipment, patient, and surgeon to be located within the same operating room. (29) Researchers have constantly struggled with these technical limits because of the seemingly impossible task of reducing the time delay between the surgeon's action and the subsequent imaging of that action performed by the remote operational device. (30) "The actual delay associated with fiberoptic cable transmission is determined by both the physical distance between the cybersurgeon and patient and the complexity of the telecommunication connection between the two and the complexity of the telecommunication conduit." (31) For example, a satellite link creates a time delay of 600 milliseconds, prompting a question of reliability of a robotic surgical procedure. (32)
For Operation Lindbergh, telecommunications provider France Telecom had to address the concern of a time delay in order to guarantee a successful operation. (33) France Telecom aimed to provide "[c]ontinuous transmission delays of less than 200 milliseconds--on both outbound and return links--previously considered impossible to achieve over this [transatlantic] distance." (34) Ultimately, France Telecom's research and development engineering team successfully lessened the time delay of the imaging, which helped make Operation Lindbergh a success. (35)
In addition to the ZEUS[R] machine used in Operation Lindbergh, the other popular remote robotic surgery system is the da Vinci system from Intuitive. (36) With the da Vinci system, the surgeon sits at a remote console and controls robotic arms to function like a surgeon's hands in real time. "The robotic 'hands' [are] actually capable of some movement and maneuvers that would be difficult, if not impossible, for a human wrist and hand to accomplish." (37)
Unlike the ZEUS robotic system, da Vinci responds to manual commands, whereas ZEUS's robotic arms are able to respond to both manual and voice commands. (38) Moreover, to move the robotic hands efficiently, the da Vinci system utilizes InSite[R] Vision, a network of fiberoptic cables, which provides stereoscopic vision. (39) This three-dimensional stereoscopic vision further distinguishes da Vinci from ZEUS, which only provides the surgeon with two-dimensional images. (40)
Regardless of the distinct capabilities of both sets of the surgical robotic equipment, da Vinci and ZEUS have plenty in common besides their hefty price tag. (41) For example, each instrument consists of two robotic arms that are adept at fine motor work. (42)
Both ZEUS and da Vinci each have robotic arms linked to a control panel via a fiberoptic cable. (43) It is from the surgeon's control panel that the "cybersurgeon" is able to control the robotic instrument during a telesurgical operation. (44) Therefore, unlike a traditional surgery where the operating doctor is physically required to be next to the patient with...
The robotic arm went crazy! The problem of establishing liability in a monopolized field.
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COPYRIGHT GALE, Cengage Learning. All rights reserved.
COPYRIGHT GALE, Cengage Learning. All rights reserved.