The robotic arm went crazy! The problem of establishing liability in a monopolized field.
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.
II. WHAT IS TELESURGERY?
A. 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 traditional hand-held surgical equipment, the cybersurgeon does not have to be anywhere near the patient. (45) This is highlighted by Operation Lindbergh. (46) As discussed above, the possible distance that can exist between surgeon and patient is limited by the inherent delay of the fiberoptic transmission, which continues to be refined. (47)
The United States Food and Drug Administration ("FDA") have consistently approved Intuitive's da Vinci robot. (48) In 2000, the da Vinci robot was the first robotic device to be approved by the FDA; Computer Motion's Zeus was approved shortly thereafter. (49)
Following FDA clearance and commercialization of the da Vinci system, Intuitive received approval by the FDA for the use of their robotic technology to perform specific surgical procedures. (50) On June 4, 2001, Intuitive Surgical announced that it received FDA clearance to use the da Vinci system for laparoscopic radical prostatectomy (the surgery at issue in the Mracek case). (51)
Contrary to the success and implementation of Intuitive's robot, the use of the ZEUS(R) robot was ultimately phased out in the United States, as a result of the Computer Motion and Intuitive Surgical merger. (52) Thus, the da Vinci reigns as the United States choice of robotic surgical equipment. (53) For purposes of this Note, discussions of ZEUS equipment and its refinements provide further analysis of developments in telesurgery and are therefore included, although it is no longer current medicine.
B. BENEFITS OF TELESURGERY
The potential for remote telesurgical procedures highlights the societal benefits arising from the hopeful-expansion of this practice. For example, "[a]n earth-bound surgeon could operate on a patient located on a space station or a patient trapped in a biologically contaminated battlefield." (54) Additionally, in situations such as urban violence or automobile accidents, where the time immediately following such an event is precious, (55) the process of bringing a cybersurgeon and the necessary surgical theater to the patient, rather than the patient to the surgeon could potentially improve patient well-being after a major trauma. (56)
Additionally, telesurgery can assist in the security of prisoners by providing medical services sans transportation of prisoners in order for them to get the requisite care. Through telemedicine, the requisite care will be brought to the prisoners. (57)
The benefits of telesurgery are not just situational. Telesurgery also provides significant advantages to the patients themselves. (58) "Strong evidence suggests that surgeons performing more of the same sort of surgery have better outcomes than those who do fewer surgeries." (59) Thus, the most efficient telesurgery network would have specialty doctors in certain types of surgeries performing that same kind of operation; seemingly, cybersurgery would be able to reduce the abundance of deaths per year attributable to medical error. (60)
Another way telesurgery reduces the risk of error is by its utilization of small incisions during many of the telesurgical operations, thus increasing the likelihood of positive surgical outcomes. (61) This minimally invasive surgery technique also provides "a shorter hospital stay, less pain, less risk of infection, less blood loss, fewer transfusions, less scarring, faster recovery and a quicker return to normal daily activities." (62)
Like patients, the surgeons of telesurgery also stand to benefit from this medical trend, as they will no longer be in direct contact with a patient's blood, thus reducing the probability of exposure to blood borne diseases. (63) Moreover, telesurgery provides these cybersurgeons with "greater surgical precision, increased range of motion, improved dexterity, enhanced 3DHD vision and improved access," which ultimately increases the chances of a successful surgery as well as decreases the likelihood of a medical malpractice lawsuit. (64)
The surgeons of cybersurgery will not be entering this uncertain field of medicine blind and inexperienced. Training technology is available for telesurgery and is comparable to the current mechanisms utilized for training by "gradually performing more and more complex tasks under the supervision of a supervising surgeon who has the ability to take over at any moment." (65)
Prior to ZEUS's demise, Computer Motion also manufactured SOCRATES[R] ("SOCRATES"), a secondary control console for the telesurgery system ZEUS. (66) SOCRATES acts as a supervisor over a surgeon utilizing the ZEUS equipment. (67) In short, the SOCRATES control panel has "robotic arm priority over the surgeon at the ZEUS control panel," thus enabling the surgeon using the SOCRATES console to negate direction given by the ZEUS surgeon. (68)
Contrary to Computer Motion's technological training, Intuitive implements personalized, hands-on teaching sessions between independent, highly-experienced faculty and the surgical team to build competence and confidence focusing on pre-, intra-, and post-operative techniques of da Vinci. (69) In addition, Intuitive covers a range of material during their comprehensive training program, including system training, clinical support, and procedure training. (70)
Lastly, the United States stands to benefit from the growth of telesurgery financially through the international market. (71) According to Dr. Eric G. Tangalos of the Mayo Clinic, the United States can generate enough income to fund the entire domestic healthcare industry by exporting American telesurgical services. (72)
With the multiple benefits of telesurgery, it is important to recognize when telesurgery is actually used for surgical operations. Focusing on the only robotic surgical equipment still in use, the da Vinci is capable of performing many complex procedures through minimal incisions. (73) "To date, tens of thousands of procedures including general (74), urologic (75), gynecologic (76), thoracoscopic (77), and thoracoscopically-assisted cardiotomy (78) procedures have been performed using the da Vinci Surgical System." (79)
A comparative analysis of the default options for a specific operation, prostatectomy, (80) which was at issue in the Mracek case, details the benefits of telesurgery even further. (81) Evidenced by the study provided, the da Vinci prostatectomy showed measurable advantages as compared to conventional open surgery and minimally invasive laparoscopic surgery. (82) For instance, through use of the da Vinci surgical equipment, patients suffered fewer complications and were more likely to have normal urinary and sexual function following the operation. (83)
As expected, the popularity of cybersurgery is growing. As of December 31, 2009, a total of 1,933 da Vinci surgical units have been sold globally. (84) Of the total robots installed, 1,028 of those units have been installed domestically. (85) In 2007, only 400 da Vinci devices were in use with the robot, control panel, and patient all at a single site, (86) further representing the growth of cybersurgery and its technological advancements. (87)
Telesurgery promises to provide great benefits to the healthcare community at large. (88) To best supply these benefits, the telesurgery industry must continue to grow. (89) However, the monopoly held by Intuitive and the subsequent lack of liability implications on the manufacturers involved in implementing this medical treatment stands in the way of the growth of telesurgery. (90) This issue was highlighted by the Mracek case. With no shared liability between health care providers (91) and the manufacturers, combined with no source of relief for an injured party, consumers of telesurgery should be wary of entering this growing market.
III. THE CREATION OF A MONOPOLY
A. PATENT INFRINGEMENT GALORE
The industry of telesurgery was not always dominated by a single corporation--Intuitive. (92) In fact, up until the merger of Intuitive and Computer Motion, the two companies were involved in heavy competition through multiple patent infringement lawsuits. (93)
In 2003, Computer Motion was the lead manufacturer of telesurgical equipment, supplying over 32 countries, 900 consumers(e.g, hospitals) and approximately 3,000 surgeons. (94) However, as the market for innovative medical technology began to embrace robotic surgical equipment, competition between Computer Motion and Intuitive also grew--calling into question Computer Motion's role as the lead manufacturer. (95) The first strike in the heated competition between Intuitive and Computer Motion took place in Delaware, where Intuitive, in conjunction with International Business Machines Corporation (IBM), filed a patent infringement suit against Computer Motion in 2001. (96) Intuitive and IBM argued that Computer Motion's AESOP and ZEUS products infringed Intuitive's 6,201,984 patent on voice-controlled surgical robots, licensed from IBM. (97) Further, Intuitive asserted that Computer Motion's HERMES product, when used in conjunction with either the AESOP or ZEUS product, also infringed the '984 patent. (98)
Pending resolution to the Delaware patent infringement case, infra, Computer Motion retaliated against Intuitive by also suing for patent infringement in California. (99) Computer Motion's 6,244,809 patent applies to its medical robotic system, including two robotic arms that operate surgical instruments, a cabinet attached to the arms, a monitor mounted to that cabinet, and handles and foot pedals for surgeons to operate. (100) "[T]he District Court for the Central District of California ... ruled that Intuitive Surgical's da Vinci Surgical System literally infringes Computer Motion's 6,244,809 patent." (101)
After the District Court granted partial summary judgment on the issue of literal infringement in favor of Computer Motion, Intuitive had the burden to show, by clear and convincing evidence, that the United States Patent Office was wrong in granting the patent. (102) Intuitive also had to show that the 6,244,809 patent was somehow invalid or unenforceable. (103) Computer Motion prevailed in the first stage of a long, grueling battle between the two companies.
Shortly thereafter, the Delaware District Court entered summary judgment of literal infringement in favor of Intuitive and IBM, setting the stage for a subsequent trial. (104) Because the court found infringement in the pre-trial phase, Computer Motion had the burden to show that the 6,201,984 patent was invalid before a federal jury. (105) The jury ultimately found in favor of Intuitive, requiring Computer Motion to pay Intuitive and IBM $4.4 million for infringement. (106)
The ongoing and overlapping patent controversy between Intuitive and Computer Motion did not seem to have an end in sight. However, in an interesting turn of events, on March 7, 2003, Intuitive and Computer Motion announced that they were merging. (107)
In the merger announcement, Intuitive and Computer Motion announced that they were forming one company in order to "combine their strengths in operative surgical robotics, telesurgery, and operating room integration, to better serve hospitals, doctors, and patients." (108) Intuitive President and Chief Executive Officer Lonnie Smith stated that, through combination of the two companies and their products, the newly formed mega-corporation "'will be able to provide surgeons and hospitals with the best possible products and support to serve their patients' needs in minimally invasive surgery. We believe both the da Vinci and ZEUS surgical system platforms will play an important and complementary role in the future of our new company...." (109) Smith further stated that each surgical product would deliver unique benefits to consumers, without any indication of discontinuing the use of Computer Motion's ZEUS robot. (110)
Intuitive's reasoning behind the merger, and paying a premium price for Computer Motion, was that Intuitive believed that they would be found liable in Computer Motion's patent infringement suit. (111)
As for Computer Motion, its Chairman and Chief Executive Officer Robert Duggan provided that, without the merger, the neither company would be able to achieve the level of success for their patients, consumers, and investors that would be possible if the two corporations worked together. (112) Moreover, Duggan explained that through "sharing our complementary technologies in networking, articulation, control[,] and visualization, we believe we will significantly strengthen the surgical capabilities of both the da Vinci and ZEUS product platforms. We look forward to working as one team to enhance the care received by patients through less-invasive surgery." (113)
However, the bottom line is that although Computer Motion was confident they would prevail in their unsettled patent litigation against Intuitive, they simply did not have the finances to sustain the inevitable litigation battle against the deep-pocketed Intuitive and IBM. (114) The merger marked the end of long-term patent disputes between the two companies. (115) Moreover, Intuitive was now empowered to focus on developing the robotics of minimally invasive surgery and its benefits for consumers, with no litigation obstacles. (116)
On June 30, 2003, Intuitive announced that it completed its merger with Computer Motion. (117)
C. FOLLOWING THE MERGER, ONLY INTUITIVE SURVIVED
While Intuitive President and CEO represented that Computer Motion's ZEUS(R) robot would still be in use, (118) parties following and analyzing the merger had their doubts. In SurgRob.Blogspot.com, immediately following a brief description of the merger, the author quipped that the merger "meant a goodbye to Computer Motion," (119) which was apparently spot-on. Following the merger, use of the ZEUS robot was discontinued and the support for other Computer Motion products decreased. (120)
Intuitive bought its competition, and essentially formed a monopoly, becoming the only big manufacturer of telesurgical robotic equipment. (121)
IV. THE PROBLEM OF A MONOPOLY AS IT RELATES TO PRODUCTS LIABILITY
A. ESTABLISHING PRODUCT LIABILITY
Section 402A of the Restatement (Second) of Torts, the law applied in Mracek, establishes "strict liability in tort, not only for injuries caused by the defective manufacture of products, but also for injuries caused by defects in their design." (122) Section 402A further provides that:
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer ... is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it was sold.
(2) The Rule stated in subsection (1) applies although (a) the seller has exercised all possible care in preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. (123)
In order to succeed in a products liability claim pursuant to Section 402A, a plaintiff must satisfy three elements. (124) First, the complainant needs to demonstrate that the product at issue was defective. (125) Second, the plaintiff must exhibit that the alleged defect existed while the manufacturer had control over the product at issue. (126) Lastly, it must be shown that the alleged defect proximately caused plaintiff's injuries. (127)
In limited circumstances, a trier of fact may infer that the product at issue is defective. (128) In order to directly prove that a product is defective, a plaintiff must show a mistake or a flaw in the product's design or fabrication. (129) However, if such direct evidence is unavailable or unascertainable, "the plaintiff may nevertheless establish the right to recover by showing that the product did not perform in keeping with the reasonable expectations of the user, thus creating an inference of specific defect for the trier of fact." (130)
Circumstantial evidence can be used to find liability so long as all other reasonable causes are negated and the evidence relied upon raises above a level of mere possibility and is not founded on speculation or conjecture. (131) Moreover, in situations where multiple inferences are possible, the plaintiff bears the burden of refuting all other theories of the cause of the accident at issue, (except the one established solely by circumstantial evidence.) (132) It is unquestionable that in Mracek the complainant failed to exclude all causes of the injury not attributable to Intuitive. (133)
Proximate causation, pursuant to Section 420A, can be shown in two ways (other than the obvious presentation of direct evidence). First, causation may be proved by process of elimination. (134) Second, plaintiff's burden may be satisfied through expert testimony, which can be used to explain: "possible causes of the occurrence, involvement of the same product in similar accidents, the elimination of other causes of the accident, and the fact that the type of accident in question does not ordinarily happen without a product defect existing." (135)
B. USE OF AN EXPERT
A plaintiff does not need to use or present expert testimony in order to demonstrate a specific defect or disprove all other possible causes for injury. (136) However, in establishing both defect and causation, the most convincing evidence is an expert's testimony that pinpoints the defect after a thorough investigation. (137)
More importantly, if the product is "exotic, newly arrived at the marketplace, and usable only through the intervention of a highly trained specialist," such as the da Vinci surgical system, an expert opinion would further the plaintiff's cause by eliminating speculation and thus aid a favorable finding by the trier of fact. Expert testimony may also break down the complexity of the object at issue. (138) This expert theory is applicable in the Mracek context. Although the use of an expert is not required to prevail in a products liability cause of action, the Mracek court was correct in stating that, because the da Vinci is so complex, expert testimony was necessary to help the jury to resolve whether the robot had a defect. (139)
In determining the admissibility of expert opinion testimony, the court generally turns on the following.
First, the court must determine whether the [expert's] opinion is based on "scientific, technical, or other specialized knowledge"; Second, the court must determine whether the expert's opinion would "assist the trier of fact" in understanding the evidence of determining a fact in issue; Third, the court must determine whether the expert has appropriate qualifications -i.e., some special knowledge, skill, experience, training, or education on the subject matter; Finally, the court must consider "the overarching requirement of reliability" by determining whether:
-the testimony is based upon sufficient facts or data
-the testimony is the product of reliable principles and methods
-the witness has applied the Principles and methods reliably to the facts of the case. (140)
Moreover, as denoted by the requirement that the expert have specialized knowledge, it is crucial that the expert, despite being qualified in the proper field, must still have specific knowledge regarding the technology at issue. (141) Thus it may be risky to obtain an expert who has specific knowledge of the product at issue but is not a specialist in the discipline in question, especially in the medical field. (142) These conditions to qualify as an expert significantly limit the number of potential specialists that may testify in a medical matter.
In a products liability suit, like in Mracek, expert testimony is necessary to establish that an allegedly defective product failed to conform to industry standards. (143) While expert testimony may not be "required," it is necessary to prevail in a telesurgical suit, which involves intricate technology and is a combination of medical malpractice and products liability actions. As such, without an expert, relief for an injured party is doubtful, if not impossible.
V. MRACEK IMPLICATIONS AND THE UNIQUENESS OF A MONOPOLY
A. NO ACCESS TO AN EXPERT WITNESS
As previously stated, experts must be both specialists in the field at issue and have specific knowledge about the technology involved. (144) However, in Mracek, the court would not allow a doctor who had performed many robotic surgical procedures to provide expert testimony of the procedure at issue on the basis of insufficient, technical knowledge. (145) The implication of this is quite simple: this narrowed field of experts places a barrier between an injured party and the sought relief. As such, in a suit against the monopoly Intuitive, an injured party is unlikely to ever prevail in a products liability action. According to the Mracek court, doctors, regardless of their specialty in telesurgery, may not use a narrative of the procedure as evidence of a defect. (146) Who, then, is left as a viable expert on the plaintiff's behalf?.
Although an expert is not required, it is strongly encouraged in a matter involving robotic surgery. (147) The Federal Rules of Evidence have specific qualifications of such an expert in this type of matter: specialized knowledge. (148) Presumably, the only potential parties who could viably be an expert could be: a manufacturer of the product at issue, a competitor of the product with specific knowledge of how the technology should work, or a user of the product with the training and experience necessary to make them knowledgeable of the product.
Given Intuitive's monopoly, the only two possible experts that could meet the court's specialized knowledge threshold in a robotic surgical procedure would be either the doctor or the manufacturer. However, the Mracek court firmly held that a doctor's narrative of the procedure to indicate how the system worked (or did not work for that matter) is not sufficient to establish a defect. (149) Because doctors are available to serve as experts, it is highly improbable that a plaintiff could enlist an expert from Intuitive to say that the robotic system was defective, as an expert is unlikely to represent a party adverse to their employer. (150)
B. INTUITIVE IS THE INDUSTRY STANDARD
Pursuant to a products liability action, in determining whether the product met the proper standard, the product must conform to industry standards. (151) Here, Intuitive is the industry; what they say, goes. (152) Because Intuitive has a monopoly, as well as limited expert witnesses, manipulation of an industry standard by such a dominant player is likely in a situation where they would be protecting themselves in a products liability lawsuit.
With no competitors or doctors to present expert testimony on the complainant's behalf, let alone a standard to compare Intuitive to, an injured party is unlikely to prevail over a deep-pocketed, monopolistic corporation.
C. ALL THAT GLITTERS IS NOT GOLD
The potential lack of liability implications on the manufacturers involved in implementing this medical treatment limits the growth of telesurgery, and consequently, the growth of Intuitive. (153)
This lack of manufacturer liability is particularly problematic, as there is currently only one main telesurgical equipment manufacturer. (154) The fear of no liability being assigned to the manufacturers hinders the entrance of surgeons and their respective hospitals into the field of cybersurgery, as they would bear all the responsibility associated with a potential lawsuit following a botched telesurgical procedure. (155) This is exemplified when Bryn Mawr Hospital was presumed to be voluntarily dismissed from the Mracek action to both provide testimony against the manufacturer and protect itself from possible liability. (156) Furthermore, since telesurgical advances may reduce the public perception of a surgeon's skill absent this technology, exposure to medical malpractice liability is extended, (157) thus making defined liability essential before health care providers enter this field.
This fear of undefined liability also extends to the developers and manufacturers that, without defining legal responsibility, have no incentive to enter the telesurgery market. To date, courts have avoided establishing any liability against manufacturers by dismissing cases for lack of expert testimony. Even with the seemingly positive implications of liability against manufacturers following the Mracek case, the court neglected to delve deeper into defining what is required in assigning liability. This leaves the door open for manufacturers to manipulate the system to their benefit, and to the detriment of the no-longer-growing field of telesurgery. More importantly, however, the door is still open for manufacturers to incur liability.
Further, since the industry is dominated by Intuitive, it would be obstructive for a new manufacturer to enter the scene of telesurgery, also hindering the development of this field.
The negative implications of Intuitive's monopoly in finding an acceptable expert does not just affect injured parties in a products liability suit. This same theory of inaccessibility of experts applies to robotic surgery medical malpractice cases, making it highly unlikely that an injured party will recover against the health care provider, rather than the manufacturer, following an unsuccessful telesurgery procedure. With such limited experts, a plaintiff may attempt to enlist the manufacturer to testify on their behalf. (158) However, the manufacturer would be foolish in pursuing such an endeavor. If Intuitive were to assist injured parties in suing the users of their products (the medical providers), no doctors or hospitals would purchase its surgical equipment, thus making Intuitive valueless.
VI. PROPOSED SOLUTION
Given Intuitive's monopoly, the two seemingly most important problems to address are: inaccessibility to experts and the struggle to create an unbiased industry standard. Without rectifying these issues, patients would remain option-less in recovering for damages following an injurious telesurgical operation. Moreover, the growth of telesurgery is hindered, as consumers in robotic surgical equipment would likely be dissuaded from continuing use of such technology without defined liability and manufacturers would suffer the consequences.
First, in remedying the lack of experts in telesurgery, Intuitive should collaborate with courts in order to appoint experts. These experts should derive from Intuitive, as they have a specialized knowledge of the mechanics at hand, and should then be provided whistleblower-like protection from firing. Questionable at first glance, this solution actually protects Intuitive's role as the dominant telesurgical manufacturer, rather than threaten it.
Robotic surgery providers would be protected from undefined liability, as there are would be accessible experts to testify as to the potential defectiveness of the product at issue. For that reason, these providers would be more inclined to practice telesurgery, thus solidifying the industry that Intuitive already controls.
Moreover, these experts, although presumably biased in their affiliation to Intuitive, would actually be unbiased because they would have job security and the permission of their employer to testify. Therefore, these experts would have no incentive to provide biased testimony and telesurgical consumers would be protected from undefined liability and burdensome lawsuits. Again, the field of telesurgery would continue to grow, rather than sputter because of Intuitive's monopoly.
Manufacturers also stand to benefit from court-appointed Intuitive experts. Pursuant to medical-malpractice cases, these experts would be able to clarify whether the surgeon at issue used the equipment properly and met the requisite standard of care. As such, manufacturers would be able to protect themselves from any inappropriate application of liability since experts would then be available to pinpoint blame. Prior to such a vehicle for obtaining experts, Intuitive risked testifying against their consumers and threatening their good standing with healthcare providers, not to mention their financial success. Additionally, by allowing internal experts to become involved with these potential lawsuits, Intuitive is better situated to rectify any flawed manufacturing practices, and is thus able to expand their business.
Intuitive will also have the advantage of simultaneously boosting the telesurgical field and their own success. By supporting court-appointed experts, consumers would be more inclined to maintain a working relationship with Intuitive. It could be presumed that, by allowing their own employees to testify, Intuitive is confident they stand nothing to lose, further solidifying their dominance in the field of telesurgery.
If this proposal were to be implemented, injured patients could sue either the manufacturer or the surgeon and have access to expert testimony. Obviously the court protections from frivolous claims would still be in place, but now plaintiffs could survive motions for dismissal following lack of evidentiary support, provided that is the only pitfall of their suit, as highlighted in the Mracek case.
In addressing the lack of a telesurgical industry standard, Intuitive should collaborate with other telesurgical parties to best develop a workable standard, much like with the court-collaboration proposal to address a lack of experts. By helping to define liability, Intuitive may seem to risk their avoidance of any products liability suit (as such suits cannot be successfully brought against Intuitive at this time). However, contrary to this initial thought, Intuitive stands to benefit from the creation of an industry standard.
Through their involvement in the development of the standard, Intuitive would be able to create an industry standard on their current practices. While biased at first glance, Intuitive is currently the entire field of telesurgery and is best suited to create such a standard, rather than an outside, unaffiliated party. Therefore, Intuitive could not reasonably stand to lose by institutionalizing and defining their internal regulations. Rather, their practices would become the norm, without any need for potential manipulation.
The benefits and advantages of telesurgery are obvious. To best continue the growth and implementation of such a desirable practice, Intuitive's monopoly must be addressed in order to protect all telesurgical parties--manufacturers, providers, and patients alike.
Margo Goldberg, Candidate for J.D., May 2012, Rutgers School of Law- Newark.
(1.) Mracek v. Bryn Mawr Hosp., 363 F. App'x. 925, 926 (3d Cir. 2010).
(2.) Prostatectomy is defined as the "surgical removal of the prostate or part of it." DORLAND'S 1LLUSTRAYED MEDICAL DICTIONARY 1553 (31st ed. 2007).
(3.) Mracek v. Bryn Mawr Hosp., 610 F. Supp. 2d 401, 402-03 (E.D. Pa. 2009).
(6.) See id. at 407.
(7.) Thomas R. McLean, Cybersurgery: Innovation or a Means to Close Community Hospitals and Displace Physicians?, 20 J. MARSHALL J. COMPUTER & INFO. L. 495, 495 (2002) [hereinafter McLean I].
(9.) See Mracek v. Bryn Mawr Hosp., 610 F. Supp. 2d 401, 402 (E.D. Pa. 2009).
(10.) Meghan Hamilton-Piercy, Cybersurgery: Why the United States Should Embrace This Emerging Technology, 7 J. HIGH TECH. L. 203, 205-06, n.8 (2007) (providing various definitions of telemedicine from the state codes of Montana, Nebraska, New Mexico, Oregon, and Texas).
(11.) Id. at 206; see also C.R. Ewell, Telemedicine: Overcoming Obstacles on the Road to Global Healthcare, 12 CURRENTS: INT'L TRADE L.J. 68, 69 (2003). Additionally, the American Medical Association defines telemedicine as "medical practice across distance via telecommunications and interactive video technology." Katherine J. Herrmann, Cybersurgery: The Cutting Edge, 32 RUTGERS COMPUTER & TECH. L.J. 297, 307 (2006) (quoting P. Greg Gulick, E-Health and the Future of Medicine: The Economic, Legal, Regulatory, Cultural, and Organizational Obstacles Facing Telemedicine and Cybermedicine Programs, 12 ALB. L.J. SCI. & TECH. 351, 364 (2002)).
(12.) Patricia C. Kuszler, Telemedicine and Integrated Health Care Delivery." Compounding Malpractice Liability, 25 AM. J.L. & MED. 297, 302-03 (1999) ("[Telemedicine] is breaking down boundaries between different types of health care providers, revolutionizing rural health care delivery, improving and facilitating care for underserved and difficult to manage populations and enhancing discourse between patients and providers.").
(13.) Heart Surgery by Robots, HARV. HEART LETTER (Harvard Medical School, Cambridge, MA), Jan. 1, 2000, at 5.
(14.) Id. at 6-7.
(15.) Press Release, Institute for Research into Cancer of the Digestive System, "Operation Lindbergh" A World First in YeleSurgery: The Surgical Act Crosses the Atlantic! (Sept. 19, 2001) available at http://www.ircad.fr/event/lindbergh/lindbergh_presse_en.pdf [hereinafter IRCAD Press Conference]. This surgery was appropriately named after Charles Lindbergh's legendary transatlantic flight. Id. at 7.
(16.) Id. at 3.
(17.) ld. at 5.
(19.) Id. at 4.
(20.) Id. at 3. The high-speed fiberoptic service was provided by France Telecom, one of Europe's top Internet service providers and one of the largest wireless operators.
(21.) Herrmann, supra note ll, at 299-300 (citing IRCAD Press Conference, supra note 15, at 5).
(22.) Laparoscopic surgery is defined as "pertaining to laparoscope," which is "an instrument, comparable to an endoscope, that is inserted into the peritoneal cavity to inspect it." DORLAND'S ILLUSTRATED MEDICAL DICTIONARY 1019 (31st ed. 2007). See also Herrmann, supra note 11, at 300 (defining laparoscopic surgery as a minimally invasive surgery which uses a tiny camera to enable the surgeon to make smaller incisions to avoid fully opening up a patient's chest or abdominal cavity).
(23.) IRCAD Press Conference, supra note 15, at 9.
(26.) Herrmann, supra note 11, at 300; see also IRCAD Press Conference, supra note 15, at 9. Use of robotic instruments in a surgery is innately remote because at least some distance is present between the surgeon and the patient, with the robot acting as the intermediary. Herrmann, supra note 11 at n. 19.
(27.) See Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1300 (Fed. Cir. 2003). It is important to note that the technological structure described above applies to Intuitive's da Vinci[TM] robot (also at issue in the Mracek case), rather than the ZEUS[R] robot used in Operation Lindbergh, though both robots utilize the same transmission system. The distinctions between these two machines are discussed later. See infra notes 35-52 and accompanying text.
(28.) Brookhill-Wilk 1, 334 F.3d at 1300.
(29.) IRCAD Press Conference, supra note 15, at 9.
(31.) McLean I, supra note 7, at 499.
(32.) IRCAD Press Conference, supra note 15, at 9.
(33.) See id. at 4.
(35.) Id. at 5.
(36.) Herrmann, supra note 11, at 301-02; see also Thomas R. McLean, Cybersurgery--An Argument For Enterprise Liability, 23 J. LEGAL MED. 167, 169 (2002) [hereinafter McLean II]. "In July of 2000, Intuitive Surgical's da Vinci Surgical System 'became the first surgical robot approved by the U.S. Food and Drug Administration.'" (quoting Jeremy Manier, Assisted by Robotics, Doctors Performing Surgeries from Afar, CHI. TR1B., Oct. 25, 2000, at A1).
In 2003, Intuitive and Computer Motion merged "to end ongoing patent disputes between the two competing companies." See Herrmann, supra note 11, n.26; see also Press Release, Intuitive Surgical and Computer Motion Announce Merger Agreement (Mar. 7, 2003), available at http://findarticles.com/p/articles/mi_m0EIN/is_2003_March_7/ai_98467154/. The CEO of Computer Motion stated:
Separately, our companies wouldn't be able to accomplish for patients and our shareholders what we will be able to accomplish together. By sharing our complementary technologies in networking, articulation, control and visualization, we believe we will significantly strengthen the surgical capabilities of both the da Vinci and ZEUS product platforms. We look forward to working as one team to enhance the care received by patients through less-invasive surgery.
Id. This is discussed more in depth later in this note. Infra notes 105-14 and accompanying text.
(37.) McLean II, supra note 36, n.13.
(38.) McLean I, supra note 7, at 498.
(39.) Herrmann, supra note 11, at 302. "The InSite Vision system uses two parallel fiberoptic cables to provide stereoscopic vision. Viewing the operative field with InSite Vision provides much the same quality of vision that is obtained by viewing an operative field with surgical 'loopes' (Designs for Vision, New York, N.Y.), a traditional image magnifying system used by cardiac surgeons." McLean II, supra note 36, n.12. Stereoscopic vision enables the viewer to see objects' length, width, and depth. It is also referred to as three-dimensional vision. OXFORD ADVANCED LEARNER'S DICTIONARY 1272 (6th ed. 2000).
(40.) McLean I, supra note 7, at 498.
(41.) Id. There is roughly a "one million dollar price tag associated with a da Vinci or Zeus instrument." Id. at 500. See also Herrmann, supra note 11, at 305 (noting that both da Vinci and ZEUS are worth one million dollars).
(42.) McLean I, supra note 7, at 498-99.
(43.) See id. at 499.
(45.) Id.; see supra note 26 and accompanying text. However, unlike ZEUS(R) surgical equipment, da Vinci, though capable of operating across long distances, is not primarily focused on such a feat. intuitive Surgical, Frequently Asked Questions, INTUITIVE SURGICAL, http://www.intuitivesurgical.com/products/products_faq.html (last visited Nov. 21, 2010)[hereinafter Intuitive Surgical FAQ].
(46.) McLean I, supra note 7, at 499. See generally Herrmann, supra note 11 at 299-300 (discussing the setup of Operation Lindbergh).
(47.) McLean I, supra note 7, at 499. See supra notes 29-35 and accompanying text.
(48.) See Regulatory Clearance, INTUITIVE SURGICAL, http://www.intuitivesurgical.com/specialties/regulatory-clearance.html (last visited Jan. 12, 2012).
(49.) See Hamilton-Piercy, supra note 10, at 207; see also Ewell, supra note 11, at 69 (noting that in July 2000, da Vinci marked the birth of new technology in the United States).
(50.) See Regulatory, Clearance, supra note 48.
(51.) Intuitive Surgical Receives FDA Clearance of the da Vinci Surgical System for Radical Prostatectomy, ALLBUSINESS.COM (June 4, 2001), http://www.allbusiness.com/medicine-health/diseases-disorders-cancer- prostate/6081889-1.html#ixzzljHQlh8jK. See also Mracek, 610 F. Supp 2d. at 402-03 (describing how the plaintiff underwent laparoscopic procedure after the da Vinci surgical robot failed during prostatectomy).
(52.) Michelle Meadows, Computer-Assisted Surgery. An Update, FDA CONSUMER MAG., July-Aug. 2005, at 39; see discussion infra notes 105-14 and accompanying text.
(53.) See Meadows, supra note 52, at 39.
(54.) McLean I, supra note 7, at 499; see also Susan E. Volkert, Telemedicine: Rx for the Future of Health Care, 6 MICH. TELECOMM. & TECH. L. REV. 147, 148-49 (2000) ("A mobile telemedicine platform was employed by the U.S. military in Bosnia. Because there were radiologists, orthopedists and other specialists in the United States to immediately address soldiers' illnesses or injuries, soldiers did not need to evacuate to Germany.").
(55.) McLean I, supra note 7, at 499-500. See also McLean II, supra note 36, at 171 n.21 ("A line of medical reports from the Ben Taub Hospital in Houston, Texas supports the conclusion that survival after major trauma is dependent on getting the trauma victim to a surgeon as quickly as possible; or, relevant to cybersurgery, getting the surgeon to the trauma victim [as quickly as possible].").
(56.) McLean I, supra note 7, at 499-500.
(57.) McLean I, supra note 7, at 500. See also McLean II, supra note 36, at 170-71 (noting that it is only a matter of time until the Texas Correction System adopts telemedicine because transporting prisoners requires extra security precautions).
(58.) Hamilton-Piercy, supra note 10, at 218-20. Contra Daniel Ostrovsky, Technology Raises Questions of Informed Consent, THE DALLY RECORD (Baltimore, MD) Oct. 14, 2005 (challenging the benefits actually received by patients because of the experimental nature of a telesurgical procedure).
(59.) Hamilton-Piercy, supra note 10, at 219; see also McLean I, supra note 7, at 517 (referencing multiple studies and explaining the "mounting clinical evidence to support the conclusion that high volume medical institutional providers are safer than low volume medical institutional providers").
(60.) Hamilton-Piercy, supra note 10, at 219; see also McLean II, supra note 36, at 167 (citing COMMITTEE ON QUALITY HEALTH CARE IN AMERICA, INSTITUTE OF MEDICINE, TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al. eds. 1999).
(61.) Intuitive Surgical FAQ, supra note 45.
(63.) McLean I, supra note 7, at 500; see also McLean II, supra note 36, at 172 (noting that the advanced capabilities of cybersurgery are likely to benefit surgeons, patients, and society as a whole).
(64.) Intuitive Surgical FAQ, supra note 45. See also Robotics: the Future of Minimally Invasive Heart Surgery, BIOMED.BROWN.EDU, http://biomed.brown.edu/Courses/BI108/BI108_2000_Groups/Heart_Surgery/Rob otics.html (last visited Nov. 21, 2010) (Cybersurgery "eliminates errors involving human hand tremor and enables precise micro-movements beyond the scope of human vision. Robotics has enabled surgeons to perform cuts and operations beyond the scale of human ability.").
(65.) Herrmann, supra note 11, at 305.
(66.) Id.; see also McLean I, supra note 7, at 498 (discussing the beginning of competition within the surgical robot market in the year 2000).
(67.) Herrmann, supra note 11, at 305.
(69.) Da Vinci Training, INTUITIVESURGICAL.COM, http://www.intuitivesurgical.com/training/,(last visited Nov. 21, 2010).
(71.) Hamilton-Piercy, supra note 10, at 219.
(72.) Id.; see also Telemedicine: An Information Highway to Save Lives, Hearing before the Subcomm. on Investigations and Oversight of the House Comm. on Science, Space, and Technology, 103d Cong. 2 (1994) (including the written testimony of Dr. Eric G.Tangalos, M.D. of the Mayo Clinic).
(73.) Intuitive Surgical FAQ, supra note 45.
(74.) General surgery is defined as surgery "that ... deals with surgical problems of all kinds, rather than those in a restricted area, or in a surgical specialty such as neurosurgery." DORLAND'S ILLUSTRATED MEDICAL DICTIONARY 1835 (31st ed. 2007).
(75.) Urologic is defined as "pertaining to urology," which is "the medical specialty concerned with the urinary tract in both male and female, and with the genital organs in the male." Id. at 2039.
(76.) Gynecologic is defined as "pertaining to the female reproductive tract or to gynecology," which is "the branch of medicine that deals with diseases of the genital tract in women." Id. at 824.
(77.) Thoracoscopy is defined as the "diagnostic examination of the pleural cavity through an endoscope." Id. at 1946.
(78.) Thoracoscope is defined as "an endoscope for examining the pleural cavity; it is instead into the cavity through a skin incision in an intercostals space." Id. at 1946. Cardiotomy is the "surgical incision of the heart for repair of cardiac defects." Id. at 300.
(79.) Intuitive Surgical FAQ, supra note 45.
(80.) See Definition of Prostatectomy, supra note 2.
(81.) Treatment Comparison: da Vinci vs. Open vs. Laparoscopy, DAVINCIPROSTATECTOMY.COM, http://www.davinciprostatectomy.com/treatment-options/dvopenlap.aspx (last visited Nov. 21, 2010); see also Ashutosh Tewari et al., Long-Term Survival in Men With High Grade Prostate Cancer: A Comparison Between Conservative Treatment, Radiation Therapy and Radical Prostatectomy--A Propensity Scoring Approach, 177 J. OF UROLOGY 911, 911-15 (March 2007) (concluding that the survival rate of men with high grade prostate cancer can be improved through radical prostatectomy).
(82.) See DAVINCIPRASTATECTOMY.COM, supra note 81.
(83.) See id. Estimated blood loss for patients undergoing da Vinci surgery is 109 milliliters, 1355 milliliters through open surgery, and 380 milliliters through minimally invasive laparoscopic surgery. The length of stay is 1.2 days for a patient undergoing a surgery with da Vinci equipment, 3 days for a patient undergoing conventional open surgery, and 2.5 days for a patient of minimally invasive laparoscopic surgery. 1.7% of patients of da Vinci procedures suffered from major complications, as compared to 6.7% of open surgery patients and 3.7% of laparoscopic patients. 3.7% of da Vinci patients suffered from minor complications, as compared to 12.6% of open surgery patients and 14.6% of laparoscopic patients. With regard to urinary function, 92.9% of da Vinci patients had normal urinary function after three months, 94.9% had normal function after six months, and 97.4% had normal function after a year. 54% of patients of open surgery had normal urinary function after three months, 80% of patients after 6
months, and 93% of patients after a year. 62% of patients of laparoscopic surgery had normal urinary function after three months, 77% of patients after six months, and 83% of patients after a year. Lastly, 86% of da Vinci patients had normal sexual function after a year, as compared to 71% of open surgery patients and 76% of laparoscopic patients. Id.
(84.) Intuitive Surgical FAQ, supra note 45.
(86.) Hamilton-Piercy, supra note 10, at 207 (citing Michelle Meadows, Computer-Assisted Surgery: An Update, FDA CONSUMER MAG. July-Aug. 2005, at 39.).
(88.) Id. at 208.
(90.) Id at 209.
(91.) For the purpose of this paper, health care providers refers solely to surgeons and hospitals.
(92.) See Hamilton-Piercy, supra note 10; see also McLean, supra note 36 and
(93.) Hermann, supra note 36, at 302.
(94.) Court Holds That Intuitive's da Vinci System Infringes Computer Motion Patent, Computer Motion Discusses Impact of Ruling, BUSINESSWIRE.COM (Feb. 11, 2003), http://www.allbusiness.com/legal/legal-services-litigation/5679506- 1.html[hereinafier BUSINESSWIRE.COM I]. These numbers may seem small as compared to recent trends; however, for that time period, these sales numbers were the largest for any telesurgery company. See Report on the Historical Intuitive Surgical vs. Computer Motion Case, SURGROB.BLOGSPOT.COM (March 24, 2010), http://surgrob.blogspot.com/2010/03/vintage-report-on-intuitive- vs-computer.html.
(95.) See SURGROB.BLOGSPOT.COM, supra note 94.
(96.) Intuitive Surgical and IBM Corporation Jointly Sue Computer Motion for Patent Infringement, BUSINESSWIRE.COM (Apr. 4, 2001), http://www.allbusiness.com/legal/legal-services-litigation/6054592-1.html (the '984 patent at issue belongs to IBM and is exclusively licensed to Intuitive, hence their joint involvement in this case); see also Intuitive Surgical Wins All Key Summary Judgment Disputes Against Computer Motion in Delaware, BUSINESSWIRE.COM (July 30, 2002), http://www.allbusiness.com/legal/ legal-services-litigation/5913557-1.html [hereinafter BUSINESSWIRE.COM II]; SURGROB.BLOGSPOT.COM, supra note 94.
(97.) BUSINESSWIRE.COM II, supra note 96.
(99.) Id.; see also BUS1NESSWIRE.COM I, supra note 94.
(100.) BUSINESSWIRE.COM I, supra note 94. See also SURGROB.BLOGSPOT.COM, supra note 94.
(101.) See BUSINESSWIRE.COM I, supra note 94.
(102.) Id. Failure to meet this burden would result in liability for Intuitive. In addition, Computer Motion would be able to have the damage award tripled if Intuitive's infringement was deemed willful, and would have the fight to enjoin Intuitive from producing, promoting, using, or selling their da Vinci Surgical System in the United States. Intuitive Surgical Announces Two Summary Judgment Rulings in California Patent Litigation, BUSINESSWIRE.COM (Feb. 11, 2003), http://www.allbusiness.com/legal/legal-services-litigation/5707801-1.html [hereinafter BUSINESSWIRE.COM III].
(103.) See BUSINESSWIRE.COM I, supra note 94. Intuitive's defense was that Computer Motion's patent would have to either be narrowly interpreted, and thus not infringed by Intuitive, or if the patent was broadly construed, it would be unworkable and therefore invalid.
(106.) Jury: Computer Motion must pay Intuitive Surgical $4.4M., ALLBUSINESS.COM, http://www.allbusiness.com/print/13400830-1-9a0bs.html (last visited Jan. 18, 2012).
(107.) Michael Baron, Intuitive Surgical, Computer Motion Agree to Merger, MARKETWATCH (Mar. 7, 2003, 11:07 AM), http://www.marketwatch.com/story/intuitive-surgical-computer-motion-agree- to-merge. Less than one month earlier, Computer Motion announced the holding of the District Court for the Central District of California. See BUSINESSWIRE.COM III, supra note 102.
(108.) Intuitive Surgical and Computer Motion Announce Merger Agreement, BUSINESSWIRE.COM (March 7, 2003), http://findarticles.com/p/articles/mi_m0EIN/is_2003_March_7/ai_98467154/ [hereinafter BUSINESSWIRE.COM IV].
Under the terms of the definitive merger agreement, Computer Motion's equity holders would receive 32 percent of the combined company on a fully diluted basis (including out-of-the-money options and warrants), and Intuitive's equity holders would receive 68 percent. The merger agreement exchange ratio formula anticipates that each outstanding share of Computer Motion common stock would be converted into approximately 0.52 shares of Intuitive common stock. In the event that Computer Motion's common stock trades at an average of less than $1.86 per share before the merger, the exchange ratio will be reduced, but shall in no event be less than approximately 0.48.... Under the merger agreement, it is anticipated that Intuitive will issue an aggregate of approximately 15.39 million shares, on a net fully diluted basis, in exchange for all of Computer Motion's outstanding common stock, preferred stock, options, and warrants. The merger is subject to the approval of a majority of the shareholders of each company and is intended to be a tax-free reorganization. In addition, Intuitive may provide a bridge loan to Computer Motion to provide working capital for its operations through the closure period if necessary.
Id.; see also Intuitive Surgical, Inc.--ISRG Current Report Filing (8-K) Exhibit 99.1 Intuitive Surgical and Computer Motion Announce Merger Agreement, EDGAROnline.com (Mar. 7, 2003), http://sec.edgar-online.com/intuitive-surgical-inc/8-k-current-report- filing/2003/03/07/section10.aspx (providing a more in depth discussion of the refined details of the merger).
(111.) SURGROB.BLOGSPOT.COM, supra note 94.
(112.) See BUSINESSWIRE.COM IV, supra note 108.
(114.) SURGROB.BLOGSPOT.COM, supra note 94; see also BUSINESSWIRE.COM IV, supra note 108. While the financial success of IBM is obvious, at the time leading up to the merger, Intuitive Surgical generated $72 million in total sales in 2002. Id.
(115.) BUSINESSWIRE.COM IV, supra note 108. Duggan, of Computer Motion, further provided that "[e]liminating intellectual property litigation and initiating technology sharing should have a positive impact on market value. In addition, this merger strengthens our organization's financial and operational capabilities." Id.
(117.) Computer Motion, Inc.: Private Company Information, BLOOMBERG BUSINESSWEEK, http://investing.businessweek.com/research/stocks/private/ snapshot.asp?privcapId =26873 (last visited Jan. 12, 2012).
(118.) See BUSINESSWIRE.COM IV, supra note 108.
(119.) SURGROB.BLOGSPOT.COM, supra note 94.
(121.) Garmin. Intuitive Surgical and Amazon.com Help Lift Nasdaq 100; Linear Technology Tumbles, ASSOCIATED PRESS FINANCIAL WIRE, May 23, 2007, at 1. According to Wachovia Securities analyst Michael Matson, Intuitive Surgical "has a monopoly on the fast-growing robot-assisted surgery market." Id.
(122.) Mracek v. Bryn Mawr Hosp., 610 F. Supp. 2d 401, 404 (E.D. Pa. 2009) (quoting Lewis v. Coffing Hoist Div., Duff-Norton Col, 515 Fa. 334. 340 (1987)). See also RESTATEMENT (SECOND) OF TORTS [sections] 402A (1965).
(123.) See also RESTATEMENT (SECOND) OF TORTS [sections] 402A (1965).
(124.) See Mracek, 610 F. Supp. 2d at 404 (citing Walton v. Acvo Corp., 610 A.2d 454, 458-59 (Pa. 1992)).
(128.) AM. L. PROD. LIAB. 3d [sections] 17:64 (West, Westlaw through 2011).
(130.) Id. ("If a product failed under conditions concerning which the ordinary consumer would have fairly definite expectations, then the jury may infer that the product is defective.").
(131.) Id. [sections] 17:57.
(132.) Id [sections][sections] 17:57, 17:64.
(133.) Mracek, 610 F. Supp. 2d at 406-07 ("[E]ven more fatal to Mracek's cause of action for strict product liability is his failure to submit any evidence of causation between what occurred in the operating room with the da Vinci robot and his erectile dysfunction."). Further, Mracek failed to provide any evidence to show that, had there been zero problems with the da Vinci system, the subsequent erectile dysfunction injury would not have happened. Id.
(134.) AM. L. PROD. LIAB. 3d [sections] 17:57 (West, Westlaw through 2011).
(136.) Id. [sections] 17:56.
(137.) See id.
(139.) See Mracek, 610 F. Supp. 2d at 405. The expert provided by Mracek gave testimony as to the robot failing to function but did not address whether the da Vinci system was defective.
(140.) ROBERT E. JONES et al., RUTTER GROUP PRACTICE GUIDE: FEDERAL CIVIL TRIALS AND EVIDENCE [sections] 8:1505 (2008-2010) (citing FED. R. EVID. 702) (emphasis in original).
(141.) Hochen v. Bobst Grp., Inc., 290 F.3d 446, 452 (1st Cir. 2002) (engineering expert's opinion found inadmissible because of lack of specific knowledge about printing press at issue); see also JONES, supra note 140, at [sections] 8:1516 (noting that the admissibility of technical or diagnostic equipment is governed by Fed. R. Evid. 702 because it comes from an expert witness).
(142.) JONES, supra note 140, at [sections] 8:1546 (Opposing counsel is most likely going to vigorously challenge the expert's qualifications; more importantly, the trier of fact may be unconvinced by the opinion if it is opposing testimony of a specialist in the field in question).
(143.) Id. at [sections] 8:1652.1 ("An expert's failure to assess whether the product has met the proper standard may result in exclusion of the expert's opinion.").
(144.) See supra notes 136-142 and accompanying text.
(145.) Lack of Expert Data Sinks Pa. Suit Over 'Robotic' Surgery: Mracek v. Bryn Mawr Hospital, 6 ANDREWS EXPERT AND SCI. EVIDENCE LITIG. REP. 11 (May 15, 2009) ("The judge said that while [operating surgeon] McGinnis' operative report provides details about the surgical procedure and mechanical problems with the da Vinci, it does nothing to link the robot's operational problems with the plaintiff's injury.") [hereinafter Lack of Expert Data].
(147.) See AM. L. PROD. LIAB.3d [sections] 17:56 (2011).
(148.) See supra notes 136-142 and accompanying text.
(149.) Lack of Expert Data, supra note 145.
(150.) Even more indicative of limited expert options, new research proclaims that surgeons who perform robotic prostatectomy operations are not proficiently skilled until the procedure has been performed more than 1,600 times. Michelle Fay Cortez, Doctors' Need 1,600 Robot-Aided Prostate Surgeries For Skills, Study Finds, BLOOMBERG.COM (Feb. 16, 2011, 4:03 PM), http://www.bloomberg.com/news/2011-02-16/doctors-need-1-600-robot- aidedprostate-surgeries-for-skills-study-finds.html
(151.) Jones et al., supra note 140, at [sections] 8:1652.1.
(152.) See discussion supra Part III.
(153.) See discussion supra Part III.
(154.) Hamilton-Piercy, supra note 10, at 219.
(155.) Id. at 222.
(156.) Mracek, 363 F. App'x. at 926.
(157.) Michael S. Young, Artificial Intelligence, Telemedicine, and Robotics in Health Care, 8 THE SCITECH LAWYER 14, 15 (2010).
(158.) Id. ("Medical device ... companies will become parties to medical-related negligence lawsuits.").
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|Date:||Sep 22, 2012|
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