I. QUALIFICATIONS OF PLAINTIFF’S STANDARD OF CARE EXPERT
Relying on the Patient’s First Act, N.J.S.A. 2A:53A-41, and subsequent case law, movants contend that plaintiff’s proposed standard of care expert, Dr. William Irvin, lacks appropriate qualifications because he does not practice in the same specialty as Dr. Bonifield. Dr. Irwin is board-certified in obstetrics and gynecology (“OB-GYN”), the same specialty as Dr. Bonifield, who is also a board-certified OB-GYN. Dr. Irwin is also board certified in the subspecialty of gynecologic oncology. While movants point out that Dr. Irwin no long practices obstetrics, this case does not involve obstetrics. Instead, plaintiff alleges that Dr. Bonifield committed medical malpractice during a Da Vinci robotic hysterectomy by severing her ureter during the surgery.
During his deposition, Dr. Irwin testified that he has been board-certified in OB-GYN since 1998 and in gynecologic oncology since 2000. Dr. Irwin sees both gynecologic oncology patients as well as patients that have various gynecologic issues other than cancer, that he refers to as “benign gynecological issues that don’t have anything to do with cancer.” Irwin Dep. at 12. Dr. Irwin explained the difference between OB-GYN and gynecological oncology as follows:
Obstetrics and gynecology involves the evaluation and management of issues that ae associated with pregnancy as well as in the non-pregnant patient issues that are associated with gynecologic function. That can conclude, for example, dysfunctional uterine bleeding or atypical uterine bleeding, include pelvic pain, vaginitis, vulvitis, ovarian cyst formation, menorrhagia, uterine leiomyomata, endometriosis. So there is a host of issues that can and do compromise the field of gynecology. I didn’t include all of them. That’s just kind of a representative sample. Gynecologic oncology involves the management of women hat have been diagnosed with malignancies of the lower female genital tract to include vulva cancer, vaginal cancer, cervical cancer, uterine cancer, fallopian tube cancer, ovarian cancer and cancer of the peritoneum.
[Id. at 14-15.]
In his own words, Dr. Irwin described his current medical practice as follows:
I see a variety of different patients. Probably about 45 percent of the patient population I have currently have known cancer and I’m managing their cancers. Those are cancers typically that I treated initially at their diagnosis and have continued to both treat them and follow them as I’ve needed to do that. The other 50 to 55 percent of my practice involves complicated surgical procedures or simple surgical procedures to address benign, non-oncologic gynecologic issues which include the litany that I gave you earlier about GYN care; typically enlarged uteri, pelvic pain, endometriosis, ovarian cyst formation, adnexal masses, postmenopausal bleeding as well as just routine annual well-woman exams.
[Id. at 15-16.]
Although he no longer delivers babies or practices obstetrics, Dr. Irwin’s current medical practice involves far more than treating gynecological cancers. In that regard, he testified that he performs endometrial biopsies, Pap smears, and routine gynecological examinations. When asked if there were “any functions or procedures that a general OB/GYN performs within the gynecological part” of his practice that he does not do, he answered: “No.” Id. at 17. When seen by Dr. Bonifield on October 3, 2011, plaintiffs “primary complaints at that time were premenstrual syndrome and the various symptoms associated with that; severe pelvic pain in the week prior to her periods; menorrhagia, or heavy menstrual flow with her periods; and pain associated with interstitial cystitis.” Id. at 17-18. Dr. Bonifield’s examination transvaginal ultrasound performed on October 7, 2011 suggested “multiple small fibroids” and “the presence of adenomyosis.” Id. at 18. Dr. Irwin testified that he performs hysterectomies on women with similar presentation to plaintiff’s “[a]ll the time.” Id. at 18.
Dr. Irwin then gave a numerical breakdown of the roughly 250 major surgeries he has performed each year for the past 20 years. Ibid. Of those more than 5,000 surgical procedures, he estimated that at least 50% were hysterectomies. Ibid. Thus, he testified that he had performed roughly 2,500 or more hysterectomies in his surgical career. Id. at 19.
Dr. Irwin began doing laparoscopic hysterectomies in 1998 with conventional stick laparoscopy. Ibid. Robotic hysterectomies were approved for gynecological applications in 2005. Ibid. He converted over largely to robotic hysterectomies that same year. Ibid. During the past four or five years he converted a large number of his robotic hysterectomies back to conventional laparoscopic hysterectomies because “the robotic approach was deemed overkill for a conventional straightforward benign hysterectomy.” Ibid. But from 2005 to roughly 2012, all of the laparoscopic hysterectomies he performed were robotic. Id. at 19-20.
Dr. Irwin underwent training to become qualified to use the Da Vinci robotic device. Id. at 28. In order to do so he had to demonstrate proficiency after practicing on the robot, first in a dry lab, then on animals. Ibid. Following that, he had to perform three robotic procedures supervised by a proctor. Id. at 29. He was then declared proficient and was credentialed at his hospital to perform Da Vinci hysterectomies. Id. at 29-30. He then started performing Da Vinci robotic surgeries on his own. Id. at 30.
Dr. Irwin served as a national proctor for robotic assisted laparoscopic hysterectomies on behalf of the Da Vinci program. Id. at 20. For some five years he “traveled around the country as a proctor to physicians that were attempting to learn robotic hysterectomies and required a proctor to sign them off in terms of evaluating their proficiency at their procedure.” Ibid. He further testified: “So between the surgeries I performed and the cases that I’ve proctored across the country there have been hundreds and hundreds of laparoscopic hysterectomies I performed or overseen 7 robotically.” Ibid. There have also been occasions when a general OB-GYN refers a patient to Dr. Irwin to perform a simple hysterectomy because it was particularly complicated. Id. at 22. Dr. Irwin also testified that the same standard of care applies to an OB/GYN and a gynecological oncologist when performing a simple hysterectomy. Id. at 27. Considering the testimony of Dr. Irwin in a light most favorable to plaintiff, and affording plaintiff all reasonable inferences, Dr. Irwin’s testimony demonstrates at the time of plaintiff’s surgery and presently, he was sufficiently credentialed. Dr. Irwin has been board-certified in obstetrics and gynecology, the same specialty as Dr. Bonifield, since 1998. Dr. Irwin’s testimony further demonstrates at the time of plaintiff’s surgery and presently, he actively treats non-cancer gynecological conditions, including performing conventional, laparoscopic and Da Vinci robotic hysterectomies. Dr. Irwin regularly examines, treats and performs surgery on patients with benign gynecological issues having nothing to do with cancer. Indeed, he estimated that at least one-half of his medical practice involves performing surgical procedures to address benign, non-oncological gynecologic issues. He regularly performs all of the functions of a general OB-GYN. At least 50% of the more than 5,000 surgical procedures that he has performed during his career were hysterectomies. Moreover, Dr. Irwin has extensive experience, and even teaches, the Da Vinci robotic hysterectomy technique. The fact that Dr. Irwin is also board-certified in the subspecialty of gynecologic oncology, and devotes approximately one-half of his medical practice to that subspecialty, does not lessen his qualifications to serve as plaintiff’s standard of care expert in this matter. In addition, the fact that Dr. Irwin no longer practices obstetrics is not controlling. This case does not involve the examination or treatment of a pregnant patient or any other aspect of obstetrics.
The court finds that Dr. Irwin is appropriately qualified as an expert in the field of gynecology, including performing conventional, laparoscopic and Da Vinci robotic hysterectomies. More specifically, he is qualified to offer opinions as to the standard of care applicable to an OBGYN in performing Da Vinci robotic hysterectomies. For these reasons, defendants’ motion for summary judgment dismissing plaintiff’s medical malpractice claim is denied.
II. PLAINTIFF’S LACK OF INFORMED CONSENT CLAIM
In count two of her Amended Complaint, plaintiff alleges that Dr. Bonifield failed to obtain her informed consent for the Da Vinci robotic hysterectomy that he performed. Specifically, plaintiff alleges that “it is generally accepted that it takes twenty (20) cases on live patients to become proficient in performing a Da Vinci Robotic hysterectomy so as to minimize the risk of intra-operative injuries to patients.” Amended Cmplt. at ¶ 42. Plaintiff further alleges that Dr. Bonifield “overstated his Da Vinci Robotic surgical experience, and failed to disclose the increased risk of intra-operative injuries to his patients based upon his lack of experience. Id. at ¶ 43. Plaintiff contends that at the time he performed her surgery, Dr. Bonifield was very inexperienced with the Da Vinci Robotic Equipment, and with the performance of DaVinci robotic hysterectomies, and that his inexperience with the equipment and the procedure significantly increased the risk of intra-operative injury to plaintiff. Id. at ¶ 44-45. Plaintiff alleges Dr. Bonifield performed his first Da Vinci robotic hysterectomy on November 23, 2011. Id. at ¶ 49. Plaintiff further alleges that at the time he recommended the Da Vinci robotic hysterectomy to her, Dr. Bonifield had only performed three Da Vinci robotic hysterectomies on live persons, and had only performed ten Da Vinci robotic hysterectomies on live persons by the time he operated on plaintiff. Id. at ¶ 47-48. Plaintiff alleges that neither Dr. Bonifield nor his staff ever informed her of his inexperience with the Da Vinci robotic equipment generally, or the increased risks attendant to that inexperience, when he recommended the procedure to plaintiff on December 6, 2011, or when he performed the surgery on February 2, 2012. Id. at ¶ 50-53, 56.
Plaintiff alleges that if she had been advised of Dr. Bonifield’s inexperience with the subject equipment and the subject procedure, she would have refused the Da Vinci robotic hysterectomy, and instead opted for a traditional total abdominal hysterectomy. Id. at ¶ 60. Plaintiff contends that the failure to advise her of Dr. Bonifield’s inexperience with Da Vinci robotic equipment and the performance of Da Vinci robotic hysterectomies breached defendants’ duty to obtain informed consent from her. Id. at ¶ 58.
“The doctrine of informed consent is . . . essentially a negligence concept, predicated on the duty of a physician to disclose to a patient such information as will enable the patient to makean evaluation of the nature of the treatment and of any attendant substantial risks, as well as ofavailable options in the form of alternative therapies.” Largey v. Rothman, 110 N.J. 204, 208,(1988); see also In re Conroy, 98 N.J. 321, 346 (1985). “Under this doctrine, no medical proceduremay be performed without a patient’s consent, obtained after explanation of the nature of thetreatment, substantial risks, and alternative therapies.” In Re Conroy, supra, 88 N.J. at 346 (quotingN.L. Cantor, A Patient's Decision to Decline Life-Saving Medical Treatment: Bodily IntegrityVersus the Preservation of Life, 26 RUTGERS L. REV. 228, 237 (1973).
Here, plaintiff argues that she was repeatedly encouraged to get the Da Vinci procedure by Dr. Bonifield and his colleague, and that she was falsely made to believe that Dr. Bonifield had “great experience with this procedure.” In the affidavit submitted in support of her prior motion for leave to amend her Complaint, plaintiff stated:
4. When I heard this I was stunned, because when Dr. Susan Walsh recommendedthe robotic procedure to me, she told me that Dr. Bonifield regularly did thisDaVinci robotic procedure for all of the physicians in the Cumberland Obstetricsand Gynecology practice. She made it seem like Dr. Bonifield regularly performed DaVinci robotic hysterectomies and that he had a lot of experience doing so. I hadnever heard about this type of surgery before then.
5. When I spoke to Dr. Bonifield prior to the procedure, he talked me into the DaVinci robotic procedure with affirmative representations to me that he had lots of experience performing the Da Vinci robotic procedure.
6. Dr. Bonifield and Cumberland Obstetrics and Gynecology’s employees (including Dr. Walsh and Donna Hill) repeatedly encourage me to have the Da Vinci robotic procedure with “experienced” Dr. Bonifield, and represented to me that I would be back to work in four weeks instead of six to eight weeks with an open procedure.
7. Had I known that the affirmative representations of Dr. Bonifield’s experience” were not true, I would have never undergone the Da Vinci robotic procedure with Dr. Bonifield on February 2, 2012.
[Plaintiff’s Affidavit at 1-2.]
On July 11, 2015, plaintiff was re-deposed by defendants as to her causes of action for lack of informed consent and medical battery. During that deposition, plaintiff gave the following explanation for the factual basis for her lack of informed consent claim:
● Dr. Walsh stated that Dr. Bonifield was the only physician that performed hysterectomies via the Da Vinci robot. This assured plaintiff that Dr. Bonifield “had the experience in that procedure.”
● Dr. Walsh “just assured me that he was the only one with the experience to do it that way.”
● Dr. Walsh never, at any time, told plaintiff how experienced or inexperienced Dr. Bonifield specifically was with the robot.
● When specifically questioned regarding any affirmative representations that Dr. Bonifield had “lots of experience performing the da Vinci robotic procedure,” plaintiff answered:
“Well, he’s the only one in the office that can do the procedure. I’m assuming that he has experience in doing it. That’s my assumption”
● When questioned whether Dr. Bonifield said anything to plaintiff about his experience, plaintiff testified: “I don’t remember verbatim now.” When then asked whether she had a general recollection of anything Dr. Bonifield said about his experience with the da Vinci robot, plaintiff answered: “No.”
● When further asked whether Dr. Bonifield had ever, at any time, told plaintiff the number of da Vinci robotic procedures he had performed, plaintiff answered: “No.”
● When asked whether there was a certain number of procedures that Dr. Bonifield would have had to perform for her to feel comfortable undergoing one with him, plaintiff answered: “I would say years of experience. I can’t give a number.”
● When asked whether anyone had told her the number of Da Vinci hysterectomies that Dr.Bonifield had performed prior to plaintiff’s Da Vinci hysterectomy, plaintiff testified:“Never nothing in number, but he’s the physician in the office who does the robot-assistedhysterectomy.”
● When questioned by her own attorney regarding what Dr. Walsh said and her impressionsfrom those statements, plaintiff testified that Dr. Walsh told her that 1) Dr. Bonifield didthe Da Vinci robotic procedures for all the other doctors in the office, 2) Dr. Walsh neverstated that Dr. Bonifield really hadn’t done many of these robotic procedures, 3) that sheassumed that since she was the only physician that did hysterectomies via robot that he hadexperience, 4) Dr. Walsh said that Dr. Bonifield “regularly does these via the da Vinci,”and 5) it was the totality of circumstances that led plaintiff to believe that Dr. Bonifield hadgreat experience with this procedure.
● When further questioned by her own attorney regarding what Dr. Bonifield said to make itseem as if he performed robotic hysterectomies “all the time or he was just learning, or something different,” plaintiff answered: “No, he – when he – I can’t remember what hesaid but my whole issue was always recovery time.” Plaintiff stated that Dr. Bonifield “justsold me on the whole procedure and I just – went with it.” When next asked whether Dr.Bonifield made it seem like he did this all the time, plaintiff answered: “Yes.” Plaintiffsaid that she was “under the impression” that this was something that he regularly did andthat he had experience. Plaintiff further testified: I just assumed that – I took their word forit.” Plaintiff then stated: “I thought he knew what he was doing. He just led me to believethat I have experience in doing this.”
● Neither Dr. Bonifield, not Dr. Walsh or Ms. Hill ever told plaintiff that Dr. Bonifield hadonly done a few of these procedures at that point. She stated that she “would not have letsomeone practice a new procedure on me. There’s no way.” Had she known of Dr.Bonifield’s inexperience, plaintiff “would have sought out another physician and weighedmy options and did more research.”
● When asked to elaborate on her testimony that “Dr. Bonifield also stated that this is theprocedure he does,” plaintiff stated: “I can’t remember verbatim what he said. I can’tremember verbatim what he said.”
In actuality, Dr. Bonifield had performed three Da Vinci hysterectomies at the time heobtained plaintiff’s consent. Dr. Bonifield had performed ten Da Vinci hysterectomies by the timehe operated on plaintiff. Rather than being based on an alleged numerical exaggeration of thenumber of robotic hysterectomies that Dr. Bonifield had performed, plaintiff’s lack of confirmedconsent claim is based on Dr. Bonifield’s relative inexperience in performing Da Vinci roboticsurgical procedures.
In his report dated December 17, 2015, Dr. Irvin stated:
Ms. Forrest was placed at even greater risk on February 2, 2012, by Dr. Bonifield’srelative lack of experience with the Da Vinci equipment. Numerous studies suggestthat it takes at least 20 cases of a given procedure with the Da Vinci robot to becomeproficient in that particular approach. According to the material provided, Dr.Bonifield had only performed 10 Da Vinci robotic hysterectomies before operatingon Ms. Forrest, the first of which was performed on November 23, 2011.
[Report at 4.]
During his deposition, Dr. Irvin stated that six of the seven risk factors for ureteral injurywere present in this matter. As to risk factor six, low surgical volume, Dr. Irvin testified:
Dr. Bonifield had only completed 10 laparoscopic hysterectomies with the use ofthe robot prior to operating on Mrs. Forrest. Studies have clearly shown looking atrobotic hysterectomies that it takes generally 20 procedures at least to attain a levelof proficiency and to reduce your complication rates to what will ultimately be yourstandard, and even after that the more you do the more proficient I think youbecome at the procedure, but studies would indicate that it takes at least 20procedures of a particular type of procedure to become proficient in that procedure.
He’d only done ten surgical procedures and he did not make Mrs. Forrest aware ofthat fact preoperatively when he was consenting her. It was his duty to let her knowthat he had only done ten of these surgical procedures and to explain to her at leastto give her the option of saying, well, I think I’d rather have you choose a route thatyou are more familiar with, or she might say that’s fine, but she never was giventhat chance preoperatively when she consented.
[Irwin Dep. at 40-41.]
Dr. Irwin also gave the following testimony regarding the information he provided to his first 19 patients who were considering robotic hysterectomies:
Q. For the first 19 Da Vinci hysterectomies that you did on your own, in those cases did you tell your patients the number of those that you performed before youconsented them?
A. I did because that in my mind is part of the true informed consent, and I gave them the option of having another approach; either a simple laparoscopic approach or an open approach.
[Id. at 47.]
Both parties cite to the seminal case on the matter Howard v. University of Medicine and Density of New Jersey, 172 N.J. 537 (2002). There, the Court was faced with the issue of whether significant misrepresentations concerning a physician’s qualifications can affect the validity of the consent obtained and thereby negate informed consent. The Court opined: “the answer obviously is that they can.” Id. at 555. Prior to this case, “[o]ur case law never has held that a doctor has a duty to detail his background and experience as a part the required informed consent disclosure, nor are we required to decide that question here.” Id. at 554. The Court engaged in the following extended analysis:
[A] patient-specific standard of what is material to a full disclosure does not apply in a claim based on lack of informed consent. Thus, plaintiff's subjective preference for a Board Certified physician, or one who had performed more corpectomies than defendant had performed, is not the actionable standard. Nonetheless, assuming the misrepresentations are proved, if an objectively reasonable person could find that physician experience was material in determining the medical risk of the corpectomy procedure to which plaintiff consented, and if a reasonably prudent person in plaintiff's position informed of the defendant's misrepresentations about his experience would not have consented, then a claim based on lack of informed consent may be maintained.
Modern advances in medicine coupled with the increased sophistication of medical consumers require an evolving notion of the reasonably prudent patient when assessing a claim based on lack of informed consent. See Schultz, supra, 95 Yale L.J. at 221-22. That said, most informed consent issues are unlikely to implicate a setting in which a physician's experience or credentials have been demonstrated to be a material element affecting the risk of undertaking a specific procedure. Largey, supra, 110 N.J. at 213-15; David W. Louisell & Harold Williams, Medical Malpractice § 22.05(3) (2001).
The alleged misrepresentations in this case about "physician experience" (credentials and surgical experience) provide a useful context for demonstrating the difficulty inherent in meeting the materiality standard required in order for physician experience to have a role in an informed consent case. We recognize that a misrepresentation about a physician's experience is not a perfect fit with the familiar construct of a claim based on lack of informed consent. The difficulty arises because physician experience is not information that directly relates to the procedure itself or one of the other areas of required medical disclosure concerning the procedure, its substantial risks, and alternatives that must be disclosed to avoid a claim based on lack of informed consent. But the possibility of materiality is present. If defendant's true level of experience had the capacity to enhance substantially the risk of paralysis from undergoing a corpectomy, a jury could find that a reasonably prudent patient would not have consented to that procedure had the misrepresentation been revealed. That presumes that plaintiff can prove that the actual level of experience possessed by defendant had a direct and demonstrable relationship to the harm of paralysis, a substantial risk of the procedure that was disclosed to plaintiff. Put differently, plaintiff must prove that the additional undisclosed risk posed by defendant's true level of qualifications and experience increased plaintiff's risk of paralysis from the corpectomy procedure. The standard for causation that we envision in such an action will impose a significant gatekeeper function on the trial court to prevent insubstantial claims concerning alleged misrepresentations about a physician's experience from proceeding to a jury. We contemplate that misrepresented or exaggerated physician experience would have to significantly increase a risk of a procedure in order for it to affect the judgment of a reasonably prudent patient in an informed consent case. As this case demonstrates, the proximate cause analysis will involve a two-step inquiry.
The first inquiry should be, assuming a misrepresentation about experience, whether the more limited experience or credentials possessed by defendant could have substantially increased plaintiff's risk of paralysis from undergoing the corpectomy procedure. We envision that expert testimony would be required for such a showing. The second inquiry would be whether that substantially increased risk would cause a reasonably prudent person not to consent to undergo the procedure. If the true extent of defendant's experience could not affect materially the risk of paralysis from a corpectomy procedure, then the alleged misrepresentation could not cause a reasonably prudent patient in plaintiff's position to decline consent to the procedure. The court's gatekeeper function in respect of the first question will require a determination that a genuine issue of material fact exists requiring resolution by the factfinder in order to proceed to the second question involving an assessment by the reasonably prudent patient. Further, the trial court must conclude that there is a genuine issue of material fact concerning both questions in order to allow the claim to proceed to trial. Finally, to satisfy the damages element in a claim based on lack of informed consent, a plaintiff typically has to show a causal connection between the inadequately disclosed risk of the procedure and the injury sustained. Canesi, supra, 158 N.J. at 505. If that risk materialized and harmed plaintiff, damages for those injuries are awarded. Ibid.
[Id. at 556-59.]
To be sure, the Court mandated that the “misrepresented or exaggerated physician experience would have to significantly increase a risk of a procedure in order for it to affect the judgment of a reasonably prudent patient in an informed consent case.” Id. at 558. Ultimately, Howard imposed a two-step inquiry: 1) whether the more limited experience or credentials possessed by the defendant could have substantially increased the plaintiff's risk of injury (which the Howard court noted typically would require the use of expert testimony); and 2) whether that substantially increased risk would cause a reasonably prudent person not to consent to undergo the procedure. Ibid.
In Howard, the plaintiff contended there that the defendant had represented before the operation that he was board-certified in neurosurgery and that he had performed approximately 60 similar operations each year for the past 11 years. Id. at 543. However, the defendant testified at his deposition that he was not board-certified at the time of surgery and had only performed “a couple of dozen” operations during his career. Id. at 544. Therefore, the Court permitted the plaintiffs to amend their complaint to include a cause of action for lack of informed consent. Id. at 560.
Defendants argue that the Howard two-prong test does not even apply because there was no actual misrepresentation regarding Dr. Bonifield’s qualifications or experience. Plaintiff argues that Dr. Bonifield and his Cumberland colleague, Dr. Walsh, affirmatively misrepresented Dr. Bonifield’s experience level. Plaintiff further contends that had she known of Dr. Bonifield’s lack of experience, she would not have undergone a Da Vinci robotic procedure performed by Dr. Bonifield, nor would a reasonably prudent patient have consented to Dr. Bonifield performing the robotic procedure.
When choosing a procedure, plaintiff alleges that she was given the option between a conventional abdominal hysterectomy or the Da Vinci robotic procedure. She claims thatshe chose the robotic procedure because she wanted to get back to work as quickly as possible, and defendant’s office informed her that the healing time for the conventional abdominal procedure was longer than that for the robot-assisted procedure. Dr. Bonifield testified that he explained to plaintiff the costs and benefits of each procedure in great detail, including that patients experience a quicker recovery and less blood loss after the robotic procedure and that the abdominal procedure typically is associated with a longer recovery time, higher blood loss, and a higher risk of infection. Viewing the facts in a light most favorable to plaintiff, and affording plaintiff all reasonable inferences, the court finds that the discovery demonstrates sufficient facts, coupled with Dr. Irvin’s report and testimony, the evidence is not so one-sided that movants must prevail as a matter of law. See Brill, supra, 142 N.J. at 540. A reasonable jury could find for plaintiff on the issue of lack of informed consent. A reasonable jury could find that Dr. Bonifield’s relative lack of experience in performing robotic hysterectomies: 1) could have substantially increased plaintiff's risk of injury, and 2) would cause a reasonably prudent patient to decline the robotic procedure. Id. at 558. Accordingly, summary judgment dismissing plaintiff’s lack of informed consent cause of action (count two) is denied.
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