Opinion
14511/10
02-11-2015
Lawrence W. Kennedy as Administrator of the Estate of Sherry Anne Kennedy deceased, and individually, Plaintiffs, v. Yoshifumi Naka, STEVE XYDAS, ELIAS ZIAS, HENRY TANNOUS, MID-ATLANTIC SURGICAL ASSOCIATES, FACULTY PRACTICE ASSOCIATES, INC., COLUMBIA UNIVERSITY MEDICAL CENTER d/b/a COLUMBIA PRESBYTERIAN MEDICAL CENTER, THE NEW YORK PRESBYTERIAN HOSPITAL, THE MOUNT SINAI MEDICAL CENTER and EDWARDS LIFESCIENCES CORPORATION d/b/a EDWARDS LIFESCIENCES LLC d/b/a EDWARDS LIFESCIENCES, (U.S.), INC., Defendants.
Gordon & Silber, P.C. Attys. For Defts. Zias; Tannous; Mount Sinai School of Med. Of NYU; The Mount Sinai Hospital 355 Lexington Avenue New York, New York 10017 Meagher & Meagher, P.C. Attys. For Pltfs. 111 Church Street White Plains, New York 10601 Martin, Clearwater & Bell, LLP Attys. For Defts. Naka;Xydas; New York Presbyterian Hosp.- Col. Univ. Med. Ctr. 220 East 42nd Street, 13th fl. New York, New York 10017-5842 Hodges Walsh & Slater, LLP Attys. For Defts. Edwards Lifesciences Corp. 55 Church Street, Suite 211 White Plains, New York 10601
Gordon & Silber, P.C.
Attys. For Defts. Zias; Tannous; Mount Sinai School of Med. Of NYU; The Mount Sinai Hospital
355 Lexington Avenue
New York, New York 10017
Meagher & Meagher, P.C.
Attys. For Pltfs. 111 Church Street
White Plains, New York 10601
Martin, Clearwater & Bell, LLP
Attys. For Defts. Naka;Xydas; New York Presbyterian Hosp.- Col. Univ. Med. Ctr.
220 East 42nd Street, 13th fl.
New York, New York 10017-5842
Hodges Walsh & Slater, LLP
Attys. For Defts. Edwards Lifesciences Corp.
55 Church Street, Suite 211
White Plains, New York 10601
Mary H. Smith, J.
The following papers numbered 1 to 18 were read on this motion by defendants Zias, Tannous, Mount Sinai School of Medicine of New York University and the Mount Sinai Medical Center for summary judgment dismissing the complaint, and on this motion be defendants Edwards Lifesciences Corporation, Edwards Lifesciences, LLC and Edwards Lifesciences (U.S.), Inc. for summary judgment dismissing the complaint and all cross-claims, and on this motion by defendants Naka, Xydas, The New York and Presbyterian Hospital for summary judgment dismissing the complaint, and on this cross-motion by plaintiffs for an Order pursuant to CPLR 3126 striking defendant Mount Sinai Medical Center's answer as a sanction for spoliation of the subject heart valve.
Apparently defendant The New York and Presbyterian Hospital incorrectly has been sued herein as The New York Presbyterian Hospital and Columbia University Medical Center d/b/a Columbia Presbyterian Medical Center.
Papers Numbered
Notice of Motion - Affirmation (Mayouhas) - Exhs. (A-L) ............................................ 1-3
Notice of Motion - Affirmation (Hodges) - Exhs. (A-LL) .............................................. 4-6
Notice of Motion - Affirmation (Glorieux) - Exhs. (A-W) .............................................. 7-9
Notice of Cross-Motion - Affirmation (McCorley) - Exhs. (Collectively) ...................... 10-12
This Part's published Rules require separately tabbed motion exhibits.
Answering Affirmation (Mayouhas) - Exhs. (A-C) .................................................... 13-14
Replying Affirmation (Mayoushas)............................................................................... 15
Replying Affirmation (Svensson) ................................................................................. 16
Replying Affirmation (Radomisili) ................................................................................ 17
Replying Affirmation (McCorley) .................................................................................. 18
Upon the foregoing papers, it is Ordered and adjudged that these separate motions by defendants for summary judgment dismissing the complaint and on this cross-motion by plaintiff for an Order imposing the sanction of striking defendant Mount Sinai Medical Center's answer are disposed of as follows:
This is a wrongful death, medical malpractice and negligence action in which plaintiffs also plead a claim for a failure to obtain consent. Decedent Sherry Anne Kennedy ("Mrs. Kennedy") had an extensive past medical and surgical history, including a recurring breast cancer diagnosis, first made in 1984, for which Mrs. Kennedy had received radiation therapy, and a double mastectomy that had been performed in 2004. Mrs. Kennedy additionally previously also had suffered cardiac issues for which she had a 2-vessel coronary bypass graft performed, in 2006, and a subsequent stent placement, on May 7, 2008, when the coronary artery bypass graft had failed.
In June, 2008, at which time Mrs. Kennedy had been 64 years of age, it had been determined that, as a result of her earlier radiation treatment, Mrs. Kennedy had induced constrictive pericarditis. She had been referred by her non-party treating physician to defendant Columbia University Medical Center ("CUMC") for evaluation for surgical intervention. While at CUMC, defendant Yoshifumi Naka, a cardiothoracic surgeon, claims to have had extensive conversations with Mrs. Kennedy and her husband as to the risks, benefits and medical alternatives to treatment of a tricuspid valve replacement. On June 24, 2008, defendant Naka, assisted by defendant Steve Xydas, a cardiothoracic surgery fellow, had performed on Mrs. Kennedy a pericardiectomy and tricuspid valve replacement with a No.27mm Carpentier Edwards pericardial valve, the latter of which had been manufactured by defendant Edwards Lifesciences Corporation. The operative report indicates that defendant Naka first had attempted to repair Mrs. Kennedy valve but that intraoperative testing had indicated that a successful repair could not be made, whereupon defendant Naka instead had performed the valve replacement. During this procedure, defendant Naka had placed temporary pacemaker leads into Mrs. Kennedy to address the possibility of her suffering postoperative arrhythmia, a known risk of postoperative heart block associated with valve replacement surgery.
Defendant Naka had explained during his deposition testimony that he had placed temporary and not permanent pacing wires at that time because Mrs. Kennedy had not been a proper patient for permanent pacing since she had normal left ventrical function and did not need left ventrical pacing for the rest of her life which would have been required for permanent pacing wires, and the placement of permanent pacing wires would have required an even more tedious surgery with an increased risk for post-operative infection.Post-operatively performed transesophageal echocradiograms and other cardiac studies performed on June 24, 2008, June 25, 2008, June 26, 2008, June 28, 2008 and July 2, 2008, all confirm that the new valve had been properly functioning. Mrs. Kennedy had remained at Hudson Valley Hospital, until July 10, 2008, at which time she had been discharged to a rehabilitation facility.
On July 17, 2008, Mrs. Kennedy had been returned to Hudson Valley Hospital, whereupon she had been diagnosed with congestive heart failure, which days later had resulted in a complete heart block and an episode of syncope, requiring emergency placement of a temporary pacemaker. According to defendants Naka, a cardiac study performed at the Hospital, on July 18, 2008, establishes that the valve had continued to function properly. The temporary pacemaker implant surgery had been performed without complications by Dr. Frank Dorsa, a non-party herein, at the Hospital. It is not disputed that placement of a temporary pacemaker is not an ideal long term solution because of the risk of damage to the implanted bioprosthetic valve.
After she had stabilized post-operatively, Mrs. Kennedy had been moved to Westchester Medical Center ("WMC"). While at WMC, Mrs. Kennedy's temporary pacemaker had been removed and a permanent pacemaker had been surgically implanted without complication, on July 22, 2008. Mrs. Kennedy had been discharged from WMC, on August 4, 2008.
On September 15, 2008, Mrs. Kennedy had presented to her cardiologist, who had instructed her to immediately go to Hudson Valley Hospital. While at Hudson Valley Hospital, Mrs. Kennedy, in what has been described as a near-death condition, had been diagnosed with severe right-sided heart failure and cardiogenic shock, as well as having cardiomegaly, bilateral pleural effusions and pulmonary vascular congestion. Mrs. Kennedy had been transported to defendant Mount Sinai Medical Center ("Mount Sinai"), and a Transthoracic Echocardiogram had been performed showing "moderate regurgitation" at the recently replaced tricuspid valve.
While at defendant Mount Sinai, defendant Elias Zias, M.D., had removed and replaced Mrs. Kennedy's bioprosthetic valve. Defendant Zias at that time also had placed a permanent epicardial lead. According to defendant Zias' operative report, the old tricuspid valve's leaflet was "apparently not closing properly," although the valve otherwise had appeared to be morphologically normal.
Defendant Henry Tannous had been an attending physician at defendant Mount Sinai present in the operating room at time that defendant Zias had performed this surgical valve replacement procedure on Mrs. Kennedy; defendant Tannous had not performed any excisions or suturing, nor had he placed the annulplasty ring on the mitral valve. Defendant Tannous had testified that he not been aware of any complications arising during that surgery and that he did not know why the old valve had not been working. According to defendant Tannous, the removed valve had been preserved and sent to pathology. After Mrs. Kennedy's stroke had been diagnosed, it had been defendant Tannous who had performed her tracheostomy, on October 6, 2008.
Mrs. Kennedy's post-operative recovery had been complicated by multiple seizures and, on September 25, 2008, it had been determined that Mrs. Kennedy had suffered an acute infarction, a well known complication to heart surgery, causing a left hemiparesis. Mrs. Kennedy, then requiring full-time skilled nursing for her impaired mobility, impaired cognitive processing speed and dysphagia, had been removed to a rehabilitation facility, on November 5, 2008.
Starting in early February, 2009, Mrs. Kennedy again had been admitted to Hudson Valley Hospital for chest, pain, atypical cough, pneumonia and palpitations, which thereafter had been followed by a number of additional Hospital admissions for chest pain, shortness of breath, respiratory failures, recurring pneumonias and MRSA. At the time of Mrs. Kennedy's final admission to Hudson Valley Hospital, on July 7, 2009, Mrs. Kennedy had been diagnosed with chronic respiratory failure and anxiety. After her transfer to Calvary Hospital, on July 16, 2009, Mrs. Kennedy had continued to gradually deteriorate. She had passed away, on April 30, 2011, at age 67. No autopsy had been performed, but Mrs. Kennedy's final diagnoses were respiratory disease, left hemiplegia from right cerebrovascular accident and severe anxiety, delirium and depression, as well as intermittent infections believed to have been caused by her genitourinary and respiratory tracts having been colonized by resistant organisms. It is unclear whether Mrs. Kennedy at that time also had active breast cancer given that she twice had developed during that time period hypercalcemia which is believed to represent recurrent or ongoing breast cancer, for which Mrs. Kennedy had received treatment.
This action ensued. Plaintiffs have alleged that defendants Edwards Lifesciences had manufactured and provided a defective bovine pericardial valve, which defendants Naka and Xydas, members of defendant Mid-Atlantic Surgical Associates (collectively "defendants Naka"), thereafter negligently had implanted in Mrs. Kennedy, along with an Edwards Tricuspid Ring, on June 24, 2008, in a manner which had deviated from the required standard of care and in such a way that they had caused the valve's failure, and that defendants Naka had failed to timely and properly treat Mrs. Kennedy's tricuspid valve regurgitation and had failed to perform appropriate pre-operative testing. Additionally, plaintiffs allege that defendants Naka had used the wrong size valve for implantation, that they had caused leaflet tissue damage on the pericardial valve during implant and/or during suturing, that they had failed to examine the valve leaflets for distortion and that they had failed to irrigate the prosthesis valve every one to two minutes during the procedure. Plaintiffs also allege that defendants Naka negligently had failed to place a permanent epicardial pacemaker lead into Mrs. Kennedy at the time that they had replaced her tricuspid valve, on June 28, 2008, because said defendants should have known that she eventually would require a permanent pacemaker, and that the subsequently arising need for an epicaridal pacemaker lead to have been threaded through the valve had caused the valve to malfunction. Plaintiffs also allege that said defendants had failed to obtain informed consent for the surgical procedure, and that said defendants' afore actions proximately had caused Mrs. Kennedy's injuries and eventual death.
Anent defendants Zias, Tannour and Mount Sinai Hospital, plaintiffs allege that they had deviated from the accepted standard of care in their failure to timely and properly have performed Mrs. Kennedy's September 22, 2008, surgery, in their failure to have administered anti-coagulant medication, in their negligently having kept Mrs. Kennedy for an excessively long period of time on a heart lung machine, thereby causing a right frontal lobe stroke and acute infarctions, and in their failure to timely have diagnosed and treated Mrs. Kennedy's stroke. Additionally, plaintiffs allege that said defendants had failed to inform Mrs. Kennedy of the risks, benefits and alternatives to the treatment rendered, that defendant Mount Sinai is vicariously liable therefore, and further that Mount Sinai negligently had granted the individual defendant doctors both hospital and surgical privileges.
In their Supplemental Verified Bill of Particulars, plaintiffs further assert that Mount Sinai had been negligent in its maintenance of the pericardial heart valve that had been removed from Mrs. Kennedy, on September 22, 2008, and specifically in its failing to have returned the valve to the manufacturer or to have preserved it in formaldehyde.
Presently, defendants Zias, Tannous, Mount Sinai School of Medicine of New York University and the Mount Sinai Medical Center (collectively defendants "Mount Sinai") are moving for summary judgment dismissing the complaint. Their motion is supported by an affirmation of Dr. Robert F. Tranbaugh, a Board certified cardiothoracic surgeon who is Chief of Cardiothoracic Surgery at Beth Israel Medical Center. Dr. Tranbaugh has reviewed Mrs. Kennedy's medical records and the depositions at bar, and he opines to a reasonable degree of medical certainty that said defendants' medical treatment of Mrs. Kennedy at all times had been within good and accepted medical practice, that none of their actions or inactions had caused or contributed to Mrs. Kennedy's injuries and death, and that a stroke is a well-known complication of cardiac surgery. Dr. Tranbaugh opines that defendants had performed the surgery within good and accepted practice and had exercised appropriate stroke precautions, including on-pump beating, and that, contrary to plaintiffs' allegations, defendants in fact had administered Heparin, an anti-coagulation medication. Additionally, Dr. Tranbaugh disputes plaintiffs' claim that Mrs. Kennedy's heart had not been properly de-aired, he opining that Mrs. Kennedy's stroke had not been caused by an air emboli but rather from her heart, which conclusion is supported by the CT scan of Mrs. Kennedy's brain showing a right fontal CVA. According to Dr. Tranbaugh, defendants had not kept Mrs. Kennedy for an excessively long period of time on the heart lung machine, and they had recognized and treated Mrs. Kennedy's stroke in a timely manner, calling in appropriate consults. Dr. Tranbaugh opines to a reasonable degree of medical certainty that it would be impossible to determine that Mrs. Kennedy's stroke and any alleged negligence by defendants Mount Sinai had been the cause of her death two and one-half years later.
Moreover, contrary to plaintiffs' claim, Dr. Tranbaugh opines that defendants had obtained informed consent from Mrs. Kennedy prior to surgery, Mrs. Kennedy having executed a consent form for "Re-op Tricuspid Valve Replacement," on September 22, 2008, which provides that she had been informed of the benefits, risks and possible complications, as well as possible alternatives to the proposed treatment, that she had understood that during the course of the operation a need might arise for other procedures, and that she had consented to the performance of such additional procedures as might be considered necessary by the surgeon. Dr. Tranbaugh also had reviewed defendant Zias' testimony as to the detailed conversations that he had had with Mrs. Kennedy and her husband, including the high risk of death at fifty percent given Mrs. Kennedy's then presenting complicated medical condition of congestive heart failure with two previous heart operations and an irradiated chest, as well as a heart block with previous reparative heart block surgeries. He opines that any reasonable person, having been fully informed of the risks, benefits and alternatives to the surgery, would have consented to have undergone the performed surgery.
The foregoing, defendants Mount Sinai argue, demonstrate their entitlement to judgment dismissing this action because plaintiffs cannot establish any departure from the required standard of care by said defendants and/or that any alleged departure had been the proximate cause of Mrs. Kennedy's injuries and death. Further, defendants Mount Sinia argue that Dr. Tranbaugh's proffered opinion makes clear that, while the surgery did carry a number of risks, including the risk of death, that Mrs. Kennedy would not have been able to live long without undergoing the surgery, that there was no viable alternative treatment and that no reasonable person would have refused to have undergone the surgery.
Lastly, defendants Mount Sinai argue that plaintiffs' apparent attempt to plead in their Supplemental Bill of Particulars a cause of action against Mount Sinai based upon Mount Sinai's failure to properly have stored the heart valve must fail because any such theory had not been pleaded in the complaint and no independent cause of action for spoliation is recognized in New York.
Defendants Naka, Xydas and The New York and Presbyterian Hospital ("Presbyterian") collectively also are separately moving for summary judgment dismissing this action, arguing that plaintiffs cannot establish medical malpractice or negligence since the record at bar demonstrates that they had comported with the required standard of care in diagnosing and treating Mrs. Kennedy, and specifically in performing the valve replacement surgery, and that plaintiffs have no cause of action for lack of prior informed consent because the record establishes that defendant Naka had discussed at length treatment options and risks with both Mrs. Kennedy and her husband and that he had obtained informed consent prior thereto. Defendants Naka maintain that intra-operative and post-operative testing, including a transthoracic echocardiogram that had been performed at Hudson Valley Hospital, on July 18, 2008, had revealed that the tricuspid valve that had been implanted by defendant Naka weeks earlier had been functioning normally, demonstrate that Mrs. Kennedy's valve had been functioning properly during and immediately after surgery. Defendants argue that Mrs. Kennedy had not developed an atrioventricular block and ventricular asystole until weeks after the replacement surgery, which conditions are known risks of surgical valve replacement in patients, like Mrs. Kennedy, with underlying cardiac disease.
Said defendants Naka also note that non-party Dr. Dorsa, at the time that he had placed the temporary transvenous pacemaker through Mrs. Kennedy's right ventricle, had been required to cross the artificial tricuspid valve that defendant Naka had implanted. Defendants Naka argue that comparisons of prior medical studies confirm that the leak that had developed in the artificial tricuspid valve implanted by defendant Naka had developed after the temporary transvenous pacemaker had been placed by Dr. Dorsa.
Defendants Naka support their dispositive motion with a copy of defendant Naka's deposition testimony wherein he had testified regarding plaintiffs' claim of lack of prior consent that he had discussed with both Mrs. Kennedy and her husband the associated risks, including but not limited to stroke, renal failure, prolonged mechanical ventilation, sternal wound infection and the possibility of a need for further surgery. Additionally, defendant Naka had testified that he had advised Mr. and Mrs. Kennedy that undergoing the surgery beneficially would improve Mrs. Kennedy's quality of life and her chances for longer survival. Thereafter, Mrs. Kennedy had executed her written consent for the valve repair or replacement surgery.
Defendants Naka also have submitted in support of their motion an affidavit from their expert, thoracic surgeon Dr. Alfred Culliford, who avers that he has read and reviewed Mrs. Kennedy's medical records and test results, has read the deposition testimony and the pleadings at bar. It is Dr. Culliford's proffered opinion within a reasonable degree of medical certainty that nothing defendants Naka, Xydas and staff at Presbyterian had done or had not done had caused the valve to fail, and that they had not departed from good and accepted standards in their care and treatment of Mrs. Kennedy, that the staff at defendant Presbyterian had appropriately arranged for consultations in pulmonology and cardiology, had Mrs. Kennedy undergo numerous appropriate studies in consideration of surgery and had performed all proper preoperative testing required by the standard of care, and that the staff properly and timely had diagnosed tricuspid valve regurgitation. Additionally, Dr. Culliford has opined that defendant Naka, after his having reviewed Mrs. Kennedy's medical records and test results, had formulated a treatment plan in accordance with good and accepted standards of medical care to repair or replace the valve in addition to his performing a pericardiectomy.
Dr. Culliford states that, in June, 2008, the time of defendant Naka's replacement valve surgery, no artificial or bioprosthetic tricuspid valves were being manufactured, and that the accepted standard of care at that time was to use a mitral valve to replace a tricuspid valve. Defendant Naka, according to Dr. Culliford, correctly had determined the size of the replacement valve to use, and properly had determined to use a bioprosthetic versus a mechanical valve since Mrs. Kennedy would require anti-coagulation for the rest of her life with a mechanical valve. He further opines to a reasonable degree of medical certainty that there is no medical basis for plaintiffs' claims that defendant Naka had used the wrong sized valve, or that he had failed to examine the valve leaflets for distortion, or that he had failed to remove calcium deposits prior to implantation.
According to Dr. Culliford, the intra- and post-operative cardiac studies that had been performed at Presbyterian and Hudson Valley Hospital all confirm that the valve implanted by defendant Naka had been functioning normally and that if the valve had been improperly placed or somehow compromised, Mrs. Kennedy's post-operative cardiac studies would have revealed such abnormalities.
Moreover, contrary to plaintiffs' allegations, Dr. Culliford opines that the standard of care had not required defendant Naka to implant prophylactic permanent pacemaker leads, on June 24, 2008, which Dr. Culliford states would have exposed Mrs. Kennedy to greater risk of post-operative infection. Defendants Naka argue that, even if the standard of care had required such, it is not foreseeable that defendant Naka's failure to have done so would have resulted in Dr. Dorsa's placement of a pacemaker through Mrs. Kennedy valve given Dr. Culliford's further opinion that a coronary sinus approach had been available to Dr. Dorsa, which procedure would not have required the surgeon to cross and thereby damage the valve.
Also contrary to plaintiffs' claims, it is Dr. Culliford's opinion within a reasonable degree of medical certainty that the most likely explanation for the post-operative failure of the valve that had been implanted by defendant Naka is that it had been damaged when non-party Dr. Dorsa had performed implantation of the temporary pacemaker in Mrs. Kennedy's right ventricle by crossing and ablating the valve, thereupon disrupting the blood flow and causing platelets to form a clot, which would have affected the functioning of the valve leaflets. It is Dr. Culliford's opinion that the malfunction of the valve had occurred through no fault of defendants at bar.
Dr. Culliford also expressly opines, based upon defendants Naka's and Xydas' deposition testimony, that defendant Xydas had been a cardiothoracic surgery fellow acting exclusively under the supervision of attending defendant Naka. He states that defendant Xydas' role during the surgery had been limited to cannulation and tying sutures, and that he had not participated in evaluating or speaking to Mrs. Kennedy preoperatively, and he had no input into what size valve would be used for the procedure and had not exercised any independent judgment with regard to the limited treatment he had rendered, and he opines that defendant Xydas had not departed from good and accepted standards of medical care in his treatment of Mrs. Kennedy and that nothing he had done or had not done had been a proximate cause or contributing factor in Mrs. Kennedy's alleged injuries and/or death.
Dr. Culliford further opines that defendant Naka appropriately had discussed with Mrs. and Mr. Kennedy the surgical procedures he would be performing, including that he would attempt to repair the extant valve but that, if that could not be accomplished, he would replace it, which decision ultimately would be made during the surgery, and that the removal of the pericaridium would be "a tedious and tough procedure." Further, Dr. Culliford opines that defendant Naka properly had discussed with the Kennedys and specifically had identified for them the risks associated with both procedures, as well as the benefits of the procedures which included better quality of life for Mrs. Kennedy and her chance for longer survival. Only after these conversations, according to Dr. Culliford, had Mrs. Kennedy properly executed a written informed consent wherein she had acknowledged her understanding of the risks and benefits.
Defendants Edwards Lifesciences Corporation, Edwards Lifesciences LLC and Edwards Lifesciences (U.S.), Inc. (collectively "defendants Lifesciences") also are moving for summary judgment dismissing the complaint alleging as against them causes of action for breach of express and implied warranties, negligent design and manufacture, product liability, lack of informed consent and wrongful death. Defendants Lifesciences maintain that plaintiffs' claim for negligent manufacturing should be dismissed because the unrefuted testimony of Walter Wiegand, Vice President of Quality Control at Lifesciences, demonstrates that the subject valve had not been defective, that it had been manufactured under state of the art conditions in compliance with industry standards and legal and regulatory requirements, that the specific valve model had been approved by the Food and Drug Administration as safe and effective as a Class III Medical Device, and that its disclosed records support Mr. Wiegand's testimony and demonstrate conclusively that the valve had been tested and inspected with respect to fabrication, packaging and/or sterilization before its leaving Lifesciences, that the valve had met all product specifications and it had left Lifesciences without defect and without modification, and accompanied by a package insert which had contained pertinent information about the valve, its design, indications, warnings and representations. One of the risks identified had been the potential for valve damage if it comes into contact with a pacemaker lead: "Do not pass catheters and transvenous pacing leads across the valve since they may cause [leaflet] tissue damage." Defendants Lifesciences further argue that Mrs. Kennedy's medical records establish that the Lifesciences valve that had been supplied to defendant Presbyterian and surgically implanted by defendant Naka had been properly operating weeks after the implantation of same, on June 24, 2008, according to all cardiac testing performed on Mrs. Kennedy.
Further, Lifesciences' witness, Donna Rodriguez, had testified that it is her job to gather information on received complaints from the Implant Patient Registry and that, following the valve's failure for the explained reason "cusps not closing properly," her team had requested in writing its return from Mt. Sinai Medical Center for Lifesciences' own evaluation, and that Mt. Sinai Medical Center had responded that it had been unavailable for return. According to Ms. Rodriguez, Lifesciences cannot make any determination about a device's malfunctioning without examining the device and, to her knowledge, no one at Lifesciences had examined the removed subject valve.
Dr. Gary Kopf, a cardiothoracic surgeon, is defendants Lifesciences' expert, who had examined the subject valve at Mt. Sinai Hospital, on May 17, 2014. According to Dr. Kopf, the subject valve had not been preserved in formalin but he had been able to observe parts of the valve leaflets which remained at the base, the sewing ring, all suture lines at the base and at the leaflet to the base. He also had observed microscopic sections taken from each of the three leaflets and, according to Dr. Kopf, the morphology of each "appeared normal" and he could not see any defect or structural deterioration. Dr. Kopf had noted that Mt. Sinai had not described in the gross pathology report any tear in any valve leaflet, which he states can be a common cause of insufficiency. If a tissue valve leaflet is observed not closing, Dr. Kopf avers that all three leaflets "usually" are involved to some extent," but that he had not observed any evidence of this in his examination of the valve. According to Dr. Kopf, however, based upon "the way the explanted valve was processed and preserved, and the portions of each leaflet that were sampled and removed, an opinion on the cause of the mild to moderate insufficiency cannot be determined solely from examination of the explanted valve."
Dr. Kopf states in his affidavit in support of defendant Lifesciences' dispositive motion that it is the professionally accepted surgical practice to use an artificial valve specifically manufactured for the mitral position as a tricuspid valve when that valve requires replacement and that the risk of damage to a tissue leaflet from a passing transvenous pacing lead is the same whether the valve is placed in the mitral or tricuspid valve position. Although Dr. Kopf states that his inspection of the limited parts of the valve had been all found to be within normal limits, he adds that the pieces of each of the leaflets that had been removed "would be the area in the bioprosthesis most likely to be damaged by the trauma of the pacemaker wires. " Dr. Kopf avers that, if there was an injury to one of the leaflets," the "most likely cause would be the attempts to cross the prosthetic valve with the pacing wires," which he describes as a "known mechanism of injury to prosthetic valves," which the manufacturer expressly warns about in its accompanying literature.
In closing, Dr. Kopf opines that, "[f]rom the current condition of the valve, it would be impossible for anyone to opine that the manufacturing process caused the mild to moderate tricuspid insufficiency which was observed three months after implant."
Defendants Lifesciences also notes the similar expert opinion proffered by defendants Naka's expert, Dr. Culliford, that the non-party surgeon who had placed the temporary transvenous pacemaker into Mrs. Kennedy had been required to cross the valve, which likely had perforated or ablated it, thereby causing the failure.
Defendants Lifesciences contend that plaintiffs' claims of defective manufacturing, design, marketing, testing and labeling of this Class III PMA-approved medical device must be dismissed because the subject device complies with the terms of PMA approval and thus that all such claims are preempted by the federal MDA 21 U.S.C. §360k(a) which bars state claims challenging the safety and effectiveness of Class III medical devices approved by the Federal and Drug Administration through the Premarket Approval process.
Additionally, defendants Lifesciences maintains that plaintiffs have not adduced any evidence proving their claims and allegations as to products liability, negligence, breach of warranty and informed consent.
Plaintiffs submit that there exists at bar a triable issue of fact as to what had caused the subject valve to fail. According to plaintiffs, defendant Mt. Sinai's failure to properly have preserved the valve after its explant "means that there is no precise method of determining the cause of the valve's failure." Accordingly, plaintiffs are cross-moving for an Order pursuant to CPLR 3126 striking defendant Mt. Sinai's answer for its "wilful and contumacious spoliation of the subject heart valve which is at the core of this case."
Plaintiffs offer the expert affidavit of Mark Swanson, a Medical Device Risk Management and International Quality Systems engineer, who had inspected the subject valve, on January 14, 2014. Mr. Swanson describes the valve at that time as having been "completely dissected" and "virtually unexaminable," which made it impossible for him to test. Nevertheless, Mr. Swanson states that the subject valve typically has a 7 to 10 year life span and that a valve would not malfunction within five months "unless the device clinician did not adequately follow the device instructions for use or for placement of the valve, or as a result of some other defect in the valve which should have been caught by the manufacturer testing. Mr. Swanson opines that there are only two likely possible causes of Mrs. Kennedy's moderate regurgitation; the valve either had been negligently placed by defendant Naka, on June 24, 2008, or the valve had been negligently manufactured and tested by defendants Lifesciences.
Plaintiffs also offer an affidavit from their undisclosed medical expert, a general and vascular surgeon. Plaintiffs' surgeon avers that s/he has read all of Mrs. Kennedy's medical records from June to September, 2008, and all of defendants' hospital and clinic charts. This surgeon however notably does not state that s/he had read the pleadings or the deposition testimony at bar. This medical expert states his/her opinion to a reasonable degree of medical certainty that defendant Naka had deviated from the accepted standards of medical care by failing to place permanent epicardial pacemaker leads during the June 24, 2008, tricuspid valve replacement surgery, and that this deviation had been a substantial factor in causing Mrs. Kennedy's stroke, residual neurological impairments and subsequent death.
This medical expert highlights that defendant Naka's operative report does not indicate any direct injury to the valve during its placement, and further notes that "a post-operative transesophageal echocardiogram reveals that the valve was functioning properly postoperatively." However, it is this expert's opinion that there is a known risk for a patient suffering a heart block after valve replacement surgery and that Mrs. Kennedy had been at a heightened risk of developing a heart block given her extensive cardiac history. This expert states that defendant Naka, having placed only temporary pacemaker leads which would protect Mrs. Kennedy only in the case of an arrhythmia in the immediate postoperative setting, "had failed to take the opportunity to place permanent pacemaker leads."This expert notes that, on or about July 19, 2008, just weeks following defendant Naka's surgical valve replacement procedure, Mrs. Kennedy had suffered a complete heart block which had required emergent placement of a temporary pacemaker, which had been placed by Dr. Dorsa, who plaintiffs' expert notes had not made any notation of complications during that procedure. Thereafter, Mrs. Kennedy had undergone placement of a permanent pacemaker procedure at Westchester Medical Center, which procedure also is noted to have been performed without complication.
Plaintiffs' expert states that a heart block is an emergent condition that requires the immediate placement of a pacemaker to regulate the heart's rhythm and, although plaintiffs' expert does not affirmatively state anywhere that the occurrence of a heart block in and of itself results in damage to the implanted valve, s/he does go on to state that "[t]he damage that was caused to the implanted heart valve would have been avoided had Defendant Naka placed permanent epicardial pacemaker wires during the June 24, 2008 procedure." Plaintiffs' expert states that defendant Zias correctly had acknowledged during his deposition that permanent pacemaker leads are placed in "most" patients and that it was particularly appropriate to have placed them in Mrs. Kennedy because of her higher risk status. Moreover, plaintiffs' expert states that the standard of care requires a physician to evaluate potential post operative complications and, although failing to identify any medical literature upon which s/he relies, plaintiffs' expert states that the placing of permanent pacemaker leads does not present any significant additional risk to patients undergoing heart valve replacement surgery. Plaintiffs' expert notably does not address defendants' expert's averments that placement of permanent pacemaker leads had not been required prophylactically in the absence of Mrs. Kennedy's left ventrical illness and that said procedure imposed a higher infection risk. Plaintiffs' expert concludes that it is his/her opinion to a reasonable degree of medical certainty that defendant Naka had deviated from the accepted standard of care in failing to place permanent epicardial pacemaker leads during the June 24, 2008, valve replacement surgery. Moreover, plaintiffs' expert states that, after Mrs. Kennedy had presented with a heart block, Dr. Dorsa "had no choice but to thread a pacemaker wire through the right ventrical, thereby crossing the heart valve," and that this was the only one available to him at that time." The expert further opines that, if defendant Naka had placed the permanent pacemaker leads as had been required by the standard of care, Dr. Dorsa would not had to have been required to thread the temporary pacemaker leads through the heart valve, and he would not possibly have damaged the valve, as opined by Dr. Culliford. Notably, plaintiffs' expert does not address defendants' experts statements that Dr. Dorsa had the option of performing the implant of a temporary pacemaker through the coronary sinus approach. Plaintiffs' expert's stated opinion is that defendant Naka's deviations from the required standard of care had caused the implanted bioprosthetic valve to fail, which had resulted in Mrs. Kennedy's stroke, neurological injuries and her eventual death.
Upon this Court's careful review of the record at bar, the parties' respective arguments and upon application of the controlling principles of law, this Court initially grants summary judgment dismissing all claims, whether stated in negligence or medical malpractice, as against defendants Xydas, Zias, Tannous, Mid-Atlantic Surgical Associates, Faculty Practice Associates, Inc., The Mount Sinai Medical Center, Columbia University Medical Center d/b/a Columbia Presbyterian Medical Center and The New York Presbyterian Hospital. The Court finds that said defendants have demonstrated entitlement to full summary judgment in their favor and that plaintiffs have failed to raise any triable issues of fact regarding the liability of these defendants for negligence and/or medical malpractice in causing Mrs. Kennedy's injuries and/or death.
As against defendants Columbia University Medical Center d/b/a Columbia Presbyterian Medical Center and The New York Presbyterian Hospital ("CUMC"), the Court now clarifies that it is dismissing all direct claims of negligence and malpractice as against them but that the Court also presently finds it unclear whether plaintiffs also have asserted a theory of respondeat superior liability against defendants CUMC based upon their alleged employment of defendant Naka. The parties have not addressed this issue. To the extent that plaintiffs also rely upon respondeat superior liability as against these defendants based upon employment, said summary judgment motion with respect thereto is denied since this Court finds infra that an issue of liability stands as against defendant Naka.
Having granted full summary judgment in favor of defendant The Mount Sinai Hospital, this Court must make special note of the fact that plaintiffs did not proffer any medical affidavit supporting any of the claims of negligence and/or medical malpractice as against defendant Mount Sinai. Although plaintiffs in their latest bill of particulars had alleged, apparently for the first time, that defendant Mount Sinai had failed to properly preserve the explanted heart valve, a bill of particulars is permitted only to amplify the pleadings and, as defendant Mount Sinai properly argues, it may not properly be used to allege a new theory of liability not originally asserted in the complaint. See Linker v. County of Westchester, 214 AD2d 652 (2nd Dept. 1995); Beer v. Goldfarb, M.D., 2014 WL 1333960 (Sup. Ct., Suff. Co. 2014). In any event, New York also does not recognize a cause of action for tortious spoliation of evidence. See Ortega v. City of New York, 9 NY3d 69 (2007); instead, redress for prejudicial spoliation of evidence must be pursued through a motion made pursuant to CPLR 3126.
Notably, plaintiffs never had moved prior to their May 12, 2014, filing of their note of issue for imposition of the sanction striking defendant Mount Sinai's answer for its alleged failure to properly have maintained the explanted heart valve even though plaintiffs necessarily knew, as early as January, 2014, following their expert Mr. Swanson's inspection of the valve, that the valve allegedly had not been properly maintained and they should have known of the likelihood of defendant Mount Sinai's moving for summary judgment dismissal. Only belatedly now, and without any, let alone adequate, explanation or excuse, have plaintiffs cross-moved for an Order striking defendant Mount Sinai's answer for its alleged wilful and contumacious spoliation of the valve. This Court necessarily perceives plaintiffs' cross-motion as an unveiled attempt to defeat defendant Mount Sinai's summary judgment motion other than on the merits, which plaintiffs cannot do. Plaintiffs' strategy will not be condoned. In this Court's view, plaintiffs' cross-motion became moot upon plaintiffs' failure to substantively have countered defendant Mount Sinai's dispositive motion with evidentiary submissions raising a triable issue of fact. Accordingly, plaintiffs' cross-motion pursuant to CPLR 3216 is denied.
The Court notes however that, were it to have reached the merits of plaintiffs' cross-motion seeking imposition of the sanction of striking defendant Mount Sinai's answer, said relief still would be denied.
It is well settled that a striking sanction for spoliation is an appropriate remedy where the evidence spoiled is a "key piece of evidence" whose destruction precludes inspection by an adverse party. See Gott v. Eusebe-Carter, 69 AD3d 566 (2nd Dept. 2010); Kirkland v. New York City Housing Authority, 236 AD2d 170, 173-174 (1st Dept. 1997); see, also Squittieri v. City of New York, 248 AD2d 201 (1st Dept. 1998). Where a Court concludes that because of the spoiled evidence one party has destroyed critical physical proof such that its opponents are " prejudicially bereft of appropriate means to [either present or] confront a claim with incisive evidence,' the spoliator's pleading is properly stricken in order to obviate a trial that is based on rank swearing contests.'" Domenco v. C. & S. Aeromatik Supplies, Inc., 252 AD2d 41, 53 (2nd Dept. 1998), quoting Hoening Products Liability, Impeachment Exception Spoliation Update, NYLJ, Apr. 12, 1993, at 6 col. 5. Obviously, the drastic remedy of striking a pleading is warranted by the principles of fairness, see Friel v. Papa, 36 AD3d 754, 755 (2nd Dept. 2007); Ianucci v. Rose, 8 AD3d 437 (2nd Dept. 2004); Klein v. Ford Motor Co., 303 AD2d 376 (2nd Dept. 2003); a party should not be able to destroy evidence and then benefit therefrom.
But in determining whether a sanction is warranted, the Court must examine a number of factors, including whether the destruction of the evidence had been done intentionally, wilfully and contumaciously, see Samaroo v. Bogopa Service Corp., 106 AD3d 713 (2nd Dept. 2013); Scordo v. Costco Wholesale Corp., 77 AD3d 725, 727 (2nd Dept. 2010), and what prejudice if any a party seeking the discovery incurs as a result of the absence of the spoiled evidence. See Ianucci v. Rose, supra; Kirkland v. New York City Housing Authority, supra. Where the missing evidence does not actually deprive the moving party of the ability to establish his case, a less severe or no sanction at all is appropriate. See Fossing v. Townsend Manor Inn, Inc., 72 AD3d 884 (2nd Dept. 2010); Gottov. Eusebe-Carter, 69 AD3d 566 (2nd Dept. 2010); Scarano v. Bribtzer, 56 AD3d 750 (2nd Dept. 2008).
Here, the Court first notes that the record demonstrates that the explanted valve, following its removal, initially had been immediately preserved in a Formalin solution, which solution Mr. Swanson states prevents damage and allows for assessment and analysis, and that it had been sent to Mount Sinai's pathology department for analysis. The Court necessarily finds that any intentional destruction or mishandling of the valve is contradicted by the foregoing.
Moreover, the analysis of the valve had been carried out on the same date as the valve's removal, September 22, 2008. The pathology report, according to Mr. Swanson,
provides a general description of the valve and general visual examination that indicates that the valve cusps are intact, free-moving with no calcification or vegetation (no material growth)
indicating the valve had been in place for a short period of time with no obvious damage. There is no record of evaluation of the closure of the leaflets.
It further is noted that sections of the edges of the leaflets of the valve had been removed. Although Mr. Swanson states that at the time of his inspection on January 14, 2014, five and one-half years later, it was apparent that the valve had not been properly maintained in Formalin, this Court cannot find that the foregoing demonstrates a wilful and contumacious spoliation of evidence, particularly where plaintiffs had waited three and one-half years after commencement of this action, and five and one-half years after the valve's removal, to have performed their own analysis of the valve. See Scordo v. Costco Wholesale Corp., supra, 77 AD3d 727; cf. Seda v. Epstein, 72 AD3d 455 (1st Dept. 2010).
Moreover, this Court notes that all parties are on equal footing with respect to the subject valve and equally disadvantaged, if at all, with respect to the current condition of the explanted valve, the pathologist's analysis of the valve, as well as any alleged deficiencies with respect thereto, as noted by Mr. Swanson, including the absence of photographs of the valve prior to dissection, and the absence of a record of evaluation of the closure of the leaflets and the state of the valve closure at the time the valve had been removed. Based upon the foregoing, this Court, were it to have considered the merits of plaintiffs' cross-motion, also would not have found that plaintiffs are bereft of the ability to prove their claims against defendants and that the extreme sanction of striking Mount Sinai's answer would not have been appropriate.
Anent defendant Naka's summary judgment motion, the Court finds that said defendants prima facie have demonstrated entitlement to dismissal of all of plaintiffs' claims and theories of malpractice and negligence asserted against defendant Naka, and that plaintiffs, with the exception of their claims that defendant Naka had deviated from the required standard of care in failing to have placed permanent as opposed to temporary pacemaker leads during the June 24, 2008, tricuspid valve surgical procedure and that this deviation had been a substantial factor in causing Mrs. Kennedy's ensuing stroke, residual neurological impairments and death, otherwise wholly have failed to address and submit supporting evidence raising any issue of fact regarding all of plaintiffs' other allegations and claims. Accordingly, the Court hereby grants individual defendant Naka summary judgment on plaintiffs' claims that defendant Naka negligently had deviated from the required standard of care, on June 24, 2008, in implanting the valve in Mrs. Kennedy in such a way that he had caused the valve's failure, that he had failed to timely and properly treat Mrs. Kennedy's tricuspid valve regurgitation, that he had failed to perform appropriate pre-operative testing, that he had used the wrong size valve for implantation, that he had caused leaflet tissue damage on the pericardial valve during implant and/or during suturing, that he had failed to examine the valve leaflets for distortion, that he had failed to irrigate the prosthesis valve every one to two minutes during the surgical procedure and that he had failed to obtain informed consent for the surgical procedure. Indeed, the Court notes that plaintiffs' medical expert does not address any of the foregoing, nor proffer any opinion supporting any such claims, and that with respect to certain alleged theories the documentary evidence belies the facts as alleged by plaintiffs.
Although plaintiffs' expert Mr. Swanson has proffered his opinion that the valve would not have malfunctioned within five months of implant unless the clinician, i.e., defendant Naka, had not adequately followed the device instructions for placement of the valve or the valve itself had been defective, the Court observes that Mr. Swanson is not a physician and that he does not and cannot address and reconcile how the post-surgical testing of the subject valve, including one test done on July 18, 2002, consistently had shown that the valve had been properly working if, as Mr. Swanson speculates, defendant Naka improperly had implanted it, and he further has not and cannot address the opinions of Dr. Culliford and Dr. Kopf, both of whom have provided a third possible explanation for Mrs. Kennedy's regurgitation and ensuing heart block, that being that a valve leaflet had sustained injury occurring during the non-party surgeon's placement of the temporary pacemaker leads.
However, defendant Naka is denied summary judgment with respect to plaintiffs' claims that he had departed from the required standard of care in his failing to place a permanent epicardial pacemaker lead into Mrs. Kennedy at the time that he had replaced her tricuspid valve, on June 28, 2008, and that such departure had been a substantial factor in causing Mrs. Kennedy's stroke, neurological impairments and eventual death. Plaintiffs successfully have raised a triable issue of fact with respect thereto through their proffered medical expert's opinion, which this Court finds said expert is qualified to give, defendants Naka's protestations to the contrary notwithstanding. Plaintiffs' expert has opined that Mrs. Kennedy had been a high risk patient for suffering a heart block, that permanent leads are implanted in most patients, especially high-risk patients like Mrs. Kennedy, that defendant Naka's implanting of permanent leads would not have posed any additional risk to Mrs. Kennedy during her heart valve replacement surgery, and that the standard of care requires a physician to evaluate potential post-operative complications and defendant Naka should have recognized that a subsequently arising need for an epicaridal pacemaker lead would require its being threaded through the valve which could cause the valve to malfunction. The parties' respective and contradicting medical expert opinions present credibility issues not properly resolved on summary judgment. See Barrocales v. New York Methodist Hosp., 122 AD3d 648 (2nd Dept. 2014); Ahmed v. Pannone, 116 AD3d 802 (2nd Dept. 2014) .
Lastly, this Court addresses defendant Lifesciences' motion for summary judgment dismissing the complaint.Defendant Lifesciences argues that plaintiffs' state claims for strict liability based upon a failure to warn and defective design, negligence, breach of the express warranty, breach of implied warranty, lack of informed consent and failure to warn all must be dismissed for lack of subject matter jurisdiction because the subject valve, a Class III medical device, had received Premarket Approval from the FDA, and thus all of plaintiffs' State claims are preempted by 21 U.S.C. §360k, the Medical Device Act of 1976, and necessarily must be dismissed. This Court agrees. See Riegel v. Medtonic, Inc., 552 U.S. 312, 330 (2008); Mitaro v. Medtronic, Inc., 73 AD3d 1142 (2nd Dept. 2010); Messner v. Medtronic, Inc., 39 Misc 3d 1213(A) (Sup. Ct. Rich. Co. 2013); see, also Tansey v. Cochlear Ltd., 2014 WL 4829453 (E.D.NY 2014); Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.NY 2014).
Moreover, the Court finds that plaintiffs, with respect to their claim alleging breach of the express warranty, have failed to identify any specific statement made by defendant Lifesciences regarding the safety or the effectiveness of the subject valve upon which they had relied and how that breach resulted in Mrs. Kennedy's injuries and/or death. See Gelber v. Stryker Corp., 752 F.Supp.2d 328, 335 (S.D.NY 2010).
Additionally, contrary to plaintiffs' argument, this Court cannot agree that either the record at bar and/or Mr. Swanson's affidavit raise any issue of fact as to whether defendant Lifesciences negligently had manufactured the heart valve. To the contrary, the record at bar unequivocally establishes that defendant Lifesciences had in place stringent manufacturing testing and oversight, as well as packaging of the valve, that defendant Naka had inspected the valve before placement and that he had not observed any irregularities or problems with it, that Mrs. Kennedy's post-operative testing consistently had demonstrated that the valve had been properly working, that the pathology examination of the valve following its explant had not revealed any mechanical problem with the valve, and Dr. Kopf has stated his findings made upon his examination of the explanted valve that he had observed no evidence on the valve's leaflets that they had been closing improperly.
As counterpoint to the foregoing, plaintiffs solely rely upon Mr. Swanson's stated opinion that Lifesciences' negligence was one of only two possible causes of the valve's failure. However, plaintiffs have offered no explanation as to how and/or why the post-operative valve testing consistently had shown that the valve was working if, as they claim, it in fact had been defective. Moreover, defendants' experts had opined that there exists a third possible explanation for the valve's failure, that being that Dr. Dorsa had caused damage to the valve during Mrs. Kennedy's temporary pacemaker implant surgery, which alternative theory plaintiffs wholly and fatally have failed to address herein.
Lastly with respect to defendant Lifesciences' motion, this Court declines plaintiffs' invitation, which is based solely upon the Court's earlier finding herein that defendant Naka is entitled to judgment dismissing claims regarding his surgical skill in the implantation of the valve, for this Court to find that the only possible cause of the valve's subsequent failure was a defect in its manufacturing. Plaintiffs' claim against defendant Naka that he negligently had implanted the valve had been dismissed because defendant Naka prima facie had established his entitlement to judgment said claim and plaintiffs had failed in their burden to raise an issue of fact with respect thereto. Especially in the absence of evidence demonstrating that the valve in fact had been defective, plaintiffs' failure to have met their summary judgment burden will not simply inure to their benefit.
Defendants Lifesciences motion for summary judgment is granted.
This action is hereby severed and Ordered continued. The parties shall appear in the Settlement Conference Part, room 1600, at 9:15 a.m., on March 3, 2015.
Dated:February 11, 2015
White Plains, New York
_________________________________
MARY H. SMITH
J.S.C.