New York State Court of Claims

New York State Court of Claims

DOMINY v. THE STATE OF NEW YORK, #2003-013-506, Claim No. 96580


A state hospital is liable for damages suffered when the recipient of a medical device implant was not notified that there were problems with the implant and, ultimately, that it was recalled. The hospital had prior notice of the product advisories and recall and, in the unusual circumstances here, stood in the position that would normally be held by a primary care physician.

Case Information

SHARON DOMINY, KEVIN DOMINY and ANDREW M. THALER, as Chapter 7 Bankruptcy Trustee
Claimant short name:
Footnote (claimant name) :

Footnote (defendant name) :

Third-party claimant(s):

Third-party defendant(s):

Claim number(s):
Motion number(s):

Cross-motion number(s):

Claimant's attorney:
Defendant's attorney:
Attorney General of the State of New York
BY: ELLEN MATOWIK, ESQ.Assistant Attorney General
Third-party defendant's attorney:

Signature date:
September 30, 2003

Official citation:

Appellate results:

See also (multicaptioned case)


Trial of this action was bifurcated and this decision relates only to the issue of liability.

In June 1985, Claimant Sharon Dominy[1]
underwent bilateral TMJ (temporomandibular joint) implant surgery at the University Hospital of the State University of New York at Stony Brook (University Hospital). The implants used were manufactured by Vitek, Inc. and were designated as being made of Proplast II. They consisted of a wafer made of a porous variant of Teflon, which was then coated with a separate film. These wafers were placed between a patient's maxillofacial bones in order to relieve the pain caused by TMJ.
Five years later, in 1990, following the issuance of several advisories related to this product, the Federal Drug Administration (FDA) issued a recall notice, taking the Vitek Proplast II implants off the market and advising that patients who had received these implants should be checked and thereafter monitored to see if the implants were disintegrating. If they were, it was recommended that they be removed. Claimant alleges that she was not aware of the recall until 1996, at which time she was already experiencing pain and discomfort that turned out to have been caused by the implants. Although both implants were subsequently removed, Claimant has been left with permanent pain and limitation of movement. She contends that the State of New York is responsible for any injury that resulted from the delay in monitoring and/or removing the implants, because it failed in its duty to provide her with prompt, adequate notice of the advisories and the recall.

The 1985 surgery was performed by Dr. Lester Stein, a private practitioner who served as a "volunteer" dental school faculty and as an attending surgeon at University Hospital, and Dr. Barry Bass, who at the time was fulfilling part of his dental residency with Long Island Jewish Hospital. Although Claimant's health insurance did not cover the procedure, Dr. Bass arranged for the fee to be waived in exchange for her agreement to allow medical information from the surgery to be used in a write-up of the procedure for the American Association of Oral and Maxillofacial Surgeons (AAOMS).[2]
Claimant's implant surgery was unique and warranted such attention because it apparently was the first bilateral implant procedure to be performed.
The surgery was uneventful and considered a success, and the immediate results were promising, with Claimant stating that she felt "pretty darn good" (Transcript, p. 57). Claimant concedes that at the time the implants were inserted, their use was widely accepted and encouraged in the medical/dental community and their use was an appropriate and reasonable response to her TMJ condition.

During the years immediately following the surgery, Claimant underwent other dental procedures at University Hospital. In early January 1996, she reported to the Hospital's dental department with complaints that her face had become swollen and black and blue "overnight" (Transcript, pp. 57-58). She was also experiencing pain that she said was different from that she had felt following some dental procedures several months earlier (Transcript, p. 87). Initially, no connection was made between these symptoms and any possible TMJ related problem (Exhibit 1-A, p. 203). The following month, however, when she returned and reported that the pain had worsened, she was advised by Dr. John P. Kelly that the TMJ implants had been recalled. A diagnostic procedure was scheduled, and on the day she reported for that, Claimant was informed by Dr. Joan Waldron, whom she had met at the time of the 1985 surgery (Transcript, pp. 55-56), that there was a class action lawsuit against Vitek because of the recall. Claimant was given a telephone number to call about the litigation. Radiographic examination revealed that the implants had fragmented and caused "severe degenerative changes" in surrounding bone in Claimant's jaw (Exhibit 36). After insurance approval was received, the implants were removed in March 1996 by Dr. Kelly at University Hospital.

According to Claimant, she was not aware of the implant recall prior to February 1996. She had received no notification about the recall from University Hospital or from the surgeons who had performed the implant procedure, and she was not aware of it from any other source. No evidence was presented to establish or even suggest that she had at some point received notification of the recall or any patient advisory. Claimant's testimony about the length of time she had suffered from symptoms that were later determined to be related to the implant malfunction was contradictory. She testified at trial that she had begun suffering this different type of pain in early 1996. At the time of the 1996 removal procedure, however, she had indicated that she had been experiencing the pain for a period of up to three years (Exhibit 1-A, pp. 77, 82, 97). When called to testify on Defendant's direct case, Claimant identified Exhibit A as a copy of a letter that she had sent to Governor Pataki after removal of her implants, citing the State Department of Health's failure to respond to her complaints that she had not been notified about the problems connected with the Vitek implants. In that letter, she indicated that she had begun having TMJ pain again in 1994. Later she testified that the pain she had referred to was eventually determined to be related to other medical conditions. In any event, there was nothing to suggest that she was aware before January or February 1996 that any earlier pain might be related to the TMJ implants or that the implants had been the subject of an FDA recall some six years earlier.

Vitek Information and Recall
Although initially these Teflon implants manufactured by Vitek were widely accepted as a great benefit to the treatment of TMJ, their effectiveness and safety began to be questioned in the late 1980's. An FDA investigation was begun, which initially resulted in a March 1990 Voluntary Safety Alert being issued by the manufacturer (Exhibit 13). This alert warned that the implants could fragment or "delaminate," causing or contributing to progressive bone degeneration and giant cell reaction. The advisory recommended that even asymptomatic patients should be closely monitored. In December 1990, the FDA itself issued a Safety Alert (Exhibit 9), recommending that all patients who had received these implants should be examined by radiographic means "immediately." The following year, in September 1991, the FDA issued a Public Health Advisory and a recall of the product (Exhibits 10, 11 and 12). The recall notice directed that
all patients who had received the implant be contacted, if that had not already been accomplished.
This information was disseminated to health care professionals by the manufacturer, by the FDA, and by dental care publications such as the Journal of Oral and Maxillofacial Surgery, the Journal of the American Dental Association, AAOMS and ECRI (formerly known as the Emergency Care Research Institute), a non-profit corporation which tests and evaluates medical equipment for the health care industry. As noted above, the recommended course of procedure was to offer patients the removal of the implants and, if necessary, surrounding soft tissue. At a minimum, patients were to be provided with periodic radiographic studies and regular follow-up examinations (
see, e.g., Exhibit 21).

It is also undisputed that the dental surgeons who had operated on Claimant in 1985 were aware of these advisories and the recall, that they gave prompt notification to their own patients, and that neither made any effort to contact Claimant. Dr. Lester Stein, an oral and maxillary facial surgeon in private practice, testified that at the time of Claimant's implant procedure he held a position on the volunteer faculty of SUNY Stony Brook Dental School. In this capacity, he taught students the techniques of oral maxillary facial surgery and trained residents in surgical techniques. He also served as attending physician to the hospital's Department of Oral Maxillary Surgery.

While admitting that in 1985 he may have sent a letter to Claimant's insurer in which he represented himself as her physician in order to seek coverage for the operation (Transcript, p. 159), Dr. Stein testified unequivocally that he did not consider Claimant to be his patient. He did not see her in his private office, did not keep a chart on her at his private office, and did not bill her for the treatment she received. He described her as a patient of University Hospital's dental clinic and said that Dr. Bass, the resident, was listed as her primary physician.

Dr. Stein became aware of the problems with the Vitek Proplast II implants in the late 1980's or early 1990's through FDA notices, through AAOMS, and from other members of the oral maxillary community. The information he received was consistent with, although perhaps not identical to, that contained in Exhibits 9-12 and 14-17. He did not recall receiving any information directly from the manufacturer. After the implants were recalled, he followed the suggestions made by the FDA and notified all of his private patients that they should have radiographs taken to evaluate the joints and to determine if the implants should be removed. Most of his patients elected to have the devices removed. Dr. Stein did not notify any of the patients for whom he had performed implant surgery at University Hospital because, in his opinion, he had no obligation to notify either them or the Hospital (Transcript, pp. 135-136, 149, 163-164).

Dr. Barry Bass, the resident surgeon who participated in Claimant's 1985 implant surgery, testified that he was familiar with the Vitek Proplast II implants, having used them both while he was a resident at University Hospital and later in his own private practice. He stopped using this device in 1990 after receiving notification of potential problems from several sources, including Vitek itself. He testified that he tried to contact all of his private patients who had received the implants, by phone and/or by mail. He was able to reach most of them, he stated, because he had kept a list of all of his "larger" cases (which included TMJ implant patients) for use when he applied for Board certification. It was from this list that he obtained information about the identity of his implant patients.

Dr. Bass did not contact any of the patients whom he had treated during his residency at University Hospital, and in fact he had not kept independent records of those patients or the surgeries. He never considered those individuals to be his patients but, rather, patients who had been brought to the Hospital by their own physicians. Consequently, he did not conduct a search for any such patients, nor did he contact the Hospital to learn the identity of any such patients.

Dr. Bass acknowledged that in the years following the surgery Claimant did become one of his private patients. In 1987, when she consulted him about a dental abscess, he took her history, and this included both a reference to the earlier oral maxillary surgery and a notation that Vitek Proplast implants had been inserted. In connection with that visit, he also obtained an x-ray and questioned her about the functioning of her temporomandibular joints, noting some mild degenerative joint disease. The degenerative changes that he noted in 1987 were, he acknowledged, consistent with the types of changes later determined to be caused by the Vitek implant malfunction. Claimant's name was not added to his list of private patients for TMJ implant surgery, however, because she had not been his patient (as opposed to the patient of the Hospital or of an attending physician) at the time the surgery was performed.

Through testimony, both at trial and from transcripts of examinations before trial, a number of Hospital employees detailed the ordering, purchasing, receipt and record keeping processes of the Hospital's several divisions.

Anthony Intellisano, R.N., currently head nurse for the operating room for the Hospital's orthopedic and oral maxillary surgery services, testified that he was first assigned to the operating room in 1986 or 1987 and took on the oral maxillary surgical services in 1992. He testified to the general operating room procedures for surgeries such as the one performed on Claimant in 1985. The chair of the relevant medical department would notify Central Supply of any medical devices that were anticipated for use in the procedure being planned. The head nurse would then check the Hospital's Central Supply inventory, often going there in person, and either the head nurse or Central Supply would also check with the Biomedical Engineering Department (BME) to see if they had any relevant information on the products to be used.

According to Mr. Intellisano, the heard nurse also keeps ''steno" books with records of patients, including oral maxillary surgery implants. It was his opinion that this would be typical practice in all operating rooms, and such logbooks were already in place at University Hospital when he was assigned to the operating room. A single entry in the log would list the name of any device being used, often with information obtained from its packaging label. The circulating nurse would then add information about the patient's date of admission and other vital information about the patient, including his or her medical records number, the date of the surgery and the implant information. These log books, he stated, are used for tracking implants as well as for other purposes. The tracking function they served is now mandated by law. As an example, he recently received a request from BME to track the number of patients who had received a particular orthopedic implant device. To accomplish this, he used the logbooks to gather that information, completed the BME form, and reported his findings to his supervisor and the Chair of the Orthopedics Department.

According to Ruth Marcolina, Assistant Director for Information Services at the Hospital, the Health Science Library maintained medical journals, but she was unable to state precisely which journals were carried at specific times. The Library typically did not receive notices from FDA relating to medical products, and it neither kept an index of FDA recalls nor had any responsibility for receiving or forwarding such recall notices.

Marion Schlee, Purchasing Agent for the Hospital after 1982 and Assistant Director of Hospital Purchasing after 1993, had no familiarity with Vitek products and could find no record in the Hospital purchasing accounts of products being ordered from that company. If her department had received notification about a recall, they would have sent it, with a cover memo, to Hospital Receiving, with copies also going to the Operating Room, BME, Central Sterile and Radiology.

In Hospital Receiving and Stores, according to Lucille Protosow, who was Director from 1982 to 1990, any product received would go to the receiving office associated with the department which had ordered it, either the University's Central Receiving, or Hospital Receiving. Medical devices that were purchased by physicians affiliated with the medical school were typically paid for out of school funds and thus the devices would go to Central Receiving. Any product alerts or recall notices received by her department would be sent to BME, which she considered to be the central repository for such information. To the best of her memory, her office received ten to twenty such notices a year, and her unit would take no further action in connection with these notices or products unless they were given some directive from BME or from the Central Sterile Department. Typically, such directions would require that certain items be pulled and returned to the manufacturer. Ms. Protosow had no recollection of anything relating to Vitek TMJ implants.

Dennis Wells, Director of University Central Receiving, was also unfamiliar with the Vitek implants or any TMJ implants and did not believe that any had come to his unit. Central Receiving gets everything that is bought with purchase orders from the main campus and the Health Sciences Center. If notification of an alert or recall relating to any product had ever been received, he would either identify the person or department that ordered it and forward it to them or, if there were no purchase order number indicated, it would be forwarded to University Purchasing.

James Fabian, who had been Assistant Director of University Central Services, and Arthur Amman, Assistant Director of University Purchasing, were also unfamiliar with any Vitek products or recalls. The procedure that they used when any recall or other important product information was received was similar to that employed by Central Receiving: they would try to identify the department which had ordered the product, sometimes contacting the vendor in hopes of identifying a purchase order number, and if that was unsuccessful and it appeared to be a medical product, the notice would be sent to Hospital Purchasing. They would not keep a copy or a record of such notices.

Raveesh Talanki, a senior biomedical engineer in BME, testified that on occasion part of his duties included conducting incident investigations. In January 1992, he was asked to investigate a Vitek implant that had been removed in an operation at the Hospital because of a concern that it might be a reportable incident under the Safe Medical Device Act (SMDA) (PL 101-629, November 28, 1990, 104 Stat 4511). Mr. Talanki was the "line contact person" for reporting such incidents to the FDA. Prior to passage of the SMDA, he stated, similar investigations would be conducted but would not be reported to the FDA because there was no requirement to do so.

With respect to the 1992 investigation of Vitek chin implants (Exhibit 35), Mr. Talanki was first contacted by the Hospital's Risk Management Department and asked to investigate. He asked the doctor who had removed the questionable device to hold it and then attempted to locate the manufacturer, but without success. He then explored a number of other sources of relevant information: Operating Room staff; the relevant medical department and ECRI. From ECRI he received three reports on the Vitek chin implant, but no information that the product had been recalled. At the same time, ECRI also provided information regarding the Vitek Proplast II TMJ implant, but because he was investigating the chin implant, Mr. Talanki did not give these reports a great deal of attention and did not communicate information about the TMJ implants to anyone else. Once it was determined that the questionable chin implant had most likely failed because of rejection by the patient, a report was made to the FDA and the matter was closed.

With respect to recalls that were issued by the FDA, Mr. Talanki testified that when one was received, a folder would be created and notification sent to the appropriate department(s). If it was a surgical device that had been recalled, most often notification would be sent both to the relevant medical department and to the appropriate operating room.

David Darnell is currently BME's Director and was its Associate Director from 1992 to 2000, and the Senior Biomedical Engineer from 1982 to 1992. In that last noted position, he had been responsible for supervising the inspection, purchase, testing and repair of medical devices. Although his department had no responsibility for actually overseeing the recall of medical devices, they would be responsible for forwarding information about such recalls to the appropriate medical departments. BME would also automatically be given notice of any recall information that was sent to medical departments. Prior to 1995, there was no written policy regarding the handling of recalls, but nevertheless the practice was consistent: copies of notices or alerts would be forwarded to the department that "owned" the device and BME would also receive a copy. Prior to the SMDA, BME also had no responsibility for tracing implants, and reports were made to the FDA only on a voluntary basis. In fact, most of the reporting was done to ECRI, and that organization would then convey the information to the FDA. The only BME report on a Vitek product between 1995 and 1999 that was sent to the FDA related to the chin implant that had been investigated by Mr. Talanki. Mr. Darnell testified that he would have been informed of the results of the investigation and approved the report being sent.

Mr. Darnell had no recollection of receiving a call from the FDA relating to the Vitek TMJ implant, and his memory was not refreshed by being shown Exhibit 5A (copy of Recall Information call sheet - 3/8/91), although he acknowledged that this document contained his phone number, correct title, and a misspelled version of his name. Had he received such a call, he stated, he would have checked with the appropriate department to determine if they were using the product. If a call from the FDA relayed an alert or recall in connection with a product, he would have made a written record of the call, obtained a copy of the alert, and again checked to see if the product was being used. If it were a non-alert matter or simply a check on a company, he would not have made any notation of the call. An ECRI alert would not have resulted in the same action because, he explained, ECRI issues a weekly journal that can contain information on hundreds of medical instruments. Thus, if ECRI had reported on an FDA alert relating to a certain product, no action would have been taken by BME unless it related to an investigation that they had conducted, or were conducting, for other reasons. Surgical removal of a device alone would not have triggered a report to BME and, thus, could not have resulted in a report to either ECRI or the FDA.

Notice of Vitek Problems
Claimant asserts that University Hospital and relevant employees had actual notice of the problems with the Vitek implants and the need to monitor patients who had received the implants at least by 1990-1991. The FDA's certified mailing list (Exhibits 3, 3A), which was used in disseminating information about the Vitek implants, shows that the Agency's warnings were sent to Dr. Stein; to Dr. Bass; to University Hospital at the address that had been listed on Vitek's shipping label; to the Hospital's Central Receiving, also at an address listed on Vitek's shipping labels, and to University Hospital O.R./Dept. of Oral Surgery, also from the Vitek list. In addition, FDA records (Exhibits 5, 5A) reveal that on February 28, 1991, a telephone call was made by Gregson Joseph to Senior Biomedical Engineer David "Darnell" [sic] at University Hospital. As indicated below, David Darnel confirmed that the telephone number used was correct, although he had no recollection of the call.[3]

In addition, Dr. Bass performed a surgical removal of Vitek TMJ implants in April 1990 at the Hospital. The unnamed patient had received bilateral implants in 1986 or 1987. According to Dr. Bass's notes, the implants were removed, at least in part, because "[b]ased on literature, the proplast-teflon implants should be removed" (Exhibit 2). The surgical removal of the implants was carried out at University Hospital and Dr. Bass was assisted by Dr. David Shafer, who was a SUNY Stony Brook oral and maxillary surgical resident at the time. Finally, Claimant points to the warning notices about the TMJ implants that were received by BME when that office conducted an investigation into the suspicious Vitek chin implant that was removed in January 1992, as discussed above.

Department of Health Investigation
Following the events in early 1996 which revealed to Claimant that the Vitek implants were defective and that she had not received prompt notification of such defect or proper monitoring of the condition of her implants, she filed a complaint with the New York State Department of Health (DOH). Following its investigation, DOH released a report in January 1997 (Exhibit 6) which, among other things, included the following finding of fact:

The director did not in conjunction with the medical staff, monitor the quality and appropriateness of patient care and ensure that identified problems were reported to the quality assurance committee and that these problems were resolved.

MR#062932 [Claimant's medical record number] documents a patient who was regularly seen at the hospital's ambulatory care pavilion, received implants to her jaw that were the subject of a safety alert by both the manufacturer and the Food and Drug Administration. There is no evidence that surgical services or the hospital addressed these patient care recommendations.[4]

Legal Issues
Statute of Limitations
In its answer, the Defendant raised, as its Third Affirmative Defense, that the claim is barred by the applicable statute(s) of limitations, and as its Fourth Affirmative Defense, that the alleged claim for medical malpractice was not commenced within two and one-half years of its accrual and is therefore barred by the Statute of Limitations, CPLR 214-a.

Counsel for Claimant asserts that the State has waived any defense based on the Statute of Limitations because the statements in its pleadings are not sufficiently "particular" to effectively raise those defenses. As authority for this proposition, however, Claimant relies exclusively -- and inappropriately -- on decisions addressing whether there has been a waiver of the time or manner of service requirements of the Court of Claims Act, not the CPLR article 2 Statutes of Limitations. As explained in one of those decisions (
Sinacore v State of New York, 176 Misc 2d 1, 4), §11(c) of the Court of Claims Act imposes a heightened pleading requirement not found in the CPLR: the requirement that the defense be stated "with particularity." Such particularity is not required to set forth an affirmative defense under the CPLR, and the Statute of Limitations is a CPLR affirmative defense (CPLR 3018[b]). Consequently, Court of Claims Act §11(c), and cases decided under that provision, are entirely irrelevant to the issue of whether a Statute of Limitations defense has been adequately pled.
On the other hand, accepting that the Third and Fourth Affirmative Defenses of the Answer were adequately pled, it does not appear that there is any merit to the defense thus raised. The claim was served in late June 1997 and filed in early July 1997. The Defendant's alleged wrong, the failure to notify Claimant of the implants' recall, may have first occurred in 1990 or 1991, but the wrong was a continuing one or, in any event, a cause of action based on that wrong did not accrue until January or February 1996 when Claimant finally received the necessary information. In Court of Claims practice, a cause of action does not accrue until the amount and extent of damages can be reasonably determined (
White Plains Parking Auth. v State of New York, 180 AD2d 729). In the instant situation, it would be impossible to determine the extent of any damage, or in fact whether any injury had occurred, until Claimant was apprised of the problems with the implants and her physical condition checked. It is possible, and tragically likely, that if she had been notified of the problem with the implants at some point in 1992 or 1994, they might not yet have begun to deteriorate and cause further injury. Thus, whether the claim is considered to sound in medical malpractice (CPLR 214-a) or, more realistically in my view, in simple negligence (CPLR 214), the action was commenced in a timely fashion with respect to the CPLR Statute of Limitations (2.5 years and 3 years, respectively).[5]

Duty of Defendant Hospital to Claimant
Both common sense and relevant case law establish that a doctor or dentist has a continuing duty to give notice to his or her patients and former patients upon learning of any defect subsequently discovered about implants and other devices that the practitioner caused to be placed in the patient's body. Both Dr. Stein and Dr. Bass acknowledge such a duty; the warnings from the FDA and other sources presuppose such a duty; and courts that have addressed the issue have found such a duty (
see, e.g., Harris v Raymond, 715 NE2d 388, 394; Reyes v Anka Research, 111 Misc 2d 152). There is no dispute between the parties on this point.
What is at issue, however, is whether the University Hospital had notice of the problems with the Vitek implants and their ultimate recall and, if so, whether it had a duty, similar to that of a patient's physician, to provide appropriate warnings to patients who received those implants during an operation performed at that facility. Research has disclosed only one of the several lawsuits brought across the nation involving these same Vitek implants that discusses the duty of a hospital as separate and apart from a patient's own doctor or dentist. In
O'Dell v Marco (1999 WL 203758, Conn Super Ct),[6] the hospital was absolved of liability because it was merely the "location of the surgery." In that case, however, the injured party was the patient of both a professional corporation of oral surgeons and a specific surgeon who was, at the time, a member of the corporation. The court granted summary judgment dismissing the claim against the hospital but declined to do so with respect to the surgeon on whom the patient had relied.
Neither of the medical practitioners who could possibly have considered Claimant to be his responsibility did, in fact, consider her to be his patient, to whom a continuing duty would be owed. To Dr. Stein, she was a "SUNY Stony Brook patient" whose surgery he was called upon to oversee, as part of his teaching duties. To Dr. Bass, she was not his patient because at the time of the operation he was merely a resident in the hospital, assisting in surgery on patients who were under the primary care of others. Neither surgeon kept records or information about the patients whom they treated in these capacities. It is not the province of this Court to determine as a matter of law whether their interpretations of their relationship with this patient were correct, or whether they owed any duty to warn Claimant, for they are not defendants in this lawsuit.[7]

Since the State also denies that Claimant was the responsibility of University Hospital, it would seem that Claimant was "nobody's child." The record contains no indication of whether there was a referring dentist or physician who sent her to specialists at the SUNY Stony Brook clinic for evaluation and treatment. If there was someone who served in that capacity and would have had complete records of the treatment given to his or her patient, who owed a primary and continuing duty of care toward Claimant, then it was incumbent on the University Hospital to come forward with evidence of that fact, as those referral or admission records would be in its exclusive possession. From the evidence presented at trial, it is clear that neither Dr. Stein nor Dr. Bass ever considered her to be his patient, except at the time of the operation itself. This was not an isolated incident about which there may have been a singular good faith misunderstanding. Dr. Stein was the supervising surgeon on many operations performed at the Hospital; Dr. Bass, as a resident, was undoubtedly involved with other patients. Neither kept records about these "Hospital" patients, and neither considered that he had a duty to do so. The Hospital had to be fully aware that Dr. Stein and Dr. Bass, and most likely other faculty members and residents, took this position with respect to patients treated at University Hospital. The Hospital was either aware, or should have been aware, that with respect to these patients neither practitioner was assuming the role of primary caregiver. Thus, it was the Hospital that stood in that position and, consequently, the Hospital that owed to those patients the same duty of continuing care that individual practitioners owe to their private patients. In these unique circumstances, unlike the situation presented in
O'Dell v Marco (1999 WL 203758, Conn Super Ct, supra), the Hospital was much more than merely the "location of the surgery," and it had an independent duty toward Claimant.

Notice to the Hospital of the Implant's Defect

The testimony of the numerous Hospital officials was ostensibly offered to indicate that none of them had
actual knowledge of the advisories and recalls relating to the Vitek Proplast implants. This had the somewhat contradictory effect of establishing that the Hospital knew that it had a duty to monitor and track medical devices, reports of problems with such devices, recalls of such devices, and the identity of patients who received the devices. That the system developed for tracking all this information may have worked poorly -- so poorly that apparently no one consciously knew about or could remember the multiple warnings relating to the Vitek TMJ implants and, with one exception, no one could find copies of any documents received -- does not negate the existence of a duty to know and to track the information. That these mechanisms were in place is probative evidence that the Hospital itself recognized its duty to make sure that the medical devices it purchased and allowed to be placed into patients were safe and that they could be located in the event of a recall.
While the Hospital may not have had a duty to actually contact those patients who were private patients of individual practitioners, it possessed the records from which the identity of all implant recipients could be readily discovered. The ease with which Mr. Intellisano was able to track recipients of the orthopedic device demonstrates that this was possible. As in that instance, the Operating Room logbook alone would be sufficient, as it contained information both about the device that was implanted and the patient who received it.

Claimant has succeeded in establishing, by a preponderance of the credible evidence, that University Hospital, and thus the Defendant, had a duty to notify her of the problems and ultimately the recall associated with the Vitek Proplast II implants and that it breached that duty, causing her harm.

Accordingly, I find the Defendant fully answerable in damages to the Claimants.

The State's Motion No. M-65194 to dismiss the claim is denied in accordance with that part of this decision addressing the Statute of Limitations and untimeliness. All other motions not heretofore ruled upon are now denied.

The Clerk of the Court is directed to enter an interlocutory judgment on the issue of liability. This claim will be scheduled for trial on the issue of damages as soon as practicable.


September 30, 2003
Rochester, New York

Judge of the Court of Claims

  1. [1]The claim of Kevin Dominy is derivative and thus, unless otherwise specified, all references to Claimant shall mean Sharon Dominy.
  2. [2]AAOMS is a voluntary membership organization and its journal is received only by its members.
  3. [3]Confusingly, Mr. Joseph's records indicate, in a check box, that he was told the implants were not used by University Hospital.
  4. [4]The parties have disagreed as to whether this portion of the DOH report can be admitted into evidence. It is my opinion that the portion relating to Claimant's case can be. The statement is a factual one which is admissible pursuant to New York Public Health Law §10(2). I note, however, that admitting this statement has very little impact, since even Defendant acknowledges that no effort was made by the Hospital to carry out the patient care recommendations with respect to Claimant. It is undisputed that she was not notified of the alerts or the recall and that no one initiated monitoring of her condition until 1996.
  5. [5]Under this analysis, it is not necessary to consider whether the tolling provisions of CPLR 214-c apply. If it were necessary to do so, I would hold that the "date of discovery," or, in the words of the Court of Appeals, the date "when the injured party discovers the primary condition on which the claim is based" (Wetherill v Lilly & Co., 89 NY2d 506), occurred no earlier than January 1996. There was simply no credible evidence that the pain and discomfort that Claimant suffered prior to that time was caused by the degenerating implants. In any event, because Claimant sought treatment from Defendant for her dental related problems in the years between 1990 and 1996, if there was any such evidence to connect those conditions to the implants, it was Defendant's own failure to give notice that such a connection was found. This cannot and should not be used to injure Claimant's interests.
  6. [6]It should be noted that O'Dell (supra) is an "unpublished" decision, although it is not evident what that means with respect to decisions from the State of Connecticut. One other case, Garnica v Louisiana State Univ. Med. Center (744 So 2d 156) involved a lawsuit very similar to the instant case, brought by an implant patient and based on allegations that the hospital breached a duty to give timely notice of the implant's defects. The decision, however, related only to a preliminary matter and did not assess the viability of the cause of action.
  7. [7]Although both Dr. Stein and Dr. Bass held positions at University Hospital at the time of surgery and, at least in Dr. Stein's case, thereafter, and might in that respect be considered State employees (see, Frontier Ins. Co. v State of New York, 146 Misc 2d 237, 247, affd 172 AD2d 13), there is no evidence from which I am able to conclude that the duties of their State position would have included providing ongoing oversight and care of the patients on whom they operated after the patient recovered from the specific operation. Any duty owed by Dr. Bass which arose from his subsequent treatment of Claimant as a private patient, and his acquisition in that respect of knowledge about the implant, is not relevant to this lawsuit.