Opinion
101470.
Decided May 25, 2004.
CHARLES G. EICHINGER, P.C., BY: CHARLES G. EICHINGER, ESQ., for Claimant.
HON. ELIOT SPITZER, NEW YORK STATE ATTORNEY GENERAL, BY: VICTOR J. D'ANGELO, ASSISTANT ATTORNEY GENERAL for Defendant.
Gunther Hattendorf, the Claimant herein, alleges in Claim Number 101470 that Defendant's agents negligently caused him personal injury when he was undergoing hip replacement surgery at Stony Brook University Hospital (hereafter Stony Brook). Trial on the issue of liability was held on October 27, 28, and 29, 2003.
FINDINGS OF FACT
On July 20, 1998 Claimant was scheduled for total left hip replacement surgery to be performed by his treating surgeon, Dr. Edward Wang, at Stony Brook. At the time he was 57 years old and suffering from kidney and liver disease and diabetes. Because of medication he had been taking for his kidney disease, his left hip had degenerated to a point that Dr. Wang recommended that he undergo total left hip replacement. When Dr. Wang advised Claimant about the risks of surgery, the possibility of infection was one risk indicated.
In a pre-operative visit made on July 10, 1998, Claimant executed a consent form indicating that he had been advised of the various risks associated with the surgical procedure and the attendant anesthesia, including "bleeding, possibly requiring transfusion, infection, scarring, poor healing, swelling, neuro/vascular injury, recurrence, reoperation, anesthetic complications, DVT, RSD, failure to resolve symptoms, [and n]eed for future surgeries." [Exhibit A].
On Saturday, July 18, 1998, Vincent Rotolo, a service technician from Buxton Medical Service Corp. (hereafter Buxton), answered a call from the central sterile supply unit (hereafter CSS) of Stony Brook to repair some of the equipment in that unit. CSS is the hospital department responsible for sterilization of surgical instruments and their storage. Buxton supplied and offered service on several machines used in the sterilization of medical instruments. Stony Brook personnel had noted a problem with the release function of the loading mechanism on the washer sterilizer, the first machine used in the process of sterilizing instruments. After fixing the problem Mr. Rotola tested the machine and left. [ See Exhibit 5]. He was unaware of any excessive humidity concerns on the part of Stony Brook at the time of his visit on July 18, 1998.
As described at trial by Stony Brook personnel, when "dirty" instruments are returned from the operating room, they are first hand washed, then put through a washer-sterilizer — which functions essentially like a dishwasher. After washing in the washer-sterilizer, the instruments are placed in small trays on a towel, wrapped in a fibrous fabric textured something like a handi-wipe, and placed in the hi-vac sterilizer. Inside the hi-vac sterilizer, the instruments are subjected to superheated water — or steam — brought to a temperature of 250° Fahrenheit for a period of 8 minutes, which sterilizes the packages of surgical instruments. The packages themselves are packed with internal test cards prior to sealing that indicate whether the appropriate steam temperature was reached for sterilization. They are also sealed with a tape that changes color when the desired steam temperature is reached. Steam is brought to the high-vac sterilizer from steam pipes attached to the machines, that branch off a main steam line, running between the third and fourth floors of the hospital. That portion of the machines is not visible in the main room of CSS, but is accessed via a smaller service area.
The CSS unit is comprised of several different areas. The largest portion is the assembly area, which contains the washer-sterilizer and the high-vac sterilizers. Immediately behind the assembly area is the service area for access to the machines. Behind the service area is the sterile storage area where case carts, containing surgical instruments assembled for various scheduled procedures and pre-packaged surgical instruments, are stored.
Corrine Van Note, the Assistant Director of CSS on weekend duty, arrived at work on Saturday, July 18, 1998 at approximately 9:00 a.m. It was another excessively hot summer day, with outside temperatures in the 90° Fahrenheit range. Noting that it is always warm in CSS because of the machines, she made a call to the east campus physical plant for a temperature/humidity reading after staff complained of the excessive heat. There also appeared to be condensation forming on an air conditioning vent in the storage room. There was not, however, any dripping of condensation onto the sterilized instrument packages. Personnel from the plant responded and noted a humidity reading of 68% using a hand held humidity recorder since there were no devices to otherwise measure humidity in CSS. Amy Provenzano, the Director of the east campus physical plant did not recall any other request from CSS on that day. When Ms. Van Note left work on Saturday, July 18, 1998, she advised personnel coming on shift that it had been hot, but that it seemed a little cooler.
On Sunday, July 19, 1998 Buxton received a call from Ms. Van Note, this time with respect to what appeared to be steam leaks from one of the high-vac sterilizers. There appeared to be high humidity in CSS — as there was in other areas of the hospital — and hospital personnel wanted to determine whether it might have its genesis in leaks from the machines. Another service technician from Buxton, John Newman, responded to the call at around noon. [ See Exhibit 6]. He removed debris from a steam trap that was part of the steam line providing steam to the high-vac sterilizers and ran the machine. Steam traps, it was explained, allow condensed water to escape from the steam before it enters the high-vac sterilizer in order to create the "dry steam" used in the sterilization process. The condensed water exits the trap, spills onto the floor underneath the machine, and exists via a drain in the floor. In this case, debris in the steam line had clogged the trap, holding it in an open position and allowing steam to escape.
Mr. Rottola noted that there is no regular maintenance schedule for clearing a steam trap, nor would one necessarily be appropriate. Over time, pipes furnishing steam would naturally disintegrate somewhat, allowing residue to discharge into the trap, and perhaps causing the trap to be held in an open position as described. Mr. Rottola pointed out that this was the type of problem that could not really be addressed until it happened. He noted that even if he were to "put in a brand new trap today, if debris was coming down that steam pipe, that brand new trap will be clogged in a minute, or the next day." [T-405].
All quotations are to the trial transcript unless otherwise indicated.
"T" indicates page of trial transcript.
There was no testimony offered concerning any standard of maintenance required for maintaining the main steam line or the pipes branching out to the machines.
On July 19, 1998 Ms. Van Note also called Ms. Provenzano for assistance in addressing continued staff complaints of excessive heat and humidity. Before Mr. Newman arrived from Buxton, Ms. Provenzano had located the steam leak from the steam trap by looking behind the machines in the service area. She also saw that some ceiling tiles in the back storage area appeared to be moist, and directed a work crew to remove and replace wet tiles. [ See Exhibit 3]. Ms. Provenzano described the area where ceiling tiles were replaced as a "30 x 30 [ft.] area, or 1/3 of the back room." [T-1093]. All the surgical instruments in the back storage area had been moved and covered before the work crew arrived to replace ceiling tiles.
Peter McDermott, the Director of CSS, testified that on Sunday, July 19, 1998 he had received a call from Ms. Van Note advising him of temperature problems in the unit. He again spoke to Ms. Van Note between 3:00 and 4:00 p.m. and was advised that the physical plant was working on the problem and had discovered a steam trap open, that some type of moisture had been found in the ceiling warranting replacement of some ceiling tiles, and that all the surgical instruments had been covered and moved.
Later that afternoon Buxton was called in again. [ See Exhibit 7]. When Mr. Rotolo arrived at 6:30 p.m. he found that a steam valve from the ceiling had been shut off, presumably sometime between 2:00 p.m. when Mr. Newman had left and Mr. Rotolo's arrival. Mr. Rotolo opened the valve to test the operation of both hi-vac sterilizers, noting that the pounds per square inch of pressure was elevated in the machines overloading the safety valves in the machines. The extra pressure caused the steam to bleed from the valve, releasing what Mr. Rotolo characterized as a minor amount of steam in the service area of CSS. Mr. Rotolo was able to decrease the pressure, but decided to turn off the main valve and return in the morning with replacement parts. Another humidity reading was taken and found acceptable. [ See Exhibit 15].
On July 20, 1998 Mr. Rotolo returned to Stony Brook at 7:30 a.m. and replaced safety valves in the hi-vac sterilizers. [ See Exhibit 8]. In discussions with maintenance personnel Mr. Rotolo announced that whatever the steam problem might be, it was not caused by his machines.
When Mr. McDermott arrived at work at 8:00 a.m. on Monday, July 20, 1998, he immediately went to CSS. He was told that the humidity continued to be high and that it was being watched. No moisture had been observed on the surgical instrument packages themselves. As he understood it, various eventualities might cause — but would not necessarily cause — contamination of surgical instruments. A high humidity environment, falling ceiling tiles, and water accumulation all might cause contamination of packaged instrument trays. He said, however, that no observable, visual signs of water droplets on the packages or ceiling tile debris, or water accumulation, were present at that time to trigger further examination of the packages.
Maintenance had brought in either fans or dehumidifiers to reduce the heat for personnel. Ms. Provenzano noted that the typical way to bring down temperature and to eliminate moisture is to place more chilled water in the air handler, but she could not say with certainty whether this action had been taken.
As the humidity continued to rise throughout the morning, at approximately 10:00 a.m. Mr. McDermott contacted Francina Singh, from the infection control unit, for assistance. She got to the unit after being paged at approximately 10:15 a.m. and noted that the humidity in the area where the instruments were stored was at 89%. No "visible moisture was identified" on the packages. [T-1116]. When Ms. Singh touched one of the packages, however, it felt damp. Calling together the other administrators — Mr. McDermott, "the administrator that covers the . . . [operating rooms]; the chairman of anesthesiology and the associate medical director" — they opened ten packages and found that three of them were moist inside. [T-117]. Both Mr. McDermott and Ms. Singh testified that between 10:30 a.m. and 11:00 a.m. the determination was made to re-sterilize all the instruments in CSS, based upon the possible "compromise" of the instruments.
At that point of the morning, Ms. Singh stated, the 7:00 a.m. surgeries were completed. Those surgeries that commenced at approximately 8:30-9:00 a.m. were either complete or "in the middle." [T-119]. It was these surgeries, including the one involving the Claimant, that were most likely to have been affected were the instruments actually contaminated. Towels from the three moist packages were sent for testing. The cultures taken of the towels were all negative for the growth of any bacteria. [ See Exhibit C]. All the doctors performing surgery were notified of the possibility that the instruments furnished to them had been compromised. She stated that there is no literature to support a correlation between moisture and high humidity and contamination of surgical instruments. By the same token, however, she stated there is a "possibility" of contamination "if the humidity is sustained for a longer time." [T-1160]. No testimony was elicited concerning what that longer time period might be.
Claimant arrived at the operating room, was prepared for surgery and was administered anesthesia commencing at approximately 9:08 a.m. [ See Exhibit 10]. Dr. Wang indicated that some positioning of Claimant's body was required in order to facilitate the ease of the procedure. Dr. Wang began the surgery at approximately 10:30 a.m., describing it as a "three part procedure." [T-616]. First, the bones are "prepared" to allow the metal implant to "seat" properly, as the components are standard size and a patient does not necessarily have a socket and a femur that will fit right away. Second, the area must be irrigated very carefully and the implant is then cemented and screwed in. In this case, the implant was to be cemented in the femur and would be secured by the presence of the bone in front in addition to surgical screws. Finally, once the implant is in place and viewed as "stable," muscles and soft tissue are put in their proper places and the wound is closed up. [T-617].
Prior to commencing the surgery he remembered inquiring if everything was "all right" with the instruments. [T-568]. He could not say if this inquiry was a specific concern based upon "rumors concerning problems in the OR environment," [T-733] or part of his routine before complex surgery.
Half-way through the surgery Tony Inteilisano, the head operating room nurse, advised him that there was a report of a potential problem with the sterilization of the surgical instruments. When Dr. Wang stepped out of the operating room to consult with hospital administrator Lori Rafkin, he was advised that due to a humidity problem within CSS, the surgical instruments he was using might have been contaminated. Deciding that if the prosthetic were to be cemented in place any infection could cause greater risk, Dr. Wang elected to stop the surgery and follow claimant's progress for several days to assure that no complications developed. Accordingly, Claimant's wound was closed and he was placed on prophylactic antibiotics.
Cultures taken at the wound site were negative for bacterial growth after a period of seven days. Based on these negative cultures and the lack of other objective indicia of infection, such as fever, Claimant returned to the operating room on July 27, 1998 for Dr. Wang to complete the surgery. Further precautions were taken on that date. A gram stain test administered prior to implantation of the prosthesis proved negative for the presence of bacteria signaling infection, and deep wound tissue samples were taken. The operation was completed and Claimant was returned to his hospital room. On July 31, 1998 deep tissue cultures taken during the second surgery "grew out a pseudomonas aeruginosa" and a "staphylococcus epidermis." [T-703]. [ See Exhibit 10]. The presence of these bacteria, as well as a bluish green discharge from the wound suggested infection. An infectious disease consultation was directed and the team concluded that the wound site was infected. In order to salvage the prosthesis, Dr. Wang had Claimant returned to the operating room on August 1, 1998. The wound site was re-opened and cleaned. Claimant was discharged from Stony Brook on August 26, 1998 without any other sign of infection.
After indicating to Claimant's counsel that an infectious disease specialist would be better qualified to render an opinion, Dr. Wang indicated that it was his "intrinsic opinion that . . . [the pseudomonas] probably came from the first operation . . . I don't think anyone knows for sure." [T-738-740].
Both Dr. Wang and Ms. Singh noted that the bacteria that grew out of the deep wound cultures taken on July 31, 1998 are among those that can cause infections. Staphylococcus epidermis is found on human skin; and pseudomonas is commonly found in fire and water, and also in the human intestine. Contact with contaminated instruments, however, is not the only way that such bacteria might be present.
Eighteen patients, including Claimant, were followed for possible problems after the events of July 20, 1998. Claimant was the only one who developed an infection.
On Claimant's direct case, in addition to his own testimony, Claimant called several maintenance workers who performed the task of replacing ceiling tiles: Mr. Rotolo, Mr. McDermott, Dr. Wang, Ms. Van Note and Amy Provenzano. One of the workers, Dwayne Bestendheider, had testified at his examination before trial that he "heard [that] a steam pipe broke or something like that" in CSS "through the grapevine." [Exhibit 4]. Another worker, now deceased, Steveion Griffin, also testified at an examination before trial that the plumbing guys "fixed the broken pipe." [Exhibit 1].
Defendant called Ms. Singh.
No other witnesses testified.
DISCUSSION AND CONCLUSION
To establish a prima facie case of negligence the following elements must exist: (1) that defendant owed the claimant a duty of care; (2) that defendant failed to exercise proper care in the performance of that duty; (3) that the breach of the duty was a proximate cause of claimant's injury; and (4) that such injury was foreseeable under the circumstances by a person of ordinary prudence. Although in this case the actions or omissions of hospital employees and of Claimant's physician are alleged to have been negligent, no medical malpractice claim is raised. Certainly, absent expert medical testimony, Claimant could not establish the elements necessary for such a claim.
In a medical malpractice claim, the Claimant has the burden of proof and must prove (1) a deviation or departure from accepted practice and (2) evidence that such deviation was the proximate cause of the injury or other damage. A cause of action is premised in medical malpractice when it is the medical treatment, or the lack of it, that is at issue. A Claimant must establish that the medical care giver either did not possess or did not use reasonable care or best judgment in applying the knowledge and skill ordinarily possessed by practitioners in the field. The "`claimant must [demonstrate] . . . that the physician deviated from accepted medical practice and that the alleged deviation proximately caused his . . . injuries' ( Parker v. State of New York, 242 AD2d 785, 786)." Auger v. State of New York, 263 AD2d 929, 931 (3d Dept 1999). Without such medical proof, no viable claim giving rise to liability on the part of the State can be sustained. Hale v. State of New York, 53 AD2d 1025 (4th Dept 1976), lv denied, 40 NY2d 804 (1976). A medical expert's testimony is necessary to establish, at a minimum, the standard of care. Spensieri v. Lasky, 94 NY2d 231 (1999).
If a claim can be read to allege simple negligence, then the alleged negligent omissions or acts by the State's employees can be readily determined by a fact finder using common knowledge without the necessity of expert testimony. Coursen v. New York Hospital-Cornell Med. Center, 114 AD2d 254, 256 (1st Dept 1986); See also De Falco v. Long Is. Coll. Hosp., 90 Misc 2d 164, 170-171 (Kings Co Sup Ct 1977).
Here, no competent medical evidence was presented, through a treating physician or an expert witness whose opinion was based upon the available medical records, to support any allegation of medical malpractice. There is no medical evidence on any medical issue and thus no proof that accepted standards of care were not met. From this record there is no indication that the actions of medical care givers amounted to simple negligence. Coursen v. New York Hospital-Cornell Med. Center, supra. Accordingly, to the extent the claim can be read to assert such theories, any cause of action for medical malpractice or simple negligence related to medical care is dismissed. Clearly, the decisions Dr. Wang made during the course of his treatment of the Claimant fall under the rubric of judgments made using the skill and knowledge of a medical professional. In order to properly evaluate whether those decisions were reasonable, a medical expert would be required to establish, at a minimum, the standard of care.
Claimant argues that it is more probable than not that the infection Claimant suffered, and the additional surgery that followed, were the result of the failure to safeguard against the use of contaminated instruments during the initial surgery, and relies on the doctrine of res ipsa loquitur as his theory of negligence.
As noted by the Second Department, "[t]o rely on the doctrine, a plaintiff must submit sufficient proof that (1) the injury is of a kind that does not occur in the absence of someone's negligence, (2) the injury is caused by an agency or instrumentality within the exclusive control of the defendants, and (3) the injury is not due to any voluntary action on the part of the injured plaintiff . . . (citations omitted)." Rosales-Rosario v. Brookdale Univ. Hosp. Med. Ctr., 1 AD3d 496, 497, 767 NYS2d 122, 123 (2d Dept 2003). Thus when a patient hospitalized for child-birth awoke from sedation and discovered she had suffered a burn on the inner portion of her knee during or shortly after receiving a vaginal examination and epidural anesthetic, the Court found that these factors satisfied, prima facie, the elements of the doctrine when defendant unsuccessfully sought summary judgment dismissing the claim. [Ibid]. The Court said that res ipsa loquitur ". . . is generally available to establish a prima facie case when an unexplained injury in an area which is remote from the treatment site occurs while the patient is anaesthetized . . . (citations omitted)." [Ibid].
Unlike the patients in those cases where the doctrine has been applied, however, Mr. Hattendorf suffered an injury at the site of his surgery, which based upon the record presented here, can occur in the absence of negligence. Cf. Rosales-Rosario v. Brookdale Univ. Hosp. Med. Ctr., supra; Kambat v. St. Francis Hosp., 89 NY2d 489, 494 (1997) (foreign object); Babits v. Vassar Bros. Hosp., 287 AD2d 670 (2d Dept 2001) (third degree burn behind right thigh of anesthetized patient during orthoscopic knee surgery could reasonably be inferred to be an injury that would not occur in the absence of negligence); Drimmer v. CUNY (Claim No 102406 Nadel, J., December 16, 2003) ( metal bar above doorway in public building fell injuring Claimant, an event not ordinarily occurring in the absence of negligence). Indeed, negating the view that the doctrine is utilized for ". . . `a narrow category of factually simple medical malpractice cases requir[ing] no expert to enable the jury reasonably to conclude that the accident would not happen without negligence' . . .", the Court of Appeals has decided that expert testimony may be allowed to establish that the injury would not have occurred in the absence of negligence. States v. Lourdes Hosp., 100 NY2d 208, 210 (2003), quoting Kambat v. St. Francis Hosp., supra, at 496. No expert testimony was offered here to establish the first element of the doctrine.
In this case, the credible evidence established that infection was always a possible risk of the surgery Claimant elected; the particular bacteria present "grew out" some time after the initial surgery — indeed, it was identified in cultures taken after the second surgery — and could have become present in Claimant for reasons other than contaminated instruments used in the first surgery — assuming the instruments were even contaminated. The mere fact of a post operative infection does not necessarily mean it is the result of negligence on the part of the Defendant.
Defendant argues that Claimant has failed to establish any breach of duty owed to Claimant, and has failed to show that any acts or omissions were the proximate cause of Claimant's infection and injury. This Court agrees.
In De Falco v. Long Is. Coll. Hosp., supra, plaintiff developed an eye infection after cataract surgery, leading to the loss of his right eye. A witness had observed a nurse pick up an eye patch that had fallen to the floor and then replace the patch on plaintiff's eye. De Falco, Id at 171. "Reasoning that this testimony was credible, the plaintiff proposed that the jury [or fact finder] might also draw a double inference therefrom, first that the fallen eye patch picked up enterobacter and staph albus germs from the floor, and second that these specific organisms thereby entered the plaintiff's eye and caused the infection. This attempted syllogism lacked an expert's explanation to show how enterobacter and staph albus bacteria are spread and how these germs cause infection, for . . . [the fact finder] may not speculate as to negligence or causal connection . . . nor can the common experience and knowledge of . . . [the fact finder] bridge this scientific gap . . . (citations omitted)." [Id]; see also Filanowicz v. Guarino, 27 AD2d 666 (2d Dept 1967).
Relying on a shaky opinion wrung out of Dr. Wang to the effect that the infection was "probably" the result of contaminated instruments used in the first surgery simply does not support the conjectural leap Claimant asks the Court to make from the asserted misfeasance to the injury alleged. Claimant has established that it was a hot July; that CSS was experiencing high humidity off and on for perhaps two days; that steam appeared to be escaping from the steam lines servicing the sterilizers in CSS; that the sterilizers required servicing for problems unrelated to their ability to sterilize instruments; that State personnel were working on the temperature and humidity problems; that the company responsible for the maintenance of the sterilizing machines was working on problems with its machines; that wet ceiling tiles were replaced in a portion of CSS during a two- or three-day period; that surgical instruments stored in CSS were protected from exposure to the environment; that the evening before scheduled surgery, surgical instruments are generally transported to the applicable operating room; that on the morning of July 20, 1998 after consultation with the infection control department it was determined that all the instruments in CSS would be resterilized because of the possibility of contamination; that physicians performing surgeries were notified; that Dr. Wang received notice and exercised his professional judgment in electing to terminate the surgery and treat Claimant prophylactically with antibiotics; that after the second surgery Claimant developed an infection; and that Claimant was ultimately discharged without further incident of infection.
More importantly, Claimant did not establish by a preponderance of the credible evidence what any environmental standards were for the storage of sterilized instruments or that high humidity at a specific level actually contaminates surgical instruments. He did not establish what maintenance, if any, for steam pipes would be required as an exercise of reasonable care or that there was any breach of the maintenance standards at the Stony Brook plant. Claimant failed to show that any instruments used on July 20, 1998 were indeed contaminated and that personnel did not take the appropriate steps to remedy the situation upon notice of contamination. Claimant did not establish that in light of the information presented to Dr. Wang about the possible contamination of surgical instruments he was using, Dr. Wang failed to exercise his best professional judgment in choosing to halt the surgery, or in any other fashion thereafter. Finally, and regardless of whatever misjudgments by individual employees may have occurred along the way, Claimant did not establish that the cause of any infection was the use of contaminated surgical instruments.
Accordingly, Claimant failed to establish his burden of showing that the Defendant was negligent and that such negligence was a proximate cause of Claimant's injury. Defendant's motion to dismiss, upon which decision was reserved, is now granted, and Claim Number 101470 is in all respects dismissed.
Let Judgment be entered accordingly.