Kelly on Malpractice

In Turner v. Steriltek, Inc., 2007 WL 4523157 (Tenn.Ct.App.) is a great primer on the difference between ordinary negligence and medical malpractice as well as the need for expert testimony in complex cases. This appeal involved the difference between ordinary negligence and medical malpractice. Steriltek does off-site sterilization of surgical instruments for Vanderbilt. On July 12, 2002, Vanderbilt’s physicians were performing surgery on the plaintiff’s daughter at VUMC, using instruments sterilized by Steriltek. During the surgery, an agent of Steriltek informed the physicians that some of the instruments they were using might be contaminated. After receiving this information, the physicians stopped the surgery before it was completed. As a result, the plaintiff’s daughter had to return to VUMC at a later date, at which time VUMC’s physicians successfully completed the necessary surgical procedure. The facts are long but necessary to understand the nuances involved, The plaintiff filed suit against Steriltek, VUMC, and VUMC’s physicians, seeking damages for negligence and medical malpractice. The defendants filed motions for summary judgment supported by expert affidavits. The trial court granted summary judgment on all claims against all defendants. The plaintiff appealed. Vanderbilt had contracted with Steriltek to provide surgical instruments, which were sterilized off-site, to Vanderbilt. The instrument sterilization process at Steriltek is complex and involves several steps. The process begins when the instruments and batteries are brought to Steriltek’s facility and unloaded in a decontamination area. They are decontaminated and sent through a washing machine. They are then reassembled and packaged in preparation for sterilization. The packaged instruments are first wrapped in a polypropylene wrap and sealed with a chemical indicator tape. Inside each wrap is a chemical indicator strip. Both the tape and the strip change colors to indicate exposure to the sterilant, which in this case was hydrogen peroxide gas. Immediately after the sterilization process, the chemical indicator tape that seals the wrap is observed for a change in color. In contrast, the chemical indicator strip is not observed until the wrap is opened at the point of use. The wrapped instruments go through several sterilization cycles. During this process, the sterilization machine tracks the parameters of each cycle, indicating pressure readings and the duration of each cycle. These parameters are printed out on mechanical tape at the completion of the process. As additional confirmation that the instruments and batteries are sterilized, Steriltek performs a biological test on each load. The biological test is performed by placing a biological test pack inside the sterilizer with the instruments. The test then determines whether the sterilant killed microorganisms present in the biological test pack. For a period of forty-eight hours after the sterilization process, the biological test pack is monitored to confirm that the sterilization process was effective. Steriltek provided the sterilization services on the instruments and batteries for the Plaintiff’s surgery. The problem here was that the batteries and instruments were delivered to Vanderbilt well before expiration of the 48-hour period required to confirm effective sterilization. On the date of the surgery, a registered nurse for Steriltek’s sterilization facility, received a report that the instruments and batteries in that load might not be sterile. The nurse for Steriltek went to Vanderbilt to retrieve the potentially-contaminated instruments. In so doing, the nurse learned that some of the instruments and batteries being used in the Plaintiff’s surgery were part of the potentially contaminated load. The nurse then advised Vanderbilt’s doctors of the problem. After receiving this information, Vanderbilt’s doctors decided to abort the surgery at that point. The Plaintiff asserted that Vanderbilt’s doctors were negligent in (1) failing to make a timely determination that the surgical instruments used during the surgery were sterilized, (2) failing to take precautionary measures to ensure that sterilized instruments were used, and (3) failing to properly examine the instruments used in the surgery to make sure they were sterilized. The Plaintiff alleged that these acts or omissions by Vanderbilt’s doctors amounted to both ordinary negligence and medical malpractice. The Plaintiff also claimed that Steriltek’s acts or omissions amounted to negligence. The Plaintiff asserted that Steriltek was negligent in failing to provide sterilized instruments and failing to provide a timely warning that the instruments were contaminated, unsterilized, or otherwise unsafe to use in surgery. Finally, the Plaintiff alleged that Vanderbilt was negligent in failing to employ protocols and procedures that would ensure that surgical instruments were sterilized and safe to use. The Vanderbilt Defendants and Steriltek filed separate motions for summary judgment. The Vanderbilt Defendants’ motion was accompanied by an expert affidavit from Dr. Schwartz. In his affidavit, Dr. Schwartz opined that he, Dr. Glenn, and Vanderbilt provided medical care to Jessica in a manner that complied with the recognized standard of care in Nashville, that all three acted with ordinary and reasonable care in treating her, and that they were not the proximate cause of any damages she sustained. The Vanderbilt Defendants asserted that they were entitled to judgment as a matter of law, based on Dr. Schwartz’s affidavit and the Plaintiff’s failure to put forth competent expert proof as required by TENN.CODE ANN. § 29-26-115, et seq. Steriltek filed its motion for summary judgment, along with the affidavit of Allen as an expert on Steriltek’s sterilization processes. In his affidavit, Allen opined that the instruments used in the surgery were properly sterilized and that the biological test had actually resulted in a “false positive.” In its motion, Steriltek argued that the subject matter of its case was so complex that the Plaintiff’s lawsuit could not survive the summary judgment motions without providing expert proof in response to them. The Plaintiff filed responses did not submit any expert proof. As to the Vanderbilt Defendants, the Plaintiff simply denied the assertion that Dr. Schwartz, Dr. Glenn, and the other Vanderbilt employees complied with the applicable standard of care. In response to Steriltek’s summary judgment motion, the Plaintiff maintained that no expert proof was required of her because the issue of whether Steriltek had breached its duty to the Plaintiff was within the common knowledge of laypersons. The Plaintiff asserted on appeal that she was not required to submit expert proof in response to the expert affidavits submitted in support of the summary judgment motions. This depended on the nature of the Plaintiff’s claims. Generally, Tennessee’s Medical Malpractice Act requires the plaintiff to provide expert proof to establish the elements of a medical malpractice claim. TENN.CODE ANN. § 29-26-115. If the defendant files a motion for summary judgment supported by competent expert proof that no medical malpractice occurred, and the plaintiff does not present expert proof to the contrary, then summary judgment for the defendant is necessary. However, if the alleged malpractice is so obvious that it is within the common knowledge of a layperson, then the plaintiff need not submit expert proof. Likewise, if the plaintiff alleges ordinary negligence, as opposed to medical malpractice, the plaintiff is not required to comply with the requirements of the Medical Malpractice Act. There is one caveat. Even if the plaintiff’s claim sounds in mere negligence, she may be required to submit expert proof of her claim. First, there is a difference between ordinary negligence and medical malpractice. The distinction between ordinary negligence and medical malpractice turns on whether the acts or omissions complained of involve a matter of medical science or art requiring specialized skills not ordinarily possessed by lay persons or whether the conduct complained of can instead be assessed on the basis of common everyday experience of the trier of fact. Peete v. Shelby County Health Care Corp., 938 S.W.2d 693, 696 (Tenn.Ct.App.1997). Also, in comparing medical malpractice with ordinary negligence, you must consider whether the defendant’s acts or omissions relate to a particular patient or to an entire group of persons. See Estate of Doe v. Vanderbilt Univ., Inc., 958 S.W.2d 117, 121 (Tenn.Ct.App.1996) (concluding that a medical center’s decision not to implement a policy to notify an entire group of former patients that they may have contracted HIV from blood transfusions constituted ordinary negligence, not medical malpractice). The Court of Appeals considered the Plaintiff’s claims against the Vanderbilt doctors. The Plaintiff’s claims as to Drs. Schwartz and Glenn sound in medical malpractice; these physicians exercised their medical judgment in deciding which instruments to use, and in making the decision to abort Jessica’s surgery. The Plaintiff did not submit opposing expert affidavits. Accordingly, summary judgment was proper as to the claims against the Vanderbilt doctors and under respondeat superior. However, the Plaintiff’s claim that Vanderbilt “negligently failed to have in place a system of proper surgical protocols, procedures, and measures to assure that surgical instrumentation was clean, sterile, and in a safe condition….” was another thing. The Plaintiff argued that this claim alleged ordinary negligence, not medical malpractice. The Court of Appeals revisited a similar issue in Estate of Doe v. Vanderbilt University, Inc., 958 S.W.2d 117 (Tenn.Ct.App.1997). In Estate of Doe, the plaintiff’s decedent had surgery, a blood transfusion, and received blood contaminated by HIV. As a result, the patient became infected with HIV and transmitted the disease to her daughter in utero. Both subsequently died of AIDS. The plaintiff then sued Vanderbilt for damages based on Vanderbilt’s failure to notify patients who had received blood transfusions that the blood they received had not been tested for HIV. Vanderbilt filed a motion for summary judgment supported by expert testimony opining that Vanderbilt’s notification policy was reasonable and in accord with the policies of other hospitals in Nashville under similar circumstances. In response, the plaintiffs submitted expert testimony from California experts, opining that Vanderbilt’s notification policy was unreasonable, and asserting that the decision on notification was an administrative decision, not a medical one. The trial court held that the plaintiff’s claims were subject to Tennessee’s Medical Malpractice Act, and, because the expert testimony proffered by the plaintiffs did not comply with the Act, granted summary judgment in favor of Vanderbilt. The plaintiffs appealed, arguing that their claims against Vanderbilt were claims of ordinary negligence, not medical malpractice, and that summary judgment was granted in error. The appellate court in Estate of Doe first noted that the term “medical malpractice” does not encompass every negligence action brought against a health care provider.” The Court of Appeals also noted that at the time Vanderbilt had a duty to warn about the danger of HIV infected blood there was no physician-patient relationship between Ms. Doe and the Vanderbilt physician. In light of all of these factors, the Estate of Doe court concluded that the plaintiff’s claim was not medical malpractice. While medical expert testimony would be “important” for a jury to determine the issue, there was no need for expert testimony. Therefore, the appellate court in Estate of Doe reversed the trial court’s grant of summary judgment, holding that the plaintiff’s expert proof did not have to comply with Tennessee’s Medical Malpractice Act. Certainly, Vanderbilt’s allegedly negligent act or omission relates to an aspect of medical care: the provision of sterile batteries and instruments for surgery. The effects of Vanderbilt’s decision to put sterilized instruments into circulation before expiration of the 48-hour biological test period are felt by the patient at the time of the treatment, when Vanderbilt has an existing relationship with the patient. In addition, medical expert testimony may be important for a jury to determine whether Vanderbilt was negligent in not having a policy of waiting forty-eight hours to make sterilized batteries and instruments available for surgery, to ensure that they were not contaminated. However, as in Estate of Doe, the decision at issue was a policy decision as to how soon to use freshly sterilized instruments. It was made well before the Plaintiff was a Vanderbilt patient. Moreover, Vanderbilt’s decision was not one of medical diagnosis or treatment. It did not involve assessment of the risks or benefits to the Plaintiff in particular, but rather to the entire group of patients facing surgery at Vanderbilt. It affected every Vanderbilt surgical patient, regardless of his or her condition, similar to Vanderbilt’s duty to provide clean surgical linens or a clean operating table. In this sense, the issue did “implicate questions of medical competence” … but instead turned on the Hospital’s independent duties as a surgical center. Estate of Doe, 958 S.W.2d at 121. Therefore, the Court of Appeals concluded that the Plaintiff’s complaint against Vanderbilt stated a claim of ordinary negligence, not medical malpractice. The Plaintiff did not need an expert to comply with TENN.CODE ANN. § 29-26-115. The Court of Appeals next considered the Plaintiff’s claims against Steriltek. In the complaint, the Plaintiff asserts that Steriltek negligently failed “to provide safe and uncontaminated instrumentation,” and failed “to warn, prior to the surgical procedure, that the equipment and/or instrumentation was contaminated, unsterilized and unsafe to use.” In support of its motion for summary judgment, Steriltek filed the affidavit of Kevin Allen, a registered nurse and the site director for Steriltek’s sterilization facility. Allen’s affidavit indicated his knowledge of Steriltek’s sterilization process, outlined the steps used in sterilizing instruments, and set forth the facts surrounding Jessica’s surgery. He stated his expert opinion that the instruments used in the Plaintiff’s surgery were in fact properly sterilized and that the biological test result was a false positive. The Plaintiff did not produce expert proof to rebut Allen’s affidavit. The parties agreed that the Plaintiff’s claims against Steriltek were not medical malpractice claims subject to TENN.CODE ANN. § 29-26-115. The Court considered the issue of whether the Plaintiff was required to submit expert testimony on this issue of sterilization. From Allen’s affidavit, it was clear that the process of sterilizing surgical instruments was complex indeed, involving interactions between chemicals and biological agents and between chemicals and surgical materials, complicated machinery, and chemical-sensing synthetic materials. It was appropriate for the trial court to determine that, in order to rebut Steriltek’s motion and supporting expert testimony on this issue, the Plaintiff was required to proffer expert testimony. Therefore, summary judgment in favor of Steriltek on this issue was proper. There is a lesson to us in all of this. You need competent experts in any case involving healthcare practicioners, the biomedical community, or the pharmaceutical industry. While the expert may not be subject to the strict requirements of TENN.CODE ANN. § 29-26-115, the need for an expert nonetheless remains. Why take on claims against healthcare practicioners or the biomedical community without an expert? It is dangerous and often fatal to your claim.

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