Client Advisory. Be Aware of Anesthesia Awareness H ANCOCK, D ANIEL, J OHNSON & N AGLE, PC. What is Anesthesia Awareness?

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1 December 30, 2004 Be Aware of Anesthesia Awareness H ANCOCK, D ANIEL, J OHNSON & N AGLE, PC Client Advisory I prayed for death. So was the testimony of a plaintiff in Richmond Circuit Court during a medical malpractice trial in November, During a 90 minute operation to replace an artificial lens that had slipped after earlier cataract surgery, the plaintiff experienced the pain and awareness of the procedure as if she had no anesthesia, yet she was paralyzed and could not do anything. Her mumbled prayers and moaning were observed and verified at the trial by a surgical assistant. The ophthalmologist performing the procedure also observed the patient s discomfort three times, and he even told her to be quiet at one point. Fortunately, the anesthesia problem did not prevent the physician from performing his job, and the eye was properly repaired. Unfortunately, the repairs also came with a $500,000 price tag payable by the doctor upon order of the jury. One of the remarkable aspects of the size of this verdict is that there were no claims for medical expenses or lost wages. In other words, there was no proof of any economic loss to the plaintiff, and the surgical repair was accomplished. However, that was not enough to prevent the jury from awarding the plaintiff over $5500 for each minute of her agony. While this award might seem high, in October 2002, a jury in Illinois awarded a woman $165,000 for three minutes of pain experienced during a caesarean section. The Washington Post recently reported that an attorney in Norfolk, Virginia has received verdicts from $150,000 to $350,000 for similar cases. The message is clear: Claims for patients being aware and awake during surgery are extremely dangerous, even without economic loss to the patient, and due to a recent storm of publicity, they will likely be on the rise. What is Anesthesia Awareness? The term anesthesia awareness is a phenomenon that has been well reported in the anesthesia literature for over thirty (30) years, but has only recently garnered national attention. In 2004 alone, lengthy newspaper articles on anesthesia awareness appeared in USA Today 1 and The Washington Post 2. These newspaper articles followed publication of recent articles in several leading peer-reviewed medical journals, including Anesthesia and Analgesia 3 and the British medical journal, Lancet 4. The 1 Robert Davis, Group Targeting Anesthesia Errors, USA TODAY, Oct. 6, 2004, at A24. 2 Sandra Boodman, Wake Up Call:, WASH. POST, Nov. 23, 2004, at F1. 3 P. Sebel, et al., The Incidence of Awareness During Anesthesia: A Multicenter United States Study, 99 ANESTHESIA AND ANALGESIA 833, (2004). 4 C. Lennmarken, et al., Neuromonitoring for Awareness During Surgery, 363 LANCET 1747, (2004).

2 Page 2 Hancock, Daniel, Johnson & Nagle, PC (HDJN) specializes in providing assistance and guidance to healthcare providers in virtually all legal matters affecting the healthcare industry. Generally, these include corporate, administrative, and transactional matters; litigation; and governmental affairs. culminating publication was the release of an October 6, 2004 Sentinel Event Alert by the Joint Commission on the Accreditation of Healthcare Organizations. There is even a dedicated website set up by an alleged victim of anesthesia awareness at (over 36,000 hits to date), which urges patients and victims to speak up about this little known and potentially devastating problem and offers to provide adhesive tags which state, I am aware of Anesthesia Awareness. Be sure it doesn t happen to me! for patients to apply pre-surgery. As research into prevention of anesthesia awareness continues, there are likely to be more publications as well as anecdotal information available to the public. With this rare complication now being thrust into the public discourse, there could be a dramatic effect on both (1) the number of anesthesia awareness lawsuits filed, and (2) the amount of the awards given by juries. Although anesthesiologists are likely to be the primary targets in these cases, any physician who utilizes conscious sedation is a potential defendant. Hospitals may also find themselves targets for failure to have proper equipment that could have warned the physicians that the patient was aware or awake while anesthetized. The increased publicity and articles written in credible journals and newspapers win half the battle for a plaintiff s attorney in an anesthesia awareness case, because the information supports what is otherwise a totally subjective claim of pain and suffering. Unless there is actual observation by another person in the operating suite, the only source of the description of the pain and suffering, or whether it even occurred, is the patient. The journal articles and anecdotal evidence in newspapers support such a claim by a patient, perhaps to the extent of improperly shifting the burden of proof in the jury s mind to making the physician prove that the patient did not suffer. Such a burden is difficult, if not impossible, to overcome. What is the extent of exposure for Anesthesia Awareness claims? There is no recent comprehensive data on settlements and awards for anesthesia awareness claims, but in 1999 the Closed Claims Project at the University of Washington published data on the issue 5. The Project (which examined over 4000 closed liability claims files from the 1970s through the 1990s) broke the types of claims into two categories: (1) those for awake paralysis, inadvertent paralysis of an awake patient, and (2) claims for recall during general anesthesia. The median settlement amount for claims of awake paralysis was $9500, while the median settlement amount of claims for recall during general anesthesia was $18, The 5 K. Domino, et al., Awareness during Anesthesia: A Closed Claims Analysis, 90(4) ANESTHESIOLOGY 1053, (1999). 6 As a point of reference, the median payment for all malpractice claims in the study, 4,104 claims, was $100,000.

3 Page 3 vast majority, 84%, of the claims examined found only temporary emotional distress, with 16% suffering recurrent nightmares, 13% undergoing psychotherapy, and 10% having post-traumatic stress disorder. While the settlement figures appear low, the authors did note a tripling of the number of such claims overall from the 1970s to the 1990s, which they attributed to increased publicity. Yet in 1999 the Project did not argue that there was a high risk of exposure from these claims because attorneys may be less likely to take on malpractice litigation involving emotional injury and potentially smaller compensation for damages. With the recent trend in publicity in 2004, and the higher verdict awards, it would be naïve to assume plaintiff s lawyers would continue to avoid taking these cases. What are the causes of Anesthesia Awareness? Lawyers at HDJN have diverse backgrounds and varying specialties and represent decades of experience in providing legal advice to healthcare providers. HDJN is one of the largest of Virginia s law firms that primarily focus their practice toward the needs of the healthcare industry. In addition, the firm has attorneys licensed to practice law in the District of Columbia, Maryland, and Tennessee. The alleged causes of this phenomenon vary considerably, and there is not yet a conclusive study providing predictable risk factors. Common causes are believed to include equipment misuse or failure and smaller doses of anesthetic drugs. 7 The Closed Claims Project found that errors in labeling and vigilance were common causes for awake paralysis, while the JCAHO Alert cited the increasing use of intravenous delivery of anesthesia, and the premature lightening of anesthesia at the end of the procedure to facilitate operating room turnover. A 1992 study did report that isoflurane in concentrations greater than 0.6 minimum alveolar concentration (MAC) prevented conscious recall and unconscious learning of factual information and behavioral suggestions, 8 but no guidelines have been established. The rate of occurrence has remained fairly steady since the initial papers on this issue, with the recent JCAHO Alert reporting occurrences between 0.1 and 0.2 % of all patients undergoing general anesthesia. The 1999 Closed Claims Project reported anesthesia awareness as high as 0.4 % during cesarean section and 1.5 % in cardiac surgery. 9 Although certain procedures seem more prone to anesthesia awareness, to date no overall algorithm has been established to predict its likelihood for one patient over another. Is Anesthesia Awareness preventable? There is also no strong consensus yet on appropriate perioperative monitoring to prevent this phenomenon from occurring. The problem with traditional references to blood pressure and heart rate during a procedure is that often those indicators will not increase despite pain, because the patient is on beta blockers or strong paralytics. The Closed Claims Project found that the classic clinical signs of tachycardia and hypertension were absent in most of the cases of recall during general anesthesia. Thus, even 7 M. Ghoneim, Awareness during anesthesia, 92 ANESTHESIOLOGY 597, (2001). 8 R. Dwyer, et al.: Isoflurane anesthesia prevents unconscious learning, 75 ANESTHESIA AND ANALGESIA 107, (1992). 9 Domino, et al., supra at 1053.

4 Page 4 The corporate/health law team at HDJN services the needs of clients within numerous areas of law, including physician contracting; fraud and abuse; Medicare and Medicaid reimbursement; corporate compliance; tax-exempt status and corporate finance; managed care; antitrust; mergers, joint ventures, and other acquisitions; real estate transactions; and general corporate issues. experienced anesthesiologists conducting chart reviews could not reliably distinguish patients who had suffered anesthesia awareness from those who had not. The recent peer-review and newspaper articles referenced above all raise references to BIS (Bispectral Index) monitors, which are manufactured by Aspect Medical Systems. Aspect s website claims that BIS monitors are in 34% of the nation s hospitals, 68% of the nation s teaching hospitals, but are only used in about 10% of operations. 10 The monitor uses a scale of 0 to 100 to project the depth of sedation in a patient, with 100 being fully awake and 40 to 60 the target range for general anesthesia. These devices have not been sanctioned as standard of care in the anesthesia literature to date, but the JCAHO Alert quoted a Food and Drug Administration announcement that, [u]se of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. 11 Also, a 2004 article in Anesthesia and Analgesia reported that emerging data suggest that BIS monitors may reduce the risk of awareness anesthesia by as much as 82%, and they are thus likely to become standard equipment. 12 Despite these arguments in favor of BIS monitors, in some cases, such as the recent trial in Richmond, a BIS monitor would have made absolutely no difference. This is because the patient was not supposed to be completely under. She had received only a short-acting sedative to calm her and numb the immediate area, followed by a regional anesthetic intended to block the pain for the duration of the procedure. In such cases, the only apparent indicator of the patient being aware is either the patient s vital signs or actual physical movements. Thus whether BIS monitors have been officially sanctioned or not (a point which will be subject of expert witness contention), the vast amount of literature and discussion of the BIS monitors means they will be at issue in any anesthesia awareness lawsuit. Healthcare providers will be faced with having to argue why: (1) they did not have a BIS monitor available, (2) why they did not use a BIS monitor if they did have access to one, or (3) why they did not use the BIS monitor appropriately. There are more than enough gray areas in these issues to create fertile ground for a plaintiff s liability arguments Boodman article, supra at F5. 11 Indicative of the expectation that use of these monitors will become widespread, Aspect s stock price rose from 9.73 on December 3, 2003 to to December 3, P. Sebel, et al., The Incidence of Awareness During Anesthesia: A Multicenter United States Study, 99 ANESTHESIA AND ANALGESIA 833, (2004).

5 Page 5 The administrative health law team at HDJN provides assistance with legal issues involving credentialing, peer review, certificates of need, medical staff, licensing, administrative compliance and appeals, as well as other administrative matters affecting healthcare providers. Conclusion Regardless of whether a BIS monitor is used, there are several sound steps recommended by the JCAHO Alert for healthcare providers to take when patients report awareness during anesthesia, including taking a detailed account from the patient, apologizing to the patient, explaining what happened, offering psychological support, and notifying other personnel involved in the patient s care about the incident and the patient s recollection. Essentially these recommendations boil down to this: Take the patient s claim of anesthesia awareness seriously and be sympathetic. Also, be prepared to address questions regarding anesthesia awareness with patients prior to the procedure during informed consent, even though it may not yet be required by standard of care. Finally, be careful of what is said during a procedure, as one study reported that 73.3% of patients experiencing anesthesia awareness understood and recalled conversations. 13 Anesthesia awareness is no longer a claim that can be counted on as a hard case for a plaintiff to prove. More likely, due to the recent storm of publicity, juries are going to be more indulgent of plaintiffs who make these claims, rather than disregard them as the product of an overactive imagination. For more information on issues relating to anesthesia awareness, please contact Bruce D. Gehle at (804) or by ([email protected]). 13 D. Schwender, et al., Conscious awareness during general anaesthesia: patients perceptions, emotions, cognition and reactions, 80 BRITISH JOURNAL OF ANAESTHESIA 133, (1998). The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel, Johnson & Nagle, PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-todate and fact-specific advice. Under no circumstances will the author or Hancock, Daniel, Johnson & Nagle, PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.

6 Page 6 Page 2 Office Locations About the Author Bruce D. Gehle is an associate with the firm of Hancock, Daniel, Johnson & Nagle, PC whose practice focuses on medical malpractice litigation and risk management issues. For more information see the attorney profiles on the firm website at Central Virginia Northern Virginia Tidewater The Park 4112 Innslake Drive Glen Allen, VA (804) fax (804) The Flint Hill Centre 3050 Chain Bridge Road Suite 300 Fairfax, VA (703) fax (703) One Columbus Center 283 Constitution Drive Suite 301 Virginia Beach, VA (757) fax (757)