Dept Of Anesthesiology & Critical Care, University Of Pennsylvania School Of Medicine

Awareness - the ASA closed claim study - a detailed review

Some background information for those unfamiliar with the ASA closed claims project (this background information is taken from the closed claim website http://depts.washington.edu/asaccp/ASA/index.shtml ): Since 1985 the ASA has sponsored this project. At the time the project was initiated, professional liability insurance was expensive for anesthesiologists and in some states difficult to obtain. The intention of the Closed Claims Project was to identify causes of loss, improve patient safety, and thereby relieve the insurance problem for anesthesiologists.  The project consists of an in-depth investigation of 7328 closed insurance claims resulting from anesthetic mishaps. Data is gathered in the form of detailed case summaries collected by ASA member anesthesiologists from insurance company claim files. Claims for dental injury, a very common, well understood, and in most cases minor injury, are excluded. Claims in which the basic sequence of events and/or nature of the injury cannot be reconstructed from the information in the insurance files are also been excluded. This results in most cases being collected from mishaps resulting in lawsuits, as files in these cases contain the most extensive information. Cases are collected from throughout the United States on a continuous basis.  The database consists of standardized summaries of each case, including patient information (e.g. age, physical status), surgical procedure and positioning, anesthetic evaluation and technique, events leading to the injury or claim, type and severity of injury, outcome of litigation, and physician evaluations of potential for prevention and appropriateness of anesthesia care. The database also includes a brief narrative summary of each claim, describing the sequence of events and adding any pertinent information not contained in the standardized data collection form.

            In my opinion the closed claims project provides a unique resource of intensively studied case experiences in which there was an outcome that was not satisfactory to the patient or their family.  It does not allow the calculation of incidence as the denominator is not known.  Because of the length of time from law suit to settlement, the data in the closed claims project tends to be old.  Thus new areas of risk or trends in settlement costs are, in my opinion, difficult to determine from this data.

            The ASA closed claims analysis of awareness during anesthesia was published in 1999 and included claims for adverse outcomes that occurred between 1961 and 1995.  A total of 4183 claims were in the database.  Seventy nine claims were for awareness with a greater proportion occurring in the 1990s compared to earlier decades.  The proportion of claims in the database was similar to burns, aspiration pneumonia and myocardial infarction.  Compared to other claims awareness more often involved women, patients younger than 60 years of age, and elective surgery.  The severity of injury for awareness claims was lower than for the other claims.  Eighteen of the claims were for awake paralysis and 61 claims were for recall during general anesthesia. 

            Claims for awake paralysis were related to intravenous infusion errors or syringe swaps.  Succinylcholine drips accounted for 10 of the 18 claims (unlabelled, mislabeled, failure to check the label).  The period of risk was preinduction or during induction when a muscle relaxant was given instead of a sedative or hypnotic.

            The highest frequency of recall during general anesthesia was during the maintenance phase (49 of 61 claims).  Recollection included recollection of conversation, feeling surgery without pain, pain, paralysis, tracheal intubation, and severe panic.  Eighty four percent sustained temporary emotional distress; 10% developed posttraumatic stress disorders.  Recurrent nightmares were described in 16% of claims and psychotherapy was described in 13%.

            Factors associated with recall during general anesthesia included: nitrous – narcotic relaxant technique  without volatile anesthetic (11 of 61 claims), hypotension requiring discontinuation of the anesthetic agent (11 instances), inadequate dose of anesthetic for no obvious reason (8), difficult intubation (5), failure to adjust anesthetic dose for morbid obesity (8), vaporizer leak (5) and failure to turn on the vaporizer (3).  In 10 cases no obvious factor could be determined.  The classic cues for light anesthesia were absent in most cases.  Five factors were significantly associated with claims for recall compared to other general anesthesia claims: no volatile anesthetic agent, female gender, obstetric or gynecologic procedure, intraoperative opioid, and intraoperative muscle relaxant.  After adjusting for risk factors and application of multiple logistic analyses – female gender and anesthetic techniques using intra operative opioid and muscle relaxants without a volatile anesthetic increased the relative frequency of claims of recall.  OB/Gyn procedures were not an independent risk factor. (From Domino KB et al: Awareness during anesthesia: A closed claims analysis. Anesthesiology 1999;90:1053-1061.)

            DSS comments: The separation of “awake paralysis” from “recall” is not done in most subsequent studies.  Notice the frequency of a drug error with respect to the occurrence of awake paralysis.  Changes in practice (decreased use of succinylcholine infusions) may decrease this incidence.  However bags of non depolarizing muscle relaxants for infusion present the same potential risk unless clearly labeled and kept away from other intravenous solutions until the time of use.  Several of the instances of awake paralysis occurred because of a syringe swap or mislabeled syringe.  An argument might be made to keep syringes containing muscle relaxant separate from antibiotics, anxiolytics, narcotics and anesthesia induction drugs.  Finally using nitrous oxide without a volatile agent was associated with a large number of instances of recall.  Fortunately that practice has almost disappeared (at least at Hospital of the University of Pennsylvania).

David S. Smith, M.D., Ph.D.

What are the risks of electronic anesthesia records in medical legal defense?

James Szalados MD, JD (Anesthesiology News, August 2007) discusses “the legal implications of anesthesia record shortcomings.”  He cites two recent cases in which failure to properly review anesthesia records contributed to problems in defense.  In case one there was a 93 minute gap in vital sign recording which was attributed to interrupted data transmission to the automated anesthesia record.  In a second case a precipitous fall in end tidal carbon dioxide was not documented on the paper print out but was present when the stored data base was accessed.  Dr. Szalados raises the following questions: 1) “which of the records – paper or electronic – is the “official” medical record for the case?” 2) “What is the duty of the professional to verify his or her records?”  Dr. Szalados notes that there is the expectation that “medical records are … accurate, legible and complete; the signing physician is expected to authenticate the record and vouch for its truthfulness; and the use of an automated record does not necessarily absolve the signing physician of liability.”  Dr Szalados notes that the “determination of which document represents the “official” medical record is … a fairly settled area of law... wherever the automated data are first collected and stored is the “original” record.  Copies are never considered to have the same value as the actual document and may be contested.  Printouts are secondary documents that may not accurately reflect the electronic data…When printouts and “final” versions of electronic patient records do not concur, the defense case will be unexpectedly compromised at trial.”  A key difference between a manually generated anesthesia record and an electronic record is that the paper record of a manually generated record is the “original” record.  In contrast an electronic record may contain information in its data base not present on the paper print out that could prove significant if care becomes a point of litigation.

David S Smith M.D., Ph.D.

Awake during surgery - a sad consequence

An Associated Press article from April 10, 2007 discusses the plight of a patient who became severely depressed and committed suicide by a self inflicted gun shot wound after being aware during surgery.  According to the lawsuit filed, the anesthesiologists gave the patient muscle relaxants but failed to administer any general anesthetic until 16 minutes after the first abdominal incision.  The lawsuit claims that the 71 year old man was never told of the improper anesthesia administration and was tormented by doubts as to whether his memories were real.  The lawsuit claims that for two weeks after his surgery the victim could not sleep, could not be left alone, suffered nightmares, and thought that people were trying to bury him alive (www.boston.com).

David S. Smith, M.D., Ph.D.

Medical legal cases of interest - OB anesthesia

The ASA closed claimed analysis program recently reported on injuries associated with regional anesthesia (Lee et al: Anesthesiology 2004;101:143-52).  Davies JM (ASA Newsletter 2004;68 http://www.asahq.org/Newsletters/2004/06_04/davies06_04.html) has discussed recent trends in obstetrical anesthesia closed claims..  Davies notes that about 12% of the 310 claims in the 1990s were related to maternal death, and 6% to maternal brain damage in which the patient survived.  They emphasized that a large proportion of the obstetrical claims were for relatively minor injuries such as headache, nerve damage, emotional distress, or back pain to name a few.

Despite the conclusions that complications from neuraxial anesthesia may have relatively smaller costs associated with them, a recent search using Factiva and Lexus Nexus has revealed a number of very expensive settlements as well as cases with successful defenses. As with my last attempt at reviewing recent anesthesia related medical malpractice cases (Clinical Advisory August 2007) my sources are limited and the information provided is also limited.  My search does not in anyway provide information about the total number of settlements and my lack of legal training may make some of my interpretations suspect.  The settlement awards in the case of verdicts for the plaintiffs are most likely shared among more than one defendant and may not represent the final settlement.

Elective C – section under spinal anesthesia resulted in death to the mother with a settlement of $6.7 million.  The claim was made that there was an intravascular injection of lidocaine (Goldsmith v Lechiara, trial date January 2004)

            C-section for fetal distress under spinal anesthesia resulted in anoxic brain injury to the mother with a settlement of $6.6 million (names withheld, settlement approval date October 2005).  According to the information provided “The plaintiff was brought to the operating room where the defendant anesthesiologist injected spinal anesthesia …The anesthesiologist’s records indicated that during the procedure, the plaintiff’s upper extremities became uniformly mottled and that the oxygen saturation monitor on the plaintiff’s finger stopped functioning.  The obstetric surgeons noted that the blood in the surgical field was dark, and the anesthesiologist was questioned about the oxygen saturation of the patient.  The anesthesiologist determined that the patient was not breathing, cardiopulmonary resuscitation was commenced, and a code was called.”

            C-section under epidural anesthesia resulted in claim of post cardiac arrest short-term memory loss, emotional labiality and inability to resume her career.  Complicating the management of the patient was the fact that the patient was a dwarf and placement of the epidural was difficult.  The patient developed breathing difficulties after injection of a single dose of local anesthetic through the epidural needle.  The verdict for the defense was facilitated by the ability to demonstrate that the injection of the epidural and the subsequent resuscitation were within the standard of care.  The defense was also able to present alternative explanations for the patient’s neurologic changes (case i.d. withheld, April 2007).

            C-section under spinal anesthesia resulted in claim of mild hypoxic ischemic encephalopathy with resulting short term memory loss.  There was a verdict for the defendant anesthesiologist (Johntee v Jefferson, trial date February 2006).

            C-section under spinal anesthesia resulted in a claim of spinal nerve injury.  There was a verdict for the defendant anesthesiologist (Schwander v. Esser, trial date April 2004).

Of greater interest are two papers that allow the beginning of an estimate of incidence.  Mhyre investigated maternal deaths in Michigan between 1985-2003 (Anesthesiology 2007;106:1096-104) and noted that of 855 reported pregnancy associated deaths, 8 were found to be anesthesia related and 7 were found to be anesthesia contributing.  Of particular interest was the finding that five of the deaths were related to hypoventilation or airway obstruction during emergence, extubation or recovery.  With respect to regional anesthesia, a 32 year old became apneic and suffered cardiac arrest in the PACU after a c-section using spinal anesthesia, a 42 year old who received a spinal anesthetic for c-section and PCA for post op pain arrested 9 hours post surgery, a 50 year old developed a high spinal and cardiac arrest after an epidural test dose given for c-section, and a 42 year old experienced bradycardia and cardiac arrest after administration of a spinal anesthetic for elective c-section.  Of particular importance from the point of view of risk was cardiac arrest and failed resuscitation in a 29 year old who underwent vacuum aspiration of an undesired first trimester pregnancy under deep sedation and was found pulseless and apneic 25 minutes after arrival in the PACU; attempts at resuscitation failed.

Auroy et al (Anesthesiology 2002;97:1274-80) provides results showing that in France during a 10 month period extending from August 1, 1998 – May 31, 1999, 487 participant anesthesiologists reported their complications after administering 5,640 spinal anesthetics.  In this study there was 1 cardiac arrest, no episodes of respiratory failure, no seizures, 2 episodes of peripheral neuropathy, and no episodes of cauda equine syndrome, central neurologic events such as stroke, meningitis or deaths.

Though serious complications such as death, brain injury, cardiac arrest after regional anesthesia in the obstetrical population appears to be uncommon, severe injury can occur as indicated both by the ASA closed claimed study, the maternal death in Michiganstudy and my recent review of malpractice cases going to trial.

David S. Smith M.D., Ph.D.

Institutional consequences to wrong sided surgery

What happens after wrong sided surgery or other procedures?– The institution’s and physician’s experience described in the Providence Journal (August 4, 2007) after a craniotomy was performed on the wrong side is instructive.  The State Health Department ordered the hospital to hire a consultant and to double check surgical sites.  The surgeon was suspended from the hospital and ordered by the Health Department to stop doing surgery and to undergo an evaluation.  The hospital apparently has had other cases of wrong sided surgery.  After a previous case the resident involved said “he knew about the policy (referring to “time out”) but had never seen the form and had never seen anyone use the form.”  I thank Dr. Kofke for providing me the links to this incident.

David S. Smith

The conflict of organizational ethics and societal rule of law

Nontherapeutic quality improvement: The conflict of organizational ethics and societal rule of law

Michael A. Rie, MD; W. Andrew Kofke, MD, MBA, FCCM

Objective: Critical care ethics focuses largely on patient autonomy. Cost containment is necessary but requires rationing and limitations on a patient’s right to consume beneficial services. No laws address a process of autonomy rights limitation to consume resources in the intensive care unit. We analyzed the frictional interface between necessary cost containment as a quality improvement activity contrasted with individual autonomy in the context of the evolution of research ethics.

Data Sources and Synthesis: Scholarly books, peer-reviewed articles, congressional record, legal sources, the World Wide Web, and the National Archives and Records Administration were evaluated in the context of current cost-containment– driven nontherapeutic quality improvement activities.

Principal Findings: Three generations in the evolution of human research ethics are identified: 1) Hippocrates to Nuremberg Code, 2) Nuremberg to Belmont, and 3) Belmont to present.  Similar ethical lapses, which place the individual at risk without disclosure for the good of future patients, have arisen recurrently in the course of history and continue presently when nontherapeutic quality improvement activities are framed as a human research activity with essentially no ethical oversight. Consequently, the fiduciary obligations of professionals and their employer institutions to their mutual patients may be at odds, creating complex layers of conflicted decision making. Nonetheless, professional Hippocratic duty to “the patient” must be congruent with the organizational ethos of limited funding “stewardship” to produce meaningful patient care. Medicine’s integrity is legally protected and mandated under the state interests (parens patria doctrine) of the common law.

Conclusion: When hospitals (society and its health insurance methods) fail to ration transparently under “cost-containment ethics,” they threaten the ethical integrity of the medical profession.  (Crit Care Med 2007; 35[Suppl.]:S66–S84)

Recent medical legal cases of interest

I think that there is value in reviewing recent malpractice cases that involve anesthesiologists.  The material at the trial court level is newer than cases at the appeals level or those that form part of the ASA Closed Claims Project.  The newness may allow some insight into current approaches to care that lead to malpractice suits.   However reports from the trial court level have potential distortions.  First, my sources are not unbiased.  One source, “Factiva”, gathers material from newspapers across the country.  It is my impression that cases found during Factiva searches tend to be from smaller demographic areas in which any malpractice case is newsworthy compared, for example, to the New York Metropolitan area where many cases might not make the “cut” for publication.  I have recently acquired improved access to the Lexus – Nexus legal news search engine; however I do not know how complete their coverage is for the level of access that I have. Second, most medical malpractice cases are settled out of court and the settlements are typically confidential, thus the cases that are reported tend to be the more sensational.  Third, the verdicts and awards given by the jury may not be the final settlement.  Settlements are often reduced by the judge (particularly when they greatly exceed the insurance coverage).  Cases are often appealed, so that the final disposition is not known at the time of the jury decision. Fourth, my interpretations of the events may not be accurate.  I do not have access to the trial records.  The material I am working from is written for the lay public or for the legal profession.  Finally I have no legal training.

 

Failure to diagnose results in a judgment of $4.0 million when an anesthesiologist does not recognize that a patient has a small bowel obstruction.  The failure to recognize the presence of obstruction in a patient who recently had a cholecystectomy but who subsequently presented with abdominal pain, distention and an NG tube in place for decompression led to failure to use a rapid sequence induction with cricoid pressure while inducing anesthesia for an exploratory laparotomy.  This failure allowed aspiration of vomitus which proved fatal (Domain v Kadowaki, April 2007).  The jury clearly felt that the failure to recognize that this patient had a post operative small bowel obstruction was below the accepted level of performance.

 

Failure to get informed consent results in a judgment of $1.5 million after an interscalene block, for post operative pain control from torn rotator cuff surgery, placed against the patient’s express wishes, resulted in severe neck pain, arm weakness, numbness and a drooping left eyelid.  The defendant anesthesiologist claimed that the patient consented.  The plaintiff said that the explanation was rushed and that he had refused to have the procedure done.  Hospital records supported the plaintiff with respect to failure to obtain consent (Gorbea vs. Palazzo, July, 2005). 

 

Failure to review a medication list results in a judgment of $700,000 when a patient taking a NSAID developed a post operative spinal cord hematoma with residual weakness in both legs and no bowel or bladder control after lumbar laminectomy surgery.  The anesthesiologist’s argument that it was not a breach of the standard of care to not read the medical record prior to surgery and that the anesthesiologist had no duty to discuss the drug with the surgeon was not accepted by the jury (Barbour v. Betz, June 2004).  In this case, as in other cases I have seen, defenses based on the concept that “it was not my responsibility” to know a particular piece of information about a patient has not been well accepted.

 

Failure to do a “time out,” followed by wrong sided knee surgery results in a judgment of $ 175,000 with 5% of the negligence assigned to the anesthesiologist.  The total settlement is unknown since the surgeon and medical center entered into confidential settlements just before trial.  According to the article in Missouri Lawyers Weekly, the facility in which the surgery took place had a policy for “time out” modeled after the JCAHO policy, however, this policy was not being followed.  The article also cited a statement that “one nurse testified that she called the time out, ‘but she didn’t even know if anyone heard her call it.’”  The argument was made by the defense that the nurse anesthetist was doing her job by monitoring the patient and providing appropriate sedation (Frey v. Midwest Anesthesia, Inc, May 2006).  As in the previous case, denial of responsibility was not accepted by the jury.

 

Failure in OR communication results in a judgment of $1.75 million when information about a change in intraoperative evoked potentials was not “heard” by the surgeon and a young women undergoing scoliosis surgery woke up partially paralyzed.   The technician monitoring the evoked potentials claimed that he had informed the surgeon; the surgeon denied receiving the information.  A later change in evoked potentials was ignored because it was attributed to anesthesia (Skaggs v Tupper, February 2005).  It is unclear from the material available for review if the anesthesiologist was a defendant.  However, the issue of poor OR communication is a common operating room problem.  One also has to ask, why the anesthetic being used made interpretation of the results difficult when the effects of anesthetics on evoked potentials are well defined and anesthesia protocols are available that allow reliable collection and interpretation of this information.

 

Failure to record vital signs results in a judgment of $750,000 after cardiac arrest and anoxic brain damage to 48 year old man who had presented for elective debridement of the third finger of his left hand.  Induction of general anesthesia and placement of a laryngeal mask airway were uneventful.  Shortly after surgery began the patient became bradycardic and suffered a cardiac arrest.  For one hour there was no recording of oxygen saturation on the anesthesia record.  The anesthesia resident’s claim that, despite the lack of recorded values, the patient had been continually monitored and given the appropriate amount of oxygen apparently did not impress the court (case citation withheld from article).

 

David S. Smith M.D., Ph.D.

NG Tubes

Though commonplace, NG tubes are associated with serious complications.  Maneuvers that may decrease the probability of complications include lubricating the tip, passage of the NG tube posterior/inferior and not superior when going into the nose, palpating the tip of the NG tube as it emerges from the nasopharynx to confirm that it is not submucosal, guiding the NG tube so it is central when it enters the hypopharynx, avoiding large amounts of force when meeting resistance to passage, checking placement by auscultation over the epigastrum during air insufflation, and post placement examination of the mouth for a coiled tube.  Questioning for a history of sinus surgery or transphenoidal surgery should be part of the pre operative evaluation.  The Pennsylvania Patient Safety Authority recently published a patient safety advisory on placement of NG tubes (Confirming feeding tube placement: Old habits die hard 2006;3:1-10; http://www.psa.state.pa.us/psa/lib/psa/advisories/v3n4december2006/confirming_feeding_tube_placement_-_old_habits_die_hard.pdf).  They emphasize that all of the traditional approaches to confirming NG tube placement such as epigastric auscultation or aspirate appearance have a high error rate and that radiographic confirmation with reading by a radiologist is the gold standard.  They note that the presence of an ET tube does not prevent NG tube placement into a bronchus.  Their concern is mostly with NG tubes for gastric feeding and the instillation of tube feeds into the lungs of patients with misplaced NG tubes, but these concepts apply also to NG tubes used for gastric decompression.

David Smith, M.D., Ph.D.

Opiods for the treatment of chronic pain: is there a risk to the physician?

            Dr Ashburn writes, in the June 17, 2007 edition of The New York Times Magazine, Tina Rosenberg wrote the cover story entitled "When is a pain doctor a drug pusher? (http://www.nytimes.com/2007/06/17/magazine/17pain-t.html?ex=1185508800&en=96ed7956679244fb&ei=5070) The focus of this article includes a discussion of the upsurge in the use of potent opioids for the treatment of chronic pain.  The article points out that as opioids have become more widely used, so has the investigation and prosecution of some of the physicians who prescribe these drugs.  In addition, several states have developed or are in the process of developing guidelines that place limits on the amounts of opioids that can be prescribed.  A summary of pain management guidelines by state can be found at http://www.fsmb.org/pdf/grpol_pain_management.pdf.  These guidelines often require patients who receive high doses of opioids (as defined by the governmental authority) be seen by a pain expert.

            The article reports on the recent prosecution and conviction of Dr. McIver.  McIver was convicted in federal court of 1 count of conspiracy to distribute controlled substances, 8 counts of distribution of controlled substances, and 1 count of dispensing drugs that resulted in a death of a patient.  He is serving concurrent sentences of 20 years for 1 of these counts and 30 years for another of these counts.  His appeals of the convictions and sentencing have failed.

            Dr. McIver appears to have prescribed very high doses of opioids to some patients.  In addition, he kept very poor records.  One investigator described his records by stating “His patient records were manila envelopes stuffed with receipts.”  In addition, it appears that McIver continued to prescribe potent opioids even when he became concerned that patients were abusing or diverting the opioids he was prescribing.

            Dr. McIver's conviction points out the importance of using common sense when prescribing opioids as a part of patient care.  Model guidelines for the use of opioids for the treatment of chronic pain have been published by the Federation of State Medical Boards of the United States.  A copy of these guidelines can be found at http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf .  However, the big question is when does physician behavior stop being an issue to be addressed by the state medical board and start being a criminal offense?  Clearly, physicians who prescribe opioids need to do so in accordance with current medical practice and must be diligent with their medical records.

            This article raises several issues that anesthesiologists will be dealing with for some time.  How strong are the data supporting the assumption that opioids are beneficial for the long-term treatment of chronic pain?  How well do we understand the risks of harm associated with this practice, which may include fundamental changes in endocrine function, hyperalgesia, changes in sexual function, and addiction, as well as the commonly-described opioid-induced adverse effects?  What is the appropriate role of governmental agencies in establishing rules for medical practice?  Do pain physicians have the interest or resources to be responsible for the care of patients requiring high-dose chronic opioid therapy?  What are the risks to the physician who prescribes opioids, and what measures can reasonably be taken to avoid investigation and possible prosecution for this aspect of medical care?

     Michael Ashburn, M.D. is Director of Pain Medicine and Palliative Care in the Department of Anesthesiology and Critical Care, University of Pennsylvania