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

Using a device without training may have cost a young girl her life

The January 6, 2009 issue of the Daily Mail (a British newspaper) relates the story of a five year old girl with hereditary spherocytosis who presented for elective splenectomy.  Multiple family members had the disease and had undergone the procedure in the past without complication.  The plan was to remove the spleen laparoscopically.  According to the article the surgical team decided to use a device that had been designed to morselize the uterus to ease removal during laparoscopic hysterectomy.  Neither the surgeon nor the surgical resident had specific training in the use of the device.  In addition the device had never been used on a child.  Somehow during the procedure the aorta was cut in two places and the girl died of hemorrhage.  Because the operation took place in Great Britain, the settlement was only about $15,000 and this was based on the lack of informed consent related to the use of the new device.  The court did not find for the plaintiff despite the fact that the spleen, the disposable parts of the device, etc. were all “lost,” that the physicians present seemed to change their account of events as time progressed, and that the family was not given access to any of the OR nurses.  The case emphasizes the risk inherent in “trying” new procedures, devices or techniques without informing the patient, obtaining appropriate training or thoroughly considering the risks.

 

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

Failure to read an x-ray results in a 2.18 million dollar settlement

Josh Atkins, M.D., calls our attention to a recent article in the Philadelphia Daily News (May 14, 2009).  After a 10 day trial a Jury awarded the money to the widow of a 51 year old man who presented to the emergency department with chest, back and leg pains.  A chest x-ray that was ordered was never read by the emergency department physician who ordered the film (he went off duty), nor was it seen by his replacement (inadequate hand off).  The radiologist read the film the next morning, but by then the patient had died. (link to original article:  ( http://www.philly.com/philly/hp/news_update/44960862.html )

 

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

Anesthesia awareness -- successful defense

This article by Lax JA and Attorri MD (Anesthesia Awarenss:  There is room for skepticism, Respiratory Therapy 2008;3:12) is particularly interesting in that it was written by two lawyers who recently, successfully defended an anesthesiologist against the claim of awareness under anesthesia.  They provide insight from the point of view of those who need to defend physicians.  It is clear from their success in the courtroom and the clarity of their article that they have a good grasp of the key issues.  Of particular importance in deceloping their defense was a careful, detailed review of just what the patient claimed to have remembered and its possible relationship to external location and time.   It is unclear to me why this timely article was published in Respiratory Therapy (http://www.nkms.com/articles/jal.article.excerpt.pdf ).  At a brief three pages it is worth reading.

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

Poor office records leads to pain medicine doctor being sanctioned by medical board

    An anesthesiologist specializing in pain medicine has been disciplined by the Texas Medical Board for “non therapeutic prescribing.”  One of his patients was admitted to an emergency room for a prescription overdose.  The Board’s citation related to failing to recognize that the patient was a drug abuser and prescribing drugs despite a lack of symptom improvement.  In a second case the physician had no records of the narcotic prescriptions he gave to a patient.  In essence the physician's records did not explain why he was prescribing, what he was prescribing or how much.  For this he will be under supervision for two years with his office records monitored by another physician.  He is also required to take 10 hours of pain management courses each year.  Source: Weatherford Democrat. September 12, 2008.

    Attemping to decipher court cases or legal adminisrative actions from newspaper accounts can be difficult.  Despite the risk of misinterpretation newspaper accounts are often the only readily available source of informaton.

 

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

Dead after knee surgery, a story of apparent multiple little failures

A 76 year old male entered a hospital for elective knee surgery.  Roughly twenty four hours after the surgery he was dead.  If the article, which appeared in the News and Observer, Raleigh, N.C. (June 8, 2008) , is at all accurate, the patient died because his doctors and nurses did not communicate with each other and no one was willing to say “stop.”  The article describes a series of “little” failures the cumulative effect of which was a fatality.  Note the following:  1) the apparent failure of those in the pre operative area to investigate what appeared to be a marked change in the patient’s medical condition, 2) an anesthesiologist who initiated treatment for angina but who did not appear to have communicated either orally or in writing about his observations or therapy (no progress note), 3) there appeared to be no one who willing to “stop” the operation for additional clincical investigation, 4) surgeons who appeared to deny any responsibility for knowing the patient’s medical condition just prior to surgery, 5) there were apparently multiple failures at many levels to document clinical findings and therapy, 6) an apparent failure to inform those responsible for the patient’s care post operatively about the suspected CHF and angina, and 7) delays in obtaining laboratory results.  Whatever time was “saved” by staying on schedule was lost many times over in the time required to be present at the multiple investigations and answer many hours of questioning.  Does the problem of communication and documentation sound familiar? (link to article: http://www.newsobserver.com/news/story/1100507.html )

 

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

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