The New England Journal of Medicine has published an article by Michael Nurok, M.D., Ph.D., Charles A. Czeisler, Ph.D., M.D., and Lisa Soleymani Lehmann, M.D., Ph.D., N Engl J Med 2010; 363:2577-2579 December 30, 2010 discussing the ethical and legal issues of doctors who perform elective surgeries while sleep deprived.
As the article references, we all know that a lack of sleep can significantly interfere with our ability to concentrate and to perform our work. Sleep deprivation adversely affects clinical performance and impairs psychomotor performance as severely as alcohol intoxication. See Pellegrini, Carlos A., Britt, L.D., Hoyt, David B., (2010) Sleep Deprivation and Elective Surgery. New England Journal of Medicine 363:27, 2672-2673. Chronic sleep deprivation degrades one’s ability to recognize the impairments induced by sleep loss. Sleep-deprived clinicians are therefore not likely to assess accurately the risks posed when they perform procedures in such a state, and they should not be permitted to decide whether or not to proceed with elective surgery without obtaining the patient’s informed consent.
What happens when a doctor is sleep deprived and is scheduled to perform an elective surgery. The Accreditation Council for Graduate Medical Education has revised its regulations regarding residents’ work hours to restrict trainees who are in their first postgraduate year to a maximum of 16 hours of continuous work followed by a minimum of 8 hours off duty.2 No such regulations exist for fully trained physicians.
There are a number of different ethical and legal questions that arise when the doctor is sleep deprived and is scheduled to perform an elective procedure.
Does the surgeon have an obligation to disclose to the patient that he or she has not slept during the past 24 hours?
Does a sleep deprived doctor need to obtain a new informed consent from a patient?
Should the surgeon give the patient the option of postponing the operation or requesting a different surgeon?
What is the obligation of the hospital when a sleep-deprived doctor is scheduled to perform an elective procedure?
Fatigue from sleep deficiency may be due to the loss of one night’s sleep, chronic insufficient sleep, repeated interruptions of sleep, or misalignment of the circadian phase – which may be attributable to long work shifts, long workweeks, a sleep disorder, or personal circumstances. Researchers have documented the adverse effects of sleep deprivation and sleep disorders on individual performance.
In surgery, there is an 83% increase in the risk of complications (e.g., massive hemorrhage, organ injury, or wound failure) in patients who undergo elective daytime surgical procedures performed by attending surgeons who had less than a 6-hour opportunity for sleep between procedures during a previous on-call night.
Not surprisingly, the article cites surveys which indicate that most patients would be concerned about their safety if they knew that their doctor had been awake for 24 hours and would want to be informed of sleep deprivation; Most patients, 80% of patients, say they would request a different provider in such circumstances.
Given the data on sleep deprivation, the associated risk of surgical complications, and patient preferences, the authors believe that hospitals should prohibit the performance of elective surgical procedures when an attending surgeon or anesthesiologist is acutely sleep-deprived – and should ensure priority rescheduling of the canceled surgery. They recommend institutions implement policies to minimize the likelihood of sleep deprivation before a clinician performs elective surgery and to facilitate priority rescheduling of elective procedures when a clinician is sleep-deprived. In addition, patients should be empowered to inquire about the amount of sleep their clinicians have had the night before such procedures.
The Sleep Research Society (SRS) has endorsed model legislation that would require physicians who have been awake for 22 of the previous 24 hours to “inform their patients of the extent and potential safety impact of their sleep deprivation and to obtain consent from such patients prior to providing clinical care or performing any medical or surgical procedures.” The American Academy of Sleep Medicine and the SRS have also endorsed model drowsy-driving legislation stipulating that the functioning of a person who has been awake for more than 22 of the previous 24 hours is impaired by sleep deprivation (www.sleepresearchsociety.org/GovernmentAffairs.aspx).
In keeping with the ethical and legal standards of informed consent, patients awaiting a scheduled elective surgery should be explicitly informed about possible impairments induced by sleep deprivation and the increased risk of complications. They should then be given the choice of proceeding with the surgery, rescheduling it, or proceeding with a different physician. If patients decide to proceed, they should explicitly consent to do so – in writing, on the day of the procedure, in front of a witness, and ideally on a standardized form designed for this purpose.
SHOULD SLEEP-DEPRIVED DOCTORS BE ALLOWED TO OPERATE? ethical and legal doctors elective surgeries while sleep deprived lack of sleep interfere ability to concentrate work. Sleep deprivation adversely affects clinical performance and impairs psychomotor performance as severely as alcohol intoxication Chronic sleep deprivation impairment Accreditation Council for Graduate Medical Education Does the surgeon have an obligation to disclose to the patient that he or she has not slept during the past 24 hours? Does a sleep deprived doctor need to obtain a new informed consent from a patient? Should the surgeon give the patient the option of postponing the operation or requesting a different surgeon? What is the obligation of the hospital when a sleep-deprived doctor is scheduled to perform an elective procedure? Fatigue sleep deficiency 83% increase in the risk of complications from sleep deprived doctors Sleep Research Society (SRS) attorney lawyer personal injury medical malpractice injured hurt harmed lawsuit claim
While the Texas Supreme Court considers two very similar cases (Walters v. Cleveland Regional Medical Center, and Methodist Healthcare System v. Rankin) involving medical malpractice of doctors, nurses and hospitals for leaving sponges inside a patient, the Texas Attorney General Greg Abbott has filed a brief with the Texas Supreme Court urging the Court to dismiss the lawsuit filed by Emmalene Rankin. Emmalene Rankin discovered a surgical sponge lodged against her colon 10 years and eight months after her hysterectomy.
The two Supreme Court cases belong to a special class of medical malpractice claims known as “sponge cases” – cases where foreign objects are improperly left inside the patient following a surgical procedure. Unlike many lawsuits about mis-diagnoses or mistreatment, in sponge cases there is no question that a medical mistake was made and usually no question about who was responsible. As a result, the doctors and hospitals involved in these cases are very likely to be held responsible if they cannot get the Court to dismiss the claims for technical reasons.
Emmalene Rankin’s Case:
In 1995, Emmalene Rankin had a hysterectomy at Southwest Texas Methodist Hospital in San Antonio. Ten years and eight months later, after pain sent her to a succession of doctors, a surgeon finally discovered the cause of her medical problems, an old surgical sponge that had been left inside her from her 1995 surgery was lodged in her abdomen.
Rankin filed a lawsuit against the hospital and two doctors, but the judge dismissed the lawsuit for violating the statute of repose, enacted in 2003 by the Texas legislature as part of “tort reform” legislation designed to lower medical and insurance costs by reducing the number of malpractice lawsuits and limiting the size of malpractice awards. According to the statute of repose enacted in 2003, “all claims must be brought within 10 years or they are time barred.” The Court of Appeals re-instated the lawsuit last year ruling that the statute of repose violated the Texas Constitution’s “Open Courts” provision. The Court of Appeals ruled that while “the Legislature is certainly entitled to set a period of time within which claims must be brought, but it may not deny a plaintiff a reasonable opportunity to discover the alleged wrong and bring suit.”
Attorneys for the hospital and doctors being sued claim that the legislature intended to limit the time period that these claims can be brought. However, Rankin’s lawyers point out that the intent of the legislature is irrelevant if the law violates the Constitution. The Texas Constitution trumps legislative power, patients must be given a chance to discover their injury before losing their constitutional right to access the court system, he argued.
This issue points out the issue on our legal system that the Constitution is the supreme law of the land, and the legislature does not have the power to enact laws that violate the Constitution. On other tort reform issues, the insurance companies and doctors’ lobbies realized that the tort reform issues presented a constitutional problem so they brought the issue to the voters of the State of Texas by asking the voters to approve a constitutional amendment which enabled the legislature to enact the tort reform measures that limited damage awards.
Tangie Walters’ Case:
Tangie Walters case is also a sponge case. In 1995, after giving birth to her child, Tangie Walters had a tubal ligation to prevent future pregnancies. Following the surgery, Mrs. Walters report abdominal pain that nurses at Cleveland Regional Medical Center dismissed as gas pains. In addition, Dr. Keith Spooner indicated that abdominal cramps were caused by uterine contractions from breast feeding, prompting Walters to bottle-feed her child. Over the next 9½ years, Walters visited several doctors to treat chronic abdominal pain and other ailments – bladder and lymph node infections, vaginal bleeding, pneumonia-like symptoms and fatigue. In 2005, a surgeon finally discovered the cause of her problems. The doctor found a sponge lodged against her small intestine. When these sponges and gauzes are left inside a patient after surgery, they can damage organs and produce inflammations, abscesses or a fibrous buildup that can be mistaken for a tumor.
Walters sued Spooner, the hospital and a nurse, but a Houston-area trial court dismissed the lawsuit for violating the statute of limitations. Walters appealed, arguing that the two-year time limit violated the Texas Constitution’s open courts provision – which guarantees access to the legal system for those with a valid claim – because she did not have a legitimate chance to discover the cause of her chronic illnesses. The Court of Appeals dismissed the lawsuit and blamed Mrs. Walters for failing to diligently investigate the cause of her pain. Although the pain presented a reasonable opportunity to discover the sponge before the legal deadline, the court said, Walters waited two years and three months to begin seeing a succession of doctors.
“Pain itself can be an indicator of injury,” the court ruled.
Each year, scores of lawsuits against medical professionals are dismissed because the Court finds that the patient did not bring the lawsuit in a timely manner. Often, such as in Mrs. Walters’ case, the issue is whether the patient should have discovered the problem sooner and brought the lawsuit in a more timely manner. These issues are extremely difficult and complex, and greatly favor the medical professionals as patients do not have the ability and resources to diagnose themselves, and even the medical professionals they see for their problems often cannot determine the source of the problem for an extended period of time. Then, even when the problem is located, the procedural legal hurdles that have been put in place that are designed to discourage lawsuits from being filed against medical professionals take a substantial amount of time to complete before the attorney can even decide if a lawsuit is appropriate.
Richard Sheehy a lawyer for one of the hospitals involved in these two cases argues that patients should not be given an opportunity to discover the wrong-doing of medical professionals and to hold them accountable for their actions by urging the Supreme Court to create an absolute two-year limit on all medical malpractice lawsuits, whether or not the injury could be discovered before the time limit passed. “I certainly believe this court may decide that … the Legislature may impose a strict two-year statute of limitations, and ‘we’re sorry that it may cause problems for a limited number of people, but we believe the legislative intent and public policy (benefits) of the two-year statute outweighs the problems that it might cause.”
In the end, these should be cases about providing the Constitutional guarantees to citizens of our state, but the political forces including the efforts of the Texas Attorney General are obviously at play in these matters as there is no explanation as to what the State’s interest is to justify why the Texas Attorney General would try to get involved to lobby for doctors and hospitals in a private lawsuit. The concern about political influence is very real when examining the track record of the Texas Supreme Court over the past few years in protecting patient’s and consumer’s rights against big business, corporate defendants, and medical professionals.
The Dallas Morning News reported that the Texas Medical Board has not followed up on its promise to get tough and to discipline doctors who engage in misconduct. According to the article, the Texas Medical Board is more focused on protecting doctors than the public. The article claims that 85 percent of the Board’s investigations led to no sanctions at all, and the number of private deal-cutting meetings – the typical generator of lower-level penalties – more than quadrupled from seven years ago. The News also reported that of the 131 doctors were disciplined at the meeting. Only two had their licenses revoked, and then only because they quit contesting the cases against them. A handful of others were suspended or surrendered their licenses rather than fight. “We’re not really in the business of jerking licenses,” said Dr. Lee Anderson, a Fort Worth ophthalmologist. “Our primary purpose in the disciplinary process is remediation.”
The importance of a Texas Medical Board that takes its business of disciplining doctors who engage in misconduct is critical. Texas is “a favorable location to practice medicine” because of a relatively strong economy and because the law in Texas imposes a cap on malpractice awards against medical providers which has discouraged patients from bring valid claims against medical providers who injure their patients through their negligence or gross negligence. Because of the limitations on damage awards in malpractice cases patients who previously filed malpractice suits are no longer able to find lawyers who are willing to file a lawsuit on a medical malpractice case, and now their only chance of holding the doctor accountable and protecting future patients from similar harm is by filing a complaint with the Texas Medical Board. According to the article, such complaints are up 35% compared to the time period prior to the imposition of the caps on damage awards.
In addition, the article pointed out that the process itself which is largely controlled by doctors and which is confidential calls into question its motives. By law, 12 of its 19 members are doctors. In addition, the process lacks transparency that the public needs from the Board to engender trust in its deciesions. Doctors have managed to enact laws that make the process secret. As a result, the public has no way of determining why the Board did not impose more significant disciplinary measures. Virtually all complaint and investigation records are confidential. Penalties generally are worked out privately and even Agreed orders do not reference patient names which makes the incidents more difficult to investigate by the general public. In addition, even when discipline is taken against a doctor, the patient involved in not notified of the discipline unless the patient filed a complaint.
The article cited several specific instances where the Board either imposed no penalty or what was presented as a slap on the hand despite the need to protect the public. The examples included:
•1) In August, the board announced decisions on four sex-related cases. Two involved doctors whom judges had already sentenced for crimes against children. Two involved psychiatrists found to have had affairs with adult patients – potentially sexual assault under Texas law, but they’ve not been charged. The child abusers were allowed to go on practicing medicine, though not with kids. The other two are working without restrictions.
•2) In August the Board also considered complaints against:
•a. Two doctors convicted of federal crimes. One of the federal convicts, was required to complete 22 hours of continuing medical education and must pass a test on legal issues;
•b. A neurosurgeon, Dr. Matthew J. Wills, who four times operated on the wrong body part four times whose punishment was requiring the neurosurgeon to complete 10 hours of continuing medical education. Dr. Wills now works as a neurosurgeon in Topeka, Kan., and according to the article, his boss called the sanction “over the top” and “a little bizarre.”
•c. A cardiologist found to have performed dozens of invasive procedures with little or no cause; and
•d. Seven physicians linked to a death including an ER doctor who was too drunk to intubate a patient – a patient who then died. That doctor must complete substance abuse therapy and submit to urine tests.
•e. The Board said it was uncommon for a sex offender to keep his medical license, in the case of Dr. Jeffrey Klem, a cardiologist who is on criminal probation after twice pleading guilty to injuring a child, in 2007 in Beaumont and in 2009 in Houston. Board records say the Beaumont plea was a response to “three allegations of unwanted sexual contact with a minor.” The board barred Klem from treating anyone younger than 21 for the next 15 years and required that he have a chaperone when treating adults. Dr. Klem must also consult with a psychiatrists, take a “professional boundaries” course and pay a $5,000 fine.
What does it take for the board to revoke a license? Consider the case of William Littlejohn, one of the two doctors who reached the end of the line in August. Dr Littlejohn ran a pain management and detoxification practice in Fort Worth but had been suspended since 2006, when the board deemed him “a continuing threat to the public health and welfare as a result of a mental condition.” Board records say Littlejohn provided a mentally ill woman with large amounts of painkillers and a gun. She nearly died of overdoses and invested more than $600,000 in an urgent care clinic the doctor was running, the records say. Littlejohn acknowledged providing the gun, saying that the woman needed it to protect herself against violent relatives. Only later, he said, did he realize she was bipolar.
As of the end of the fiscal year 2009, there are:
•· Approximately 48,000 practicing statewide
•· 820 doctors are on medical probation
•· 3,129 newly licensed doctors in 2009
•· 6,968 complaints received by Texas Medical Board in 2009
•· The board has initiated 2,873 investigations
•· 411 doctors disciplined
•· Only 10 licenses were revoked
•· 21 licenses surrendered in lieu of disciplinary proceedings
You can check to see if you doctor has a disciplinary history by viewing the Texas Medical Board’s Web site, http://www.tmb.state.tx.us/. Click “Check Your Doctor” in the blue bar on the left, then accept the usage terms and use the search form.
We encourage you to read the full article from the Dallas Morning News posted on October 11, 2009 as “Physician misconduct often tolerated by state medical board, analysis finds.”