Shoulder Dystocia and the Duty of Informed Consent

This is from an article I published in Medical Malpractice  Law and Strategy Vol. 29, Number 6, March 1, 2012

Shoulder dystocia is a birth complicated by a failure to deliver the fetal shoulders through gentle downward traction on the fetal head. It poses an obstetric emergency, and is associated with brachial plexus injuries, fractures of the clavicle and humerus, and in some severe cases, hypoxic-ischemic encephalopathy and even death.

Shoulder dystocia can occur when there is impaction of either: 1) the anterior fetal shoulder behind the maternal pubis symphysis; or 2) the posterior fetal shoulder on the sacral promontory. Fetal macrosomia (a.k.a. "big baby syndrome") and maternal diabetes increase the risk of encountering shoulder dystocia during a delivery. In addition, other antepartum conditions can also forecast that a delivery is at an increased risk for shoulder dystocia, including maternal obesity, multiparity, post-term gestation, previous history of a macrosomic birth and a previous history of shoulder dystocia.

With this array of possible indicators for shoulder dystocia, when must the physician bring the possibility of this complication to the patient’s attention in order to obtain informed consent for or against induced labor or cesarean section?

ACOG Guidance Insufficient

The American Congress of Obstetricians and Gynecologists (ACOG) offers some guidance concerning the duty of the physician to obtain informed consent from a patient at risk of a delivery completed by shoulder dystocia. ACOG takes the position that "planned cesarean delivery to prevent shoulder dystocia may be considered for fetal macrosomia with estimated fetal weights exceeding 5000 grams in women without diabetes [11 lb .36 oz] and 4,500 grams [9lb 14.73 oz] in women with diabetes." Robert J. Sokol et al., ACOG Practice Bull. No. 40: Shoulder Dystocia, Compendium of Selected Publications, 682-687 (2002) (replaces Practice Pattern No. 7, Oct. 1997). Id. at 684. ACOG’s position about when it is appropriate for a physician to consider offering an expectant mother the option of a cesarean section when there is a diagnosis of fetal macrosomia seems overly rigid. First, ACOG concedes that ultrasonogaphy is not always an accurate predictor of macrosomia. Id. at 683. Second, while ACOG has suggested that a baseline level weight should be used to trigger when it is acceptable to consider a cesarean section due to a suspicion of macrosomia, the organization simultaneously recommends that when a mother has a prior history of encountering shoulder dystocia during labor and delivery, several factors need to be taken into consideration when discussing the risks and benefits of an elective cesarean section with the patient, including estimated fetal weight, gestational age, maternal glucose intolerance and the severity of the prior neonatal injury.

Issues of logical consistency aside, it would be a mistake to conclude that ACOG Practice Bulletin No. 40 sets forth the standard of care regarding when it is appropriate to discuss a planned cesarean section with an expectant mother in the face of evidence suggesting an increased risk of encountering shoulder dystocia during a delivery. A physician’s duty of informed consent is governed by state law, and different states have different legal requirements about how this obligation must be fulfilled. Moreover, common law and statutory law governing a physician’s duty of informed consent can evolve and change.

Consider State Law

State law is not uniform regarding what a physician must do to meet his or her obligation of informed consent. First, some states hold that a doctor’s duty of informed consent involves only disclosure of risks that are customarily disclosed by physicians. Laurent B. Frantz, Annotation, Modern Status of Views as to General Measure of Physician’s Duty to Inform Patient of Risks of Proposed Treatment, 88 A.L.R. 3d 1008 (1978). Arkansas is a state that follows this approach. It has a statute that requires a plaintiff alleging a breach of a duty of informed consent to prove that the information the doctor failed to provide "would customarily have been given to a patient" in the plaintiff’s circumstances "by other medical care providers with similar training and experience" and "in the locality in which the medical care provider practices or in a similar locality." A.C.A. § 16-114-206.

Other states take the position that a substantial risk must be disclosed to a patient in order for a physician to meet his duty of informed consent, unless the physician can demonstrate that there is either a local or a national standard that suggests that nondisclosure is appropriate. This second standard was used by the Colorado Court of Appeals in Stauffer v. Karabin, 492 P2d 862, 865 (Colo. App. 1971).

A third view is that a doctor’s duty of informed consent is measured by what a reasonable physician would disclose in similar circumstances. This is the approach the Supreme Court of Kansas took in Natanson v. Kline, 350 P.2d 1093, 1106 (1960).

The first three views regarding a doctor’s duty of informed consent have been characterized as the "traditional" or the "professional" standard formulation of a doctor’s duty of informed consent. D. Louisell and H. Williams, Medical Malpractice § 22.08 at 22-23 (1987). The "professional" standard "rests on the belief that a physician, and only a physician can effectively estimate both the psychological and physical consequences the risk inherent in a medical procedure might produce [in] a patient." Largey v. Rothman, 110 N.J. 204, 210 (1988).

In 1972, a new standard of disclosure for informed consent was established by the United States Court of Appeals for the District of Columbia Circuit in the case of Canterbury v. Spence, 464 F.2d 772 (D.C.Cir.), cert. den., 409 U.S. 1064 (1972). Under this fourth view of informed consent, the scope of the information a physician is required to disclose is measured by "the patient’s need for information material to his decision whether to accept or reject a course the proposed treatment." This fourth standard of informed consent is known as the "prudent patient" or "materiality of risk" standard. Under this view, for a physician to meet his duty of informed consent, he must disclose all information that is material to a patient’s decision. Canterbury, supra, at 786-787. A risk is material "when a reasonable patient, in what the physician knows or should know to be the patient’s position, would be ‘likely to attach significance to the risk or cluster of risks’ in deciding whether to forego the proposed therapy or to submit to it." Largey, supra, at 211-212 (quoting Canterbury, supra, at 787).

Conclusion

In those jurisdictions adapting the "traditional" or "professional" standard formulation of the duty of informed consent, ACOG Practice Bulletin No. 40 could certainly influence an analysis of the amount of information and options a physician is required to offer to an expectant mother when there is antepartum evidence suggesting an increased risk of shoulder dystocia. Nevertheless, jurisdictions that have adopted the more modern "prudent patient" or "materiality of risk" standard of informed consent reject the notion that a physician’s obligation to provide information is limited to what is disclosed under the customs and practices of the medical profession. Consequently, it would be prudent for obstetricians to look beyond ACOG Practice Bulletin No. 40 and examine their states’ legal requirements regarding the duty of informed consent when making office policy decisions about when to speak to patients about planned cesarean delivery in the face of antepartum evidence suggesting an increased risk of shoulder dystocia during delivery.

The Lack of Progress in Patient Safety

Originally published in Medical Malpractice Law & Strategy, January 2011, Vol. 28, No. 4.

In November 1999, the Institute of Medicine (IOM), a branch of the National Academy of Sciences, published a study declaring that a threshold improvement in the quality of health care was urgently needed because medical negligence committed in hospitals in the United States was killing more people annually than motor vehicle accidents, breast cancer and AIDS. Kohn LT, et al, To Err Is Human: Building a Safer Health System, National Academy Press pg. 26 (1999). (Hereafter 'To Err Is Human''). The impact of that study, and its 'Jarring" analogy that the annual number of deaths from hospital negligence would be equal to the downing of a jumbo jet every single day, "galvanized the public and health professionals and led to congressional hearings, media exposes, and millions of anxious patients." Robert M. Wachter, M.D. , The End of the Beginning: Patient Safety Five Years After 'To Err Is Human," W4 Health Aff (Millwood) Web Exclusives 534 (2004). (Hereafter 'The End of the Beginning'').

It is not an overstatement to say that as a result of the IOM study, in 1999 the United States came to the realization that medical mistakes were a problem of epidemic proportions. Id.

A Call for Change

To Err Is Human declared that the health care industry needed to take the following steps to make health care safer:

• Create leadership roles, research patient safety issues and develop tools and protocols to enhance knowledge of safety issues that exist;
• Create nationwide mandatory and voluntary error reporting systems so that it could identify and learn from medical errors;
• Raise safety standards through the use of oversight organizations, professional groups and health care purchasers; and
• Implement safety systems that enhanced safe practice at the health care delivery level.

Howard Larkin, 10 Years, 5 Voices, I Challenge. To Err Is Human Jump-Started a Movement to Improve Patient Safety. How Far Have We Come? Where Do We Go From Here? 83 Hosp. Health Netw. 24 (2009). (hereafter "10 Years, 5 Voices 1 Challenge'').

There was an initial flurry of activity following the IOM report in 1999. Five years after the study was released, the federal government, private foundations, health plans, hospitals and clinics were all investing more in patient safety then they had been in 1999. The End of the Beginning supra, at 543. Notwithstanding this fact, as early as 2004, there was recognition that efforts to advance patient safety were not moving forward comprehensively enough to be responsive to the problem ld. Studies of specific hospital systems revealed that while some areas of patient safety systems were improving, other were declining due to changing hospital priorities, budgets and philosophies. Daniel R. Longo, OblSb, ScD, The Long Road to Patient Safety: A Status Report on Patient Safety Systems 294 JAMA 2858, 2863 (2005). (hereafter ''The Long Road to Patient Safety'').

In To Err Is Human, the IOM called for a 50% reduction in medical errors in five years, but 10 years later it was clear that progress in the area of patient safety was still far short of that goal. Lucian Leape, et al., Transforming Healthcare, a Safety Imperative, 18 Qual. Saf. Health Care 424 (2009). Indeed, one commentator observed that "[s]hockingly modest progress has been made given the impact of the problem, how many people were made aware of it and how many efforts have been made to address it." 10 Years, 5 Voices 1 Challenge, supra, at 28. ''The current status of hospital safety systems is not close to meeting IOM recommendations." The Long Road to Patient Safety, supra, at 2858. Data from recent studies measuring safety progress suggests that "patient safety progress is slow, and cause for great concern." ld. 

Why the Loss of Momentum?

Various reasons have been given for loss of momentum in the patient safety movement over the last 10 years. First, there was no organization set up to implement and oversee the plans set forth in To Err Is Human. 10 Years, 5 Voices 1 Challenge, supra, at 28. Additionally, the health care industry has displayed a reluctance to engage in recommended error reporting systems. ld. Although we are beginning to see changes, for the most part, payment systems throughout the last 10 years generally did not reward patient safety or penalize unsafe practices. ld. at 27. Finally, "Some of this lack of progress may be attributable to the persistence of a medical ethos, institutionalized in the hierarchal structure of academic medicine and health care organizations, that discourages teamwork and transparency and undermines the establishment of clear systems of accountability for safe care." Transforming Healthcare, a Safety Imperative, supra, at 424.

A Scathing Review

On Nov. 18, 2010, the New England Journal of Medicine published a study that attempted to quantify the impact of patient safety measures on in-patient hospital admissions. Christopher P. Landrigan, M.D. et al., Temporal Trends in Rates of Patient Harm Resuhing from Medical Care, 363 New Eng. 1. Med. 2124 (2010). (Hereafter Trends in Rates of Patient Harm). The New York Times identified Trends in Rates of Patient Harm as "one of the most rigorous efforts to collect data about patient safety" since the publication of To Err Is Human. Denise Grady, Study Finds No Progress in Safety at Hospitals, N.Y. Times, Nov. 24, 2010 at A1

Trends in Rates of Patient Harm examined hospital admissions in a stratified random selection of hospitals in North Carolina between 2002 and 2007. Trends in Rates of Patient Harm, supra, 2124-2125. The study was restricted to adult patients. The authors specifically chose to evaluate the impact of patient safety efforts in North Carolina because that state showed a high level of engagement in efforts to improve patient safety. In spite of this, the study revealed that ''harm resulting from medical care was common, with little evidence that the rate of harm had decreased substantially over a 6-year period ending in December 2007." ld. at 2130. The review revealed that 25.1% of the patients receiving medical care in the hospitals surveyed suffered from medically induced harm. Id. at 2124-2125. Sixty-three percent of these were entirely preventable. ld. at 21 

Proposed Law Changes May Further Patient Pain

On Dec. 1,2010, The National Commission on Fiscal Responsibility (NCFR) published a report with suggestions to be pursued by Congress and the Senate to deal with the federal deficit. NCFR, The Moment of Truth, Dec. 1,2010,http://www.fiscalcommission.govsites/fiscalcommission.gov. Several recommendations of the NCFR seek to restrict the rights of redress of patients harmed by medical malpractice, in the name of reducing the federal deficit. There appears to be bipartisan support for creating "safehaven"rules for health care providers who follow best practices of care, for creating a more restrictive federal statute of limitations for all medical malpractice cases, and creating specialized "health courts" to replace the jury system Id. at 29. Some members of the NCFR recommended that the legislature consider the imposition of a federal statutory cap on damages. Id.

More of the Same?

Ten years ago, To Err Is Human announced that the health care industry was "a decade or more behind other high-risk industries in its attention to ensuring basic safety." To Err Is Human, supra, at 5. The report was so shocking in part because "silence surrounds" the issue of medical malpractice. Id. The goal of To Err Is Human was noble: to break the cycle of inaction in the health care industry. Id. at 3. Action was urged 10 years ago because doctors (not lawyers) finally declared that the status quo was not acceptable and could no longer be tolerated. 

It is difficult to imagine the last 10 years' history of the patient safety movement occurring in any other industry. If 10 years ago jumbo jets were falling from the sky every day and we learned from a study (conducted by the airline industry itself) that the resulting individual tragedies were avoidable if air carriers followed safe practices, citizens would demand change and there would be bipartisan support for government intervention to stop preventable deaths. The idea that thousands of deaths already occurred because of air carriers' failure to follow safety standards would be considered utterly scandalous. You certainly would not expect people to stand idly by while the planes continued to full from the sky every day for ten more years. If the planes did keep falling, nobody would dream of suggesting that we should reduce airline accountability to the victims who were dying because of preventable errors.