Your reputation as an Ob-Gyn is your most valuable asset. The Ob-Gyn Risk Alliance is committed to helping you protect your important professional identity.
Increasing your understanding of Ob-Gyn claim trends helps you reduce uncertainty and increase the control you experience. The following articles, written by members of our defense panel who specialize in defending Ob-Gyn professional liability claims, provide insight into current and emerging trends.
Transvaginal Mesh Reclassification
In early January of 2016 the FDA reclassified mesh used for transvaginal repair of pelvic organ prolapse (POP) from a class II to a class III medical device. The reclassification means this use of mesh is now in the high-risk category.
In 2011 the FDA identified potential serious complications associated with transvaginal placement of surgical mesh for POP repair. It conducted an analysis of published scientific literature and reviewed several thousand reports of complications related to transvaginal mesh; it also considered and discussed approximately 200 public comments. Due to this reevaluation, the FDA determined that reclassifying mesh used for transvaginal repair of POP was appropriate.
The FDA also is mandating certain requirements on mesh manufacturers, including submission of a “premarket approval application that supports the safety and effectiveness of surgical mesh.”1 This requirement is only applicable for mesh intended to be used for transvaginal repair of pelvic organ prolapse. If a manufacturer already has its product on the market, it has 30 months to comply with this new FDA requirement.
1Schneider ME. FDA reclassifies transvaginal mesh for pelvic organ prolapse. Ob Gyn News Digital Network. January 4, 2016. Available at: http://www.obgynnews.com/specialty-focus/gynecology/single-article-page/fda-reclassifies-transvaginal-mesh-for-pelvic-organ-prolapse-as-high-risk/dbab8ecf775cd19b6ccb1dafa87bfc19.html.
LAPAROSCOPIC UTERINE POWER MORCELLATION IN HYSTERECTOMYAND MYOMECTOMY
The U.S. Food and Drug Administration (FDA) issued a news release on April 17, 2014, stating the agency, “…discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids…” due to secondary risks of spreading cancerous tissue beyond the uterus.i
Additionally, the FDA recommends all available treatment options be considered for women with symptomatic uterine fibroids. If it is determined that laparoscopic power morcellation is the best option, the FDA recommends the physician provide additional information to the patient: that fibroids may contain unexpected cancerous tissue which may be spread. The FDA further notes that some clinicians and medical institutions recommend the use of a specimen bag during morcellation.
Medical specialty organizations responded to this news release by reviewing scientific evidence and best practices related to the FDA’s concerns and recommendations.
The American College of Obstetricians and Gynecologists (ACOG) issued a Special Report in May 2014ii. This report summarizes the benefits and risks of power morcellation in gynecologic surgeries. The findings indicate gynecologic power morcellation continues to be an option for some patients. Preoperative evaluation and diagnosis are important when considering use of power morcellation. Physicians considering power morcellation as an option during gynecologic surgery would do well to counsel patients and discuss the risks, benefits, and alternatives.
The Special Report also recommends physicians specifically counsel patients of the potential risk of unexpected cancer. This counseling would include that the use of the power morcellator may increase the risk of the cancer spreading to other areas of the body. More specifically, the Special Report states that in the case of strongly suspected or known uterine cancer, the power morcellator should not be used.
Addressing the Special Report, Hal C. Lawrence, III, M.D., Executive Vice President and CEO of ACOG, said, “…It’s critical that we not severely restrict treatment options for women who would benefit from minimally invasive gynecologic surgery while minimizing the risk for the small number of women who may have an occult or hidden cancer.”
The American Association of Gynecologic Laparoscopists (AAGL) also issued a report in May 2014, Morcellation During Uterine Tissue Extractioniii. Preoperative evaluation, intraoperative diagnosis, and postoperative pathology are addressed. Key points include:
- Clinicians are encouraged to obtain a detailed history. Such a history would include age, menopausal status, abnormal bleeding, estrogen exposure, history of tamoxifen use, and pelvic irradiation to determine the choice of surgical approach.
- Endometrial sampling and imaging can be useful preoperatively to diagnose unrecognized uterine pathology and determine whether morcellation is appropriate.
- Increased caution should be used in postmenopausal women secondary to the higher incidence of uterine cancer or sarcoma. Uterine tissue morcellation should only be performed when there is no suspicion of malignancy.
- Although specimen retrieval pouches for containment of uterine tissue are available, further investigation for safety and improved outcomes is necessary.
- Physicians should discuss with patients the risks, benefits, and alternatives of surgery utilizing morcellation to facilitate informed consent. These include:
- the risk of dissemination of malignant tissue which may worsen prognosis;
- dissemination of benign tissue, which may result in reoperation or additional treatment; and
- that pathologic evaluation may be more difficult, and that injury to adjacent organs is possible.
ProAssurance has received a number of questions from our insureds about the FDA advisory. As a liability insurance company, it is not our practice to give clinical advice. We do, however, want to be sure medical facilities and physicians are aware of potential issues. As with any procedure, it is important to properly document the medical record. That documentation will reflect the discussion of indications for the procedure and the medical judgment supporting the recommendation. It’s also important to thoroughly document that the risks, benefits, and alternatives to the procedure were reviewed, and the patient was advised of the FDA advisory. ProAssurance’s Risk Resource advisors have developed a sample consent form to assist insureds in addressing this unique risk.
The information in this summary is current as of May 2014. This is an evolving topic; please check back for updates at ObGynRiskAlliance.com or consult with a ProAssurance Risk Resource advisor (call 844.223.9648 or email RiskAdvisor@ProAssurance.com).
i http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm393809.htm [last accessed 06192014]
ii http://www.acog.org/Resources-And-Publications/Task-Force-and-Work-Group-Reports/Power-Morcellation-and-Occult-Malignancy-in-Gynecologic-Surgery [last accessed 07082014]
iii http://www.aagl.org/wp-content/uploads/2014/05/Tissue_Extraction_TFR.pdf [last accessed 07082014]
Emerging Birth Trauma Liabilities: Using Magnesium Sulfate to Prevent Cerebral Palsy
New theories of liability arise when formerly experimental or untested treatments are scientifically vetted and incorporated into standard practice. Physicians would do well to keep pace with new developments as they transform into proven therapies.
One current theory is the administration of magnesium sulfate before preterm birth to reduce the risk of cerebral palsy (CP). While this theory has been tested, it is not currently accepted as a proven therapy or “standard of care.” The “obstetrical standard of care” is what a reasonable obstetrician of ordinary judgment, learning, or skill would do under the same or similar circumstances in a given case.
Scientific data have shown an apparent benefit (reduction of moderate or severe CP) for fetuses exposed to magnesium sulfate, but important questions remain unanswered. Three randomized controlled trials conducted in the past decade evaluated the fetal neuroprotective benefit of antenatal exposure to magnesium sulfate.1,2,3
Meta-analysis of pooled results from the three trials revealed magnesium sulfate exposure did not significantly affect the primary outcome (death or moderate or severe CP at or beyond two years of corrected age). However, a secondary outcome (moderate or severe CP) occurred less frequently in the group exposed to magnesium sulfate.4 There is no consensus regarding inclusion criteria, optimal dosages, duration of exposure, gestational age for administration, or treatment regimen. This uncertainty prevents the creation of a standard of care for the use of magnesium sulfate for CP prevention. Until additional studies can identify a safe, therapeutic standard for magnesium sulfate use, arguably no standard of care exists.
Prevention of CP has been, and will continue to be, an important goal. However, the means to achieving that goal remain unclear. ACOG’s official opinion on the subject is found in Committee Opinion No. 455: “Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection.” This opinion was first released in March 2010 and reaffirmed in 2013.
It is noteworthy that ACOG’s official opinion took the form of a committee opinion rather than clinical management guidelines contained in a practice bulletin. The implication is that clinicians have not yet derived clear recommendations regarding the optimal use of magnesium sulfate. The committee opinion does, however, acknowledge the conclusions of the above-noted trials, stating: “The available evidence suggests that magnesium sulfate given before anticipated early preterm birth reduces the risk of cerebral palsy in surviving infants.”
The committee opinion further states, “Physicians electing to use magnesium sulfate for fetal neuroprotection should develop specific guidelines regarding inclusion criteria, treatment regimens, concurrent tocolysis, and monitoring in accordance with one of the larger trials.” Physicians are well advised to keep abreast of the development and dissemination of such guidelines; they may create a new standard of care in the future.
1Crowther, CA, et al. Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial. JAMA 2003; 290:2669-76.
2Marret, S, et al. Magnesium sulfate given before very preterm birth to protect infant brain: the randomized controlled PREMAG trial. BJOG 2007; 114:310-8.
3Rouse, DJ, et al. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N. Engl. J. Med. 2008; 359:895-905.
4Doyle, LW, et al. Magnesium sulfate for women at risk of preterm birth for neuroprotection of the fetus. Cochrane Database of Systematic Reviews 2009, Issue 1.
Donald Lenderman is a Principal at Kitch, Drutchas, Wagner, Valitutti & Sherbrook, where he is a member of the Birth Trauma Team and National Coordinating Counsel Team. For more than 40 years, The Kitch Firm, with nearly 1 attorneys and six offices in the Great Lakes region, has been committed to meeting the legal needs of healthcare providers nationwide.Copyright © 2014Kitch, Drutchas, Wagner, Valitutti & Sherbrook;
Posted here with permission.
Documentation Assists Defense of Shoulder Dystocia Cases
Claims involving shoulder dystocia are one of the two most common types of claims brought against Ob-Gyns. When a child suffers a permanent brachial plexus injury, the Ob-Gyn is exposed to a potential malpractice claim. These cases are very attractive to plaintiff attorneys because they involve a very young child who has an obvious and permanent injury. The plaintiff attorney will likely secure an expert witness to testify that shoulder dystocia should never have occurred, arguing a C-section should have been performed. The expert may also testify the Ob-Gyn used excessive force or traction during delivery.
Myriad literature has been published on this topic during the past 20 years. The vast majority agree “shoulder dystocia is most often unpredictable and unpreventable.” A recent survey reflects there is still no clear consensus on how to prevent shoulder dystocia or whether management decisions may prevent injury.1
Some experts claim shoulder dystocia is predictable and preventable—asserting injuries are avoidable. However, obstetrical studies have repeatedly shown this is not an accurate claim. Due to the unpredictability of shoulder dystocia, there is nothing you can do to prevent it from occurring. We can, however, provide suggestions that may reduce the likelihood of a malpractice claim when this complication does occur.
Plaintiff attorneys often cross-examine defendant Ob-Gyns on issues involving the patient’s obesity, weight gain, diabetes, and slow progress of labor, arguing shoulder dystocia could have been predicted and prevented by C-section. ACOG states, “Prophylactic Cesarean delivery may be considered for suspected fetal macrosomia with estimated fetal weights greater than 5000 grams in women without diabetes and greater than 4500 grams in women with diabetes.2
Your prenatal record does well to reflect you are aware of the patient’s obstetrical history, documenting discussions of risk factors (e.g., estimated fetal weight, diabetes, any history of shoulder dystocia, or any other recognized risk factors). When you document discussions, reflect your discussion of items such as: risks of vaginal delivery, confirmation that the patient understood these risks, and the patient’s decision to have a vaginal delivery.
In litigating a brachial plexus injury, plaintiff’s experts likely will claim excessive traction must have been used during the delivery. Obstetrical literature clearly establishes this is an inaccurate statement. Therefore, with every such delivery, it is critical to document exactly what occurred and what was done. Literature over the past two decades consistently states acceptable emergency procedures include: the McRoberts maneuver, suprapubic pressure, the Woods or Corkscrew maneuver, or delivery of the posterior arm.
Keep in mind plaintiff’s experts will be attempting to describe a delivery they did not witness that occurred several years ago. A detailed, informative delivery note will aid your defense team in refuting plaintiff experts’ testimony. A strong delivery note, when shoulder dystocia is involved, includes the following:
- a list of healthcare providers present during the
delivery (plaintiff experts may claim there weren’t
sufficient personnel present);
- when shoulder dystocia was diagnosed;
- a description of obstetric maneuver(s), in order, that
were used to relieve the shoulder dystocia;
- the length of time it took to perform each maneuver;
- a notation of which arm was anterior and which arm
was posterior; and
- documentation of any pulling or use of traction.
Plaintiff attorneys are focusing more and more on birth trauma cases, especially cases involving shoulder dystocia; it is important you are proactive and do whatever possible to minimize risk and ensure patient safety. It is also important you thoroughly document—during prenatal care—that you are aware of potential complications. If shoulder dystocia occurs during delivery, document the truth—including detail such as you refrained from panicking, responded appropriately, and performed the appropriate maneuver(s).
Remember, you are the expert who was actually present at the delivery. You used the maneuvers and traction you deemed necessary. It is imperative you provide accurate documentation reflecting exactly what happened during delivery.
1Gherman, RB, et al. A survey of Central Association members about the definition, management and complications of shoulder dystocia. Obstetrics Gynecology 2012; 119: 830-837
2Shoulder dystocia. ACOG Practice Bulletin No. 40. ACOG. November 2002
Thomas R. Shimmel is a Principal at Kitch, Drutchas, Wagner, Valitutti & Sherbrook, where he is a member of the Birth Trauma Team and National Coordinating Counsel Team. For more than 40 years, The Kitch Firm, with nearly 100 attorneys and six offices in the Great Lakes region, has been committed to meeting the legal needs of healthcare providers nationwide.Copyright © 2013Kitch, Drutchas, Wagner, Valitutti & Sherbrook;
Posted here with permission.
ADHD & Perinatal Hypoxic Ischemic Events—The New Plaintiffs’ Frontier?
In 2008 four to twelve percent of children in the United States between five and 17 years of age were diagnosed with ADHD. The national annual cost of ADHD-related illnesses in children under 18 was estimated to be between $38 and $52.4 billion. This staggering figure doesn’t include the cost of care for other mental and physical conditions commonly linked to ADHD. Children diagnosed with ADHD often require intensive medical care along with specialized social and educational services.1
The Journal of Pediatrics reports that the prevalence and chronic nature of ADHD—combined with rising healthcare costs—makes ADHD-related treatment “a public health priority.” In December 2012 a retrospective study investigated the association between ischemic hypoxic conditions (IHCs) and ADHD, indicating “the role of IHCs in the development is unexplored.” The authors hypothesized that if independent risk factors for ADHD—such as IHCs—could be identified, this could lead to early diagnoses when treatment is more effective. They further suggested that early diagnosis could lead to possible interruption of “modifiable” clinical conditions, such as preeclampsia and fetal asphyxia, which may be risk factors for ADHD. The authors concluded that IHCs, “especially birth asphyxia,” are strongly and independently associated with the increased risk of ADHD.1
These unproven assertions create new concerns for physicians, hospitals, and professional liability insurance carriers. The study implies that not only are labor and delivery events strongly associated with ADHD, but that ADHD may be avoidable in some circumstances. These conclusions open the door to an extension of causation theories and damages in birth-related injury cases.
You and your defense counsel should be prepared to challenge the scientific basis and reliability of this study, which may be employed by plaintiffs’ attorneys, especially in cases where damages are uncertain.
1Getahun D, Rhoads GG, Demissie K, Lu SE. In utero exposure to ischemic-hypoxic conditions and attention-deficit/hyperactivity disorder. Pediatrics. 2012; 131(1): 53-61.
Laura Witty is a Partner at Kitch, Drutchas, Wagner, Valitutti & Sherbrook, where she is a member of the Birth Trauma Team and National Coordinating Counsel Team. For more than 40 years, the Kitch Firm, with nearly 100 attorneys and six offices in the Great Lakes region, has been committed to meeting the legal needs of healthcare providers nationwide.Copyright © 2013Kitch, Drutchas, Wagner, Valitutti & Sherbrook;
Posted here with permission.