Clinical Review

Cutting the legal risks of laparoscopy

Author and Disclosure Information

Despite laparoscopy’s increasingly broad application, safety and efficacy data for this modality have accumulated in a piecemeal fashion. An attorney surveys the field and offers recommendations on avoiding medicolegal claims.


 

References

KEY POINTS
  • In a recent review of medical liability claims for laparoscopy, women were claimants in 95% of cases, and most were under the age of 40. OBG was the physician specialty involved in the majority of these claims.
  • Absolute contraindications to laparoscopy include hypovolemic shock, intestinal obstruction with extensive bowel distention, a large pelvic or abdominal mass, and severe cardiac decompensation.
  • The most critical aspect of laparoscopy is the placement of the first trocar and sleeve through the incision near the umbilicus. For this reason, it is the most legally defensible.

In December 1995, a 37-year-old mother of 2 entered a Michigan hospital to have her gallbladder removed. The surgeon made a small incision above the umbilicus and inserted a laparoscope to begin the operation. When he viewed the peritoneal cavity, the physician observed “a little bleeding,” which he assumed was a result of the initial trocar insertion.

The woman’s blood pressure dropped to 105/52 mm Hg from 126/66 mm Hg. Unfortunately, the anesthesiologist did not inform the surgeon of this drop or ask if there was any bleeding. When the patient’s blood pressure dropped again—to 85/50 mm Hg—and her heart rate accelerated to 120 bpm, the anesthesiologist assumed she was suffering from a pulmonary embolism. He instructed the surgeon to step away from the table so that the patient could be repositioned. During the 10 minutes spent searching for emboli, the patient bled to death.

What went wrong? At the onset of the procedure, during insertion of the first trocar, the iliac artery had been severed. Not surprisingly, the claim resulting from this incident was settled for a substantial sum of money.

By analyzing this and other cases, and by reviewing the medical literature, we can get a clearer picture of the types and causes of injuries most commonly associated with laparoscopic procedures. The Ob/Gyn can reduce the likelihood of complications—and the risk of related litigation—by remaining vigilant for circumstances that may lead to such injuries, planning accordingly, and training staff properly.


A relatively new technology

Until the mid-1980s, laparoscopy was used primarily as a diagnostic tool or to perform sterilization.1 Indeed, the first reported appellate case involving laparoscopy was a failed tubal ligation in 1974. That year, 9 appellate cases involving failed tubal laparoscopic surgery were initiated and lost by the plaintiffs.2

We must recognize the paucity of large clinical studies that have examined the safety and efficacy of many current laparoscopic applications.

In 1986 in Germany, Mühe reported the first laparoscopic cholecystectomy,3 and in 1989 the first laparoscopic vaginal hysterectomy was performed.3 Now, scarcely more than a decade later, we have come to take much of laparoscopic technology and application for granted. That may prove to be a mistake.

When assessing the safety and efficacy of laparoscopic diagnostics and surgical procedures, we must take into account the relative newness of the procedure as well as the availability of alternative technologies (e.g., ultrasound, magnetic resonance imaging [MRI], medications) as competing diagnostic and treatment modalities. We also must recognize the paucity of large clinical studies that have examined the safety and efficacy of many current laparoscopic applications. Unfortunately, there is no national reporting mechanism for laparoscopic-associated morbidity and mortality, and published data tend to come from university settings rather than field operators.

Think defensively

One of the best ways to avoid litigation is to anticipate it routinely. By that I mean that the clinician should regularly consider whether his or her management decisions could inadvertently lead to legal claims. When it comes to laparoscopy, the first consideration should be whether the minimally invasive surgery is indeed the best approach.

The benefits most commonly cited in support of laparoscopy include a shorter operative time, hospital stay, and convalescence; earlier diagnosis; less pain; fewer complications; improved cosmetic results; and lower costs. But not all of these benefits routinely apply. Many depend on the specific laparoscopic procedure being considered.

For example, laparoscopic diagnosis and surgery generally do result in shorter hospital stays and a quicker return to work, but thanks to new technologies—particularly in the realm of imaging—diagnosis can sometimes be achieved earlier with an alternative method than is possible with laparoscopy. In addition, variables such as operative time, complications, costs, and use of pain medication vary according to procedure.

When they compared the safety and efficacy of laparoscopic and abdominal hysterectomy, Nezhat et al found that women undergoing the laparoscopic approach spent more time in surgery (160 versus 120 minutes) but had significantly shorter hospital stays (2.4 versus 4.4 days). Laparoscopic hysterectomy also allowed for a shorter convalescent period (3 versus 5 weeks) and fewer complications. Although these results are preliminary (due to the small number of subjects), the authors concluded that, in the hands of experienced laparoscopists, laparoscopic-assisted vaginal hysterectomy is preferable to abdominal hysterectomy for select candidates.4

Next Article: