Trial Magazine

In the last two decades, fetoscopic surgery has been used to treat fetal anomalies that would result in significant impairment or fetal death if not treated in utero. It involves ultrasound-guided placement of a fetoscope—a small, fiberoptic instrument—in the uterus to see the fetus and placenta.¹ The procedure can treat various conditions—from congenital diaphragmatic hernia to bladder outlet obstruction—but its use to treat twin-to-twin transfusion syndrome (TTTS) is the most common.² TTTS occurs when identical twins share a placenta with blood vessel connections that cause blood to flow unevenly between the fetuses.³ One fetus develops a small amniotic sac, while the other’s becomes too large. Laser fetoscopy allows a laser inserted into the fetoscope to coagulate and collapse these blood vessel connections. If not treated, one or both fetuses often die.⁴ TTTS occurs in approximately one in 2,500 pregnancies, and its occurrence is expected to rise with the increase in fertility-assisted pregnancies.⁵

Since the procedures are almost always digitally recorded—capturing the surgical errors on video—you have compelling visual evidence that can be played for the jury.

When performed below the standard of care, these surgeries can cause injury—such as cerebral palsy and hypoxia leading to brain damage—that do not become apparent until after birth, and plaintiffs and their attorneys may not be aware of the underlying liability for those injuries. Fetoscopic surgery malpractice cases are hard-fought, especially when the malpractice causes severe neurological impairment or fetal death. However, since the procedures are almost always digitally recorded—capturing the surgical errors on video—you have compelling visual evidence that can be played for the jury. Plaintiff attorneys should be aware of the resulting injuries and some crucial strategies to build and present these cases at trial.

Operative fetoscopy was developed in the 1990s by a surgeon from Yale University.⁶ In 1998, Selective Laser Photocoagulation of Communicating Vessels (SLPCV), a type of fetoscopy, was first described in the medical literature as a superior treatment method for TTTS.⁷ An endoscope maps vessels on the placenta to identify all connections contributing to TTTS, and then the laser is used to disrupt blood flow and collapse the vessels. SLPCV swiftly became the standard of care for advanced TTTS.⁸ As SLPCV and operative fetoscopy began to flourish, surgeons and hospitals rushed to establish fetal care centers offering these procedures, but few physicians had training or experience performing fetoscopic surgery.⁹

Case Selection

When evaluating a potential case, consider the following issues early on.

Traditional negligence. In SLPCV, for example, surgical errors range from missing the target with the laser to firing at the wrong target, which can eventually result in acute hypoxia or fetal death. The video of the surgery is the best evidence for this. Firing at the wrong target disrupts the function of healthy placental tissues and blood vessels needed to nourish and oxygenate the fetus.

Medical battery. Some fetal surgeons may be liable for medical battery under certain circumstances.¹⁰ Due to the lack of training and not having the proper equipment available, surgeons have resorted to performing open fetal surgery, even though the consent documentation calls for fetoscopy. Pay careful attention to the description of the procedure and the nomenclature in the consent form compared to the operative reports.¹¹ For example, the consent form may say “fetoscopy” while the surgical report may say “exploratory laparotomy.”

Selective exclusion. Liability for medical negligence also arises when surgeons misdiagnose certain conditions and claim that the patients are not candidates for fetoscopy. Even though fetal death is almost certain without treatment of TTTS, some surgeons perform fetoscopy only in the less technically challenging presentations for the lowest risk patients—and do not treat it at all in high-risk patients. Injuries also include neurologic aftereffects due to the delay in treatment.

Scientific misconduct. Some surgeons also started government-funded clinical trials. In one case, the complication and death rates in a clinical trial were so concerning that the data and safety monitoring board stopped the study and required the surgeons to undergo additional training. The surgeons covered up the results, and the patients have never been advised. When a potential client was a participant in a clinical trial involving fetoscopy, you should carefully investigate, as there could be a claim for medical battery. In trials where the efficacy of established surgeries is being tested, the study does not involve experimenting with the technique. Since the technique is established, an inordinate number of deaths above what should be expected should not occur in these clinical trials.

Fetoscopy cases differ from other birth injury cases because patients often do not suspect malpractice.

Inherent risks. Fetoscopy cases differ from other birth injury cases because patients and families often do not suspect malpractice. Since pregnancies requiring fetoscopy usually are considered high risk already, parents often attribute adverse outcomes to nature. But neurological injuries and fetal death caused by fetoscopic surgery mistakes are often discernible from those resulting from the pregnancy or the underlying condition—especially when there was an uneventful labor and delivery. These cases may involve a spectrum of complications—such as infection, genetic conditions, and extreme prematurity—that must be excluded as the cause of the injury. It is important to exclude other causes early in the evaluation process.

Building Blocks

Once you have screened your case, discovery is crucial. These strategies are especially useful in these cases.

Dig for evidence. Finding proof that the hospital and the defendant surgeon were negligent in various ways is essential to building your case. For example, if appropriate, include a cause of action in your complaint for corporate negligence against the hospital.¹² This significantly broadens the scope of discovery. In support of such a claim, you can properly seek statistical and outcome data for the procedures performed by the defendant surgeon, which can show poor outcomes due to surgical incompetence, indicating that the hospital should not have granted privileges to the surgeon. Most surgeons publish their outcomes or keep records, so you should request these in discovery.

If the patient was selectively excluded from fetoscopic surgery, consider a corporate negligence claim against the hospital for failing to adopt and enforce adequate policies and procedures to prevent selective exclusion driven by performance-based or research goals.¹³ This should help open the door to the data demonstrating that an inordinate number of patients were denied surgery. Many surgeons and universities publish portions of this data in medical journals and on their websites. Use those publications to defeat the privacy arguments that inevitably will be raised in discovery. It is also prudent to submit Freedom of Information Act requests at both the state and federal levels seeking data about the funding program in place, the incentives, and the reported outcomes.

If the defendant surgeon was previously involved in clinical trials, data from those trials can also unearth crucial evidence. If a trial was federally funded, this data will be publicly available. In one matter, we discovered critical safety board memos that documented warnings to the defendant surgeon about the exact type of surgical errors that allegedly caused the client’s cerebral palsy in the underlying case.

Use multimedia depositions. One key strategy is to use multimedia depositions to take the defendant through the surgery frame-by-frame. It is standard practice to videotape fetoscopic laser surgery and this video will be part of the patient’s medical file.¹⁴ The fetoscope is fitted with a video camera that projects the surgical field on a large monitor in the operating room. The laser has a HeNe (helium neon) beam, which allows the operator to visualize the target that the beam will strike when fired. Each time the laser is fired, the tip of the fiber may emit a signal that can help identify the precise moment of the shot and that can be correlated with the timer on the video.

Using the video and timer, make the defendant identify each target and admit each time it is missed—screenshot each admission and each misfiring, and mark it as an exhibit for trial. In one case, the surgeon misfired more than 25 times trying to reach a single small target.

The same tactic also can be applied when the patient was selectively excluded from laser surgery. In one instance, the defendants claimed that certain anomalies present on ¬the ultrasound formed the basis for preclusion. Just as with the laser surgery video, take the defendants through the ultrasound and force them to circle the obscure or nonexistent sonographic findings. Then screenshot and mark the ultrasound images as exhibits for trial.

Lock down the exclusions. It is also important to eliminate all other potential causes. Fetoscopic surgery is most often required in otherwise high-risk pregnancies, so defendants aggressively attempt to exploit any other potential cause. Depose the treating physicians and secure their testimony ruling out or excluding other causes. Make a list of each treating doctor’s findings, and then force the defense experts to admit that they disagree with multiple treating doctors. In cases when one twin is not affected and the other twin is impaired, it is helpful to show how the potential or phantom causes did not impair the healthy twin.

Trial Presentation

Now take what you’ve gathered in discovery and use it in trial.

Attack reputation and character. Evidence of a person’s character or character trait is not admissible to prove that on a particular occasion the person acted in accordance with that character or trait.¹⁵ Yet time and again, especially in fetal surgery cases, defense counsel stake their case on the reputations of the doctor and the affiliated hospital. Be prepared to present both empirical and statistical data of the defendant’s substandard prior outcomes for the surgery in question. File motions in limine to preclude defendants’ improper character evidence, and point out that if they open the door, the ¬plaintiff may rebut with evidence of prior bad acts.¹⁶ Use Federal Rule of Evidence 404 or your jurisdiction’s equivalent, as well as corresponding case law allowing rebuttal of improper character evidence.¹⁷

Debunk the myths. Defendants will inevitably turn to a multitude of often old, inaccurate, and inapplicable data about the prevalence of neurological impairment or fetal death in high-risk pregnancies. Preempt this attack with data showing the relatively low risk of neurological impairment when fetoscopic laser surgery is competently performed. One study of TTTS outcomes lists the incidence of severe neurological impairment at only four out of 100, which is on par with regular monochorionic (identical twins sharing the same placenta) pregnancies.¹⁸

The data and case reports presented by the defense often will be easily distinguishable. For example, many of the data sets involve extreme prematurity, significant placental insufficiency, or other conditions that would have been screened out at case selection. Educate the jurors on the mechanisms that cause adverse outcomes in the population group as a whole, and then confirm that those mechanisms were not present in the plaintiff’s case. Another tip is to construct a single chart excluding all other causes and risk factors as not present or unlikely to have contributed. The focal point is that, with the other factors excluded, all evidence points to surgical malpractice.

Concrete evidence. Even with the defendant’s malpractice visible on video, which will certainly be salient to the jurors, it is important to go further and make this “concrete.” The ¬videoscopic view of fetoscopic laser surgeries is only several millimeters wide and then displayed on monitors. Work backward and reconstruct an anatomical artistic rendering of the surgical field together in one view, rather than only the single lens of a fetoscope. Depict the targets along with the laser shots required for successful treatment. Contrast that with a depiction of the actual misfired laser shots. This will give the jurors both the hard video evidence and the perspective to understand its full context.

Keep in mind that although manu-facturers have added HeNe beams and artificial flashes of light when the beam is fired to make the laser visible, the laser beams do not emit visible energy, and thermal damage from the misfiring is not readily apparent. You can have photomicrographs (photos of microscopic images) of the devitalized and damaged tissue prepared for the pathologist to present to the jurors. These strategies link the surgical malpractice and corresponding injury for the jurors.

The nature of fetoscopic surgery cases and how the field developed is such that any case can exceed the bounds of a traditional malpractice action. Careful attention to case selection, case building, and trial presentation will maximize success.

Jeffrey B. Killino is managing partner at The Killino Firm in Philadelphia. He can be reached at jkillino@killinofirm.com.

Notes

1. Rubén A. Quintero & Walter Morales, Operative Fetoscopy: A New Frontier in Fetal Medicine, 44 Contemporary Obstetrics/Gynecology 45 (1999).
2. Id.
3. Id.
4. Margaret Dziadosz & Mark I. Evans, Re-Thinking Elective Single Embryo Transfer: Increased Risk of Monochorionic Twinning—A Systematic Review, 42 Fetal Diagnosis & Therapy 81 (2017).
5. Id.
6. Quintero & Morales, supra note 1.
7. Rubén A. Quintero et al., Selective Photocoagulation of Placental Vessels in Twin-Twin Transfusion Syndrome: Evolution of a Surgical Technique, 53 Obstetrical & Gynecological Survey 97S (Dec. 1998). 
8. Marie-Victoire Senat et al., Endoscopic Laser Surgery Versus Serial Amnioreduction for Severe Twin-to-Twin Transfusion Syndrome, 351 N. Engl. J. Med. 136 (2004).
9. See Ramesha Papanna et al., Use of the Learning Curve-Cumulative Summation Test for Quantitative and Individualized Assessment of Competency of a Surgical Procedure in Obstetrics and Gynecology: Fetoscopic Laser Ablation as a Model, 204 Am. J. Obstetrics & Gynecology 218, e19 (2011); Suzanne H.P. Peeters et al., Simulator Training in Fetoscopic Laser Surgery for Twin-Twin Transfusion Syndrome: A Pilot Randomized Controlled Trial, 46 Ultrasound Obstetrics & Gynecology 319 (2015); Tuangsit Wataganara et al., Model Surgical Training: Skills Acquisition in Fetoscopic Laser Photocoagulation of Monochorionic Diamniotic Twin Placenta Using Realistic Simulators, 133 J. Visualized Experiments e57328 (2018).
10. Some courts have found that medical battery can be a viable claim in these cases, but there are no reported case outcomes yet.
11. See, e.g., Perry v. Shaw, 106 Cal. Rptr. 2d 70 (Cal. Ct. App. 2001). Keep in mind that damages caps may not apply to the intentional tort of medical battery.
12. See, e.g., Thompson v Nason Hosp., 591 A.2d 703 (Pa. 1991).
13. Id.
14. The recording setup and format varies among hospitals.
15. Fed. R. Evid. 404(a)(1) (“Evidence of a person’s character or character trait is not admissible to prove that on a particular occasion the person acted in accordance with the character or trait.”); see also Fed. R. Evid. 404 advisory comm. n.—2006 amend. (“The Rule has been amended to clarify that in a civil case evidence of a person’s character is never admissible to prove that the person acted in conformity with the character trait.”) (emphasis added).
16. Helfrich v. Lakeside Park Police Dep’t, 497 Fed. App’x 500, 509 (6th Cir. 2012) (citing U.S. v. Savoco, 151 Fed. App’x 28, 30 (2d Cir. 2005)).
17. Id.
18. Douglas L. Vanderbilt et al., Predictors of 2-Year Cognitive Performance After Laser Surgery for Twin-Twin Transfusion Syndrome, 211 Am. J. Obstetrics & Gynecology 388.e1 (Oct. 2014).