By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Los Angeles

Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services (2004-2013)
California Hospital Medical Center
Los Angeles

Elena N. Sandell, JD
UCLA School of Law, 2018

News: An appellate court affirmed a $2.5 million verdict in favor of a husband whose wife passed away days after a routine hernia surgery. The jury found the physician’s gross negligence had caused the patient’s death and that a nurse’s actions contributed to the patient’s pain and suffering.

On appeal, the defendants argued the evidence did not support the jury’s findings. However, the appellate court rejected these arguments and affirmed the award.

Background: An adult woman was referred to a physician for the treatment of a hiatal hernia, a condition in which the stomach protrudes into the chest through the hiatus, an opening in the diaphragm. The physician determined the patient required surgery to return the stomach to its proper position, but alleged the patient would need to lose weight prior to the surgery. A few months later, the patient underwent laparoscopic surgery to facilitate the required weight loss. Following the laparoscopic surgery, the physician performed the hernia surgery, assisted by a registered nurse.

The hernia repair was performed by attaching a mesh closure to the patient’s diaphragm using a device commonly referred to as a “tacker.” The device uses absorbable “tacks” to attach prosthetic material to soft tissue. Each tack is approximately 5 millimeters in length. At the time of insertion, the device presses them as far as 6.7 millimeters into soft tissue. Because of these precise measurements, the manufacturer expressly warns against the use of a tacker if the total distance between the surface of the tissue and any underlying bone, blood vessel, or organ is less than 6.7 millimeters. Additionally, the manufacturer cautions against the use of a tacker during diaphragmatic hernia repair on the diaphragm near the pericardium, aorta, or inferior vena cava.

When questioned about his use of the tacker, the physician testified he had used the same procedure in several hernia repair surgeries before without incident. The physician also opined that he preferred tacks to sutures because tacks were less likely to tear, thus decreasing the likelihood of hernia recurrence. The physician used the tacker to attach the mesh to the muscular edge of the diaphragm, which he did not measure but “ballparked” its thickness to be approximately 10 millimeters.

The patient appeared stable after surgery. However, after two days she began complaining that her heart was racing and she was experiencing abdominal pain. An ECG revealed a fast, irregular heart rate, as well as excess fluid in the patient’s pericardium near the tacks. She received blood-thinning medication and morphine, but about one hour later she went into cardiac arrest. Resuscitation was unsuccessful.

An autopsy revealed the patient’s pericardial sac contained blood, likely caused by prolonged heart compressions. Furthermore, the autopsy revealed puncture marks on the patient’s heart, and acute and chronic inflammation of the pericardium. The acute pericarditis most likely occurred at the time of the surgery. It concluded that unequivocal evidence of surgical trauma could not be demonstrated.

The patient’s husband filed a medical malpractice lawsuit against the physician, the registered nurse who assisted with the surgery, and the corporate employer of the physician and nurse. The defendant care providers denied liability, claiming the use of the tacker did not constitute malpractice. Expert witnesses for both sides offered conflicting opinions about the propriety of the tacker, although experts agreed that alternative methods were available.

After a six-day trial, the jury found the physician’s use of a tacker was negligent and awarded the plaintiffs $5.1 million: $2.6 million in compensatory damages for pain, suffering, and loss of consortium, and $2.5 million in punitive damages. The defendants appealed, arguing the evidence was insufficient to support the jury’s finding. The appellate court rejected those arguments and affirmed the award.

What this means to you: This case raises important considerations about making appropriate choices in the selection of equipment and methods for treatment, as well as the importance of retaining a qualified and persuasive expert witness in the event of litigation. Liability for the care providers in this case arose as the result of the tacker, which likely pierced the patient’s pericardium and punctured her heart, causing cardiac arrest and death. As to the suitability of the tacker, that is when expert testimony becomes relevant as experts for the patient and care providers presented conflicting opinions about whether the tacker was appropriate to use in these circumstances. When a medical malpractice action becomes a battle of the experts, as frequently occurs, it is of the utmost importance to critically evaluate prospective experts and choose the right expert for you — an expert who is knowledgeable and persuasive.

In this case, the battle of the experts determined the outcome of the litigation, as the jury agreed with the patient’s expert and theory of the case. Although the final autopsy identified puncture marks on the deceased’s heart, the defendants argued those injuries likely resulted from the chest compressions performed during attempts to resuscitate the patient after she went into cardiac arrest. Additionally, the defendants noted that the autopsy report indicated no evidence of surgical trauma could be demonstrated.

The defendant physicians retained an expert physician witness — a general and gastrointestinal surgeon — whose theory was the patient died of longstanding damage to her heart caused by the hiatal hernia, injury caused by blood-thinning medication, and prolonged resuscitation efforts. The expert witness provided insight as to the choice of using tacks on the diaphragm as well as an interpretation of the patient’s postsurgical condition. The expert opined that despite the manufacturer’s warning regarding a tacker for diaphragmatic hernia repair, it was common practice to use this device to fasten material to the muscular wall of the diaphragm, which was certainly thick enough to withstand the 5 millimeter tacks. The expert added that the manufacturer’s warning likely was placed to prevent their own liability, rather than an express preclusion for using the tacker in this manner. As additional evidence to the positive outcome of the surgery, the expert noted that the patient’s vitals were stable and she felt fine immediately after the surgery. Had the physician punctured the pericardium when inserting the tacks, the patient would have not felt well after the procedure, according to the defendants’ expert.

Unsurprisingly, as is the case with innumerable medical malpractice actions, the plaintiffs retained and presented testimony from an expert whose opinion conflicted with the defendants’ expert. This expert was a general surgeon who had performed nearly 1,000 hiatal hernia surgeries, and expressly opined to a “reasonable degree of medical certainty” the treatment of this patient was below the standard of care expected from the average qualified surgeon and registered nurse assistant. The plaintiffs’ expert believed the punctures on the patient’s heart as well as the choice to go against the manufacturer’s recommendations demonstrated the tacks had injured the patient and caused her death, and the defendant physician acted negligently in using the tacker.

With an inconclusive autopsy report and two expert witnesses clearly presenting opposing conclusions based on the known facts, the jury looked to a source of less biased information: the manufacturer’s specific warning, which recommended against use on the diaphragm during diaphragmatic hernia repair procedures.

The jury agreed with the patient’s expert and supporting manufacturer’s warning, concluding the punctures on the patient’s heart were sufficient evidence that the physician’s conduct had caused the patient’s injuries and subsequent death. Accordingly, the care providers’ actions fell below the applicable standard of care. On appeal, the appellate court confirmed the jury had a “substantial basis on which to reject the defense theory of the case” given the expert testimony and manufacturer’s warning.

This case demonstrates how the choice of not following a manufacturer’s warnings can be extremely detrimental to care providers even if an expert witness presents a plausible argument and opines the injuries were the result of other causes. Relying on a manufacturer’s recommendations and warnings are valuable tools that should never be overlooked, disregarded, or ignored. Although these may be partially intended for manufacturers to protect themselves from litigation, these also are developed after extensive research during pre-market testing phases of new products. Proceeding in total disregard of manufacturers’ warnings, especially when alternative methods or equipment may provide similar, safer treatments, could constitute malpractice. Physicians and care providers who are unsure about manufacturers’ warnings can contact the manufacturer and request specific details about a warning or recommendation to shed valuable insight as to the rationale behind the warning.

REFERENCE

  • Decided on Feb. 28, 2020, in the Appeals Court of the State of Massachusetts, Case Number 18-P-1373.