Surgical stapler manufacturer Ethicon Endo-Surgery cannot be held liable in the death of a woman who suffered infection from a leaked staple line and, later, pulmonary thromboembolism after bariatric surgery, a panel of appeals judges has ruled. Their opinion reverses a previous jury ruling that awarded damages to a woman who alleged that the company's "negligent marketing" of its LONG45A Endocutter device contributed to the patient's death.
The lawsuit stems from a May 2005 gastric bypass surgery performed on Rebecca Castaneda, who had an over-50 body mass index and suffered from diabetes and high blood pressure. As described in court documents, surgeon John Mason, MD, began the procedure laparoscopically using Ethicon Endo-Surgery's LONG45A Endocutter, which works with staples sized 1mm (white cartridge), 1.5mm (blue) and 2mm (green) in height. The stapler's instructions for use warn surgeons not to use the green-cartridge staples "on any tissue that requires excessive force to compress 2.0mm or on tissue that compresses easily to less than 2.0mm," according to court documents. Similar instructions are provided for the blue cartridges.
Dr. Mason reportedly began firing with the blue cartridge but found that the staples did not completely close. He converted the surgery to an open procedure and began using the stapler with a green cartridge to close the gastrotomy on the pouch and remnant sides of the stomach, observing that those staples created a solid line.
Several days after surgery, Ms. Castaneda began developing complications that, after exploratory surgery, appeared to be caused by "a pinhole leak in the green staple line on the remnant side," through which bile had escaped, causing infection and fever, according to court documents. Though the patient initially appeared to be recovering well from the exploratory surgery and repair, she became unresponsive and went into cardiac arrest 7 days after that procedure. She went in for a third surgery but died that day. An autopsy later determined pulmonary thromboembolism to be the cause of death; the green staples "were not malformed," the autopsy found.
In an amended complaint filed after the first lawsuit resulted in a hung jury, plaintiff Celia Gillies (who filed individually and on behalf of a minor heir to Ms. Castaneda's estate) alleged strict liability and negligence on the part of Ethicon for its "defective design, manufacture, assembly and marketing of the surgical staplers and/or staples," among other causes of action.
The trial court jury did not agree with most of Ms. Gillies' claims, but answered "yes" to the question of whether "the negligence, if any, of [Ethicon] proximately caused the occurrence in question," and awarded $320,000 in damages to Ms. Gillies. Ethicon appealed that ruling.
In an April 26 opinion, Justice David Bridges with the Court of Appeals of Texas in Dallas notes that Ms. Gillies non-suited her "design defect claim" and told jurors in the trial court that she was not asserting a manufacturing defect. "Therefore, the only remaining negligence claim asserted against [Ethicon] was a claim for negligent marketing," he writes on behalf of a 3-judge appeals panel.
Expert testimony was required to prove negligent marketing, but the appeals judges were not swayed by the testimony of Ms. Gillies' witness, a biomedical engineer who admitted that Ethicon warned doctors not to use the LONG45A Endocutter on tissue thicker than 2mm.
"We conclude [Ms. Gillies] failed to provide expert testimony establishing either the appropriate standard of care for her negligent marketing claim or that [Ethicon] failed to comply with that standard," writes Justice Bridges. Therefore, the appeals court reversed the trial court's verdict and ruled in favor of Ethicon.
Irene Tsikitas
