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The Pennsylvania Supreme Court has ruled that evidence of the risks and complications associated with surgical procedures can be admissible in medical negligence cases.

In a June 18 opinion in Mitchell v. Shikora, the high court unanimously ruled that such evidence could be admissible in certain cases. The justices were split 5-2, however, with regard to whether such evidence should have been allowed in the Mitchell case specifically, with the majority reversing a Superior Court ruling that found an Allegheny County trial judge had improperly allowed jurors to hear about the risks and complications of a hysterectomy.

Justice Debra Todd, writing for the majority, said the Superior Court's decision went against the Supreme Court's 2015 ruling in Brady v. Urbas, which allowed evidence of general risks and complications in some medical malpractice cases.

“The Superior Court appropriately recited the core analysis in Brady—that evidence of the risks of a procedure may be relevant in particular cases,” Todd wrote. “Yet, the court nevertheless effectively set forth a bright-line rule, determining in this case that evidence that one of the risks of a laparoscopic hysterectomy is perforation of the colon, even if the surgery is performed with due care, is irrelevant to the issues of standard of care and breach of duty.”

In May 2017, a three-judge panel of the Superior Court held that, despite the defense's argument that the risks and complications associated with hysterectomies was necessary to establish the standard of care, allowing the evidence in at trial was prejudicial to the plaintiffs.

Plaintiff Lanette Mitchell sued Dr. Evan Shikora, alleging negligence, and later sought to exclude evidence about whether bowel injury was a known risk or complication of the surgery. Superior Court Judge John Musmanno noted in the court's 2017 opinion that, although the trial court did not allow in evidence related to informed consent, including conversations between Shikora and Mitchell or evidence of Mitchell's consent despite the risks, the jury was allowed to hear about the general risks and complications associated with a laparoscopic surgery.

“Acknowledging a liberal threshold to determine the relevancy of such evidence, we nevertheless emphasize that the evidence must be probative of whether defendants' treatment of Mitchell fell below the standard of care,” Musmanno wrote for the Superior Court panel. ”The fact that one of the risks and complications of the laparoscopic hysterectomy, i.e., the perforation of the bowel, was the injury suffered by Mitchell does not make it more or less probable that Dr. Shikora conformed to the proper standard of care for a laparoscopic hysterectomy and was negligent. Indeed, in deciding to undergo this surgery, Mitchell expects that the treatment will be rendered in accordance with the applicable standard of care, regardless of the risks.”

But the Supreme Court's majority ruling held that the Superior Court took the wrong approach in its analysis because it went beyond the Brady ruling's limit on informed-consent evidence by barring evidence of complications known to be a risk even of non-negligent treatment.

Todd said, “risks and complications evidence may assist the jury in determining whether the harm suffered was more or less likely to be the result of negligence. Therefore, it may aid the jury in determining both the standard of care and whether the physician's conduct deviated from the standard of care. We recognized as much in Brady.”

“Ultimately, it is for the jury to determine whether a patient's injury is the result of negligence,” Todd continued. ”We find that, without the admission of testimony of known risks or complications, where appropriate, a jury may be deprived of information that a certain injury can occur absent negligence, and, thus, would be encouraged to infer that a physician is a guarantor of a particular outcome.”

In a concurring and dissenting opinion joined by Justice Kevin Dougherty, Justice Christine Donohue departed from the majority's holding that risk and complication evidence should have been allowed at Mitchell's trial.

“When a jury concludes that a physician met the applicable standard of care and an injury nonetheless occurred, the court's instructions will have made clear that the physician is not liable to the plaintiff,” Donohue said. “Evidence of risks and complications of the procedure in this case, comingled with evidence of the standard of care, did not help to clarify the jury's function but instead muddled it.”

Rudolph Massa represents Mitchell.

“Through the Superior Court's prior holding and, now, the Pa. Supreme Court's decision, a light now shines on risk/complication evidence,” Massa said in an email. “This light will allow trial attorneys to challenge evidence of risks/complications where the evidence does not pass scientific muster. A trial based on evidence that is not supported by the medical scientific community is not based on truth. Our communities deserve the truth.”

John Conti of Dickie, McCamey & Chilcote represents Shikora and said that the decision would have a wide impact.

“That decision is enormously consequential for all health care providers because it reaffirms the right of physicians to defend malpractice cases by offering evidence that injuries can occur even with the exercise of due care,” Conti said. “This evidence includes medical literature including the risks and complications inherent in a given procedure.”

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