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Court reinstates medical devices products liability suit

Posted On: Apr. 23, 2021 3:57 PM CST


A district court set too high a standard and erred in dismissing expert testimony in a medical devices products liability case, a federal appeals court held Thursday, in reinstating the litigation.

The 11th U.S. Circuit Court of Appeals in Atlanta held that the testimony of a physician who had no experience working with robot-assisted laparoscopic hysterectomies, yet who had worked on thousands of such cases, should not have been dismissed in a case involving the safety of a tool used in this procedure, according to Thursday’s ruling in Tamanchia Moore v. Intuitive Surgical Inc.

Ms. Moore, who underwent a robotically assisted laparoscopic hysterectomy procedure in 2013, later suffered from severe abdominal pain and an inability to urinate, and required four procedures to address the problem, according to the ruling.

She discovered that in performing the procedure her doctor had used a pair of robotic, miniature, electrified scissors produced by Sunnyvale, California-based Intuitive Surgical Inc. that were susceptible to forming microcracks along the shaft, which could leak electric current during an operation and burn the surrounding flesh. The tool was recalled by Intuitive a few months later.

Ms. Moore filed suit against Intuitive in U.S. District Court in Albany, Georgia, charging the instrument’s design was defective and unreasonably dangerous to patients such as herself, that Intuitive had failed to warn consumers of its danger, and that Intuitive had violated the Georgia Fair Business Practices Act. She also sought punitive damages.

To help her case, she retained as an expert witness Dr. Michael Hall, who had performed more than 4,000 hysterectomies, but had not used the instruments at issue in the case.

The court held a two-day hearing on his testimony’s admittance, based on the U.S. Supreme Court’s 1983 ruling in Daubert vs. Merrell Dow Pharmaceuticals Inc., which set guidelines for expert scientific testimony.

The court agreed with Intuitive that Dr. Hall was unqualified to testify, and because he was Ms. Moore’s only causation expert, it granted the company summary judgments dismissing the case.

The ruling was overturned by a unanimous three-judge appeals court panel. The lower court concluded Dr. Hall was unqualified to testify about Ms. Moore’s injury because he could not adequately describe the differences between the instruments used in robotic surgery and traditional surgery, among other factors, the ruling said.

“Here, the district court abused its discretion” in reaching this conclusion, it said. “Even if we accept these deficiencies as true for our analysis here, each concerns the reliability of Dr. Hall’s opinion, not his qualifications to testify,” it said.

The district court “imposed an admissibility standard on expert qualifications that was ‘too high,” it said, in citing an earlier case. 

“Our case law does not support a bright line rule that an expert witness is qualified to testify regarding the cause of an injury only if he personally has used the allegedly defective product,” it said.

Nothing in the record “suggests that robotically assisted laparoscopic hysterectomies should be treated as a different field of expertise for Daubert purposes than traditional laparoscopic hysterectomies.”

To the contrary, the district court, Dr. Hall and Intuitive Surgical’s own causation expert “said that a hysterectomy is performed in the same manner and carries the same risks regardless of whether or not a robot is issued,” the ruling said, in overturning the lower court ruling and remanding the case for further proceedings.

Attorneys in the case did not respond to requests for comment.