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The Court restores damages for medical devices



A district court set an excessive standard and erred in dismissing expert testimony in a medical device case, holding a federal appeals court on Thursday, and reinstating the disputes.

The 11th U.S. District Court in Atlanta held that the testimony of a physician who had no experience working with robotic assisted laparoscopic hysterectomies, but who worked with thousands of such cases, should not have been rejected in a case concerning the safety of a tool. used in this proceeding, according to Thursday's judgment in Tamanchia Moore v. Intuitive Surgical Inc.

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

She discovered that by performing the procedure doctors had used a pair of miniaturized, electrified scissors produced by Sunnyvale, California-based Intuitive Surgical Inc. that were susceptible to forming microcracks along the shaft, which could leak electrical current during surgery and burn the surrounding meat. The tool was recalled by Intuitive a few months later.

Ms. Moore sued Intuitive in the U.S. District Court in Albany, Georgia, and charged the instrument's design was flawed and unreasonably dangerous to patients like herself, that Intuitive had failed to warn consumers of its danger, and that Intuitive had violated the Georgia Fair business practice . Act. She also claimed damages.

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

The court held a two-day hearing on the adoption of its testimony, based on the 1

983 Supreme Court ruling in Daubert v. Merrell Dow Pharmaceuticals Inc ., Which set guidelines for scientific testimony.

the court agreed with Intuitive that Dr. Hall was unqualified to testify, and since he was Moore's sole causal expert, the company granted summary judgments dismissing the case.

The decision was overturned by a unanimous panel court with three judges. . The lower court concluded that Dr. Hall was unqualified to testify about Moore's injury, as he could not describe the differences between the instruments used in robotic surgery and traditional surgery, among other factors, according to the decision.

"Here, the district court abused its discretion" to reach this conclusion, it said. "Although we accept these shortcomings 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" introduced a permit standard for expert qualifications that was "too high", it said, in an earlier case.

"Our case law does not support a clear line rule that an expert witness is qualified to testify about the cause of an injury only if he has personally used the alleged defective product ", it stated.

Nothing in the Protocol "suggests that robotic assisted laparoscopic hysterectomies should be treated as a different area of ​​competence for Daubert purposes than traditional laparoscopic hysterectomies."

On the contrary, the district court, Dr. Hall and Intuitive Surgical's own causal expert "said that a hysterectomy is performed in the same way and carries the same risks regardless of whether a robot is issued or not", was mentioned in court to overturn the court decision and reconsider the case for further negotiations.

Lawyers in the case did not respond to a request for comment.

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