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Jury Returns Unanimous Defense Verdict for International Medical Device Distributor

Case Study

Jury Returns Unanimous Defense Verdict for International Medical Device Distributor

April 18, 2018
Michael D. Shalhoub

Following a nearly three-week jury trial involving a complicated medical malpractice/medical device action, Goldberg Segalla’s Michael D. Shalhoub and Lisa M. Robinson, partners in the firm’s Life Sciences practice, secured a unanimous defense verdict for a leading international medical device distributor — significantly, the company’s first trial since its inception in 1971.

The action arose from a bladder stone procedure performed on a patient, a local dentist, at a hospital in Syracuse, New York. After trying to use lasers to break up the stone, the surgeon resorted to a mechanical lithotrite, which our client — the American subsidiary of a German, family-owned company, the world’s leading manufacturer of endoscopes — sold to the hospital many decades ago. The device came with warnings about the potential for misalignment and instructions on how to safely remove the device without injury. During the surgery, the doctor was unable to remove the device properly, and, consequently, had to engage in open surgery to manually realign the jaws and facilitate the removal. The hospital investigated the incident and found that the device was not defective. Instead, a loose screw had caused the misalignment, and the hospital had thereafter fixed the device and put back in service.

The dentist claimed that since the surgery he suffered from permanent and complete erectile dysfunctions as well as urinary and other issues. His wife had a derivative claim for loss of consortium due to her and her husband’s alleged inability to have intercourse. They sued the surgeon, the hospital, and the lithotrite manufacturer. Notably, the plaintiffs’ engineering expert had been previously precluded from testifying in a medical device case in the U.S. District Court for the Northern District of New York. Their urology expert, however, testified by video conference that the plaintiffs’ dysfunction was caused by the surgery.

The surgeon-defendant is a recognized expert urologist specializing in stone disease. He testified that he knew how to use the device, was aware of the risk that the jaws could become misaligned, and that he followed the instructions for use (IFUs) but did not know why he could not realign the jaws. The surgeon called an additional expert urologist, who testified that the lithotrite is safe for use, and that the inherent risks are well known to any urologist trained to use the device. Additionally, a second urologist from John Hopkins medical school, one of the world’s leading erectile dysfunction experts, opined that the plaintiff’s complicated medical history was the true cause of plaintiff’s issues, and that it was anatomically and physiologically impossible for the surgery to have caused the alleged erectile dysfunction. On behalf of our client, Mike and Lisa offered a highly qualified expert biomedical engineer who confirmed that the device was not defective and that the IFUs for the device were adequate.

In the closing argument, the plaintiffs’ counsel sought $7-8 million for pain and suffering and $2 million for the wife’s past consortium claim. While the plaintiff’s counsel made no specific request for future damages, they did mention in passing the figure $100 million. Following the three week trial, the jury took only three hours to return its unanimous defense verdict.