Judge Declines Plea to Overturn Pelvic Mesh Liability

Defective Medical Devices
Defective Pelvic Mesh
Transvaginal Mesh
Boston Scientific

By Zac Pingle

On Monday, October 3, Judge Joseph Goodwin of the Southwest West Virginia US District Court ruled that Boston Scientific (BSC) did not provide a substantial argument to overturn a Federal Court ruling in 2014.

In 2014, after a ten-day trial involving Boston Scientific’s Obtryx pelvic mesh device, Boston Scientific was found liable for the injuries sustained by four women who used the device to treat urinary incontinence. The federal ruling mandated that Boston Scientific compensate the women for a total of $18.5 million including punitive damages.

Last year, Boston Scientific requested the court to overturn the 2014 ruling on the grounds that the plaintiffs failed to link their injuries directly to the Obtryx design flaws, failed to show that Obtryx is not reasonably safe, and that the punitive damage awards were too excessive and were a miscarriage of justice. Boston Scientific attempted to show that Obtryx is not reasonably safe by showing that the device is within the normal standard of care for urinary incontinence. The company further argued that the plaintiffs failed to prove their claim of failure to warn of the risks because they did not show that their injuries were directly related to the Obtryx defects.

Judge Goodwin disagreed with Boston Scientific’s argument on the grounds that a reasonable jury would be able to conclude that the dangers of Obtryx were not justifiable for the potential medical gain based off of expert testimony and evidence provided at the trial.

“[Boston Scientific] first argues that the plaintiffs failed to establish that Obtryx is ‘not reasonably safe’ because it is within the standard of care for treatment of SUI. BSC conflates the standard for medical malpractice with that used for strict liability. Here, the question is whether the manufacturer used reasonable care in designing the Obtryx,” Goodwin wrote. “...A reasonable jury could balance the risks and benefits based in the significant evidence the plaintiffs produced at trial on the Obtryx’s risks. From this evidence, a reasonable jury could conclude that the risks associated with the Obtryx are not justified by its benefits and, as a result, the product is not reasonably safe.”

The court also addressed the company’s claim of the plaintiff’s not directly linking their injuries to the Obtryx’s defects. Judge Goodwin wrote: “Because I find that the plaintiffs’ experts specifically connected at least one of the above defects to each plaintiff’s injuries [scarring, degradation, contraction, etc.], a reasonable jury would have no need to ‘infer the existence of a defect by circumstantial evidence… The plaintiffs’ injuries through expert testimony, likewise could have been revealed through clinical testing of the Obtryx. Therefore, a reasonable jury could find BSC’s failure to conduct clinical trials before marketing the Obtryx proximately caused the plaintiffs’ injuries.”

In closing, Judge Goodwin asserted that Boston Scientific knew that lack of clinical testing before marketing its product could result in safety issues. He found that because Boston Scientific failed to respond to “explicit warnings from the manufacturer” about the materials used to make the Obtryx, and because the company “suggested hiding negative studies to physicians considering using the Obtryx,” that a reasonable jury could conclude that Boston Scientific’s conduct justified compensation of all damages awarded in 2014.

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