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Punitive Damages Claims May Proceed Against Boston Scientific

Defective Medical Devices

Several plaintiffs that were implanted with Boston Scientific’s Obtryx transobturator Mid-Urethral Sling System alleged in their lawsuits that the manufacturer, Boston Scientific, ignored warning that devices containing polypropylene should not be implanted in humans.

Micrograph of polypropylene.

Micrograph of polypropylene.

These plaintiffs assert that Boston Scientific was aware that the polypropylene used in the Obtryx device should not be implanted in humans based upon a Material Data Safety Sheet (“MSDS”) which warned Boston Scientific not to implant the material in humans. Despite this warning, Boston Scientific used Chervon Phillips’ polypropylene in its Obtryx device.

Plaintiffs also asserted that Boston Scientific knew it needed to conduct long term safety studies of the polypropylene material in the Obtryx device based on a written agreement between Boston Scientific and its polypropylene supplier, which cautioned Boston Scientific to make its own determination of the safety and suitability of the polypropylene materials in its products. However, an internal Boston Scientific document showed that Boston Scientific sponsored no clinical studies on the Obtryx device.

In ruling on defendant Boston Scientific’s Motion for Summary Judgment on punitive damages asserted by the Plaintiffs, Judge Goodwin found that the plaintiffs have proffered sufficient evidence to survive summary judgment on the punitive damage issue. “A reasonable jury could find that by ignoring a warning on the MSDS and failing to conduct clinical testing, Boston Scientific’s actions were wanton, willful, or reckless under West Virginia punitive damages law,” Judge Goodwin concluded.

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