On February 23, 2010, Sharon Pelkey was implanted with the Advantage Fit System to treat her stress urinary incontinence. The surgery was performed by Dr. James Hamilton and took place in a hospital in Kilmarnock, Virginia.

Ms. Pelkey has filed suit against the maker of the Fit system, Boston Scientific Corp. (BSC) asserting that the Advantage Fit caused her to experience multiple complications. She has asserted claims of negligence, strict liability (design defect, manufacturing defects and failure to warn), breach of express and implied warranties, and punitive damages.

Micrograph of polypropylene, the material used in some meshes

Micrograph of polypropylene, the material used in some meshes

Boston Scientific moved for Summary Judgment on the punitive damage claim, asserting this is “without evidentiary or legal support.” The parties disputed whether Massachusetts or Virginia law applies to the punitive damages claim. BSC asserts that Massachusetts law applies because the focus of the punitive damages inquiry is corporate conduct and that the alleged conduct took place in Massachusetts where BSC is headquartered. BSC also noted that the Advantage fit was designed and labeled in Massachusetts.

In moving for summary judgment on the punitive damage claim, BSC argued that Ms. Pelkey has presented no evidence of “malice” or “criminal indifference.” BSC pointed to its submission of the Advantage fit to the FDA prior to marketing the product, and the fact that the FDA cleared the product “with full knowledge of its potential benefits and risks.” BSC also noted that “mesh systems like the Advantage Fit remains the ‘worldwide standard of care’ for treatment like that undergone by Plaintiff.”

Ms. Pelkey asserted that BSC was aware that the polypropylene used to construct the Advantage Fit should not be implanted in the human body. The device constructed using polypropylene resin supplied by Chevron Phillips Chemical Co. Ms. Pelkey pointed to a Chevron authorized material safety data sheet (MSDA) which warned that the polypropylene resin should not be used “in medical applications involving involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

Despite the MSDA warning and the admonition from BSC’S polypropylene supplier to conduct its own test, Ms. Pelkey contends that an internal BSC document indicates that BSC sponsored no clinical studies on the Advantage Fit before selling the device. Furthermore, Ms. Pelkey alleges BSC never warned through its Directions for Use that the Advantage Fit was made of a component that was not safe for permanent implantation in the human body.

Judge Goodwin concluded, “in light of the MSDS warning and BSC’s failure to conduct clinical testing, a reasonable jury could find that BSC acted in conscious disregard of Pelkey’s rights, or acted with reckless indifference to the consequences.”

“A reasonable jury could also find that BSC knew that the Advantage Fit ‘probably would cause injury to another’, and that BSC was aware of the danger involved with placing the Advantage Fit into the stream of commerce” Judge Goodwin stated. “In sum, the plaintiff has presented sufficient evidence to overcome summary judgment on the plaintiff’s punitive damage claim.” Therefore, Judge Goodwin, denied BSC’s summary judgment motion on a punitive damage claims claim in and Advantage Fit mesh case, ruling that the Plaintiff sufficiently alleged that the manufacturer acted with ‘reckless indifference.'”