US District Judge Joseph R. Goodwin upheld $14.3 total verdict in favor of three women who suffered ongoing pain from the Obtrx transvaginal mesh system manufactured by Boston Scientific Corporation.
“There was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” the judge wrote.
Boston Scientific was found liable of strict liability for defective design, strict liability for failure to warn, negligence and punitive damages. A jury in US District Court in the Southern District of West Virginia in Charleston returned the verdict for the plaintiffs in November 2014. The case is Carol Sue Campbell v. Boston Scientific Corporation, Case No. 2:12-cv-08633 (Oct. 3, 2016).
The case is part of consolidated litigation in MDL 2326, which contains 19,000 individual cases. There are six other MDLs against the transvaginal mesh manufacturers, with more than 70,000 cases currently pending:
- Boston Scientific TVM Litigation MDL 2326
- Bard TVM Litigation MDL 2187
- Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
- Neomedic TVM Litigation MDL 2511
- Cook TVM Litigation MDL 2440
- Coloplast TVM Litigation MDL 2387
- American Medical Systems TVM Litigation
- Caldera TVM Class Action In California
Plaintiffs Chris Wilson, Carol Campbell and Jeanie Blankenship had the Obtryx Transobturator Mid-Urethral Sling System implanted between 2009 and 2011. All suffered severe pain in their abdomen, pelvis, vagina, dyspareunia (painful intercourse) and painful urination. Each had unsuccessful revision surgery, which also left them with continuing pain.
- Wilson recovered $3.75 million in compensatory damages and $1 million in punitive damages.
- Campbell recovered $3.25 million in compensatory damages and $1 million in punitive damages.
- Blankenship recovered $4.25 million in compensatory damages and $1 million in punitive damages.
Boston Scienfitif argued that it met the standard of care in the medical community, which did not require clinical trials. “However, as mentioned above, compliance with industry standards is not necessarily proof of reasonable conduct,” the judge held.
A key point of evidence was the Material Safety Data Sheet issued by Chevron Phillips Chemical Company LP with regard to their Marlex polypropylene. The plaintiffs presented evidence at trial that the MSDS included a Medical Application Caution, which stated: “Do not use [Chevron Phillips] material in medical applications involving permanent implantation in the human body . . . .”
Yet after learning this, Boston Scientific never performed any testing of their mesh inside the human body, didn’t halt the release of the Obtryx and didn’t disclose the new information.
The plaintiffs presented evidence related to a study conducted by Dr. Hilary Cholhan and funded in part by BSC. The Cholhan study “identified pariurethral banding as a previously unreported complication” of the Obtryx and noted that “[s]urgeons should be aware of the pariurethral banding and subsequent internal dyspareunia as a potential complication.”
When asked about the study, Alex Robbins, a BSC sales representative and training manager, stated that, because of its negative outcome, the study would not be useful to the sales force and should not be given to physicians.
The judge disagreed with Boston Scientific’s arguments that the verdict was against the weight of the evidence, that jury instructions were confusing, or that in closing arguments a plaintiff attorney improperly tried to appeal to the jury’s sympathy.