This is the second win in as many months in a Massachusetts courtroom for pelvic mesh maker, Boston Scientific.
The Obtryx pelvic mesh implanted in Maria Cardenas of Utah was not defectively designed, the jury ruled Friday.
The company provided adequate warnings about its health risks as well, according to the jury. A failure to warn about all of the potential risks of the pelvic mesh is one of three elements of a defective product case which include defective manufacture and defective design.
The warnings are intended to go to the physician, the end user, so he or she can provide a patient with true informed consent before they agree to a medical procedure.
Jurors deliberated for 17 hours before coming to their decision, reports Bloomberg.Cardenas claims the Obtryx sling caused her pain and permanent damage, according to her lawsuit.
She had it removed surgically but portions of the polypropylene mesh device remain behind.Boston Scientific is facing more than 12,000 similar lawsuits over its family of polypropylene mesh implants used to treat incontinence and pelvic organ prolapse.
Attorney Doug Monsour told Bloomberg (here), “We will continue to fight these cases, since the product at issue is made of mesh that is not intended to be inserted in the human body.”
The case is Cardenas v. Boston Scientific Corp., No. 12-02912, Middlesex County Superior Court, Massachusetts (Woburn).
According to Courtroom View Network, the testimony presented conflicting opinions on whether the Obtryx was safe and effective. The sales team at Boston Scientific pushed the product even though they knew it could shrink 20% or more inside the body.
The company offered testimony from experts that the polypropylene mesh has a history of safe use and there are more than 20 clinical studies demonstrating its safe design.
Boston Scientific is also facing thousands of cases in Charleston, West Virginia where more than 66,000 similar cases filed against six manufacturers have been consolidated before Judge Joseph Goodwin.
In other litigation, another defective product case naming Boston Scientific is underway in Dallas and the case of Jo Huskey in her claims against Johnson & Johnson has just rested the plaintiffs’ case.
The patients say they had no idea the risks of the implants which include chronic pelvic pain, chronic infection, painful sex (dyspareunia), nerve damage and systemic issues among others. Most women attempt multiple surgeries to have the mesh removed, but they are intended to be a permanent implant, one that never underwent Food and Drug Administration approval for safety and efficacy.
That information is excluded from these trials as is the number of claims filed around the country. #
Courtroom View Network coverage here.