Was Transvaginal Mesh Lawsuit Win for Boston Scientific a One-Off?

Boston, MAThe attorney representing a transvaginal mesh plaintiff following a jury verdict favoring the defendant, Boston Scientific, is not concerned over other TVT sling lawsuits pending, given her view that pretrial orders prevented jury members from seeing key evidence related to allegations of product defect and inadequate warnings.

The plaintiff in the transvaginal mesh lawsuit, Diane Albright, alleged that her use of the Pinnacle TVT sling manufactured by Boston Scientific caused her severe pain and other transvaginal mesh complication since having the device implanted in 2010 to treat a bladder prolapse condition. The plaintiff claimed that neither she nor her surgeon was apprised of risks associated with use of the product prior to implantation.

The plaintiff held that the Pinnacle Pelvic Floor Repair Kit, manufactured with plastic, was too large and heavy to be implanted safely and nearly impossible to remove in the event of transvaginal mesh complication.

It was reported that testimony from an expert witness for the plaintiff was disallowed following a petition by the defendant on grounds the witness’ expert opinion had been barred in similar litigation against a Boston Scientific competitor.

The jury, following two days of deliberations, returned a verdict favoring Boston Scientific on July 29. It’s the first of several cases in the Boston Scientific transvaginal mesh lawsuit pool to go to trial.

The plaintiff is considering an appeal, in part due to the disallowed expert witness testimony and the loss of key evidence available to the jury through pretrial orders.

The plaintiff also points to the issuance by the US Food and Drug Administration (FDA), this past April, of two proposed orders with an eye to the reclassification of transvaginal mesh as a high-risk treatment option for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). For some time the FDA has been of the view that use of TVT mesh for treatment of SUI and POP may no longer be the safest option, and thus should be considered only as a last resort when all other methods of treatment have been exhausted.

New transvaginal mesh treatment options: for better or for worse?

Historically, POP and SUI were treated by way of invasive surgery involving the fashioning of a sling to shore up sagging organs from a patient’s own tissue. Eventually, mesh was used (borrowing from hernia repair procedures) to treat POP and SUI. However, the adoption of minimally invasive arthroscopic surgical techniques designed to minimize blood loss and healing time saw the insertion of coiled, rolled or folded transvaginal mesh into the treatment area through a small incision.

Critics say it is this adoption of minimally invasive surgery combined with use of mesh that has proven to be the foundation for vaginal sling problems. TVT side effects can include migration of the mesh away from the initial insertion point and penetration through the vaginal wall. Many patients have seen their TVT mesh become intertwined with bowels and other organs, making removal next to impossible.

Plaintiffs have alleged that they were not aware of this potential for complication when they consented to the use of transvaginal mesh as a treatment option for POP and SUI. As for the FDA, one key purpose for the issuance of orders back in April was to facilitate the requirement for manufacturers to apply for premarket approval with the FDA.

It should be noted that premarket testing and clinical trials were not required of transvaginal mesh manufacturers through the issuance of a 510(k) clearance, due to the ongoing and successful use of mesh for other medical procedures. The 510(k) clearance allows for products and medical devices substantially similar to other devices already on the market and used successfully to avoid the time and expense of premarket clinical trials.

Boston Scientific is facing in excess of 10,000 lawsuits over its Obtryx Sling System and the aforementioned Pinnacle kits. Other manufacturers, including Ethicon, a subsidiary of medical giant Johnson & Johnson (J&J), Covidien PLC and C.R. Bard Inc., also face a tidal wave of lawsuits.

This past April, Endo International PLC reached a settlement to resolve a majority of the 22,000 transvaginal mesh lawsuits against its subsidiary, American Medical Systems Inc. That settlement was worth $830 million.

The case is Diane Albright v. Boston Scientific Corp., Case No. MICV2012-00909, in the Superior Court of the Commonwealth of Massachusetts, County of Middlesex.