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August Heats Up with Additional Transvaginal Mesh Trials

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Boston, MAHot August night is the opening salvo to Neil Diamond’s 1969 smash hit, “Brother Love’s Travelling Salvation Show.” The term also describes the heat percolating through the courts within the TVT sling file, with a second bellwether trial against Boston Scientific opening last week in state court and a federal trial against Ethicon Inc. (Ethicon) kicking off in federal court next week.

But it’s the Boston Scientific transvaginal mesh lawsuit, which kicked off August 14 in Massachusetts state court, that pundits and industry watchers will be scrutinizing closely. That’s because Boston Scientific won its first bellwether case last month, a decision which before then had bucked the trend of jury findings for the plaintiff. Advocates of women having been injured allegedly due to complications stemming from TVT mesh products will be interested in seeing which way the pendulum swings in this case.

The approval of transvaginal mesh, inserted arthroscopically for the treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) by the US Food and Drug Administration (FDA) via the much-maligned 510(k) clearance appears to have backfired following a cascade of reports detailing transvaginal mesh complication and thousands of lawsuits. Plaintiffs have claimed mesh has migrated and penetrated the vaginal wall, or has become intertwined in bowels, intestines or other internal organs. Plaintiffs have been left with, in many cases, intense pain and limited mobility.

Revision surgery is often needed - and on occasion - is not even possible, leaving the patient in chronic pain.

According to various court records and reports, juries tend to return verdicts for the plaintiff. This has been the case at the conclusion of many a transvaginal mesh lawsuit tried in state courts in Texas, California and New Jersey.

Will this second bellwether trial against Boston Scientific in Massachusetts state court also find for the defendant or the plaintiff? In the first trial, the plaintiff claimed that the design of Boston Scientific’s Pinnacle Pelvic Floor Repair Kit was defective. The plaintiff also claimed that Boston Scientific failed to adequately warn patients and health care professionals with regard to the risks. The Middlesex County jury involved in that case rejected the plaintiff’s assertions, and found for Boston Scientific.

While all this is going on, the FDA continues to backpedal on the file, by requiring transvaginal sling manufacturers to undertake post-market testing for the right to continue marketing the products. It should be noted that such testing was not originally required as part of the 510(k) clearance. Some manufacturers have since abandoned transvaginal mesh altogether, rather than invest further in the TVT portfolio. The FDA, while stopping short of pulling transvaginal mesh from the market, no longer considers mesh as the first and most appropriate treatment option for POP or SUI.

Meanwhile, the lawsuits over TVT side effects keep coming. There are thousands. More than 500 cases pending in Massachusetts state court have been consolidated before Justice Diane M. Kottmyer. Tens of thousands of cases have been consolidated in multidistrict litigation before US District Judge Joseph Goodwin in Federal Court in West Virginia. Defendants include Johnson & Johnson and its subsidiary unit, Ethicon, as well as C.R. Bard and the aforementioned Boston Scientific.

Other cases involving the TVT sling procedure have been consolidated in state courts in New Jersey and Pennsylvania.

It’s a huge file, which we follow, for now, one case at a time. The bellwether trial now underway against Boston Scientific involves a completely different legal team for the plaintiff. Industry watchers will want to see how this vaginal sling trial plays out, as the federal case against Ethicon starts on August 22.

It will take more than one night. But it certainly will be a hot August in more ways than one.

The case currently underway is Maria Cardenas v. Boston Scientific Corp., Case No. MICV2012-02912, in the Superior Court of the Commonwealth of Massachusetts, County of Middlesex.


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