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First Settlements Reached in J&J Transvaginal Mesh Cases

Johnson & Johnson In what may be a sign of things to come, Johnson & Johnson has recently agreed to settle four cases involving allegedly defective and dangerous vaginal mesh implants, including one matter that was currently at trial stage in Missouri.

This represents the first instance in which J&J and its Ethicon subsidiary have reached resolution with individuals claiming that they suffered serious and lasting harm as a result of mesh products designed to treat conditions including stress urinary incontinence and pelvic organ prolapse.

Settlement marks shift in J&J’s litigation stance

For the past several years of pending transvaginal mesh litigation, J&J has adamantly declined to engage in settlement discussions with plaintiffs’ lawyers and competitor manufacturers seeking to achieve a global resolution of lawsuits relating to these devices. Therefore, the decision to settle these four matters may suggest that the drug and device giant is adjusting its position, at least in certain circumstances. The transvaginal mesh settlement offers no admission on the part of J&J/Ethicon of any wrongdoing in terms of the development, marketing or promotion of the devices, so their impact on the thousands of transvaginal mesh cases still pending across the country remains to be seen.

Allegations relating to transvaginal mesh products

Vaginal mesh products gained widespread acceptance as a means to repair damaged tissue and to provide strength to vaginal walls that had weakened. Seen as an effective treatment for pelvic organ prolapse and stress urinary incontinence, implantation of mesh made from animal tissue, synthetic materials or a combination of the two has been a popular procedure for several years.

However, many female mesh recipients began to experience surgical mesh complications very soon after their procedures occurred, with adverse event reports skyrocketing from 2011 onward. The U.S. Food and Drug Administration eventually issued a safety notice warning the public of potential side effects and providing a reminder that available alternative treatments for the conditions at issue may indeed be preferable. As a result of heightened agency scrutiny, it was revealed that many mesh products had never been subjected to traditional clinical safety trials and were possibly the cause of debilitating, sometimes permanent harm.

Status of transvaginal mesh litigation nationwide

While potentially significant, the recent transvaginal mesh settlement announcement has not yet had any impact on the over 21,000 lawsuits currently pending in several multidistrict litigations (MDLs) being managed by Judge Joseph Goodwin in the U.S. District Court for the Southern District of West Virginia. These MDLs were established as a means to streamline transvaginal mesh lawsuits with similar fact patterns and allegations, to facilitate discovery processes and prevent inconsistent pretrial rulings.

Bellwether MDL cases are chosen for early trial in order to give the parties clear insights into how a typical jury is likely to assess testimony, evidence and legal theories in other, similar matters. The initial Ethicon bellwether trial produced an outcome favoring the defendant, while the second such trial resulted in a $3.27 million verdict for the plaintiff.

Judge Goodwin recently delayed a third bellwether trial involving J&J/Ethicon, moving its start date from December 4, 2014 to March 2, 1015. While no reason was given for the change, Judge Goodwin ordered all MDL parties to participate in a joint status conference, perhaps to gauge progress toward potential settlement. Whether the recently announced settlements in four cases brought under state law will have any bearing on J&J’s overall resolution strategy remains unclear.

  1. Los Angeles Times, Johnson & Johnson to settle four cases over vaginal-mesh implants,
  2., J&J agrees to first vaginal mesh-implant suit settlements,
  3. FDA, Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,