Ethicon Gynecare TVT Mesh Lawsuit Set For Trial to Begin Feb. 2014

The first federal bellwether trial involving an Ethicon Gynecare TVT vaginal mesh lawsuit is set to begin in February 2014, after being pushed back a month by the judge presiding over the litigation.

On October 4, U.S. District Judge Joseph R. Goodwin issued an Order (PDF) scheduling a lawsuit filed by Carolyn Lewis against Johnson & Johnson’s Ethicon subsidiary to begin on February 10, 2014. The case was previously expected to begin in January 2014.

Lewis filed her complaint in July 2012, alleging that she experienced problems with Gynecare TVT mesh manufactured by Ethicon that was implanted in November 2009.

The lawsuit is one of two “bellwether” cases selected for early trial dates next year involving Ethicon Gynecare TVT mesh, with a second trial involving a lawsuit brought by Judy Brown previously set to begin on May 27.

A third bellwether cases is scheduled for later next year, involving an Ethicon Prolift mesh lawsuit set for trial to begin in August 2014. However, the specific case that will go before a jury in that bellwether trial will not be determined until early next year.

Federal Litigation over Vaginal Mesh and Bladder Slings

More than 30,000 product liability lawsuits are pending nationwide involving complications associated with vaginal mesh products made by Ethicon and other medical device manufacturers.

The transvaginal surgical mesh products have been used in recent years for treatment of pelvic organ prolapse or female stress urinary incontinence. However, according to allegations raised in the complaints, the manufacturers failed to adequately warn about the risk of painful and debilitating vaginal mesh complications, including a risk that the mesh may erode through the vagina, cause infections or other problems.

In the federal court system, six different MDLs, or multidistrict litigations, have been centralized before Judge Goodwin for coordinated pretrial proceedings. In addition to lawsuits against Johnson & Johnson’s Ethicon subsidiary, other MDLs have been established for cases involving products manufactured by C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast Corp. and Cook Medical.

According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation, there are currently 9,841 American Medical System (AMS) mesh lawsuits, 9,617 Ethicon Gynecare mesh lawsuits, 5,998 Boston Scientific mesh lawsuits, 4,568 Bard Avaulta lawsuits, 1,022 Coloplast bladder sling lawsuits and 124 Cook Medical biologic mesh lawsuits.

In addition to the federal litigation, thousands of cases are pending in various state court systems nationwide.

Vaginal Mesh Trials and Settlement Negotations

In each of the federal MDLs, a small group of cases are being prepared for early trial dates, known as “bellwether” lawsuits, which are designed to help the parties gauge how juries are likely to respond to certain evidence that may be repeated throughout a number of claims.

A series of four “bellwether” trials involving Bard Avaulta mesh began in July, with the first case resulting in a jury award of $2 million, including punitive damages designed to punish the manufacturer for their actions surrounding the sale of the mesh. On the first day of trial in the second case, Bard reached an agreement to settle the lawsuit rather than proceed with the trial. A third case is expected to begin this month, followed by a fourth case scheduled to start in November.

Additional trials are scheduled to begin in December 2013 involving AMS mesh, with bellwether trials involving Boston Scientific mesh scheduled to begin the same month as the Ethicon trials.

At the state court level, at least two cases have already gone to trial. In July 2012, a California jury awarded $5.5 million to a woman who experienced complications with Bard Avaulta mesh. In March 2013, a New Jersey jury awarded $11.1 million in damages to a woman who received Ethicon mesh.

The early trial dates scheduled in the federal court system are designed to facilitate possible vaginal mesh settlement agreements that could resolve the litigation without scheduling thousands of cases for individual trials nationwide.

Recent reports suggest that many of the manufacturers are actively negotiating cases, with Bloomberg News indicating earlier this month that a group of lawyers are negotiating with attorneys for C.R. Bard, AMS, Boston Scientific, Coloplast and Cook Medical. However, Johnson & Johnson’s Ethicon subsidiary does not appear to be involved in the negotiations, indicating that they intend to seek dismissal of thousands of cases they believe have no merit before considering a settlement.

In June, it was reported that Endo Health Solutions reached AMS vaginal mesh settlements to resolve an unspecified number of claims against the company’s American Medical Systems subsidiary for a combined $54.5 million. However, that agreement only involved a small number of plaintiffs’ law firms.

If an agreement is not reached by each of the manufacturers to settle or otherwise resolve a large number of the cases after the bellwether trials, it is possible that Judge Goodwin will begin remanding hundreds of cases back to the U.S. District Courts where they were originally filed for individual trial dates.