The FDA in April 2014 proposed to reclassify transvaginal mesh implant for urinary incontinence or pelvic organ prolapse to “high risk” from moderate risk. With over 60,000 mesh claims filed in the court system and another 50,000 claims expected to be filed, transvaginal mesh litigation is one of the biggest product liability litigations ever filed.
More than 60,000 transvaginal mesh lawsuits are now pending in the Southern District of West Virginia under Chief Judge Joseph R. Goodwin. They involve seven mesh manufacturers, including American Medical Systems, Inc., C.R. Bard, Inc., Boston Scientific and Ethicon, Inc. According to Bloomberg News, a global settlement in 2013 of multiple mesh manufacturers should happen prior to January 2015.
Claims against all the transvaginal mesh manufacturers similarly allege that their products were defectively designed and manufactured, and that they failed to provide adequate warnings regarding their association with organ damage, mesh erosion, infection and other serious vaginal mesh complications. Women have suffered physical and emotional injuries and financial loss and their partners have suffered loss of consortium. Many women have undergone multiple revision surgeries in an attempt to remove the mesh.
The following litigation updates against major mesh manufacturers American Medical Systems, Boston Scientific, C.R. Bard and Ethicon are current as of October 2014.
American Medical Systems
More than 20,000 transvaginal mesh lawsuits have been filed against American Medical Systems, Inc. (AMS), a subsidiary of Endo International Plc. Most of the lawsuits are currently pending in a multidistrict litigation underway in U.S. District Court, Southern District of West Virginia. AMS is the only major mesh manufacturer to announce a global settlement agreement on a portion of its outstanding claims, the majority of which are pending. According to Reuters, Endo has set aside funds to cover transvaginal mesh claims from $1.2 billion to about $1.6 billion. The company has not admitted to any liability regarding the lawsuits.
Ethicon. Johnson & Johnson
Johnson & Johnson’s Ethicon division reported it is facing about 30,000 mesh claims. More than two-thirds of TVM Ethicon claims have been consolidated in a multidistrict litigation currently underway in the U.S. District Court, Southern District of West Virginia. According to court documents, a Pretrial Conference is slated for November 24, 2014 for the proceeding’s third bellwether trial. The trial is scheduled for December 4, 2014 (Bellew v. Ethicon, Inc., et al., 2:13-cv-22473).
The jury in the first Ethicon trial in September awarded $3.27 million to Jo Huskey and her husband, Allen. The lawsuit claimed that Mrs. Huskey has sustained life-long, irreversible complications resulting from the TVT-O pelvic mesh sling device, from which she will never recover. The $3.27 million verdict included $200,000 awarded to Mr. Huskey for loss of consortium damages (In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2327).
On October 15, 2014, Ethicon asked a federal judge to reverse the award, claiming that the plaintiff didn’t have enough evidence to support the allegations in her complaint. Ethicon asked that the verdict be tossed and granted either a judgment as a matter of law or a new trial (Huskey v. Ethicon, Case No. 12-5201).
C.R. Bard
Bard is close to settling hundreds of its Avaulta transvaginal mesh cases for more than $21 million, according to the law firm Bernstein Liebhard LLP. In August of 2014, Bard agreed to settle 500 cases for approximately $43,000 each. This deal was struck when a federal judge overseeing thousands of TVM lawsuits in West Virginia ordered C.R. Bard to prepare about 500 cases for trial, according to Bloomberg News.
More than 9,000 transvaginal mesh lawsuits against Bard have been filed in the U.S. District Court, Southern District of West Virginia. These federal cases involving Avaulta mesh have been consolidated for coordinated pretrial proceedings.
Boston Scientific
Boston Scientific is facing about 14,000 lawsuits that are currently pending in the Southern District of West Virginia as well as hundreds of similar lawsuits that have been filed in US state courts. Last month, Boston Scientific was ordered to pay $73 million in punitive and compensatory damages after a trial in Texas state court involving its Obtryx sling. The punitive damages were reduced to comply with Texas law and the judgment is now set at $34 million (Salazar v. Lopez, No. DC-1214349, District Court for Dallas County, 95th Judicial District of Texas (Dallas).
The drug company asked for a Motion to Dismiss Punitive Damage claims in seven cases that allege injury due to its Obtryx Transobturator Mid-Urethral Sling System, which was denied by federal Judge Joseph R. Goodwin. All of the Boston Scientific TVM lawsuits claim that the company was aware that the polypropylene material used in mesh devices should not be implanted in the human body. Further, plaintiffs allege that Boston Scientific knew it hadn’t adequately tested long-term safety of the Obtryx mesh, but failed to do so (In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation - MDL No. 2326).