Judge Upholds $11.1 Million Gynecare Mesh Verdict

Judge Carol E. Higbee upheld an $11.1 million jury verdict, which resolved a transvaginal mesh lawsuit filed in 2008 on behalf of a woman and her husband. Johnson & Johnson and the company’s subsidiary, Ethicon, had sought to overturn the verdict. However, Judge Higbee rejected the company’s post-trial motions and denied their request for a new trial. The vaginal mesh lawsuit verdict awarded the plaintiff $3.35 million in compensatory damages, plus $7.76 million in punitive damages.

According to the plaintiff’s complaint, she had received the defendant’s Gynecare Prolift sling device during a surgery in 2006 for the purpose of treating pelvic organ prolapse (POP). Her lawsuit claimed the device hardened improperly while it was inside her and subsequently eroded through the vaginal wall. Her lawsuit pointed to 18 subsequent surgeries she was forced to undergo, which removed pieces of the mesh. Despite the revision surgeries, the plaintiff alleged significant and unresolvable pain that interfered with her ability to sit and caused intercourse to be painful.

Judge rejects Johnson & Johnson’s arguments

The plaintiff received the favorable verdict in February 2013, after which Johnson & Johnson attempted to appeal. The defendants claimed in their post-trial motions that the punitive damages were not allowable by the law and that the plaintiff’s evidence did not adequately prove her claims. Ethicon further argued that the jury verdict involved an excessive amount of money.

Judge Higbee rejected the defendants’ arguments, stating that the evidence presented at trial was sufficient to support the plaintiff’s claim that Ethicon had withheld warnings of the risks of the Gynecare mesh, despite knowing that there were problems with it. Johnson & Johnson had attempted to argue that punitive damages were erroneously awarded because, under New Jersey law, the FDA’s approval preempted them. However, as the Judge noted in her ruling, the plaintiff’s injuries were sustained two years before the FDA granted approval for the medical device. Therefore, the Judge ruled the plaintiff could be granted punitive damages. Judge Higbee further noted that the substantial size of the vaginal mesh lawsuit verdict was not excessive because the jury could have granted even more in damages.

Gynecare mesh withdrawn from the market

On May 10, 2012, Ethicon informed the FDA that it planned to withdraw many of its Gynecare mesh products from the market. This move did not constitute a recall of the device. The company still planned to continue selling its Gynecare Gynemesh product, with the caveat that it be inserted only through the abdomen, rather than the vagina. The defendants planned to withdraw the products gradually, phasing them out completely by the beginning of 2013.

Industry experts speculated that the withdrawal of the products from the market was in response to the numerous adverse event reports involving serious complications, in addition to several deaths reportedly associated with the devices. Additionally, while the plaintiff in this particular vaginal mesh lawsuit has achieved resolution of her case, Johnson & Johnson still faces thousands of product liability lawsuits filed by plaintiffs who received the product.

To date, there are still over 18,000 lawsuits pending against Johnson & Johnson, with a total of almost 60,000 lawsuits filed against a handful of manufacturers who designed and sold similar vaginal mesh devices. The federal cases have been consolidated as part of various transvaginal mesh multidistrict litigation (MDL).

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