Ethicon, J&J Receive Favorable Verdict in Pelvic Mesh Case

In early October, a jury in Texas rendered a verdict favorable to Ethicon and Johnson & Johnson in a lawsuit which alleged serious problems with the Gynecare Prosima Pelvic Floor Repair System.

The plaintiff in this case received the implant in April of 2012 as a means to treat her pelvic organ prolapse and contended that the transvaginal mesh caused her serious bodily harm requiring surgery to remove parts of the system. She also claims she suffers from ongoing pain, bleeding, scarring and other difficulties.

Causes of action against Ethicon, J&J

The pelvic mesh lawsuit, filed in April of 2014, included a number of serious claims against the device makers. It was alleged that Ethicon/J&J marketed and sold devices that were defective in their design, defectively manufactured, breached express and implied warranties and failed to warn physicians and the public at large about known dangers posed by the devices. The Prosima system had been approved for entry into the U.S. market by the FDA under the Section 510(k) process, which many believe does not require sufficient trials and testing to ensure patient safety.

The plaintiff in this case cites scientific studies which argue that despite the claims of the device manufacturer, the monofilament polypropylene mesh used in the products is in fact biologically incompatible with tissue in the human body, prompting a serious immune response and subsequent degradation of that tissue. The complaint also cited high failure, complication, injury and revision surgery rates linked to the mesh device systems and the irreversible harm that can result.

Lawsuit’s claims in line with growing concern over pelvic mesh

Pelvic mesh systems of this type have been the subject of intense scrutiny in recent years, beginning with the October 2008 issuance by the FDA of a Public Health Notification alerting the public to more than 1,000 adverse event reports relating to the Prosima system and similar products.

July of 2013 saw the agency step up its concern about these mesh devices, issuing a Safety Communication highlighting additional worries about the high incidence of complications linked to the systems. The FDA stated at that time that it was far from certain whether the use of transvaginal mesh to address pelvic organ prolapse and stress urinary incontinence was a better option than more traditional kinds of remedies.

Device maker hails outcome

The trial in this mesh case began on September 21, with the jury commencing deliberations on October 2. The October 5 verdict in favor of the defense was immediately heralded by representatives of Ethicon as being wholly in line with the facts of the case and fully vindicating the company’s claim that it had always proceeded responsibly with regard to the marketing, development and sales of the Prosima system.

The company reiterated its insistence that the mesh device was not the cause of the plaintiff’s ongoing medical difficulties and that patient safety has been and will continue to be the firm’s main priority.

However, Ethicon has not prevailed in other cases, such as a suit brought by Linda Gross who suffered injuries from the company’s Gynecare Prolift mesh. In 2013, a jury awarded Gross $11.5 million in damages  after determining the defendant failed to adequately warn consumers about potential risks.

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