Testimony continued this week in a transvaginal mesh lawsuit trial involving hundreds of Australian women, as a senior Johnson & Johnson executive took the stand to defend his company’s handling of the controversial implants.
According to The Guardian, the Johnson & Johnson’s vice-president of medical affairs, Piet Hinoul, was called to provide details on a single report of a transvaginal mesh complication received the company’s Ethicon, Inc. subsidiary in 2009.
The report in question involved a woman in the U.K. who had developed two infections following implantation of an Ethicon pelvic mesh product, the first 12 months after her surgery and the second three years later. Emails authored by Hinoul described those complications as a “transitory foreign body response”, a normal reaction that was addressed in the company’s instructions for use to surgeons.
Hinoul recommended against reporting the case to the U.K.’s medical device regulator, asserting that Johnson & Johnson was only obligated to report complications that were not listed in the product’s instructions for use.
During questioning, the plaintiffs’ attorney accused Hinoul of placing Johnson & Johnson’s interests above the interests of patients, and asserted that he had taken an unreasonable approach to the instructions for use to protect the company.
Hinoul denied both accusations.
The Australian transvaginal mesh lawsuit was brought on behalf of more than 700 women who accuse Ethicon, Inc. of marketing defective transvaginal mesh implants that caused chronic pain and made intimacy impossible. According to the class action complaint, many of these women will be forced to endure painful vaginal mesh complications for the remainder of their lives.
The Australian transvaginal mesh trial got underway in July and could continue for several more months. The lawsuit is considered a landmark case both for the number of women involved and the expected length of the trial.
Transvaginal mesh implants have been implanted in thousands of women to treat pelvic organ prolapse or stress urinary incontinence. Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding serious complications potentially associated with the devices. In July 2011, the FDA reversed its opinion that vaginal mesh complications related to prolapse repair were rare, and questioned whether such procedures offered any additional benefits compared to traditional non-mesh surgery.
Hundreds of thousands of women in the U.S. have since filed transvaginal mesh lawsuits against Ethicon and other devices manufacturers, including American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic. Juries hearing these cases have rendered verdicts for both plaintiffs and defendants. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.
Most recently, a jury in Philadelphia, Pennsylvania awarded more than $57 million in compensatory and punitive damages to a woman who suffered serious complications following implantation of two of Ethicon’s TVT mesh devices.
Earlier this week, the U.S. Supreme Court refused to hear Ethicon’s appeal of a $3.27 million verdict in a 2014 federal case involving its TVT-O mesh implant.