After a 9-day trial, an Indiana federal jury on Friday ordered a $35 Million verdict against a Johnson & Johnson subsidiary, Ethicon Inc., for its defective pelvic mesh device. The jury found that Ethicon failed to adequately warn about risks of the device, which was sold in an “unreasonably dangerous condition.”
As a result, the plaintiff claimed, the device caused her to experience several painful complications. The verdict returned $10 Million in compensatory damages and $25 Million in punitive damages. This latest verdict follows 6 other pelvic mesh losses for Johnson & Johnson, all of which cost Johnson & Johnson tens of millions of dollars. Over 8,700 similar claims are currently in multidistrict litigation.
J&J Pelvic Mesh Lawsuit: Defective Design and Failure to Warn
In January 2009, an Indiana woman was implanted with Ethicon’s Gynecare Prolift device, a transvaginal mesh implant introduced to the market in 2005.
The device was intended to treat the woman’s pelvic organ prolapse, a common form of pelvic floor disorder, but resulted in more of the adverse effects she had hoped to end. Painful intercourse, groin pain, and bladder spasms were among the symptoms she suffered, according to a complaint she filed in 2012 after her doctor identified the implant as a possible cause.
In her trial, the woman cited Prolift’s high rates of failure, injury, and complication in previous cases. She also pointed to a 2011 FDA safety alert warning healthcare providers and patients of possible complications when treating pelvic organ prolapse with surgical mesh, which was prompted by more than 1,000 adverse event reports. Some women required multiple post-implant surgeries.
Contrary to evidence, this case alleged, Ethicon had marketed the device as safe after failing to adequately evaluate its benefits and risks. The case also argued that, though the device is designed for convenient implantation, the manufacturer had established no safe procedure for removal in the event of failure.
Ethicon’s Dubious Response
Johnson and Johnson’s Ethicon subsidiary responded to the verdict with messaging similar to its marketing, rebutting the call for scientific evidence. In an interview, a spokeswoman said:
“Ethicon intends to appeal this verdict as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications. Pelvic organ prolapse is a serious and debilitating condition with limited treatment options. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for some women.”
This wouldn’t be the first case to draw such a defense, nor the first time Johnson & Johnson disregarded the claims of individuals. Instead, what these allegations show is an inexcusable failure to highlight the potential risks customers undertake when using the product in question. According to the FDA, pelvic mesh has not been proven safer nor more effective than other available repairs for pelvic organ prolapse.
Following its 2011 alert, the FDA ordered pelvic mesh manufacturers to perform additional testing on their devices. Instead, the following year, Johnson & Johnson removed 4 Ethicon products (including Prolift) from the market altogether. But for many women, the damage was already done.
Could Lawsuits Deter Future Wrongdoing?
Besides the numerous cases regarding Johnson & Johnson’s pelvic mesh products, irreparable damage was wrought by several others. Recent lawsuits filed against the pharmaceutical giant and its subsidiaries concern defects in their hernia patches, hip implants, blood thinners, and other injurious devices and drugs marketed aggressively as safe.
Johnson & Johnson has also settled several asbestos claims since evidence found links between asbestos-contaminated talcum powder and ovarian cancer. Internal memos, recently released to the public, show that company executives knew about talc contamination in its Baby Powder and Shower to Shower products, knew about asbestos risks, and proceeded to sell hundreds of millions of dollars’ worth of talc-containing products to the public anyway.
In other cases, Johnson & Johnson bills its testing methods as thorough and its intentions as pure. But verdicts have revealed a clear, willful, and seemingly relentless disregard for patient safety over many years. Through its latest verdict, the Indiana jury hopes to send a strong message to Ethicon, and its parent company, Johnson & Johnson, about the consequences its negligence.