Critics of transvaginal mesh medical devices, as well as plaintiffs involved in litigation focused on the devices, were given a Christmas present in December when a New Jersey jury awarded $15 million in a lawsuit against Johnson and Johnson’s subsidiary Ethicon. The gifts have kept up in the New Year, with a federal appeals court in early February upholding a $18.5 million transvaginal mesh verdict against Boston Scientific Corp.
These events on the litigation front are occurring in a wider context, as they happen as criticism of the tranvaginal mesh devices grows. In the UK, a health watchdog group has called for a ban on the medical devices. In Australia and New Zealand, the devices have been pulled from the shelves.
In addition, a lawyer representing hundreds of women claiming injury due to their use of a transvaginal mesh is making a significant claim: that Johnson & Johnson knew of the device’s adverse effects prior to marketing its transvaginal mesh.
Transvaginal Mesh Litigation Across the World
On Feb. 6, the 4th U.S. Circuit Court of Appeals ruled to uphold a 2014 verdict against Boston Scientific. The verdict involved four women and was for a total of $18.5 million; the company had previously reached undisclosed settlement amounts with two of the plaintiffs, but this recent ruling is a result of the company’s appeal of the remaining two plaintiffs.
This recent ruling was just more bad news for Boston Scientific where it concerns its transvaginal mesh devices. In a recent filing with the U.S. Securities and Exchange Commission, the company acknowledged it was facing more than 48,000 claims involving the devices.
As recently as December, Boston Scientific settled just south of 400 transvaginal mesh lawsuits in U.S. District Court, Southern District of West Virginia. The terms of the settlement have not been made public.
Also in December, a New Jersey jury awarded a woman who has experienced constant pain since having a transvaginal mesh produced by Ethicon, Inc. — the Johnson & Johnson subsidiary — implanted, an award of $15 million. The Bergen County Superior Court jury based their decision on the finding that the medical device lacked adequate warnings regarding its associated risks. Ten million dollars of the jury’s award was punitive, with $4 million being compensatory and the remaining $1 million being for, interestingly, the plaintiff’s husband for the loss of conjugal affection.
Over in the U.K., transvaginal mesh faces a critical climate. The National Institute for Health and Care Excellence (NICE) has recommended a ban on the medical devices. Insofar as treating women suffering from pelvic organ prolapse, the group recommends that the devices only be used for research.
NICE’s recommendation concerned only transvaginal mesh devices used to treat pelvic prolapses. The group does not recommend the same ban for mesh devices used to treat stress urinary incontinence.
It is thought that even if NICE’s recommended ban is not adopted by the U.K.’s National Health Service, it will effectively have the impact of issuing a virtual ban.
“The recommendations by NICE is highly significant, as I think they will make us all reevaluate the way we use mesh,” Dr. Sohier Elneil, urogynaecologist and mesh expert, as well as a former NICE board member told Sky News. “I think there will be a snowball effect because people will look very carefully at the product per se rather than the application, because we know the product has its own problems; it’s a foreign substance and obviously reacts with the tissue around it.”
Meanwhile, in Australia, Johnson & Johnson has pulled its transvaginal mesh device from the market. The Therapeutic Goods Administration, the agency which regulates medical device’s in the country, had previously issued a requirement that transvaginal mesh devices include information about the risks of severe chronic pain, groin pain and bladder perforation. Johnson & Johnson, according to the agency, did not meet the Jan. 17 deadline to include such information, but has instead withdrawn the device from the market.
Nearby in New Zealand, the country’s neighbor’s decision to require additional warning information on transvaginal mesh devices is having a direct impact. Due to the TGA request, New Zealand’s own regulatory body, Medsafe, is removing a number of surgical mesh products from market.
Did Johnson & Johnson Know?
Also in Australia, an attorney — or barrister — who represents hundreds of plaintiffs claiming injury due to transvaginal mesh devices, is claiming that Johnson & Johnson knew of the product’s risks before sending it to market.
Tony Bannon, of Shine Lawyers, has been making a case against Ethicon in Sydney’s Federal Court since July of last year. His plaintiffs have described injuries including vaginal pain, pain during sex, perforated organs, muscular degeneration, painful bowel movements and incontinence, discharge, nerve damage and having the device erode through their vaginal wall.
In wrapping up his arguments recently, Bannon told the jury that the manufacturer had known for years about the mesh’s ability to erode through the vaginal wall. The attorney cited a 2010 study, funded in part by Ethicon, that found a 15.6 percent erosion rate.
Bannon cited an email from Dr. Piet Hinoul, a vice president with Ethicon: “Why must [the erosion rate] be a reason to stop a trial? How many needed surgery? How large were these erosions? Were the surgeons looking for an excuse to stop the trial?”
That trial is ongoing.