Mesh Medical Device News Desk, May 24, 2016 ~ She was
just one person who was mesh-injured.
“Susan” cannot be named because she is involved in litigation, but in 2012 she filed a complaint with her
home state of Washington, specifically the State Attorney General’s Consumer Protection Division.
Susan told the office about her mesh injuries, about how there was no warning about the dangers of mesh, no informed consent and about how thousands of women were also duped into believing a “minimally invasive” procedure could cause a lifetime of pain.
After years of investigation, today Washington State AG Bob Ferguson announced his office is filing a lawsuit against Johnson & Johnson for deceiving the public and the state about the safety of its pelvic mesh implants, a violation of the state’s Consumer Protection Act (CPA).
The suit asks the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution. See the press conference here.
The fines alone could reach tens of millions of dollars, and for the company, the revelations are something J&J tried to keep from the public.
The Washington State AG announced the action today as did the Attorney General for California Kamala Harris, also alleging deceptive trade practices and violations of consumer protections.
The allegations are New Jersey-based Johnson & Johnson and its Ethicon division failed to tell patients and doctors about the risks of pelvic mesh implants, made of polypropylene and used to shore up sagging organs or to treat incontinence. As a result, thousands of women were implanted who today suffer in some cases, irreversible complications including pain, repeated infections, nerve damage and an end to their sex lives.
“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”
Washington State estimates 12,000 women there were implanted with J&J pelvic mesh. California believes there are 42,000 Ethicon mesh-implanted women there while J&J sold nearly 790,000 of its mesh implants from 2008 to 2014.
California and Washington led a group of 46 states and the District of Columbia in investigating the company’s practices. There is no word tonight whether other states also plan to file consumer protection violation lawsuits against J&J.
In a statement to Associated Press, J&J denies it did anything wrong and calls the lawsuits unjustified.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.
“Ethicon is concerned that the Attorneys General’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.”
However, the mesh to treat stress urinary incontinence has already been found to be defective in several jury trials around the country and is falling out of favor with some doctors.
There are in excess of 120,000 defective product lawsuits naming pelvic mesh made by seven manufacturers, filed by injured women in courts around the U.S.
Johnson & Johnson is facing about 45,000 lawsuits, more than another other defendant. Additionally, the company is facing similar defective product actions filed overseas including Scotland, Canada, Israel, Australia, among other countries.
Mesh used to treat pelvic organ prolapse or POP, has been quietly removed from the market by J&J. The FDA announced this year it will require testing for safety and efficacy before POP mesh can be marketed. Mesh for SUI remains on the market and is still referred to as “The Gold Standard” by medical societies, many of which are led by doctors who have financial arrangements with mesh manufacturers.
J&J introduced the TVT (transvaginal tape) in the U.S. in 1998, followed by the TVT-O (obturator), TVT-Secur, TVT Exact, TVT Abbrevo, Prolift, Prolift M+, Prisima and Artisyn. None of the mesh underwent clinical trials but that did not stop the company from proclaiming it was safe and effective.
Susan tells MND, “Maybe it will inspire others to file complaints with their Attorney General’s Offices. It took courage to make the call. I did not want to discuss my vagina or my leaky bladder with anyone, let alone a strange man. I was so angry when I discovered that the mesh could not be seen with MRI, x-ray or any other technology that my rage overtook my shame. My rage gave me the courage to make the call to a Senior Assistant Attorney General. He had not heard of mesh and he didn’t watch TV so was unaware of the mesh adds. I gave him the lowdown. He was about to retire so he did nothing with the information. Lisa Erwin, Assistant Attorney General, replaced him. Lisa Erwin and her Investigator, Mary Beth Haggerty-Shaw took the ball and ran with it. Now, once again, we have a courageous man of integrity (AG Robert Ferguson) who is stepping out to fight Goliath in the pharmaceutical industry. I am crying tears of joy today. “
The complaint can be found here. Violations include:
- The Washington AG complaint states several violations of the Consumer Protection Act including assurances of safety and effectiveness of defendants mesh products even though that had not been validated in clinical trials.
- Compensating sales reps and doctors to contact hospitals and conduct presentations as well as direct to consumer marketing based on false assurances.
- Mesh was misrepresented to consumers as “soft and pliable and “a new and revolutionary surgical procedure,” while the company failed to disclose that it could incite foreign body reactions, shrink, fold, create bacterial colonies resistant to antibiotics, degrade, erode and oxidize.
- The company misrepresented the pelvic mesh for SUI and POP had been “FDA approved” which indicates some oversight. In reality, the FDA does not regulate most medical devices other than to require a predicate device been named that is the “substantial equivalent.”
- The Defendant did not include the dangers of mesh in its instructions for use (IFU). The risk of dyspareunia (painful sex) was not included until 2015; the risk of infection was included in 2012.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.