Other LanguagesMoney will go to women harmed by Bard’s conduct
OLYMPIA — Attorney General Bob Ferguson today announced that Bard, a medical device manufacturer and formerly one of the biggest manufacturers of transvaginal mesh devices, will pay $2.38 million to Washington for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices.
The money will go into a larger restitution fund, established after the Johnson & Johnson mesh recovery, for women who received transvaginal mesh devices. In April 2019, Ferguson announced a similar, separate resolution of Ferguson’s case against Johnson & Johnson over the company’s failure to disclose the serious risks of their surgical mesh devices. On the eve of trial, Johnson & Johnson agreed to pay $9.9 million to Washington.
All women who received transvaginal mesh implants in Washington are eligible to receive funds from the recovery. Between all major transvaginal mesh manufacturers in the United States, tens of thousands of Washingtonians were implanted with transvaginal mesh devices and will be eligible to receive restitution. Attorney General Ferguson’s restitution fund is separate from and not related to any recovery Washingtonians receive in a personal injury lawsuit regarding surgical mesh devices. Many lawsuits have been filed across the country regarding these devices.
The Attorney General’s Office will announce a formal claims process in the future. Due to privacy protections, the Attorney General’s Office does not know the identity of the many women implanted with transvaginal mesh in Washington state. Consequently, the Attorney General’s Office cannot reach out to all affected women directly. For questions about the mesh fund, please visit www.WAAGMeshSettlement.com or email info@WAAGMeshSettlement.com for more information. If you have previously submitted a claim at WAAGMeshSettlement.com, we already have your identity and information, and you do not need to do anything further.
In addition to the monetary payment, Bard must implement legally enforceable corporate reforms that will prevent the company’s harmful conduct from continuing in the future. These reforms include training for employees who sell the devices, clear information about risks in marketing materials, and full disclosure of the company’s role as a sponsor in clinical studies. Bard stopped all transvaginal mesh production in 2016, but these terms will apply if they begin manufacturing these devices again.
Washington is leading a bipartisan coalition of 48 state attorneys general and the District of Columbia in filing today’s resolution. Washington’s $2.38 million is part of a total nationwide recovery of $60 million.
“Bard deceived Washington women about the risks of its mesh devices,” Ferguson said. “Meanwhile, these patients faced life-altering side effects. I’m proud that our team could hold a powerful interest accountable and provide millions in relief to those who were harmed.”
Background
The surgical mesh devices Bard manufactured were implanted through the vagina and used to treat two conditions — pelvic organ prolapse, when organs shift from their normal position, and stress urinary incontinence. These conditions are non-life-threatening and can be treated via multiple, surgical and non-surgical methods.
The devices, made of polypropylene, are permanently implanted into the body to hold up falling organs. Removing the mesh is extremely difficult, and in some instances, impossible.
Bard failed to disclose serious and life-altering risks of its transvaginal mesh devices, such as scarring and shrinking of bodily tissue, pain with sexual intercourse, chronic pain and recurring infections, among other complications, according to the state's complaint.
Bard knew that some of the most serious risks it failed to include — chronic pain, infections and more — were associated with the use of its mesh devices. It also knew that the impact of these reactions would exponentially increase due to the difficulty of removing the mesh once implanted.
In 2016, Bard stopped selling all transvaginal mesh devices nationwide.
Details of injunctive relief
As part of today’s resolution, Bard is legally required to meet strict injunctive terms should the company ever re-enter the market for transvaginal mesh, including the following:
- Bard must describe complications in terms reasonably understandable to a patient in marketing materials that are intended to reach patients or consumers.
- In any training in which Bard provides risk information, Bard must disclose significant complications and complications inherent to mesh.
- When submitting a clinical study, clinical data, or preclinical data for publication, Bard must disclose its role as a sponsor and any author’s potential conflict of interest.
- Bard cannot cite to any clinical study, clinical data, or preclinical data regarding mesh, for which it has not complied with the disclosure requirements in the injunction.
- Bard must register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
- Bard must adequately inform and train independent contractors, agents, and employees who sell, market, or promote mesh regarding their obligations to report all patient complaints and adverse events to the company.
Assistant Attorneys General Daniel Allen and Breena Roos are lead attorneys on the case.
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The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Visit www.atg.wa.gov to learn more.
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