Ohio Settles Lawsuit With Johnson & Johnson

COLUMBUS, OH — A multi-state lawsuit against Johnson & Johnson, accusing the company of deceptive marketing, has been settled to the tune of $117 million. Ohio will receive $6.3 million under the settlement, Dave Yost, state attorney general, announced.

The lawsuit accused the company of misleading marketing of its transvaginal surgical mesh devices, which are surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse, Yost said.

A multi-state investigation accused Johnson & Johnson of not disclosing the possible side effects of the device, including chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations and vaginal scarring.

The lawsuit said Johnson & Johnson officials were aware of the possible side effects but did not sufficiently warn customers or surgeons. However, the settlement does not include an admission of misconduct, according to Johnson & Johnson.

“Patients can’t make the best decision for their health unless they and their health care providers know all the pros and cons of a product,” Yost said. “These companies didn’t paint a clear picture of the device’s medical risks, preventing patients from making well-informed decisions.”

The settlement does require Johnson & Johnson to fully disclose the device's risks on promotional materials, in addition to the product’s “information for use” package inserts. According to Yost, the company must now:

• Stop referring to the mesh as “FDA approved”
• Stop suggesting risks associated with mesh can be eliminated by surgical experience or technique alone.
• Ensure product training provided to medical professionals covers all risks associated with the mesh.
• Stop claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur.
• Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs.
• Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring.
• Disclose that risks include that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications and that revision surgeries are also associated with a risk of adverse reactions.

The lawsuit and investigation include 41 states and the District of Columbia.