Carr Announces Multistate Settlement with Johnson & Johnson and Ethicon, Georgia to Receive More Than $3.3M
Monday, October 21st, 2019
Attorney General Chris Carr announced a multistate settlement along with 40 states and the District of Columbia requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $116.9 million for their deceptive marketing of transvaginal surgical mesh devices.
“Failing to adequately inform patients and doctors of the serious risks associated with these devices put in jeopardy the welfare of countless women,” said Attorney General Carr. “That is unacceptable, and we think this settlement sends a strong message.”
A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use. Georgia will receive $3,375,570.03 under the settlement.
The multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and scarring. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and District of Columbia. The settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Among the specific requirements, the companies must:
Refrain from referring to the mesh as “FDA approved” when that is not the case
Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone
Ensure that product training provided to medical professionals covers the risks associated with the mesh
Omit 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 (when in fact they will 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 following states are also party to this multistate settlement: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.