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South Carolina to get $4M in medical device settlement

Staff Report //October 18, 2019//

South Carolina to get $4M in medical device settlement

Staff Report //October 18, 2019//

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South Carolina is getting $4,097,718 in a multistate settlement involving Johnson & Johnson and its subsidiary, Ethicon Inc., for deceptive marketing of transvaginal mesh devices.

S.C. Attorney General Alan Wilson announced the nearly $116.9 million settlement involving 40 other states in a news release Thursday. Women injured by the product will receive payment for past and future medical costs through separate lawsuits brought by victims.

A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to disclose risks associated with their use.

Transvaginal mesh is a synthetic material that is surgically implanted to support the pelvic organs of women who suffer from pelvic organ prolapse or urinary incontinence. Evidence uncovered in the investigation revealed the companies were aware of the possibility of serious medical complications but did not sufficiently warn consumers or the surgeons who implanted the devices. 

Under the settlement, Johnson & Johnson agreed to pay $116.86 million to the 41 participating states and the District of Columbia. The settlement also includes injunctive relief, which requires full disclosure of the device’s risk and accurate information on promotional material and the product’s informational package inserts.

Companies also are prevented from referring to the mesh as “FDA-approved,” must inform medical professionals of the risks involved with using the surgical mesh and disclose risks associated with its use. The companies must also disclose that additional surgeries may be necessary to treat complications, and that those surgeries may not resolve complications and may contain a risk of adverse reactions.

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