Johnson & Johnson is facing bigger problems over the company’s Ethicon subsidiary’s vaginal mesh devices than just dealing with the thousands of lawsuits pending against it. J & J officials have indicated that they are now dealing with an investigation by the Department of Justice and numerous states over the company’s marketing practices linked with the vaginal meshes as well.
The DOJ is looking to see if the company engaged in illegal marketing practices when launching the surgical mesh devices, which may also show that the drug giant defrauded the government health coverage programs. J & J announced the investigations against it in the company’s annual filing with the Securities and Exchange Commission (SEC) for 2012. In that filing, J & J indicated that the DOJ had issued a multi-state Attorney General investigation over the mesh products used for hernia and urogynecological purposes such as pelvic organ prolapse and stress urinary incontinence. The company is being investigated by 42 different states that are trying to figure out if Ethicon “entered into a tolling agreement with the states involved to hold off on filing a lawsuit.” Ethicon already faces over 1,800 lawsuits over the complications linked with the Gynecare Prolift vaginal mesh kit — one of which has already resulted in a $3.3 million award for plaintiff Linda Gross.
Both pelvic organ prolapse and stress urinary incontinence occur after childbirth or menopause. Vaginal mesh lawsuits also have been filed against numerous other makers of various mesh devices, including C.R. Bard, Coloplast, American Medical Systems and Boston Scientific. The lawsuits all claim failure to warn once it was discovered that the vaginal mesh devices were causing complications that often required surgical removal of the device to correct. Some of those complications include erosion, infections, vaginal scarring and painful intercourse.