The Kentucky Attorney General has filed legal action against Johnson & Johnson and its Ethicon Inc. division, alleging the companies manufacture defective vaginal mesh products.

The Attorney General alleges the companies concealed the dangers regarding defective vaginal mesh products in order to protect the market value of the products.

The Attorney General is seeking millions in civil penalties under Kentucky’s Consumer Protection Act, alleging that Johnson & Johnson misrepresented these defective vaginal mesh products as safe and effective to the public and health officials.

Johnson & Johnson’s vaginal mesh products were approved under the FDA 510(k) process, which allows products to be approved quickly without pre-clinical trials.

As long as the product proves to work at an equivalent level with a similar already released product, the product qualifies for the 510(k) process.

Normally medical devices have to undergo approximately 1,200 hours of review to determine their safety and efficacy, which produces a much more thorough investigation. Johnson & Johnson’s defective vaginal mesh products were approved by the FDA 510(k) process in order to bypass the long safety evaluation process.

Overview of Johnson & Johnson Defective Vaginal Mesh Products

According to the Attorney General, over 15,000 women in Kentucky were implanted with defective vaginal mesh products from Johnson & Johnson and suffered serious complications. The company allegedly failed to provide sufficient warnings regarding side effects and did not provide any surgical instructions.

By doing this, Johnson & Johnson prevented both doctors and patients from making informed choices for their medical decisions. These women suffered from the following complications: urinary dysfunction, pain from sexual intercourse, mesh erosion and device failure.

Previously in 2005, Johnson & Johnson medical director Axel Arnaud proposed stronger warnings be attached to the vaginal mesh products.

More specifically Arnaud recommended this warning to be added to the company’s vaginal mesh products: “Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.”

Johnson & Johnson opted not to include this warning on the vaginal mesh products, with patients and doctors later complaining that they believe they were not given adequate warnings against vaginal mesh complications.

The FDA has recently reclassified vaginal mesh devices as high risk, requiring them to undergo the agency’s strictest safety evaluations before going to market.

At this time, there are seven separate multidistrict litigation (MDL) movements consisting of 70,000 vaginal mesh lawsuits filed against Johnson & Johnson.

These claims are pending in West Virginia, with each claim alleging injuries from the defective vaginal mesh products.