After a long saga of painful injuries to women and declining market sales causing companies to exit the market, the federal government recently ordered a halt in sales of mesh implants used to treat pelvic organ prolapse. However, this does not end the legal problems facing the makers of this product that proved to be deficient.

West Virginia files a pelvic mesh lawsuit

Pelvic-mesh

Transvaginal mesh lawsuit

Not only do they still face private lawsuits brought by injured patients, but state regulators are also now in the process of bringing legal action against them, compounding their legal problems. In September 2019, West Virginia filed a lawsuit against Ethicon, a major manufacturer of the product, alleging violations of state laws in its marketing practices in selling the product. Ethicon is a subsidiary of Johnson and Johnson.

 

The history of this product is unfortunately one that is filled with scores of injury reports and tens of thousands of lawsuits against the makers of the product. The mesh was inserted through the vagina to stabilize the pelvis. The mesh was made of synthetic material and remained in the body after surgery. Like hernia mesh, there were numerous problems after the mesh either migrated or disintegrated. The shifting mesh caused damage to the internal organs with which it came into contact.

Susceptible to infections

The mesh was also susceptible to infections, and when those occured, surgeons had difficulty fully extracting the mesh from the body. The end result is that tens of thousands of women have suffered from ongoing complications from what was supposed to be a routine surgery. After years of lawsuits and negative publicity, the dozens of companies manufacturing the product shrank to just two before the FDA put a stop to all sales of this product.

J and J sells defective products

Ethicon, a subsidiary of Johnson & Johnson, was one of the market leaders in this product before pulling out of the market. Ethicon has a history of recalls / market removals across the world and alleged defects in its mesh products and has faced thousands of lawsuits for these offerings. In addition to the civil lawsuits, Ethicon now faces the possibility of regulatory action.

California file lawsuit against ethicon

This specific lawsuit alleges that Ethicon misled consumers when it advertised the risks and effectiveness of pelvic mesh. This follows lawsuits that have been filed against the manufacturer by several other states. Ethicon has settled with some states that have filed actions while contesting other lawsuits. It is currently defending itself in court against charges brought by Callifornia.

Allegations of misrepresentation

The West Virginia lawsuit was filed by Attorney General Patrick Morrisey. One of the main charges is that Ethicon misrepresented the safety of the product. According to the complaint, Ethicon represented that the product was approved by the FDA. Pelvic mesh went through the 510(k) process, which is a much less stringent form of review. This process just requires manufacturers to show the FDA that the device at issue is similar to an already approved product on the marketplace. According to the state, the difference between a 501(k) Premarket Notification product and a FDA-approved product is significant.

Concealing risks?

In addition, Ethicon has been accused of concealing some of the risks of the product in its advertising and its instructions to physicians. Specifically, left out key information that related to some complications and side effects that would have been material for physicians. Doctors were a key demographic to keep informed since they made decisions about whether to use this mesh product during surgery.

Failure to update label

The complaint further alleges that Ethicon misrepresented the risks of the products in its “Warnings and Precautions,” Even after some of the complications were known, the company allegedly failed to update this label. The company knew of the side effects that women were experiencing and there was internal discussion about updating the label, but the company still did not do so. The complaint alleges that the primary reason for not doing this at the time was the company had already printed a batch of these warnings and did not want to pay extra to have them reprinted.

No safe way to remove

Normally, Instructions for Use should contain the information that any physician using the product would need to know. This would include all of the known complications. Physicians need the ability to be able to have an open discussion with patients of the benefits and risks of usage of the product. However, the company did not disclose to the doctors that there was no safe and effective way to remove the pelvic mesh from the body. This is a similar problem that has been encountered by hernia mesh patients.

Making product appear safe

The complaint further claims that Ethicon selectively quoted from studies with snippets that it claimed were evidence of the product’s safety, Ethicon is accused of funding a particular series of studies that it used as proof that this product was not harmful. The company purportedly did not disclose that the authors of these studies were actually paid consultants who were given financial incentives to produce data that showed that the products were safe. In addition, West Virginia claims that Ethicon even further took this study out of context, making this product appear safer. Companies will often cite studies as evidence of a product’s safety as they appear to be an objective measure of the danger of a product or the lack thereof.

Misleading the public

The complaint states that Ethicon knew all along of the dangers of the product at the same that it was misleading the public about the possible complications. The state has evidence of numerous emails where physicians specifically inform Ethicon of the side effects that their patients were encountering. Yet the marketing and instructions still remained the same, even after these communications. West Virginia claims that this violates numerous state consumer protection laws. The state is seeking an injunction that would keep Ethicon from employing similar practices in selling its surgical mesh products in the state. Ethicon also makes hernia mesh implants, so this case could have implications for the company’s hernia mesh business in the state.