Johnson & Johnson has faced a number of legal issues surrounding its transvaginal mesh product for women. Although the company pulled the product from the marketplace years ago, Johnson & Johnson is still in the process of settling thousands of older cases. In addition to scores of product liability lawsuits filed by injured women, state attorneys general have gone after the company for the practices it used to market this product that turned out to be dangerous. Johnson & Johnson settled this legal action and Arizona will receive $2.8 million from the settlement. While this is one legal issue out of the way for Johnson & Johnson, the company still faces several thousand lawsuits stemming from this particular product before this chapter of company history closes.
History of Transvaginal Mesh
Transvaginal mesh was one of the most controversial medical devices in history. The product was an implant inserted through the vagina to treat pelvic organ prolapse and stress urinary incontinence. Of course, it is referred to in the past tense since the FDA ordered the remaining two companies that sold the product to pull it from the marketplace earlier this year due to safety concerns. The issue with transvaginal mesh was that the mesh would shrink, fray or migrate out of place. When this happened, it would cause women intense debilitating pain.
Many women required several subsequent surgeries to remove the mesh and, even then, surgery was still unsuccessful since the mesh is virtually impossible to remove once it has been implanted. Other women suffered organ damage since the shifting mesh contacted other nearby internal organs. Tens of thousands of women had their lives ruined by this product. The product is blamed for 80 deaths and approximately 10,000 serious injuries. Reports of injuries from the transvaginal mesh have been worldwide.
In addition to the consumer lawsuits, Johnson & Johnson also faced a lawsuit from state attorneys general. This lawsuit was rooted in the company’s marketing that is used to sell the product. 41 states and the District of Columbia had filed suit claiming that the company did not fully disclose the risks of its product. This meant that women and their physicians could not make an informed health choice about whether to receive the mesh as an implant.
While failure to disclose product risks is a ground for a product liability lawsuit from an injured consumer, it can also form the basis of a state enforcement action. State laws require an element of truth in advertising, and companies cannot resort to deceptive practices to market their products. In many cases, the same conduct that can cause a company to lose a lawsuit to a consumer can also be a violation of the laws of a state. A failure to disclose, even if it is not an affirmative misrepresentation, can still be a deceptive marketing practice. Companies owe an obligation to consumers when marketing a product not to make any material misstatements or omissions.
With regard to transvaginal mesh, the company made claims about the safety of the product that were not true. Johnson & Johnson represented that the product was FDA-approved when that was not the case. It also did not disclose that the side effects could be permanent along with other general failures to provide relevant information.
Here, Arizona’s share of the settlement was $2.8 million. However, when it is the state the brings these charges against companies, unless there is a settlement fund established, the money does not go to the people who have been wronged by the conduct. The money will go into the state’s coffers, but sometimes the states will use it to help victims.
In this case, Johnson & Johnson settled the case without admitting liability for its actions. The company did agree to take several steps to change the way that it markets its transvaginal mesh product. However, the company has already taken the product off the market due to the dangers and will not be selling it in the future. Some of the provisions of the agreement will presumably apply to the marketing of Johnson & Johnson’s other products.
Notably, this settlement does not apply to every state. California’s lawsuit against Johnson & Johnson is proceeding separately from this case. There was a July 2019 trial in state court and a verdict will be issued in the future. The company could face damages as high as $1 billion depending on how the court values the potential violations of state law. The company has defended against the claims arguing that the disclosure given to women was adequate.
On the civil side of the ledger, Johnson & Johnson has had a difficult year when it comes to its transvaginal mesh product. Two different juries in Philadelphia have hit the company with damage awards of $120 million and $80 million respectively. Both of these verdicts are currently on appeal where the company is attempting to either have the verdicts overturned or the steep punitive damages reduced. In general, pelvic mesh has resulted in nearly $8 billion of settlements between product makers and consumers.
For Johnson & Johnson, the transvaginal mesh settlement represents just the latest in its year that has been filled with legal defeats. The company has lost verdicts in cases alleging that its talc powder is carcinogenic as well as litigation relating to its role in the opioid crisis. Johnson & Johnson also was assessed a large verdict in the Risperdal lawsuits. The company has also settled nearly a billion dollars of cases relating to transvaginal mesh. This has had a depressing effect on the company’s share price as investors have worried about the sum total of its liability. If you or a loved one has been injured by transvaginal mesh, contact the Law Offices of Sadaka Associates for an evaluation of your case.