TVT-O is a plastic mesh that is used to treat urinary incontinence. It is inserted into the body vaginally. However, the product has been known to cause serious side effects in the women who have received it. As a result, Johnson & Johnson, the manufacturer of the product, has been hit with several large jury verdicts for damages. This includes a staggering $120 million verdict issued by a jury in Philadelphia that not only sought to compensate the plaintiff for her suffering, but also attempted to hold the company accountable for its conduct through punitive damages.
TVT-O is intended to stop urinary leakage from occurring. The mesh is inserted underneath the urethra and is a permanent implant into the body. Once the mesh is placed in the body, the surrounding tissue grows around it and incorporates the mesh into the area.
However, in practice, this is not what has happened for thousands of women. Mesh products are usually made out of plastic substances. The manufacturers of these products claim that the plastic is inert and is not a home for bacteria or any other kinds of infections. However, many women have developed infections at the site of the mesh. Some women have reported chronic urinary tract infections that have caused them constant pain. Other women report that it is difficult or impossible to have sexual relations due to the mesh. Many women who have received this mesh have had to undergo numerous follow up surgeries to help them cope with the pain.
This particular case focused on the design on the mesh in arguing that it was defective. The design of this particular product both caused it to erode after it was implanted and may it susceptible to infection. In addition, the plaintiff maintained that Johnson & Johnson failed to conduct the required testing on this product. Had it done so, it would have discovered that the product was defective and dangerous. Courts in two other jurisdictions had previously reached the same conclusion that the product was defective as plaintiffs prevailed in courts in both West Virginia and Texas.
Much of this particular verdict consisted of punitive damages assessed against the company. A jury will add punitive damages to the verdict when it believes that corporate misconduct merits it. Many different plaintiffs have argued that Johnson & Johnson has known of the defects in its products for a long time and, instead of warning patients or pulling the product from the marketplace, continues to take steps to hide the fact that its product is dangerous. This is evidenced by some of the grounds in the lawsuits that plaintiffs are filing against the company. Johnson & Johnson is accused not only of selling a product with design defects, but also of fraudulent concealment of these defects. This is the type of conduct that tends to anger juries and causes a visceral reaction when they are deciding damages. Other recent product liability cases such as the Roundup litigation where the jury has seen corporate misconduct have also resulted in high punitive damage awards.
Johnson & Johnson has been the defendant in numerous legal actions both in Philadelphia as well as nationwide for side effects from its family of vaginal mesh products. The company has lost a number of lawsuits recently, including another one for a different type of mesh where the jury assessed it with an $80 million verdict. Just in Philadelphia court alone, the company has been hit with verdicts totaling over $300 million. Johnson & Johnson faces tens of thousands of lawsuits nationally for all of its types of mesh products with several other cases currently being heard in Philadelphia and hundreds more in the future.
Notwithstanding the reports of complications and the large jury verdicts against it, Johnson & Johnson adamantly maintains that this product is completely safe. Even though the company exited the market for other types of vaginal mesh that was deemed dangerous, it refuses to pull this particular product from the market. The company simply believes that the jury heard and incomplete presentation of the evidence due to a judge’s evidentiary ruling, and had the jury been able to hear evidence about the FDA’s approval of the device, it would have reached a different verdict. The company is appealing the verdict. Oftentimes, these large verdicts are reduced on appeal, even if the judgment remains. However, another recent verdict against the company in Philadelphia was upheld by the court on appeal.
Given the company’s defiant and unapologetic stance, it is likely that lawsuits will continue for the foreseeable future. However, as the company loses more high-profile cases with large punitive award verdict, they may seek to negotiate a settlement. Potential plaintiffs who have been injured by this product should seek legal counsel to consider the possibility of filing a claim against Johnson & Johnson.
The Law Offices of Sadaka Associates is well-versed in handling these cases. If you have experienced complications due to transvaginal mesh, please contact our office for a free evaluation of your case.
Learn more about Medical Device Lawsuits.