A federal judge in California recently entered an order approving a $12.3 million settlement involving Caldera Medical’s transvaginal mesh product and associated insurance claims. According to the terms of the settlement, Caldera’s insurance company will provide $10.6 million in payments to nearly 3,000 members of the class, in addition to over $600,000 in payment for attorney’s fees and costs associated with the lawsuit.
The judge issued the order despite 36 objectors who wanted the court to order an independent audit. The objectors argued that there was not enough evidence regarding whether the payment would be larger if the company, based in Agoura Hills, CA, went through a liquidation.
Regarding the mesh product, Caldera’s Vertessa Lite mesh was made of polypropylene mesh and used repair pelvic organ prolapse. Some reports estimate that as many as 40 percent of women experience some type of prolapse and that as many as 250,000 surgical procedures are performed to address this condition each year. When marketing the product, Caldera claimed that it was 31 percent stronger than other comparable mesh products on the market, lighter, and that it featured stronger suture pull-out strength.
In June 2015, the company received a 510(k) clearance from the US Food and Drug Administration. Through this process, a medical device company must give the FDA 90-days notice that they intend to market a new medical device. The FDA then undertakes an examination of the product to determine whether it is equivalent to a comparable device on the market that has already received approval from the agency.
According to a number of lawsuits filed against Caldera, the mesh device contains a design defect that puts patients who receive it at risk for experiencing mesh erosion, scarring, migration, and other potentially permanent side effects including chronic pain. The company is also facing a number of lawsuits regarding its Desara and T-Sling pelvic mesh products containing similar allegations about severe injuries resulting after implantation of the devices.
If you have experienced an injury as the result of a transvaginal mesh product, you may be entitled to compensation. Currently, there are countless lawsuits pending against a variety of companies who developed, manufactured, and marketed transvaginal mesh products. These lawsuits generally allege that the manufacturers failed to provide adequate warnings about the potential side effects of the devices and that some of the devices contained a design defect. Virtually every state in the US has adopted some type of strict liability cause of action, which allows an injury victim to receive compensation from a manufacturer who sells a product that is designed in a defective manner or which fails to include proper warnings about its side effects and potential dangers.
At Moll Law Group, our dedicated team of dangerous medical device lawyers have handled numerous transvaginal and pelvic mesh cases and are prepared to help you investigate your claim, gather evidence, and assert your rights. Based in Chicago, we proudly serve women and their families throughout the country, including New York, California, and Texas. We offer a free consultation to help you learn about your legal rights and options. To set up your appointment, call us now at 312-462-1700 or contact us online.