In the first pelvic mesh trial to go forward against Boston Scientific, the plaintiff obtained a victory from a Massachusetts court, which overturned a prior verdict rendered in 2014 that had dismissed the case. The plaintiff will now be able to proceed with a new trial. Boston Scientific’s pelvic mesh product has been the subject of thousands of lawsuits, resulting in the compilation of a Multi-District Litigation proceeding in West Virginia.
The plaintiff in the case, Diane Albright, contended that the company’s Pinnacle mesh product was designed in a defective manner and resulted in her experiencing serious injuries. The woman received the device to treat her pelvic organ prolapse condition. In July 2014, the jury hearing her case concluded that Boston Scientific designed the device properly and that it provided sufficient warnings about the risks associated with the product. The plaintiff appealed this verdict, stating that the lower court judge erred when it precluded the jury from hearing evidence regarding a material safety data sheet for the polypropylene that the company included in the mesh. The plaintiff argued that this MSDS document showed that the chemical was not appropriate for implantation in the human body.
The plaintiff also contended on appeal that the judge committed reversible error in preventing two letters from the FDA that were sent to Boston Scientific from being included in the evidence. The letters included directions from the federal agency ordering Boston Scientific to perform post-market surveillance studies for its mesh product. The letter also showed that the FDA agreed to suspend this order to perform studies after Boston Scientific said that it was no longer intending to sell the mesh product.
On review by the Massachusetts Appeals Court, the reviewing justices determined that the jury should have been given an opportunity to review the MSDS sheet and the two letters from the FDA. The letters could have been used at the very least to cross-examine witnesses offered by Boston Scientific. And when it came to the MSDS documents, the appellate court stated that these were material evidence tending to show that the company knew or should have known about the potentially dangerous side effects of the materials it used to make its mesh product.
The plaintiff had also argued on appeal that the lower court erred when it excluded evidence regarding the 501(k) clearance that the company received for its mesh product. This term describes a process by which a medical device manufacturer can obtain a fast-tracked approval from the FDA to market and sell a new product if that product is substantially similar to one that has already been approved. The judge concluded that evidence of the 501(k) application and approval would have confused the jury or created unnecessary issues in the case.
If you have suffered injuries as a result of using a transvaginal mesh product, you may be entitled to compensation. At Moll Law Group, our transvaginal mesh attorneys have assisted injured women and their families throughout the country, including in Florida, Texas, California, and New York. Offering a free consultation to help you learn more about your potential case, we will treat you with the personal attention and compassion that you deserve during this difficult time. Call us now at 312-462-1700 or contact us online.