Transvaginal Mesh Lawsuit Background. After more than ten years, a woman’s transvaginal mesh (TVM) case is finally over. Johnson & Johnson (J&J) has exhausted their appeals after repeatedly appealing a verdict that had awarded the plaintiff more than $11 million in damages for her TVM injuries.
The plaintiff had been suffering from pelvic organ prolapse and stress urinary incontinence and had transvaginal mesh surgery ten years ago to alleviate her condition. Shortly after receiving the Prolift implant, the plaintiff experienced extreme pain and multiple complications. These included nerve damage so serious she was not able to work in her profession as a nurse, have sex with her husband, or sit comfortably for more than 20 minutes at a time. The plaintiff underwent three surgeries to remove the mesh.
The plaintiff and her husband filed a lawsuit against Johnson & Johnson, Ethicon Inc., and Gynecare in November 2008, the first such case against the pharmaceutical giant.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from medical devices, including transvaginal mesh implants.
After a case that dragged on until February 2013, the jury decided the following: Prolift was not defectively designed; J&J did not provide sufficient warnings to the surgeon who performed the implantation; J&J’s failure to provide adequate warnings was a direct cause of the plaintiff’s injuries; J&J did not make a fraudulent misrepresentation to the plaintiff’s implanting surgeon; J&J made a fraudulent misrepresentation to the plaintiff; and J&J’s fraudulent misrepresentation to the plaintiff was a direct cause of her injuries.
Financial Compensation Awarded
The plaintiff was awarded $3.35 million in compensatory damages and $7.76 million in punitive damages by the jury. At one point, it was reported that following the verdict, J&J moved for judgment notwithstanding the verdict. The judge, however, reserved decision. J&J fought the decision up until the present when the plaintiff finally got justice.
The pain the plaintiff suffered was undeniable. J&J faces thousands more comparable lawsuits. It is hopeful that the coming year will bring justice for these women.
Similar to J&J, Boston Scientific, a Massachusetts-based company founded in 1979, lost its appeal in its Obtryx mesh trial involving four different women. In 2015, a jury awarded the women $18.5 million. Boston Scientific faces about 16,000 additional lawsuits, reports U.S. Recall News (December 16, 2016). The drug manufacturer made $7.6 billion in transvaginal mesh sales, so it had the financial means available, but the TVM lawsuits in 2017 will most assuredly make a significant dent it its profits.
Boston Scientific’s ProtoGen was the first mesh sling to be made. It was pulled from the market in 1999 due to safety concerns, but other manufacturers developed their own mesh products using ProtoGen’s design. The manufacturers of a number of these products have since removed their mesh products from the market.
Boston Scientific is one of six major manufacturers named in lawsuits filed by over 70,000 women injured by surgical mesh implants.
FDA Warns of Complication with TVM Devices
The U.S. Food and Drug Administration (FDA) approved TVM devices to treat pelvic organ prolapse and stress urinary incontinence. These conditions are meant to be improved when additional support is provided by the mesh implant for the sagging pelvic organs and muscles.
In 2011, the FDA warned that complications appeared to be disturbingly frequent, despite what had been previously communicated in 2008 by the agency. The FDA said the most common transvaginal mesh injuries reported were: mesh erosion, infection, pain, urinary problems, recurrence of prolapse, and incontinence.
In addition, patients with TVMs experienced perforation of the bowels, bladders, and blood vessels.
Transvaginal mesh implants were approved through 510(k), meaning the device makers do not have to provide evidence of the safety and efficacy of the new product as long as it is “substantially equivalent” to a product that has been previously approved. This fast track method has been criticized by plaintiffs as well as patient advocates due to issues and safety concerns with other medical devices also approved through 510(k).
Consequently, the FDA has reclassified the TVM from “moderate risk” to “high risk,” so it may no longer be approved by way of the 510(k) process. The TVM must now go through the FDA’s more stringent premarket approval (PMA) providing proof that the products are both effective and safe.