
A Michigan woman who allegedly suffered severe vaginal mesh side effects is among the most recent plaintiffs to join the transvaginal mesh multidistrict lawsuit litigation (MDL) currently underway in a West Virginia federal court. Plaintiff Henriette Vanegmond filed her complaint in the U.S. District Court for the Southern District of West Virginia on May 8, 2012. Her husband William is a co-plaintiff in the suit. The couple alleges that Endo Pharmaceuticals and its subsidiary American Medical Systems (AMS) designed and marketed a defective and dangerous device.
The specific device at issue, which was implanted in Vanegmond, is the Monarc Subfascial Hammock and Perigee System with Intepro Lite. The Monarc Hammock is a type of transvaginal polypropylene mesh system designed to treat pelvic organ prolapse and stress urinary incontinence, common conditions that affect millions of women. According to Vanegmond’s vaginal mesh lawyer, soon after the device was implanted she began to suffer severe side effects, including extreme pain, tissue damage, and painful scarring. She reportedly required additional surgeries to remove the device and repair the damage it caused.
The Vanegmonds’ eleven-count vaginal mesh lawsuit alleges that Endo and AMS negligently designed and sold a defective device, but it also alleges that both companies consistently underreported adverse events and withheld information regarding their product’s high rates of failure and complications. The complaint alleges that both companies knew of the high risk of dangerous vaginal mesh side effects, but failed to warn either patients or medical professionals – a failure that the complaint describes as “despicable” and “contemptible.”
Vanegmond alleges that had she been fully informed of the high risks of failure and complications associated with the mesh device, she would not have agreed to its implantation.
Though the monofilament polypropylene mesh is advertised as biologically inert, medical evidence has shown that the material provokes a serious adverse immune response in some patients. The immune response can cause tissue damage and contribute to the rapid failure of the mesh. When the mesh erodes or extrudes, intensive and invasive medical treatments are required to find and remove the mesh and repair the damage. These reoperations can be painful, debilitating, and highly risky.
Hundreds of women like Vanegmond have filed vaginal mesh lawsuit claims to recover damages for their injuries. Many of those claims, brought to court by a vaginal mesh lawyer, have been consolidated at the state level in the ongoing New Jersey mass tort, and at the federal level in the West Virginia MDL.
New York resident Angela Wright, along with her husband, filed a Yasmin lawsuit on May 7, 2012, in the U.S. District Court, Northern District of New York. Wright blames manufacturer Bayer for injuries sustained allegedly as a result of the ingestion of Yaz and Yasmin, namely, Yaz blood clots.
Yasmin was approved by the FDA in 2001 for use as a combination oral contraceptive, with comparative drug Yaz approved in 2006 for similar use. Since then, several studies have indicated that these birth control pills and others that contain the progestin “drospirenone” put women at an increased risk of side effects like blood clots, stroke, Yaz pulmonary embolism, and even Yaz death.
According to her Yaz lawsuit, Wright first began using Yaz and Yasmin around January 2010 and stopped using it in June 2011. Allegedly as a result of taking the drug, she suffered bilateral pulmonary emboli (blood clots in the lungs), deep vein thrombosis, abdominal pain, vaginal spotting/bleeding, and dysuria (painful urination).
Many women who took these oral contraceptives complain of similar injuries. Yaz pulmonary embolism—a complication of deep vein thrombosis—can be particularly dangerous and even cause Yaz death if not detected quickly enough. Blood clots form in the deep veins of the legs, and then can travel through the blood stream to lodge in an artery leading to the lung. The result is an increase of pressure on the right ventricle of the heart, and a decrease in blood supply to the lung.
In December 2011, an FDA advisory panel announced that the Yaz side effects warning label was inefficient. A prior FDA analysis of adverse event reports determined that 10 in 10,000 women taking Yaz would develop blood clots, compared to 6 in 10,000 in women taking other hormonal contraceptives. A second FDA study showed a 75% increased risk of Yaz blood clots.
On April 10, 2012, the FDA released an announcement stating they were requiring new warning labels on all birth control pills that contain drospirenone, detailing recent studies that suggest these pills may carry a slightly higher risk of blood clots than pills using other progestins.
Wright notes in her Yasmin lawsuit that the defendants were warned at least three times by the FDA in 2003, 2008 and 2009 for misleading the public through use of television ads that minimized the risks of the contraceptives. She further states that the defendants ignored the increased risk of developing Yaz blood clots, despite the scientific and medical evidence available.
Wright brings counts of negligence, manufacturing and design defects, failure to warn, liability, negligent misrepresentation, fraud and deceit, unfair and deceptive trade practices, and consumer fraud. She and her husband seek punitive and exemplary damages.