MA Appeals Court Reinstates Pelvic Mesh Lawsuit

As reported by Harris Martin, an appeals court in Massachusetts has reversed the dismissal of a pelvic mesh lawsuit against Boston Scientific and American Medical Systems (AMS), after finding the case adequately claims injuries resulting from the implants. The court order handed down on October 9 overturned a prior ruling in Suffolk County Superior Court, which dismissed this case on the basis that it did not meet pleading standards of surgical mesh litigation.

Allegations cited in the complaint state that the plaintiff suffered severe transvaginal mesh complications including vaginal scarring, mesh erosion and other adverse effects purportedly caused by devices manufactured by the two companies. The products in question are the Perigee Transobturator Anterior Prolapse Repair System made by AMS and the Monarch and Pinnacle Pelvic Repair Systems produced by Boston Scientific. The Massachusetts appeals court further determined that the claimant adequately alleged the defendants negligently manufactured, promoted and sold the products and/or engaged in unfair or deceptive practices.

According to thelawsuit, the devices’ polypropylene material is biologically incompatible for their intended purpose. The claimant alleges severe bodily injuries from using the mesh devices and had to endure several corrective surgeries to address her complications.

“Allen has alleged, amongst other things, that she was implanted with three devices that were marketed as a safer alternative to other products and procedures on the market; that these products contained a mesh component that has a tendency to erode, thereby causing severe complications; that the defendants did not provide either her or her physicians with any warnings as to the products’ propensity to erode; and that, after these devices were implanted, she experienced recurrent pain and has since undergone multiple revisionary surgeries,” the Massachusetts court stated.

Surgical mesh litigation escalates in federal court

Like manufacturers Cotoplast, Ethicon and C.R. Bard, both Boston Scientific and American Medical systems have been named as defendants in thousands of products liability lawsuits currently pending in courts around the country. The bulk of these pelvic mesh lawsuits have been transferred to multidistrict litigations (MDLs) consolidated in the U.S. District Court for Southern District of West Virginia, where Judge Joseph Goodwin is overseeing all pretrial proceedings. The MDLs currently pending include C.R. Bard (MDL No. 2187), Johnson & Johnson’s Ethicon subsidiary (MDL No. 2327), American Medical Systems (MDL No. 2325), Boston Scientific Corp., (MDL No. 2326), Cook Medical (MDL No. 2440), and Cotoplast (MDL No. 2387).

Court dockets show that more than 25,000 cases have been centralized in West Virginia federal court, and while the lawsuits involve different brands of surgical bladder slings and pelvic mesh implants, the alleged injuries and complications are quite similar among the plaintiffs. The majority of women who pursued a pelvic device injury lawsuit argue that the implants suffer design and manufacturing defects, putting patients at unnecessary risk for mesh erosion, chronic infections, abscesses, organ injury and other life-altering side effects.

Since October of 2008, the FDA has cautioned the public about serious complications associated with pelvic mesh implanted through the vagina (transvaginal placement) to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), warning that complications are not rare, and risks of surgical mesh may outweigh their perceived benefits.

Complications from transvaginal mesh “not rare” says FDA

The FDA website indicates that from January 2008 through December 2010, the agency received 2,874 reports of vaginal mesh complications associated with pelvic mesh used to treat POP and SUI. Since then, federal regulators have determined that adverse events associated with transvaginally placed mesh can be life-threatening for women, often times requiring multiple revision surgeries to remove the devices and attempt to repair the internal damage.

Even more alarming, the FDA concluded that approximately 10 percent of patients undergoing transvaginal POP repair with mesh experienced erosion within 12 months of surgery. These results were based on data from 110 studies including 11,785 women. It comes as no surprise then that thousands of women who were treated with vaginal mesh are now pursuing monetary damages for their pain, suffering, medical expenses and lost wages through a pelvic device injury lawsuit.