In making its decision, the Judicial Panel found that the lawsuits "share factual questions concerning such matters as the design, manufacture, safety, testing, marketing and performance" of the hernia patches. The panel also noted that each of the lawsuits involved allegations of defects in the Kugel Mesh Patch.
One lawsuit filed against C.R. Bard, parent company of Davol Inc., alleges the hernia patch malfunctioned, causing the plaintiff to suffer nerve damage. According to the lawsuit, the plaintiff required subsequent surgeries to remove the defective hernia patch.
A different lawsuit was filed by the estate of an Ohio man who allegedly died after complications from a defective Kugel Mesh Patch. According to the lawsuit, the man developed a bowel obstruction at the hernia site. The patient underwent three surgeries in six days to repair the problems, including removing his small bowel and spleen. However, his condition was fatal and he died less than six months after having the hernia patch implanted.
The Kugel Mesh Patch was designed to repair ventral hernias, caused by thinning of scar tissue that forms after surgery. The patch is inserted through a small incision and is held closed by a memory recoil ring that allows the patch to spring open once it is properly inserted. However, the memory recoil ring can break, causing serious complications including infections, bowel perforations and chronic intestinal fistulae.
Because of the reports of complications related to the Kugel Mesh Patch, the patch was the subject of a Class 1 FDA recall. The recall was categorized as Class 1 because there is a reasonable probability that defects associated with the patch could cause severe health consequences and, in some cases, death. However, despite recalling all unused units, doctors were told not to remove the patch from patients unless necessary.
READ MORE LEGAL NEWS
Davol Inc. has been reprimanded by the FDA for failure to accurately report the severity of complaints about the Kugel Mesh Patch. The FDA also reported serious problems in the manufacturing, storage and packing of Davol's products and warned Davol to create a proper system to handle product complaints.
Lawsuits filed against Davol Inc. include charges of wrongful death, negligence, deceptive trade practices, fraud, and product liability. Plaintiffs allege that Davol Inc., knew about problems with the Kugel Mesh Patch long before doctors and patients were warned. Furthermore, they argue that Davol Inc. and C.R. Bard did not properly carry out a recall of the patches.