The bellwether trial, which began on August 2 before U.S. District Judge Edmund A. Sargus, Jr. is underway in the Southern District of Ohio. Included in the trial is in-person of video-tape testimony from about 24 fact and expert witnesses.
FDA Expert Witness
Bard asked that expert witness testimony of Dr. Michael G. Beatrice, acting as an FDA expert, be excluded, but Judge Sargus rejected the request. Beatrice will likely testify on the FDA’s labeling requirements and regulations.
“Dr. Beatrice relies on his knowledge and expertise on FDA regulations, rendering his opinions reliable,” determined the Court. “He worked for the FDA for twenty-two years as a regulator, inspector, and review; spent 13 years at a multinational corporation as a regulatory and compliance officer, and since then has served as a consultant doing the same.”
The FDA has stated that numerous complications associated with mesh products are associated with products that have been recalled but are still used. C.R. Bard (among others) is accused of manufacturing and selling a defective product while also failing to warn both patients and doctors about the risk of mesh failure and its complications.
Plaintiff Steven Johns, who had problems with Bard’s Ventralight ST mesh, has been selected from thousands of cases in the multi-district litigation (MDL) claiming that “defects in defendant’s polypropylene hernia mesh products can lead to complications when implanted in patients.” Patients who have undergone surgery to repair a hernia may experience serious complications if the mesh fails to adhere or slips out of place, including adhesions, damage to organs, infections and more.
According to Johns’ lawsuit filed in October 2018, “Plaintiff’s position is that the device was defective and unreasonably dangerous in that it did not perform as reasonably expected given its intended use, and that there were safer alternative designs which were economically and technologically feasible at the time the device left Defendants’ control. Plaintiff further alleges that Defendants failed to provide adequate warnings about the risks (including complications, frequency, severity and duration), the inadequate research and testing prior to distribution, and the proper way to use the Ventralight ST mesh.”
The FDA states that a hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot.
The hernia is removed or pushed back into the abdomen during hernia repair surgery. The surgeon then closes the weakened abdominal muscles with a piece of mesh made of synthetic plastic called polypropylene that is sewn into place to strengthen the abdominal wall.
READ MORE SURGICAL MESH LEGAL NEWS
C.R. Bard, now branded as Bard, was purchased for $24 billion by Becton Dickinson, a medical technology developer specializing in vascular, urology, surgery and oncology devices. In recent years, over 16,000 product liability lawsuits have been filed against Bard throughout the federal court system and Rhode Island state court.
If you had a hernia mesh that was implanted after 2010, was removed or corrected, and caused injury, you may want to seek legal help: you may be entitled to compensation.