Johnson & Johnson and it’s Ethicon subsidiary face a product liability lawsuit, which alleges that a Tennessee man suffered a recurrent hernia, adhesions and other complications after the failure of an Ethicon Physiomesh patch.
The complaint (PDF) was filed by Robert Burdge in the U.S. District Court for the Western District of Tennessee on May 22, indicating that the Johnson & Johnson hernia mesh was defectively designed, and posed an unreasonable risk of severe adverse reactions.
During a laparoscopic repair of an incision hernia in December 2014, Burdge had a 35cm by 25cm Ethicon Physiomesh patch implanted in his body, which was marketed as a safe and effective hernia repair product. However, Burdge indicates that he developed severe complications from the Johnson & Johnson hernia mesh, resulting in a second surgery in September 2016.
At that time, doctors discovered Ethicon Physiomesh failure, resulting in a large incisional hernia and extensive adhesions. The old Physiomesh had to be resected from his abdominal wall and explanted, leaving Burdge with severe and permanent injuries, which continue to impact his daily activities and may require additional surgery in the future, according to the lawsuit.
Ethicon Physiomesh is a hernia mesh made by the Johnson & Johnson subsidiary, which includes two layers of polyglecaprone-25, also known as Monocryl, and two underlying layers of polydioxanone film. The manufacturers coat a polypropylene mesh, which is supposed to minimize adhesion and inflammation and help the mesh incorporate into the body. However, the hernia mesh design has been associated with numerous reports of problems.
“[T]he multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing,” the lawsuit filed by Burdge states. “When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications.”
Burdge’s complaint is one of a growing number of Johnson & Johnson hernia mesh lawsuits filed in federal courts nationwide by individuals who experienced complications that were allegedly caused by the Ethicon Physiomesh design. Plaintiffs indicate they have suffered infections, adhesions, severe internal damage and have had to undergo risky revision surgery to have the mesh removed. Often, pieces of the mesh must remain within the body.
Rather than promptly issuing a nationwide hernia mesh recall, Johnson & Johnson opted to simply remove the product from shelves and cease further sales within the United States last year. However, individuals throughout the U.S. continue to have the defective product in their body and may face continuing risks that the Ethicon Physiomesh may fail.
As hernia mesh lawyers continue to review and file a number of lawsuits for individuals nationwide who had Ethicon Physiomesh implanted, a motion was filed last month with U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to transfer all cases to the Middle District of Florida for coordinated discovery pretrial proceedings. The panel heard oral arguments on the motion last week in San Antonio, Texas.
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