On August 1st, the Honorable Judge Richard Story of the Northern District of Georgia began the process that will hopefully hold medical device manufacturer Ethicon to account for the manufacture of a device it allegedly knew was defective in design.
In accordance with a court order issued last month, an initial case management conference was held on Tuesday, August 1st. The outcome of the conference will determine how parties to the lawsuit should prepare their cases as they discuss the issues surrounding the lawsuit.
While the details and exact injuries vary, all cases share one important cause of action; every one of the seventy plaintiffs have suffered from severe injuries because of the Physiomesh product. Similar in construction to the pelvic meshes that created so many problems years ago, the hernia mesh is used in order to repair abdominal muscles that have weakened. However, these meshes have been implicated in infections and internal bleeding due to organ perforation as they erode and become embedded in surrounding tissues, causing chronic, debilitating pain.
In some cases, the results have been fatal. In other cases, repeated revision surgeries are required – and surgeons are not always able to remove the mesh.
Last year, Ethicon issued an “Urgent Field Safety Notice” to surgeons and health care providers and institutions, advising them of “higher than normal” injury recurrence and excessive need for revision surgery. When the Physiomesh received FDA approval in 2010, it was touted as a better product that its competitors, employing materials that were supposed to prevent the very complications it has now been shown to cause.
To support claims of the injured parties, plaintiffs' counsel cite a study, published last year in the professional journal Surgical Endoscopy, in which researchers compared the Physiomesh to a similar product, the Ventralight ST. The study found that the Physiomesh was less effective and caused greater pain, despite a coating of polyglecaprone (also known as polyethylene terephthlate, or PET). It should be noted that the Ventrallight ST has no such coating.
The actual trial will not be starting for at least another three months. However, this week's status conference is a significant first step, at which both sides are expected to recommend the best ways in which to expedite proceedings and come to an agreement on presentation of evidence as well as a proposed schedule for the trial itself.