The Honorable Judge Richard Story, who is presiding over multidistrict litigation involving the Ethicon Physiomesh hernia mesh, recently issued an order that provides guidelines for attorneys representing the plaintiffs who have suffered severe, and in some cases, permanent injury because of the device's failure. Judge Story's order requires plaintiffs to request that their surgeons preserve the mesh device as well as any tissue removed during revision surgery.
Their lawyers must then have the samples sent to Steelgate, Inc., a biomedical storage facility located in Bradenton Florida. Plaintiffs are required to follow a set procedure, which includes collecting and preserving the specimens, storing them properly, then having them evaluated, and analyzed by qualified medical personnel, subject to strict conditions. The order also requires that all collected evidence be made available to attorneys on both sides, and gives specific timelines. Storage and testing expenses incurred will be shared equally between counsel for the plaintiffs and the defense.
There are a number of aspects to this ruling of which plaintiffs and their counsel should be aware. Plaintiffs who have yet to undergo revision surgery must make a formal request to their hospital, asking that any device and tissue removed during the procedure be preserved and shipped to Steelgate, since many hospitals simply destroy such materials. Plaintiff's lawyers are responsible for documenting the preservation and shipment. If counsel on either side wants samples tested, they are required to notify the court ten days in advance. Such testing is limited to imaging and other observations, unless both sides agree to more extensive examination of the samples in question – but it may not involve destruction of any part of the samples.
Currently, there are nearly 900 lawsuits over the Ethicon Physiomesh pending before the U.S. District Court for the District of Northern Georgia in Atlanta. This is up from 67 lawsuits that were first consolidated in the MDL one year ago. Complaints allege a range of painful and debilitating injuries due to defective design, ranging from recurrence of the hernia to massive infections and intestinal blockage and even migration to other regions of the body. Manufacturer Ethicon, a subsidiary of Johnson & Johnson, recalled the Physiomesh in 2016 after receiving hundreds of adverse event reports. However, so far Ethicon has failed to give any reasons for the device failures.
Between January 1 and March 31 of this year, the FDA received in excess of 1500 injury reports related to hernia mesh devices. The first Ethicon Physiomesh trials are scheduled to begin in September 2019.