The U.S. Judicial Panel on Multidistrict Litigation created a multidistrict litigation (MDL) for claims against Physiomesh makers Ethicon and Johnson & Johnson, Righting Injustice reports. The MDL consolidates the cases in the Northern District of Georgia located in Atlanta with Judge Richard W. Story presiding.
The MDL consolidates nearly 70 lawsuits pending that were pending in 36 different district courts across the country. The complaints share common claims including deteriorating mesh that separates from the abdominal wall and travels through the body. Mesh fragments can perforate or puncture organs and cause chronic pain, infections and even death.
As Beasley Allen has described before, Physiomesh is used to repair areas of weak muscle, called hernias, in the abdomen. The mesh is used to reinforce the abdominal wall, where it is attached, and to keep the hernia from reopening. The U.S. Food and Drug Administration (FDA) approved Physiomesh in April 2010 through its fast-track 510(k) process, allowing it to bypass rigorous medical testing because of its similarities to a product already on the market – Ethicon’s Proceed transvaginal mesh. Proceed transvaginal mesh was also fast-tracked to market.
Physiomesh and transvaginal mesh are made of polypropylene, which is a flexible plastic product known to erode once implanted. Yet, because both products were fast-tracked to market, neither were safety-tested in humans prior to their market debut and scientists did not have the opportunity to observe the adverse side effects prior to mass production and marketing.
ConsumerSafety.org notes that Ethicon settled approximately 3,000 lawsuits related to problems with its polypropylene transvaginal mesh products in January 2016 as part of an MDL with thousands more claims pending. Righting Injustice reports that approximately 330,000 Physiomesh hernia repair kits were sold worldwide with likely half of them were sold in the U.S.
In May of last year, Ethicon issued a Field Safety Notice and quietly withdrew the product from markets in the U.S., Europe and Australia. The Notice warned that Physiomesh, which is considered a medical device, seemed to have higher rates of hernia recurrence and re-opening in patients using the device as compared to patients using similar devices. Yet, neither Ethicon nor Johnson & Johnson officially recalled Physiomesh.
* * *
If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, contact Matt Munson by calling 800-898-2034 or by email at Matt.Munson@BeasleyAllen.com.