The Ethicon Physiomesh hernia repair lawsuits continue to heat up. In June 2017, the MDL panel centralized all federal product liability lawsuits involving Ethicon Physiomesh hernia repairs before U.S. District Judge Richard Story in the Northern District of Georgia. This means that no matter where you are, you case lawsuit in federal court against Ethicon for its defective hernia mesh will be in Georgia under Judge Story.
As of October 2017, there are a little over one hundred lawsuits that have been filed in the MDL class action. But it is expected by many that the total number of Ethicon Physiomesh cases will total in the thousands. We believe many of these hernia repair cases involving the Ethicon Physiomesh and Artium C-Cur could have a significant trial and settlement value.
If you believe you have a case, call us today at 800-553-8082 or get a free-online consultation.
Physiomesh is a type II medical device. It was approved by the FDA through a backdoor called 501(k). It means the product was not tested by the FDA as other new products would be because it is "substantially similar" to other surgical meshes. So Physiomesh piggybacked off previous mesh systems like Prolene, UltraPro, and Physiomesh. Naturally, they have all had their problems. Prolene has been the subject of FDA recalls and other actions.
There are probably lots of medical devices that should receive 501(k) approval. But it is incredible how the discussion of the product history in mass tort lawsuits begins with "the product got 501(k) approval...."
Physiomesh has a unique five-layer design. There are two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”). The latter is coated by a polypropylene mesh.
Despite the Physiomesh's 501(k) approval, this is a novel design for a hernia repair product. This design is not used in any other hernia repair product. This multilayer coating was sold to doctors and patients as an innovation that would limit adhesions and inflammation and help the mesh incorporation into the body. Non-absorbable mesh, made from synthetic materials, is intended to remain within the body permanently. This new design was supposed to do a better job of effectuating that purpose.
Instead, the multi-layer coating did just the opposite of its touted purpose of better incorporation of the mesh into the body. Instead, some patients had an intense inflammatory response.
Plaintiff's lawyers also allege that the multi-layer coating of Physiomesh is cytotoxic, immunogenic, and not biocompatible. The result is delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications.
This mesh also has had its share of tears -- arguably because arguably the "lightweight" feature it was selling was too light. The brittleness of the mesh also leads to degradation. This mesh may also have had too little polypropylene exposed which means that the mesh was not correctly incorporated into the abdominal cavity.
Ultimately, researchers found that Physiomesh (including Prolene Mesh) yielded higher rates of recurrence and reoperation than other comparable mesh material products intended for the same use. On May 25, 2016, the evidence of these problems with the Physiomesh reached a critical mass. In a field safety notice, Ethicon/Johnson & Johnson admitted to doctors what many of them were already doing anyway: stop using the Ethicon Physiomesh.
Was this a recall? If you could waterboard a corporation, they would probably still say no. But the line between a recall and a voluntary withdrawal is pretty razor thin. It looks like what it is. Ethicon took the product off the market because it was no safe.
What We Can Expect in These Lawsuits
It is hard not to look back to the ring issues with the Kugel Mesh cases to figure out where these claims are going.
The Kugel mesh patch is made of two pieces of mesh that surrounds a flexible plastic ring. The surgeon places the mesh patch in a small incision. The surgeon would fold the patch and put it at the site of a hernia. The released ring would then spring back into its original shape, flattening the patch. The mesh-like material would serve as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.
Like the Ethicon Physiomesh, this mesh patch was prone to break, leading to bowel perforations and chronic intestinal fistulae. These are severe conditions that pose a significant health risk to hernia patch patients. The problem with the Kugel hernia patch was that the plastic component could break and cut through a patient's internal organs and tissue. In many cases, the memory recoil ring can break while being inserted. If the Kugel recoil ring snaps, the most common complication is bowel perforations or rupture and chronic intestinal fistulae.
The common thread is the idea of grabbing as much market share as possible without keeping an eye on safety.
What Will Be the Average Settlement Value of Ethicon Physiomesh?
We do not know how much the average settlement value will be in the Ethicon Physiomesh or Artium C-Cur or even whether these cases will end in a settlement. But the smart money bets that these claim will ultimately reach a global settlement where most of the claims resolve where few if any plaintiffs ever see the courthouse steps.
What we do know is that the average settlement in the Kugel hernia mesh cases were about $70,000. The conventional wisdom is that the average settlement value of the Ethicon Physiomesh cases will be higher.
Get a Lawyer from Your Ethicon Physiomesh Claim
Our lawyers are reviewing cases for compensation for mesh hernia patch cases throughout the United States Call our mesh hernia patch attorneys at 1-800-553-8082 click here for a free online web consultation.
Remember, all of these cases are handled by our attorneys under a contingency fee agreement. What does this mean? It means the lawyers are fronting all of the cost of bringing the case and you only pay an attorneys' fee or pay back our expenses if we obtain a Physiomesh settlement with Ethicon.