Woman Sues Ethicon After Intestines Push Through Hernia Mesh

Ethicon PhysiomeshA Georgia woman filed a products liability suit against Johnson & Johnson and Ethicon when loops of her intestines protruded through multi-layer Physiomesh hernia mesh, causing an intestinal obstruction and severe pain.

She and her husband charge the companies with defective design, failure to warn, negligence and loss of consortium in Connie Franklin and Marvin Franklin v. Johnson & Johnson, No. 4:17-cv-00031, Feb. 2, 2017, US District Court, Middle District of Georgia

As many as 300,000 people may have been implanted with Physiomesh since the FDA approved the product via the 510(k) process in 2010. Ethicon issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

  • On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
  • The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.

See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Cannot remove Physiomesh

Connie Franklin was implanted with a 20 cm by 25 cm section of Physiomesh to repair an incisional hernia. After suffering pain, nausea and vomiting, she had surgery again on August 1, 2016 for a hernia recurrence.

“The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of Ms. Franklin’s intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of Ms. Franklin’s intestines,” the complaint says.

“Ms. Franklin underwent a prolonged surgical procedure to attempt to remove the Physiomesh from her intestines and to remove the mesh that failed to incorporate into the abdominal facsia. Portions of the Physiomesh could not be removed, and remain in Ms. Franklin’s body.”

Physiomesh has a unique design incorporating five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design is not used in any other hernia repair product sold in the United States.

“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not,” the complaint says.

The defective design causes delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications. When the Physiomesh degrades, the polypropylene mesh is exposed to the adjoining tissue and becomes adhered to organs, causing bowel perforation or erosion, fistula formation, bowel strangulation, hernia incarceration and other injuries.

The plaintiffs argue that neither they nor their physician was adequately warned about the defective and dangerous condition of the product.

Attorneys for the plaintiffs are Henry G. Garrard, III, James B. Matthews, III, Andrew J. Hill III, Josh B. Wages and Patrick H. Garrard of Blasingame, Burch, Garrard & Ashley in Athens, GA.

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JPML Creates New MDL 2753 for Atrium C-Qur Hernia Mesh

Atrium Medical c-qur surgical mesh
Atrium Medical C-Qur surgical mesh

The Judicial Panel on Multidistrict Litigation (JPML) on Dec. 8, 2016 created the new MDL 2753 to consolidate lawsuits over Atrium Medical Corp. polypropylene surgical mesh patches.

Atrium promotes the C-Qur line of surgical mesh products for permanent abdominal wall reinforcement in hernia surgeries, claiming that the C-Qur Mesh’s proprietary Omega-3 barrier coating reduces scar tissue formation between the mesh and the patient’s intestines (clinically known as “adhesions”) while promoting permanent fixation of the mesh to the abdominal wall.

Causes complications

The plaintiffs charge that the C-Qur mesh incites an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications.

Atrium agreed in a brief filed on Nov. 1 that the MDL should be assigned to US District Judge Landya B. McCafferty in Concord, New Hamshire.

  • Atrium, based in Merrimack, NJ, had sales of $200 million in 2011, with the U.S. market accounting for 70% of sales and the remaining 30% sales through proprietary sale offices in the United Kingdom, Germany, France, the Netherlands, India, Australia and New Zealand.
  • Half of the pending cases are in the District of New Hampshire and no other district has more than one C-Qur Action.

A total of 15 cases are pending in seven different federal districts. Discovery has already begun in Zissa v. Atrium Medical Corporation, Civil Action No. 5:15-CV-00718 DAE, Western District of Texas, and in Fergerson v. Atrium Medical Corporation, Civil Action No. 2:16-cv-02058, District of Kansas.

Key plaintiff attorneys include Robert J. Bonsignore of Bonsignore, LLC in Belmont, NH, Aaron Broussard of Broussard & Hart in Lake Charles, LA, and Adam M. Evans of the Hollis Law Firm in Prairie Village, KS.

 

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