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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4th Circuit Finds Evidence Sufficient to Uphold $3.27M Ethicon Pelvic Mesh Verdict

Ethicon polypropylene pelvic mesh
Ethicon polypropylene pelvic mesh

The Fourth US Circuit Court of Appeals upheld a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial, dismissing defense arguments that the FDA’s 510(k) shortcut approval process shielded them from liability. The court ruled that the plaintiffs offered sufficient evidence and that the trial judge committed no reversible error.

The case is Jo and Allen Huskey v. Ethicon, Inc. and Johnson & Johnson, No. 15-2118, 4th Cir.; 2017 U.S. App. LEXIS 1402. It is one of 31,676 lawsuits filed in Ethicon, Inc., Pelvic Repair System Products Liability Litigation in MDL 2327 supervised by US District Judge Joseph R. Goodwin in the Southern District of West Virginia in Charleston.

In 2014 a jury found Ethicon liable for design defect, failure to warn and loss of consortium claims. “The Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm,” the appeals court said.

On appeal, Ethicon argued that:

  1. The Huskeys failed to prove a specific flaw in the TVT-O’s design — as opposed to a general complication flowing from implantation.
  2. Comment k of the Restatement (Second) of Torts § 402A shielded it from liability.
  3. It was error to exclude evidence about the FDA 510(k) approval of the TVR-O and a study about pelvic mesh by an FDA advisory committee.

Flaws in TVT-O’s design

The first design flaw was making the TVT-O out of polypropylene. Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and one of the Huskeys’ expert witnesses, testified that “the body recognizes [the polypropylene mesh] as a foreign material, and . . . will continue to attack it in this way until it’s removed or destroyed or it’s gone.”

The second flaw was using heavy-weight mesh, which also causes a foreign body response. Dr. Brigitte Hellhammer, a former Ethicon employee, testified that lightweight mesh “would help in reducing a foreign body response, inflammatory response, and would reduce the potentiation for scar plating.”

“A reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect,” the court ruled.

Ethicon argued that Comment K of the Restatements shielded it from strict liability because “some products…are quite incapable of being made safe for their intended and ordinary use.” The appeals court rejected the argument because “the expert testimony allowed the jury to infer that Ethicon could have designed the TVT-O with lightweight mesh without sacrificing any performance. Consequently, the jury could reasonably conclude that the TVT-O was not unavoidably unsafe.”

No error excluding FDA evidence

Ethicon argued that the district erred in excluding evidence of the TVT-O’s compliance with the FDA’s Section 510(k) evaluation process, and that a 2011 FDA Advisory Committee deemed mesh slings, including the TVT-O, safe and effective.

In 2003 Ethicon received FDA clearance under the 510(k) shortcut to market the TVT-O because it was substantially equivalent to a pre-existing device, the Gynecare TVT. The appeals court ruled that excluding this was correct, because “the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only “tangentially” examines the safety of the product going through the process.

It was also correct to exclude a 2011 review by an FDA Obstetrics and Gynecology Devices Advisory Committee of published literature about pelvic mesh treatment. “While the district court did not permit Ethicon to present evidence as to the FDA’s view of the underlying studies, it did permit Ethicon to introduce those studies themselves. The FDA did not use its own analysis of the TVT-O to reach a conclusion regarding the device’s safety and efficacy. Rather, it simply opined on the work others had done,” the court said.

Three unsuccessful surgeries

Jo Huskey of Illinois had the Tension-Free Vaginal Tape-Obturator (“TVT-O”) implanted in 2011 to treat stress urinary incontinence. It is a sling made of polypropylene in a heavy-weight laser-cut mesh. A few weeks later the surgeon discovered that the mesh had eroded, causing her to experience pelvic pain. On June 29, 2011 he had a second surgery to cover the exposed mesh, but it did not relieve the pain. She had a third surgery on November 18, 2011, revealing an infection the complete erosion of the right side of the mesh.

She and her husband filed suit in 2012. In 2014 the jury awarded Mrs. Huskey $3.07 million in total damages, allocated between past expenses for medical care, previous pain and suffering, and future pain and suffering. The jury awarded Mr. Huskey an additional $200,000 for his loss of consortium.

“To this day, the remaining mesh and scar tissue from her operations cause Mrs. Huskey to experience severe pain, particularly when engaging in physical activity and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, she will require medication for pain management; no surgical intervention can permanently cure her,” the Fourth Circuit said.

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MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Ethicon PhysiomeshEthicon, a division of Johnson and Johnson, issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

The notice included a recall of existing stock currently held by health care facilities for all variations (product codes) of the Physiomesh Product Line.

  • 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.

The recall of “on the shelf” products should serve to prevent future hernia repair patients from being implanted with Physiomesh however, this recall does not help those already implanted with the defective hernia mesh product.

We estimate that as many as 300,000 individuals may have been implanted with Physiomesh since the product was approved by the FDA via the 510k process in 2010.

MDL Motion Expected

A large number of lawsuits are expected to be filed resulting from injuries alleged to be caused by Ethicon Physiomesh. It is probable that, as more cases are filed, a motion to consolidate will be filed before the Judicial Panel on Multidistrict Litigation (JPML). Given the fact that Ethicon has recalled the Physiomesh product line, this litigation may move rapidly.  It is possible that an MDL could be formed as early as 2017.

The emerging litigation related to injuries caused by Physiomesh will be discussed in the November 11th – November 14th Four Days to Mass Tort Success Course  in Fort Lauderdale. We will continue to update our subscribers on this emerging litigation. If you are not already a subscriber to the Mass Tort Nexus App, please sign up today at this link: Sign Up

Current litigation

Matthew Huff filed a complaint (See Huff vs Ethicon) in the Southern District of Illinois in April 2016.  The Huff complaint alleges that after being implanted with Physiomesh he was hospitalized beause of an infection in and around the mesh, which caused two abdominal abscesses and an intestinal fistula. These complications from the Physiomesh implant required extensive surgery.

Joanne Quinn filed a complaint (See Quinn vs Ethicon) in the Middle District of Florida in September 2016. The Quinn complaint alleges that the implanted Physiomesh did not improve her condition and in fact resulted in further complications including bowel obstruction. Quinn alleges that due to complications related to Physiomesh she was required to undergo a significant surgical procedure in an attempt to correct the complications allegedly caused by Phsyiomesh.

Shortly after the FDA approved Physiomesh, surgeons and other medical providers began filing adverse event reports, by the end of 2012 an estimated 90 adverse event reports had been filed related to Physiomesh. Today an estimated 650 Adverse Event Reports have been filed in the FDA’s Maude Adverse event reporting System since Physiomesh Composite Mesh was approved by the FDA in 2010 via the 510k market approval pathway. Despite this alarming number of adverse event reports, the FDA took no action prior to the manufacturer’s recall of all Physiomesh Products in May.

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