Mesh Medical Device News Desk, January 30, 2019~ Bard Hernia Cases Moving Forward, Using the lessons of TVM.
Bard MDL 2846 (2:18-md-02846) has formed in the Southern District of Ohio, Eastern Division, and is reported to be user-friendly for the law firms involved in this multidistrict litigation (MDL).
These product liability trials are expected to be heard in 2020 before Chief Judge Edmund A Sargus Jr.
Image: Composix mesh, Hollis Law
Which Bard hernia meshes are involved is a common question. All polyproylene (PP) meshes are eligible for litigation with the exception of Bard soft mesh. That may be used as an example of a better alternative mesh that could have been used, a requirement under many state laws. It is a lighter large pore flat mesh. The heavier polypropylene mesh is known to trigger a foreign body response that in many patients never stops.
Experiencing a defect in the mesh necessitating surgical intervention is the key to being able to file a case in this MDL.
There is a defendant profile form Bard has to fill out in every case, which the defendant protested, according to lawyers for the plaintiff. It will require a physician implanting mesh to reveal how much he was paid by industry. That amount will be compared to compensation listed in two required filings – OpenPayments.com or ProPublica’s DollarsforDoctors.com.
As for the pathology protocol – patients and their law firms are urged to preserve the evidence of an explanted mesh, particularly the gross specimen. A preservation letter to the doctor involved will have the specimen preserved at SteelGate ($25 a month) or elsewhere. This is especially important if there is a meshoma.
The common benefit assessment in this MDL is 10% – 7% for attorneys’ fee and 3% for expenses. It represents a hold back and shall not be altered. The 10% comes off the top and there will be no local counsel fee.
In addition to the MDL filing, cases can be filed in New Jersey, the home of C.R. Bard, New Jersey or the home of Davol, Rhode island.
Check out the website www.BardMDL.com for information on the case.
PLAINTIFF LOSES BARD COMPOSIX KUGEL PATCH CASE
Georgia Bowersock, 59, lost her life in October 31, 2016 one year after having a hernia repair with a mesh made by C.R. Bard.
Her surgeon implanted a Composix Kugel Patch and one year later, she died of complications arising from an abdominal wall abscess. The Bowersock family sued Bard and Davol, the patent holder for the mesh, alleging it was defective and that caused her death.
The family retained three experts but ultimately they had trouble establishing causation.
It could not be established that her mesh adhered to her bowel or perforated her organs. One of the experts theorized that the mesh patch had buckled and formed a stiff edge that perforated her bowel causing a fistula or break, then healed prior to explantation or discovery of the mesh in the bowel. She has suffered cross contamination of fecal material in her body, a general sign that the bowel is perforated in some manner.
Bowersock also suffered obesity, diabetes, chronic obstructive pulmonary disease. She suffered a heart attack after a hospitalization for infections.
On January 22, Judge Diane Sykes for the U.S. Court of Appeals, Seventh Circuit wrote that the cause of death was a novel cause since there was no ring breakage or obvious mesh adhesion or puncture of organs. The plaintiffs did not prove their case and the judge at trial entered a summary judgment for Bard and Davol. The appeals court affirmed.
COMPOSIX KUGEL PATCH
The Composix Kugel Patch was marketed in 2001 and patients soon began reporting problems with the plastic ring. If not breaking outright, it was reported to buckle or contract. In December 2005, Bard recalled the extra large models and then expanded the recall several months later.
As of March 2012, Davol discontinued Composix with a suggested replacement of Ventrio or Ventrio ST Hernia Patch products.
Mrs. Bowersock sought treatment for an abdominal wall hernia in May 2005. In July, her physician implanted a model included in the second recall. he testified he would not have used that patch has he known about the defective memory rings.
On October 4, 2006, she went to the emergency room with an abdominal-wall abscess. She received antibiotics for a staph infection and was sent home after the abscess was drained.
Mrs. Bowersock returned several days later with a large wound infection. While hospitalized she suffered cardiac arrest, and placed on a ventilator. A second blood culture found the presence of staphylococcus epidermidis and enterococcus faecalis or fecal bacterial. She continued to deteriorate until her death October 31, 2006.
Her sons and sister sued Bard in federal court in Indiana. Bard moved to exclude the causation opinion offered by the experts as unreliable and unsupported by the medical records. Bard also sought summary judgment.
U.S. Court of Appeals, Seventh Circuit opinion January 22, 2019
Bard Transfer Orders, August 2018
The Indiana Lawyer, Judgment for Mesh Implant Makers Upheld After Woman’s Death
Hollis law – History of Kugel Patch