In recent years, the U.S. Food and Drug Administration (FDA) has received numerous reports of serious injuries from polypropylene mesh implants used during hernia repair surgery. And now, after years of battling transvaginal mesh lawsuits, Johnson & Johnson subsidiary Ethicon finds itself at the forefront of the expanding litigation over defective hernia mesh products.
Hernia Repair, Ethicon’s Plastic Mesh, and Reports of Injuries
While small hernias can usually be repaired with a few sutures, more complex hernias can require major reconstructive surgery of the abdominal wall. In these case, surgeons will commonly stitch a mesh patch over the hernia to strengthen the repair. While some types of mesh are better at preventing hernia recurrence than others, mesh can increase the risk of certain side effects.
Introduced in the U.S. in mid-2010, Ethicon’s Physiomesh is a hernia patch made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into a fabric. The patch is laminated between two layers of Monocryl, which is intended to have anti-inflammatory or anti-adhesion benefits.
Not long after U.S. doctors began implanting Physiomesh during hernia repair surgeries, the FDA and Ethicon began receiving a high volume of Adverse Event Reports concerning injuries suffered by hernia patients. One of the most common complaints to the FDA was that the mesh’s laminate coating resulted in its “failure to incorporate” (where the mesh fails to have tissue in-growth and does not adhere to the peritoneum (abdominal wall) as intended). The FDA complaints include reported incidents of the mesh folding over, shrinking, and becoming detached. When it becomes “free-floating,” the migrating mesh can cause a variety of life threatening complications including bowel obstruction and organ failure.
Urgent Safety Notice, Global Market Withdrawal, and Litigation
On May 25, 2016, an urgent field safety notice was issued in Switzerland after European studies found higher rates of hernia recurrence and re-operation when Physiomesh was used compared to similar hernia mesh products. Soon thereafter, Johnson & Johnson issued a voluntary global market withdrawal of its Ethicon Physiomesh Flexible Composite Mesh due to an increased risk of side effects.
After numerous Physiomesh defective product lawsuits were filed against Johnson & Johnson and Ethicon, on June 2, 2017, the Judicial Panel on Multidistrict Litigation (JPML) consolidated the Physiomesh cases into the Northern District of Georgia and formed In RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation (MDL 2782). U.S. District Judge Richard W. Story is presiding over the litigation.
Since formation of MDL 2782 last year, the District Court has issued several procedural orders governing important pretrial issues such as mandatory service of Plaintiff Profile Forms and disclosure of medical records and documentation supporting product identification. In the Court’s recent Practice and Procedure Order No. 7, the Court established the following timeline for the litigation:
- By May 15, 2018, twenty-four (24) cases will be selected by the parties for the “Initial Discovery Pool” (12 selected by plaintiffs and 12 selected by the defense). The 24 cases will be subject to case-specific factual discovery after the exchange of fact sheets.
- On June 22, 2018, an additional 10 cases will be selected for the Initial Discovery Pool.
- By December 1, 2018, the parties will select 10 cases from the Initial Discovery Pool for expert discovery (“Trial Pool Cases”).
- By May 15, 2019, the Court will determine the manner of trial, the order of selection of plaintiffs for trial, and timing of the trials (“Trial Cases”).
- The first Physiomesh bellwether trial is scheduled for September 16, 2019.
In this latest procedural order, the Court encouraged the parties to select Discovery Pool and Trial Pool cases that will be representative of all filed cases in order that the process of selection and trial will be helpful for evaluation and resolution of the entire docket of cases. To date, over 400 Physiomesh lawsuits have been consolidated for pre-trial motion and discovery purposes in MDL 2782.
Ethicon isn’t the only hernia mesh manufacturer facing lawsuits. There are currently consolidated actions pending against Atrium Medical Corp.’s C-Qur line of polypropylene surgical mesh brands and C.R. Bard Inc., for a variety of its synthetic mesh products.
Do I have a Physiomesh Lawsuit?
At PAGLIALUNGA & HARRIS we represent individuals who have been injured after receiving surgical mesh implants during hernia repair surgery. PAGLIALUNGA & HARRIS is currently accepting Physiomesh induced injury cases nationwide. If you or somebody you know had hernia recurrence or surgery, you should contact our lawyers immediately for a free case consultation. Call toll free 24 hours a day: (888) 604-3438.
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