Ethicon Hernia Mesh Litigation Moves Forward, following Recall

Ethicon Physiomesh Lawsuits Proceed, Court Documents Show

Court documents indicate that Ethicon is facing personal injury claims involving its Physiomesh Flexible Composite Mesh. The mesh, which is used in hernia repairs, was recalled due to a high rate of recurrence and revision. Plaintiffs in the lawsuit allege that the hernia mesh is defective and caused injuries. Ethicon is accused of failing to disclose the risks.

Parker Waichman LLP has represented numerous clients in personal injury lawsuits regarding mesh products. The firm continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh or hernia mesh lawsuit.

Ethicon is facing lawsuits alleging injuries from its recalled Physiomesh. One injury claim was filed in the U.S. District Court, Middle District of Florida on Sept. 22. Another Physiomesh lawsuit is pending the U.S. District Court for the Southern District of Illinois; the case will go to trial on Jan. 22, 2018, court documents show.
Ethicon recalled its Physiomesh on May 25, 2016. The mesh device is used for minimally invasive abdominal and groin hernia repair. The recall was issued after data from two large independent hernia registries, one in Denmark and the other in Germany, showed that the Physiomesh was associated with higher recurrence/reoperation rates compared to the average rates of comparator set of meshes, Ethicon said in its recall latter.

The company wrote in its “Urgent Field Safety Notice” that the increased rates of reoperation may stem from several difference sources. “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors” Ethicon said.

Since the cause of elevated recurrence rates is unknown, Ethicon was not able to provide recommendations regarding recurrence with the Physiomesh. “Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” the letter states.

“Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”

Hernia Mesh Lawsuits over Atrium Medical C-Qur

Ethicon is not the only device maker facing lawsuits over hernia mesh products. Atrium Medical is being sued over its C-Qur (pronounced “secure”) hernia mesh. The U.S. Judicial Panel on Multidistrict Litigation (JPML), who decides whether to consolidate cases into a multidistrict litigation (MDL), will hear Oral Arguments regarding the litigation on Dec. 1 in Charlotte, North Carolina, court records show. Plaintiffs filed a motion to transfer these claims to the U.S. District Court, District of New Hampshire on Oct. 10.

MDLs are a type of mass tort where many lawsuits with the same allegations are transferred to one court before one judge. The JPML creates this type of group litigation in order to speed up the legal process for complex cases. Gathering cases together in one court eliminates duplicate discovery and streamlines proceedings. In this case, lawsuits allege that the C-Qur caused injuries and Atrium Medical failed to disclose the risks. Court documents show that at least 15 such lawsuits have been filed.

Alleged injuries associated with the C-Qur include infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.

Roughly 1,500 C-Qur Edge mesh devices were recalled in August 2012 because the Omega-3 fatty acid coating on the mesh could adhere to the inner packaging liner due to high humidity. Atrium notified physicians of the issue and instructed them to inspect the mesh before implanting it in patients. However, the company did not pull the product from the shelves. The U.S. Food and Drug Administration (FDA) designated the recall as Class II, meaning it is a situation where the recalled product can cause temporary or medically reversible adverse events, or the probability of serious adverse events is remote.

The C-Qur was introduced in 2006. Plaintiffs allege that the mesh was cleared through 510(k), which allows devices to be approved without clinical testing so long as they are deemed “substantially equivalent” to a previously approved device. Unlike products that are cleared through premarket approval (PMA), manufacturers do not have to submit clinical data to prove their products are safe and effective. 510(k) has come under scrutiny in light of safety concerns with certain medical devices, including transvaginal mesh and metal-on-metal hip implants.

Transvaginal Mesh Litigation

Parker Waichman comments that Ethicon has also faced litigation over other mesh products, specifically transvaginal mesh implants used for pelvic organ prolapse and stress urinary incontinence. Thousands of women sued Ethicon and other pelvic mesh manufacturers alleging that the devices are defectively designed and led to injuries, including mesh erosion where the mesh goes through the vaginal tissues and damages other organs.

Women have filed lawsuits over the Ethicon Gynecare TVT, Prolift and other transvaginal mesh products. In January, the company agreed to pay $120 million to settle 2,000 to 3,000 lawsuits. The company is still facing an additional 42,000 vaginal mesh lawsuits. The largest number of transvaginal mesh products are filed against J&J, court documents show.

The J&J vaginal mesh litigation has resulted in some verdicts. In September 2014, jurors awarded $3.27 million to the plaintiff. Verdicts of $11 million and $1.2 million were handed down in 2013 and 2014, respectively.
Transvaginal mesh lawsuits have also been filed against C.R. Bard, American Medical Systems, Boston Scientific and Coloplast.

The FDA has warned that transvaginal mesh complications are “not rare”. The agency said in 2008 that the most common injuries associated with transvaginal mesh include:

• Mesh erosion
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse
• Incontinence

There have also been reports perforation in the bowels, bladder and blood vessels.

Filing a Hernia Mesh or Transvaginal Mesh Lawsuit

If you or someone you know suffered injuries related to the use of a hernia mesh or a transvaginal mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

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