Bard Hernia Mesh Lawsuit

Bard Hernia Mesh MDL 2846

On April 10, 2018, the Hollis Law Firm and three other law firms filed a joint motion to consolidate all Bard polypropylene hernia mesh cases filed in federal courts nationwide. The initial filing by the plaintiffs indicated that 54 cases were pending in 17 different states nationwide. Attorneys for Bard replied less than one month later, noting the number of cases filed in federal court had surged to nearly 100. On August 2, 2018, the Judicial Panel on Multidistrict Litigation (JPML) held that “[a]ll of the actions share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory, allergic, and foreign body responses.” The JPML then consolidated all federally filed Bard polypropylene hernia mesh cases to create IN RE: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation (MDL 2846) and transferred all cases to Chief Judge Edmund A. Sargus, Jr. and Magistrate Judge Kimberly A. Jolson in the Southern District of Ohio, Columbus Division. C. Brett Vaughn of the Hollis Law Firm was appointed to the Plaintiff’s Executive Committee and as Chair of the Science and Expert Committee for the Bard hernia mesh MDL. Attorney Adam Evans of the Hollis Law Firm was also appointed to the Science and Expert Committee for MDL 2846. There are currently approximately 300 polypropylene hernia mesh lawsuits within the Bard MDL.

The Bard hernia mesh MDL is off to a very fast pace. Within the first few months of the MDL it was decided that trials would begin on May 8, 2020. Additionally, the judges are holding monthly meetings with lawyers from each side to ensure that the litigation continues to move forward towards trial. The plaintiffs are currently waiting with much anticipation to begin receiving internal documents from the Defendants. It is estimated that plaintiffs will receive and be able to start reviewing millions of internal company documents related to hernia mesh by January of 2019. The defense is losing one of their most powerful tactics: Delaying…

Bard Hernia Mesh Rhode Island State Court Consolidation

There are also over 2,600 Bard hernia mesh lawsuits pending in Rhode Island state court, the home state of Bard’s subsidiary Davol. Superior Court Presiding Justice Alice Gibney has been overseeing the Bard RI state court lawsuits since May 5, 2017. It is currently unknown when Bard hernia mesh lawsuits filed in RI state court will go to trial. For strategic reasons, the Hollis Law Firm is no longer filing Bard hernia mesh cases into RI state court, unless it is necessary due to jurisdictional issues.

Bard Hernia Meshes Included in Bard Hernia Mesh MDL 2846

The following Bard hernia meshes utilize polypropylene in their design:

  • 3DMax
  • 3DMax Light (Not included in Bard RI state court lawsuits)
  • Composix
  • Composix LP (Not included in Bard RI state court lawsuits)
  • Marlex / Bard Mesh
  • PerFix Plug
  • PerFix Plug Light (Not included in Bard RI state court lawsuits)
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Ventralight ST (Not included in Bard RI state court lawsuits)
  • Ventrio
  • Ventrio ST
  • Composix Kugel
  • Kugel
  • Modified Kugel
  • Composix EX

Bard Hernia Meshes Excluded from Bard Hernia Mesh MDL 2846

The following Bard hernia meshes do not utilize polypropylene in their design and are therefore excluded from the Bard hernia mesh MDL:

What is the Basis for the Bard Hernia Mesh MDL?Polypropylene Hernia Mesh Lawsuit

Non-Medical Grade Polypropylene

A common thread in all hernia mesh lawsuits against Bard is that their products contain non-medical grade, substandard, or adulterated polypropylene. Bard has been the hernia mesh industry juggernaut, dominating well over 50% of the market share for decades. The FDA didn’t look closely at medical devices until an amendment in 1976 which required innovative medical devices to undergo rigorous human studies and pre-market evaluation/approval by the FDA. However, Bard’s initial polypropylene hernia mesh known as Marlex entered the market prior to the 1976 amendment requiring human studies. Unfortunately, the FDA also created a loophole for future hernia mesh devices to get around pre-market approval (human studies) known as 510(k) clearance process. Under the heavily abused 510(k) clearance process, companies can skip human studies by claiming their device is substantially similar to a device that was on the market prior to the 1976 amendment, or is substantially similar to another device which obtained 510(k) clearance. The FDA pre-market approval process has now been in place for over 30 years, yet Bard has never once went through the pre-market approval process for any hernia mesh that contains polypropylene, regardless of its design or other components. The FDA has never required Bard to conduct human studies and has granted ALL Bard 510(k) clearances simply because the device contains polypropylene. This is absolutely shocking, considering the extensive amount of research and evidence in the last 20 years that conclusively proves polypropylene degrades in the human body! To make matters even worse, it has been established in public court documents that Bard began using non-medical grade polypropylene (plastic) over a decade ago! For a company like Bard to allow non-medical grade plastics to be implanted in humans is unthinkable, but the regulatory process which allowed this to happen is clearly ineffective, if not corrupt.

ePTFE Permanent Coating

Numerous Bard hernia meshes include expanded polytetrafluoroethylene (ePTFE) in their design, such as the Composix Kugel, Composix LP, Composix EX, Ventralex, and Ventrio hernia meshes. ePTFE is known to contact at an even faster rate than polypropylene! As a result, the mesh begins to curl and deform as the ePTFE shrinks post implantation. Additionally, ePTFE breaks down in the presence of bacteria. As ePTFE breaks down, it creates small nooks and crannies that harbor bacteria and protect the bacteria from the bodies defense system. The bacteria can then form what is known as a biofilm and cause long term and systemic infections. ePTFE also increases the permanent foreign body load, creating an even greater immune response to the hernia mesh implant. The increased immune response then causes the polypropylene to degrade at an even faster rate.

ST Resorbable Coating

Several Bard polypropylene hernia meshes incorporate the resorbable ST coating, including the Ventralex ST, Ventrio ST, Ventralight ST, and SepraMesh. The ST coating is intended to prevent dangerous adhesions from forming between internal organs and the Bard polypropylene mesh, yet the ST coating disappears five to seven days after implantation! After the ST coating disappears from the Bard mesh, adhesions can form to the bowel, resulting in debilitating pain, bowel obstructions, subsequent surgeries, and even bowel resections!

Bard ST Hernia Mesh Class ActionThe ST coating of various Bard hernia meshes is derived from a product manufactured by Sanofi Genzyme called Seprafilm. Bard utilizes acidic polymers to adhere the ST coating to the underlying polypropylene mesh. These acidic polymers take many months to fully resorb in the body. As a result, wound healing is significantly delayed, and the risk of infection, seroma, fistula, and abscess formation are significantly increased.

Bard Hernia Mesh Lawsuit

Contact the Hollis Law Firm today at 1-800-701-3672 for a free Bard hernia mesh case evaluation. This is not exactly a hernia mesh class action, because each claim is an individual lawsuit that must undergo an in-depth case specific evaluation. The specific facts of your potential Bard hernia mesh lawsuit will determine if your mesh lawsuit is compensable and to what amount. All hernia mesh cases are handled on a contingent fee basis (we only get paid if you get paid). The lawyers at Hollis Law Firm represent hernia mesh victims nationwide. Call 1-800-701-3672 for a free Bard hernia mesh lawsuit case evaluation.

 

 

Content Created By:

C. Brett Vaughn RN, BSN, JD

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