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The most recently formed hernia mesh multidistrict litigation (MDL) in the District of Massachusetts (In re Covidien Hernia Mesh Prods. Liab. Litig. No. II; MDL 3029 (D. MA)) is gaining traction, with nearly 500 cases filed and six bellwether cases selected.
The reason this MDL is garnering so much attention are multiple factors.
For starters, the pro hac vice (PHV) waiver enables attorneys who are licensed elsewhere to participate in the MDL’s jurisdiction without the need for PHV admission. No parties in any transferred actions are required to obtain local counsel in the District of Massachusetts.
Next, U.S. District Judge Patti B. Saris issued a Direct Filing Order in this MDL. This means that in the interest of eliminating potential delays associated with transferring to the Court actions that have been filed in other federal district courts and to promote judicial efficiency, attorneys can file their actions in the U.S. District Court for the District of Massachusetts through the Court’s electronic filing system, rather than in the federal district court in which they would otherwise have had to file their cases.
The PHV waiver and Direct Filing Order translate to no local counsel fees, which otherwise could have presented a financial obstacle for firms throughout the country that want to participate in MDLs but cannot justify or afford the expense.
An easy Short Form Complaint for all products makes it easier for participating lawyers to gather information across all products and file their claims using an abbreviated form.
A short PPF focuses on information relevant to the hernia mesh claim.
All the orders and forms for the Covidien MDL 3029 can be found on the LPR Covidien Hernia Mesh MDL Court Orders and Forms website.
A hernia typically requires surgical intervention. Although some surgical repairs use only sutures, such procedures use synthetic mesh more often. This litigation focuses on the Defendants’ hernia mesh devices composed of plastic mesh and used for surgical repair. These synthetic products are all manufactured with polymer—either polyester or polypropylene.
Covidien is the only major manufacturer of mesh to use polyester. “It’s by far the very worst permanent implant material you could put in a patient’s body,” said Levin Papantonio Rafferty (LPR) Attorney Tim O’Brien, who is leading the Covidien MDL with Co-lead Kelsey Stokes.
“Covidien insists the materials used in their hernia mesh devices are inert,” O’Brien explained. “However, polyester and polypropylene are both non-inert materials. Both are biologically incompatible with human tissue. As a result, they often trigger chronic immune responses. The Defendants do not publicize this fact.”
Stokes added, “Whether multifilament or monofilament, polyester is not biocompatible. Polyester incites a chronic inflammatory response that triggers a cascade of injuries in the patient. Polyester is not only highly inflammatory but also weak, which defeats the purpose of using it in the first place.”
Decades of scientific research support O’Brien’s statement.
2003 – Annals of Surgery published a study that assessed methods of preventing adhesion to prosthetic mesh. The researchers observed the effects of Sepramesh (polypropylene mesh with Seprafilm coating) and Parietex composite mesh, which comprises polyester mesh and collagen coating. The scientists found that “Infection was more prevalent with Parietex composite mesh, with concurrent increased mesh surface covered by adhesions after 30 days (78%).”
2006 – The Association for Academic Surgery presented research evaluating adhesion formation in rabbits after being implanted with mesh devices. The authors acknowledged that “exposure of the abdominal viscera to polypropylene or polyester meshes is known to be associated with bowel erosion and fistulization.”
2010 – Results of a study published by Hernia included random biopsies at 3 months, which showed an increased foreign body reaction to coated polyester mesh.” Researchers concluded that “polyester-based mesh induced a more intense foreign body reaction and was exposed to significantly more shrinkage than the covered polypropylene mesh.”
2012 – A scientific study published in the Journal of Surgical Research in 2012 explored the effects of synthetic meshes by comparing histopathologic responses to various synthetic meshes implanted in mice. The researchers concluded that polyester mesh appeared to create a local hostile environment, inducing the greatest foreign body reaction and lasting chronic inflammatory response.
2013 – In another study published in a 2013 issue of Hernia, researchers evaluated the efficacy of a certain therapy for treating mesh infections after hernia repairs. The research established that infection of multifilament materials requires complete mesh removal because the body is unable to eliminate the infection through its natural immune response or with the help of medication.
2015 – Hernia published the findings from a study of monofilament polyester mesh (Parietex TCM, Covidien) in open incisional hernia repair. Researchers reported that “with a mean follow-up of 13 months, 8 (22%) recurrences have occurred. On reoperation, 7 (19%) of these patients had mechanical failure or fracturing of the mesh.” The scientists concluded that the mesh “appears to have a high incidence of mechanical failure in the context of open incisional hernia repair.”
2018 – A study published in Materiale Plastice revealed that recurrence and shrinkage rates are more than double in polyester mesh as compared with polypropylene mesh.
In June 2022, the Judicial Panel on Multidistrict Litigation formed MDL 3029. The JPML assigned the Honorable Patti B. Saris, United States District Judge for the District of Massachusetts, to preside over the MDL, In re Covidien Hernia Mesh Prods. Liab. Litig. No. II; MDL 3029 (D. MA). The Honorable M. Page Kelley serves as the Chief Magistrate Judge for the District of Massachusetts and will serve in that function with MDL 3029.
For around 30 years, Covidien has been manufacturing, testing, marketing, selling, and distributing 20 hernia mesh devices across the globe. MDL 3029 deals with nine of these devices.
Although the Food and Drug Administration (FDA) gave clearance for Covidien to market the hernia mesh devices implanted in the Plaintiffs in this litigation, the agency has not formally reviewed the devices for safety and efficacy.
Bettina R. Jones filed her Complaint against Covidien, Medtronic, and others alleging that in January 2015, Jones underwent surgery for repair of a ventral hernia. The repair was conducted using a Covidien 15x10cm Parietex Optimized Composite. The Complaint states that in January 2021, Jones underwent an additional surgery “due to an infested mesh with a draining fistula.” The surgeon discovered “dense fibrosis” surrounding the sinus tract with “adherent small intestine, mesh, and chronic abscess.” The condition required a bowel resection of around 75 cm. The entire hernia mesh device was removed.
Gilbert Grijalva’s Complaint against the same Defendants states that in November 2019, Grijalva was implanted with a Covidien Symbotex to repair his hernia defect. In August 2020, while conducting a diagnostic laparoscopy, Dr. Frederick Stephen Wright noticed that the mesh had “tightly adherent” omentum “stuck to it.” According to the physician, the small bowel was stuck to the mesh and “wrapped up in the mesh omentum matric,” causing an obstruction. The mesh was removed in its entirety.
Noah Hursh also filed a Complaint against these Defendants, alleging that in January 2016, he underwent surgery to address groin pain. During the procedure, the surgeon noted that the nerve was “densely stuck in scar tissue associated with the hernia mesh.” A portion of the mesh with the nerve and neuroma was removed.
Cruz Marmolejo’s Complaint states that in September 2019, he underwent a left inguinal repair prompted by groin pain. During the procedure, his surgeon observed the patient’s mesh had migrated near the public tubercle—causing Marmolejo’s pain. The surgeon removed the mesh. The pathology diagnosis was scarring (fibrosis) and chronic inflammation.
The new Covidien MDL’s Plaintiffs’ injuries and the damages have all resulted from Defendants’ three categories of hernia mesh products: their Bare (Non-Coated) Polymer Hernia Mesh Devices; their Resorbable Collagen Barrier Devices; and their Devices with Microgrips.
The types of post-hernia repair personal injuries from implantation of Covidien’s hernia mesh devices include:
The most common post-hernia repair medical problems are:
According to the Plaintiffs’ Statement of the Case, “Other adverse medical events may also occur after device implantation, including hernia mesh migration, and shrinkage or contraction. Plaintiffs in this MDL have been subject to many of those hernia mesh post-repair medical problems.”
The causes of action against Covidien in MDL 3029 include:
Plaintiffs’ injuries, resulting from their implantations with Defendants’ hernia mesh devices, triggered this newest MDL litigation against Covidien. Plaintiffs now seek damages and other remedies proximately caused by Defendants’ hernia-mesh-related misconduct.
The medical problems resulting from the implantation of these hernia mesh devices require present and future medical treatment, present medical expenses, and quite likely future medical expenses. Damages sought in these cases include:
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