Craig Rosenbaum | November 8, 2019 | Defective Medical Devices
Hernia mesh is a surgical implant, often made of a synthetic plastic called polypropylene, that reinforces torn or damaged tissue around hernias and strengthens it as it heals. Hernia mesh is used in about 90% of hernia repair surgeries in the United States. Hernia mesh products include patches that are designed to go over or under the damaged tissue, plugs that fit inside the hole in the tissue, and sheets that can be custom cut and fitted for the patient’s specific hernia. While hernia mesh can prevent a hernia from recurring, it can also cause serious complications. The complications include, but are not limited to: infection, bowel obstruction, severe pain, mesh migration, organ perforation, and hernia recurrence.
C.R. Bard, Inc. and Bard Davol
C.R. Bard, Inc. is a multinational developer, manufacturer, and marketer of medical technologies, and is one of the largest manufacturers of hernia mesh. Bard, and their subsidiary Davol, have been at the center of multi-district hernia mesh litigation that commenced in Rhode Island near the end of 2017. The federal cases against Bard and Davol have been consolidated into multi-district litigation 2846 in the United States District Court for the Southern District of Ohio. As of October 2019, there are 3,545 pending actions against Bard in the multi-district hernia mesh litigation.
The center of the hernia mesh cases revolves around the polypropylene mesh used. The different types of mesh used by Bard that are named in the litigation include: Ventralex, 3DMax, Composix E/X, PerFix, Supramesh, and Kugel patch. The plaintiffs in the Bard multi-district litigation are alleging that the designs contained a defect which make it a dangerous medical device, the manufacturer did not warn the medical community or the public of the risks associated with the mesh, the design defect caused injuries and death, and the manufacturer knew or should have known about the risks.
Where the Litigation Stands Today
The Bard multi-district litigation has taken off at a very fast pace. Within the first few months of litigation being filed it was determined that trials would begin in May 2020. Furthermore, judges have been meeting month with plaintiff and defense lawyers to ensure that litigation has maintained the proper pace so trial can begin as scheduled.
Bard’s Hernia Mesh Litigation History
This multi-district litigation is not the first time Bard mesh problems have been placed under scrutiny. Two separate Class I recalls were issued for Composix Kugel Patch in 2005 and 2007. Class I recalls are the highest level of alert and indicate the product is likely to produce serious harm or injury. Moreover, it was revealed during the ensuing lawsuit that company which had manufactured the plastic used in the Composix Kugel Patch had warned Bard that the product was not suitable for use in humans. Bard eventually settled over 3,000 cases for $184 million in relation to the Composix Kugel Patch mesh in 2011.