Atrium Hernia Mesh
By Dan C. Bolton and Farid Zakaria
Keller, Fishback & Jackson LLP
In June 2014, Keller, Fishback & Jackson LLP filed a multi-plaintiff case in California Superior Court against Atrium Medical Corporation (Atrium) and related corporate entities.
The eight plaintiffs underwent hernia repair surgery with polypropylene mesh manufactured by Atrium and later suffered serious complications, including chronic and debilitating pain, erosion, adhesions, organ and nerve damage, chronic inflammation, sexual difficulties and revision surgeries.
Shortly after the case was filed, the defendants removed (transferred) the case to federal court in the Northern District of California, contending that the federal district court had jurisdiction over the case. A case originally filed in state court must meet certain criteria before being transferred to federal court. One basis for transfer is where there is “complete diversity of citizenship” between the parties; that is, all of the plaintiffs and all of the defendants are “citizens” of different states. That is not the case, though, in this suit since at least one plaintiff and one defendant are from the same state.
In a fourteen-page opinion issued on October 30, Blasco.OrderGrantingMotiontoRemand) Chief Magistrate Judge Elizabeth Laporte ruled that the defendants improperly removed the case and that it must be sent back to Alameda Superior Court in California. Having failed in its dilatory tactic, Atrium must now concentrate on the merits of the plaintiffs’ claims.
Polypropylene hernia mesh presents many of the same risks as transvaginal mesh, another dangerous medical device impacting thousands of women in the United States and currently the subject of nationwide litigation. Both products have undergone minimal regulatory scrutiny under a legal framework that does not require the submission of safety and efficacy data to the Food and Drug Administration.
The lawsuit against Atrium emphasizes that the warnings for hernia mesh are inadequate and conceal important safety information. In the product literature relating to polypropylene mesh, Atrium typically includes just one sentence about adverse reactions and no substantive discussion about the serious dangers of polypropylene mesh.
Polypropylene hernia mesh is frequently used in hernia repair surgery, though it is not always necessary given the likelihood of complications. Despite relentless marketing by manufacturers, many doctors steer away from polypropylene mesh and use a mesh-free procedure known as the Shouldice technique, which has been used for decades and has low rates of failure.
Manufacturers have touted mesh for hernia repair as safe and effective, yet published research has found high rates of serious complications. One researcher observed there have been many “reports of various degrees of degradation … stress cracking and mesh shrinkage along with infection, chronic inflammation and the stimulation of sclerosis (hardening of tissue).” The researcher concluded, “based on available evidence the polypropylene used for surgical treatment of various structural defects is not inert after implantation in the human body.”
In fact, a debilitating consequence of hernia repair with mesh is inguinodynia, or chronic groin pain. This condition results from the deformation of mesh after implantation, the persistent foreign body reaction that follows and entrapment of the nerves near mesh. The medical literature reports an extraordinarily high rate of chronic groin pain after hernia repair with mesh—in some reports approaching 50%, and even higher in others.
As a Harvard medical professor recently asked in the title of his medical journal article: “Why do we continue to perform mesh repair in the face of the human toll of inguinodynia?”
Despite the abundance of scientific and medical information in the published medical literature relating to the dangerous properties and serious risks of polypropylene mesh, the lawsuit asserts that the defendants have made a deliberate decision to aggressively market polypropylene mesh, to ignore the dangers, and to paint a misleading picture of safety and efficacy in the product information provided to physicians and patients. This lawsuit seeks to hold Atrium responsible for the resulting harm to the plaintiffs.
Dan C. Bolton is Of Counsel and Farid Zakaria is an associate in the Los Angeles office of Keller, Fishback & Jackson LLP. The firm represents plaintiffs nationwide in pharmaceutical and medical device litigation, including hernia and transvaginal mesh, prescription drug, hip implant and power morcellation cases. Mr. Bolton oversees the pharmaceutical and medical device practice. Mr. Zakaria has a background in molecular and cell biology.