New plaintiffs continue to join the ranks of individuals filing claims against manufacturers of hernia mesh products, with a federal trial scheduled for later this year in New Hampshire. Plaintiffs’ complaints in these cases range from product failure or migration, to severe pain, infections and organ perforations.
In New Hampshire, more than 400 plaintiffs have filed claims against Atrium Medical Corp. The pharmaceutical company employed the use of fish oil in the manufacturing of its hernia mesh, and it turns out that might not have been a good idea, with a judge reasoning that the substance might have created a “breeding ground for bacteria.”
Down south, in Mississippi, another hernia mesh claim has been lodged. A man has filed a lawsuit against C. R. Bard, Inc., contending that the company’s mesh product failed after implantation and caused him serious pain.
And in Florida, a previous hernia mesh trial has been revisited and upheld. An outcome that surely pleased the prevailing defendants, Bard and Davol, Inc.
Atrium’s Fish Oil Problem
The hundreds of plaintiffs involved in litigation against New Hampshire-based Atrium are targeting the company’s C-QUR mesh products. Those meshes are coated with a fish oil derivative mean to quell inflammation.
This is unique and important to the litigation. In addition to other issues plaintiffs have with these meshes, attorneys are arguing that the fish oil coating is also a problem.
In a complaint filed in 2017, Judge Landya B. McCafferty in U.S. District Court in Concord agreed. The judge wrote that the product caused an “unreasonable risk of severe risk of severe adverse reactions” and described the fish oil coating as “an ideal breeding ground for bacteria.”
As the fish oil coating degraded, there are allegedly also issues with the polypropylene mesh underneath. The mesh could adhere to the organ.
Also in this New Hampshire litigation is the issue of the presence of human hair being found in the medical devices. The plaintiffs’ attorneys are citing a warning letter from the U.S. Food and Drug Administration pertaining to the matter, as well as a subsequent shut down of a manufacturing facility.
The FDA issued its letter in 2012, citing “35 confirmed instances of hair being found in sterile medical devices.” And following additional issues — such as a high infection rate in rats in lab trials, as well as an issue with the device’s coating adhering to packaging in high humidity situations — a consent decree was issued by U.S. District Court in 2015. The decree prevented the company from operating at its Hudson plant (except for “medically necessary” devices bound for overseas) until it addressed various issues and also slapped the company with a $12 million fine.
In this current litigation in New Hampshire, with plaintiffs in both federal and state court, Atrium has denied the plaintiffs’ allegations. In courtroom remarks made in 2017, when both sides laid out their case, Atrium’s attorney contended that the company’s use of fish oil reduces inflammation and has no more problems than other types of mesh products. And as in other hernia mesh cases, the attorney also laid responsibility for any negative issues with Atrium’s product at the feet of the physician, stressing that “proper surgical technique and proper fixation” is paramount to the procedure’s success.
At this time, federal litigation in New Hampshire is set for November.
Mississippi Case Filed
A Mississippi plaintiff who says he suffered injuries following the implantation of a Bard Ventralex mesh has filed a lawsuit in a Southern District courtroom.
After undergoing surgery in March of 2014, the Mississippi plaintiff began experiencing issues with the mesh. He experienced significant pain and three years later had to undergo surgery again to change to a different type of mesh product.
The plaintiff is claiming that Bard should have known that its mesh product was incompatible with human tissue. In this case, the plaintiff is seeking $75,000 in damages.
Florida Ruling in Favor of Bard and Davol Upheld
In early February, pharmaceutical companies Bard, Inc. and Davol, Inc., received some reassuring news. A federal judge decided to uphold a previous ruling in favor of the companies from last year.
Last year, a judge in the U.S. District Court for the Southern District of Florida found that Bard and Davol were not to blame for plaintiff Norma Olmo hernia mesh-related complications. In short, the judge’s decision centered on the argument that much of the responsibility in these cases lies with physicians. In this case, the court found that a doctor is essentially aware a device could fail and should warn his patient accordingly.
In this recent appeal ruling from the U.S. Court of Appeals for the Eleventh Circuit, the decision essentially reiterated this point: “… the manufacturer’s duty to warn runs to the physician, not directly to the patient.”
50,000 Hernia Mesh Lawsuits and Counting
Hernia meshes are used to repair hernias, with the surgical implant acting as a patch. In recent years a number of drug companies that manufacture versions of the device have been the target of lawsuits, from patients who claim that they have suffered because of the mesh products.
Plaintiffs have cited issues such as insufficient warnings and the marketing of unsafe products, as well as a failure to adequately test mesh products and the manufacturing of outright defective products. Issues that arise range from excessive pain to nerve damage, infection, and autoimmune reactions. There are also instances where the mesh has adhered to organs, or migrated or shrunk.
In the last decade, waves of plaintiffs have filed claims against a number of pharmaceutical companies. In August 2010, a $1.5 million was awarded to a hernia mesh plaintiff. The next summer, Bard settled more than two thousand lawsuits for $184 million.
In 2014, Bard paid $319 million to settle another 6,000 cases. That same year, Endo International paid $830 million to settle 20,000 cases. A couple of years later, Johnson & Johnson paid $120 million to settle 3,000; the company, however, still faces 40,000 other claims.
In addition to Bard and Atrium, other manufacturers currently facing litigation include Ethicon and Covidien. There’s more than 50,000 such cases pending nationwide.