By Larry Bodine and Victoria Blute.
If you’re a plaintiff lawyer who’s starting or expanding a practice in mass torts, you may want to think about a hernia mesh practice.
As many attorneys know, mass torts are product liability lawsuits against drug companies and device makers over dangerous drugs and devices.
Frequently, there are thousands of plaintiffs, and their cases are ordinarily consolidated into a single court. In this blog post, we’ll talk about defective surgical mesh commonly used to repair hernias.
If you’re interested to learn more about marketing a hernia mesh practice, you can watch our free hernia mesh webinar.
The C-Qur (pronounced “secure”) Hernia Mesh is made by Atrium is headquartered in Hudson, NH. Atrium is a subsidiary of an enormous German holding company called Maquet Getinge.
It’s still early in this litigation involving the C-Qur Hernia Mesh. If you’re an attorney thinking of starting a practice in this area, it’s very inexpensive to sign up clients right now.
There are many potential plaintiffs. There are an estimated one million hernia operations conducted each year, and statistically, they occur in a little under 2 percent of all men.
The defendants have deep pockets. Maquet Getinge, which owns Atrium, has annual sales of $3.3 billion worldwide. Based on previous cases, a mass settlement, when one takes place, could range somewhere in the area of $70,000. In one case that actually went to trial over surgiccal mesh, the plaintiff recovered $1.5 million.
Currently, the cases are consolidated into a multi-district litigation docket before US District Judge Landya McCafferty in New Hampshire, under MDL 2753. This was created last December in 2016 and so far, there are about 24 cases filed.
In this litigation, the plaintiffs allege that the C-Qur mesh was:
Here are some of the complications that arise from the mesh’s placement:
Foreign body response. The polypropylene mesh causes inflammation and encapsulation of the foreign body with scar tissue; the body rejects it. There’s a very high rate of rejection.
There’s also a high rate of infection because the coating of the hernia mesh prevents fluid from escaping. It allows fluid to pool and remain dormant for months, becoming a breeding ground for bacteria.
The mesh is known to perforate organs. A hole can form in an organ such as the intestines when coming in contact with parts of the hernia mesh. This causes chronic, intense pain until the mesh has been removed. It can require additional surgeries — many patients who have had this mesh implanted require revision surgery.
It can also cause bowel obstruction. The mesh can cause dense adhesions that connect to the hernia mesh and interfere with proper bowel function.
The C-Qur Hernia Mesh was never tested for safety of efficacy by the FDA.
The FDA gave it a 510(k) approval in March of 2006. The approval was based on the fact that it was “similar” to an earlier version of the mesh, meaning that the FDA never tested it.
There were a series of warnings and recalls that increased the liability.
The first warning came in 2012 when the FDA issued a warning letter to Atrium, saying their sterilization process was defective. The FDA found 35 separate complaints of human hair being embedded into the mesh. There were multiple instances of C-Qur infections that the company failed to report.
There was a recall that took place on August 9, 2013. Atrium Medical recalled 95,286 units because the coated mesh could adhere to the inner packaging when exposed to high humidity.
In reality, however, no actual products were pulled from the market.
Atrium simply wrote a letter to doctors notifying them of the “stickiness” problem.
Finally, there was a FDA injunction against the company stopping them from producing the mesh, and that took place on Feb 4, 2015. It was followed up by more than 10 inspections by FDA investigators, who found major violations in the quality system regulation, the medical device reporting regulation, and the correction and removal regulation.
There are lots of examples here of failure to test the product and bad activity by the manufacturer.
Finally, there were numerous scientific articles dating back to 2009 (just three years after the mesh was on the market) all the way up to February of 2016, that finds the mesh causes an increase in adhesions. Additionally, these articles found that the C-Qur hernia mesh causes more infections than all the other brands combined.
What is the settlement value of a hernia mesh case? For guidance, we should look to previous hernia mesh litigation involving the Kugel hernia patch.
Back in 2010, CR Bard and its subsidiary, Davol, Inc. settled 2,600 cases involving the Composix Kugel hernia patch for a total mass settlement of $184 million dollars. That comes down to roughly $70,000 per case.
This took place after a federal court jury found that the Kugel mesh was defective and awarded $1.5 million to the plaintiff, Christopher Thorpe, in 2010.
Similarly to the C-Qur mesh, the patients with Kugel mesh charged that it caused dangerous side effects like bowel obstruction and perforation, adhesions and infections due to a metal ring inside the patch that was prone to breaking.
Just like the C-Qur mesh, the Kugel mesh also received the shortcut 510(k) approval from the FDA. It was never tested for efficacy or safety. When the FDA approved it in 2006, they simply said that it was substantially equivalent to a previously approved mesh.
Another key point in liability is recalls.
Before litigation began against the Kugel mesh, there were a wave of recalls in 2005 and 2006. There was a second wave in 2007. In that year, on June 22, all the federal cases were consolidated into the Rhode Island Federal Court in MDL 1842 before Senior US District Judge Mary M. Lisi. Out of some 3,000 cases, only six remain in the MDL.
A third type of mesh to keep on the horizon: the Ethicon Physiomesh flexible composite mesh.
There are already dozens of lawsuits filed against Ethicon, a division of Johnson & Johnson. There’s been a motion filed to create a multi-district litigation docket, and that was filed in March. There’s no decision on whether to create it yet.
In any event, Ethicon issued an urgent field safety notice and withdrew their product from the market in May 2016. The notice included a recall of all existing stock held by healthcare facilities for all variations of the Physiomesh product line.
On the same day, Health Canada issued a recall for Physiomesh products.
The Australian Therapeutic Goods administration issued a hazard alert in June.
The recall of the on-the-shelf products should serve to prevent future hernia repair patients from being implanted with the mesh. However, that recall doesn’t help those who were already implanted with it.
It’s estimated that as many as 300,000 people have been implanted with Physiomesh since the product was approved in 2010.
There are two kinds of hernia mesh to look at: C-Qur Mesh and Ethicon Physiomesh.
In both cases there are many potential plaintiffs and well-funded defendants.
There’s a history of settlements involving the Kugel mesh patch and in both cases, a long history of bad behavior by the companies involving recalls and even a court order to stop manufacturing.
The science backs up the danger of the mesh, and of course, there was a lack of safety testing by the FDA. The C-Qur mesh and Ethicon Physiomesh are two good places to start if you want to grow or begin a hernia mesh mass torts practice.
Now that you know about the history of defective hernia mesh and how straightforward the litigation can be, what it comes down to is this:
To learn about attracting potential clients for hernia mesh cases, watch our webinar on hernia mesh from our Mass Torts Marketing series.
Do you have questions about marketing a mass torts practice? LawLytics can help. Call us at 800-713-0161 or schedule our call.
