Many patients have filed lawsuits claiming that their hernia mesh, a device designed to provide comfort and relief from pain, caused their pain to increase. Worse, some hernia meshes had fused to their patients so fully that multiple messy revision surgeries were required to amend the damage done by their implanted device. There have been many Mesh recalls that have also been attributed to faulty design. Manufacturers have been accused of not informing patients of the risks linked to hernia mesh.
Hernia mesh manufacturers are companies or corporations that seek to mass-produce a hernia mesh product for sale and implantation. These companies are often highly successful and appropriately compensated for the very necessary work of providing essential medical devices to patients. The major manufacturers that produce hernia mesh are:
These manufacturers are also the chief defendants in a hernia mesh lawsuit. Some of these manufacturers have had multiple products completely recalled and others have avoided public notice. One thing they all have in common, however, is a duty of care to provide a safe, thoroughly vetted implant product. Hernia mesh manufacturers make a very particular type of product. Some natural meshes and all synthetic meshes are implanted in an extremely sensitive part of the body. For synthetic meshes, the intent is to be left in the patient for life. This is a huge burden of trust that patients must invest in manufacturers in order to seek relief for their hernias. , there are a number of things that can go wrong for hernia mesh recipients and some injuries may be due to defects in the design of the mesh implant.
There are many reasons the hernia mesh lawsuits are incredibly complex and long-running. For a start, we are not dealing with an individual manufacturer, nor a single product. Hernia surgery and, as a consequence, hernia mesh production is a massive business in the United States, with hernia repair generating about $48 billion annually. Around 20 million hernia repairs are carried out on a yearly basis, and this number is set to increase given the association with risk factors such as obesity. All of this creates a situation where we have multiple companies facing litigation, multiple products recalled for being dangerous, and thousands of plaintiffs bringing lawsuits for a variety of different injuries.
As stated, the entire issue is complex, and there seems to be a long way to go before it becomes less so despite various lawsuits, settlements and continued recalls of mesh products over the last 15 years. Below we will run through the major hernia mesh companies, their product recalls and lawsuits they face in 2020:
C.R. Bard, Inc., is notable for having made the biggest hernia mesh settlement to date - $164 million. However, it is not out of the woods yet as Bard is facing thousands of lawsuits gathered together in a multidistrict litigation (MDL) in Ohio. As of 2020, six different Bard Kugel hernia mesh products have been recalled. The company also produces Vetralex Patch hernia mesh through its subsidiary, Davol Inc. Ventralex has yet to be recalled by the FDA, but legal proceedings have begun in Rhode Island against Davol. It seems likely that the Ventralex hernia mesh lawsuit settlements will be just as expensive for Bard as the other cases it faces.
Ethicon, Inc., is a subsidiary of Johnson & Johnson. Ethicon has specialized in wound closure and surgical sutures since the 19th century. Today, however, it faces an MDL in Georgia with over 2000 plaintiffs who accuse the company of providing defective hernia mesh products and for failing to warn doctors of the potential complications. The case was filed in Georgia by Wright and Schulte, LLC, acting on behalf of individuals against Ethicon. The Wright and Schulte hernia lawsuit is not limited to Ethicon/J&J, however, as Richard Schulte was also named in the Plaintiffs Steering committee in a case against Atrium Medical Corp. Wright and Schulte is also reviewing cases against Bard and Covidien Pariterex (Medtronic).
As of 2020, there are now four J&J/Ethicon hernia mesh products recalled. These are from three distinct product lines – Physiomesh, Proceed, and Prolene. We are also informed that the MDL based in the Southern District of Georgia is planning a bellwether trial for Ethicon hernia mesh cases, possibly as early as January 2021. A bellwether trial is an important indicator for mass tort cases, and it could provide us with some insight into future Johnson and Johnson hernia mesh lawsuit settlements.
Mass hernia mesh recall dates from the mid-2000s, but it seems that problems still remain in 2020. Indeed, there is speculation that hernia mesh surgery could one day be banned by the FDA; just as it did for pelvic mesh produced for transvaginal repair.
There has been criticism of how products are tested, and some criticism of hernia mesh recalls – FDA standards and procedures. For example, new hernia mesh products are approved by the FDA under a process known as 510(k). To gain approval, manufacturers must show that the new product is fundamentally similar – “substantial equivalence” – to one already approved by the FDA. That make sense from a safety perspective. However, a study on these regulations showed that manufacturers were demonstrating that “substantial equivalence” with products that are on the hernia mesh recall list.
Hernia mesh implants are often lumped into the same group. While it is true that hernia meshes all serve to accomplish the same goal, it would be incorrect to equivocate one type with the other.
Some of the most common hernia meshes that are cited in a hernia mesh lawsuit are as follows:
Inguinal hernia mesh, which treats intestinal protrusions near the groin or lower abdomen.Even after making these distinctions, the material of the hernia mesh can also change a patient’s chance of experiencing complications. Typically patients will have one of two options for mesh materials: natural or synthetic.The natural mesh is derived from animal tissue, usually from a cow or pig, and often this type of mesh has fewer complications. One major reason for this may be that natural meshes are not designed to be permanent, but instead act as a placeholder for your body to repair the hole in the area naturally.
The downside to natural meshes, however, is that they will degrade and lose strength over time. This may not make them ideal for serious hernias or for areas that may not heal fully over time.
As an alternative, synthetic meshes can be put in. Synthetic meshes can be absorbent, behaving similarly to animal meshes, or non-absorbent, becoming a permanent fixture in the body.
Synthetic non-absorbent meshes are typically used to permanently reinforce an area of the body. These are usually implanted via laparoscopic surgery and this combination can be the basis for many of the side effects and complications that patients experience.
Some of the side effects listed by the Medtruth that may indicate a failure of the hernia mesh include:
These are not the limit to the damage that could be inflicted, however, as the mesh is left in the body it could also lead to a variety of damaging complications. It is important that if these symptoms begin to appear, a medical professional should be consulted.
According to the FDA, the following complications have been reported either in their adverse event reporting system or in a hernia mesh lawsuit:
This is not a complete list, however. Any health risk that abates after the removal of a hernia mesh can be attributed to the mesh’s presence. Unfortunately, some meshes may require multiple, painful revision surgeries to remove the mesh.
These flawed devices have often found themselves on the receiving end of multiple manufacturers and FDA recalls.
After surgery of any kind, it might take years for problems to become apparent. This is certainly the case for hernia mesh surgery. However, those who have suffered complications have reported symptoms of torn hernia mesh. These are listed below:
Some hernia mesh devices have been labeled as so harmful that they require a total recall. These products have been deemed by the FDA to be irreparably flawed and therefore they must be removed.
The following hernia mesh devices have been recalled by the FDA in their entirety:
Most recalls were the combination of a large number of adverse event reports and hernia mesh lawsuit findings. Through these combined methods, manufacturers were forced to accept responsibility for denying the complications of hernia mesh implants and change their practices.
In most cases, after the FDA requires a manufacturer to initiate a total recall of a product line, the other products that are substantially similar will undergo review to ensure there are no additional calls for a recall. In this way, a hernia mesh lawsuit can not only compensate victims of undisclosed events, but also massively improve device safety for other patients.
Hernia repairs are one of the most common surgeries, with around 20 million performed each year globally. The majority of these surgeries require the implanting of hernia mesh, a medical procedure that stretches all the way back to the 19th century. Hernia mesh insertions became common in the United States from the 1950s.The reason we point to this history lesson is to stress the fact that this is a common procedure and one that should have been perfected over time. However, in more recent times, it seems that companies producing hernia mesh products did not warn patients of the potential complications when using new hernia mesh products, leading to pain and suffering for thousands, if not millions, of Americans. A more recent timeline for hernia mesh is shown below, which includes significant hernia mesh recall dates:
As we have seen, the biggest award paid so far from hernia mesh producers was the $164 million from C.R. Bard in 2011. We may have had a greater insight into potential awards from the current hernia mesh MDLs in 2020 if the Covid-19 outbreak had not caused delays to bellwether trials. 2021 will almost certainly give us more of an idea of how much will be awarded in hernia mesh lawsuits.
How much will hernia mesh producers have to pay out to settle the cases? It is difficult to say. Indeed, it’s worth remembering that hernia mesh problems are not confined to the United States, and many of the companies involved in hernia mesh lawsuits are multinational. Nevertheless, there is reason to believe that the final bill for companies like Johnson & Johnson and C.R. Bard could reach billions of dollars. We know this because those same companies have had to pay huge amounts – the bill is now estimated at $8 billion – due to similar levels of damage caused by pelvic/ vaginal mesh procedures. While the case is different from the hernia mesh case, it shows, nonetheless, the massive liability costs these companies could be facing.
A statute of limitations is a maximum timeframe set out for legal proceedings to be initiated after the event in question has occurred. The length of a statute of limitations can vary from state to state, and it will depend on the type of crime or civil case. Personal injury or product liability cases, such as the hernia mesh lawsuit, can be complicated as damage can occur over time. Some states might time the statute of limitations from the date of surgery, whereas others implement a ‘discovery’ rule, meaning the statute of limitations begins only when you have discovered the problem – and that could be years after surgery.
The important thing is that you speak to an experienced hernia mesh lawyer to find out what your rights are under the statute of limitations for hernia mesh cases in your state. Indeed, it’s worth bearing in mind that the statute of limitations only applies to the initial filing of a lawsuit, and it cannot run out once your case has been filed. So, even if you are cutting it fine or unsure whether the statute of limitations has passed, speak to a hernia mesh legal expert to find out your options.
It might be assumed, erroneously, that the hernia mesh case is a class-action lawsuit. It’s an easy mistake to make as thousands of cases are bundled together to litigate against a handful of hernia mesh companies. However. the hernia mesh lawsuits fall under the category of mass tort lawsuit. There are several differences between mass tort cases and class actions.
The most important distinction we can make, though, is that class-action lawsuits treat the litigation as a single case, regardless of how many plaintiffs take part. Conversely, each individual is treated separately in a mass tort case. Most mass torts are organized into MDLs (multidistrict litigations), which enables the legal process to run a bit more efficiently. Otherwise, judges would have to hear 1000s of separate cases.
Class-Action Lawsuit: A representative action where one plaintiff or consumer group represents a large number of plaintiffs. If secured, financial compensation would be shared out equally.
Mass Tort: A legal action where the plaintiffs have separate – but related – cases. MDLs allow for mass tort cases to be bundled together for efficiency, allowing lawyers to share information, etc. However, each plaintiff’s case is judged on its own merit when it comes to compensation.
It can be difficult to estimate exactly how long lawsuits will last. A hernia mesh lawsuit may last for years before an attorney extends an offer to settle. If the case settles, the verdict may be appealed numerous times, each time adding the time to file and argue the case again.
For this reason, many times an attorney serving plaintiffs will work on contingency. A contingency is a common, but not universal, practice which basically means that an attorney will accept all of the fees, costs, and hours up front in exchange for a predetermined percentage of the verdict or settlement.
Under contingency, an attorney can continue to pursue justice for their clients without concerns of the client running out of funds to pursue justice. Hernia mesh lawsuits may have a variable timeline from filing to the conclusion, but the general events are similar.
In addition to a sharp influx of hernia mesh lawsuit filings, the FDA and other investigative bodies have been examining the damage caused by hernia mesh on a global scale.
In January 2020, the BBC Network investigated hernia meshes and found that many hernia mesh devices were approved without rigorous testing because they were highly similar to an existing product. This is very similar to the U.S. FDA’s 510(k) pathway which follows a similar process.
A study published in the ANZ Journal of Surgery in April 2020 has explored the safety of inguinal hernia mesh. In a study of a “total of 1711 hernia in 1366 patients” that “were repaired from 2002 to 2016” with 1047 of those repaired using laparoscopic surgery the long-term effects of chronic pain were examined.
The FDA has also become more aware of the complications and has advised patients and medical workers on how to monitor hernias for complications and damage. Additionally, the FDA has updated the mesh pages for manufacturers whose meshes have been recalled following complications.
We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.