A Bard hernia mesh lawsuit is a mass tort claim against C.R. Bard for injuries caused by the company's hernia mesh implants. These medical devices have been known to erode after being implanted. This can cause severe side effects and chronic pain. Victims have filed lawsuits demanding compensation to cover their:
- Medical expenses,
- Lost wages,
- Reduced earning capacity,
- Pain and suffering, and
- The loss of consortium for their family.
So many hernia mesh lawsuits have been filed against Bard that they have been consolidated into multidistrict litigation, or MDL, to speed up the recovery process.
In this article, our personal injury lawyers at Shouse Law explain:
- 1. What Bard hernia mesh products are the subject of litigation?
- 2. Which cases qualify to file a lawsuit?
- 3. Injuries and complications from Bard hernia mesh products
- 3.1. Hernia mesh erosion and shrinkage
- 3.2. Adhesion, bowel obstruction, and fistulas
- 3.3. Infected hernia mesh implants
- 3.4. Hernia mesh migration
- 4. Grounds for Bard hernia mesh lawsuits
- 5. Potential settlements and compensation
- 6. Hernia mesh MDLs in Rhode Island and Ohio
- 7. Who is Bard/Davol?
1. What Bard hernia mesh products are the subject of litigation?
Because so many of Bard's hernia mesh implants are made of the same materials, most of its models are the subjects of pending lawsuits.
The models that have already spawned lawsuits include the:
- 3DMax Light,
- Bard Mesh, sometimes called the “Marlex Mesh” or the “Bard Flat Mesh,”
- Bard-Pre-Shaped Mesh, sometimes called the “Bard Keyhole Mesh,”
- Composix E/X,
- Composix Kugel,
- Modified Kugel Patch, often referred to as the “MK Patch,”
- Parastomal Patch,
- Perfix Light,
- Perfix Plug,
- Sepramesh IP Composite,
- VentralightST with Echo,
- VentrioST, and
There are also some models of Bard's hernia mesh implants that have not led to lawsuits, but seem likely to, in the future. These include:
- Composix L/P,
- Composix L/P with Echo,
- Modified OnFlex,
- Polysoft, and
- Ventrio Light.
Some of these models have certain product numbers that have proven to be defective.
2. Which cases qualify to file a lawsuit?
You are qualified to file a Bard hernia mesh lawsuit if all of the following apply to you:
- You had a hernia repair surgery,
- During your surgery, one of Bard's hernia mesh products was implanted,
- You had an adverse reaction or suffered a side effect after the procedure,
- Your medical conditions were caused by the hernia mesh implant, and
- The injuries that you suffered are monetarily quantifiable.
If all of these factors apply to your situation, you can file a lawsuit and demand compensation.
In most cases, though, victims are not sure if one or several of these factors apply to them. Talking to a lawyer can be the best way to determine if you are eligible to file a lawsuit. It is important to do so as soon as you notice that you might have been hurt: If the statute of limitations expires before you file a claim, you will not be allowed to proceed.
3. Injuries and complications from Bard hernia mesh products
Bard's hernia mesh implants have been linked to numerous side effects. Some of them are the result of the implant's tendency to erode. Others are dangers that come with the implant's intended design.
Possible side effects of a Bard hernia mesh implant have included:
- Bowel obstruction,
- Recurring hernias,
- Internal bleeding,
- Mesh shrinkage, and
- Chronic pain.
Some of these side effects trigger other side effects. For example, a shrinking mesh implant can cause chronic pain and internal bleeding before breaking away and migrating somewhere else.
In most cases, these side effects can require a mesh removal procedure. Those procedures are often complicated by the very side effects that make them necessary.
3.1. Hernia mesh erosion and shrinkage
The most common defect in Bard's hernia mesh products has been that they erode and shrink after being implanted. Because they are designed to combine with the abdominal wall to prevent another hernia, that shrinkage tugs on internal tissue and causes pain.
Many of Bard's hernia mesh products are especially prone to erosion and shrinkage because they are made of polypropylene. This type of plastic oxidizes, or deteriorates, when it comes in contact with oxygen. After being implanted, these hernia mesh products are surrounded by oxygen-rich blood and tissue. This can trigger the erosion process.
Once the mesh begins to erode, it shrinks and shrivels. This pulls on any tissue the mesh has adhered to. The mesh implant can erode to such an extent that it pulls away from the abdominal wall. This can cause:
- New hernias, as the support of the mesh is lost and the mesh tears away part of the abdominal tissue,
- Perforated muscles and organs, and
- Chronic pain.
It can also lead to migration if the mesh tears completely away from the abdominal wall. The mesh can roll up and travel inside the body, causing medical complications wherever it goes.
3.2. Adhesion, bowel obstruction, and fistulas
Hernia mesh can also adhere to and combine with sensitive organs and tissues. This can create serious medical complications that can be life-threatening, including bowel obstructions and fistulas.
Bard's hernia mesh products are designed to adhere to the abdominal wall. With the added strength of the mesh, the abdominal wall is supposed to be able to prevent future hernias. The entire design of the mesh is to facilitate this adhesion – the mesh is made of polypropylene to create scar tissue that grows into the mesh's porous structure.
However, hernia mesh can also adhere to other organs or tissues. If the mesh sticks to something it was not supposed to stick to, it can create serious problems. This is why many of Bard's hernia mesh products have forward-facing and backward-facing sides – to prevent unwanted adhesions.
Those preventative measures do not always work, though. Many of these hernia mesh products are made of two different kinds of plastic, each of which oxidizes and erodes at different rates. As a result, Bard hernia mesh implants can adhere to unwanted tissues in spite of the preventative measures taken in their designs.
When the implant adheres to an unwanted tissue, it is known as a fistula. The connection between the abdominal wall and the other tissue can cause:
- Internal bleeding,
- Muscle and tissue perforation,
- Chronic pain, and
- Reduced mobility.
If the hernia mesh implant adheres to the bowel, though, the result is a bowel obstruction, or a blockage in the intestines. This condition can be life-threatening as scar tissue builds up and stops the digestive flow.
3.3. Infected hernia mesh implants
Bard's hernia mesh implants have also been known to get infected.
Most of Bard's mesh products are made of the plastic polypropylene. Polypropylene is a light, porous plastic. While the size of the pores makes polypropylene ideal for hernia implantations, those pores can also be breeding grounds for bacteria. If the implant is not sterilized before the surgery, or if it becomes compromised during or after the procedure, it can lead to an infection.
3.4. Hernia mesh migration
Bard's hernia mesh products can also migrate, or move away from the site of the implant, if they are poorly secured or if they erode and deteriorate.
An implant's erosion is a common cause of a migrating hernia mesh. As the mesh oxidizes and shrinks, it can peel away from the abdominal wall. If it peels away completely, the mesh can move around inside the patient.
A hernia mesh implant can also migrate if the moors, or tacks, that are used to stick it to the abdominal wall come off. This can happen if the mesh erodes soon after being implanted and there has been little time to create ingrowth in the mesh's pores. The erosion can cause the mesh to loosen, slide off the tacks, and migrate.
4. Grounds for Bard hernia mesh lawsuits
There are two grounds for hernia mesh lawsuits against Bard:
- Bard's hernia mesh implants were defectively designed, and
- Bard failed to warn people of the dangers of their mesh implants.
4.1. Defective design
Bard hernia mesh lawsuits claim that the hernia mesh implants were defectively designed. Those design problems made it unnecessarily likely for people to get hurt. The lawsuits argue that the design defects entitle victims to compensation to hold Bard accountable for its actions.
Defective design arguments are different for certain hernia mesh products. However, four design defects are prevalent in Bard hernia mesh lawsuits:
- Bard's mesh products are made of polypropylene that erodes after being implanted,
- Some hernia mesh products are supposed to prevent unwanted adhesions, but fail to do so,
- Most of Bard's hernia mesh implants are difficult to remove, and
- A few Bard products have “memory rings” that break.
Bard hernia mesh lawsuits claim that Bard should have known that polypropylene would erode after being implanted, but decided to use it, anyway.
As early as 2005, Chevron Phillips, the company that makes Marlex polypropylene, found out that Bard was using its plastic as an implant. Knowing that polypropylene was not designed for implants, Chevron Phillips refused to sell Bard any more polypropylene. Presumably, Chevron Phillips wanted to avoid being sued for the problems that polypropylene would cause inside the human body.1
However, Bard already had approval from the U.S. Food and Drug Administration (FDA) for hernia mesh products made of polypropylene. Rather than change materials, Bard turned to substandard polypropylene from China that oxidized even more quickly.2 Hernia mesh products from that polypropylene started being sold by 2014.3
Lawsuits claim that these newer mesh products are even more defective than older ones.
Bard hernia mesh claims also argue that mesh designs do not adequately prevent unwanted adhesions.
Many Bard mesh products have a backside made of material designed to prevent adhesion. That material, though, also erodes after being implanted. When it erodes and shrinks, it is powerless to stop an unwanted adhesion to the now-uncovered side of the hernia mesh.
Bard hernia mesh lawsuits claim that this design defect has caused adhesions, bowel obstructions, and fistulas.
Lawsuits also claim that Bard's hernia mesh products are defective because their design makes them almost impossible to remove if something goes wrong.
The polypropylene mesh that makes up most Bard mesh designs was made to create “ingrowth.” This ingrowth consists of scar tissue that fills the pores between the plastic strings of the mesh. It combines the mesh and the tissue of the abdominal wall to strengthen internal muscle and prevent another hernia.
It also makes it nearly impossible to remove a hernia mesh implant that is causing chronic pain or has become infected.
Finally, some Bard hernia mesh devices are made with “memory rings.” These allow surgeons to fold the implant for insertion through a small incision. Once inside, the memory rings, which are made of metal, unfold the implant to its original shape.
However, those memory rings have been known to break after being implanted. When they do, they can pierce and perforate internal tissue and organs.
4.2. Defective warning, or failure to warn
Bard hernia mesh lawsuits also claim that Bard failed to warn doctors and patients of the risks of using their mesh as an implant to correct a hernia.
Companies that make medical devices and implants have a legal duty to warn people about the risks of side effects associated with their products. Doctors rely on those warnings to give medical advice, while surgeons rely on them when they choose which implant to use on a patient. Even patients use warnings when they weigh the pros and cons of whether to get a hernia repair procedure.
However, medical companies like Bard often do what they can to avoid having to warn people of the dangers of their products. Doing so often cuts into the company's profits.
Bard hernia mesh claims argue that Bard failed to adequately communicate the potential for their implants to cause severe side effects. Instead, Bard touted its mesh implants as the safest device on the market.
5. Potential settlements and compensation
Punitive damages are rare. They would force Bard to pay extra for their especially egregious conduct.
Compensatory damages, on the other hand, are meant to compensate a victim for their:
- Medical bills,
- Anticipated future medical expenses,
- Lost wages,
- Reduced earning capacity,
- Physical pain,
- Mental anguish, and
- Family's loss of companionship.
Some of the lawsuits against Bard for injuries caused by its hernia mesh products were settled in 2011 for $184 million.4 This settlement set aside around $60,000 for each victim in the multidistrict litigation. However, individual claims against Bard for its hernia mesh products continue to be filed. Additionally, more victims continue to join the MDLs currently pending against Bard to recover compensation from the settlement.
6. Hernia mesh MDLs in Rhode Island and Ohio
There are two MDLs against Bard over injuries caused by its hernia mesh products:
- MDL 2846 in federal court in the Southern District of Ohio,5 and
- A state law claim in the state courts of Rhode Island.6
A multidistrict litigation, or MDL, is a court procedure that consolidates similar lawsuits against a single defendant. It is similar to a class action in many ways. However, unlike in class actions, consolidated lawsuits often split after pretrial procedures. This allows victims to share evidence and defendants to streamline the discovery process, without combining trials.
Bard settled many of the cases in the Rhode Island MDL in 2011.7 However, thousands of lawsuits remain in that case.
As of August, 2019, there were an additional 2,503 hernia mesh lawsuits pending in federal court in the Southern District of Ohio.8 They are all being heard by Chief Judge Edmund A. Sargus.
7. Who is Bard/Davol?
Bard hernia mesh lawsuits are being filed against two companies:
- C.R. Bard, and
- Davol, a corporate subsidiary of C.R. Bard.
C.R. Bard, also known simply as Bard, is itself a subsidiary of Becton, Dickinson and Company.9 Bard is a medical technology company that creates and manufactures medical devices. It is headquartered in Murray Hill, New Jersey.
Bard's subsidiary Davol is headquartered in Warwick, Rhode Island, where many of the hernia mesh lawsuits have been filed in state court.
Call us for help…
If you have had a hernia procedure and think you are suffering side effects, you should get legal help. Contact our attorneys at Shouse Law soon, before the statute of limitations expires.
See Scott Pelley, “Gynecological Mesh: The Medical Device that has 100,000 Women Suing,” CBS News (April 17, 2019).
See note 1.
See note 1.
BioSpace, “Davol Lawsuits to Largely End with C.R. Bard $184 Million Settlement,” (July 6, 2011).
In re: Davol/C.R. Bard Hernia Mesh Multi-Case Management, No. PC-2018-9999.
See note 4.
“Becton Dickinson buys CR Bard for $24 billion to form medical supply giant; Bard shares surge 20%,” CNBC (April 23, 2017).