Proving your hernia mesh claim is not as simple as linking your injuries to the hernia mesh product. Your product liability attorney must satisfy several elements to prevail in a hernia mesh lawsuit. But even then -- the manufacturer (or other defendant) will aggressively try to defend itself.
Here, the hard questions about proving a hernia mesh caused your injuries, and receiving fair and just compensation are addressed. We will discuss key things to know before filing a hernia mesh lawsuit, including:
- 1. What are the types of defective product claims you can make in a lawsuit?
- 1.1 What are defectively manufactured medical devices?
- 1.2 What are defectively designed medical devices?
- 1.3 What are defectively marketed medical devices?
- 2. Who are the potential defendants and their potential defenses?
- 3. What are some defenses that the defendants can make?
- 4. What if the FDA did not recall the hernia mesh implant used in my hernia repair surgery?
- 5. How do you determine which jurisdiction to file your lawsuit?
- 6. What are the two things you should do before you file your hernia mesh lawsuit?
- 7. How do you get started on your lawsuit?
There are typically three claims a person can made when he or she wants to sue a company for its product. The same claims apply in defective hernia mesh lawsuits. These three claims are:
- Defectively manufactured hernia mesh implants
- Defectively designed hernia mesh implants, and/or
- Defectively marketed hernia mesh.
Each claim must be proven on its own merit if the claim is made in a lawsuit. As such, more than one claim can be made within the same lawsuit.
Medical devices that have been defectively manufactured are medical devices that deviate in some way from the other products made. In other words, a problem at the facility caused an error in production. This type of claim is generally the most common of the three claims. When medical devices are defectively manufactured, it can impact only some products or all of the products if all were made when the error is production was occurring.
In hernia mesh cases, your attorney will likely have to satisfy the following elements:
- The implant was sold in the ordinary course of business -- like most other like products.
- The implant was manufactured with a material defect.
- The implant was used in a reasonable and foreseeable way by the plaintiff.
- The implant's defect caused the plaintiff's injury.
Examples of defectively manufactured hernia mesh include Ethicon's Physiomesh. These mesh products were made in a facility in violation of quality systems regulations and more than 30 of its implants were manufactured in some way that hair samples were present in the mesh. This defective manufacture of hernia mesh can trigger -- and did and continues to do so -- lawsuits.
Medical devices defectively designed are those devices that may have been manufactured according to the blueprint but have a design that is faulty in some way. Defective design can involve either the way the device is designed or the materials the product is made of. When the design is defective, all medical devices under that design are defective regardless of how they were manufactured.
In hernia mesh cases, your attorney will need to satisfy the following elements
- The hernia implant was sold in the regular course of business.
- The hernia implant was defectively designed in a material manner.
- The hernia implant was used in a reasonable and foreseeable fashion by the plaintiff.
- The hernia implant's defect caused the plaintiff's injury.
These elements are not dissimilar than those required to prove defective manufacture of hernia mesh. The only difference is the design is defective, not the manufacturing of the product.
Examples of defectively designed hernia mesh include:
- Atrium's C-QUR hernia mesh, which incorporated a ring that would break and was composed of materials that were harmful to internal tissue and organs.
- C.R. Bard's Sepramesh design allows the mesh easy to fold over and migrate, causing injury, and the materials that make up the mesh are harmful.
- Ethicon's Physiomesh, Proceed, and Prolene hernia meshes are all prone to breaking, tearing, and are made up of harmful materials.
- Covidien is coated with an ineffective file and the mesh used is poorly design and tears or unravels easily.
The above descriptions are not full summaries but only brief examples of some defective hernia mesh products now undergoing or being considered for lawsuits.
Defective marketing of a medical device like a hernia mesh is not as easily identified and proven as defective manufacture and designs are. Here, marketing refers to instructions, recommendations, warnings, or lack thereof, or any other information provided to consumers to market the product.
Most often this claim involves
- The defendant providing insufficient warning of the potential dangers involved when using the device.
- The defendant providing inaccurate instructions to medical professionals on how to use the device effectively and safely.
- The defendant engaging in untrue or inaccurate sales pitches and advertisements.
In hernia mesh cases, your attorney will need to satisfy the following elements:
- The device was sold in the regular course of business.
- The device was dangerous but sold without adequate warnings of the same.
- The device was sold without sufficient warnings or instructions.
- The device was used in a reasonable and foreseeable manner by the medical professional and plaintiff.
- The device injured the plaintiff who used the device due to insufficient warnings or instructions.
An example of this type of claim is Ethicon's Physiomesh. It's labeling did not provide enough warning about its failure rate and subsequent injuries that can be caused by the mesh failure. In part it is because this product was approved by the FDA through the 510(k) process, thus, clinical studies were not required. It wasn't until patients and medical professionals began filing adverse reports did the issues related to the product materialize.
In fact, a recent study published in February 2018 in the Journal of American College of Surgeons concludes that for hernia mesh devices, the labeling and reporting are clearly insufficient. 1
In a lawsuit, you always want to list all potential defendants, and your experienced attorney will do so. It is particularly important in hernia mesh cases so that you can receive just and fair compensation. In these cases, many of the manufacturers are subsidiaries of other companies. Ethicon is a subsidiary of Johnson & Johnson while Atrium Medical Corporation is a subsidiary of Maquet Cardiovascular.
But the manufacturers are not the only potential defendants in defective medical device lawsuits. You should consider every person and entity within the chain of distribution of the hernia mesh product. This means you should consider every person or entity that was involved with the product since its conception to the moment it reached the consumer: you.
Potential defendants include but is not limited to:
- Manufacturer of the product
- Laboratory that tested the device, especially if dependent of the manufacturer
- Sales representative who met with doctors or other medical professionals to pitch the product
- The doctor who recommended the hernia mesh product
- Hospital where you were operated.
When you file a lawsuit against a large manufacturer of hernia mesh devices, that manufacturer will use its aggressive, well-resourced team of lawyers to fight your claims. Their lawyers have only the interests of the company in mind, and your lawsuit -- if successful -- harms those interests. So they will throw everything at you.
Not only are these attorneys armed with resources and skill, they may have valid defenses. These defenses include
- You assumed the risk of the injury that resulted. Basically, you chose to accept hernia repair surgery with mesh products over sutures. As such, you assumed the risk. If you were well aware of all the risks involved in the application of mesh for your hernia repair, then the defendant has a likely defense.
- There is another reason for your injury -- the product was not the direct cause of your injury. For many patients undergoing surgery for hernias, they have other ailments and health conditions. One of those conditions could have led to whatever injury you believe was caused by the mesh implant. If the defendant can demonstrate another health condition or other “thing” caused your injury, then it could have a defense.
- You behaved in a way that injury resulted -- the product was not the direct cause of your injury. Maybe you were provided a care plan, but you chose not to follow it accordingly. Maybe you were supposed to remain in bed or limit your activities, but you chose to try to go play a sport. Whatever the reason, if your conduct can be traced backed to the injury, then it could be a defense for the manufacturer or other defendant.
- The statute of limitations has expired. The statutes of limitations vary according to the state. You may have as little as 1 year to 10 years from the time the implant was inserted or from the date you discovered the injury. No matter how long you have, times flies. We all know this. You must seek legal counsel immediately to first understand your rights, and second to know how long you have to file a lawsuit if that is what you choose to do. The sooner you do so, the sooner your attorneys can get started. Evidence in these kinds of cases and disappear or be harder to discover as time passes. And if the statute of limitations does expire, you have no recourse. It's over. The defense wins. And you do not get the compensation you deserve.
These defenses, though strong defenses in some cases, can be refuted. Your attorney, if hired in time, can develop strategies to weaken or disprove these defenses.
It does not matter if the FDA did not recall the hernia mesh implant used in your hernia repair surgery. It certainly helps your case, though, if the FDA had recalled your specific product.
Recalls of hernia mesh implants have increased dramatically over recent years. If you were implanted with a mesh product for your hernia repair, you may have been implanted with one that has been recalled. Either way -- whether there has been a recall or not -- make sure you or your doctor files an adverse report describing the injury.
After your health matters have been addressed, seek legal counsel. An experienced personal injury or products liability attorney will be able to review your case, medical records, the mesh itself, among other pieces of the case, to determine what your best options are.
Determining jurisdiction will be the responsibility of your experienced attorney. Depending on where you live, where the company is located, and the actual questions of fact, your case could be filed in state court, a federal court like a U.S. district court, or removed from either of the latter courts to multidistrict litigation -- which could be located in a different state.
Your attorney will be able to identify things you should know before you file your case. As a general overview, keep the below things in mind if you are considering a lawsuit.
1. Find out who the manufacturer is and the exact product used.
You have probably discerned the need for this already, but in case not: identify the manufacturer and the product used. As a reminder, the primary manufacturers and their respective products that are currently undergoing or in the process of being sued are provided in the below chart.
Physiomesh Flexible Composite
Also see our article on how to identify my hernia mesh product.
2. Collect evidence as soon as you believe something is wrong.
Obtain the date of your surgery and all medical records and names of medical personnel involved in the surgery. If you were required to have the mesh removed, gather those records as well. To note, it is very important to ask your doctor to preserve the removed hernia mesh and tissue.
In RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability, the court issued an order outlining how to preserve a removed hernia mesh for evidence. 2 The process is provided via four stages.
- Preservation and collection. If you must have the mesh removed, be certain to advise your doctor that the mesh and any tissue removed with it must be collected and preserved.
- Storage. Among other things, the materials must be stored at a location where all parties have access to it for analysis.
- Evaluation of “Materials” and division of “Gross Specimens". A gross examination may be conducted by either or both parties.
- Other pathology. Both parties can examine paraffin blocks and/or histology slides using routine pathology methods. 3
Preservation is important. The mesh itself will be the key piece of evidence.
In medical device lawsuits, you do not sue because you were injured by the device. Surgery and most medical devices have some risk to them, even if limited in some case. In this kind of lawsuit, you sue because the manufacturer did not meet the legal standard for designing, manufacturing, and marketing the device in a way that would reduce your risk of harm. Your attorney will identify the difference between the two.
With that said, the best way to get started is to contact experienced legal counsel to discuss your case. At Shouse Law Group, our personal injury and product liability attorneys will review your case and advise you of your options. We are thorough, we are comprehensive, we know the law, we know the procedures, and we are well-resourced to counter any defense the manufacturer's legal team may try to throw at us. Contact our law office today.
- Kahan, L.G., Blatnik, J.A. Critical Under-Reporting of Hernia Mesh Properties and Development of a Novel Package Label. J Am Coll Surg. 2018 Feb;226(2):117-125. doi: 10.1016/j.jamcollsurg.2017.10.020.
- In RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability. Practice and Procedure Order No. 11. U.S. District Court for Northern District of Georgia Atlanta Division, MDL Docket No. 2782, Civil Action No. 1:17-MD-02782-RWS.