Hernias are a common health problem for adults. How they’re treated often depends on an individual’s overall health and how the hernia affects their daily life. When medical treatment is needed, surgery making use of a special mesh is the common recommendation. But some of these meshes have caused problems for some patients. One such surgical mesh in particular has been the Strattice Reconstructive Tissue Matrix (Strattice mesh). To understand the issue with the Strattice mesh, let’s first get some background information.

What Is a Hernia and How Is it Treated?

A hernia is a medical condition where there’s a hole or weakness in a wall of tissue, such as fascia or muscle. Because of this hole or weakness, an internal organ or fatty tissue will protrude or push through and into a part of the body where it shouldn’t be. This can cause pain, organ dysfunction (through a loss of blood supply or obstruction in the organ), swelling and/or a visible bulge at the site of the hernia.

Depending on the severity and location of the hernia, as well as the condition of the patient, surgery is often recommended. Until somewhat recently, this typically involved cutting into the body, then pulling existing tissue surrounding the hernia together to close the hole.

The benefit of this approach was that it used the patient’s own tissue to repair the hernia. A disadvantage was that it could lead to the hernia coming back. To address this issue of hernia recurrence, hernias started being repaired with meshes. These were screen-like sheets that were used to strengthen and support the tissue weakness causing the hernia.

The earlier surgical meshes were made out of synthetic materials, such as polypropylene. These weren’t ideal because they sometimes led to problems, including:

• Inflammation
• Adhesions (fibrous bands of tissue that connect organs and other parts of the body)
• Patient discomfort, including severe pain
• Perforated organs
• Infection
• Bowel blockages
• Internal bleeding
• Nerve damage
• Fistulas (a connection between tissues or organs in the human body that are not normally connected)

Many of these issues stemmed from the patient’s body treating the synthetic mesh as a foreign body. Because of the problems linked to synthetic meshes, many lawsuits have been filed against their makers.

Due to the problems associated with synthetic meshes, medical device companies tried surgical meshes made from biological materials. By using human or animal tissues to create a surgical mesh, the hope was that the patient would produce a lower foreign body response, have a lower risk of infection and eventually replace or supplement the biological mesh with the patient’s own tissue. One such product was the Strattice mesh, although this product had its problems.

What’s Wrong With the Strattice Biologic Hernia Mesh?

The Strattice mesh was made from pig skin, which was supposed to make it far more compatible with the human body compared to meshes using synthetic materials. Yet according to some of the patients who received the Strattice mesh, they suffered many problems that were common with synthetic meshes. These problems potentially stemmed from the biological mesh coming apart or breaking down inside the body.

According to the allegations in one Strattice mesh lawsuit, the extent of the problem with the Strattice mesh includes 450 adverse medical event reports. Of these 450 reports, there have been six deaths, at least 340 injuries and at least 107 product malfunctions.

The Strattice mesh has a history of FDA recalls, including a Class 3 Device Recall in 2010 for a mislabeling error and a Class 2 Device Recall in 2011 because it was being used in a way that hadn’t been properly approved.

Because of the problems some patients have had with the Strattice mesh, they filed suit against the maker of the Strattice mesh, including LifeCell Corporation and related business entities like Allergan, Inc. and Allergan USA, Inc.

Lawsuits Stemming From Alleged Problems with the Strattice Hernia Mesh

So far, the bulk of the Strattice-related lawsuits have been filed in New Jersey, both in federal and state court. At least 50 of the state court cases have been consolidated into multi-county litigation, or MCL. Some of the causes of action made by Strattice mesh plaintiffs include:

• Design defect
• Failure to warn
• Negligence
• Negligent misrepresentation
• Fraud
• Breach of express warranty
• Breach of implied warranties
• Violation of consumer protection laws

MCL in New Jersey is similar to multi-district litigation in federal court. But instead of individual cases from U.S. district courts getting consolidated into a single federal district court, the individual state cases from New Jersey county courts get consolidated into a single New Jersey county court. The Strattice mesh MDL has been sent to Atlantic County.

What Happens Next?

According to a September 15, 2022 Amended Case Management Order, the first trial has been scheduled for January 29, 2024. Until then, the parties will finish up handling pre-trial matters, such as discovery, deciding the order the cases will go to trial and filing any necessary motions.

If you received a hernia mesh, you should talk to your doctor about what you need to do to address any potential medical concerns. If it turns out something went wrong with the mesh, give me a call at (919) 830-5602 and we’ll see if there’s something I can do to help.

Clients approach their defective product cases in different ways. Some call me with an injury caused by a medical device and say, essentially, “figure it out.” I have no problem with a client taking this position. Others keep detailed notes and meticulous records and send me a package of documents that can be several inches thick. I never require a client to do this initial “leg work,” but it can often jump start a case against the device manufacturer. If you are inclined to be more involved in the process, at least early on, I have noted some important tasks below you can accomplish to launch your hernia mesh case.

Let’s start with two assumptions: (1) you had hernia mesh implanted in your body in the past, and (2) you have suffered injury because of the hernia mesh. Where do you go from there?

Identify Your Product

It starts with this. The first and best place to go for this evidence is the product stickers page. These product stickers are found with the hospital’s medical records from the original implant surgery. It will look like a sheet of paper with a label or labels (“stickers”) attached to the page. These product stickers will identify (often in very small type) the manufacturer, the reference number, the catalog number, the lot number. It will likely mean very little to you when you see it, but trust me, it is an important document. I will say this: when a new client calls me with a mesh injury and promptly sends me the product stickers page, I know we are off to the races.

Caveat: the product stickers page is not always available. I’m not sure why, but occasionally a hospital will throw away the product stickers. It is an awful practice. In that case the hernia mesh must be identified through the implant surgery records (such as reference to the product in the operative note) and in a last resort through the billing records from the hospital. In some cases I have gotten the implant surgeon to sign an affidavit attesting to the specific product implanted. No matter how we get it done, we must identify the product implanted.

Gather Medical Records

This step is related to the step above, but involves more information and more documentation. You will need to contact all your medical care providers and ask for all medical records relating in any way to your hernia mesh surgery, as well post-surgery treatment. This would include implant and revision operative reports, discharge summaries, pathology reports, hospital notes, and other information gathered in the mesh implant surgery. These documents are the foundation of a strong hernia mesh lawsuit.

Identify Your Injury

Virtually all injury begins with the onset of pain or discomfort. But for a successful hernia mesh case, we will need to get specific. In most hernia mesh cases, there will have been a medically necessary revision surgery. The hernia mesh is implanted, it causes complications and pain, and it has to be removed. (That is, if it can be removed.) In normal medical procedures, revision surgeries should not be necessary; therefore, revision surgeries are inherently an injury to the patient. Beyond that, it will be important to identify the specific kind of injury the hernia mesh caused. Hernia mesh frequently causes adhesions, which are bands of scar tissue that bind organs or tissue together. Hernia mesh also causes inflammation, scarring, folding or curling, rejection, allergic reactions, and other serious complications. These injuries will likely be described in the medical records.

This step is important for a secondary reason: so we can identify whether the injury was caused by something other than the failure of the hernia mesh. In some cases after hernia mesh surgery, injury can occur because of surgical infection (that is, infection shortly after implant surgery), from other surgical complications, or even from an outside trauma (like a bad fall or a car crash).

Chart Your Hernia Mesh Timeline

You will need to confirm the dates of implantation, the identify the dates of onset of symptoms, the date of revision, and the dates of further revisions (if more revisions happened). Beyond that, you can use the product stickers to identify the hernia mesh implanted, and you will want to identify the hospital where you had the mesh implanted, the surgeon who performed the surgery, and the location and surgeon for any revision surgeries.

Maintain a Symptoms Journal

I always encourage this. It is simple enough: When you first begin to notice any sensations or pains which seem abnormal or unexpected, write down the date and a brief description of the pains on a piece of paper (or a notes app on your smart phone). The more detail the better—note the kind of pain you feel, the location, and any other descriptions. This journal may provide important information for your doctors but also for me as your attorney when I prepare a settlement package or a lawsuit. A pain/symptoms/well-being journal can provide valuable information to an attorney putting together the best case for you in the event you have a viable claim against a manufacturer for a failed hernia mesh product.

Contact a Good Product Liability Lawyer

Remember, you are not expected to do the work listed above. I have done this investigation often and I have gotten quite efficient at putting together strong cases. If you had hernia mesh revision surgery, you can contact me and ask me to sort it all out. So give me a call ((919) 830-5602) or use the contact form on this page to launch your hernia mesh case.

Note: A version of this article appeared on this site in July 2017.

When a device or drug maker pays money to an injured person for a defective product, several costs must be repaid from these funds. There will likely be medical liens, expenses of litigation, attorney’s fees, and health insurance liens. You can get an overview of these cost repayments in a post I wrote last year. In today’s post I want to take a closer look at health insurance liens (and the related concept of health insurance “subrogation”), mainly because health insurance companies can take a big bite out of your product liability settlement funds. Best to understand this unpleasant news upfront.

How Do Health Insurance Liens Work?

If you have health insurance, much of the cost of your medical care will be paid by your health insurance plan. Let’s say you need revision surgery to remove defective hernia mesh. The total cost of the surgery is $36,000.00, but under contracted payment rates between the hospital and your health insurance company, the cost is reduced to $24,000.00. Under your agreement with your insurance company, it pays $20,000.00 for this surgery and you pay a total of $4,000.00 in “co-pays” (that is, the amount you must pay “out of pocket” under your health insurance plan). So far so good.

A week after the surgery, while you recover from the operation (and watch afternoon commercials asking if you have been injured by defective hernia mesh), you receive a letter from your health insurance provider asking specific questions about how you were injured. The health insurance company is trying to figure out if a third-party is ultimately responsible for your injuries and thus for the costs of your revision surgery. The insurance company may want to know if you are pursuing a product liability claim against the manufacturer of the hernia mesh. It is no secret that the health insurance company is looking to be reimbursed for the payments it made for your mesh revision surgery. The moment you file a lawsuit against the product manufacturer, your health insurance company will submit a “lien” identifying its claim to some of the settlement funds. And trust me, these companies will not let this claim go lightly; they will pursue reimbursement aggressively, and you will most likely have a contractual responsibility to pay the health insurance company from your settlement funds. In fact, if possible the insurance company will expect to be repaid 100% of the costs it paid for your health care caused by the negligence of others.more

Health insurance subrogation is the closely-related concept whereby your health insurance carrier pays for your health care and then directly pursues reimbursement of those payments against the negligent third party or the third party’s insurance provider. Subrogation is the substitution of one person or entity for another with respect to an insurance claim or debt, and the entity substituted will obtain all the rights associated with the insurance claim or debt. What this means is that if your health insurance company pays money for your medical care, and it turns out your injuries were caused by a negligent third-party (such as a distracted driver or the manufacturer of hernia mesh) then the health insurance provider can step forward and demand to be repaid for the costs it incurred in your treatment. Essentially, it can pursue a lawsuit against the negligent third-party on its own, without you.

But Isn’t My Health Insurance Company Supposed to Pay for My Health Care?

In a word, yes. And these companies will pay for your health care related to injuries you sustain from a failed medical device, a problem prescription, or a car crash. At least, they will pay what they are required to pay based on the health insurance contract (and not a penny more). However, if a third party is at fault, they will want to be repaid from the third party for payments made.

This repayment can sting because it will naturally lower your overall net award from your product liability settlement. It also stings because you have paid health insurance premiums for years to provide medical care when you are injured, and the moment you receive compensation for an injury caused by someone else, your health insurance company will expect to be repaid for the medical care it paid on your behalf.

Let me put it another way, in any given year you may not receive any health care, but you paid monthly health insurance premiums every month. The insurance company does not give you that money back, and there is no mechanism for you to recover these premiums in a year when you did not need health care. What can I say? The health insurance industry has a more robust lobby in Washington D.C. than do individuals injured by defective products.

How Much Can the Health Insurance Company Take of my Product Settlement?

This can be the shocking part: in some cases the health insurance lien can be larger than the third-party is willing to pay in settlement. This means that you as the injured person may receive nothing from pursuing an injury claim against a negligent person or company. Quick example: you are hurt by the failure of a metal-on-metal artificial hip, but in the revision surgery you suffer a mild heart attack. Your health care related to your recovery from the heart attack eventually costs the health insurance company $225,000.00, but the hip manufacturer will only offer $300,000.00 to settle your case. In that situation, after other costs are paid there would be no money left over for your pain and suffering.

Some good news is that many states recognize the “Made Whole Doctrine.” This doctrine is a defense to a health insurance provider’s lien or subrogation rights. It goes like this: the insured (or injured person) must be “made whole” before an insurance company may step in and assert its rights to be repaid. But a word of caution: often the subrogation rights of insurance companies is stronger than the defense of the made whole doctrine.

If the “Made Whole Doctrine” does not protect you in your state, the other modest good news is that health insurance companies will occasionally work with a competent lawyer to lower the overall health insurance lien. For example, in the above example the health insurance company may agree to take two-thirds of the total cost for the health care “to get the deal done.” In that case, there would be money left over for you.

Finally, in many multidistrict litigation settlement agreements, the parties negotiate an arrangement for the product manufacturer to pay the health insurance liens and other liens as part of the overall settlement package. This can be one of the more attractive features of a multidistrict litigation settlement.

If you have more questions, call me: (919) 830-5602.

Note: this is not legal advice.