Surgical repair of a hernia often involves implanting a mesh screen to help strengthen the affected area, but defective mesh material or a failed implant can cause serious complications, and mesh manufacturers (and in some cases, health care providers) can face liability for resulting harm to patients. In this article, we'll look at the legal landscape surrounding hernia mesh, and explain your legal options when a hernia mesh implant causes health problems.
When a patient experiences a hernia—which occurs when bodily tissue or an organ squeezes through a weak spot in surrounding muscle—there's often a good chance that the problem can come back. This is known as a "high rate of recurrence" in medical-speak. So it's no surprise that over one million hernia repairs are performed each year in the U.S., according to U.S. Food and Drug Administration estimates. Hernia mesh is a small, screen-like medical implant used to help strengthen a surgically-repaired hernia, with the aim of preventing recurrence. The material used to manufacture mesh is either biological (a very expensive option) or synthetic (a cheaper and much more common choice). This small, flexible screen is typically positioned to provide support to the weakest spot in the repaired area.
But as with any surgical procedure, especially those involving the implant of a medical device, there are risks associated with the use of hernia mesh. According to the FDA, the most common complications include:
As we'll see later, some of these complications can be attributable to a defect in the mesh material, but in some instances, a health care provider's mistake can cause or contribute to the patient's harm. Whatever the source of the complications, in many cases the best solution is repair or replacement of the implant, which means additional surgery is often necessary. In recent years, thousands of patients have filed hernia mesh lawsuits against medical device manufacturers like C.R. Bard, Inc., Ethicon, Inc. (owned by Johnson & Johnson), and Atrium Medical Corporation.
A number of specific hernia mesh recalls have been issued in the last fifteen years or so. In some instances, entire product lines have been recalled and are no longer on the market, but in most cases a hernia mesh manufacturer has recalled a specific number of affected units after receiving reports of problems. For example, certain lot numbers of an Ethicon Inc. hernia mesh product were recalled in 2014, after it was discovered that an incomplete seal on the device might cause the mesh to lose its coating, making it easier for the mesh to adhere to surrounding tissue.
It's important to note that there has been no market-wide recall of all hernia mesh products, and the FDA has issued no large scale orders or recommendations that might suggest use of hernia mesh might be banned or even limited. Manufacturers continue to develop hernia mesh products (one recent innovation involves 3D-printed mesh), and health care providers continue to utilize hernia mesh as a viable treatment option to prevent hernia recurrence. (Learn how a recall affects a product liability case.)
The first thing to know here is that if you've received a mesh implant as part of a hernia treatment plan, but you're not experiencing any complications related to the implant, you're not a candidate for an injury lawsuit against the mesh manufacturer or anyone else.
A threshold requirement for the filing of any hernia mesh injury lawsuit is measurable harm caused by a defective or failed implant. And of course, if you are experiencing complications of any kind, your most important first step is talking with your doctor about what’s happening. You can also report the problem to the FDA. Whether or not you decide to speak with a lawyer right away, at this stage two steps are critical to preserving your rights:
If you decide to file a hernia mesh lawsuit, you're entitled to seek compensation for all economic and non-economic harm stemming from the complications of the failed implant, including the cost of additional medical treatment to correct the problem, any income you lost because of that extra medical care and recovery time, and your physical discomfort and mental distress ("pain and suffering"). Collectively, these kinds of losses are known as your "damages."
As we've been discussing, most hernia mesh lawsuits arise when a defect in the mesh causes infection, tissue perforation, or some other medical problem necessitating repair or removal of the implant. In instances where a problem with the mesh itself is the source of complications, legal fault sits squarely on the mesh manufacturer, and the injury lawsuit will rely on some variation of a legal concept known as "product liability." Learn more about proving a product liability claim.
But in some situations, a surgeon or other health care provider's mistake (or other sub-standard care) might be to blame when a hernia mesh implant fails to perform as expected. In those kinds of cases, an injured patient might argue that the surgical error or other mistake amounted to medical malpractice. Get details on when it's medical malpractice, and when it isn't.
Proper evaluation of the patient and a full understanding of the intersection between medicine and the law is crucial to any hernia mesh lawsuit. This is one of many reasons to have the right lawyer (and that lawyer's team of experts) on your side. When you're experiencing unexpected medical problems because of a surgical implant that was meant to improve your health, you shouldn't be expected to figure out (let alone prove) who's to blame. That's your lawyer's job.
This question pertains to the statute of limitations, which is a law that sets a deadline for filing a lawsuit in court. More specifically, the issue here is that if you try to file your hernia mesh lawsuit after the applicable statute of limitations time limit has passed, the court won't accept your case, and you'll be left without a legal remedy for the mesh manufacturer's (or the care provider's) wrongdoing. To complicate the issue even more, different deadlines apply to different kinds of lawsuits, and every state sets its own time limits.
The good news is that, regardless of who you decide to sue over health complications resulting from your hernia mesh implant (whether the device manufacturer, a health care provider, or both) and regardless of the legal theory you'll be relying on (product liability and/or medical malpractice), the statute of limitations "clock" almost certainly won't have started to run on the day when the hernia mesh was first implanted.
Instead, the event that usually starts the filing deadline clock in any kind of hernia mesh lawsuit is the date on which you learn (or should reasonably have realized, in the eyes of the law) that your health problems are linked to a problem with your hernia mesh implant, especially when symptoms don't show up right away. Whether it's a product liability claim or a medical malpractice lawsuit you're thinking of filing, if it's been less than two years since the onset of complications from your hernia mesh implant, chances are you still have time to get your case started under the statute of limitations. But in some states, the deadline could be as short as one year. An attorney will have the expertise to understand how the statute of limitations applies to your situation.
Probably not. The class action process isn't really suitable for resolution of injury claims involving failed hernia mesh implants. That's mainly because, even among plaintiffs who received the same implant, only to have it fail in the same way, there's still too much disparity among individual cases (in terms of severity of complications, necessary course of future medical care, and impact on the plaintiff's life and livelihood) to make a class action appropriate in these so-called "mass tort" cases.
Instead, federal "multidistrict litigation" (MDL) is the best option for grouping hundreds or even thousands of cases against certain mesh manufacturers. With MDL, pre-trial proceedings are largely consolidated, but the plaintiffs still control their own legal destinies.
Here's a snapshot of the three biggest hernia mesh MDL actions:
Your attorney will consider whether your hernia mesh case is suitable for MDL, and help you determine the best course of action.
Most injury-related lawsuits reach a settlement at some point before a trial takes place, and hernia mesh cases are no exception. As touched on above, many hernia mesh claims are funneled into multidistrict litigation (MDL), and a judge's main objective when overseeing an MDL is to coax the parties toward early settlement. One of the first hernia mesh MDL settlements came in 2011, when C.R. Bard Inc. agreed to pay $184 million to around 2,700 plaintiffs whose hernia mesh implants caused a variety of complications. That settlement averages out to a little over $68,000 per claimant. But the value of a particular hernia mesh lawsuit will depend on the plaintiff's unique experience and circumstances, including:
Learn more about what goes into calculation of settlement in a product liability case.
Yes. Filing a hernia mesh lawsuit over often-serious health complications isn't the same as filing a car insurance claim after a fender bender. These cases often require expertise across multiple arenas (legal, medical, and procedural), and the ability to go up against high-powered defendants and still come away with a positive result.
But how do you choose the right lawyer for your hernia mesh case? You can research lawyers in your area via an online search (and perhaps by checking state bar association websites), and you can utilize resources like AllLaw to connect with a potential hernia mesh attorney. Our chat and information submission features can help you provide details on your situation.
You might also want to ask around and see whether anyone in your circle of friends and family has had a good experience being represented by a lawyer, on any kind of legal issue. Chances are that lawyer doesn't typically handle medical device cases, but maybe they can refer you to a qualified lawyer somewhere in their network of contacts.
No matter how you end up connecting with a potential hernia mesh attorney, even if your first meeting is online or over the phone, it's important to ask the right questions.
Learn more about how a mass tort lawyer gets paid and get more tips on finding the right injury lawyer for you and your case.