From artificial hip joints to devices that monitor blood sugar and inject insulin in diabetic patients, medical devices are becoming increasingly popular as technology improves.
It’s estimated that the US comprises around 40 percent of the world market for such devices, and about 32 million Americans use medical devices. While many of these items provide health benefits, there are also potential risks.
The FDA has the authority to regulate medical devices, but manufacturers can seek expedited approval through the 501(K) path if their device is similar to another already on the market. In some situations, this may lead to a device being approved with little scrutiny.
Data suggests that 501(K) approved devices are 11.5 times more likely to be recalled than those that undergo a more rigorous approval process.
Would you know if you had a defective medical device? Not necessarily.
When a device has obviously failed to do its job, patients are usually aware of the problem. For example, if your insulin pump stops working entirely, you’ll probably notice symptoms of blood sugar issues fairly quickly.
But not every medical device fails in an easily-detected manner. Some may work as intended but cause unexpected side effects.
There are also situations where patients are injured by a surgical tool or other medical device they may not even know was used in their care.
Do You Need an Illinois Defective Medical Devices Attorney?
If you even suspect a medical device may have injured you or have suffered serious and unexplained health problems during or after using a medical device, please speak with a defective medical devices lawyer to learn more about your situation.
If we find that you received a defective device that caused you harm, we may be able to seek compensation from the manufacturer.
However, some people may not suspect that their medical device caused a problem or even know that a specific device was used (such as when a defective device complicates surgery).
If you have any unexplained symptoms or have suffered a serious health complication without having any risk factors, it might be worthwhile to consider any medical devices you do know about or any surgeries you’ve had.
What Are Some Examples of Defective Medical Device Cases?
Here are some examples of defective medical devices that have been the subject of lawsuits:
Hip Replacement Joints
Every year, around 300,000 people undergo hip replacement surgery to relieve pain and improve mobility. For most patients, these operations are successful, but all surgeries have risks.
Unfortunately, certain replacement hip joints can increase the risk of complications or even necessitate a second hip replacement.
Multiple recalls have been issued for specific models of hip joints, including those produced by Stryker, De Puy, Smith & Nephew, Zimmer Durom, Exactech, and more.
If you suspect a problem with your artificial hip, we recommend contacting your doctor to find out the exact brand and model number. This is a good idea even if your doctor assures you the hip hasn’t been recalled.
It’s possible that there are problems with the model, but these haven’t come to light yet, especially if your hip is a newer model.
The problems you might have from a faulty hip joint vary depending on the specific model. Most commonly, we see issues with metal-on-metal joints that wear down prematurely or leach metals into nearby tissues.
The first situation usually results in continued pain, discomfort, and limited mobility for the patient, which may prompt a second surgery.
The second situation can be more insidious. Metallosis occurs when bits of chromium or cobalt from a prematurely decaying hip joint leach into surrounding tissues and the bloodstream.
Sometimes, this causes hip pain, but in other cases, it doesn’t. Instead, the metals travel through the bloodstream to other areas, including the brain, heart, eyes, and other organs.
It may take a long time to diagnose the issue if the patient isn’t having hip pain. To further complicate matters, metallosis can happen years after the initial surgery.
A patient who recovered fully and returned to normal activities years ago may never think to connect their vision or heart problems with their hip transplant.
In both situations, the only solution is to have revision surgery – essentially, the patient has to undergo hip replacement surgery all over again. This can result in expensive medical bills, weeks or months away from work, pain and suffering, and other damages.
Surgical mesh is used in various surgeries to lend additional support to damaged or weakened tissues. One common use is in hernia surgery to prevent the recurrence of a hernia.
It’s also used in other abdominal and gynecologic surgeries to prevent organ prolapse. Some surgical meshes work well, but certain varieties have been recalled or withdrawn from the market, including some models made by Bard, Ethicon, Atrium, Gentex, and Parietex.
As with artificial hip joints, the most common issue is that the mesh can degrade. While an artificial hip can cause local pain or metallosis, the degraded mesh can migrate, tearing or puncturing nearby tissues or organs.
In the case of hernia repairs, the hernia may recur, but at the same time, the mesh could cause damage to other organs. Patients with transvaginal mesh implanted could experience issues with the mesh impacting their bladder, intestines, reproductive organs, and more difficulties.
People with defective mesh may suffer pain, bleeding, infection, inflammation, and other issues, sometimes requiring hospitalization and surgery. Worse, some are initially dismissed by doctors if no obvious cause for their symptoms can be found.
In most cases, the only solution is to remove the defective mesh and replace it with a better product. However, if the mesh has become entangled with other organs or tissue, this surgery can be complicated, and there may be higher risks of complications.
What Is a Multi-District Litigation or MDL?
A multi-district litigation, or MDL, is a way of handling numerous lawsuits against a single entity for roughly the same reason. They are typically used in product liability cases because there are often hundreds or thousands of plaintiffs or injured people spread across the country.
An MDL groups these cases together in a single district court, which is usually chosen for its location relative to evidence or discovery materials, witnesses, etc.
Although the cases are combined for discovery and other pre-trial proceedings, they remain distinct and, if no settlement is reached, will be transferred back to their home jurisdiction after pre-trial proceedings end.
In many of these cases, the district court will reach a summary judgment or dismiss the claims, or the defendant will agree to a settlement before an individual case actually goes to trial.
What Is the Statute of Limitations on Defective Medical Devices Cases in Illinois?
The statute of limitations in these cases is typically two years from the date you began using the defective device (or it was used in your surgery) or two years from when you learned of the defect or should have known about it.
This is sometimes complicated if the patient has had symptoms for a long time before learning the cause. If we can show through medical records that you saw multiple doctors searching for answers, we can argue that you showed due diligence in seeking a diagnosis.
Will You Be Notified If Your Medical Device Has Been Recalled?
It depends on the type of recall and the specific situation. The FDA does not order many recalls, but many are voluntarily performed by the manufacturer.
Depending on the problem with the device, they may simply take it off the market, or they may issue new instructions for healthcare providers on how to use the product – for example, they might advise not to use the device in patients with a history of certain health problems.
A conscientious physician should contact patients if they should no longer use a device, but for various reasons, this doesn’t always happen. A notification sent to the doctor’s office could get lost, their letter to you could get lost, you may have moved to a new address, they may not think the device will cause you any harm, etc.
There are also three types of FDA recalls, which are less common than voluntary ones.
- Class III recall. You probably won’t receive notification for this type of recall, which is the most common and least serious. A Class III recall often means the FDA doesn’t believe the device is truly harmful to patients, but the manufacturer has violated some rules.
- Class II recall. This is a more serious concern. The FDA believes there is a serious risk of injury or death for consumers, but they don’t necessarily think it’s an immediate threat. They will advise the manufacturer to recall the dangerous devices and notify consumers. Usually, there is a press release and some news coverage with information on what patients who have the device should do. Generally, patients are advised to contact their doctors immediately if discontinuing device use without medical supervision could be dangerous.
- Class I. This is the most serious and rare type of recall. It means the FDA believes there is an immediate and substantial risk of severe injury or death from the continued use of the device. Defective devices should be tracked down and recovered from the patients – if they are implanted devices, the users will need surgery. Although unlikely, if you’ve received a device that is subject to this type of recall, you should be contacted because the manufacturer has a responsibility to track all defective devices and contact their end users.
If you have concerns that you may have missed hearing about a recall, you can run a search for any news items on the device’s brand name and model number. If a recall was announced, there should be at least a few news articles about it online.
If Your Medical Device Wasn’t Recalled, Does That Mean It Isn’t Defective?
Not necessarily. A recall is usually a good indication that the device may not work optimally or could have caused at least some patients harm.
But the absence of one doesn’t prove a device is safe. There is always a first patient to experience a problem with a defective device – and a second, third, fourth, and so on.
In many cases, a recall isn’t issued until hundreds or even thousands of complaints have been filed with the FDA, and sometimes not even then.
If you have symptoms that you believe are caused by a medical device, we recommend speaking with your doctor. The potential problem is that they may dismiss your concerns if there hasn’t been an official recall.
As far as they know, the device is safe and effective. As a result, they may suggest lifestyle changes or prescribe medication that doesn’t help.
You can also read the product reviews to see if other patients have reported similar issues. However, it’s important to take what you read online with a grain of salt – anyone can post a negative review, including competitors, disgruntled ex-employees of the device manufacturer, etc.
At the same time, if you notice a pattern of very specific and unusual complaints that line up with your symptoms, it’s possible there is a problem the manufacturer hasn’t identified or acknowledged yet.
If so, we recommend consulting a defective medical devices lawyer to learn what other steps you can take to get answers.
Consult an Illinois Defective Medical Devices Law Firm Today
Dealing with serious health complications can be expensive, stressful, and painful, especially with defective implantable devices that must be surgically removed.
If you or a loved one have suffered serious consequences or wrongful death from a medical device or even suspect you have, please contact The Fakhouri Firm Accident and Injury Lawyers for a free consultation.
We’ll review your case, answer your questions, and explain the options for pursuing compensation. If we find evidence that the device was defective, we can seek damages for your medical bills, lost income if you missed work, pain and suffering, permanent disability or disfigurement, and more.
Founder and lead attorney Robert S. Fakhouri graduated from the Chicago-Kent College of Law and was one of the youngest people ever to join the Illinois Bar. After founding The Fakhouri Firm, he has dedicated himself to helping injured people seek the compensation they need to move forward with their lives.