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Defective Medical Device Lawyers Serving People Injured in Chicago, Illinois & Beyond

Medical Device Recall LawsuitThe combination of lax regulation and device makers who are focused on profit leaves tens of thousands of people each year at risk of serious injury from medical devices. These injuries can have life-altering consequences for the person hurt and their family.

When you or a loved one has been injured by a defective medical device, you have legal rights. You can file a product liability lawsuit against the company that designed and sold a dangerous medical device.

Defective Medical Device Lawyer Helping Injured Patients

If you are one of the tens of thousands of people each year who have been injured by a defective medical device, you may be entitled to substantial financial compensation. However, first you need an experienced attorney who knows how to navigate a legal system that is built to protect these companies that sell faulty devices.

Medical device makers will use every trick possible to try to defeat your case because they are facing massive liability. The attorneys at Rosenfeld Injury Lawyers are experienced in medical device lawsuits and could help injured patients file the most effective legal complaint possible.

Medical Product Recall Attorney Share Recall Causes

One common misconception is that defective medical devices are larger implants such as a pacemaker or the Medtronic insulin pump. In fact, medical devices can be anything implanted in the body or used outside the body. In fact, it is any device that is used for medical purposes. It does not even need to be something that is electronic.

There are many things that you may not think of as medical devices. For example, the hernia mesh that is implanted to try to stabilize and repair the muscles is a medical device. This means that the universe of possible defective medical devices is very large.

Why There are Thousands of Defective Medical Device Cases in the U.S.

The United States is the largest market in the world for medical devices. In the U.S. alone, there are 6,500 companies that make medical devices. This does not include foreign companies that sell products to U.S. consumers. In 2017, the total size of the medical device market in the U.S. was over $150 billion. This amount is growing yearly at faster than the rate of inflation.

Here are some examples of things that would qualify as a medical device:

  • Surgical robots that help doctors reach difficult areas during medical procedures.
  • Transvaginal mesh used in pelvic organ prolapse surgery
  • Surgical staplers that help doctors close wounds after surgery
  • Ultrasound and MRI machines used to test patients
  • Blood pressure cuffs used in the doctor's office

Medical devices range from Class I to Class III. The lowest risk medical devices such as bandages are a Class I recall. Higher risk medical devices are categorized as Class III. It is these devices that have the highest chance of causing serious injury when they are defective or malfunction.

When so many complex products play such an integral role in the health of millions of people, there is quite a bit that can go wrong. There are many medical devices that sustain and improve the lives of the people that use them. Unfortunately, that is not always the case.

Medical device recalls are all too common in the United States. Defective medical devices kill thousands of Americans each year and injure many more. The common statistic cited is that defective medical devices killed 83,000 people over a ten-year span. This is based on reports made to the FDA. In that same time span, there were reports of over 1.7 million injuries.

Why You Need a Defective Medical Device Attorney

The problem with medical devices is that the FDA is a lazy regulator in a number of senses. The FDA has a process by which medical device makers can avoid a full-scale review if they can demonstrate that the product is substantially similar to one that was already approved. This is called the 510(k) approval process, and it means that many devices end up being approved without rigorous FDA testing.

Medical Product Recall Attorney Share Recall Causes

The FDA has been bitterly criticized for this lax oversight process, yet it continues to allow thousands of products each year to make their way through with no testing. The dangers of the 510(k) approval process were demonstrated in a study of foot and ankle products. Over a ten-year period, there were 161 devices in this category that were recalled. 98% of the recalled devices were approved through the 510(k) process. There is little wonder why there are so many defective medical devices.

Defective medical devices have a number of negative impacts on the lives of patients. Even if the patient is not injured, they may need to go through the trouble and expense of having to replace the medical device. However, the major effects come when these defective medical devices cause physical harm. Then, there are a number of different damages that patients can suffer. They include:

What Medical Device Manufacturers Must Pay You in a Lawsuit

  • Medical expenses, including the cost of medical and health care and any long term nursing or rehabilitation
  • Lost wages, both for the time that they have not been able to work and for future lost earnings
  • Emotional distress, pain and suffering
  • Wrongful death damages if one was killed by a defective medical device
  • Loss of consortium for a spouse

The first thing to know is what to do if you or a loved one have been injured by a defective medical device. You will need a medical diagnosis to begin the defective medical product lawsuit process. You should see a medical professional immediately to get treatment and correct the problem if possible. Since some medical device injuries can be life threatening, you should see a doctor immediately if you even suspect that something is wrong.

Once you realize that you have suffered injury or side effects from a medical device, you should report the problem to the U.S. Food and Drug Administration. The FDA has its own reporting system that patients can use to inform them about a medical device injury. Manufacturers are under the obligation to let the FDA know about deaths or serious injuries caused by medical devices.

There are many different things that can happen during a medical device recall. Any type of corrective action that a manufacturer takes after learning that there is a problem with the device can be considered a recall. This includes when they take minor steps to fix the device that the patient continues to use.

However, some medical device recalls are more serious. The company itself will initiate most medical device recalls. In some cases, the FDA itself will order the company to recall the device.

When you are ready to file a medical device recall lawsuit, you should consult with a lawyer. Some lawsuits may be preempted, meaning that the device maker cannot be sued for state law claims when they filed federal FDA regulations. However, there are a number of exceptions to the doctrine of preemption. Your medical device recall lawyer will know how best to argue your case when the device maker tries to argue that it is exempt from a lawsuit.

Ways That a Medical Device can be Defective

Assuming that you are able to file a lawsuit, you will need to show that the medical device is defective. A medical device recall lawsuit will be the same as any other product liability lawsuit, assuming that your attorney is able to make it around the preemption doctrine.

There are three different ways that a medical device can be defective. This is similar to all product liability lawsuits. The following are the three different ways that you can prove that a medical device is flawed:

  • Design Defect - Sometimes, the way that the device maker has designed the product makes it dangerous. When the design of the medical device is unreasonably dangerous or the product is not safe for its intended and reasonably foreseeable uses, the seller may be liable for the design defect.

A recent example of an alleged design defect in a medical device involves a surgical blanket that is used to regulate a patient's body temperature during surgery. There are claims that the design of the surgical blanket causes it to gather and draw in contaminants from the operating room floors and directs it into the patient's body into their surgical wounds. This results in patients developing deep joint infections.

  • Manufacturing Defect - Sometimes, the design of the medical device is perfectly safe but something goes wrong in the manufacturing process that causes the product to be unreasonably dangerous. When this happens, the product as manufactured departs from the design, and the product does not perform as the designers intended.

A major example of alleged defective manufacturing is found in the slew of hernia mesh lawsuits. The lawsuits claim that hernia meshes shrivel and disintegrate in the patient's body. They may also migrate out of place, damaging organs and tissue that is in the path of the mesh. This could cause patients a lifetime of pain.

  • Marketing Defect - The device manufacturer must inform the public of any dangers of using their products and the possible harm that it can cause. This allows medical professionals and their patients to make informed decisions about whether they want to use the device. This type of product liability claim may also be filed for false claims that the manufacturer makes that harm the patient.

The failure to warn was at the center of many of the legal claims brought in the wake of the pelvic mesh disaster that injured thousands of women. For example, a jury ordered Boston Scientific to pay $6 million to an injured plaintiff because the company failed to warn her of the hazards that are associated with the IVC filters.

Below is some information on some of the more noteworthy medical device lawsuits filed in recent years.

DePuy Hip Implant Lawsuits

Medical device company Stryker paid $5 billion to settle lawsuits related to two of its hip implant products that were used in hip replacement. These implants had a design defect in that metal parts contacted and ground against other metal parts. This released ions and toxins into the body. Patients had to have had a second surgery to replace this dangerous product. Evidence showed that the company knew of the actual danger of the metal hip implant but continued to sell it anyway.

Dow Corning Breast Implants

Dow entered into a settlement with the plaintiffs in this case for over $4 billion. The company's breast implants were made out of silicone. This sickened women whose bodies could not handle the implant of a hazardous substance. Some women developed systemic diseases such as rheumatoid arthritis or lupus. Other women suffered a leak, and the silicone entered the breast cavity and surrounding areas. Many women needed to have their implants replaced in a subsequent surgery. Eventually, 170,000 lawsuits were filed, forcing the company to seek bankruptcy protection.

Dalkon Shield

The Dalkon Shield was an implantable birth control device that was used by millions of women in the 1970s. Women were severely sickened by this product, suffering septic abortions and infections. Thousands of women were hospitalized, and three users for every million died from the product. The product's maker, A.H. Robins, faced over 300,000 lawsuits brought by injured women. This was the biggest product liability case since asbestos, and the billions of dollars in litigation costs forced A.H. Robins into bankruptcy. This still remains one of the largest lawsuits ever in the medical device industry.

Common Questions About Defective Medical Device Claims

Here are the answers to some commonly asked questions about defective medical device lawsuits

What Happens When a Medical Device is Recalled?

A medical device recall can mean any one of a number of things. It could be as minor as the device needing to be fixed. At the other end of the spectrum, the device must be removed from the market or even the patient's body. The device could require a major repair to save a patient's life. This is when there is a possibility that the injured patient can file a medical device recall lawsuit.

What is the Medical Device Safety act?

The law about medical device lawsuits is uncertain right now. There is a doctrine of preemption that prohibits plaintiffs from filing state law claims if the medical device received premarket approval from the FDA. The Medical Device Safety Act takes away some of the liability protection that medical device makers have when the FDA approves their product. It would give people the same right to sue device makers as they have to sue drug companies.

What Class of Medical Device can be Recalled by the FDA?

Any class can be recalled by the FDA, although recalls of Class III devices are the most serious. These are defects in high-risk devices that can cause deadly injury.

What is a Class II Medical Device Recall?

This is the middle ground when it comes to a device recall. Here, there is the possibility of a near-term health issue that is not life threatening. Alternatively, there is a very small possibility of a more serious problem. Either way, it does not rise to the level of a more serious Class III recall because there is no imminent threat to life and safety.

Product Liability Lawyers Dealing With Medical Device Defects

If you or a loved one have been injured by a defective medical device, you have legal rights. The maker of that product may be liable to pay you substantial financial compensation. The attorneys at Rosenfeld Injury Lawyers can provide you with a free case evaluation that would let you know if you have possible grounds to file your own civil claim.

Give our law firm a phone call at our toll-free number or fill out a contact form to schedule your free consultation and case review. You pay no out-of-pocket expenses and owe us nothing unless we are able to help you recover. You should learn your legal options quickly so you can file a lawsuit within the applicable statute of limitations.

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