Defective Medical Device Lawyers
Medical Device Recall Lawsuits
The 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 appliance, you have legal rights.
You can file a product liability lawsuit against the company that designed and sold a dangerous medical product. Please contact us today to learn more about your legal options.
Defective Medical Devices Attorneys Helping Injured Patients
If you are one of the tens of thousands of people each year who have been injured by a defective medical appliance (metal hip implants, other hip implants, etc.), you may be entitled to substantial financial compensation.
However, first you need experienced attorneys who know how to navigate a legal system that is built to protect these companies that sell faulty devices.
A medical device manufacturer will use every trick possible to try to defeat your case because they are facing massive liability.
A medical product lawyer at the Rosenfeld Injury Lawyers are experienced in medical product lawsuits due to defective medical products and could help injured clients across the United States file the most effective legal complaint possible against a medical device manufacturer. Call us for a free case review.
Medical Product Liability Claims Against a Manufacturer
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 type of medical equipment 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 product. 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 according to the drug administration FDA.
This does not include foreign companies that sell products to U.S. consumers. In 2017, the total size of the medical gear 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 medical product cases that our law firm is currently or formerly involved in:
- Surgical robots that help doctors reach difficult areas during medical procedures.
- Transvaginal mesh used in pelvic organ prolapse surgery
- Hernia mesh
- IVC Filters
- Allergan Breast Implants
- Metal hip implant
- 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 devices 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.
Defective products 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 drug administration (FDA). In that same time span, there were reports of over 1.7 million injuries.
Why You Need Experienced Defective Medical Device Attorneys
The problem with medical devices is that the FDA is a lazy regulator of medical device manufacturers in a number of senses.
The US Food and Drug Administration (FDA) has a process by which medical product 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.
The Food and Drug Administration 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 health consequences 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 appliance.
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 in the United States.
Please contact us if you have any questions about your legal rights with a medical product attorney in our law firm.
What Medical Appliance Manufacturers Must Pay You in a Lawsuit
Examples of recoverable damages (also referred to as compensation) in a defective product case against manufacturers include:
- 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 product
- 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 appliance. 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 appliance 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 defective medical products, 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 product 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 product 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 gear 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 product recall lawsuit, you should consult with a lawyer at an experienced law firm. 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 lawyer will know how best to argue the cases for the clients 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 product 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 medical gear 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 product is flawed:
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 product 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.
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 mesh 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.
The device manufacturer must inform the public of any dangers of using their appliances 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 on behalf of clients.
DePuy Hip Implant Lawsuits
Medical product company Stryker paid $5 billion to settle lawsuits related to two of its hip implant appliances that were used in hip replacement. These implants had a design defect that released toxins into the body. Evidence showed the company knew of the danger but continued to sell it.
Dow Corning Breast Implants Lawsuits
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. These caused diseases and required corrective surgeries.
Dalkon Shield Lawsuits
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.
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 product 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.
What Is the Medical Device Safety Act?
The Medical Device Safety Act takes away some of the liability protection that medical product 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 Products 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 Product Defects
If you or a loved one have been injured by a defective medical device (metal hip implants, other hip implants and defective medical appliances), you have legal rights and a defective medical device lawyer can help.
The maker of that product may be liable to pay you substantial financial compensation. The medical device attorneys at the law firm of Rosenfeld Injury Lawyers can provide clients across the nation with a free consultation that would let you know if you have possible grounds to file your own civil claim.
Give the medical products lawyers of our law firm a phone call at our toll-free number to fill out a contact form to schedule your free consultation. 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 for compensation within the applicable statute of limitations. Please contact us today for a free case evaluation with our firm.
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