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What Is Nerve Damage?

Nerve damage is an injury to our nerves. Nerves are part of a “telephone wiring” system for our bodies. They pass messages between our brain and the rest of our body. ⁽¹⁾

“A nerve injury can affect your brain’s ability to communicate with your muscles and organs. Damage to the peripheral nerves is called peripheral neuropathy.” ⁽²⁾

Types of Nerve Damage

Our nerves and nervous system are involved in everything our bodies do. They regulate our breathing, control our muscles, and sense heat and cold.

Bodies are made up of three types of nerves. We can experience three general types of nerve damage: ⁽³⁾

• Autonomic nerve damage – control involuntary or only partially voluntary bodily functions, such as heart rate, blood pressure, and temperature.
• Motor nerve damage – control muscle movement and action.
• Sensory nerve damage – send information from our skin and muscles to our spinal cord and brain. Our brain then recognizes pain, cold, heat, and other sensations.

Causes of Nerve Damage

Our bodies are incredibly complex. It may sound hard to believe, but there are actually over 100 different types of nerve damage. People can suffer nerve damage and pain due to cancer and diabetes, among other illnesses. ⁽⁴⁾

Compression or trauma are other possible causes of severe and irreversible pain and disability. Anything at all injuring your nerves cause damage and nerve pain — a pinched nerve, crush injury, even carpal tunnel syndrome. Examples of compression and trauma injuries include: ⁽⁵⁾

• Vehicle accidents – Every year, around two million people suffer permanent injuries due to car accidents. Death from car accidents is also an unfortunate reality. In one year alone, over 40,000 people died due to traffic accidents. ⁽⁶⁾
• Construction and other worksites – More than 90 people died in a New York City work-related accident in one year. The same year, over 140,000 people were injured or made ill in nonfatal work-related accidents. Passersby can also be harmed if proper warnings and precautions aren’t posted. ^{(7) (8)}
• Fires and explosions – The City of New York Fire Department reported there were over 40,000 fires across the city in a year. Burn injuries can result in peripheral neuropathy and nerve compression syndromes. These conditions can “lead to substantial morbidity.” ^{(9) (10)}
• Slip and falls – You can seriously hurt yourself if you slip and fall. If you hit your head, for example, you could suffer a traumatic brain injury (TBI). A TBI can cause nerve damage and pain, or even death. In one year, nearly 61,000 people died after sustaining a TBI. ^{(11) (12)}
• Laceration/cut to the nerve – Nerves can be damaged by a cut. If so, it may no longer be able to transmit signals to your brain because the connection is broken. You could accidentally sustain a serious injury using a defective tool, piece of equipment, or appliance. This can happen either in your workplace or at home. ⁽¹³⁾

Symptoms of Nerve Damage

Depending on the nerves damaged and how the damage occurred, you can experience a variety of symptoms. Symptoms of damage to the nerves controlling your muscle movement include: ⁽¹⁴⁾

• Weakness.
• Muscle atrophy.
• Twitching.
• Paralysis.

Symptoms of damage to the nerves controlling your ability to recognize sensation include: ⁽¹⁵⁾

• Pain.
• Sensitivity.
• Numbness.
• Tingling.
• Burning.

Symptoms of damage to your autonomic nerves include: ⁽¹⁶⁾

• Lightheadedness.
• Dry eyes and mouth.
• Too much or too little sweating.
• Constipation.
• Bladder problems.

Diagnosing and Proving Nerve Damage

Nerve damage can happen in many ways. To diagnose you, doctors need to perform a full physical exam, as well as a neurological exam. For the neurological exam, your doctor checks things like your reflexes, muscle strength, level of sensation, and coordination. ⁽¹⁷⁾

Your doctor may also use these types of diagnostic tests: ⁽¹⁸⁾

• Blood tests – Blood tests can reveal vitamin deficiencies, diabetes, and abnormal immune function.
• Imaging tests such as a CT or MRI – These scans can show possible herniated disks, pinched or compressed nerves, or tumors affecting your blood vessels and bones.
• Nerve function tests, such as an EMG – An electromyography “records electrical activity in your muscles.” This test may detect nerve damage resulting from an accident. Other nerve function tests can record how your autonomic nerve fibers are working and check to see if your body is able to sweat. They can record how well you are able to sense touch, vibration, cooling, and heat.
• Nerve biopsy – Your doctor removes a small portion of one of your nerves to check for an unusual response.
• Skin biopsy – Your doctor removes a tiny bit of skin and looks for a reduction in your nerve endings.

Liability

Were you or a loved one injured in an accident that wasn’t your fault? If so, and you suffered nerve damage, you may be eligible for compensation from the party at fault. For example, in rules of the road, someone else may be responsible for causing your vehicle accident.

Accidents can happen anywhere. People who own or maintain properties are expected to safeguard their employees and the public from hazards.

On or near a construction site, the property owner or general contractor might be responsible if something falls and hits you or if you fall on an unsafe walkway. Premises liability may be a consideration if you get hurt falling in a restaurant bathroom, a grocery store, or the parking lot of a big box store.

Maybe you were injured while using certain tools or a piece of equipment for your job. Or maybe you bought a product of some kind, leading to serious injury. Manufacturers and distributors of the equipment and those products may be held responsible for your injury.

How W&L Can Help

Weitz & Luxenberg is a national, recognized law firm serving clients for nearly 40 years. We were founded with one main purpose: to help people seriously harmed by the actions of others.

We are located in the heart of New York City and have represented clients from all over the state. Every state’s specific rules and laws are different. If you were injured in New York, we encourage you to consult with an attorney who has the New York wrongful death and personal injury laws down pat.

Plus, look for a firm with a solid history of winning. Weitz & Luxenberg has won over $26 billion on behalf of our clients over the years. Here are just a few notable successes:

• $100,000s settlement – A woman lives with irreversible brain and nerve damage, pain, and other medical complications. She suffers because a suitcase fell from an overhead bin on an airplane and landed on her. We sued the airline and settled this lawsuit out of court for six figures.
• $20.5 million verdict – A man suffered permanent nerve damage and paralysis when a hit-and-run driver slammed into his car. The court ruled in our client’s favor because of the defendant’s extreme recklessness and negligence.
• $Multimillion settlement – A young man has to live the rest of his life with nerve damage and paralysis. It happened because he fell 25 feet from an apartment building’s unsafe, second-story walkway. He landed on the pavement. The building owner failed to meet city safety codes.

What Is a Catastrophic Injury?

Right off the top of your head, you may think of a catastrophic injury as an injury damaging your spine, spinal cord, or brain, and resulting in permanent harm. Actually, the definition is much broader and more basic.

According to Cornell Law School, catastrophic injury is “an injury, the direct and proximate consequences of which permanently prevent an individual from performing any gainful work.” ⁽¹⁾ This definition covers a wide number of injuries.

Examples of Catastrophic Injury

You can experience many different types of catastrophic injury. These include:

• Traumatic brain injury — Traumatic brain injury (TBI) occurs suddenly, generally with a blow, bump, or jolt to your head. It can also occur when an object penetrates your skull. ⁽²⁾ People who survive a TBI can face effects “that last a few days, or the rest of their lives.” ⁽³⁾
• Spinal cord injury — Each year, roughly 17,000 people suffer a spinal cord injury. Usually, they have suffered trauma to their vertebral column. ⁽⁴⁾ “A spinal cord injury… often causes permanent changes in strength, sensation and other body functions below the site of the injury.” ⁽⁵⁾
• Paralysis — Paralysis means you have lost “strength in and control over a muscle or group of muscles.” Usually, paralysis is due to damage “along the chain of nerve cells that runs from the body part to your brain and back again.” ⁽⁶⁾
• Burn injuries — You can suffer burn injuries from fire, hot liquids or solids, friction, cold, radiation, chemicals, or electricity. All burn injuries damage your tissues ⁽⁷⁾
• Amputation — Amputation refers to the loss or removal of a body part, no matter the size. Sometimes amputation happens during or following a traumatic accident, such as a car accident or an industrial or occupational event. ⁽⁸⁾

You can suffer an immediate amputation when a body part is severed or torn away in a catastrophic accident. Also, you could sustain a serious crush injury or burn from a traumatic event. Doctors might not be able to salvage your damaged body part. They might need to remove it surgically to save your life. ⁽⁹⁾

Causes of Catastrophic Injury

Catastrophic injuries can occur from many types of accidents. Some of these include:

• Motor vehicle accidents — Every year in New York, thousands of people are involved in motor vehicle accidents. Daily, vehicle collisions number in the hundreds.
• Public transportation accidents — Public transportation is not necessarily any safer than driving your own car. In fact, thousands of people in New York file personal injury lawsuits each year because they were hurt taking buses, trains, and subways.
• Explosion — Explosions both above ground and below ground can cause multiple life-threatening injuries. You can be burned, hit by or penetrated by flying objects and debris, or thrown due to the blast.
• Fire — In one year alone, over 40,000 fires occurred across New York City. You can suffer burns ranging from minor to severe, as well as lung damage and death.
• Slip and falls — Hundreds of thousands of people end up in hospitals each year due to slip and falls. Debilitating fractures and head trauma are just two types of injuries occurring from falls.
• Falling objects — Hundreds of people die each year from falling objects. People who work in certain industries, such as construction, face this very real danger every day. But passersby can also be seriously injured.

Legal Options

Negligence is “A failure to behave with the level of care that someone of ordinary prudence would have exercised under the same circumstances. The behavior usually consists of actions, but can also consist of omissions when there is some duty to act (e.g., a duty to help victims of one’s previous conduct).” ⁽¹⁰⁾

Basically, someone can be considered negligent if they failed to act the way a reasonable person would have acted in a given situation. Negligence can mean doing something carelessly or recklessly without thinking of how those actions could hurt someone else. Negligence can also mean not doing something — not offering care or assistance — when most reasonable people would have. ⁽¹¹⁾

Hiring a Catastrophic Injury Attorney

If you were seriously injured because of someone else’s actions or inactions, you may have a case falling under the category of negligence. An experienced, reputable, personal injury attorney can help you evaluate your particular circumstances. You may be able to pursue compensation.

Negligence is a complex legal term. Hiring the right person to handle your personal injury case is critical.

Your selected attorney acts on your behalf and guides you through the legal process. Your attorney must prove the defendant had a duty to act or did not act, and the breach caused your injury. ⁽¹²⁾

How W&L Can Help

Weitz & Luxenberg was founded nearly 40 years ago to help people who were harmed by the actions of others. We have been handling personal injury and wrongful death lawsuits ever since.

Our firm is based in New York City, and we know our state statutes and laws inside and out, from top to bottom. More importantly, we have a proven history of winning.

Over the years, our firm has secured over $26 billion dollars on behalf of our clients. Here are a few examples of our successes:

• $6-figure settlement – A woman suffered a catastrophic injury on an airplane when a suitcase from an overhead bin fell and struck her. She is not able to work and continues to experience cognitive difficulties, headaches, neck pain, noise sensitivity, sleep problems, anxiety, and fatigue.
• $20.5 million verdict – A man was left confined to a wheelchair after he was severely injured in a hit-and-run vehicle accident. Our client had left work and was driving home when another driver slammed into his car full force.
• $Multimillion settlement – A man in his 30s suffered catastrophic injuries. He fell 25 feet from an apartment building’s second-story walkway and landed on pavement. The accident might not have occurred if the building owner had followed New York City codes in keeping the premises reasonably safe.

What Are Blood Clots and Pulmonary Embolisms?

Blood clots are a risk to your health and can lead to pulmonary embolisms. You want to avoid having them.

“A blood clot is a clump of blood that has changed from a liquid to a gel-like or semisolid state. Clotting is a necessary process that can prevent you from losing too much blood in certain instances, such as when you’re injured or cut.” ⁽²⁾

“A pulmonary embolism (PE) is a sudden blockage in a lung artery. It usually happens when a blood clot breaks loose and travels through the bloodstream to the lungs.” ⁽³⁾

Increased Risks for Blood Clots and Pulmonary Embolism

Usually, “blood clots start as a response to injury of a blood vessel.” Any time you undergo a surgical procedure at a hospital or other health care facility, you face increased risk of a blood clot or pulmonary embolism. Even a slight injury to a blood vessel can activate your body’s response. ⁽⁴⁾

When an injury occurs to a blood vessel, the blood stays right there initially. A protective clot begins to form from two substances: platelets and fibrin. ⁽⁵⁾

Platelets are a type of blood cell. Fibrin is a strong string-like substance. These substances come together to form “what is called a platelet plug.” They plug up the cut or hole in the blood vessel. ⁽⁶⁾

Being immobile for long periods of time poses a real danger. “Long hospital stays, surgeries and trauma may significantly increase your risk of blood clots.” ⁽⁷⁾

Sometimes blood clots do not stay in one spot. They may move throughout your body. These moving clots are particularly dangerous.

Blood clots can travel to the lungs, heart, and brain. Life-threatening and irreversible damage is possible. ⁽⁸⁾

Symptoms of Blood Clots and Pulmonary Embolisms

Experienced health care providers should know the most common blood clot signs and risk factors. They should know how to prevent clots and PEs from occurring.

Whether you have had an inpatient or outpatient procedure, your health care provider should be on the lookout for potentially serious blood clots. When you leave the hospital or other facility, they should provide you with appropriate postoperative instructions and follow-up care. ⁽⁹⁾

Possible symptoms of a blood clot in a deep vein include: ⁽¹⁰⁾

• Swelling.
• Pain.
• Tenderness.
• Redness of the skin.

Symptoms of a pulmonary embolism include: ⁽¹¹⁾

• Difficulty breathing.
• Irregular or unusually fast heartbeat.
• Chest pain or discomfort.
• Coughing up blood.
• Extremely low blood pressure, fainting, or light-headedness.

Causes of Blood Clots and Pulmonary Embolisms

Blood clots can occur when you get hurt, such as if you fall. But there is not always a known cause. “Blood clots form when certain parts of your blood thicken, forming a semisolid mass. This process may be triggered by an injury or it can sometimes occur inside blood vessels that don’t have an obvious injury,” according to the Mayo Clinic. ⁽¹²⁾

The cause of a pulmonary embolism “is usually a blood clot in the leg called a deep vein thrombosis that breaks loose and travels through the bloodstream to the lung.” ⁽¹³⁾

Injuries Caused by Pulmonary Embolisms

Pulmonary embolisms can lead to severe medical complications. These include: ⁽¹⁴⁾

• Permanent damage to the lungs – Lung tissue can be irreversibly damaged when blood cannot reach your lungs because of a blood clot. ⁽¹⁵⁾
• Low oxygen levels in your blood – This condition is called hypoxemia. Depending on how low your levels are, you can experience everything from headaches and shortness of breath to decreased brain and heart function. ⁽¹⁶⁾
• Damage to other organs in your body from not getting enough oxygen – Your body needs oxygen to function properly. “Without oxygen, the brain, liver, and other organs can begin to sustain damage mere minutes after symptoms start.” ⁽¹⁷⁾
• Death – Blood clots and pulmonary embolisms can kill you. “Up to one-third of patients with a pulmonary embolism (PE) will die of cardiac arrest before the dangerous clot is identified in a hospital or emergency department. A big reason for the high mortality rate is that the symptoms of PE are typically non-specific until it progresses to an emergency situation.” ⁽¹⁸⁾

Failure to Prevent Blood Clots and PE

When blood clots develop and lead to a PE, they can cause a heart attack or stroke. Medical malpractice occurs when a patient who is at high risk of clots or PE isn’t properly monitored and treated to prevent them. Or a blood clot or PE isn’t correctly diagnosed.

There are medications and medical equipment to help prevent blood clots from forming. You might suffer from avoidable blood clots if a health care professional does not give you the appropriate medication. Or if the equipment is misused or malfunctions – or not used at all.

Some research suggests, “The most frequently cited negligent act was the failure to give prophylactic anticoagulation, even after discharge.” ⁽¹⁹⁾

Researchers reviewed cases from three decades and found, “The most frequently claimed injury was death in 222 cases (80%).” ⁽²⁰⁾

Blood Clot Legal Options

If medical professionals fail to properly diagnose and treat your blood clot or pulmonary embolism, you can file a medical malpractice lawsuit. It may also be medical malpractice if they do not appropriately monitor a patient who is at high risk, and fail in their medical responsibility to prevent a likely clot or PE.

If your blood clot injury occurred in New York, you need guidance from a reputable New York personal injury attorney. You need someone with extensive medical malpractice litigation experience.

Malpractice is a specific type of law. Although every state has medical malpractice laws, each state follows its own specific statutes of limitation and regulations. You need to consult with someone who knows the ins and outs of your particular state’s complex legal process.

Once you find the right attorneys and firm for you, they know exactly how to assist you. They work with you to help you achieve the best possible outcome for your specific circumstances.

How W&L Can Help

Weitz & Luxenberg is based in the heart of New York City. Our attorneys have been handling medical malpractice cases across the state of New York for decades.

If you were severely injured due to your doctor’s negligence in preventing your blood clot or pulmonary embolism – or if a loved one died – our attorneys can help you.

We can provide you with legal guidance. You may be entitled to compensation. Plus, we have a proven track record of winning.

Here are a couple examples of our successes:

• $1.2 million settlement – A young woman underwent a tummy tuck at an outpatient facility. Shortly afterwards, she developed a pulmonary embolism. Ultimately, she died. The equipment the doctor used during her surgery to prevent a PE was found to be defective.
• $500,000 – A woman’s uterus was irreversibly damaged following a basic OB/GYN procedure. This damage was due to multiple misdiagnoses, botched surgeries, and severe complications. One of these potentially life-threatening complications was a pulmonary embolism.

Neck and Back Injury Statistics

Each year, roughly 6 million people show up at hospital emergency rooms due to trauma-related injuries to their neck, head, and face. ⁽²⁾ Also, approximately 12,000 people suffer traumatic spinal cord injuries annually in the United States. ⁽³⁾

“Trauma to the neck and back can lead to spinal cord injury and permanent disability.” ⁽⁴⁾

Causes of Neck and Back Injury

Many types of accidents can lead to severe neck and back injuries. These include:

• Transportation accidents: Some statistics claim nearly 2,000 New Yorkers die each year due to motor vehicle traffic-related injuries. ⁽⁵⁾
• Falling objects: More than 230 people die annually from falling objects. ⁽⁶⁾
• Slip and falls: Millions of people end up in hospitals each year due to injuries from falls. ⁽⁷⁾
• Medical malpractice: Medical errors are one of the leading causes of death in the United States, ranking number 3. ⁽⁸⁾
• Defective work equipment: Machines of one kind or another are all around us. When they work, they make our lives a lot easier. However, when something goes wrong, you can suffer severe injuries and die. Several of the most hazardous machines are tractors, forklifts, excavating machines, and cranes. Hundreds of people die each year from mishaps with work equipment. ⁽⁹⁾

Neck and Back Injury Signs and Symptoms

Spinal cord injuries of any kind may result in one or more of these signs and symptoms: ⁽¹⁰⁾

• Loss of movement.
• Loss or altered sensation, including the ability to feel heat or cold, or touch.
• Loss of bowel or bladder control.
• Exaggerated reflexes or spasms.
• Changes in sexual function and sensitivity.
• Pain or intense stinging sensation due to nerve damage.
• Difficulty breathing, coughing, or clearing secretions from your lungs.

Back pain can range from a basic muscle ache to a burning, shooting, or stabbing sensation. In addition, pain may spread down your leg. The pain may worsen when you bend, twist, lift, stand, or walk. ⁽¹¹⁾

Other possible symptoms of neck or back injury may include: ⁽¹²⁾

• Paralysis of an extremity.
• Numbness.
• Tenderness.
• Stiffness.
• Tingling.
• Localized pain.

Additional damage may also occur over days or weeks due to bleeding, swelling, inflammation, or fluid accumulation in and around your spinal cord. ⁽¹³⁾

Types of Neck and Back Injuries

You can suffer a traumatic spinal cord injury due to major traumatic events, such as falls, motor vehicle accidents, or acts of violence. Vehicle crashes continue to rank as the leading cause of injury, followed by falls and then gunshot wounds. ⁽¹⁴⁾

You can also suffer a neck or back injury doing work using your upper body and arms. ⁽¹⁵⁾

Your back gets injured from: ⁽¹⁶⁾

• Sprains — overstretched or torn ligaments.
• Strains — tears in tendons or muscle.
• Spasms — sudden contraction of a muscle or group of muscles.

You can also suffer an injury playing sports or being in an accident damaging your tendons, ligaments, or muscles. These injuries can cause pain, compress your spine, and cause discs in your spine to rupture or herniate. ⁽¹⁷⁾

Back injuries can lead to nerve and spinal cord problems, including: ⁽¹⁸⁾

• Spinal nerve compression, inflammation, and further injury.
• Sciatica, caused by something pressing on your sciatic nerve. If you have this condition, you may feel “shock-like or burning low back pain” along with pain going through your buttocks and down one leg.
• Spinal stenosis, meaning your spinal cord has narrowed. This condition puts pressure on your spinal cord and nerves.
• Spondylolisthesis occurs when a vertebra of your lower spine has slipped out of place. The nerves exiting your spinal column can become pinched.
• Herniated or ruptured discs occur when your intervertebral discs become compressed and bulge outward.
• Infections of different parts of your spinal column.
• Cauda equina syndrome, means you have a ruptured disc pushing into your spinal canal. This compression presses on the bundle of your lumbar and sacral nerve roots. You can suffer permanent neurological damage if you do not receive appropriate treatment.

Legal Options Due to Neck or Back Injury

If you or a loved one has suffered a severe neck or back injury, you may have grounds for a personal injury lawsuit. If someone else’s negligence led to your injury, they may be liable. You may be entitled to compensation.

Negligence is an important consideration when filing a personal injury lawsuit. “Negligent conduct may consist of either an act, or an omission to act when there is a duty to do so.” ⁽¹⁹⁾

If you are considering filing a lawsuit, seek out a reputable, highly experienced law firm specializing in personal injury and wrongful death litigation. We can provide you with the resources and knowledge necessary to explore your legal options.

How W&L Can Help

Weitz & Luxenberg has been helping people harmed by the actions and negligence of others for nearly 40 years. We are based in New York and know the state’s statutes and regulations inside and out.

Our dedicated team of personal injury attorneys also has a proven history of winning. We have secured over $26 billion dollars on behalf of our clients over the years.

Here are a couple examples of our wins:

• $ Hundreds of thousands – A woman was injured in her neck and spine when a suitcase from an overhead bin on an airplane dislodged and fell on her.
• $20.5 million – A man spends the rest of his life in a wheelchair after suffering a severe neck injury in a hit-and-run vehicle accident.

What Are Philips CPAP and BiPAP Devices Used For?

“A continuous positive airway pressure (CPAP) machine is the most commonly prescribed device for treating sleep apnea disorders.” ⁽¹⁾ Basically, these devices send a steady flow of oxygen into your mouth and nose while you are sleeping. The devices keep your airways open and help you breathe.

A CPAP machine uses a compressor, or motor. This motor generates a steady stream of pressurized air. The air moves through an air filter into a flexible tube. This tube allows purified air to move into a mask you wear. The mask is sealed around your nose and/or mouth. ⁽²⁾

Ideally, you experience uninterrupted sleep. Because the air from this device is pressurized, it pushes against any blockages. Your airways remain open and your lungs receive oxygen. ⁽³⁾

Types of Breathing Machines

In addition to CPAP devices, other breathing machines include APAP and BiPAP devices. All are intended to help you breathe normally while you are sleeping. Here is a breakdown of these devices: ⁽⁴⁾

• CPAP – This breathing device is programmed to generate pressurized air at one constant air pressure level. If you want to change the air pressure setting, you need to reset the device.
• APAP – This automatic positive airflow pressure machine monitors how you breathe throughout the night. It adjusts the air pressure automatically if you change position while you are sleeping. This device also compensates for medications you are taking that may have changed how you breathe.
• BiPAP – A bi-level positive airflow pressure device comes with two pressure settings. One uses pressure for inhaling. A second uses a lower pressure for exhaling. BiPAP devices can come with a backup respiratory rate to help patients with central sleep apnea. The backup makes sure you breathe. This device works better if you cannot tolerate CPAP machines, or have higher levels of carbon dioxide in your blood.

Foam Inhalation Can Cause Serious Injury or Death

According to the U.S. Food & Drug Administration (FDA), “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” ⁽⁵⁾

On November 12, 2021, the FDA provided an update on the recall. The FDA had inspected a Philips facility “to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations.” ⁽⁶⁾

During the inspection, the FDA learned that Philips’ replacement foam, which is silicone-based, may contain volatile organic compounds (VOCs). The FDA requested an independent laboratory test the foam for any potential safety risks.

Additionally, the FDA inspection revealed that Philips was aware no later than 2015 that the polyester-based polyurethane foam (PE-PUR) foam that is the subject of the recall had a degradation issue that was dangerous to users. Internal company testing also revealed the toxicity and potential carcinogenicity of the PE-PUR foam degradation products, yet Philips chose to keep using the PE-PUR foam over safer alternatives. ⁽⁷⁾

Philips Respironics, the manufacturer, used PE-PUR foam to lessen the sound and vibration of its breathing devices. However, if this foam comes into contact with your airways or digestive tract, dangerous side effects or medical complications may occur: ⁽⁸⁾

• If the foam breaks down, you may inhale or swallow foam particles.
• Foam particles may release toxic chemicals, which you can breathe in or ingest.

Inhaling or swallowing PE-PUR foam particles can lead to serious injury. Possible injuries can be life-threatening. Injuries may also be permanent. Medical treatment may be necessary to prevent irreversible damage. ⁽⁹⁾

Complaints and Dangerous Side Effects

Philips has received complaints from patients. Some patients have noted black debris, or particles, in their breathing device’s air pathway. Patients have reported headaches, irritation in their upper airway, chest pressure, a cough, and sinus infections. These side effects may be linked to inhalation of foam particles. ⁽¹⁰⁾

If you have inhaled or swallowed PE-PUR foam particles, you may experience a variety of side effects and complications, including: ⁽¹¹⁾

• Headache
• Dizziness
• Irritation of the eyes, nose, respiratory tract, or skin
• An inflammatory response
• Hypersensitivity
• Nausea and vomiting
• Toxic and carcinogenic effects to your internal organs

Potential Life-Threatening Health Complications

Long-term, permanent, and life-threatening health complications – including cancer – of PE-PUR foam are possible. If you are diagnosed with any of these conditions, your illness may be linked to your use of Philips CPAP and BiPAP:

• Acute Respiratory Distress Syndrome (ARDS)
• Reactive Airway Disease
• Respiratory failure
• Recurrent pneumonia (pneumonitis)
• Pleural effusion
• Lung/Pulmonary disease
• Lung/Pulmonary damage
• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma
• Sarcoidosis
• Chemical poisoning

Breathing Machines May Cause Cancer

Another serious concern is the possibility of developing different types of cancer. These cancers include:

• Lung
• Thyroid
• Lymphatic
• Leukemia
• Nasal
• Lymphomas
• Multiple myeloma
• Oral, including palate and tonsils

Philips Recalls Breathing Devices

On June 30, 2021, the FDA alerted the public that Philips recalled certain devices due to concerns regarding its polyester-based polyurethane sound abatement foam. ⁽¹²⁾ The FDA has recognized this as a Class I recall, “the most serious type of recall. Use of these devices may cause serious injuries or death.” ⁽¹³⁾

“The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries, difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.” ⁽¹⁴⁾

As of May 2, 2022, the FDA reported it has not received all the chemical risk information requested from Philips. However, the company has posted a clinical information update for doctors. ⁽¹⁵⁾

On that same date, a proposal was issued by the FDA’s Center for Devices and Radiological Health (CDRH). It requests Philips submit “a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015.” The CDRH is also “Continuing to encourage Philips Respironics to have a consistent and transparent approach for repairing or replacing the impacted devices.” ⁽¹⁶⁾

There have been more than 48,000 complaints, including 44 deaths, reported as of July 22, 2021. All serial numbers of these types of devices and models have been recalled: ^{(17) (18) (19)}

Recalled CPAP and BiPAP Devices

• Continuous ventilator, minimum ventilatory support, facility use – E30.
• Continuous ventilator, non-life supporting – DreamStation ASV; DreamStation ST, AVAPS; SystemOne ASV4; C-Series ASV; C-Series S/T and AVAPS; OmniLab Advanced+.
• Noncontinuous ventilator – SystemOne (Q-Series); DreamStation; DreamStation Go; Dorma 400; Dorma 500; REMstar SE Auto.

Recalled Ventilators

• Continuous ventilator – Trilogy 100; Trilogy 200; Garbin Plus, Aeris, LifeVent.
• Continuous ventilator, minimum ventilatory support, facility use – A-Series BiPAP Hybrid A30 (not marketed in U.S.); A-Series BiPAP V30 Auto.
• Continuous ventilator, non-life supporting – A-Series BiPAP A40; A-Series BiPAP A30.

Additional models were recalled in December 2021 by Philips and announced by the FDA on January 26. According to the FDA, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. ⁽²⁰⁾

These additional recalled items were manufactured and distributed between April 15 and May 24, 2021:

• Trilogy Evo ventilator. ⁽²¹⁾
• Repair kits for the Trilogy Evo muffler assembly. ⁽²²⁾

Legal Options

If you or a loved one suffered serious medical complications or a health injury after using a recalled Philips medical device, you may be entitled to compensation. Compensation may cover medical expenses, as well as your pain and suffering, loss of earnings, and potential future income loss. Punitive damages may also be awarded.

Possible compensation you could receive includes:

• Costs due to doctor visits.
• Medication reimbursement.
• Nursing and other related care costs
• Money for days you were not able to work due to your injury.
• Money for future income you cannot make if your injury does not allow you to work.

How W&L Can Help

As an experienced, national law firm, Weitz & Luxenberg has made it our mission to stand up to medical device manufacturers who sell faulty products that harm people. These breathing devices fall into that category.

Our attorneys have a successful track record of winning billions of dollars in settlements and verdicts for our clients. Here are a couple examples of our victories for our clients that were led by Ellen Relkin, partner and chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group:

• $1 Billion+ – Weitz & Luxenberg helped secure this settlement with Stryker on behalf of thousands of patients injured by the company’s Rejuvenate and ABGII modular hip implants.
• $2.5 Billion – Weitz & Luxenberg played a key role in helping achieve this settlement with DePuy on behalf of thousands of patients injured by the company’s ASR hip replacement implants.

Our team of knowledgeable medical device attorneys is prepared to help you. In fact, Brendan McDonough is not only a medical device attorney on the team, but he is also a medical engineer.

“I’m proud to be able to use my engineering skills to further the legal case against defective medical devices that harm our clients,” emphasizes Mr. McDonough. “When manufacturers create devices that cause injury, they deserve to be held accountable.”

W&L Takes the Lead

Weitz & Luxenberg is helping lead the charge against Philips Respironics for their defective CPAP devices. Mr. McDonough was selected to speak about the dangers associated with the toxic and carcinogenic compounds released by these devices at Mass Torts Made Perfect and the HarrisMartin Webinar Series: Philips CPAP, BiPAP & Ventilator Litigation in September 2021.

Our law firm is offering you a free consultation. Contact us so we can help you explore your legal options.

What Are Welding, Cutting, and Brazing?

“Welding joins pieces of metal by use of heat, pressure or both.” ⁽²⁾ Welding may involve the use of blow torches or electric arcs. Sometimes welding involves use of “oxy-acetylene gas, electrical current, lasers, electron beams, friction and chemical reactions.” ⁽³⁾

Unlike welding, “cutting processes involve separating or severing a piece of metal through intense heat generated to melt the metal. Cutting processes include oxygen and fuel gas and electrical arc gouging.” ⁽⁴⁾

“Brazing is a process similar to welding in that a liquid filler metal is heated and flows between two or more metal surfaces to be joined.” ⁽⁵⁾ Braze metal is liquefied and then spread over the surface to be joined. In welding, both the base and filler metals are heated to a molten state.

Workers At Risk

“Statistics show that more than 1 in 250 construction workers will suffer fatal injuries from welding over a working lifetime,” reports Industrial Safety & Hygiene News (ISHN). ⁽⁶⁾ The U.S. Bureau of Labor Statistics (BLS) reports 49 fatalities among welders, cutters, solderers, and brazers in 2019. ⁽⁷⁾

While the causes of welding accidents are numerous, most can be prevented. A significant factor leading to welding incidents resulting in injuries is failures in training.

Causes of Injury

“A construction worker may need to have welding training for a certain project, while a plumber also needs to know how to weld for his career. It is imperative that someone who is welding on the job — or even doing it at home — has the right training and equipment,” notes ISHN. ⁽⁸⁾ Inexperience and lack of training can cause accidents leading to injuries.

Other causes of welding, cutting, and brazing injuries are:

• Fires and explosions. Work of a “hot work” nature performed within less than 35 feet of combustible materials can result in fires or explosions. Hot work teams must have someone designated as a “fire watch” whose job is to look for embers, sparks, or anything possible of starting a fire; extinguish a fire; and alert people of a fire. ⁽⁹⁾
• Burns. BLS data show out of 1,820 nonfatal occupational injuries and illnesses involving days away from work, 60 were due to heat and thermal burn injuries. This was among welders, cutters, solderers, and brazers employed by private industry. ⁽¹⁰⁾
• Radiation. Radiation or electromagnetic energy, such as ultraviolet rays, can cause burns to the eyes. These burns are sometimes called “welders’ eye” or “arc eye.” The effects of these burns may be delayed for up to several hours after exposure. ⁽¹¹⁾ Burns of this nature result in conjunctivitis, “an inflammation of the mucous membrane of the front of the eye.” ⁽¹²⁾
• Electric shock/electrocution. “Damaged or improperly maintained equipment — such as cables or missing/burned out insulators, or faulty connections — can cause shock injuries or electrocution.” ⁽¹³⁾
• Fumes and gases. Exposure to emissions of hazardous fumes, like hexavalent chromium and manganese, are a serious health risk. Failure to control exposure to fumes and gases can lead to serious conditions like nervous system issues, cancers, suffocation, and problems with the septum. ⁽¹⁴⁾

Welding Injuries

Welding accidents can result in a variety of possible injuries. “Health hazards from welding, cutting, and brazing operations include exposures to metal fumes and to ultraviolet (UV) radiation. Safety hazards from these operations include burns, eye damage, electrical shock, cuts, and crushed toes and fingers.” ⁽¹⁵⁾

Common welding injuries include:

• Burns. These injuries can range from mild to lethal. Burn injuries result from the intense heat and pressure used in the welding process. While most burn injuries are visible, others may appear over time. ⁽¹⁶⁾
• Exposure to radiation. Exposure to ultraviolet radiation or infrared radiation can cause pain and scarring from thermal burns to the eyes. These types of injuries are due to the electric arc in the welding process. ⁽¹⁷⁾
• Exposure to light. “When our eyes are exposed to intense visible light, a variety of optical injuries can occur. Retinal damage is a common result of exposure to intense visible light during the welding process.” ⁽¹⁸⁾
• Exposure to fumes. During welding, fumes from metals can damage the lungs or lead to cancer. “Exposure to hexavalent chromium can cause lung cancer or issues with the respiratory tract, such as the development of sores in the nose or a hole in the septum, which separates the nasal passages.” ⁽¹⁹⁾
• Hearing Loss. Noise is another welding hazard. ⁽²⁰⁾ “Welders are exposed to loud noises, intense heat, blinding light and breathing in potentially dangerous welding fumes… fumes have been shown to have a major negative impact on hearing… exposure to certain chemicals or heavy metals combined with loud noise are said to cause even more harm to the hearing than either types of exposure alone.” ⁽²¹⁾
• Neurological Issues. Welding fumes can have damaging neurological effects resulting in permanent harm to auditory nerve fibers and cells of the inner ear. They can also cause Parkinson’s disease-like symptoms, including tremors and poor balance. ⁽²²⁾

If you have sustained serious injuries from a welding accident, it is best to consider all of your legal options. An attorney can help you explore those options and take steps toward remedying your situation financially.

Legal Options

Welding lawsuits cases may fall under the legal concept of negligence. Negligence is defined as a “failure to behave with the level of care that someone of ordinary prudence would have exercised under the same circumstances. The behavior usually consists of actions, but can also consist of omissions when there is some duty to act.” ⁽²³⁾

When a welding accident results in a fatality, the case may fall under wrongful death. This is defined as, “A death caused by the wrongful act of another, either accidentally or intentionally.” ⁽²⁴⁾ Wrongful death claims are usually brought by family members to gain compensation for the loss of both their loved one and their loved one’s income. ⁽²⁵⁾

Who Is Liable?

In welding accident cases, employers not providing a safe working environment may face liability for injuries sustained on the job. For example, if workers are welding in areas where there is not proper ventilation and engineering controls have not been employed or are inadequate. Engineering controls may include such things as exhaust ventilation or fume extraction welding guns. ⁽²⁶⁾

Another instance where an employer may be liable is if it does not provide safety gear or adhere to proper Occupational Safety and Health Administration (OSHA) safety standards and guidelines.

Manufacturers can be held accountable if faulty equipment or equipment design resulted in injury. For example, a design flaw of valves on an acetylene tank leads to an explosion.

It is not only workers who can be permanently injured, or die, from a welding accident. A person passing by when someone is welding could also fall victim to flying sparks and end up blinded or scarred.

How W&L Can Help

Welding accidents can result in catastrophic injuries, but obtaining compensation for those injuries often requires legal action. This is where an experienced attorney can help.

W&L has helped clients for nearly 40 years. We have a successful history of obtaining compensation for our clients in personal injury cases, like welding accidents. We hold those responsible accountable for the harm done to our clients.

Some of our successes include:

• W&L recovered $2.96 million after a negligent co-worker driving a hi-lo overturned it, amputating part of our client’s leg. The company was also found accountable for the accident because there were not adequate vehicle barriers around the pit where the men were working.
• W&L recovered $10 million for our client when a negligently designed bungee cord brake system failed. The brakes for the zip line he was on broke and struck him in one eye, resulting in permanent blindness in the eye.

What Is Maculopathy?

Maculopathy is “any pathologic condition or disease of the macula, the small spot in the retina where vision is keenest.” This condition is also called macular retinopathy. ⁽¹⁾

Types of maculopathies include: ^{(2) (3) (4)}

• Age-related macular degeneration.
• Hereditary maculopathies.
• Cellophane maculopathy.

Age-Related Macular Degeneration

Age-related macular degeneration is common. In people 50 years and older, this condition is a leading cause of vision loss. ⁽⁵⁾ This condition develops when the central portion of the retina, the macula, degenerates. When this occurs, side or peripheral vision may remain intact, but central vision is often lost. ⁽⁶⁾

Approximately 11 million people in the United States have age-related macular degeneration. ⁽⁷⁾

The dry form is the most common type of age-related macular degeneration, approximately 85-90 percent of all cases. In this type, yellowish deposits build up beneath the retina, causing progressive vision loss. This form typically affects both eyes, though vision loss typically occurs in one eye before the other. ⁽⁸⁾

Ten to fifteen percent of dry form age-related macular degeneration cases progress to the wet form. The wet form of age-related macular degeneration “is characterized by the growth of abnormal, fragile blood vessels underneath the macula. These vessels leak blood and fluid, which damages the macula and makes central vision appear blurry and distorted.” Unfortunately, the wet form can cause severe, rapid vision loss. ⁽⁹⁾

Hereditary Maculopathies

You can also develop problems with your retinas because you have an inherited maculopathy. Hereditary maculopathies include:

• Doyne honeycomb retinal dystrophy (DHRD): This condition generally begins to show itself in early to mid-adulthood. It does lead to vision loss, but that loss varies from person to person. DHRD is characterized by small, round, white spots called drusen accumulating beneath the pigmented layer of the retina, known as the retinal pigment epithelium. The National Institutes of Health’s (NIH’s) National Center for Advancing Translational Sciences notes, “Over time, drusen may grow and come together, creating a honeycomb pattern.” ⁽¹⁰⁾
• Stargardt disease: This typically autosomal dominant eye disease, according to the American Academy of Ophthalmology, “is the most common hereditary macular dystrophy, with a prevalence of 1 in 10,000, and it accounts for approximately 7% of all retinal dystrophies.” This condition, characterized by “beaten-bronze” or a “bull’s-eye” pattern macular lesions, usually shows up in children and young adults before they turn 20 years of age. For someone diagnosed with this disease, the prognosis is poor. Visual acuities tend to range from 20/200 to 20/400. ⁽¹¹⁾
• North Carolina macular dystrophy: Researchers named this autosomal dominant disorder after working with a large North Carolina family who had descended from three Irish brothers. Other cases have been discovered in affected families throughout the world. The condition begins to show itself in infants or at birth. Visual acuity generally ranges from 20/20 to 20/200. ⁽¹²⁾
• Sorsby fundus dystrophy, also called Sorsby pseudoinflammatory macular dystrophy: This rare, progressive autosomal dominant retinal dystrophy can lead to bilateral central vision loss. Usually, this condition does not show itself until you are in your 30s or 40s. ⁽¹³⁾
• Best vitelliform macular dystrophy, also known as Best disease: Onset of this autosomal dominant, progressive condition begins in childhood. The prognosis is relatively good. Visual acuity remains pretty good over time. However, in the disease’s later stages, central vision loss may occur. ⁽¹⁴⁾
• Adult vitelliform macular dystrophy, or adult-onset foveomacular vitelliform dystrophy: This condition refers to a group of diseases that are similar to Best disease. However, these diseases do not show signs until patients have reached young or middle adulthood, unlike Best disease. The prognosis overall is favorable. ⁽¹⁵⁾
• Congenital retinoschisis, or juvenile X-linked retinoschisis: This disease is rare and progressive. Usually, this X-linked recessive disease is first detected in childhood. Children with the disease have decreased central vision. Roughly 1 in 5,000 to 1 in 25,000 people worldwide may have this condition, which “is the most common juvenile-onset macular degeneration in males.” ⁽¹⁶⁾
• Dominant cystoid macular dystrophy, or dominant cystoid macular edema: This condition is extremely rare and progressive. This disease usually first appears at 30 years of age or older. The visual prognosis is usually poor. ⁽¹⁷⁾
• Central areolar choroidal dystrophy: This rare disease usually first shows up between the ages of 20-40. Central visual deterioration is progressive. The final visual prognosis is poor, often worse than 20/200. ⁽¹⁸⁾

Cellophane Maculopathy

Cellophane maculopathy is known by multiple names, including macular pucker, retina wrinkle, premacular fibrosis, internal limiting membrane disease, and surface wrinkling retinopathy. A macular pucker refers to scar tissue that forms on the macula. Some people do not experience any vision loss due to a macular pucker, whereas, although rarely, some experience severe vision loss. ⁽¹⁹⁾

As the NIH’s National Eye Institute notes, people with a macular pucker “may notice that their vision is blurry or mildly distorted, and straight lines can appear wavy. They may have difficulty in seeing fine detail and reading small print. There may be a gray area in the center of your vision, or perhaps even a blind spot.” Most of the time, vision does not progressively worsen with cellophane maculopathy. ⁽²⁰⁾

Elmiron and Maculopathy

Elmiron is approved as a treatment for interstitial cystitis. Interstitial cystitis is a chronic condition affecting the bladder. Symptoms include bladder pressure, bladder pain, and occasionally, pelvic pain. The pain can range from mild to severe. If you have this condition you may also feel like you need to urinate more frequently. ⁽²¹⁾

Studies have linked Elmiron used in patients with interstitial cystitis to retinal damage. An article published by the American Academy of Ophthalmology described patients treated at Emory Eye Center who presented with a unique pigmentary maculopathy after taking Elmiron for interstitial cystitis. ⁽²²⁾ This study is one among many that have been recently published. ^{(23) (24) (25)}

At least one recently published article has found that even after Elmiron is discontinued, the maculopathy that has been linked with its use may continue to worsen. ⁽²⁶⁾

Filing Lawsuits for Elmiron and Maculopathy Injuries

If you took Elmiron, you may now have been diagnosed with specific types of maculopathies. These include pigmentary maculopathy, retinopathy, degenerative maculopathy, macular or pattern dystrophy, or retinal pigment epithelium atrophy.

Symptoms of these eye diagnoses may include:

• Vision loss.
• Vision impairment.
• Scotoma.
• Halo vision.
• Unilateral (one eye) or bilateral (both eyes) blindness.
• Blurred vision.
• Metamorphopsia (distortion of linear objects or lines; such that they appear curved).
• Reduced night vision.

Lawsuits are being filed accusing Elmiron’s manufacturer, Janssen Pharmaceuticals (owned by Johnson & Johnson), of failing to properly warn the public about the risk of vision loss or other eye problems. In one such lawsuit, a woman claims to have “sustained retinal damage and impaired vision as a result of taking the prescription drug Elmiron to treat a bladder pain syndrome known as interstitial cystitis.” ⁽²⁷⁾

According to the lawsuits, many patients, studies, and government agencies “have established that Elmiron causes retinal damage.” However, these suits claim, “defendants have failed to warn, advise, educate or otherwise inform Elmiron users, prescribers or governmental regulators in the United States about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring.” ⁽²⁸⁾

As of June 2020, the Elmiron warning label now warns “pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.” ⁽²⁹⁾

How W&L Can Help

Weitz & Luxenberg is currently accepting cases involving clients who have been diagnosed with certain types of maculopathy after taking Elmiron.

If you or a loved one has been diagnosed with maculopathy after using Elmiron, you may be entitled to financial compensation. We can help you explore your legal options.

We have a team of attorneys with experience in pharmaceutical product liability law. As a national personal injury law firm, we have dedicated ourselves to helping clients harmed by defective drugs for more than three decades.

“When you are prescribed a drug to help relieve your symptoms of interstitial cystitis, you expect it to be safe,” says Danielle Gold, lead Elmiron attorney for W&L. “However, some patients taking Elmiron have developed serious vision problems and the retinal damage may be irreversible. This is a devastating injury and we plan to hold the defendants accountable.”

W&L attorney Ms. Gold has been appointed to serve on the Plaintiffs’ Executive Committee in the Elmiron multidistrict litigation (MDL) centralized in the District of New Jersey. Discovery is underway and a Science Day presentation is scheduled.

Our attorneys have secured billions of dollars in verdicts and settlements on behalf of our clients. Among our successes are:

• $9 billion — W&L helped secure a jury verdict of $9 billion on behalf of a client who developed bladder cancer after taking Actos, a diabetes drug.
• $13.5 million — W&L achieved a $13.5 million verdict on behalf of our client who had taken the pain medication Vioxx. He and many others suffered heart attacks after taking this medication to treat arthritis and other pain conditions.

Knee Replacement Overview

Knee replacement surgery is performed to alleviate pain and restore function in a damaged knee. During the procedure, a surgeon removes a damaged or diseased knee joint and puts an artificial implant in its place.

Another name for knee replacement surgery is total knee arthroplasty (TKA). Knee replacement is often an inpatient procedure. ^{(3) (4)}

What Makes Someone Require a Knee Replacement?

Most people who receive knee replacement surgery have arthritis. But injury, other diseases, or simply years of use can also damage the knee. ⁽⁵⁾

Your doctor may recommend knee replacement surgery if: ⁽⁶⁾

• Your knee pain prevents you from sleeping.
• Your knee pain prevents you from doing everyday activities such as walking.
• Your knee pain prevents you from taking care of yourself.
• Other treatments have failed to reduce your knee pain.

Who Typically Gets Knee Replacements?

More than 98% of patients who undergo total knee replacement surgery are 45 or older. The procedure is most common for people 65 and older. However, younger people make up an increasing percentage of knee replacement patients. ^{(7) (8)}

The average age for knee replacement patients dropped significantly from 2000 to 2010. ⁽⁹⁾ Knee replacement surgeries performed on people aged 45-64 tripled from 1999 to 2008. ⁽¹⁰⁾

Most knee replacements only last a decade or two before wearing out. This means these younger knee replacement patients are likely to “outlive” their devices and will eventually require revision surgery to replace them.

How Many Knee Replacements Are Done Each Year?

More than 750,000 people had knee replacement surgery in 2014 according to data from the Healthcare Cost and Utilization Project. ⁽¹¹⁾ Researchers project the number of knee replacement procedures will increase to 1.26 million by 2030 as baby boomers continue to age. ⁽¹²⁾

Knee Replacement Recalls

Eager to meet the rapidly growing demand for knee replacements, medical device manufacturers have sold knee implants without first adequately testing their safety.

The U.S. Food and Drug Administration (FDA) has a 501(k) Program that allows companies to promote new medical devices if they can prove the device is “substantially equivalent” to a device already on the market. ⁽¹³⁾ As a result, new devices can gain approval and be sold to the public without first undergoing clinical trials.

Because of this approval process a dangerous flaw may not reveal itself until after a device has been implanted inside the bodies of thousands of consumers.

When Do Companies Recall an Implant?

When a company discovers a problem with a device, it needs to issue a recall. According to the FDA, “recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.” ⁽¹⁴⁾

Manufacturers have issued recalls for a number of knee replacement devices, including:

• Arthrex iBalance Total Knee Arthroplasty ⁽¹⁵⁾
• Smith & Nephew Journey BCS Knee Replacement ^{(16) (17)}

In 2015 and 2016, Arthrex, Inc. instituted recalls of the iBalance tibial tray because of tibial baseplate loosening. The trays were manufactured with a smooth surface that may have resulted in poor bonding between the tray and the knee. ⁽¹⁸⁾

Five years after stopping production, Smith & Nephew issued a recall of its first-generation Journey BCS Knee in 2018. The manufacturer cited “a revision rate over 1.5 times” the average as the reason for the recall. ^{(19) (20)}

FDA Class 2 Recalls

All of these recalls were categorized as Class 2 by the FDA. Class 2 means a product “may cause a temporary or reversible health problem” or has a slight chance of causing “serious health problems or death” ⁽²¹⁾

The FDA medical device recall database contains the most up-to-date information about recalls of knee implants and other devices.

Lawsuit Allegations

Unfortunately, some people experience severe health problems following knee replacement surgery. ABC News reported on a woman whose knee implant left her in “constant pain, 24/7,” and too disabled to work. ⁽²²⁾ She’s not alone: an estimated one-third of patients with knee replacements continue to experience chronic pain following the procedure. ⁽²³⁾

What Symptoms Are People Experiencing from Knee Replacements?

People suffering from failed knee implants may experience these symptoms:

• Pain.
• Swelling.
• Instability.
• Loss of range of motion.
• Inability to walk.

Failed knee implants often require revision surgery. Revision surgeries carry greater risk than primary surgery. They are more likely to have complications. ⁽²⁴⁾

Knee Replacement Revision Surgery

Revision surgeries are expensive. The average cost of revision surgery is nearly $50,000. ⁽²⁵⁾

Revisions surgeries are also more likely to result in extended hospitalization. ⁽²⁶⁾ The average hospital stay for a knee revision is slightly more than 5 days. ⁽²⁷⁾ Revisions also require follow-up care and physical therapy.

What Injuries or Health Problems Are People Suing For?

Many knee implant patients who had to undergo revision surgery because their devices prematurely failed due to loosening or breakage have filed lawsuits against the device manufacturers.

Reasons for revision surgery include: ^{(28) (29)}

• Mechanical loosening.
• Implant failure/breakage.
• Bone fracture and osteolysis (bone tissue loss).

If you have been harmed by a faulty knee implant, you may be able to receive compensation for your medical expenses as well as for your pain and suffering. If the complications required you to miss work for medical treatments or left you unable to work due to a disability, you may also be entitled to compensation for lost wages.

Settlement Amounts

Weitz & Luxenberg’s Defective Drugs and Medical Devices Litigation Unit has represented thousands of patients harmed by defective orthopedic devices.

Ellen Relkin, co-chair of the team, has served in court-appointed leadership roles in multiple large hip implant litigations:

• As co-lead counsel, Ms. Relkin helped negotiate a $2.5 billion settlement for patients harmed by defective DePuy ASR hip implants. The standard base payment for patients enrolled in the settlement was $250,000. This amount was separate from reimbursements made to Medicare and other health insurers to cover revision surgeries and associated care.
• As lead and liaison counsel, Ms. Relkin worked to negotiate a $1 billion settlement for patients harmed by recalled Stryker Rejuvenate and ABG II hip implants. The base award was $300,000 per failed implant. Additional compensation was provided to patients who suffered greater complications.
• Ms. Relkin was also one of two court-appointed members of the settlement oversight committee for the recalled Stryker LFIT Femoral Head. A confidential private settlement with Stryker was announced in late 2018.

Who Should Be Filing a Lawsuit?

You may want to consider filing a lawsuit if you had a knee replacement and then:

• You needed to have revision surgery to correct a defective knee implant.
• Your doctor has told you that you will need revision surgery in the future but you are not able to have the procedure due to medical reasons.
• You experienced severe medical complications with your knee implant, especially complications related to premature loosening and other forms of implant failure.

Tips for People Who Are Filing Lawsuits

Some tips if you are considering filing a lawsuit:

• Don’t delay! The law limits the time you have to file a lawsuit, and the deadline varies from state to state. Speak with an attorney as soon as possible so you can file before the statute of limitations closes.
• Consult an attorney before participating in a manufacturer recall. Some recalls require you to waive your right to participate in a lawsuit, which would prevent you from receiving compensation.
• If you have not yet had your revision surgery, make arrangements with an attorney to have the explanted device and tissue samples properly stored as evidence.
• Gather all your medical and pharmaceutical records in one place.

How Can W&L Help You?

Consulting with an attorney experienced in handling lawsuits for defective medical devices can help you understand your options. Weitz & Luxenberg’s Defective Drugs and Medical Devices Litigation Unit has both the experience and the resources to handle complex litigations against powerful corporations.

The general public should not be test subjects for unproven new devices. We believe companies who rush unsafe products to the market should be held accountable.

It would be our privilege to help you obtain justice for the injuries you’ve suffered.

About Melanoma Skin Cancer

Skin cancer is abnormal growth of your skin cells. Primarily, skin cancer develops on body parts you have exposed to the sun — such as your scalp, ears, face, lips, neck and chest, arms, or hands. Women may also develop skin cancer on their legs.

You can get melanoma anywhere on your body. Melanoma can form in normal-looking skin or develop in an existing mole. In men, melanoma tends to show up on the face or torso. In women, melanoma usually shows up on the lower legs.

The Mayo Clinic lists these possible signs of melanoma: ⁽¹⁾

• A large, brownish spot with darker speckles.
• A mole changes in color, feel, or size, or it bleeds.
• A small lesion with an irregular border and portions appearing pink, white, red, blue, or blue-black.
• An itchy or burning painful lesion.
• Dark lesions on your palms, soles, fingertips or toes, or on mucous membranes lining your nose, mouth, anus, or vagina.

Melanoma can also form on areas you rarely expose to the sun, including your palms, beneath your fingernails or toenails, or your genital area. ⁽²⁾

Melanoma Skin Cancer Statistics

“Skin cancer is the most common form of cancer in the United States.” ⁽³⁾ There are three major types — basal cell carcinoma, squamous cell carcinoma, and melanoma. ⁽⁴⁾ “At least one in five Americans will develop skin cancer by the age of 70.” ⁽⁵⁾

Millions of adults are treated each year for basal cell and squamous cell carcinomas. In addition, thousands of people a year are diagnosed with melanoma.

Nearly 97,060 new cases of melanomas of the skin were reported in the U.S. in 2022. Of these, 8,350 people died from this cancer. ⁽⁶⁾

In New York alone, more than 4,830 cases of melanoma were reported in 2022. ⁽⁷⁾ And 370 people died of this cancer in 2023. ⁽⁸⁾

Over the past decade, the number of new invasive melanoma cases has been rising. According to the Skin Cancer Foundation, the number of new melanoma cases diagnosed in 2021 is expected to increase by 5.8%. Also, the number of deaths from melanoma is expected to increase by 4.8%. ⁽⁹⁾

Basal cell carcinoma statistics: This is the most common form of skin cancer. Each year, roughly 3.6 million cases are diagnosed in the U.S. ⁽¹⁰⁾

Squamous cell carcinoma statistics: This is the second most common form of skin cancer. Roughly 1.8 million cases are diagnosed each year across the country and it kills over 15,000 people in the U.S. annually. ⁽¹¹⁾

Consequences of Misdiagnosis

If you or a loved one developed malignant melanoma and was misdiagnosed, your 5-year survival rate drops depending on how far your disease has spread.

The earlier your melanoma is diagnosed correctly, the better your overall prognosis. Overall survival after 5 years depends on many factors: ⁽¹²⁾

• The thickness of your primary melanoma — your outlook is better if it is thinner.
• If your melanoma spread to distant sites — your outlook is better if it has not spread.
• If your lymph nodes, which help fight infection, were involved — your outlook is better if they are healthy.

Many people with melanoma are cured by their initial surgery. ⁽¹³⁾ A false negative misdiagnosis may “translate to a reduced chance of survival for some patients.” ⁽¹⁴⁾

Melanoma Survival Rate

Getting the correct early diagnosis and treatment of melanoma could have made all the difference for you. A delay in correct diagnosis and treatment can mean the difference between life and death.

Delaying the correct diagnosis and treatment of stage 1 melanoma by just one month increases your risk of dying by 5%. Further delay of a correct diagnosis and treatment increases your risk of dying dramatically — waiting 119 days to begin treatment poses a 41% higher risk. ⁽¹⁵⁾

If melanoma has spread to your lymph nodes when you are diagnosed, your survival rate is only about 66%. If melanoma has metastasized to distant organs by the time you are diagnosed correctly, your chance of surviving falls to just 27%. ⁽¹⁶⁾

In children, treatment of melanoma is frequently “delayed due to misdiagnosis of pigmented lesions, which occurs up to 40 percent of the time.” ⁽¹⁷⁾

What Makes a Skin Cancer Misdiagnosis Medical Malpractice?

Sometimes medical professionals fail to meet their duty of care. If they do and you suffered serious complications because of misdiagnosed, untreated skin cancer, you may have a case of medical malpractice. Speak with an experienced, reputable attorney about your legal options.

A big part of your case involves negligence. Did your health care provider’s conduct fall short of what is considered a reasonable standard of care? ⁽¹⁸⁾

Your attorney must show your doctor acted negligently in the care you received and you were injured as a result. Your attorney must prove your health care provider: ⁽¹⁹⁾

• Owed you a professional duty.
• Breached the professional duty.
• You were injured due to your health care provider’s breach of that duty.
• You deserve to be compensated.

Working with Your Attorney

When you hire an attorney to handle your case of medical malpractice, your attorney files an allegation of medical negligence according to your state’s statute of limitations. Your attorney also handles all legal matters on your behalf.

In addition, your attorney explains how the legal process works and what happens as you move forward. You can ask your attorney any questions about your situation and your case. Your attorney does everything allowable to achieve appropriate compensation on your behalf.

How W&L Can Help

The legal system is complex. Medical malpractice laws vary from state to state. If your injury occurred in New York, hire someone with a high-quality reputation for handling medical malpractice cases in New York.

Weitz & Luxenberg is such a law firm. We have nearly four decades of know-how handling personal injury, wrongful death, and medical malpractice cases in New York. We are based out of Manhattan but handle cases all over the state and around the country.

We also have a solid history of winning medical malpractice cases. Here are just a couple examples:

• $500,000 settlement — A young woman suffered irreparable damage to her uterus because she was misdiagnosed. She had an IUD implanted and had complications. Time and again, she visited the Emergency Room (ER). She was misdiagnosed, suffered debilitating and life-threatening complications, and underwent multiple surgeries.
• $2.2 million settlement — A young woman died due to a misdiagnosis. She underwent a tonsillectomy performed by a specialist. She later reported to an ER because her throat hurt and she had difficulty swallowing. Health care providers at the ER misdiagnosed her and provided the wrong treatment. They discharged her even though she wasn’t any better. Within just two days, she died from internal bleeding because her surgical wound had ruptured.