The Schmidt Firm, LLP

Cold Therapy Class Action Lawsuit

sarah — Mon, 20 May 2013 21:54:50 +0000

If your cold therapy machine caused you to suffer frostbite, nerve damage, skin damage, skin necrosis, or other complications, you may be seeking justice through a cold therapy class action lawsuit. Our lawyers are not accepting class action claims at this time — we believe our clients can maximize their individual settlement through an individual cold therapy lawsuit.

What You Can Do & How a Cold Therapy Class Action Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting cold therapy induced injury cases in all 50 states. If you or somebody you know was injured by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Cold Therapy Class Action Lawsuit

The Schmidt Firm, LLP provides legal representation to the victims of medical devices. Although we are nationally recognized as a class action law firm, we are not pursuing a cold therapy class action lawsuit at this time. The reason is because we believe we can help our clients maximize their individual compensation through an individual cold therapy lawsuit.

Through an individual lawsuit, your attorney can help you fight for the highest amount of compensation you can get based on the individual merits of your case. An individual attorney can also help explain the legal process, plan your legal strategy, and argue your case in court.

Your cold therapy lawsuit could be compensated for:

Pain, suffering, emotional injuries
Medical bills and future care
Lost wages or employment
Permanent disability (amputation)
Decreased quality of life
Punitive damages

About Class Action Lawsuits

Class action lawsuits have advantages for certain types of litigation. For example, many class action lawsuits have been filed by employees who were denied fair compensation for work and overtime benefits. In this case, a class action makes sense because a large number of people can band together, hire legal representation, and fight for the compensation they deserve. It wouldn’t make sense for one person to file a lawsuit alone because their legal expenses would be more than any settlement, even if they won.

Why Our Law Firm is Filing Individual Lawsuits Instead of a Cold Therapy Class Action Lawsuits

Cold therapy machines are associated with some extremely severe and debilitating injuries. One plaintiff, Whitney Engler, suffered extreme frostbite on her legs and was awarded more than $12.5 million for her cold therapy lawsuit. Her lawyers successfully convinced the jury to award more than $7.5 million in punitive damages, which are additional damages to punish the extreme negligence of the manufacturer. This is a good example of why it pays to hire excellent legal representation.

It is also a good example of why it is unlikely that a cold therapy class action lawsuit will be used to resolve a substantial number of cold therapy lawsuits. Because the injuries are so severe, individual plaintiffs have an incentive to fight for the highest amount of compensation they deserve based on the merits of their case.

Furthermore, people in a class action lawsuit could be forced to accept a “low-ball settlement,” high attorney’s fees, and less compensation than what they really deserve. Even if the lawsuit is awarded compensation, damages are usually split evenly among the class members. Once they accept a settlement, their future options for filing a lawsuit could be extremely limited.

How Can a Cold Therapy Lawyer Help?

Our cold therapy lawyers can help you:

Find out if the “statute of limitations” has expired and how much time you have left to file a lawsuit.
Decide whether to accept a settlement offer from the manufacturer. We can also review documents that might limit your ability to file a lawsuit in the future.
File a lawsuit, plan your legal strategy, and argue your case in court.
Fight for the compensation you deserve for your cold therapy lawsuit.

Do I have a Cold Therapy Lawsuit?

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Cold Therapy and Nerve Damage

sarah — Mon, 20 May 2013 18:06:35 +0000

Patients who are not warned about the risk of using a cold therapy machine for too long can suffer devastating nerve damage (peripheral neuropathy) and other injuries. This is why patients should check their skin frequently for symptoms of nerve damage — including numbness, pain, cold sensitivity, loss of fine motor skills, and more. Unfortunately, our lawyers are concerned because many people have been injured when their doctors failed to adequately warn them about the risk of cold therapy and nerve damage.

What You Can Do & How a Cold Therapy Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting cold therapy induced injury cases in all 50 states. If you or somebody you know was injured by nerve damage caused by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Does Cold Therapy Cause Nerve Damage?

Cold therapy machines can cause permanent nerve damage (also known as “peripheral neuropathy”) as a complication of cold injuries like frostbite and skin necrosis. These injuries occur when patients use the machines for several hours of “continuous cold therapy” without checking their skin for symptoms of nerve damage.

Experts recommend taking several steps to reduce your risk of nerve damage and other injuries from a cold therapy machine:

Talk to your doctor about the risks of cold therapy, proper temperature, duration of treatment, and how to recognize symptoms of nerve damage.
Protect your skin from extremely cold temperatures by placing a towel under the compression pad.
Check your skin every 20-30 minutes for symptoms of nerve damage and allow your skin to warm up while deeper tissues stay cool.
The therapeutic benefits of cold therapy do not increase below 15ºC (59ºF), but the risk of skin and nerve damage increases.

Patients at Risk of Nerve Damage

Patients who are at high risk of nerve damage should not use a cold therapy machine unless specifically directed by a physician. These patients include:

Raynaud’s phenomenon
Cold allergy
Cryoglobulinemia (disease that causes damaged blood vessels)
Paroxysmal cold hemoglobinuria (disease that causes release of hemoglobin after exposure to cold temperature)
Arthritis
Pheochromocyotoma (disease that can cause abnormal skin sensations and other complications)
Anesthetic skin (numbness)
Severe cardiovascular disease
And more

Symptoms of Nerve Damage

The symptoms of nerve damage vary depending on the types of nerves that have been injured and the extent of the injury. The nerves that sense pain are delicate branching structures that extend into the upper layers skin (epidermis). Nerves that sense heat and cold are located deeper in the skin. Because pain nerves are the first to be damaged by cold therapy, patients often fail to realize when they are getting too cold. The result is that patients may become numb or feel abnormal sensations (tingling, burning, warmth, etc.) instead of cold.

Symptoms of nerve damage from cold therapy include:

Tingling and burning sensation
Deep pain
Numbness (loss of feeling in arms and legs)
Muscle weakness
Loss of fine motor coordination
Skin discoloration, redness, swelling, or hardness
Cold sensitivity

Do I have a Cold Therapy Lawsuit?

Cold Therapy and Frostbite

sarah — Fri, 17 May 2013 20:47:24 +0000

Individuals who treat their injuries with a cold therapy machine may be too numb to recognize the first symptoms of frostbite. Although frostbite can typically be avoided by checking the skin frequently and re-warming the skin every 20-30 minutes, many people do not take precautions because they are not aware of the risk. Several people who suffered frostbite injuries have filed a cold therapy frostbite lawsuit, and the first lawsuit was awarded $12.5 million in December 2012.

What You Can Do & How a Cold Therapy Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting cold therapy induced injury cases in all 50 states. If you or somebody you know was injured by frostbite caused by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Cold Therapy and Frostbite

Frostbite is the most common injury associated with cold therapy machines, and it occurs when patients deliver “continuous cold therapy” for many hours, days, or weeks.

Our lawyers are concerned that many patients who use cold therapy machines are not being adequately warned about precautions they must take to avoid frostbite. The clinical benefits of any cold therapy machine end at 15ºC (59ºF). Exposing an injured body part to colder temperatures increases the risk of frostbite, skin damage, and nerve damage.

Furthermore, experts recommend that a cold therapy machine should be used for 40 minutes maximum, and normally only 20-30 minutes at a time, and only while awake. They also recommend checking the skin frequently and allowing the skin to re-warm while deeper tissues stay cold.

What is Frostbite?

Frostbite is an injury that occurs when ice crystals form out of the water inside and around cells. These ice crystals can cause severe damage to cells and circulation. The extent of the injury often is not obvious at first. However, after thawing, tissues may become extremely swollen, discolored, blistered, inflamed, and even blackened (a symptom of skin necrosis).

Treatment for frostbite may involve slowly and carefully re-warming the tissue in a hospital. If frostbite has caused necrosis of skin or tissues, the patient may require surgery to remove the dead skin and graft healthy skin onto the injury. In the most severe cases, patients may require amputation of their frostbitten limb.

Case Report of Frostbite from Cold Therapy

Cold therapy machines have caused extremely severe cases of frostbite on multiple occasions. One description of this injury was published in 2007 in Orthopedics. Surgeons treated a 53 year-old man with devastating frostbite on both of his knees after using a Breg Polar Care 500 cold therapy machine for several weeks: Severe Frostbite of the Knees After Cryotherapy (GRAPHIC)

Symptoms of Frostbite from Cold Therapy

Symptoms of frostbite can include:

Numbness
While cold, skin become red and tingly, then turns white, waxy, and hard
Patient may feel deceptively warm and comfortable
When thawed, skin becomes painful, discolored, and swollen
Skin turns dark red, purple, or black
Skin necrosis or tissue death
Loss of fine motor control
And more

Do I have a Cold Therapy Lawsuit?

The Schmidt Firm, LLP is currently accepting cold therapy injury cases in all 50 states. If you or somebody you know was injured by frostbite caused by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

DePuy Withdraws Metal-on-Metal Hip Implant Liners

sarah — Fri, 17 May 2013 16:12:47 +0000

May 17, 2013 — The declining popularity and safety concerns surrounding metal-on-metal hip implants has led DePuy Orthopedics to discontinue the Ultamet and Complete hip implant liners. According to a press release, the metal liners are used exclusively with the Pinnacle hip implant. However, the Pinnacle is not affected, and the decision “is not related to safety or efficacy, and is not a recall.”

DePuy will re-focus their portfolio on ceramic and plastic hip implants, which have been linked to lower rates of complications than metal-on-metal hip implants. More than 10,000 people have filed ASR hip implant lawsuits against DePuy after their implant failed prematurely.

The ASR and other metal-on-metal hip implants were marketed toward younger, more active patients because they were marketed as longer-lasting than plastic or ceramic hip implants. However, researchers discovered this to be false.

DePuy stated that they will “simplify and streamline” their medical device portfolio over the next few years by discontinuing other products and re-focusing their strategy on plastic and ceramic implants. Advances in technology, physician preferences, and concerns about safety have dramatically reduced the market value of metal-on-metal hip implants.

In addition to declining market, the U.S. Food and Drug Administration (FDA) has also proposed regulatory changes that would make it more expensive for a manufacturer to approve a new metal-on-metal hip implant. Instead of “fast-track” approval under the controversial 510(k) process, which allows manufacturers to avoid safety studies, they would be required to submit Pre-Market Approval (PMA) applications, which have more rigorous requirements for safety testing.

DePuy has faced enormous criticism for not thoroughly testing the ASR metal-on-metal hip implant before it was approved. In one of the first trials involving the ASR, evidence emerged that the ASR failed DePuy’s own internal company safety tests in 2007. However, instead of improving the ASR, DePuy redesigned the test. After the ASR was marketed and implanted in 93,000 people, it was linked to a 37% five-year failure-rate.

Do I have a Metal-on-Metal Hip Implant Lawsuit?

The Schmidt Firm, LLP is currently accepting metal-on-metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a defective hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Symptoms of Skin Necrosis

sarah — Thu, 16 May 2013 15:52:02 +0000

The problem with cold therapy machines is that patients who use them for hours may be too numb to realize when their skin is getting too cold, and they can easily miss the first symptoms of skin necrosis (skin discoloration, swelling, pain, and more). By they time they remove the compression pad and examine their skin, irreversible skin necrosis has already occurred. Over time, the skin may blister, blacken, peel away, and cause additional complications.

What You Can Do & How a Cold Therapy Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting cold therapy induced injury cases in all 50 states. If you or somebody you know was injured by skin necrosis caused by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Symptoms of Skin Necrosis

The symptoms of skin necrosis (death of skin and tissue) grow progressively worse depending on the thickness of skin involved in the injury. The most mild forms of skin necrosis only involve the uppermost layers (epidermis). More serious skin necrosis symptoms involve lower layers of skin (dermis), subcutaneous fat, and even tissues below the skin (nerves, ligaments, etc.).

Although these symptoms can be very severe, the first signs of skin necrosis often go unnoticed by people using a cold therapy machine. The problem is that the machines are advertised as superior to traditional ice packs because they can provide up to 11 hours of “continuous cold therapy.”

Many people falsely believe cold therapy machines are safe to use for hours at a time. They fail to check under the compression pad for symptoms of skin necrosis, frostbite, and other injuries. Furthermore, many people do not realize that skin necrosis symptoms can occur at above-freezing temperatures.

Symptoms of skin necrosis can include:

Partial thickness skin necrosis (mild): Symptoms only affect the epidermis, causing redness, rash, swelling, feelings of burning or tingling. The skin may feel hot and dry, and it may look mottled blue, gray, or red.
Deep partial thickness skin necrosis (moderate): Blisters filled with clear fluid form within 24 hours of the injury. The patient may have some temporary nerve damage, including increased cold sensitivity, burning, tickling, pricking, or numbness.
Full thickness skin necrosis (severe): Blisters filled with blood form (hemorrhagic blisters). The skin turns deep red, dark purple, blackens, and may begin peeling away from the rest of the body. Necrosis may include nerves and subcutaneous tissue. Permanent cold sensitivity and surgery are potential complications.

List of Skin Necrosis Symptoms

Pain
Skin discoloration (redness)
Swelling or fluid accumulation
Blisters (may be filled with clear fluid or blood)
Skin turns dark red, purple, or black
Abnormal sensation (tingling, prickling, burning, etc.)
Numbness or loss of sensation
Skin appears hard, dry, waxy, white, pale, or grayish-yellow
Skin death, decomposition, or infection (gangrene)

Do I have a Cold Therapy Lawsuit?

Cold Therapy and Skin Necrosis

sarah — Wed, 15 May 2013 21:53:31 +0000

Skin necrosis, a side effect of cold therapy machines, occurs when the skin dies after prolonged exposure to cold temperatures. Unfortunately, many people have been injured by cold therapy and skin necrosis because they were not aware of the risk. Although these machines are advertised for “continuous cold therapy” for up to 11 hours, using them for more than 20-30 minutes at temperatures below 59º F is associated with a risk of skin damage, nerve damage, skin necrosis, and other complications.

What You Can Do & How a Cold Therapy Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting cold therapy injury cases in all 50 states. If you or somebody you know was injured by skin necrosis caused by a cold therapy machine, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Overview: Skin Necrosis

Symptoms of skin necrosis

Skin necrosis occurs when a large number of cells in the skin die. It may affect only the epidermis (uppermost layers of skin), or extend into the dermis (deeper layers of skin) and subcutaneous tissues. In the most severe cases, skin necrosis also involves necrosis of nerves, muscles, tissues, ligaments, and more.

Necrotic skin cannot be healed and is highly susceptible to bacterial infection. Therefore, standard treatment is debridement (surgical removal of the skin) followed by grafting of healthy skin from another area of the body.

Cold Therapy and Skin Necrosis

High-volume cold therapy machines are advertised as superior to traditional ice-packs because they can provide up to 11 hours of “continuous cold therapy.” The machines pump freezing-cold water into a compression pad attached to a patient’s body.

It may seem counter-intuitive, but skin necrosis from cold therapy can occur above freezing temperatures. The beneficial effects of cold therapy end at about 15ºC (59ºF) — below those temperatures, there is an increased risk of injury. Furthermore, skin damage is more likely to occur from prolonged cooling than quick cooling (with an ice pack, for example, which is typically removed every 10 minutes to allow the skin to re-warm while deeper tissues stay cold). Over time, slow cooling can cause intra- and extracellular shifts in protein and ion levels, which may cause extensive tissue damage, skin damage, nerve damage, skin necrosis, and more.

Case Report of Skin Necrosis from Cold Therapy

One of the most vivid depictions of the dangers of skin necrosis from cold therapy was published in January 2007, in Orthopedics, in a study titled: Severe Frostbite of the Knees After Cryotherapy (GRAPHIC).

To avoid cold therapy complications like skin necrosis and frostbite, the surgeons recommended:

“Current recommendations for cryotherapy include 20-30 minutes of cryotherapy with a maximum time of 40 minutes, always with a protective covering (usually a towel) between the cryotherapy wrap and the skin. The cycle can be repeated every 2 hours while the patient is awake.”

Do I have a Cold Therapy Lawsuit?

Samsca Lawsuit

sarah — Wed, 15 May 2013 19:05:59 +0000

Samsca (tolvaptan) has been associated with an increased risk of liver failure, which may require a liver transplant or cause death. The link between Samsca and liver injury is especially concerning for patients at risk of liver disease, but anyone can be injured. Our lawyers are now accepting Samsca lawsuits because the warnings regarding this severe, life-threatening side effect were inadequate.

What You Can Do & How a Samsca Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Samsca induced injury cases in all 50 states. If you or somebody you know was injured by Samsca, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

UPDATE: FDA Safety Warning for Samsca and Liver Failure

April 30, 2013 – In a new Safety Announcement, the U.S Food and Drug Administration (FDA) has issued this recommendation:

“Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.”

January 25, 2013 – After a study linked Samsca and “significant liver injury,” the FDA published this Drug Safety Communication to warn about the link between Samsca and liver failure. Click here to read more.

What is Samsca?

Samsca (tolvaptan) is a medication that helps balance excessively low concentrations of salt (sodium) in the bloodstream by inducing urination, which removes extra body water. This treats a condition called hyponatremia.

Samsca was developed by the drug company Otsuka, and it was approved by the FDA in 2009. It belongs to a class of drugs known as selective vasopressin V2-receptor antagonists, which help balance levels of salt and water by influencing the hormones that regulate blood chemistry.

Study of Samsca and Liver Failure

Researchers first found an association between Samsca and liver failure after conducting a 3-year, placebo-controlled study of Samsca in approximately 1,400 people with kidney disease. Samsca is not FDA-approved to treat patients with kidney disease.

Unfortunately, three patients in the study developed “significant” symptoms of liver damage — including elevated liver enzymes (ALT) and bilirubin in their blood. Experts determined that Samsca “probably or highly likely” caused these injuries.

When researchers checked other patients for liver injury, they found that 42 out of 948 patients (4.4%) on high-dose Samsca (120mg per day) had elevated liver enzyme levels that were 3X higher than the upper-limit of “normal.” Only 1% of the patients on a placebo had the same symptoms of liver injury.

After the study was published, the FDA warned:

“These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”

The manufacturer, Otsuka, also warned in a “Dear Doctor” letter:

“The ability to recover from liver injury may be impaired in patients with … underlying liver disease, including cirrhosis.”

Symptoms of Liver Injury from Samsca

Samsca patients and their doctors should be aware of the symptoms of liver injury. The FDA recommends that Samsca should be discontinued if a liver injury occurs. Furthermore, it should not be used in patients at high risk of liver disease.

Symptoms of liver injury include:

Fatigue
Anorexia (weight-loss, loss of appetite)
Abdominal pain (upper-right side)
Urine is dark, cola-colored, or amber
Jaundice (yellowing of skin or whites of the eyes)

Samsca Side Effects

The Prescribing Information warns about the risk of many life-threatening Samsca side effects, including:

Liver side effects: These side effects include liver failure, which will require a transplant and potentially lead to death.
Osmotic demyelination syndrome: This side effect is included in a “Black Box Warning,” which is the most serious type of warning. It occurs when sodium levels are increased too quickly.
Gastrointestinal bleeding: This side effect was seen in 10% of patients who had pre-existing cirrhosis of the liver.
Dehydration: Samsca causes excessive urination, which can deplete fluid volume in the body. Dehydration occurred in 3.3% of patients in clinical trials.
Hypovolemia and hypovolemic shock: This side effect occurs as a complication of dehydration, when there is not enough water for normal blood volume, and the heart is unable to circulate blood or oxygen in the body.
Hyperkalemia (high potassium): This can occur when fluid loss cause an imbalance of potassium levels in the blood. It can interfere with electrical activity in the heart and cause life-threatening arrhythmias.

Common Samsca side effects include:

Urination is excessively frequent or high-volume
Dry mouth
Constipation
Thirst
Weakness
Fever
Elevated blood-sugar levels (hyperglycemia)
Anorexia (weight-loss, lack of appetite)

Do I have a Samsca Lawsuit?

Da Vinci Robotic Surgery Class Action Lawsuit

sarah — Mon, 13 May 2013 19:01:20 +0000

As the popularity of the Da Vinci Robotic Surgery System has grown, so has the number of injuries. If you were injured, you are not alone. Many other people have also been harmed, and you may be looking for a Da Vinci robotic surgery class action lawsuit. Although many lawsuits have already been filed, the lawsuits are actually individual robotic surgery lawsuits.

What You Can Do & How a Robotic Surgery Class Action Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Da Vinci Robotic Surgery System induced injury cases in all 50 states. If you or somebody you know was injured by robotic surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Why Our Law Firm is Not Filing a Class Action Lawsuit Against Robotic Surgery

The lawyers at The Schmidt Firm, LLP are nationally recognized as class action attorneys, but we are not currently pursuing a Da Vinci robotic surgery class action lawsuit because we believe we can maximize our client’s individual compensation through an individual lawsuit.

We are concerned because a class action lawsuit settlement must be shared among the class members. One individual’s compensation may be less than what they deserve. Don’t settle for less than what you really deserve — robotic surgery injuries are extremely severe, and you have undoubtedly faced substantial physical and financial losses.

We can help you fight for compensation, including:

Pain, suffering, emotional injuries
Medical expenses (including future care)
Lost wages, business, or employment
Permanent injuries or disability
Loss of consortium
Wrongful death of your loved one
Punitive damages against Intuitive Surgical

About Class Action Lawsuits

Class action lawsuits are a popular and convenient way for a large group of people to seek compensation for the same injury. One example would be a group of employees who file a class action lawsuit against a corporation for denying them overtime pay. Class actions are a special litigation that make sense when it would be too expensive for one individual to fight for compensation alone. All of the plaintiffs joint their claims together into one claim, and any settlement is shared among the class members.

Problems With Class Action Lawsuits

You may be surprised to learn that many robotic surgery lawsuits have been filed, but these are not class action lawsuits. The problem with a robotic surgery class action lawsuit is that it individuals who were severely injured may be forced into a “low-ball settlement,” high attorneys’ fees, and receive less than what they would have gotten through an individual lawsuit.

The United States has a special type of litigation to improve efficiency when a large number of medical device injury lawsuits are filed: Multi-District Litigation (MDL). An MDL reduces the risk of conflicting rulings in lower courts, helps save money, and expedite a potential settlement. An MDL is created in one federal court and many lawsuits are transferred into this court.

Usually, the majority of lawsuits in an MDL are independent lawsuits (although an MDL may also contain class actions). Unlike a class action, individual lawsuits in an MDL stay independent, retain their own legal counsel, and can return to their state court if they are not resolved.

Do I have a Da Vinci Robot Surgery Lawsuit?

Urgent Warning: Da Vinci Robot Surgery Scissors Cause Burns

sarah — Mon, 13 May 2013 16:50:08 +0000

May 13, 2013 — Intuitive Surgical, the manufacturer of the Da Vinci Surgical Robot, issued an “Urgent Medical Device Notification” to doctors and hospitals on May 8. They warned about burns and electrocutions caused by the EndoWrist Monopolar Curved Scissors (or “Hot Shears”), an instrument used to burn, cauterize, and cut tissue during robotic surgery. The problem is that doctors may fail to notice “micro-cracks” in the scissors’ insulation, which may cause electricity to arc and burn tissue outside the surgical area.

Although Intuitive said that only one patient injury has been linked to the “micro-cracks,” the FDA has received thousands of unexplained reports of burns, electrocutions, and patient injuries in the last few years. Intuitive is also facing several lawsuits alleging that defective insulation on the Monopolar Curved Scissors can cause electrical burns.

One such lawsuit was filed in July 2012 by Elisa Rister and her husband in the U.S. District Court for the Northern District of California. According to her complaint, she chose to have a hysterectomy with the Da Vinci robot because she was told that it would provide a better outcome, less pain, and faster healing time. Instead, she suffered devastating long-term complications when the robot damaged her ureter. According to the lawsuit:

“The device is defective in that it relies on the use of monopolar energy to cut, burn and cauterize tissue, whereas safer methods are available such as bipolar energy and ultrasonic energy … The device has inadequate insulation for its arms thereby allowing electrical current to pass into tissue … [Insulation] becomes torn and worn in places, without the awareness of the physician.”

Intuitive has been receiving complaints about the Monopolar Curved Scissors for years, but they have only issued a warning a few months after the U.S. Food and Drug Administration (FDA) announced an investigation into the safety of the Da Vinci robot.

Intuitive also included a section titled “Precautions and Warnings for Usage of the EndoWrist Monopolar Curved Scissors”:

Don’t apply energy when the tips of the Monopolar Scissors are not in contact with tissue (“air-firing”)
Be aware of critical anatomy when firing the electrical scissors.
Look at the surgical field, including areas below and behind the scissors, which may not be visible from the viewfinder.
Only use EndoWrist instruments that have been validated.
Consider the patient’s condition and any factors that could increase their risk of injury (radiation therapy, for example).
Don’t exceed the maximum monopolar cautery settings, because this may result in electrical arcs and burns outside the surgical area.

Do I have a Da Vinci Robot Surgery Lawsuit?

The Schmidt Firm, LLP is currently accepting Da Vinci robot surgery induced injury cases in all 50 states. If you or somebody you know has been injured by the Da Vinci Surgical Robot, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Humira Histoplasmosis Lawsuit Awarded $2.2 Million

sarah — Fri, 10 May 2013 19:29:19 +0000

May 10, 2013 — Plaintiff Milton Tietz has been awarded more than $2.2 million in the first Humira histoplasmosis lawsuit to go to trial. The 12-member jury in Cook County, Illinois, found that Abbott Laboratories failed to adequately notify doctors about the risk of histoplasmosis, a life-threatening opportunistic fungal infection.

The lawsuit was filed on behalf of Delores Tietz, a woman who started taking Humira in October 2009 to treat rheumatoid arthritis. According to the complaint, within less than seven months, she developed a fever and chest pain. She spent weeks in the hospital as doctors struggled to diagnose her illness. Her family was told that she would probably die from the disease. It was finally determined that Humira was causing a life-threatening histoplasmosis fungal infection.

Histoplasmosis is a rare fungal infection that occurs when a person breathes spores of the Histoplasma capsulatum fungus, usually in areas with feces from birds or bats, such as caves or attics. The disease causes pneumonia-like symptoms.

Histoplasmosis infections very rarely occur in healthy people. However, they are more likely to occur in patients who are taking Humira (adalimumab). Humira, a tumor-necrosis factor blocker (TNF), treats diseases like arthritis and Crohn’s disease, which are caused by an over-reactive immune system, by lowering the body’s entire immune-system response. Not surprisingly, this increases the risk of infections like histoplasmosis, and also certain types of cancer.

The link between Humira and infections has been known for quite some time. Humira was first approved in 2003, and in 2006, the Journal of the American Medical Association published a study linking Humira to a doubled risk of pneumonia and tuberculosis.

It took the U.S. Food and Drug Administration (FDA) until 2008 to issue a Safety Communication linking Humira and histoplasmosis. It took Abbott Laboratories even longer to warn physicians. Abbott waited until May 2010 to warn doctors, which was more than 20 months after the FDA warning, and 10 days after Delores Tietz was hospitalized with a Humira-induced histoplasmosis infection.

Do I have a Humira Histoplasmosis Lawsuit?

The Schmidt Firm, LLP is currently accepting Humira induced injury cases in all 50 states. If you or somebody you know has been injured by Humira, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.