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Posted On July 20, 2018 Class Actions
If you have an aggressive form of leukemia, a pricy chemotherapy drug might stop cancer from progressing, but more and more patients are developing life-threatening side effects from this medication.
Stroke, heart attack, amputation, these are just a few of the serious adverse events that can result from taking Tasigna.
You might have a claim if you:
Some of the medical conditions that might entitle you to compensation include:
Console and Associates have 25 years of experience handling personal injury claims. Over that time, we’ve worked with law firms across the country, including those that handle Tasinga claims. If we cannot handle a claim, our goal is to connect you with an experienced attorney who can. If you were diagnosed with Atherosclerosis after taking Tasinga, call today. We’ll ask you a few questions so that we can put you in touch with the right attorney.
Cancer is a devastating disease. Chronic myelogenous leukemia (CML), in particular, can be aggressive, but there are medicines such as Tasigna that were developed to treat it.
The drug’s manufacturer, Novartis, boasted in 2017 that the FDA had approved labeling changes that made Tasigna, the first and only CML therapy with treatment-free remission data in its label., In other words, updated labels for Tasigna now address the possibility that some patients whose leukemia goes into remission may be able to stop taking Tasigna, according to the FDA. About half of patients who take Tasigna for Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia go into remission when they stop taking the medication. Others have to take the drug longer, possibly, for the rest of their lives.
Tasigna: A Billion-Dollar CML Drug
The cost of holding off the devastating effects of worsening leukemia is steep. In 2017, Tasigna made Novartis $1.841 billion.
Health insurers pay more than $100,000 per year for one patient to take Tasigna, according to the National Cancer Institute. Patients themselves may be stuck with copays as high as $1,600 per month, The New York Times reported.
What if you made the financial sacrifices, and endured the draining side effects like fatigue, headache, and nausea and vomiting, and took this costly drug to aid in your cancer battle, only to find that it led you to develop potentially deadly damage to your cardiovascular system?
Research has shown a link between Tasigna and a condition called atherosclerosis, also known as arteriosclerosis. Hundreds of cancer patients taking Tasigna developed this serious condition. The medical emergencies that resulted were life-changing, and in some instances, deadly.
Atherosclerosis is a disease in which plaque builds up inside the arteries that move blood throughout your body. This plaque is composed of cholesterol, fat, calcium, clotting materials in the blood, and other substances, according to the American Heart Association. When plaque builds up, it makes your arteries harder and narrower, so that blood can’t pass through the vessels as easily.
“What’s Wrong With Tasigna?”
Numerous types of atherosclerosis are associated with Tasigna, including:
From January 2005 through January 2013, at least 277 patients taking Tasigna developed atherosclerosis, according to a review of the Novartis global safety database. Shortly after, Health Canada released safety information communication for the public that conveyed these findings.
Just 14 of the reports of atherosclerosis involved Canadian patients, but the problem was taken seriously all the same. Health Canada updated the medication’s label and warned doctors and patients about the risks. Canadian cancer patients were urged to make their doctors aware of any conditions that could contribute to developing atherosclerosis, to avoid having multiple risk factors for this serious condition. Doctors were warned to screen patients with leukemia for developing atherosclerosis as well as to test cholesterol and blood sugar levels throughout the treatment.
Unfortunately, patients and doctors in the United States weren’t given the same crucial information about Tasigna as those in Canada. Pharmaceutical manufacturer Novartis was aware of the reports. However, these warnings never trickled down to doctors in the U.S. or their patients, according to the Daily Hornet.
Instead, doctors prescribing Tasigna in the United States had to find out about the danger years after the risks were already known elsewhere in the world. They encountered the research in journals only to realize that their own patients who were currently on the drug were at risk.
This is no minor mistake or lapse in judgment. By, failing to warn patients in the U.S. about the risk, the drug manufacturer allowed this medication more time to cause substantial harm to patients. American patients have died because of the atherosclerosis complications caused by Tasigna. These patients may have survived their cancer battle and gone on to lead full and healthy lives, if Tasigna didn’t pose this risk in the first place, or if those patients could have been more closely monitored to stave off the dangers of atherosclerosis. But the only way doctors could have known to continue testing Tasigna patients for atherosclerosis throughout their treatment would be if the risk was made known in the U.S.
Today, the risk of, cardiovascular events, is listed on the warning label for Tasigna, according to the FDA. But for the patients who took the drug before this risk became widely known, and their families, the brief mention that now exists is too little, too late.
What Could Have Been
American doctors could have monitored patients on Tasigna more closely for atherosclerosis if they had been aware of the risk.
They could perform more tests to check for the condition before it progressed to potentially lethal severity.
But without knowing that there is a link between Tasigna and atherosclerosis, these doctors had no cause to monitor patients without cardiac risk factors for the dangerous buildup of plaque in their arteries. Sharing this knowledge with the doctors prescribing Tasigna could have made all the difference for the patients harmed by the drug.
By not warning U.S. doctors and patients when the danger first became apparent, the manufacturer of Tasigna put you or your family member’s life on the line. The loss or life-threatening health condition that resulted from Tasigna stemmed from this negligence.
This didn’t have to happen to your family. When you’re grieving the loss of your health or your loved one’s life, understanding how this happened, and taking action, can help your family move forward.
Atherosclerosis is a common condition that becomes more prevalent with age. About half of Americans over age 40 have cholesterol deposits in their arteries, and the plaque buildup slowly gets worse over time, WebMD reported.
Part of what makes atherosclerosis so dangerous is that patients often notice no symptoms until it is too late, according to Mayo Clinic. That’s a big problem even with slowly progressing atherosclerosis that gets worse over decades, with some patients never knowing they have the condition until a medical emergency happens. For patients on Tasigna, that worst-case scenario can happen even more unexpectedly because plaque buildup can occur so quickly.
If your loved one passed away due to a cardiovascular or arterial vascular occlusive event, it can be difficult to understand what happened. You knew your family member had leukemia, but it seemed like the cancer treatment was working. Perhaps you didn’t know your loved one even had heart disease, very possibly, because he or she didn’t, at least not until starting Tasigna.
Your family member might still be alive today if only taking Tasigna hadn’t exposed him or her to atherosclerosis complications. You deserve answers and accountability for your loss. You deserve closure that can help your family come to terms with this terrible and unexpected tragedy.
Pursuing a wrongful death lawsuit against the maker of a dangerous pharmaceutical product hits the drug manufacturer where it hurts: the company’s bottom line. It is unacceptable that Novartis continued raking in hundreds of millions of dollars every year on a drug that, it had already warned patients and doctors in Canada, posed such a deadly risk.
By suing pharmaceutical companies like Novartis for the full amount of compensation you’re entitled to, for the loss of your loved one’s life and all of the economic and non-economic results of that loss, you’re sending a message that the drug manufacturer can’t brush off or ignore:
Just because a patient survived an event arising from atherosclerosis doesn’t mean that everything is okay. The damage to your health has already been done, and it may be permanent.
Can Atherosclerosis Be Reversed?
While some research suggests that atherosclerosis may be able to be reversed in some people, there’s no easy or quick way to get rid of plaque buildup.
Dietary changes, appropriate exercise regimens, and the use of statin medications may help reduce the risk of future complications by stopping atherosclerosis from getting worse. In some studies, these measures have shown the potential to help reverse atherosclerosis, according to Harvard Medical School.
However, there’s no guarantee that even the biggest lifestyle changes and most liberal use of lipid-lowering medications will reverse your or your loved one’s plaque buildup. Even if these measures do show some promise, there’s no way to be sure that they will work quickly enough to stop another medical emergency from happening.[/su_box]
If you or a loved one had a stroke due to atherosclerosis, you already know that life may never be the same. While rehabilitation is certainly possible after a stroke, some of the damage done to your brain may be irreversible. Many stroke survivors experience physical, cognitive, and emotional conditions after a stroke. Those serious conditions, including paralysis, memory loss, and language difficulties, may last for the rest of the individual’s life.
When you have any reason to suspect that taking Tasigna played a part in your or your family member’s stroke, it’s important that you speak to a lawyer right away. Filing a Tasigna class action lawsuit can help you afford the care you need after a stroke. Whether you need cutting-edge rehabilitation techniques or round-the-clock nursing care, winning a Tasigna lawsuit settlement can help you or your loved one to have the best life possible after a stroke.
Even for survivors of myocardial infarctions, the damage that occurs during a heart attack is permanent. After the frantic race to the hospital and the urgent procedures needed to treat the medical emergency, life doesn’t simply go back to normal.
Can Tasigna cause a heart attack? Research shows that coronary artery stenosis, or the hardening and narrowing of the coronary arteries that supply blood to the heart, is one of numerous atherosclerosis side effects reported in clinical trials of Tasigna. You may also hear related terms like coronary heart disease (CHD) and coronary artery disease-related to these conditions.
As plaque builds up in the coronary arteries, it restricts blood flow to the heart. When your artery becomes blocked, not enough blood can reach the heart, so the muscle becomes deprived of oxygen. As a result, the tissue that makes up the muscle of the heart begins to die.
You can hold Novartis responsible if taking Tasigna played a role in suffering a heart attack.
Tasigna Amputation Lawsuits
When atherosclerosis develops in arteries other than those responsible for moving blood to the heart or brain, like those that carry blood to the legs, your limbs may not receive the oxygen they need to function. Over time, infections like gangrene can develop, particularly in the lower limbs. When a serious infection affects your leg, doctors may have no choice but to amputate a part of your limb to stop the infection from spreading or worsening.
An amputation will change your life forever. While prostheses and rehabilitation therapy can help limb loss survivors adjust to their, new normal, what they have lost is truly irreplaceable. The manufacturer of the drug that caused this to happen to you should be held accountable.
Because it took so long for the truth about the cancer drug to come out, lawsuits involving this chemotherapy medication have only recently begun, with the first filed in 2016. There aren’t yet any Tasigna lawsuit settlements for victims in situations like yours.
Disclaimer: Results may vary depending on your particular facts and legal circumstances.
$390 Million | Dishonest Marketing
Though Tasigna injury lawsuits are still in their early stages, this isn’t the first time Novartis has been in legal trouble related to the cancer drug. In 2015, the pharmaceutical company agreed to pay $390 million to settle claims that it paid kickbacks to specialty pharmacies for promoting a number of the company’s medications, including Tasigna.
This money went to the federal and state government entities involved in the suit and relates to a slightly different matter, inappropriate promotion of the medications, so it’s not intended to suggest that every Tasigna injury claim will result in such a high payout. However, the fact that the company’s handling of matters related to this drug has already landed it in legal trouble once can certainly offer hope to the families harmed by Tasigna side effects.
The potential payout from a Tasigna injury claim can be significant. The conditions caused by Tasigna, like stroke, heart attack, amputation, and death, are serious. You may be able to seek compensation for losses such as:
Our Tasigna atherosclerosis attorneys can help you understand the basics of the ongoing litigation against drug manufacturer Novartis. Read on for more information about Tasigna, atherosclerosis, and other side effects.
When you’re ready to get help for your Tasigna lawsuit claim, let us know. We’re here for you.
What Is Tasinga?
Tasigna is the brand name of a medication known as nilotinib. It’s one of several Novartis drugs used for oncology, or the treatment of cancer. Specifically, Tasigna and another Novartis medication, Gleevec (imatinib), are in a class of drugs called tyrosine kinase inhibitors (TKIs).
TKIs essentially works by targeting cells with an abnormal gene known as BCR-ABL. This gene produces a protein, tyrosine kinase, which contributes to out-of-control growth of cancerous chronic myeloid leukemia (CML) cells. By inhibiting this protein, drugs like Tasigna can stop cancer cells from growing, reproducing, and progressing to a more serious and deadly stage.
Tasigna is a form of oral chemotherapy, pills that patients can take at home to fight their cancer.
What Is Tasinga Used For?
Tasigna treats a specific form of leukemia, cancer that develops in the bone marrow cells and invades the blood, the American Cancer Society reported. The kind of cancer treated by Tasigna accounts for about 15 percent of leukemia cases in adults.
How Does Tasinga Work?
TKIs like Tasigna fight this form of cancer by inhibiting the production of the protein that causes these cancerous white blood cells to keep increasing. Instead of getting worse, as cancer would if the Philadelphia chromosome abnormality caused cancer cells kept growing unchecked, patients may go into remission. Some are even able to stop taking TKI drugs and remain cancer-free long-term.
Who Uses Tasinga?
Tasigna is approved for treating Ph+ CML in the following circumstances:
How Effective Is Tasinga?
For some patients, Tasigna has proven highly effective at treating Ph+ CML. Novartis boasts a five-year estimated overall survival rate of 93.7 percent. Other TKIs, like Gleevec (imatinib), have an estimated survival rate in the low 90s.
As encouraging as these statistics are, the successful treatment of aggressive Ph+ CML cancer is just one part of the equation. A medication that saves your life from cancer but can cause a deadly stroke or heart attack is still putting vulnerable patients at serious risk.
How Much Does Tasinga Cost?
Cancer drugs are notoriously expensive, and nilotinib is no exception. A health insurance company typically pays more than $100,000 for just one year of treatment for one patient. Even patients with insurance often have trouble affording the massive copays for such a pricey medication.
Why does the cost of Tasigna matter? Manufacturer Novartis has been accused of making an intentional, decision not to warn U.S. physicians and their patients of the atherosclerosis risk as, part of an aggressive marketing strategy to sell Tasigna over competing for TKI drugs, the Daily Hornet reported.
Novartis certainly has a lot to lose if the drug is recalled or discontinued. The drug brought in $1.841 billion of revenue for the manufacturer in 2017.
What Does the Research Say About Tasigna and Atherosclerosis?
Research pointing to a link between Tasigna and atherosclerosis dates back to 2011. In the American Journal of Hematology, researchers reported an association between the cancer drug and peripheral artery disease, sudden death, myocardial infarction, spinal infarction, and subdural hematoma. In this early study of a small patient population, 33 percent of the 24 patients studied experienced an adverse vascular event.,
In 2013, an article in the journal Leukemia reported a risk of peripheral arterial occlusive disease (PAOD) associated with leukemia drugs in the class known as tyrosine kinase inhibitors (TKIs).
Researchers found that nilotinib (the generic name for Tasigna) was associated with higher rates of PAOD versus imatinib, another TKI drug sold under the trade name Gleevec.
What Is CML?
CML, or chronic myeloid leukemia, first grow in the myeloid cells of the bone marrow. These cells are responsible for forming blood products such as platelets, red blood cells, and most white blood cells. When an abnormal genetic change occurs in these cells, they become leukemia cells that grow and spread into the blood.
There is a different kind of CML forms of leukemia. Tasigna treats one that’s known as Philadelphia chromosome-positive (Ph+) CML.
What Is The Philadelphia Chromosome
The Philadelphia Chromosome refers to how CML cells are abnormal. In patients with the abnormality known as the Philadelphia Chromosome, two of the 46 chromosomes found in the human body, chromosomes 9 and 22, have broken off and switched places to create a new abnormal chromosome.
The problem with the new chromosome is that the BCR-ABL1 gene that develops within it creates a faulty protein. Instead of telling the bone marrow to make the right amount of white blood cells needed to maintain a healthy immune system and protect the body from infection, this protein causes the body to produce too many white blood cells. Often, these cells are also damaged or immature. Because there are so many of these cells being produced, they crowd out normal, healthy cells. If left unchecked, these abnormal cells will cause serious damage to the body, leading to fatigue, anemia, organ failure, and death.
You think you have a case against Novartis, but you’re not sure you can afford a lawyer. That’s what the drug manufacturer wants you to think. The reality is that moving forward filing a Tasigna atherosclerosis lawsuit should cost you nothing upfront.
Most attorneys who handle Mass Tort claims operate on a contingency fee basis. This means that they advance all of the costs associated with filing your claim and don’t accept payment unless they get you a settlement. This means that you don’t pay anything for their help, or typically for the claim itself until you win your claim. If the attorney handling your claim can’t reach a settlement, you’ll owe nothing.
Nothing can undo the serious harm you suffered because of Tasigna. But holding the manufacturer accountable can help you in many ways.
What’s going on with lawsuits involving Tasigna? Here are the latest updates our injury lawyers are following:
Atherosclerosis is a particularly dangerous adverse event, but it’s far from the only side effect of taking Tasigna.
The FDA lists the most commonly reported non-hematologic adverse reactions as:
More than 20 percent of reports of adverse reactions involved the side effects of this nature.
There were also hematologic adverse drug reactions, or reactions relating to the blood and bone marrow. The most common hematologic side effects reported to the FDA are:
Another risk of Tasigna is that it prolongs the QT interval. The QT interval is the time it takes the muscle of the heart to contract and refills with blood so that it can keep pumping blood throughout the body. A prolonged QT interval upsets the normal rhythm of the heart.
Sudden deaths have been reported with Tasigna.
Because of the risk of the prolonged QT interval, patients should undergo electrocardiogram (ECG) tests prior to taking Tasigna to ensure that their baseline heart rhythm is normal. Shortly after starting Tasigna and as needed throughout treatment, additional ECGs should be performed.
If you experience significant side effects from taking Tasigna, then it might be worth discussing other treatment options with your doctor. If the side effects that you experienced were severe and posed a long-term health problem, you should reach out to an attorney to find out how to pursue a Tasigna side effects lawsuit.