Tasigna, also known as nilotinib, is an oral medication from Novartis released in 2007 to treat a type of cancer called Philadelphia chromosome-positive chronic myeloid leukemia (CML).
Tasigna fights leukemia by blocking certain proteins that promote the growth of new white blood cells. Originally disparaged for its astronomical $7,000 per month price, the drug now costs over $14,000 per month.
Recently, Novartis paid $390 million to settle charges from the U.S. government that they paid kickbacks to pharmacists to promote and dispense Tasigna.
There are a number of side effects linked to Tasigna, including hypertension, skin rash, nausea, muscle and joint pain, headache, fatigue, heart arrhythmia, vomiting, diarrhea and constipation.
Beginning in 2011, however, researchers discovered an increased occurrence of peripheral arterial diseases (PAD) in patients taking Tasigna. This continued with a clinical trial in 2013 noting similarly higher rates of PAD among those taking the drug.
Then, in April of 2013, Novartis, along with officials from Health Canada, warned patients and doctors that taking Tasigna may increase the risk of atherosclerosis, a thickening of the arteries and precursor to peripheral arterial disease.
Despite additional warnings from researchers about the risk of atherosclerosis and PAD from Tasigna, Novartis never notified doctors, patients or the FDA in the United States of the dangers. It is believed thousands of patients may have been affected as a result.
Lawyers are now filing lawsuits against Novartis on behalf of those who developed atherosclerosis or peripheral arterial disease after taking Tasigna, based on the company’s concealment of the dangers.
Researchers from the Mayo Clinic, University of Nebraska, University of Vienna and Health Canada have identified a link between the drug Tasigna and the arterial disease atherosclerosis.
Atherosclerosis causes the walls of the arteries to grow thicker and harder, which leads to the buildup of plaque. This causes a condition called peripheral arterial disease (PAD), which is a narrowing of the blood flow space in the arteries.
Arterial diseases like atherosclerosis can develop quickly and affect any artery of the body. Often, they cause permanent damage before they are even discovered. Risks include:
Health Canada has urged anyone with elevated blood sugar, heart problems, high cholesterol or high blood pressure to notify their doctor before taking Tasigna, as they may be more at risk of atherosclerosis and PAD.
The agency has also instructed doctors to monitor patients taking Tasigna for signs of atherosclerosis.
Unfortunately, these dangers were not made public to patients and doctors in the United States, the largest market for Tasigna use.
Novartis faces liability to those affected by atherosclerosis or peripheral arterial disease after taking Tasigna due to their failure to warn patients of the risks in the United States.
This isn’t the first time the Swiss company has been accused of hiding the dangers of Tasigna. In 2013, officials at Novartis Japan were charged with hiding side effect reports from a study of the drug’s complications.
Lawyers expect thousands of people in the United States have been affected by the company concealing Tasigna’s PAD risks, with damages ranging from minor hospitalization to death.
Those who’ve used Tasigna and been affected by any of the following may qualify for a lawsuit:
If you believe you or a family member were affected, it is important to speak with a lawyer as soon as possible. It costs nothing to investigate your case or file a claim unless you receive compensation, and the time may be limited.
Despite warnings from Canada’s official health agency and several independent research publications that Tasigna may increase the risk for deadly atherosclerosis and arterial diseases, there has not been a Tasigna recall.
In cases like this where several thousand people may be at risk, the FDA and manufacturer will weigh the risks and benefits, as the drug may actually help others without side effects. Also, Tasigna represents nearly $1.8 billion in yearly revenue for Novartis, so a recall is unlikely.
In fact, studies are underway aimed at actually increasing the usage of Tasigna, as a preliminary trial showed it may be beneficial to those with Parkinson’s Disease in low doses.
However, those taking the drug should remain aware that it carries risks for peripheral arterial disease and atherosclerosis.
No. Families have already filed lawsuits for injury or death related to Tasigna atherosclerosis. However, to date no one has organized cases into one single Tasigna class action lawsuit. Doing so would rest control of the class under the representation of one law firm, with each participant having to share in whatever award is received.
Instead, cases like this - which involve hundreds or thousands of similar injuries around the country from one product – are usually filed individually, then consolidated into one multidistrict litigation (MDL) court for more efficient handling.
MDL-type lawsuits allow you to choose who will represent you as well as what will happen with your case. And, they’ve been successful at securing multi-billion-dollar settlements for drug injuries such as Yaz blood clots and Actos bladder cancer.
A lawsuit filed in California federal court by surviving family members of Dainis Lauris allege he died after suffering near-total arterial blockage in certain areas of the body from atherosclerosis linked to taking Tasigna. Court filings show Novartis warned of atherosclerosis dangers in Canada but not in the U.S. Case No. 16-393 - Lauris et al. V. Novartis AG et al.
Novartis agrees to pay $390 million and admit wrongdoing to settle charges that it paid illegal kickbacks to pharmacies for promoting its drug Tasigna among Medicare and Medicaid patients.
Novartis is cited in Japan for failing to report side effects in 33 cases among a study of 3,000 patients taking their leukemia drug Tasigna.
Researchers from the Mayo Clinic and University of Nebraska publish a case study in the American Journal of Hematology describing the rapid onset of atherosclerosis that caused a patient’s stroke.
Health Canada and Novartis jointly issue a warning for Tasigna, advising patients and doctors that those taking the drug may have an increased risk of developing arterial diseases like atherosclerosis. No warning is issued in the U.S.
In a report published in the journal Blood, researchers from the Medical University of Austria again suggest patients taking Tasigna have an increased risk of arterial disease over those not taking the drug.
Researchers from the University of Vienna first publish a report in the American Journal of Hematology noting that several patients undergoing treatment with Tasigna quickly developed peripheral arterial disease.
Tasigna is approved by the FDA as a more potent version of Novartis’ cancer treatment Gleevec, just before Gleevec loses patent protection.
Victims of a drug-related injury who are contemplating pursuing a lawsuit against the manufacturer often have similar questions in deciding if it is worth their time. These include:
In short, the claim process is relatively easy and cost-free for the injured patient or family, and can result in significant awards, but can take a year or so to conclude. We will attempt to answer each question below.
Investigating whether you are eligible and filing a claim is easy. DrugNews can connect you with a lawyer today that will discuss your case, research medical records and determine if you are eligible, then file your lawsuit, all without you having to gather records on your own.
Drug injury lawsuits can take a year or more to gather records, file claims, interview medical experts, consolidate MDL cases, negotiate settlements and/or prepare for trial. However, this is typical of most types of lawsuits.
The entire process, from your initial attorney contact to the resolution of your case, will not cost you anything unless you receive an award. In that case, attorneys’ fees of between 33% and 40% will be deducted from your award, as will the costs of investigating and filing your case. In other words, your attorney only gets paid if they win and you owe nothing if you don’t recover.
Your case may be filed in your state or in a consolidated court thousands of miles away. Regardless, your attorney will attend nearly all of the necessary events on your behalf, and you will only need to attend in the rare instance that your case is selected for trial.
Lawsuits for atherosclerosis injuries related to Tasigna can range from minor hospitalization stays to death cases. Therefore, each case has a unique value based on the degree of injury. So far, no verdict or settlement has been awarded. However, lawyers expect cases to range from the high five figures to well over $1 million.
Choosing the right lawyer for your case is nearly as important as the facts of the case itself. Since these cases are fought against powerful international pharmaceutical companies with teams of lawyers, DrugNews recommends choosing a law firm that specializes in drug injury litigation, with extensive experience and the resources to pursue your case to completion.
DrugNews works only with lawyers and law firms that have handled thousands of defective drug and medical device lawsuits. Contact us today to speak directly with a lawyer about your case at no cost.