Tasigna (nilotinib) is a chemotherapy medication for patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML). If a doctor prescribed Tasigna as part of your treatment regimen and you experienced adverse side effects as a result, you could have grounds for a product liability claim. Contact the NYC Tasigna Lawsuit Attorneys at Sullivan Papain Block McGrath & Cannavo, PC for a free case evaluation.
Tasigna is a tyrosine kinase inhibitor. What Tasigna inhibits is the growth of leukemia cells by addressing the proteins that stimulate this growth – tyrosine kinase. The Food and Drug Administration (FDA) has approved Tasigna for the treatment of chromosome-positive chronic myelogenous leukemia. However, this drug may not be entirely safe for patients to consume. Patients taking Tasigna have reported a range of serious health effects.
QT prolongation is a heart rhythm disorder that can cause atherosclerosis (plaque buildup in the arteries) and even death. Although the manufacturer of Tasigna warned consumers of more common side effects, such as nausea and fever, it failed to warn of life-threatening complications. The creator, Novartis Pharmaceuticals, later issued a warning regarding potential atherosclerosis to doctors in Canada, but never gave a formal warning in the United States.
A number of studies have been conducted, linking the use of Tasigna to severe side effects such as atherosclerosis and other cardiovascular problems that can lead to stroke, amputation, and sometimes death.
As mentioned above, Atherosclerosis is a life-threatening condition in which plaque builds up in the arteries, restricting blood flow to other areas of the body. This condition can then lead to peripheral artery disease, in which blood flow can be permanently blocked from circulating, thus resulting in amputations or even death.
The first study linking Tasigna to Atherosclerosis was published in 2011, and other studies since then have discovered similar conclusions. The study involved 24 patients being treated with Tasigna. Researchers found that three patients developed peripheral artery occlusive disease (PAOD) that swiftly progressed and required multiple angioplasties and/or surgeries in the first few months of treatment. None of the patients had PAOD before receiving treatment, and researchers suggested that those prescribed the drug should first be screened for PAOD and other vascular risk factors. The study concluded that Tasigna, “may be associated with an increased risk of vascular adverse events, including PAOD development. In a subgroup of patients, these events are severe or life-threatening.”
Tasigna’s manufacturer, Novartis, later issued a public health announcement in Canada, warning that atherosclerosis was detected in clinical trials. The announcement reported that 277 cases of atherosclerosis had been identified over an eight-year time period between 2005 and 2013. No such warning has ever been released in the U.S.
In 2015, Novartis agreed to pay $390 million to a number of state and federal governmental agencies in a settlement after being accused of paying kickbacks to pharmacies for promoting the use of Tasigna. Many cases against Novartis are still pending and in the early stages of litigation. The main accusation that the company is facing is their failure to warn Americans of the increased risk of atherosclerosis.
A confidential settlement was reached in a wrongful death case filed by Kristi Lauris and concluded in November 2018. Lauris’ husband passed away from severe atherosclerosis-related conditions after beginning to take Tasigna. According to the complaint, “Upon taking Tasigna, Dainis Lauris developed severe, accelerated and irreversible atherosclerosis-related conditions, which caused, among other things, 100-percent narrowing of his femoral arteries, 40- to 60-percent narrowing of his coronary arteries, and 70-percent narrowing of his cerebral arteries.”
A lawsuit filed against Novartis in February 2018 by Bruce Becker, 66, claims developed rapidly progressing atherosclerosis in his carotid arteries after taking Tasigna, which resulted in a stroke. Becker’s lawsuit is still pending.
In a different case, filed by Dennis McWilliams and his wife Lori, the couple pursued punitive damages and a claim for consortium due to Dennis having suffered a stroke in 2013 after switching to Tasigna. Novartis filed a motion to dismiss the case, as they argued that a warning for atherosclerosis was not added to Tasigna because the FDA would not have approved it. The judge overseeing the case denied Novartis’ motion to dismiss, however he did agree that punitive damages could not be claimed by McWilliams. In November 2018, both parties agreed to a Voluntary Dismissal with Prejudice.
A Tasigna lawsuit will typically take the form of a product liability claim. Product liability claims seek to reimburse consumers for the losses they suffered because of a defective or dangerous product. A lawyer with experience handling these types of claims can boost your chances of securing compensation. Your attorney can take care of settlement negotiations and make sure an insurance company does not take advantage of you using deny-or-delay tactics. When you hire a lawyer, you will benefit from a lot of legal resources working toward your recovery.
You have been through enough as someone fighting Philadelphia chromosome-positive CML. Finding out a drug that was supposed to treat your cancer might have caused additional injuries can make you feel helpless or angry. If you have this suspicion after taking Tasigna, contact an attorney to discuss filing a product liability lawsuit. A product liability claim could give you the financial compensation you need to move forward after suffering severe side effects from the dangerous drug Tasigna.
Find out if you have grounds for a product liability claim during a free consultation at Sullivan Papain Block McGrath & Cannavo, PC. If we accept your case, we may then help you bring your lawsuit against the appropriate defendant. Talk to an attorney about your situation today. Call us at (212) 732-9000 or contact us online.