FDA Touts Successes Achieved by Tasigna (nilotinib) Despite Severe Side Effects Causing Premature Death or Injury
Parker Waichman LLP Continues to Investigate Claims that Tasigna can have Debilitating and Deadly Side Effects
On December 22, 2017, the U.S. Food and Drug Administration (FDA) announced that it would permit a label change for Tasigna (nilotinib) [ “Tasigna”]. Tasigna is used to treat patients with Philadelphia chromosome positive [“Ph+”] chronic myeloid leukemia [“CML”]. The FDA stated that the manufacturer of Tasigna, Novartis, may change the product label to include a claim that Ph+ CML patients who have been taking Tasigna for three or more years, and whose leukemia has responded to the treatment according to specific criteria, may stop taking Tasigna while continuing to be regularly monitored for disease recurrence. This is positive news for people suffering from this horrible disease.
Tasigna is a member of a class of drugs called tyrosine kinase inhibitors [“TKIs”], which are used to treat CML. The declaration made by the FDA essentially touts long-term Tasigna use as a way to enter a period of treatment-free remission [“TFR”] for some patients with Ph+ CML. Of course, the FDA stops short of making such a claim. However, the FDA did not wipe the slate clean for Tasigna. In this same December 22, 2017 announcement, the FDA continued to list numerous severe side effects that people who have taken ‘Tasigna’ have suffered. Some of the severe side effects appeared without warning. Those side effects can cause serious illness, disability, or even premature, sudden death. As a result of Novartis’ failure to warn about possible deadly side effects from taking Tasigna, plaintiffs have filed lawsuits seeking damages around the country.
If you or a loved one took Tasigna for Philadelphia-positive Chronic Myeloid Leukemia and developed side effects such as atherosclerosis, arteriosclerosis, coronary arterial disease, or peripheral arterial disease, or suffered from arterial blockages that resulted in a heart attack, stroke, or amputation, then you could be eligible for a significant financial settlement or award. Fighting a debilitating disease like Ph+ CML is challenging enough. You do not need to have your medical condition worsened by adding other severe problems like atherosclerosis. Instead, your energy should be concentrated on beating cancer and returning to good health. Achieving remission only to be stricken by another severe and potentially life-threatening illness caused by a drug that is supposed to cure you is a cruel twist of fate, and one for which Novartis must be held accountable.
Good News Does Not Alleviate All Problems
The fight to beat cancer is obviously a life-altering experience. The FDA announcement that people might be able to stop taking Tasigna after long-term use and achieving remission does not mean that patients should not be made aware of all of the possible side effects that a person taking Tasigna could suffer. Tasigna is just one TKI-class drug that is a long-term treatment option for people with Ph+ CML. Some CML patients take ‘Tasigna’ because they have already tried other drugs without success, and Tasigna may be a last resort. For other patients, another TKI-class drug with similar effectiveness may be a valid option, and that drug’s benefits and risks should be weighed against those presented by taking Tasigna. In order for that to happen, people need to be made aware of the risks of serious side effects they may suffer due to taking Tasigna.
Treatment with Tasigna exposes patients to numerous side effects that are very serious, and possibly lethal. The FDA required Novartis to distribute Tasigna with a “Black Box Warning.” A Black Box Warning calls attention to the patient, doctor, and pharmacist that taking this drug could be deadly. In the case of Tasigna, the Black Box Warning cautions patients to avoid taking the drug if they have an abnormal heart rhythm known as long QT syndrome. ‘Tasigna’ can kill a person who suffers from long QT syndrome without warning. Death could be sudden, and the Black Box Warning calls people’s attention to the risk of sudden death.
Other warnings about potentially severe side effects are absent from the box. Even though the FDA stated in its December 22, 2017 announcement that severe side effects typically associated with Tasigna use occurred less often in patients who stopped using Tasigna, the FDA does not require Novartis to include warnings about all such side effects. Specifically, the FDA does not require Novartis to package Tasigna with a warning calling heightened attention to the likelihood that the patient could develop atherosclerosis from taking the drug. Atherosclerosis is a hardening of the arteries that causes blockages. Arterial blockages could lead to:
- Heart attack
- Strokes
- Infections
- Necrosis [tissue decay]
- Amputations and
- Kidney failure.
All of these diseases may lead to premature death or disability.
Surprisingly, the FDA has not issued a formal recall of Tasigna. Only now do they include atherosclerosis as a possible side effect, included as just one in a list of many side effects, thereby making the possibility of being stricken with atherosclerosis seem distant and remote. The Canadian Health Agency took a different approach.
As far back as April 2013, Health Canada warned healthcare professionals that Tasigna showed signs of causing atherosclerosis in clinical tests and after-market follow-up examination. Health Canada reviewed Novartis’ Global Safety Database from January of 2005 until January of 2013. Novartis’ database showed that they knew about 277 patients from around the world who developed atherosclerosis. As a result of this analysis, Health Canada required Novartis to put a warning on the ‘Tasigna’ packaging cautioning patients and healthcare professionals about the atherosclerosis threat posed by Tasigna.
Novartis has a Duty to Warn About the Dangers of Tasigna
A drug manufacturer is liable for damages patients suffer as a result of side effects that the manufacturer failed to disclose. In this instance, any side effect like atherosclerosis, and atherosclerosis-related conditions, that Novartis failed to disclose could result in liability for damages arising from the side effect suffered by patients who took ‘Tasigna’. Failure to warn may be more broadly described as a marketing defect. Manufacturers have a duty to market their wares responsibly, that is, they cannot make any false claims and must disclose potential, non-obvious hazards. Atherosclerosis is one example of a non-obvious hazard.
A jury also could hold Novartis responsible for a plaintiff’s damages on the basis of strict liability. Strict liability means that the plaintiff must prove that the manufacturer made the product, the product had a defect or the manufacturer failed to warn about a possible hazardous condition, and that defect or undisclosed hazardous condition caused the plaintiff’s harm. In a strict liability claim, the plaintiff does not have to prove that the defendant was negligent in some way or otherwise intentionally committed a wrongful act.
Damages Available for Failing to Warn About Atherosclerosis
The amount of damages a plaintiff might receive depends on the particular facts of each case. Evidence of the plaintiff’s injuries can be located in medical records, medical bills, treatment records, and pharmacy records. Additionally, the plaintiff could seek lost wages or loss of economic opportunity because he or she fell ill or became disabled from taking Tasigna.
The plaintiff may seek other damages as well. The plaintiff can claim loss of bodily function for paralysis or amputation. The jury must determine how much, if anything, the loss of limb or paralysis is worth. Furthermore, the plaintiff could claim compensation for pain and suffering. Damages for pain and suffering damages are compensation for the mental anguish, physical pain, and loss of quality of life the plaintiff suffered from taking Tasigna.
Family members may claim damages as well. The family or personal representative of a decedent’s estate can file a claim for wrongful death seeking compensation for the loss of the whole life of the person who died. Also, a spouse could claim loss of consortium, even if the plaintiff did not die. Additionally, some jurisdictions permit minor children to file a loss of friendship claim if the relationship between the minor children and the plaintiff has eroded because of the side effects caused by ‘Tasigna’.
Lastly, the plaintiff could seek punitive damages from Novartis. Punitive damages, as the name implies, aims to punish the defendant for its behavior. Also, the imposition of punitive damages should act as a deterrent to future misconduct by the drug manufacturer.
The Time to File a Claim Is Limited
State laws called “statutes of limitations” limit the time to file a claim against Novartis for failing to warn that Tasigna might cause atherosclerosis or any other side effect you may have suffered. Every state has its own statute of limitations laws. Your drug defect lawyer from Parker Waichman will assist you in identifying the statute of limitations that applies to your potential product liability claim, and can help to pursue a timely legal claim against Novartis.
You Right to File a Claim if You Have Atherosclerosis after taking Tasigna
Contact Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form to meet with one of our experienced ‘Tasigna’ defect lawyers. Parker Waichman LLP does not charge a fee unless we recover financial compensation for you. Call today to find out why Parker Waichman LLP will make a difference for you and your family.
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