Tasigna lawsuits claim the drug causes extreme side effects like bleeding, birth defects, long QT syndrome, cardiovascular events, and even sudden death. Multiple Tasigna lawsuits have been filed against drugmaker Novartis, but while the company paid $390 million in 2015 to settle a federal lawsuit, only two Tasigna settlements with former patients have been finalized to date.
Why Are People Filing Tasigna Lawsuits?
Tasigna is a member of the class of drugs called tyrosine kinase inhibitors (TKIs), which help to prevent the spread of cancer cells by blocking a specific protein known as Bcr-ABl. It is most often used to treat forms of chronic myeloid leukemia that are resistant to Gleevec (imatinib), the first-line chemotherapy option for CML. In addition to cancer, Tasigna has also been studied in clinical trials as a possible treatment for Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), dementia, and Huntington's disease.
The Tasigna lawsuits being filed against Novartis focus on a specific number of serious complications that have been identified through medical studies of the drug. The U.S. Food and Drug Administration (FDA) has required black box warnings for some of these side effects, including the risk of sudden death and QT prolongation.
Severe Tasigna Side Effects
Some of the dangerous Tasigna side effects referenced in lawsuit claims include:
Sudden Death: One of the most frightening complications that can occur in patients who take Tasigna is sudden death. Although some researchers suspect that heart rhythm problems played a role in these deaths, there is no way to reliably predict who is at risk.
Long QT Syndrome: The QT interval is a measurement of the heart's electrical cycle. Tasigna has been shown in studies to extend the QT interval in some people, which can lead to a type of irregular heartbeat known as torsade de pointes. This is a serious condition that can result in syncope (fainting), seizure, or even death.
Cardiovascular Events: Problems related to the heart and blood vessels are among the most common severe side effects of Tasigna, primarily due to atherosclerosis-related conditions. These problems include ischemic heart disease-related cardiac events (heart attacks), ischemic cerebrovascular events (strokes), peripheral artery disease and blocked arteries in the arms, legs, or extremities.
Bleeding: Severe bleeding potentially leading to death may occur in CML patients who take Tasigna. Individuals who take an anticoagulant such as Pradaxa or Xarelto may need to be especially careful.
Tasigna Drug Interactions: Tasigna can cause problems if taken with certain drugs, including CYP3A inhibitors (including some HIV drugs), CYP3A inducers, and drugs that regulate the heart rhythm.
Birth Defects: Some studies have shown an increased risk of harm to fetuses in pregnant women who take Tasigna.
Tasigna can also cause problems for some people who have or have had certain medical conditions, including lactose intolerance, pancreatitis, or a total gastrectomy.
Other Tasigna Side Effects
In addition to these severe side effects, Tasigna also has a number of more common side effects, several of which may be often associated with the underlying cancer.
- Fluid retention or swelling
- Weight gain
- Pleural effusion
- Pericardial effusion
- Pulmonary edema
- Lactose problems
- Electrolyte problems
- Elevated Serum Lipase
- Low blood counts
- Nausea or vomiting
- Rash or itching (pruritus)
- Joint pain (arthralgia)
- Fever (pyrexia)
- Night sweats
- Growth and development problems in children
FDA Warning About Tasigna Marketing on Facebook
In 2010, the FDA sent a warning letter to Novartis Pharmaceuticals that the company's advertising efforts on Facebook violated the agency's guidance on the use of social media for marketing drugs. It was the first warning letter of its kind sent by the FDA.
The FDA highlighted several problems with Tasigna's Facebook ads in its warning letter:
- Risks: The ads did not adequately inform readers of the risks of taking Tasigna, including the black box warnings included on the warning labels.
- Indications: The ads incorrectly implied that Tasigna could treat all forms of CML, rather than a subset of people with the disease.
- Effectiveness: The ads used terms like "next-generation" in describing Tasigna, suggesting that it was more effective than similar drugs, but the FDA said such claims are unsubstantiated.
In addition, the FDA warning letter said that Novartis failed to properly submit its ads for review, as required by regulation, before running the ads on Facebook.
Health Canada Tasigna Warning
Problems with Tasigna have also been identified by Health Canada, the Canadian government's agency charged with overseeing the health and safety of Canadian citizens. Specifically, in 2013, Health Canada issued an alert related to Tasigna and the possible development of atherosclerosis in those who have taken the drug. The alert indicated that Novartis had reported at least 277 cases of atherosclerosis in people who took Tasigna, based on clinical trial data collected between 2005 and 2013.
Current and Recent Tasigna Litigation
As of the start of 2019, there have been several Tasigna lawsuits filed by individuals who took the drug or their surviving family members. No multidistrict litigation or class action lawsuits for Tasigna have been set up yet.
Dennis McWilliams was diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in 2007, and he began taking Tasigna in June 2011 after his doctor determined that it might offer a better potential treatment than Gleevec (imatinib). About two years later, McWilliams suffered a stroke.
In August 2017, McWilliams and his wife Lori filed a lawsuit against Novartis claiming that Tasigna had caused his stroke. They also argued that the pharmaceutical company had failed to properly inform them and their doctor about the potential risks of the cancer drug. As such, the McWilliams sued the drugmaker over failure to warn and a loss of consortium (companionship).
As with many such cases, pretrial motions by both the defendants and plaintiffs delayed the beginning of the trial. Novartis initially tried to have the case thrown out, arguing that the FDA's approval of the drug label protected them against liability, but the court denied the motion. Novartis also tried to undermine the testimony of the McWilliams' expert witness, Dr. Sonal Singh, but Judge Robin L. Rosenberg - the federal judge overseeing the case - ruled that Dr. Singh's testimony would be allowed.
Lauris was initially diagnosed with CML in 2001 and received a prescription for Tasigna from his oncologist in October 2012. Less than a year later, Lauris was diagnosed with peripheral arterial occlusive disease, but was taken off Tasigna when his oncologist happened upon an article linking the chemotherapy drug with atherosclerosis.
Lauris underwent surgery for a blockage in his left leg, but due to complications, he suffered a major stroke and went into a coma, dying a few days later. The postmortem autopsy discovered rampant atherosclerosis in Lauris's cerebral blood vessels.
Lauris's wife Kristi file a lawsuit against Novartis in the United States District Court in the Eastern District of California, on behalf of herself and the couple's daughter. The lawsuit alleges that the drug Tasigna contributed to Lauris's health problems, and includes claims of products liability, negligence, and wrongful death.
Novartis has not offered a blanket settlement to cover all Tasigna lawsuits, as sometimes happens in mass tort litigation. However, the company has reached Tasigna settlements with some former patients in individual cases.
McWilliams Settlement: Dennis and Lori McWilliams and Novartis reached a settlement in August 2018, resolving the couple's lawsuit against the company (see details about the case above). The terms and amount of the settlement were not disclosed. This was the first known Tasigna settlement to resolve claims about the chemotherapy drug's severe side effects.
Lauris Settlement: A settlement of the Lauris case was finalized in November 2018. Because the case was brought on behalf of a minor, the settlement amount and certain other details were sealed by court order. Additional court documents show that the settlement was set up as a 7-year guaranteed period annuity, to help cover tuition and living costs while the Lauris' daughter attended college.
Federal Tasigna Settlement
In 2015, Novartis Pharmaceutical Corporation, the U.S. subsidiary of Novartis AG, announced a $390 million settlement with the U.S. Department of Justice over claims of illegal kickbacks to pharmacists. The government claimed that Novartis had inappropriately encouraged specialty pharmacies - pharmacies that distribute costly or uncommon medications like chemotherapy - to recommend refills on Tasigna along with several other drugs, including Exjade and Myfortic.
The case was brought to light by a whistleblower who formerly worked as a Novartis sales manager, David Kester. Two of the pharmacies involved, Accredo Health Group and Bioscrip Inc., paid a total of $75 million in their own settlement for the same illegal kickback scheme.
Frequently Asked Questions About Tasigna Lawsuits
Can I File a Tasigna Lawsuit?
If you or a loved one meet all of the following conditions, you may be eligible to submit a claim:
- Diagnosed with Ph+ chronic myeloid leukemia
- Took Tasigna as a chemotherapy treatment
- Experienced a severe side effect, such as atherosclerosis (or a condition stemming from it), QT syndrome, a cardiovascular event, or sudden death
If you or your loved one experienced all of these things, you may be eligible for compensation, but it is important not to wait too long or you could miss the filing deadline, which differs from state to state.
How Much Is a Tasigna Lawsuit Worth?
Because there have only been a few lawsuits submitted so far, and because each individual case is unique, it can be difficult to predict how much you or your family could receive as part of a Tasigna settlement or verdict.
Typically, plaintiffs in Tasigna cases will look for both economic and noneconomic damages related to their problems. These include:
- Treatment costs
- Cost of travel to and from medical appointments
- Lost income
- Pain and suffering
- Loss of companionship (consortium)
- Punitive damages
What Does It Cost to File a Tasigna Lawsuit?
Product liability lawsuits like the ones being filed against Novartis are almost always taken on contingency. This means that you will only pay legal fees once you receive compensation. You will not have to pay any money up front.