In March 2016, California resident Kristi Lauris filed the first wrongful death Tasigna lawsuit against the drug’s manufacturer, Novartis AG. Her father, Dainis Lauris, died in 2014 from a massive stroke after switching from Gleevec to Tasigna (generic name: nilotinib). With medical studies showing an association between Tasigna and atherosclerosis-related injuries (including sudden death), more claims are sure to follow.

What Is Tasigna?

Tasigna is a second-generation tyrosine kinase inhibitor (TKI) drug that’s prescribed to Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients. Swiss drug manufacturer Novartis developed Tasigna to replace its first-generation TKI medication, Gleevec (imatinib), after that patent expired in 2015. And it’s obvious why Novartis wanted another patented cancer drug to replace Gleevec: in 2015 alone, it generated $4.7 billion in global sales. More than half those profits came directly from leukemia patients in the United States. In 2017, 28 Tasigna capsules costs $12,104.20 at WalMart. Now, Novartis is running two large Tasigna clinical trials on Parkinson’s and Alzheimer’s patients, hoping to extend its FDA approval.

Japanese Tasigna Clinical Trial Plagued By Legal Woes

Novartis faced misconduct charges related to Tasigna’s 2013 Japanese clinical trials comparing different leukemia drug outcomes in 3,000 study subjects. Japanese officials opened an investigation after lawyers discovered Novartis failed to include 33 adverse event reports from that clinical trial. After violating local laws, the company terminated several high-level employees at Novartis Pharma KK due to the alleged safety cover-up.

Novartis Pays $390 Million to Settle Federal Tasigna Lawsuit In 2015

In 2015, Novartis AG agreed to pay the U.S. Department of Justice $390 million to settle a federal Tasigna lawsuit. According to a statement from attorney Preet Bharara, “This is the third substantial settlement in connection with Novartis’s scheme to use kickbacks to co-opt healthcare providers’ independence.” This federal suit accused Novartis of illegal marketing practices as well as participating in a kickback scheme. The second allegation involved paying specialty pharmacies to push prescriptions on unsuspecting Medicaid as well as Medicare patients. Significantly, lawyer Kelly Slate noted this case marked the largest government recovery ever from a False Claims Act violation.

Canadian Warning Cited In Wrongful Death Tasigna Lawsuit

In 2013, Novartis and Health Canada released a warning about the increased risk for developing atherosclerosis-related complications while taking Tasigna. The Lauris Tasigna lawsuit cites this warning as evidence that Novartis AG intentionally hid these side effects from American consumers. Why didn’t Novartis issue a similar warning through the FDA for physicians and patients in the United States? For now, that may be a question that only a jury can answer.

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