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Drug Injury Lawsuits

investigating tasigna complication claims

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Injured patients and plaintiffs have filed lawsuits against the drug manufacturer Novartis AG due to complications following the use of the leukemia treatment Tasigna (nilotinib).

Tasigna lawsuits and attorneys have argued that the treatment causes atherosclerosis, a cardiovascular disease that causes plaque to form inside the arteries.

Complications include peripheral artery disease, limb amputation, and death. Plaintiffs allege that Novartis knew about Tasigna risks, but hid critical information from patients and medical providers.

In 2013, Novartis released a public safety alert warning admitting that Tasigna was linked to cases of atherosclerosis-related conditions during clinical trials. But prior to the announcement, Novartis failed to warn about this potential side effect in their marketing materials.

In 2017, the U.S. Food and Drug Administration updated the product label to include information for providers about how to discontinue the drug in certain patients.

Patients prescribed Tasigna are urged to watch for symptoms of atherosclerosis:

  • High blood pressure
  • Peripheral artery disease
  • Chest pain
  • Muscle weakness
  • Kidney problems

Joe Lyon is a Tasigna Attorney reviewing drug-related injury cases and Lawsuits. Plaintiffs nationwide should contact a pharmaceutical injury lawyer to discuss legal options.

What is Tasigna?

Tasigna (nilotinib) is a chemotherapy drug used to treat chronic myelogenous leukemia (CML), a type of blood cancer. The medication belongs to a class of drugs known as “tyrosine kinase inhibitors,” which inhibit the production of abnormal BCR-ABL tyrosine kinase proteins, and slows down the accelerated growth rate in abnormal cancer cells.

Approved by the U.S. Food and Drug Administration (FDA) in 2007, Tasigna has seen positive results in many CML cancer cases. However, there are serious cardiovascular risks associated with the treatment, including atherosclerosis, a disease that increases the rate of heart attacks and strokes.

Tasigna Studies

As early as 2011, medical journals began reporting on clinical studies that found that use of the drug caused increased risks of atherosclerosis. In some cases, patients required repeated angioplasty surgeries.

In 2013, the journal Leukemia reported that patients treated with Tasigna had higher rates of arterial disease than those being treated with alternatives. Study results published in the American Journal of Hematology in 2016 also found an increased risk of peripheral artery disease.

Researchers have screened CML patients for peripheral artery occlusive disease (PAOD) and found that the disease is more common in patients taking Tasigna than in those taking alternative treatments.

What is Atherosclerosis?

Atherosclerosis causes plaque buildup in the arteries, narrowing blood flow and results in a reduction in oxygen-rich blood delivered to the body. When plaque builds up, pieces of the plaque can break loose and cause blockages and complications. Side effects of atherosclerosis include the following:

Chronic Myelogenous Leukemia (CML)

CML is a blood cell cancer that affects white blood cells, or leukocytes. According to the American Cancer Society (ACS), a genetic mutation called the Philadelphia chromosome can occur while cells are still developing and leads to the formation of an abnormal gene called BCR-ABL, and ultimately causes CML cells to grow out of control.

CML is a slow-growing cancer that gets worse with time. The cancer cells crowd out the healthy white blood cells. CML cells can also cause a shortage of red blood cells and platelets, leading to anemia and excessive bleeding.

Tasigna Side Effects

Common side effects include nausea, rash, headache, fatigue, itching (pruritus), vomiting, diarrhea, cough, constipation, joint pain (arthralgia), upper respiratory inflammation (nasopharyngitis), fever (pyrexia), night sweats, low levels of low blood platelets (thrombocytopenia) and low levels of certain blood cells (myelosuppression or thrombocytopenia, neutropenia and anemia).

Tasigna has been linked to atherosclerosis, as well as the following more severe side effects:

  • Peripheral arterial occlusive disease (PAOD)
  • Femoral artery stenosis
  • Coronary artery stenosis
  • Carotid artery stenosis
  • Limb amputation
  • Strokes
  • Pancreatitis

Tasigna Cardiac Injury Lawsuits

The Lyon Firm and drug injury lawyers work to hold negligent drug manufacturers accountable when patients suffer atherosclerosis or other cardiovascular side effects related to Tasigna.

We understand the physical and emotional strain a cancer diagnosis places upon families, and better care should be expected for everyone.

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Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this relate to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of drugs that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 


Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.


Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.