Tasigna Lawsuits Consolidated In New Jersey Multicounty Litigation

Introduction

New Jersey’s Supreme Court has announced centralization of all Tasigna lawsuits across the country before Superior Court Judge Rachelle Harz in Bergen County for coordinated pretrial proceedings.

Novartis, the manufacturer of Tasigna, faces several lawsuits claiming that it failed to warn the users about the risk of blood flow problems that might lead to artherosclerosis, a stroke, heart attack, amputations or death due to the drug.

Currently, 64 plaintiffs have filed lawsuits in New Jersey Superior Courts alleging that the consumption of the drug has caused severe injuries to them. All the lawsuits claim that the manufacturer intentionally hid the risks associated with the drug that results in heart attacks, strokes, peripheral vascular disease, and amputations.

Centralized cases consolidated before the judge as part of a New Jersey MCL involves the transfer of claims pending throughout the state or all pretrial proceedings. The MDL will consider each lawsuit as an individual case and will also help in preventing repeated evidence and testimony throughout the litigation.

Tasigna is a part of a class of drugs known as kinase inhibitors and was approved by the FDA in 2007. It is prescribed for the treatment of adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia. The professionals even prescribe it to the adults intolerant to prior therapy of chronic phase and accelerated phase Ph+ CML.

In April, a similar request for consolidation of the cases was made in the U.S. District Court for the Southern District of Illinois where the plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all claims brought in the federal court system.

U.S. District Judge Robin Rosenberg, of the Southern District of Florida, issued an order on July 9, 2018, granting part permission to the plaintiffs in the Tasigna lawsuit to pursue claims against Novartis; however, he barred them from pursuing punitive damages in one claim.

The ruling allowed a product liability case filed by a couple to proceed, involving allegations that the Tasigna manufacturer failed to provide adequate warning about the drug’s side effects like constricting and hardening of arteries, which caused the plaintiff to develop a stroke. Judge Rosenberg refused to dismiss the case based on preemption. To prove a preemption claim, the defendants were supposed to present that the state failure-to-warn laws conflict with the drug's federal approval.

The Court ruling indicated that Novartis failed to prove that the FDA would have disapproved of a stronger label warning for Tasigna. However, the Court supported the defendant in denying punitive damages to the plaintiffs due to the New Jersey law which prohibits awarding punitive damages if the drug is approved by the FDA.

Plaintiffs filed a motion on July 13 to allow partial reconsideration of the summary judgment requesting to allow pursuing punitive damages. The motion stated, “Under New Jersey law, punitive damages are available ‘where the product manufacturer knowingly withheld or misrepresented [material and relevant] information required to be submitted under the agency’s regulation. Plaintiffs showed that Novartis not only withheld from the FDA material information related to atherosclerosis-related conditions associated with Tasigna but that it knowingly made material misrepresentations to the FDA.”

Tasigna is a kinase inhibitor that is said to work in the body by interfering with protein signaling cancer cells to multiply. This medication is used to treat adult patients who have been diagnosed with chronic myeloid leukemia. This drug is also effective in the treatment of Philadelphia chromosome-positive myeloid leukemia that can be chronic as well as accelerated. Tasigna comes along with side effects like skin rash, itching, headache, diarrhea, constipation, and minor cold symptoms.

The patients should immediately consult with the doctor if patients using Tasigna comes across severe side effects like painful urination, rapid weight gain, high blood sugar, and signs of liver disease.

Tasigna comes in the form of a gelatin capsule which has a strength of 150 - 200 mg. The dosage recommendation is usually twice a day which should be eaten one hour before eating food or two hours after having food. The physicians sometimes need to alter the dosage depending upon various health factors. Tasigna might interact with various other drugs, therefore doctors should be well informed about the other medication being taken by patients.

Pregnant women should stay away from taking Tasigna as unstudied risk can be pass on to the newborn baby while breastfeeding. There has been no establishment of Tasigna safety usage in pediatrics.

Patients need to note that while taking Tasigna they should avoid grapefruit and grapefruit juices as they interact with this drug and leads to unwanted side effects. Stomach acid reducers like Pepcid, Tagamet, or Zantac should be taken 10 hours before taking this medication or 2 hours after having the drugs. Also, an antiacid that contains aluminum like Di-Gel, Gaviscon, Maalox, etc should be taken two hours before or after this medication. Tasigna can cause severe heart problems to patients who are already taking medication for asthma, mental illness, high blood pressure, and depression.

A Court trial was scheduled for September 17, 2018, and a status conference for August 15, 2018. Growing number of Tasigna lawsuits claim it causes atherosclerosis (hardening of the arteries), which can develop a stroke, heart attack, or can even lead to death.

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