Consolidation of Tasigna Drug Injury Cases Involving Atherosclerosis-related Diseases and Medical Conditions

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On August 12, 2021, the United States Judicial Panel on Multidistrict Litigation (JPML) created a new federal court multi-district litigation (MDL) matter for Novartis AG’s cancer drug Tasigna. This newly created Tasigna MDL involves Tasigna drug injury lawsuits filed against Novartis allege that Tasigna caused atherosclerosis-related diseases and subsequent Tasigna side effects such as lower-limb amputations, aneurysms, strokes, heart attacks, blood clots, and kidney/renal failure.

For background, Tasigna (nilotinib) was approved by the FDA in 2007 for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). In April 2013 a so-called “Dear Doctor” letter was sent out in Canada by Novartis Pharmaceuticals Canada Inc. warning about some serious side effects associated with Tasigna and a drug label change with new information concerning those leukemia drug Tasigna side effects. To date, however, there has still not been any “Dear Doctor” letter sent in the US by Novartis, nor has any similar Tasigna drug label change made by Novartis in the US.

About these Tasigna drug injury cases, since at least 2013 Tasigna has been linked to atherosclerosis, which is a disease that results in thickening, hardening, and blocking of the arteries due to the buildup of plaque. The following medical conditions are considered to be atherosclerosis-related diseases:

  • Peripheral Arterial Disease (PAD) involving lower limbs;
  • Peripheral Arterial Occlusive Disease (PAOD);
  • Ischemic Heart Disease; and,
  • Ischemic Cerebrovascular Disease.

In turn, these serious medical conditions can result from, or are secondary to, atherosclerosis-related diseases:

  • Strokes / Cerebrovascular Accidents (CVA)
  • Heart Attacks / Myocardial Infarctions (MI)
  • Lower Limbs Amputations
  • Aneurysms, e.g., Brain Aneurysm
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Chronic Kidney Disease
  • Kidney / Renal Failure

As such, these various medical conditions are considered to be Tasigna side effects.

As regards the newly created Tasigna MDL for those Tasigna drug injury lawsuits filed in the federal court system, from the August 10, 2021, JPML Transfer Order issued for IN RE: TASIGNA (NILOTINIB) PRODUCTS LIABILITY LITIGATION, MDL No. 3006:

All actions can be expected to share factual questions arising from allegations that Novartis failed to appropriately warn of the risks that use of Tasigna may cause severe atherosclerotic injuries. Despite warning doctors and patients in Canada of the heightened risks of atherosclerotic-related conditions, plaintiffs contend that Novartis concealed its knowledge of Tasigna’s unreasonably dangerous risks from plaintiffs, other consumers, and the medical community in the U.S. All plaintiffs bring claims for strict products liability – failure to warn and negligence. Issues of general causation and Tasigna’s labeling and regulatory history appear common to all actions….

Novartis opposes centralization, arguing that there are too few actions to justify centralization and that informal cooperation is feasible. We are not persuaded by these arguments…. [Footnotes omitted.]

As we reported in this earlier article, “Tasigna Drug Injury Lawsuits Consolidated for Pretrial Proceedings: June 2021 Update“, in early June 2021, the New Jersey Supreme Court consolidated some other Tasigna drug injury lawsuits filed against Novartis for pretrial proceedings as part of a New Jersey state court multi-county litigation (MCL).

For the past few years, well before these recent Tasigna MDL and Tasigna MCL orders, we have been investigating Tasigna drug injury lawsuits against Novartis for patients who were diagnosed with an atherosclerosis-related disease and thereafter suffered subsequent Tasigna side effects, such as an amputation, aneurysm, stroke, or heart attack.


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