Drug Injury Watch

Tasigna Lawsuits Federal Court MDL Order Issued in August 2021 After July 2021 JPML Hearing

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.

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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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Research Tools to Find Safety and Warnings Information for Possible Drug Injury Cases

We Point Out Some Resources From FDA and National Library of Medicine Which Will Get You Started

 

(Posted by Tom Lamb at Drug Injury Watch)

 

At the Law Offices of Thomas J. Lamb, we represent people in drug injury cases where there is a serious injury or death involving a prescription drug and the legal liability rests with a pharmaceutical company based on products liability law.

When investigating relevant background facts for potential drug injury cases, we often start with these reliable resources:

DailyMed from the U.S. National Library of Medicine

The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i.e., "in use" labeling). DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements, and medical foods. The NLM provides DailyMed to the public and does not accept advertisements. The labeling on DailyMed is typically reformatted to make them easier to read.

Drugs@FDA: FDA-Approved Drugs from the U.S. Food and Drug Administration

Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.

Drug Safety and Availability from the U.S. Food and Drug Administration

Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products.

FDA Adverse Event Reporting System (FAERS) from the U.S. Food and Drug Administration

FDA Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all marketed drug and therapeutic biologic products. It contains adverse event reports FDA has received from manufacturers as required by regulation along with reports received directly from consumers and healthcare professionals. We provide downloadable files only; you cannot search the database online.

Here is a list of the drug injury cases that our law firm is involved with at the present time.

If we can assist you or someone you know with a possible drug injury case, you can submit an online Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Some Current Drug Injury Lawsuits Being Filed Against Pharmaceutical Companies as of August 2021

Drug Injury Lawsuits are Personal Injury or Wrongful Death Cases Involving a Serious Side Effect or a Severe Adverse Reaction

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A drug injury lawsuit usually involves a personal injury case or wrongful death case filed on behalf of the person who experienced a serious side effect or a severe adverse reaction caused by a prescription drug. Some unsafe drugs have been the subject of FDA warnings or a drug recall, while other drugs remain on the market with "black-box" warnings and continue to be prescribed by doctors today.

Here are some of the prescription drugs for which law firms are currently filing drug injury lawsuits against the responsible pharmaceutical companies:

 

• Xeljanz causing heart problems such as heart attacks and strokes as well as Xeljanz causing cancers.
  
  
• Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.
  
  
• Elmiron causing eye problems such as retinal pigmentary changes and pigmentary maculopathy resulting in vision loss.
  
  
• Injectafer causing hypophosphatemia / electrolyte disorders leading to serious medical complications such as rhabdomyolysis, respiratory failure, cardiac arrest, arrhythmias, and osteomalacia.
  
  
• Belviq causing pancreatic cancer, colorectal cancer, colon cancer, rectal cancer, and lung cancer.
  
  
• Ocaliva causing serious liver injury, hepatic / liver failure, and drug-induced hepatitis.
  
  
• Uloric causing cardiovascular death, sudden cardiac arrest or sudden cardiac death, heart failure, myocardial infarction or heart attack, stroke, unstable angina with urgent coronary revascularization, and other heart-related problems, as well as acute renal failure and acute kidney injury.
  
  
• Invokana / Farxiga / Jardiance / Invokamet / Xigduo / Glyxambi / Synjardy / Qtern / Steglatro / Steglujan / Segluromet causing Fournier’s Gangrene, also known as necrotizing fasciitis of the perineum.
  
  
• Tasigna causing atherosclerosis-related diseases and subsequent serious side effects such as stroke, heart attack, lower-limb amputations, aneurysms, and kidney/renal failure.
  
  
• Actemra causing liver injury, liver failure, hepatitis, pancreatitis, heart failure, heart attacks, strokes, and interstitial lung disease.

 

The best way to make a claim for legal compensation for an injury or death caused by a serious side effect or a severe adverse reaction is by filing an individual drug injury lawsuit (not a class action).

Each state has a statute of limitations that determines the time period within which one may file a drug injury lawsuit. For example, in some states a personal injury claim must be filed within 1 or 2 years from the date that the serious side effect or the severe adverse reaction is diagnosed. Likewise, some states require that a wrongful death claim be filed within 1 or 2 years from the date of a death which was caused by a serious side effect or a severe adverse reaction. It is very important to realize that these statutes of limitations, or deadlines, vary from state to state.

Because of these strict filing deadlines, you should not delay in finding an experienced drug injury lawyer when you may have a possible case involving a serious side effect or a severe adverse reaction.

At the Law Offices of Thomas J. Lamb, we know that you have options when it comes to finding the right lawyer to handle your drug injury lawsuit. On our FAQ page, we provide answers to some questions prospective clients often ask us when making their decision about hiring a lawyer for their case. We look forward to possibly working on your behalf.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)