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Xeljanz Lawsuits and What You Need to Know

In 2019, the National Law Review reported the rise of lawsuits linked to Xeljanz — a rheumatoid arthritis (RA) drug. The medication, which operates by suppressing the user’s immune system, causes a heightened risk of pulmonary embolisms and deep vein thrombosis (DVT) in the affected patients.

In February 2021, the US FDA published that clinical trials connected the Xeljanz medication to cancer and severe heart-related issues.

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Xeljanz Lawsuits and What You Need to Know

In 2019, the National Law Review reported the rise of lawsuits linked to Xeljanz — a rheumatoid arthritis (RA) drug. The medication, which operates by suppressing the user’s immune system, causes a heightened risk of pulmonary embolisms and deep vein thrombosis (DVT) in the affected patients.

In February 2021, the US FDA published that clinical trials connected the Xeljanz medication to cancer and severe heart-related issues. 

The agency also discovered that the 5mg and 10mg of Xeljanz caused an increased risk of these injuries.

Many have suffered health conditions like cancer, heart attacks, strokes, or blood clot problems from ingesting defective Xeljanz. 

This life-threatening error shouldn’t go without some form of compensation from the at-fault manufacturer. So, you’d need to hire a top lawyer to represent you in court and seek a settlement that tallies all your losses.

Below, we’ll take an in-depth look at the Xeljanz drug and what you need to know before filing a claim. 

Ready to know more? Let’s get started!

What Is Xeljanz?

Xeljanz (tofacitinib) is a prescription immunosuppressive drug manufactured by Pfizer, Inc. Patients like Xeljanz due to its oral intake and potency over injection-based immunosuppressive drugs like Humira or Remicade. 

The FDA approved Xeljanz in 2012 as a medication to treat adults with moderate rheumatoid arthritis. 

In 2017, the agency licensed the drug to treat active psoriatic arthritis. Xeljanz also got the go-ahead to treat severe ulcerative colitis a year later. 

The drug falls within the scope of Janus kinase (JAK) inhibitors, which operate by inhibiting the activity of two enzymes called JAK-1 and JAK-3. 

The enzymes signal specific immune responses, which may prompt the arthritis’ inflammatory nature. Xeljanz also reduces joint pains, swellings, and tenderness.

What Are the Main Legal Issues Surrounding Xeljanz?

Pfizer, Xeljanz’s manufacturer, created a defective drug and didn’t deliver adequate warnings to healthcare experts and consumers about its potentially severe side effects. 

After approving Xeljanz in 2012, the FDA instructed Pfizer to execute a postmarketing trial to determine the likely long-term risks connected to the 5mg and 10mg “twice a day” doses of Xeljanz alongside methotrexate in patients with rheumatoid arthritis. 

An FDA study found the medication connected to blood clotting challenges. 

The agency said it noticed a “statistically and clinically important difference” in the pulmonary embolism rates and death of individuals who used Xeljanz compared to those on other related drugs. Note that Xeljanz’s 10mg dose was the format reviewed to curate this report. 

The safety monitoring board published the preliminary results from its 2019 study. Here, it reported 19 blood clot cases in the lungs of patients who ingested 10mg of Xeljanz twice daily. Just three patients who took TNF blockers developed blood clot challenges. 

Also, the agency announced 45 patients among those who took 10mg of Xeljanz twice daily died. Meanwhile, 25 patients died among those who took TNF blockers. Due to the result of the study, the FDA asked Pfizer to include a black box warning on all Xeljanz drug labels. 

Surprisingly, despite the FDA reports of PEs and DVTs between 2013 and 2018, Pfizer announced that they’d conducted another study that yielded results dissimilar to the FDA’s.

The warning will alert patients and medical personnel about the extensive risk of blood clots and death when patients take 10mg of Xeljanz twice daily. Rheumatoid arthritis patients aged 50 or higher were amongst the most affected. 

The said demography showcased at least one risk of cardiovascular ailments. 

Pfizer added the black box warning on Xeljanz in July 2019. This caveat described the high risk of sudden death from heart-related illnesses. 

The notice indicated that rheumatoid arthritis patients aged 50 years had a higher chance of experiencing sudden cardiovascular-related deaths if they ingested 10mg of Xeljanz twice a day. 

However, by the time the caveat was placed on Xeljanz packaging, numerous persons had already purchased the defective drug, thereby falling victim to the adverse side effects of Xeljanz.

What Injuries and Side Effects Were Reported Among Xeljanz Users?

After the Food and Drug Administration conducted its study on Xeljanz, it discovered severe side effects like cancer, venous thromboembolism, and cardiovascular issues. 

If you or a close relative took Xeljanz and had any of the listed side effects, consider filing a product liability claim against the drug’s manufacturer — Pfizer — for a settlement. 

Here’s some context into Xeljanz’s major side effects: 

Blood Clots 

After the FDA announced the life-changing side effects connected to Xeljanz, attorneys started representing clients who suffered two unique formats of blood clots — pulmonary embolisms and deep vein thrombosis — after taking the drug. 

Pulmonary embolisms refer to harmful blood clots that move to the patient’s lungs. 

Major symptoms in patients suffering from PEs include irregular heartbeat, chest pain, and labored breathing. Deep vein thrombosis, the other blood clot format, may cause swelling, pain, tenderness, and redness in areas of the body where the blood clot traveled or formed.

Here are the varying venous thromboembolism forms that could result from taking Xeljanz:

  • Arterial thrombosis
  • Cerebrovascular accident
  • Deep vein thrombosis (DVT)
  • Ischemic stroke
  • Pulmonary embolism
  • Pulmonary thrombosis
  • Transient ischemic attack

Medical doctors may treat blood clots through surgery, compression stockings, or drugs. Sometimes, patients must be placed on medications for the rest of their lives to avoid future lumps. Patients who develop blood clots are eligible to get a settlement for injuries sustained by taking Xeljanz in a lawsuit.

Cardiovascular-Related Illnesses

According to an FDA report in February 2021, safety trials linked Xeljanz to a significant risk of severe cardiovascular events. Heart attacks are amongst the most reported cardiovascular issues connected to the use of Xeljanz, from a January 2021 report by Pfizer.

Other cardiovascular events linked to Xeljanz include:

  • Cardiac arrest
  • Cardiovascular death
  • Congestive heart failure
  • Coronary revascularization 
  • Myocardial infarction

Cancer and Other Malignancies

The latest Xeljanz black box warning, which dates to 2019, informs patrons and medical personnel about an increased risk of lymphoma and other cancers. 

Lung cancer ranked among the most reported cancer cases in patients who ingested Xeljanz, according to a January 2021 report by Pfizer.

The cancers and malignancies identified by the FDA’s Xeljanz study include:

  • Breast cancer
  • Colon cancer
  • Lung cancer
  • Non-Hodgkin’s lymphoma
  • Prostate cancer

Other side effects in Xeljanz users include paraplegia, limb paralysis, perforation of the stomach or intestines, and unjust death.

How Much Compensation is Receivable in a Xeljanz Lawsuit?

Getting hurt, diseased, or injured for taking a drug from the doctor or purchased at a pharmacy based on your doctor’s prescription makes you eligible to file a lawsuit against the drug’s manufacturer.

You shouldn’t fall ill for spending your money on drugs. Depending on the result of the court proceedings, you may qualify for compensation.

However, how much you’ll receive as compensation for your Xeljanz-related injury heavily relies on the severity and type of health issue stemming from Xeljanz intake. 

When someone employs an injury lawyer to represent their claim and seek settlement, they can rest assured that these legal practitioners will employ all resources at their disposal to uncover all losses the health issues brought to them. 

The best personal injury lawyers will also employ major Xeljanz lawsuit information to get compensation under any or all of the following sub-headings:

  • Punitive damages, if applicable.
  • Previous and future medical expenses incurred in treating your medical condition
  • Previous and future pain and suffering resulting from our injuries, both physical and mental 
  • Permanent injuries or disability
  • Wage losses, if applicable
  • Funeral expenses
  • Other financial losses incurred due to your injuries

Why Hiring a Legal Firm Offering Free Case Reviews Is the Right Path to Tow

Numerous attorneys are at your disposal. However, to hire the lawyer that suits your preferences to the T, we recommend hiring those that offer free case reviews on cases. 

That way, you won’t pay a dime for a professional legal adviser to access your case and proffer solutions in the long run. 

How Does Liability Law Apply to Xeljanz Cases?

In most states across the US, patients who sustained health problems from using a defective drug may file a lawsuit under the following legal theories:

  • Failure to Warn: If the drug manufacturer failed to inform the public of the risks associated with the drug’s use or give enough information about the drug’s use, which rendered the drug dangerously or unsafe, the drug’s users could file a complaint in court.
  • Manufacturing Defects: When a drug’s producer designs a prescription drug and there’s a defect during the manufacturing process, a user may file a complaint against the manufacturer.
  • Design Defects: This defect refers to a situation where a drug is manufactured to design specifications but turns out ineffective or unsafe due to the drug’s design.

The first theory is the primary explanation behind the Xeljanz. The best personal injury attorney knows how to properly research clients’ peculiar Xeljanz claims to defend their rights in court. 

Depending on some factors in the court proceedings, the client may qualify for compensation from the drug’s manufacturers.  

Timeline of Press Reports on Pfizer’s Xeljanz Lawsuits

The following is a timeline of press reports concerning Xeljanz usage: 

February 25, 2019: Risk of Blood Clots in Lungs and Death

In this safety publication, the FDA announced safety clinical trials on Xeljanz showed a heightened risk of blood clots in the lungs. Patients who take 10mg twice daily to treat rheumatoid arthritis are at risk of these blood clots. 

The circular indicated that the agency had approved the drug only to treat ulcerative colitis and RA patients shouldn’t use the medication. 

In response, Pfizer transitioned its RA patients who ran the twice-daily 10mg dose to the 5mg twice-daily dose. Doctors were instructed to watch their patients against symptoms of pulmonary embolism.

February 19, 2019: Pfizer Announces Dosage Transition

Pfizer announced in a press release that it’d transition rheumatoid arthritis study patients who ingested 10mg of tofacitinib twice a day to 5mg of tofacitinib. The drug maker announced this after the Rheumatology Data Safety Monitoring Board on tofacitinib raised the alarm with the 10mg twice daily treatment group. 

July 26, 2019: Boxed Warning

During this publication, the FDA highlighted that it had approved warnings about Xeljanz and included severe boxed warnings. 

The notice communicated the risks of taking the 10mg twice-daily dose for RA. The report added that patients with ulcerative colitis could face the risk of blood clots and death.

January 27, 2021: Pfizer Highlighted Cardiovascular Issues

Pfizer issued a press release showing trial results that link Xeljanz to major adverse cardiovascular events (MACE). The study observed a total of 4,362 subjects and 135 of which experienced MACE. 

Myocardial infarctions were the cardiovascular events with the most occurrence. 

The same release also showed different malignancies connected to Xeljanz’s use. 164 of the observed 4,362 subjects suffered different malignancies. Lung cancers were most frequent.

February 4, 2021: Severe Heart Problems and Cancer

The agency published a drug safety report that warned the public of safety clinical trial test results. The safety clinical trials’ results also showed an increased risk of severe heart problems and cancer. 

According to Xeljanz, the trial explored other potential threats of taking Xeljanz, like blood clots in the lungs and death.

September 1, 2021: Life-threatening Heart-Related Events, Cancer, Blood Clots, and Death

In this circular, the agency reported it had completed a review of a ‘large randomized safety trial.’ Conclusions from the trial on Xeljanz and Xeljanz XR (tofacitinib) showed a seismic risk of major cardiovascular-related problems like strokes, heart attack, cancer, blood clots, and death. 

The FDA concluded that using any dose of Xeljanz put people at a high risk of blood clots. This conclusion led to an update to the drug’s black box warning. 

Hire a Personal Injury Lawyer Today

People may qualify to file Xeljanz lawsuits if they or a loved one took the medication for rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis and suffered from health complications afterward. 

Common problems with taking Xeljanz included blood clots, cardiovascular issues, or cancer. 

Depending on the court’s proceedings, the concerned patient may qualify for compensation from the drug’s manufacturer.  

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