The Xeljanz lawsuits against drug manufacturer Pfizer Inc. allege that the rheumatoid arthritis medication causes liver damage, cancer, pulmonary embolisms, and/or blood clots in the lungs, pelvis, thighs, or legs.
Here are five key things to know about the current Xeljanz litigation:
- The primary legal claims are that Pfizer defectively designed the drug and failed to warn doctors and patients about Xeljanz‘s dangerous side effects, particularly at high doses.
- It was not until July 30, 2019, that an FDA Black Box Warning was added to Xeljanz and Xeljanz XR to disclose blood clot risks.
- Then it was not until February 4, 2021, that the FDA issued a Drug Safety Communication revealing a link between the use of Xeljanz and cardiovascular events and cancer.
- Plaintiffs’ attorneys are seeking compensation for medical expenses, lost wages, diminished earning capacity, pain and suffering, and loss of consortium.
- Each Xeljanz injury lawsuit is progressing individually, though everyone’s claims may eventually consolidate into one federal multidistrict litigation (MDL).
Shouse Law Group is a mass tort law firm that is representing patients throughout the United States who were injured by these JAK inhibitors:
- Tofacitinib (Xeljanz, Xeljanz XR)
- Baricitinib (Olumiant)
- Upadacitinib (Rinvoq)
- Ruxolitinib (Jakafi)
- Fedratinib (Inrebic)
In this article, our Xeljanz lawsuit attorneys will discuss:
- 1. What is the latest with the Xeljanz lawsuits?
- 2. Is Xeljanz making me sick?
- 3. How much money can I get if I sue?
- 4. What is Xeljanz used to treat?
- 5. What are Xeljanz’s side effects?
- 6. Do I need an attorney?
1. What is the latest with the Xeljanz lawsuits?
Currently, Xeljanz victims are bringing individual lawsuits against Pfizer in state and federal courts throughout the United States.
However, these lawsuits are ripe for consolidation into either a class action or multidistrict litigation (MDL). This is because there are potentially thousands of victims who have been hurt through a single course of conduct, and consolidating the cases will expedite the litigation and settlement process.
If there is a Xeljanz MDL, it will likely be out of New York (Pfizer’s headquarters) or Delaware (where Pfizer is incorporated).
1.1. What are the legal grounds?
The four primary legal grounds in Xeljanz lawsuits are:
- Pfizer defectively designed the drug in a way that is causing your illness, and Pfizer should be held liable for the foreseeable injuries the defects cause.
- There was a manufacturing defect, where the drug may have been contaminated while Pfizer was making it.
- Pfizer was negligent in its duty to create safe medications for patients, and its “breaches” caused your injuries.
- Pfizer failed adequately to warn healthcare providers and patients of the risks of taking the drug; in fact, it was only in 2021 that Xeljanz got a comprehensive black box warning giving healthcare professionals the information necessary to determine whether to prescribe the drug.
Other causes of action that Xeljanz lawsuit attorneys may bring include negligent misrepresentation, fraudulent concealment, and warranty claims.
2. Is Xeljanz making me sick?
According to its black box warning, Xeljanz puts you at an increased risk for:
- liver damage,
- cancer, and/or
- blood clots and pulmonary embolisms (PEs)
2.1. Xeljanz and liver damage
One study published in Annals of the Rheumatic Diseases found that the three liver biomarkers (ALT, AST, and Bilirubins) were more likely to be greater in the 8,115 study participants taking Xeljanz than the 1,841 other partipants on a placebo. Sometimes their biomarkers were more than three times the upper limit of normal.1
One of the clinical trials run by Pfizer found similar results (though it involved only 140 people). 19% of people taking Xeljanz showed increased ALT readings as compared to only 4% of those who took a placebo. Worse, 3% of Xeljanz users had ALT readings three times the upper limit of normal.2
The “Kremer study” published in Arthritis & Rheumatology also showed a strong link between higher Xeljanz doses and an increased risk of liver damage.3 Note that liver damage is more prevalent in Xeljanz users who have been consuming alcohol.
2.2. Xeljanz and cancer
Xeljanz users face an increased risk of cancer, as determined by two medical studies that interpreted the results of 19 Xeljanx clinical trials.4
It turns out Xeljanz negatively affects JAK enzymes, which are responsible for the growth and spread of cells and therefore the development of malignant tissue. Xeljanz has been connected to several types of cancer, such as:
- Non-melanoma skin cancer (NMSC) – the most commonly reported,
- Lung cancer – the second-most commonly reported,
- Breast cancer,
- Non-Hodgkin’s Lymphoma (blood cancer),
- Gastric cancer,
- Melanoma skin cancer,
- Colon cancer,
- Prostate cancer, and
- Pancreatic cancer.
On February 4, 2021, the FDA announced that Xeljanz posed a heightened risk of cancer.5
2.3. Xeljanz and blood clots and pulmonary embolisms
Study A3921133 – one of the randomized clinical post-marketing trials that Pfizer was required to perform as a part of the FDA approval process – shows that Xeljanz increases the likelihood of developing a blood clot in the lungs. This study started in 2014 and is ongoing.
In February 2019, Pfizer announced that the study participants taking 10 milligrams of Xeljanz twice each day were developing blood clots in their lungs and suffering a pulmonary embolism more than five times as often as people taking a tumor necrosis factor inhibitor drug (TNF blocker). Specifically, 19 Xeljanz patients got clots while only three on TNF blockers (such as AbbVie’s Humira) got clots.
Moreover, 45 patients who took the twice-daily 10 mg Xeljanz dose passed away, while only 25 of the patients who took TNF blockers passed away. Pfizer admitted that this was a “statistically and clinically important difference.”6
CURRENT XELJANZ BLACK BOX WARNING
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY AND THROMBOSIS
Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled. Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR use.
- Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study.
Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.
Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been observed at an increased incidence in rheumatoid arthritis patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study. Many of these events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis. For patients with ulcerative colitis, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response
(An earlier version of this warning was added to Xeljanz packaging in July of 2019 and then modified in September of 2021 to include risks of cancer and heart problems.)7
3. How much money can I get if I sue?
Our Xeljanz lawsuit attorneys are seeking compensatory damages from Pfizer to cover all your financial losses, including:
- Medical expenses, past and future,
- Lost wages and reduced ability to earn an income, and
- Pain and suffering, including emotional distress.
If the case goes on to trial, the court may impose punitive damages as well – which Pfizer can well afford. In 2018 alone, the company earned $1.7 billion from Xeljanz.8
3.1. Wrongful death cases
If your family member died from Xeljanz, you can bring a wrongful death claim against Pfizer. In most states, you would have to prove the following:
- The victim died;
- The death resulted from the drugmaker’s wrongdoing; and
- Surviving family members have suffered financial hardship from the loss.
Depending on the state, the compensation for a wrongful death lawsuit may include:
- Funeral expenses,
- Loss of consortium and companionship, and
- Lost financial security.
4. What is Xeljanz used to treat?
The U.S. Food and Drug Administration (FDA) has approved Pfizer‘s prescription medication Xeljanz (tofacitinib) to treat:
- Rheumatoid arthritis (RA) since November, 2012,9
- Psoriatic arthritis (PsA) since December, 2017,10 and
- Ulcerative colitis since May, 2018.11
Xeljanz works by
- blocking the creation of the protein cytokine, thereby suppressing the immune system; and
- slowing down Janus kinase (“JAK”) enzymes, which are responsible for DNA transcription and the growth of new cells.
By slowing down JAK enzymes, Xeljanz prevents the joint inflammation triggered by too much cell growth.12
4.1. Types and dosages
There are two types of Xeljanz pills:
- Xeljanz, which comes in 5-milligram pills. Rheumatoid arthritis or psoriatic arthritis patients typically take a twice daily dose, though patients with kidney or liver problems take a single dose of Xeljanz. Meanwhile, patients with moderate to severe ulcerative colitis typically take 10 milligrams of Xeljanz twice each day.
- Xeljanz XR – short for “extended-release” – which comes in higher dose 11-milligram pills that delay the release of the drug throughout the day. It is only indicated for patients:
- taking the drug for rheumatoid arthritis or psoriatic arthritis, and
- who do not have kidney or liver issues or a conflicting medication.13
5. What are Xeljanz’s side effects?
Nine potential Xeljanz side effects include:
- Infections to the respiratory tract,
- Sinus infections,
- An abnormally low white blood cell count, also known as neutropenia,
- High blood pressure,
- Sore throat,
- Runny nose or nasal congestion, and
However, there can be far more serious side effects. In addition to potentially causing liver damage, cancer, and blood clots, Xeljanz can lead to:
- Serious infections,
- Stomach or intestinal perforations and tearing,
- Immune system problems,
- Strokes – often indicated by numbness or paralysis,
- Major adverse cardiac events (MACE), including such cardiovascular risk factors as heart attacks (myocardial infarctions), cardiovascular death, congestive heart failure, coronary revascularization, cardiac arrest, and chest pain – which are all life-threatening.14
The gravity of these side effects led the European Medicines Agency to refuse to permit Xeljanz for use in Europe. This is the European Union’s equivalent of the FDA.15
6. Do I need an attorney?
If you were injured by taking Xeljanz, you may be entitled to substantial money damages. However, suing a large pharmaceutical company like Pfizer is complicated and daunting.
An experienced mass tort attorney will take care of the entire process for you from start to finish, including:
- gathering your medical records and relevant evidence,
- composing and filing all the legal paperwork, and
- aggressively negotiating for the largest settlement possible.
Here at Shouse Law Group, our Xeljanz lawyers do not get paid unless we win your case. This way, you have zero to lose and everything to gain by letting us hold Pfizer to account. If you or your loved one was injured, contact us for a consultation and case review today.
Shouse Law Group represents victims throughout the U.S. injured by dangerous drugs or medical devices. Submit an online intake form or call our personal injury law firm’s phone number.
The statute of limitations to file a Xeljanz lawsuit varies by state; therefore, contact our mass tort and class action attorneys right away for a case evaluation.
- See generally, Berhan A, “Efficacy, safety and tolerability of tofacitinib in patients with an inadequate response to disease modifying anti-rheumatic drugs: a meta-analysis of randomized double-blind controlled studies,” BMC Musculoskeletal Disorders 14:332 (November 26, 2013). Soriano ER, Madariaga H, Castañeda O, Citera G, Schneeberger EE, Cardiel MH, Hendrikx T, Graham D, Shi H, Ponce de Leon D, “FRI0099 Liver enzyme abnormalities after tofacitinib treatment in patients with hepatic steatosis from the rheumatoid arthritis, psoriatic arthritis and psoriasis clinical programs,” Annals of the Rheumatic Diseases 77(2):593-4 (June 15, 2018). Note that the three liver biomarkers are Bilirubins, ALT (Alanine transaminase), and AST (Aspartate transaminase).
- ClinicalTrials.gov Identifier No. NCT00603512, “Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan.”
- Joel Kremer et. al., A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone (“Kremer study”), Arthritis Rheum (2012).
- Cohen SB, Tanaka Y, Mariette X, et al., “Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials,” Annals of the Rheumatic Diseases 76(7):1253-1262 (2017) (one study covered 6,194 patients, and the other covered 5,671).
- Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib), FDA (February 4, 2021).
- See Rahimtoola A, Bergin JD, “Acute pulmonary embolism: an update on diagnosis and management,” Current Problems in Radiology 30(2):61-114 (February 2005). ClinicalTrials.gov Identifier No. NCT02092467, “Safety Study Of Tofacitinib Versus Tumor Necrosis Factor TNF Inhibitor (TNF blockers) In Subjects With Rheumatoid Arthritis.”
- Press Release re. new warnings on Xeljanz: “Increased risk of pulmonary embolism and mortality in rheumatoid arthritis patients receiving 10mg twice daily in a clinical trial,” Pfizer (March 26, 2019). Note that venous thromboembolic events (VTEs) include deep vein thrombosis (DVT), arterial thrombosis, cerebrovascular accidents, ischemic strokes, pulmonary thrombosis, and/or transient ischemic attacks.
- Pfizer Reports Fourth-quarter And Full-year 2018 Results, Pfizer.
- FDA Approval Letter for Xeljanz (November 6, 2012).
- Press Release, “Pfizer Announces FDA Approval of Xeljanz® (tofacitinib) and Xeljanz® XR for the Treatment of Active Psoriatic Arthritis,” Pfizer, (December 14, 2017).
- FDA Approval Letter for Xeljanz to Treat Ulcerative Colitis (May 30, 2018).
- Kunihiro Yamaoka, et al., The Janus kinases (Jaks), Genome Biol. (2004).
- Xeljanz Warning Label (May 2018).
- ClinicalTrials.gov Identifier No. NCT02092467, “Safety Study Of Tofacitinib Versus Tumor Necrosis Factor TNF Inhibitor (TNF blockers) In Subjects With Rheumatoid Arthritis.”
Pfizer and FDA references
- Pfizer shares co-primary endpoint results from post-marketing required safety study of Xeljanz (tofacitinib) in subjects with rheumatoid arthritis (RA), Pfizer (January 27, 2021).
- Pfizer Announces Modification To Ongoing Tofacitinib FDA Post-Marketing Requirement Study In Patients With Rheumatoid Arthritis, Pfizer (February 19, 2019).
- Communication of new safety information for Xeljanz (tofacitinib), (February 28, 2019).
- Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib), FDA (February 4, 2021).
- FDA Adverse Events Reporting System (FAERS) Public Dashboard, FDA.
- FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR), FDA Drug Safety Communication (July 26, 2019).
- Xeljanz, Xeljanz XR (tofacitinib), drugs.com.
- Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigates, FDA (February 25, 2019).
- FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions, FDA (September 1, 2021) (“Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, [the FDA] concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib”).
- Xeljanz Prescribing Information, Pfizer.
- Curtis JR, Lee EB, Kaplan IV, et al., “Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancies across the rheumatoid arthritis clinical development programme,” Annals of the Rheumatic Diseases 75(5):831-41 (2016).
- Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH, “Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate,” Arthritis Care and Research 63(8):1150-8 (August 2011).
- Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, et al., “A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone,” Arthritis and Rheumatism 64(4):970-81 (April 2012).
- What is Venous Thromboembolism?, Centers for Disease Control and Prevention (CDC).
- ‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors, Healio (February 16, 2021).
- Angus Liu, FDA weighs tighter restrictions for Pfizer’s Xeljanz on the heels of safety red flags, Fierce Pharma (February 2021).
- John Gever, No Xeljanz Plan Yet From FDA, MedPage (February 4, 2021). Note that old age and/or smoking were associated with higher incidents of heart and blood clot problems.
- Pfizer Shares Co-Primary Endpoint Results from Post-Marketing Required Safety Study of XELJANZ® (tofacitinib) in Subjects with Rheumatoid Arthritis (RA), BioSpace (January 27, 2021).
- Allison Prang, “FDA Requires Box Warnings for Pfizer Drug Xeljanz Patients taking 10-milligram dose twice a day could experience a higher risk of blood clots or death,” Wall Street Journal (July 26, 2019).
- Steven R. Ytterberg, et al., Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis, New England Journal of Medicine (January 27, 2022).
- Carlos Alves et. al., Risk of Cardiovascular and Venous Thromboembolic Events Associated With Janus Kinase Inhibitors in Rheumatoid Arthritis, Journal of Clinical Rheumatology (March 2022) (“Current evidence suggests that the risk of cardiovascular and venous thromboembolic events is similar among the JKIs”).
- PRNewswire, The European Medicines Agency’s Updated Guidelines for JAK Inhibitors in Rheumatoid Arthritis – A Cause for Concern? Spherix Investigates, Yahoo Finance (December 7, 2022)