A Xeljanz lawsuit is a mass tort claim against the drug manufacturer Pfizer. Especially when taken at high doses, the popular rheumatoid arthritis drug Xeljanz may cause serious side effects including:
- Blood clots in the lungs, pelvis, thighs, or legs,
- Pulmonary embolisms,
- Liver damage, and also
The pending Xeljanz lawsuits allege that Pfizer defectively designed the drug and failed to warn people about the dangerous side effects. Therefore, plaintiffs seek compensation for:
- Medical expenses,
- Lost wages and other income, including reduced earning capacity,
- Pain and suffering, and also
- Loss of consortium.
Shouse Law Group is a mass tort law firm that is representing patients from throughout the United States in the current Xeljanz litigation. These lawsuits are progressing individually. But the claims likely will consolidate into a federal multidistrict litigation.
We are currently accepting cases where victims were injured from JAK inhibitors, including:
- Xeljanz (Tofacitinib)
- Baricitinib (Olumiant)
- Tofacitinib (Xeljanz, Xeljanz XR)
- Upadacitinib (Rinvoq)
- Ruxolitinib (Jakafi)
- Fedratinib (Inrebic)
On July 30, 2019, a new FDA Black Box Warning was added to Xeljanz and Xeljanz XR (Tofacitinib) to disclose blood clot risks. Then on February 4, 2021, the FDA issued a Drug Safety Communication revealing a link between the drug and cardiovascular events and cancer.
On September 1, 2021, the FDA required a modified black box warning on Xeljanz disclosing these risks. The current warning states that:
“Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred.”
In this article, our Xeljanz lawsuit attorneys explain:
- 1. What is Xeljanz and Xeljanz XR?
- 2. Why is Xeljanz a hazardous drug?
- 3. What are the legal grounds for a Xeljanz lawsuit?
- 4. What compensation can victims get?
- 5. What compensation can families get for wrongful death?
- 6. Are there any lawsuits against Xeljanz?
1. What is Xeljanz and Xeljanz XR?
- Rheumatoid arthritis (RA) in November, 2012,1
- Psoriatic arthritis (PsA) in December, 2017,2 and also
- Ulcerative colitis in May, 2018.3
The drug works by slowing down Janus kinase enzymes. These “JAK” enzymes are responsible for DNA transcription. This – in turn – triggers the growth of new cells. But too much growth causes joint inflammation. By slowing down JAK enzymes, Xeljanz prevents this chain of events from happening.
1.1. Xeljanz dosing and administration
Xeljanz is popular because of its pill form. Earlier treatments for rheumatoid arthritis were injectibles.
There are two types of Xeljanz:
- Xeljanz, which comes in 5-milligram pills, and also
- Xeljanz XR – short for “extended-release” – which comes in higher dose 11-milligram pills that delay the release of the drug throughout the day.
People taking Xeljanz to treat rheumatoid arthritis or psoriatic arthritis normally take a 5-milligram tablet, two times per day.4 People with kidney or liver problems – or people on certain other medications – generally only take a single daily dose of one 5 milligram tablet.5
On the other hand, those taking Xeljanz for moderate to severe ulcerative colitis typically take 10 milligrams of Xeljanz, twice per day. This is in the absence of other medication or liver or kidney problems.6
In sum, the use of Xeljanz XR is only indicated for people:
- taking the drug for rheumatoid arthritis or psoriatic arthritis, and also
- who do not have kidney or liver issues or a conflicting medication.
This 11-milligram dose of tofacitinib is only taken once per day.7
2. Why is Xeljanz a hazardous drug?
Xeljanz has helped many people. But the drug blocks the creation of the protein cytokine, thereby suppressing the immune system. Common side effects are:
- 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 also
However, there can be far more serious side effects. These include such life-threatening conditions as:
- Serious infections,
- Stomach or intestinal perforations and tearing,
- Problems with the immune system,
- Strokes – often indicated by numbness or paralysis,
- Major adverse cardiac events (MACE), including heart attacks (myocardial infarctions), cardiovascular death, congestive heart failure, coronary revascularization, and also cardiac arrest,
- Liver damage (including elevated enzymes),
- Cancer, and also
- Venous thromboembolism (blood clots) and other venous thromboembolic events (VTEs), including:
- deep vein thrombosis (DVT) – often indicated by cramp pains, swelling, warmth, and redness or discoloration;
- arterial thrombosis;
- pulmonary thrombosis;
- cerebrovascular accident;
- ischemic stroke;
- transient ischemic attack; and/or
- pulmonary embolism (“PE”) – often indicated by back or chest pain, irregular heartbeat, lightheadedness, coughing up blood, sweating, clammy or blue skin, difficulty breathing and speaking, and/or shortness of breath
According to the FDA Adverse Events Reporting System (FAERS) Public Dashboard, hundreds of Xeljanz patients reported DVTs and PEs.
The gravity of these side effects led the European Medicines Agency to therefore refuse to approve Xeljanz for use in Europe. This is the European Union’s equivalent of the FDA.8
2.1. Xeljanz and liver damage
One of Xeljanz’s serious side effects is liver damage.9 This is particularly prevalent when someone taking Xeljanz has also been consuming alcohol.
Numerous medical studies and safety clinical trials that have looked at Xeljanz have monitored three liver biomarkers:
- Alanine transaminase, or ALT
- Aspartate transaminase, or AST, and also
One study consolidated the results of 25 other studies. These studies involved 8,115 people taking Xeljanz and 1,841 others taking a placebo. It found that all three biomarkers were more likely to be higher in people taking Xeljanz than those on a placebo. Sometimes more than three times the upper limit of normal.10
One of the clinical trials run by Pfizer found similar results. It involved only 140 people. But the trial found that 19% of people taking Xeljanz had elevated ALT readings. This is compared to only 4% of those taking a placebo. Worse, 3% of Xeljanz participants had ALT readings three times the upper limit of normal. This is compared to no one in the placebo group.11
Another study found a strong connection between the dosage of Xeljanz and the likelihood and the severity of liver damage. Higher Xeljanz doses are related to worse liver damage.12
2.2. Xeljanz and cancer
Taking Xeljanz has also been found to increase the odds of someone developing malignant tissue, known as cancer. Xeljanz affects JAK enzymes, which are responsible for the growth and spread of cells. Therefore, Xeljanz has not been strictly associated with one type of cancer. Rather, it has been connected to a variety of cancer types, including:
- 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 also
- Pancreatic cancer.
A pair of medical studies analyzed the then-pending results of 19 Xeljanz clinical trials.13 One study covered 6,194 patients taking Xeljanz, while the other covered 5,671. Both looked at how many of the patients in the study developed cancer, including non-melanoma skin cancer. Both found that the number of people who took Xeljanz faced an increased risk of cancer. On February 4, 2021, the FDA announced that the drug posed a heightened risk of cancer as well as heart problems, particularly heart attacks.
2.3. Xeljanz and blood clots in the lungs and pulmonary embolisms
Xeljanz increases the likelihood of developing a blood clot in the lungs. These emergency medical conditions can cause a pulmonary embolism, or a blocked lung artery. In fact, pulmonary embolisms kill an estimated 50,000 people in the U.S. every year.14
One of the randomized clinical post-marketing trials that Pfizer was required to perform as a part of the FDA approval process was Study A3921133.15 This study began in 2014 and is ongoing.
In February 2019, Pfizer announced that the study participants taking 10 milligrams of Xeljanz twice every day were getting 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 got clots. (TNF blockers include AbbVie’s Humira.)
Moreover, 45 patients who took the twice-daily 10 mg Xeljanz dose died, while only 25 of the patients who took TNF blockers died. Pfizer acknowledged that this was a “statistically and clinically important difference.”
Clots may require blood thinners and can be treated by compression stockings and/or surgery.
2.4. Black Box Warning
In July 2019, the FDA added a black box warning to Xeljanz. It discloses an increased risk of blood clots and sudden cardiovascular death in RA patients age 50 or older with at least one cardiovascular risk factor and who take 10 mg of Xeljanz twice a day. In addition, the boxed warning reveals the risk of blood clots and death to people taking the drug for ulcerative colitis. Then in September of 2021, the FDA required the black box warning to include risks of cancer and cardiac events.16
The black box warning reads as follows:
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
3. What are the legal grounds for a Xeljanz lawsuit?
3.1. Defective design
One of the legal grounds for Xeljanz lawsuits is that Pfizer defectively designed the drug. In other words, the drug’s chemical makeup is the cause of the victims’ illnesses.
This argument seeks to hold Pfizer accountable for its negligence when it designed and produced Xeljanz. Pfizer’s poor conduct at this stage in the drug’s development should make it liable for the foreseeable injuries it caused.
(Another potential cause of action is a manufacturing defect. This claim alleges that the drug was contaminated during the manufacturing process.)
3.2. Failure to warn
Xeljanz lawsuits also claim that Pfizer failed adequately to warn healthcare providers and patients of the risks of taking the drug. Doctors and patients rely on safety communications and disclaimers to make informed healthcare decisions. Consequently, Pfizer put profit over health by not disclosing the risks.
Xeljanz did not get a black box warning until 2019. Now that there is an adequate warning label, healthcare professionals may think twice about prescribing this drug.
(Other related causes of action that attorneys may bring include negligence, negligent misrepresentation, fraudulent concealment, and warranty claims.)
4. What compensation can victims get?
A successful personal injury lawsuit would recover compensatory damages for these financial losses:
- Medical expenses, past and future,
- Lost wages and reduced ability to earn an income, and/also
- Pain and suffering, including emotional distress
If the case goes to trial, the judge may impose punitive damages as well.
Meanwhile, Pfizer has profited handsomely from Xeljanz. In 2018 alone, the company earned $1.7 billion from the drug.17
5. What compensation can families get for wrongful death?
When Xeljanz causes a fatality, family can bring a wrongful death claim against Pfizer. In most states, plaintiffs would have to prove the following:
- The victim died;
- The death resulted from the drugmaker’s wrongdoing; and also
- Surviving family members have suffered financial hardship from the loss.
The compensation that a wrongful death lawsuit can recover is different from a personal injury lawsuit. Rather than focusing on compensating the victim, wrongful death lawsuits focus on compensating the victim’s relatives and loved ones. Depending on the state, the compensation for a wrongful death lawsuit can include:
- Funeral expenses,
- Loss of consortium and companionship, and also
- Lost financial security.
6. Are there any lawsuits against Xeljanz?
Yes. Currently, each Xeljanz lawsuit against Pfizer is moving individually through the court system. 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.
Both class actions and MDLs are tools that the justice system uses to consolidate similar claims against a common defendant. However, there are some important differences between the two.
|Combines similar lawsuits for their entire path through the court system.||Consolidates lawsuits only for pretrial procedures.|
|Has a lead plaintiff representing the entire class.||Does not have a lead plaintiff.|
|The class must be certified.||No certification process is required.|
|There is one trial.||There are multiple bellwether trials.|
It is expected that the Xeljanz MDL may be established in New York (where Pfizer is headquartered) or Delaware (where Pfizer is incorporated).
The trend in dangerous drug cases is to litigate by MDLs instead of class actions.
In conclusion, Shouse Law Group creates attorney-client relationships throughout the U.S. with people harmed by dangerous drugs or medical devices. Submit an online intake form or otherwise call our 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 free case evaluation.
- 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).
- Xeljanz Warning Label (May 2018).
- See note 4.
- Also see note 4.
- European Medicines Agency, “Refusal of the marketing authorisation for Xeljanz (tofacitinib),” (July 26, 2013);
- 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 programmes,” Annals of the Rheumatic Diseases 77(2):593-4 (June 15, 2018).
- 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.”
- Kremer study.
- 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).
- 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, “Increased risk of pulmonary embolism and mortality in rheumatoid arthritis patients receiving 10mg twice daily in a clinical trial,” Pfizer (March 26, 2019);
- Pfizer Reports Fourth-quarter And Full-year 2018 Results, Pfizer.
Pfizer and FDA references
- See also 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).
- Also see Pfizer Announces Modification To Ongoing Tofacitinib FDA Post-Marketing Requirement Study In Patients With Rheumatoid Arthritis, Pfizer (February 19, 2019).
- See also Communication of new safety information for Xeljanz (tofacitinib), (February 28, 2019).
- Also see 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 also FDA Adverse Events Reporting System (FAERS) Public Dashboard, FDA.
- Also see 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).
- See also Xeljanz, Xeljanz XR (tofacitinib), drugs.com.
- Also see 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).
- See also 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.
- See also 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).
- Also see 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).
- See also 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).
- See also What is Venous Thromboembolism?, Centers for Disease Control and Prevention (CDC).
- Also see ‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors, Healio (February 16, 2021).
- See also Angus Liu, FDA weighs tighter restrictions for Pfizer’s Xeljanz on the heels of safety red flags, Fierce Pharma (February, 2021).
- Also see 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.
- See also 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).
- Also see 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).