A Xeljanz lawsuit is a mass tort claim against Pfizer, the manufacturer related to the popular arthritis pill Xeljanz. Especially when taken at high doses, Xeljanz (and in particular Xeljanz XR) has been linked to serious side effects, including:
Xeljanz lawsuits claim that Pfizer defectively designed the drug and failed to adequately warn people about those side effects. Plaintiffs seek compensation for:
- Medical expenses,
- Lost wages and other income, including reduced earning capacity,
- Pain and suffering, and
- Loss of consortium.
These lawsuits are currently progressing individually. But the claims likely will be consolidated into federal multidistrict litigation in the near future.
Just this past July 30, 2019, a new FDA Black Box Warning was added to Xeljanz and Xeljanz XR (Tofacitinib).
Shouse Law Group is currently representing victims nationwide who suffered injuries as a result of taking Xeljanz. In this article, our class action attorneys explain the risks associated with Xeljanz, how a lawsuit would work, the compensation that you can recover in a successful lawsuit, and the statute of limitations that would govern the case. Specifically, we will discuss:
- 1. How do Xeljanz and Xeljanz XR work?
- 2. Side effects of Xeljanz
- 2.1 Xeljanz and liver damage
- 2.2 Xeljanz and cancer
- 2.3 Xeljanz and blood clots in the lungs and pulmonary embolisms
- 3. What are the legal grounds for a Xeljanz lawsuit?
- 3.1 Defective design of Xeljanz
- 3.2 Victims claim Pfizer failed to warn people of the risks of taking Xeljanz
- 4. Compensation for people hurt by Xeljanz
- 5. Compensation available in wrongful death claims over Xeljanz's side effects
- 6. The progress of Xeljanz lawsuits
1. How do Xeljanz and Xeljanz XR work?
Xeljanz is the brand name for the drug tofacitinib. It was designed and is sold by the giant pharmaceutical company, Pfizer, to treat rheumatoid arthritis. The U.S. Food and Drug Administration (FDA) has approved it to treat:
- Rheumatoid arthritis in November, 2012,1
- Psoriatic arthritis in December, 2017,2 and
- Ulcerative colitis in May, 2018.3
The drug works by slowing down Janus kinase enzymes. These enzymes, also known as JAK enzymes, are responsible for DNA transcription, which triggers the growth of new cells. If there are problems in this process, one of the results can be unwanted tissue growth in the joints. The extra tissue comes at the expense of bone structure and cartilage that are crucial for the joint's function. The extra tissue also leads to inflammation and pain that gets exacerbated when the body's immune system attacks the tissue, which it sees as a threat.
The result is the medical condition known as rheumatoid arthritis.
By slowing down JAK enzymes, Xeljanz aims to prevent this chain of events from happening.
1.1. Xeljanz dosing and administration
Xeljanz has been particularly popular because it is administered orally, in a pill form. Earlier treatments for rheumatoid arthritis had to be injected.
Those Xeljanz pills come in two doses:
- Xeljanz, which comes in 5-milligram pills, and
- Xeljanz XR – short for “extended-release” – which comes in 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, twice per day.4 People with kidney or liver problems, or people on certain other medications, only take one 5 milligram tablet per day.5
Those taking Xeljanz for moderate to severe ulcerative colitis, on the other hand, typically take 10 milligrams of Xeljanz, twice per day, in the absence of other medication or liver or kidney problems.6
Xeljanz XR is only meant for people taking the drug for rheumatoid arthritis or psoriatic arthritis and who do not have kidney or liver issues or a conflicting medication. The 11-milligram Xeljanz XR pill is only taken once per day.7
2. Side effects of Xeljanz
While Xeljanz has helped many people who suffer from rheumatoid arthritis and psoriatic arthritis and ulcerative colitis, it has also come with common side effects, like:
- 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 have also been far more serious side effects that have occurred at an alarming level, such as:
- Blood clots,
- Serious infections,
- Stomach or intestinal perforations and tearing,
- Problems with the immune system,
- Pulmonary embolism,
- Deep vein thrombosis,
- Liver damage, and
- Cancer, including blood cancers like Lymphoma
Many of these side effects can be fatal. Consuming alcohol together with Xeljanz can increase the risk of many of these complications, particularly liver damage.
The gravity of these side effects, coupled with what it found to be less-than-satisfactory results, led the European Medicines Agency – the European Union's equivalent of the FDA – to refuse to approve Xeljanz for use in Europe.8
2.1. Xeljanz and liver damage
One of Xeljanz's serious side effects is liver damage,9 which is particularly prevalent when someone taking Xeljanz has also been consuming alcohol.
Numerous medical studies and clinical trials that have looked at Xeljanz have monitored three biomarkers that doctors use to gauge the health of a patient's liver:
- Alanine transaminase, or ALT
- Aspartate transaminase, or AST, and
One study consolidated the results of 25 other studies, covering 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. While it only covered 140 people, the trial found that 19% of people taking Xeljanz had elevated ALT readings, compared to only 4% of those taking a placebo. Worse, 3% of Xeljanz participants had ALT readings three times the upper limit of normal, 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, with higher Xeljanz doses 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, also known as cancer. Possibly because Xeljanz affects JAK enzymes, which are responsible for the growth and spread of cells, Xeljanz has not been strictly associated with one type of cancer. Rather, it has been connected to a variety of cancer types, including:
- Lung cancer,
- Breast cancer,
- Gastric cancer,
- Non-melanoma skin cancer,
- Prostate cancer, and
- 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 Xeljanz-takers had developed cancer, including non-melanoma skin cancer. Both found that the number of people who took Xeljanz faced an increased risk of developing cancer.
2.3. Xeljanz and blood clots in the lungs and pulmonary embolisms
Perhaps the most severe side effect of Xeljanz is the increased likelihood of developing a blood clot in the lungs. These emergency medical conditions can cause a pulmonary embolism, or a blocked lung artery.
Pulmonary embolisms kill an estimated 50,000 people in the U.S. every year,14 making a blood clot in the lungs a serious medical problem that requires immediate attention.
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 was set to be completed in 2020. It covered 4,400 people with heart problems and rheumatoid arthritis, comparing their heart health when they took Xeljanz to when they took a tumor necrosis factor inhibitor drug.
On February 19, 2019, Pfizer learned 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 the tumor necrosis factor inhibitor drug. They were also having pulmonary embolisms three times as often as the expected rate for people taking the normal Xeljanz of dose 5 milligrams, twice per day.16
3. What are the legal grounds for a Xeljanz lawsuit?
Victims who have suffered one of these serious side effects of Xeljanz have filed lawsuits against Pfizer for defectively designing Xeljanz and for failing to warn doctors and patients of the risks of taking the drug.
3.1. Defective design of Xeljanz
One of the legal grounds for Xeljanz lawsuits is that Pfizer defectively designed the drug, leaving it with serious and unnecessary problems that could cause severe side effects.
This argument seeks to hold Pfizer accountable for its negligence when it designed and produced Xeljanz. Lawsuits making this claim argue that Pfizer's poor conduct at this stage in the drug's development should make it liable for the foreseeable injuries that it caused.
3.2. Victims claim Pfizer failed to warn people of the risks of taking Xeljanz
Xeljanz lawsuits also claim that Pfizer failed to adequately warn doctors and patients of the risks of taking the drug.
Doctors rely on safety disclosures made by the pharmaceutical companies that produce the drugs they prescribe. Without those disclosures, doctors are left with an incomplete understanding of the risks that certain drugs can cause when they prescribe them to patients.
Additionally, patients rely on safety disclosures from pharmaceutical companies when they do their due diligence on a drug's side effects. Patients use these disclosures to make informed health care decisions and weigh the pros of taking a drug against its cons and side effects.
However, drug companies know that they stand to lose money by disclosing all of the severe risks of a drug they have created. Fully disclosing the extent and severity of all of a drug's side effects could deter patients from taking the drug, make doctors think twice about prescribing it, and even scuttle the pharmaceutical company's attempts to get the drug approved by the FDA.
Product liability law draws a line in the sand between these competing interests by requiring drug companies to make reasonable disclosures about the drugs they are selling.
Xeljanz lawsuits claim that Xeljanz's warning label and other marketing and promotional material downplayed the risks of the drug's side effects. They argue that Pfizer should be held accountable for that failure to warn people by covering the costs of the injuries that its failure has caused.
Only in July of 2019 has the FDA ordered that the drug contain a black box warning.
4. Compensation for people hurt by Xeljanz
If you have been hurt by Xeljanz, a successful personal injury lawsuit would recover compensatory damages. These damages aim to cover your losses and bring you back to where you were, before you were hurt. They include:
- Medical expenses, including those that are reasonably anticipated in the future,
- Professional repercussions of your injuries, like your lost wages and reduced ability to earn an income, and
- Compensation for your pain and suffering.
Additionally, punitive damages may be a possibility in a Xeljanz lawsuit if it can be shown that the defendants' conduct was especially disturbing.
5. Compensation available in wrongful death claims over Xeljanz's side effects
If a loved one was taking Xeljanz and was killed by one of the side effects of the drug, you can file a wrongful death claim against Pfizer. In most states, you would have to show the following to win a wrongful death lawsuit against Pfizer:
- Your loved one died;
- Their death was caused by Pfizer's negligence; and
- Surviving family members have suffered financial hardship from the loss.
The compensation that a wrongful death lawsuit can recover is slightly different from a personal injury lawsuit, as well. Rather than focusing on compensating the victim, wrongful death lawsuits focus on compensating the victim's relatives and loved ones. Depending on the state you file your claim, the compensation for a wrongful death lawsuit against Pfizer can include:
- Funeral expenses,
- Loss of consortium and companionship, and
- Lost financial security.
6. The progress of Xeljanz lawsuits
Currently, each Xeljanz lawsuit that has been filed against Pfizer is moving through the court system on its own. However, these lawsuits are ripe for consolidation into either a class action or multidistrict litigation (MDL) 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 to streamline the process. However, there are some important differences between the two:
- Class actions combine similar lawsuits for their entire path through the court system, while MDLs only consolidate them for pretrial procedures,
- Class actions have a lead plaintiff representing the entire class, while lawsuits in MDLs do not,
- Class actions have the initial step of certifying the class by proving there are enough victims, that each case presents the same legal issue, and that the lead plaintiff is a typical member of the class and represents the interests of the others in it, while MDLs are formed by the court system without the certification process, and
- Class actions lead to one trial which, if lost, means none of the victims in the class action will recover compensation, while lawsuits in an MDL are all free-standing from each other.
Recent years have seen a distinct movement away from class actions to resolve mass tort claims like these Xeljanz lawsuits, and towards the use of an MDL.
Press Release, “Pfizer Announces FDA Approval of Xeljanz® (tofacitinib) and Xeljanz® XR for the Treatment of Active Psoriatic Arthritis,” Pfizer, (December 14, 2017).
See note 4.
See note 4.
See note 4.
European Medicines Agency, “Refusal of the marketing authorisation for Xeljanz (tofacitinib),” (July 26, 2013); 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).
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,” published at 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).
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) and 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).
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 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); 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).