Products Liability
The arthritis drug Xeljanz may cause serious and potential blood clots in some users. This was not initially disclosed as a side effect – now there is a warning. The Xeljanz lawsuit is for victims who did not get a warning.
November 2023 Xeljanz Update – New Study on Acne Risk
A new study has indicated that Xeljanz and similar drugs, which are commonly used for treating inflammation and autoimmune conditions like ulcerative colitis and rheumatoid arthritis, may heighten the risk of developing acne. Researchers from Harvard have found that patients taking a class of medications called Janus Kinase (JAK) inhibitors, including well-known treatments like Xeljanz and Rinvoq, were four times more likely to experience acne compared to those not taking these drugs.
The study, published in the Journal of the American Medical Association Dermatology, involved a systematic review and meta-analysis of 25 different studies, encompassing over 11,000 participants. The researchers focused on JAK inhibitors, specifically JAK1, combination JAK1 and JAK2, and tyrosine kinase 2-specific inhibitors, while examining the potential side effects of acne. The findings revealed that patients using JAK inhibitors had a 3.83-fold increased likelihood of developing acne compared to those on a placebo.
That is a big difference. Will this result in class action litigation? I doubt it. But it underscores what we don’t know about drugs like Xeljanz and Rinvoq.
Janurary 2023 Xeljanz Update:
A New England Journal of Medicine study underscores a key claim plaintiffs are making in these lawsuits: there is a greater incidence of adverse cardiovascular events and cancer with Xeljanz than with other treatment options.
November 2021 Xelijanz Lawsuit Update – New Study
A new study published in the November issue of the Journal of Clinical Radiology found that Xeljanz and all other drugs in the same family known as JAK inhibitors carry an inherent risk of blood clots and serious adverse cardiovascular events.
The researchers were not able to determine whether Xeljanz presented a significantly higher risk of cardiovascular events or blood clots compared to other JAK inhibitors.
The study calls for further research into Xeljanz and other JAK inhibitors to better understand the comparative risks presented by the drugs. Not for nothing, this study also strengthens the arguments Xeljanz lawyers are making for the victim in these lawsuits.
September 2021 Update (finally a warning)
On September 1, 2021, the FDA announced that it was requiring Xeljanz to come with a new, beefed-up warning label that conspicuously warns that users may have an increased risk of potentially life-threatening conditions such as heart attack, cancer, blood clots, and stroke.
This new warning requirement from the FDA comes after the agency conducted its review of recent Xeljanz clinical trials and related studies, which first determined that users of the drug had a higher rate of serious heart-related problems, cancer, pulmonary embolism, and fatalities.
In its safety communication announcing the new warning label requirements, the FDA also clarified the evidence linking Xeljanz and cancer. According to the FDA, Xeljanz users displayed significantly higher rates of lymphoma and lung cancer compared to a control group. Evidence linking Xeljanz to other types of cancer was less definitive.
Xeljanz
Xeljanz, an oral Janus kinase (JAK) inhibitor, was developed by Pfizer Inc. and received approval from the Food and Drug Administration (FDA) for treating adult patients with moderate to severely active rheumatoid arthritis (RA) in November 2012. The drug was later approved for active psoriatic arthritis (PsA) in December 2017 and moderate to severely active ulcerative colitis (UC) in May 2018. Xeljanz was marketed as a breakthrough treatment for these autoimmune conditions, promising relief to patients with chronic inflammatory diseases.
Xeljanz is similar in many ways to a biologic. But this drug is a new subcategory of disease-modifying antirheumatic drugs (DMARD) called “JAK inhibitors.” Xeljanz blocks Janus kinase (JAK) pathways that are involved in our immune responses. These agents target specific steps in the process. So, in theory, these drugs don’t wipe out the entire immune response as do some other RA treatments
The drug is primarily used for the treatment of very severe cases of rheumatoid arthritis. However, Xeljanz has also been used to treat ulcerative colitis and psoriatic arthritis. Pfizer aggressively marketed Xeljanz and quickly became one of the company’s blockbuster drugs because it was effective in treating these diseases.
Xeljanz is now one of the most heavily marketed and profitable drugs in history. Pfizer has reaped billions of dollars in sales from Xeljanz. Pfizer reported $2.4 billion in worldwide Xeljanz sales in 2020. This is big money, the kind of drug a pharmaceutical company desperately wants to keep in the market.
Normal approved dose levels for Xeljanz are 5 mg and 10 mg twice a day. To prevent arthritis inflammation, Xeljanz has to essentially block or suppress a user’s natural immune system responses. As a result, the drug always had a long list of potentially serious side effects. For example, the boxed warning states, “Patients treated with Xeljanz are at increased risk for developing serious infections that may lead to hospitalization or death.” But blood clots were not listed as a potential side effect of the drug. They are now.
Pfizer pushed Xeljanz like crazy. It ran an aggressive marketing campaigns to promote Xeljanz, both to prescribing physicians and directly to consumers. This aggressive marketing resulted in substantial sales, making Xeljanz one of Pfizer’s most profitable drugs. The marketing efforts emphasized the drug’s effectiveness while allegedly downplaying the risks associated with its use.
Xeljanz and Blood Clots
As part of the initial FDA approval for Xeljanz back in 2012, Pfizer was required to conduct a long-term post-market research study. This post-approval study aimed to evaluate the potential risks of cardiovascular problems resulting from the drug.
The initial results of this long-term study were provided to the FDA at the beginning of 2019 and they caused major concerns. Specifically, the study found that the higher Xeljanz dose (10 mg twice daily) appeared to cause life-threatening blood clots in some patients.
Black Box Warning on Xeljanz
In response to these study results, the FDA issued a safety announcement, and Pfizer was required to add a “black box warning” (the most serious type of drug label warning) about the risk of blood clot deaths at higher doses. The higher, 10 mg dose of Xeljanz is no longer approved for the treatment of arthritis because the risk of blood clots is considered too high.
This whole class of drugs is giving cause for concern. In June 2021, the FDA decided to further extend the review period for Jakafi, a bone marrow disease drug by Incyte that is looking to get approved for steroid-refractory chronic graft-versus-host disease. What is the concern? The concern is that it might cause cardiac complications and/or cancer. Similarly, expanded approval of Abbie’s Rinvoq is being held up as abrocitinib.
Xeljanz Lawsuits
Pfizer is now facing a rapidly growing number of lawsuits by users of Xeljanz who suffered blood clots or similar injuries. All pharmaceutical companies must fully research the safety of their drugs before they are approved and released. This is particularly true with completely new types of drugs such as Xeljanz.
Drug companies also have a legal duty to warn about any potential risks, side effects, or health concerns associated with their drug. This is information is often critical because it enables doctors to make informed decisions about drug safety for individual patients.
Xeljanz blood clot lawsuits against Pfizer are alleging that the company breached its duties to the public in several ways:
- Pfizer negligently failed to conduct adequate safety research and testing before getting approval for Xeljanz.
- Pfizer knew that the higher dose of Xeljanz caused blood clots and other problems, but failed to disclose this information.
- Pfizer failed to warn that higher doses of Xeljanz may cause blood clots and cardiovascular problems.
Most of these allegations appear to be fairly valid and Pfizer will likely be facing serious liability in these cases. The warnings about Xeljanz and blood clots are fairly recent, so not many blood clot lawsuits have been filed against Pfizer at this point.
Pfizer will likely be named in hundreds of Xeljanz lawsuits across the country. As of February 2022, there is still no MDL class action. But that could change.
Our Xeljanz lawyers do not have a sense of how many lawsuits there will be. It will depend on whether the people who suffered blood clots on Xeljanz connect the dots back to the drug. If enough lawsuits are filed, you can expect a Xeljanz class action lawsuit to be filed. In that case, plaintiffs’ lawyers will seek to have all Xeljanz lawsuits in federal court to be handled for discovery and bellwether trials under a single judge.
Xeljanz Lawsuit Plaintiffs’ Claims
Xeljanz lawsuits involve the following health events:
- Pulmonary Embolism
- Stroke
- Deep Vein Thrombosis
- Other types of blood clot injury
There are five core clams in the lawsuits:
1. Failure to Warn and Concealment of Risks
The plaintiffs allege that Pfizer failed to warn users about the serious risks associated with Xeljanz, including heart-related events, cancer, blood clots, and death. They claim that Pfizer was aware of these risks but did not include adequate warnings in the product’s labeling or medication guide.
2. Negligence and Reckless Conduct
The plaintiffs assert that Pfizer negligently and recklessly failed to inform the medical community and consumers about the dangers of Xeljanz. This includes a failure to conduct adequate premarketing and post-marketing safety assessments and to update the drug’s labeling with newly acquired safety information.
3. Strict Products Liability
The lawsuit claims that Xeljanz is defective and unreasonably dangerous due to the absence of proper warnings about its risks. Pfizer is accused of placing this defective product into the stream of commerce, resulting in harm to the plaintiffs.
4. Fraud and Fraudulent Inducement
The plaintiffs accuse Pfizer of intentionally misrepresenting and concealing the true risks of Xeljanz to ensure continued sales. They allege that Pfizer provided false information about the drug’s safety and efficacy, misleading both prescribing physicians and consumers.
5. Breach of Warranty
The lawsuit includes claims of breach of both implied and express warranties. The plaintiffs argue that Pfizer falsely warranted that Xeljanz was safe and fit for its intended use, despite knowing the drug was dangerous and could cause severe health issues.
How Will Pfizer Defend the Xeljanz Lawsuits?
Pfizer is in a bind, right? Everyone agrees now that Xeljanz causes blood clots and Pfizer did not warn of the risk. So how do you defend that?
Pfizer will pull out the old drug defense lawyer saw of preemption. It will argue that federal law preempts victims’ ability to question the Xeljanz warning because it claims a manufacturer cannot unilaterally change an FDA-approved boxed warning.
Our lawyers believe this argument is unlikely to be successful in Xeljanz lawsuits.