Xeljanz is a drug made by Pfizer Inc. marketed to individuals with severe arthritis. The drug acts as an anti-inflammatory that suppresses the immune system response to reduce symptoms of joint pain. While the vast majority of side effects are known to doctors and clearly printed on the drug’s label, at least one side effect is not: Blood clots.
Conditions That Xeljanz Treats
Xeljanz is used to treat:
Xeljanz and Blood Clots
A recent study prompted an FDA warning that Xeljanz, taken in sufficient enough quantities, can increase a patient’s risk of blood clots in the lungs. Those who have taken the medication and suffered blood clots will be able to file claims against Pfizer.
The data was made available on the FDA Adverse Events Reporting System. Between 2013 and 2018, patients reported 52 cases of deep vein thrombosis (DVTs) and 79 cases of pulmonary embolisms. Fifteen patients died as a result of complications related to clotting problems.
What Is a Pulmonary Embolism?
A pulmonary embolism is a blood clot that travels into the lungs, blocking one of the main arteries. When the blood clot comes from the deep veins in your legs, it is called deep vein thrombosis (DVT).
Once the clot travels to the lungs, it blocks the flow of blood there resulting in life-threatening symptoms. These include:
- Shortness of breath,
- Chest pain, and
- Bloody cough.
Those with pulmonary embolisms may also experience pain and swelling in their legs, cyanosis, irregular heartbeat, racing heartbeat, fever, lightheadedness, and dizziness.
Since your blood carries nutrients to the organs of your body, a pulmonary embolism can result in severe damage to the lungs, including tissue death. This is known as an infarction. A stroke is an infarction, or a blockage of blood to your brain. A pulmonary infarction is a blockage of blood to your lungs.
FDA Approval of Xeljanz
When Xeljanz was first approved by the FDA in 2013, the FDA ordered additional studies to determine whether or not there were cardiovascular risks associated with the drug. It wasn’t until February of 2019 that Pfizer announced that there were risks associated with blood clots at higher doses. Pfizer issued a press release telling doctors that they should transition their patients from 10 mg twice daily to 5 mg twice daily.
Studies and reports of adverse reactions showed that there was a clear link between pulmonary embolisms and those who were taking the drug at the higher dose. In July of 2019, Pfizer approved a warning on the label about the clotting risk. Those who experienced clotting problems while on the drug before July of 2019, may be able to file a claim if they can show they were injured.
Drug lawsuits are a kind of product liability lawsuit. Product liability lawsuits are filed based on one of three theories. Those are: When a manufacturer designs a product defectively, when a manufacturing defect results in injury, and when the manufacturer fails to warn about potential risks of a product. In this case, Pfizer is immune from liability related to other side effects since they warned doctors and patients beforehand. For a patient to successfully file a claim against Xeljanz, they will need to prove all of the following is true:
- The patient was being treated for arthritis with Xeljanz or Xeljanz XR;
- The patient was taking 10 mg twice daily of Xeljanz or Xeljanz XR; and
- The patient experienced a pulmonary embolism, pulmonary thrombosis, deep vein thrombosis, stroke, or any other ailment related to blood clots.
In the case that a patient can prove those elements, they can successfully file a claim with an attorney against Pfizer for failing to warn doctors and patients about the blot clot issue.
Future Xeljanz Lawsuits
Since by now it has been well established that Xeljanz causes blood clots in higher doses, and Pfizer intends on admitting this and making sure that doctors and patients both know the risks before taking the medication, future claims against Pfizer will not be possible. However, that doesn’t mean that a patient who prescribed an unsafe dosage of a medication has no recourse to recover. It simply means that Pfizer will not be the liable party.
This can complicate matters since the claim would not be a product liability claim, but a medical malpractice claim. Typically, product liability claims are easier to file and easier to litigate. An injured plaintiff does not prove that the company that produced the product was negligent. An injured party need only show that they used the product in a way that could be anticipated by the company, and that they were injured as a result.
In a medical malpractice claim against a doctor, a plaintiff must be able to show medical negligence occurred. In addition, depending on what state you reside in, there may be other statutory restrictions on medical malpractice claims, including damage caps. But since a prescribing doctor is expected to know what a potentially lethal dose of a medication is and the complications that can arise from over-prescribing it, proving medical negligence in such a case would not necessarily be difficult.
Wrongful Death Lawsuits
Among the plaintiffs are 15 families that believe that they say they lost loved ones who were taking Xeljanz to treat their arthritis. Many of these are deaths that could have been prevented while Pfizer balked at data coming out of the FDA database recording adverse medical events and waited for the safety study to be completed. That didn’t happen until early 2019, though it should have been obvious given the FDA data that the drug was causing problems for a number of patients.
File a Xeljanz Claim Today
If you’ve been injured by Xeljanz or you’ve lost a loved one who was on Xeljanz, talk to the Roger Ghai Law Offices today. We can help you file a claim and recover money damages for any injuries you suffered. If you lost a family member, we can help you file a wrongful death lawsuit against Pfizer. Give us a call or talk to us online to set up a free consultation.