Zydelig Lawsuit – How to File a Lawsuit

Zydelig (idelalisib), made by Gilead Sciences, carries a boxed warning for fatal and serious liver, bowel, lung and infection problems. The FDA also ended two of its approved uses in 2022. In 2016, Health Canada announced that Canadian trials were being stopped after serious adverse events, including deaths. The European Medicines Agency also reviewed the drug’s infection risk. As of October 2026, no Zydelig lawsuit, MDL or settlement is filed. If you take Zydelig, talk to your health care provider before changing treatment. Approval for relapsed CLL with rituximab remains in place, and the label still says the drug is not recommended for first-line treatment of any patient.

Latest Zydelig Lawsuit Updates

May 26, 2022: FDA Withdraws Two Zydelig Indications

On May 26, 2022, the FDA withdrew approval of two indications for Zydelig. They were relapsed follicular lymphoma and relapsed small lymphocytic lymphoma (SLL) [1]. Gilead Sciences had asked for the withdrawal in a letter dated January 10, 2022. The notice says the withdrawal does not affect any other approved indication.

September 21, 2016: FDA Approves Zydelig Labeling Changes

On September 21, 2016, the FDA approved changes to Zydelig’s labeling, known as supplement S-004 [2]. They added serious infections as a new Warning and Precaution. The changes also updated safety information on severe diarrhea and colitis, pneumonitis, severe cutaneous reactions and neutropenia. The approval also added a limit: Zydelig is not indicated and not recommended for first-line treatment of any patient.

July 8, 2016: EMA Completes Its Zydelig Safety Review

On July 8, 2016, the European Medicines Agency safety committee finished its review of Zydelig. The review began March 11, 2016 at the request of the European Commission [3]. The committee found the benefits still outweigh the risks in CLL and follicular lymphoma. It confirmed a risk of serious infections, including Pneumocystis jirovecii pneumonia.

May 3, 2016: Health Canada Warns of Serious Infections

On May 3, 2016, Health Canada and Gilead warned health professionals of lower overall survival and more serious adverse events, mostly infections [4]. The events came from trials that added Zydelig to standard first-line CLL treatment and early relapsed indolent non-Hodgkin lymphoma treatment. Most were infections, including sepsis and pneumonia.

March 17, 2016: Health Canada Announces Trials Are Stopped

On March 17, 2016, Health Canada announced that four Canadian clinical trials of Zydelig with other cancer medicines were being stopped [5]. The trials were halted after reports of more serious adverse events, including deaths. Three more trials were to be amended.

July 23, 2014: FDA Approves Zydelig

On July 23, 2014, the FDA approved idelalisib, sold by Gilead as Zydelig, for relapsed CLL when used with rituximab [6]. Under its accelerated approval program, the FDA also approved the drug for relapsed follicular lymphoma and relapsed SLL after two prior therapies.

What Is Zydelig?

According to the National Cancer Institute, Zydelig is approved to treat relapsed chronic lymphocytic leukemia (CLL) [7]. It is used with rituximab in patients who may be treated with rituximab alone due to other health problems. The Zydelig label calls it a kinase inhibitor [8]. A 2015 review of the FDA approval describes it as an oral drug that blocks PI3K delta.

Who May Be Affected?

People treated with Zydelig for relapsed CLL, together with rituximab, are the group the current label covers. The boxed warning names liver injury, severe diarrhea or colitis, pneumonitis, serious infections and intestinal perforation. Only an individual legal review can say whether your own facts support a claim, because each person’s treatment, symptoms and records differ.

Reported Injuries or Damages

No injury is alleged in court. The Zydelig label’s boxed warning reports these fatal and/or serious events among Zydelig-treated patients:

• Hepatotoxicity in 16% of patients
• Severe diarrhea or colitis in 20%
• Pneumonitis in 4%
• Infections in 48%
• Fatal and serious intestinal perforation across clinical trials

These are label and regulator findings, and they do not prove that Zydelig caused any one person’s illness. The European Medicines Agency also reported more serious infection-related events, such as pneumonia, in three clinical trials.

Recall and Regulatory Background

Zydelig has not been recalled. A withdrawal at the maker’s request is not a recall, and it does not establish liability.

Evidence to Preserve

Records can show what you took, when you took it and what happened next. Keep these items together in one place:

• Prescription and pharmacy records showing the Zydelig dose and dates
• Medical records and test results, such as liver tests, imaging, infection and hospital records
• A dated diary of symptoms such as diarrhea, cough or fever
• The medication guide and any letters from the prescriber
• Receipts and insurance statements
• Communications with doctors and Gilead
• The names of your treating providers

Filing Deadlines

Injury claims come with filing deadlines that state law sets. The time limit depends on where you live and when the injury and its diagnosis happened. Some states start the clock at diagnosis. A late claim can be barred even if the facts support it. Speak with a lawyer promptly so you do not lose that right.

Frequently Asked Questions

Can You Sue a Pharmaceutical Company for Side Effects?

You may be able to sue a pharmaceutical company for side effects through a product liability claim. The answer depends on the facts and on state law. For Zydelig, the boxed warning lists the serious effects that regulators report.

What Does the Research Say About Zydelig Safety?

Zydelig safety research includes the EMA review, which recommended that all patients get antibiotics to prevent Pneumocystis jirovecii pneumonia. They should take them during treatment and for up to 2 to 6 months after it stops.

What Should I Do If I Am Taking Zydelig?

If you are taking Zydelig, do not stop until you talk with your healthcare professional. Health Canada’s May 3, 2016 notice (RA-58118) told patients and caregivers to talk with their healthcare professionals first, not to stop the drug alone.

Is There a Zydelig Lawsuit?

The Zydelig lawsuit that exists is a patent suit involving Natco. It is not an injury claim by a patient. The FDA withdrawal notice, Federal Register 2022-11277 (87 FR 32031), is a regulatory filing and not a court case.

References

1. https://www.federalregister.gov/documents/2022/05/26/2022-11277/gilead-sciences-inc-withdrawal-of-approval-of-indications-for-relapsed-folli
2. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf
3. https://www.ema.europa.eu/en/news/prac-concludes-review-zydelig-issues-updated-recommendations-use
4. https://recalls-rappels.canada.ca/en/alert-recall/zydelig-idelalisib-increased-risk-fatal-and-serious-infections
5. https://recalls-rappels.canada.ca/en/alert-recall/international-clinical-trials-including-trials-canada-are-being-stopped-due-serious
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC4665051/
7. https://www.cancer.gov/about-cancer/treatment/drugs/idelalisib
8. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/zydelig/zydelig_pi.pdf