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Table Of Contents
- Complera Lawsuit Overview
- Latest Complera Lawsuit Updates
- FDA Reports and Statistics
- Complera Injuries & Side Effects
- Do You Qualify for a Complera Lawsuit?
- Complera Recall Information
- Statute of Limitations for Complera Lawsuits
- FAQs
- 1. Who Is Eligible to Join the Complera Lawsuit?
- 2. What Compensation Might be Available Through a Complera Lawsuit?
- 3. How Long Does It Take for a Lawsuit Like the Complera Case to Be Resolved?
- 4. Can I File a Class Action Lawsuit for Complera Injuries?
- 5. What Are the Symptoms of Kidney Disease Related to Complera?
- Get a Free Complera Class Action Lawsuit Evaluation With Our Lawyers
Complera Lawsuit Overview
The Complera lawsuits claim that Gilead Sciences did not properly warn patients and healthcare providers about serious side effects linked to tenofovir disoproxil fumarate (TDF), which is a main ingredient in the HIV medication.
Complera is part of a large HIV drug market, with Gilead reportedly earning more than $11 billion yearly from its HIV treatments. Patients who develop kidney disease related to TDF often face expensive medical care.
Treatments for advanced kidney disease can cost over $70,000 per year per patient, excluding costs for bone fractures and related health issues.
Plaintiffs argue that long-term use of Complera may cause serious kidney damage, such as chronic kidney disease and kidney failure, along with bone density loss that can lead to fractures, osteopenia, and osteoporosis.
Research from the International Association of Providers of AIDS Care shows these risks affect many of the estimated 40 million adults in the U.S. with kidney disease, a large number of whom may be unaware of their condition [1].
In 2025, Gilead agreed to a $202 million settlement over accusations of paying kickbacks to promote HIV drugs including Complera.
People who have experienced kidney or bone problems after taking Complera may qualify for compensation.
Latest Complera Lawsuit Updates
- 2024 Update: Multiple lawsuits against Gilead Sciences, the manufacturer of Complera, continue to progress through the court system. Plaintiffs allege that Gilead knew about the serious kidney and bone risks associated with tenofovir disoproxil fumarate (TDF) but failed to disclose these dangers while actively working to delay the development of safer alternatives [2].
- 2023 Developments: Several bellwether trials have been scheduled to help determine the potential value of Complera cases. These initial trials are critical in establishing precedents for subsequent litigation and potential settlement frameworks for the thousands of cases pending nationwide.
- 2022 Consolidation: Courts have consolidated many individual Complera lawsuits into coordinated proceedings to streamline the litigation process. This allows for more efficient handling of similar cases while still preserving each plaintiff’s right to individual compensation based on their specific injuries and circumstances.
FDA Reports and Statistics
While the FDA approved Complera for the treatment of HIV, the agency has received numerous adverse event reports related to its use.
The FDA Adverse Event Reporting System (FAERS) has documented cases of severe kidney damage and bone density loss associated with tenofovir disoproxil fumarate-containing medications like Complera.
According to clinical studies and post-marketing surveillance:
- Patients taking TDF-containing medications like Complera have shown a 1-3% decline in bone mineral density within the first year of treatment.
- The risk of kidney adverse events is approximately 20% higher in patients taking TDF-containing regimens compared to alternative treatments.
- An estimated 10% of patients experiencing kidney damage from TDF may progress to chronic kidney disease requiring long-term care.
- Studies have shown that switching from TDF-containing medications to newer formulations can improve markers of bone and kidney health.
Despite these concerns, the FDA has not issued a recall of Complera, instead opting to update labeling to include warnings about potential kidney and bone side effects.
Complera Injuries & Side Effects
Complera contains tenofovir disoproxil fumarate (TDF), which has been linked to serious side effects affecting the kidneys and skeletal system, particularly with long-term use.
- Kidney Damage: Kidney toxicity, chronic kidney disease (CKD), acute kidney injury, and kidney failure (renal failure) requiring dialysis or transplantation.
- Bone Disorders: Bone demineralization, loss of bone density, osteopenia (early-stage bone loss), and osteoporosis (severe bone loss increasing fracture risk).
- Fracture Risk: Increased susceptibility to bone fractures, particularly in the spine, hip, and wrist, due to compromised bone integrity.
- Lactic Acidosis: A dangerous buildup of lactic acid in the bloodstream that can lead to organ failure if not treated promptly.
Do You Qualify for a Complera Lawsuit?
You may qualify for a Complera lawsuit if:
- You were prescribed and took Complera for HIV treatment.
- You experienced kidney problems such as chronic kidney disease, kidney failure, or required dialysis after taking the medication.
- You suffered bone density loss, osteoporosis, or bone fractures while on the medication.
- Your injuries required medical treatment, hospitalization, or ongoing care.
- You can provide medical documentation linking your injuries to Complera use.
Evidence Required for a Complera Lawsuit
To strengthen your case against the manufacturer, you should gather:
- Medical records documenting your Complera prescription history (dosage, duration of use).
- Laboratory test results showing kidney function deterioration or bone density loss.
- Documentation of diagnoses related to kidney disease or bone disorders.
- Records of hospitalizations or treatments for Complera-related injuries.
- Imaging studies showing bone fractures or decreased bone density.
- Statements from your healthcare providers about the connection between your injuries and Complera.
Damages You Can Recover
Victims of Complera-related injuries may be eligible to recover compensation for:
- Medical expenses for treatment of kidney disease, bone disorders, or other related injuries.
- Costs of ongoing medical care, including dialysis, kidney transplantation, or bone treatments.
- Lost wages and diminished earning capacity due to your injuries.
- Pain and suffering associated with your injuries and treatments.
- Emotional distress caused by your diagnosis and medical procedures.
- Punitive damages in cases where the manufacturer’s conduct was particularly egregious.
Complera Recall Information
As of 2024, the FDA has not issued a recall for Complera despite the reported side effects. Instead, the agency has required updated labeling to include warnings about potential kidney and bone risks associated with the medication.
Gilead Sciences continues to market Complera while also promoting newer tenofovir alafenamide (TAF) based medications, which are claimed to have improved safety profiles.
Critics and plaintiffs allege that Gilead delayed the development and release of these safer alternatives to maximize profits from their TDF-based medications like Complera before patent expiration.
This strategy allegedly exposed patients to unnecessary risks that could have been avoided with earlier access to safer formulations.
Statute of Limitations for Complera Lawsuits
The time limit to file a Complera class action lawsuit varies by state but typically ranges from 1-3 years from the date you discovered or reasonably should have discovered that your injury was related to Complera use. This is known as the “discovery rule” in many jurisdictions.
Some important considerations regarding the statute of limitations:
- In most states, the clock starts ticking when you first learn of both your injury and its potential connection to Complera.
- Some states have stricter time limits than others, with some as short as one year.
- The statute of limitations for product liability claims may differ from those for personal injury.
- Special rules may apply if the injured person is a minor or is mentally incapacitated.
Because these timeframes can be complicated and vary significantly between jurisdictions, it’s crucial to consult with an attorney as soon as possible after discovering a potential Complera-related injury.
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FAQs
1. Who Is Eligible to Join the Complera Lawsuit?
Individuals who have taken Complera and suffered serious side effects such as kidney damage or bone disorders may be eligible to file a lawsuit. Each case is evaluated based on the specific injuries sustained and the timeline of medication use.
2. What Compensation Might be Available Through a Complera Lawsuit?
Compensation available through Complera litigation may include medical expenses, pain and suffering, lost wages, and possibly punitive damages. The amount varies based on the severity of injuries, medical costs incurred, and impact on quality of life.
3. How Long Does It Take for a Lawsuit Like the Complera Case to Be Resolved?
It can take several years for pharmaceutical liability cases to be resolved. The duration varies widely due to the complexities involved in litigation, the number of plaintiffs, and whether the case settles or goes to trial.
4. Can I File a Class Action Lawsuit for Complera Injuries?
While class actions are possible, our lawyers prefer filing individual lawsuits for Complera cases. This approach allows each plaintiff to pursue compensation based on their specific injuries and circumstances, often resulting in more appropriate settlements than class actions.
Symptoms of kidney disease may include weight loss, poor appetite, swollen extremities, shortness of breath, fatigue, blood in urine, increased urination (particularly at night), sleep problems, itchy skin, muscle cramps, and nausea. Many people don’t notice symptoms until the condition is advanced.
See all related dangerous drugs lawsuits our attorneys covered so far.
Get a Free Complera Class Action Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for injuries caused by Complera. Each state has specific statutes of limitations that restrict the time you have to file a lawsuit after discovering your injury, typically ranging from 1-3 years depending on your location.
At Schmidt & Clark, LLP, we offer:
- Free, confidential consultations to evaluate your potential Complera case
- No upfront costs or fees – we only get paid if we win your case
- Experienced pharmaceutical litigation lawyers who understand the complexities of dangerous drug cases
- Individual representation to maximize your potential compensation
Free Case Evaluation: Again, if you’ve been harmed by the side effects of Complera, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
References
- https://www.iapac.org/fact-sheet/complera/
- https://litprollc.com/tenofovir-disoproxil-fumarate-tdf-litigation/