Invokana Lawsuit | 2025 Latest Updates

Invokana Lawsuit Overview

The Invokana lawsuit involves legal claims against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals for failing to adequately warn patients and doctors about serious side effects of the SGLT2 inhibitor diabetes medication.

The primary allegations include failure to warn about risks of diabetic ketoacidosis, kidney failure, amputations, and other severe complications.

Johnson & Johnson currently faces approximately 55 Invokana lawsuits in state courts across the U.S., with federal cases consolidated in New Jersey under multidistrict litigation.

The FDA has received over 101 confirmable reports of acute kidney injury and at least 20 cases of ketoacidosis associated with SGLT2 inhibitors, leading to multiple safety warnings and black box warnings for amputation risks.

Latest Invokana Lawsuit Updates

• May 28, 2025 – New research from the University of California, San Francisco published in JAMA Surgery found that SGLT2 inhibitors including Invokana increased the risk of euglycemic diabetic ketoacidosis (eKA) by 11% among 7,439 surgical patients, though the drugs also reduced acute kidney injury risk by 30% and lowered 30-day mortality rates [1].
• March 2019 – A study presented at the American Diabetes Association’s annual meeting showed that diabetes patients who took Invokana had a doubled risk for amputations of the toes or feet compared to patients who took a placebo [2].
• May 16, 2017 – The FDA required a black box warning on Invokana and Invokamet labels about increased risk of leg and foot amputations based on data from the CANVAS and CANVAS-R studies, marking the agency’s strongest safety warning [3].
• December 19, 2016 – A panel of judges ordered all federal Invokana lawsuits alleging ketoacidosis and kidney failure be transferred to the District of New Jersey for consolidation into multidistrict litigation before Judge Brian R. Martinotti [4].

FDA Reports and Statistics

The FDA has documented extensive safety concerns with Invokana through its Adverse Event Reporting System (FAERS).

From March 2013 to October 2015, the agency received at least 101 confirmable reports of acute kidney injury associated with SGLT2 inhibitors, with some cases requiring emergency hospitalization and dialysis treatment.

Between March 2013 and June 2014, at least 20 cases of ketoacidosis in patients using these diabetes medicines were reported to the FDA.

The agency noted these cases were atypical, with glucose levels only mildly elevated at less than 200 mg/dL compared to typical DKA cases with glucose levels greater than 250 mg/dL.

The FDA has also documented dozens of cases of life-threatening kidney infections associated with Invokana, many starting as UTIs that progressed to kidney or blood infections.

Invokana Injuries & Side Effects

Invokana has been linked to a wide range of serious side effects and complications that can result in permanent disability or death, leading to numerous lawsuits against the manufacturer.

• Diabetic Ketoacidosis (DKA): Life-threatening condition where the body produces dangerous levels of ketones, causing blood to become acidic.
• Kidney Failure: Severe kidney damage requiring dialysis or transplantation, with symptoms including reduced urine output and swelling.
• Lower Limb Amputations: Increased risk of toe, foot, and leg amputations due to poor circulation and infections.
• Heart Attack and Stroke: Cardiovascular complications that can result in permanent disability or death.
• Severe Urinary Tract Infections: UTIs that can progress to life-threatening kidney and blood infections.
• Bone Fractures: Increased risk of bone breaks and abnormalities affecting mobility and quality of life.

Key Findings from the UCSF Study

The UCSF research team discovered a nuanced risk-benefit profile for patients taking SGLT2 inhibitors prior to surgery:

• 11% higher risk of eKA among SGLT2i users versus non-users
• 30% reduced risk of postoperative acute kidney injury (AKI)
• Lower 30-day postoperative mortality rate (1.1% vs. 1.5%)

Furthermore, the data indicated that patients who developed eKA were hospitalized for an average of six days, compared to just three days for those who did not experience this complication.

“In this retrospective matched case-control study, patients treated with SGLT2i had a slightly but statistically significantly higher risk of postoperative eKA compared with control patients,” the authors wrote. “It also showed a lower risk of AKI and 30-day mortality.”

Do You Qualify for an Invokana Lawsuit?

You may qualify for an Invokana lawsuit if:

• You took Invokana between 2013 and 2025 for type 2 diabetes treatment.
• You experienced serious side effects including diabetic ketoacidosis, kidney failure, amputations, heart attack, stroke, or severe UTIs.
• The injuries required medical treatment or hospitalization.
• You can provide medical documentation linking your injuries to Invokana use.

Evidence Required for an Invokana Lawsuit

To pursue a successful Invokana lawsuit, you will need to gather comprehensive documentation and evidence:

• Medical Documentation: Complete medical records showing your diabetes diagnosis, Invokana prescription history, and treatment for complications.
• Prescription Records: Documentation of your Invokana prescription including dates, dosages, and prescribing physician information.
• Injury Documentation: Medical records detailing the onset and treatment of side effects, including hospitalization records and surgical reports.
• Expert Medical Testimony: Medical experts who can establish the causal connection between Invokana use and your injuries.
• Pharmacy Records: Documentation showing when and how long you took Invokana.

Damages You Can Recover

Successful Invokana lawsuits may result in compensation for:

• Medical Expenses: Past and future medical costs including emergency treatment, surgery, dialysis, and ongoing care.
• Lost Wages: Income lost due to inability to work during recovery and long-term disability.
• Pain and Suffering: Compensation for physical pain, emotional distress, and reduced quality of life.
• Punitive Damages: Additional compensation intended to punish the manufacturer for negligent conduct.

Invokana Recall Information

To date, Invokana has not been recalled in the U.S. or any other country. However, the FDA has issued multiple safety warnings and required label changes due to serious side effects.

The agency has strengthened kidney warnings, added black box warnings for amputation risks, and issued drug safety communications about ketoacidosis risks.

The drug has been on the market since March 2013, and investigations into its potential health risks are ongoing. The FDA continues to monitor adverse event reports and may take additional regulatory action as new safety data emerges.

Statute of Limitations for Invokana Lawsuits

The statute of limitations for filing an Invokana lawsuit varies by state, typically ranging from 2 to 3 years from the date of injury discovery or when you reasonably should have known about the connection between your injuries and Invokana use.

Some states may have different limitation periods for product liability versus personal injury claims. Because there is a time limit to file your claim, you must seek professional legal advice quickly if you feel you were injured by Invokana.

It’s crucial to consult with an experienced attorney as soon as possible to ensure your rights are protected and to avoid missing critical filing deadlines.

FAQs

1. Can I file a lawsuit if I suffered severe side effects from taking Invokana?

Yes, if you suffered severe side effects from taking Invokana, you may be eligible to file a lawsuit. A lawyer experienced in pharmaceutical litigation can help you explore your legal options and seek compensation for your medical expenses, lost wages, pain and suffering, and other damages.

2. What compensation might be available in an Invokana lawsuit?

Compensation may include medical expenses, lost wages, pain and suffering, and in cases of severe injury or death, compensation for long-term care or wrongful death. The amount will depend on the severity of your injuries and how they have impacted your life.

3. How can I prove that Invokana caused my injuries?

Proving that Invokana caused your injuries typically involves gathering medical records, prescription evidence, and expert testimony linking the drug to your health issues. A lawyer can assist in collecting and presenting the necessary documentation.

4. What is diabetic ketoacidosis and how does Invokana cause it?

Diabetic ketoacidosis is a life-threatening condition where the body produces dangerous levels of ketones, making blood acidic. Invokana can trigger this condition even with normal blood sugar levels, complicating diagnosis and treatment.

5. Are there other SGLT2 inhibitors that cause similar problems?

Yes, other SGLT2 inhibitors such as Jardiance, Farxiga, and Xigduo XR have been linked to similar complications like ketoacidosis and kidney problems.

6. How long does an Invokana lawsuit typically take?

Lawsuits can take from 18 months to several years, depending on the case’s complexity and whether it goes to trial or settles. Federal cases are consolidated in New Jersey under multidistrict litigation.

7. What should I do if I’m still taking Invokana?

Never stop taking Invokana or any medication without consulting your doctor. If you experience symptoms of ketoacidosis or kidney problems, seek immediate medical attention.

8. Do I need to pay attorney fees upfront for an Invokana lawsuit?

Most pharmaceutical liability attorneys work on a contingency fee basis, meaning there are no upfront costs, and attorney fees are only collected if your case is successful.

9. Can family members file wrongful death claims for Invokana deaths?

Yes, family members may be able to file wrongful death claims if their loved one passed away due to complications from Invokana use.

10. What are the symptoms of kidney failure from Invokana?

Symptoms include reduced urine output, swelling in the legs and feet, shortness of breath, excessive drowsiness, nausea, confusion, and chest pain or pressure.

See all related dangerous drug lawsuits our attorneys covered so far.

Get a Free Invokana Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Invokana injuries. With statute of limitations periods varying by state – typically only 2 to 3 years from the date of injury discovery – it’s crucial to act quickly to protect your rights.

Schmidt & Clark offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – you pay nothing unless we win
• Payment only if we win your case through our contingency fee structure
• Experienced legal representation in pharmaceutical litigation and dangerous drug cases

Don’t wait – contact Schmidt & Clark today to discuss your potential Invokana lawsuit and learn about your legal options. Our experienced team is ready to fight for the compensation you deserve.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC12044541/
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC6509073/
3. https://www.drugwatch.com/news/2017/05/19/invokana-fda-black-box-warning-amputation/
4. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2750-Initial_Transfer-12-16.pdf