Table of contents
- Latest Invokana Lawsuit Updates
- April 30, 2025: Study Compares SGLT2 Inhibitors Around Surgery
- July 6, 2021: Federal Invokana MDL Terminated
- August 26, 2020: FDA Removes Amputation Boxed Warning
- August 18, 2020: FDA Approves Label Change for Invokana
- March 12, 2019: Diabetologia Publishes CANVAS Amputation Analysis
- October 16, 2018: Law Firm Seeks Settlement Fund After Confidential Deals
- October 12, 2017: Court Order Records 865 Cases
- May 16, 2017: FDA Confirms Amputation Risk
- December 7, 2016: Panel Centralizes Invokana Cases in New Jersey
- September 17, 2015: Ontario Class Action Filed Against Janssen
- What Is Invokana?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Is Invokana Hard on the Kidneys?
- What Does the Research Say About Invokana and Amputation?
- What Is the Difference Between Invokana and Invokamet?
- Does the Dose Change the Amputation Risk?
Lawsuits allege that Invokana may have caused diabetic ketoacidosis, kidney damage and leg or foot amputations. Janssen Pharmaceuticals, Inc. makes and markets the type 2 diabetes drug. Its active ingredient is canagliflozin.
Federal cases were combined in December 2016 as MDL No. 2750 in the District of New Jersey. That MDL was terminated on July 6, 2021, and no federal MDL is pending.
The FDA required a Boxed Warning for amputation risk in 2017 and removed it in 2020. The risk remains in the label’s Warnings and Precautions section.
Latest Invokana Lawsuit Updates
April 30, 2025: Study Compares SGLT2 Inhibitors Around Surgery
A JAMA Surgery case-control study by Tallarico and colleagues looked at surgery patients who used SGLT2 inhibitors. It compared them with matched controls [1]. The study covered the whole drug class. It did not focus on Invokana alone.
Euglycemic ketoacidosis around surgery was 11% higher in users. Acute kidney injury after surgery was 31% lower. The 30-day mortality rate was 30% lower.
July 6, 2021: Federal Invokana MDL Terminated
The federal Invokana MDL, MDL No. 2750, was terminated on July 6, 2021. The case was heard in the District of New Jersey.
August 26, 2020: FDA Removes Amputation Boxed Warning
The FDA Drug Safety Communication removed the Boxed Warning about leg and foot amputation risk for canagliflozin, sold as Invokana, Invokamet and Invokamet XR. It cited new data from three clinical trials [2].
The risk is still described in the Warnings and Precautions section. The FDA said the risk, while still increased, is lower than previously described, particularly when appropriately monitored.
August 18, 2020: FDA Approves Label Change for Invokana
In an approval letter, the FDA approved Janssen’s supplement to the Invokana new drug application, NDA 204042/S-034. It removed the Boxed Warning for Lower Limb Amputation from the Prescribing Information [3].
Janssen’s supplement was dated and received October 18, 2019. The approval took effect on the date of the letter, August 18, 2020.
March 12, 2019: Diabetologia Publishes CANVAS Amputation Analysis
The journal Diabetologia published a further analysis of the CANVAS Program. It reported amputation rates of 6.30 versus 3.37 per 1,000 participant-years with canagliflozin versus placebo [4].
The hazard ratio was 1.97, with a 95% confidence interval of 1.41 to 2.75. The article appeared in volume 62, issue 6, pages 926 to 938.
October 16, 2018: Law Firm Seeks Settlement Fund After Confidential Deals
Douglas & London, P.C. asked the federal court to set up a qualified settlement fund. Its memo said it had entered confidential master settlement agreements with the Janssen defendants [5].
The agreements cover certain claimants it represents. They allegedly suffered diabetic ketoacidosis, acute kidney injury and amputation injuries. The settlement amounts are not public.
October 12, 2017: Court Order Records 865 Cases
In Case Management Order 23, the court recorded that 865 cases had been filed in the District as of October 5, 2017. Of those, 728 complaints had been served [6].
May 16, 2017: FDA Confirms Amputation Risk
The FDA issued a Drug Safety Communication confirming an increased risk of leg and foot amputations with canagliflozin, sold as Invokana, Invokamet and Invokamet XR. The agency required a Boxed Warning.
December 7, 2016: Panel Centralizes Invokana Cases in New Jersey
The Judicial Panel on Multidistrict Litigation centralized the Invokana cases in New Jersey as MDL No. 2750 in its transfer order. It assigned the litigation to Judge Brian R. Martinotti [7].
The litigation consisted of 55 actions, and 44 more related federal actions were reported. Janssen supported centralization of only Invokana and Invokamet cases.
September 17, 2015: Ontario Class Action Filed Against Janssen
A proposed national class action was filed against Janssen Inc. in Ontario, CBC News reported [8]. It alleges Invokana can cause kidney damage.
The suit claims more than $1 billion in damages. None of the allegations has been proven in court, and the proposed class has not been certified.
What Is Invokana?
Invokana (canagliflozin) lowers blood sugar (A1C) in adults and children aged 10 years and older with type 2 diabetes. The manufacturer’s Invokana website says it works along with diet and exercise [9].
Janssen developed and manufactured the drug. The lawsuits on this page also involve Invokamet and Invokamet XR, which also contain canagliflozin.
Who May Be Affected?
People who took Invokana, Invokamet or Invokamet XR (canagliflozin) for type 2 diabetes and had diabetic ketoacidosis, kidney damage or a leg or foot amputation may be affected.
The CANVAS analysis named three risk factors for amputation. They were prior amputation, peripheral vascular disease and neuropathy. It found no at-risk group specific to canagliflozin.
The federal cases involved people who took Invokana or Invokamet and alleged harm from the drug. Eligibility depends on an individual legal review of your records, including each prescription date and each diagnosis date.
Reported Injuries or Damages
Plaintiffs in the federal actions alleged that Invokana or Invokamet may cause diabetic ketoacidosis and kidney damage. They said Janssen failed to adequately test the drug and warn of its risks.
Other claims alleged amputation and acute kidney injury. In 2017, the FDA confirmed a higher risk of leg and foot amputations. The CANVAS analysis in Diabetologia and the 2025 JAMA Surgery study are research, not court findings.
Recall and Regulatory Background
The FDA has not recalled Invokana, Invokamet or Invokamet XR. It used a label change instead. Patients and doctors can report side effects to the FDA.
The FDA says patients should monitor for new pain, tenderness, sores, ulcers and infections in the legs and feet. They should also keep up preventive foot care.
The Judicial Panel on Multidistrict Litigation’s order also names Farxiga and Jardiance as other SGLT2 inhibitors. For that drug class, see our Farxiga lawsuit information.
Evidence to Preserve
Keep every record that shows what you took and what happened to you:
- Prescription and pharmacy records showing the drug (Invokana, Invokamet or Invokamet XR), strength and dates of use
- Medical records and test results for any ketoacidosis, kidney injury or amputation
- Hospital and surgery records from any related stay or procedure
- Photographs of foot or leg wounds, taken with dates
- Diabetes and other medication lists from your doctors
- Medical bills and proof of lost work
- Letters and messages with doctors, pharmacies or the manufacturer
Store copies of everything in one place. Keep old pill bottles and packaging, and add dates to photographs when you can.
Filing Deadlines
Injury claims have time limits set by state law. The limit depends on where you live and on when the injury and its diagnosis happened.
Some states start the clock at diagnosis, and a missed deadline can end a claim. Check with a lawyer promptly so you do not lose your chance to file.
Frequently Asked Questions
Is Invokana Hard on the Kidneys?
Is Invokana hard on the kidneys? Kidney damage was alleged in the federal cases and the Ontario action. The FDA later approved canagliflozin to reduce the risk of end-stage kidney disease in certain patients with diabetic kidney disease.
What Does the Research Say About Invokana and Amputation?
The research on Invokana and amputation includes the CANVAS analysis. In it, 187 participants (1.8%) had atraumatic lower extremity amputations. The authors concluded canagliflozin increased amputation risk, mainly minor, in that group. Projected amputations were fewer than major cardiovascular events averted.
What Is the Difference Between Invokana and Invokamet?
The difference between Invokana and Invokamet is the active ingredients. Invokana contains canagliflozin alone, while Invokamet contains both canagliflozin and metformin. The federal cases covered both drugs together, according to the transfer order.
Does the Dose Change the Amputation Risk?
The dose did not clearly change the amputation risk in the CANVAS analysis. The authors reported that the risk was similar for the 100 mg and 300 mg doses of canagliflozin in this study group.