What the Lawsuits Alleged
Invokana (canagliflozin) is an SGLT2-inhibitor diabetes drug made by Janssen (Johnson & Johnson). Lawsuits alleged it caused serious harms — diabetic ketoacidosis (a dangerous buildup of blood acids), acute kidney injury, and, uniquely among these drugs, leg and foot amputations — and that the manufacturer failed to warn adequately. Invokana is the SGLT2 drug specifically linked in the litigation to amputations.
The claim is a failure-to-warn theory about severe side effects that emerged after the drug’s 2013 approval.
The Warnings and Settlement
Regulators responded over time: the FDA added ketoacidosis warnings to SGLT2 inhibitors in 2016 and, in 2017, required a black-box warning — its most serious — on Invokana about the increased risk of leg and foot amputations. In October 2018, Johnson & Johnson and Janssen settled a large portion of roughly 1,000 Invokana lawsuits in a New Jersey MDL through a confidential settlement.
The later black-box requirement is significant because plaintiffs argued the risk was knowable earlier than it was disclosed.
What Patients Should Know
This is legal-news coverage, not medical advice; SGLT2 inhibitors have real benefits and should not be stopped without a doctor. The main litigation has largely resolved. Anyone who suffered an amputation or ketoacidosis while taking Invokana should keep the prescription and medical records and consult qualified counsel about remaining options.
Before You Act
Thinking About Filing a Claim?
Most plaintiff lawyers offer a free initial consultation and work on contingency, meaning no fee unless there is a recovery. LawsuitWatch is not a law firm: we publish explainers, and we do not provide legal advice, representation or referrals. Your state bar directory is the reliable place to find and verify a lawyer.
Invokana Lawsuit: Amputation and Ketoacidosis Claims: Frequently Asked Questions
Answers to the most common questions about this case and your legal options.
What is the Invokana lawsuit about?
Allegations that Invokana, an SGLT2 diabetes drug, caused diabetic ketoacidosis, kidney injury and leg/foot amputations, and that Janssen failed to warn. It later got a black-box amputation warning.
Is there an Invokana settlement?
Yes. In 2018, Johnson & Johnson and Janssen reached a confidential settlement resolving a large portion of about 1,000 Invokana lawsuits in a New Jersey MDL.
Does Invokana still carry an amputation warning?
The FDA required a black-box amputation warning in 2017. Regulators have since updated SGLT2 labeling over time; discuss risks and benefits with your doctor.
Legal Disclaimer
This article is general legal information, not legal advice, and does not create an attorney-client relationship. Case status, eligibility criteria, and any amounts described are as reported at the date shown and may change. Consult a licensed attorney in your jurisdiction about your own situation.