The Farxiga ketoacidosis lawsuit refers to legal claims filed against AstraZeneca and Bristol-Myers Squibb alleging that their diabetes drug Farxiga (dapagliflozin) caused patients to develop diabetic ketoacidosis without adequate warning. The litigation consolidated into Multidistrict Litigation No. 2776, which was terminated in September 2020 with the closure of 67 cases””notably without any verdicts or settlements being reached.
As of 2025-2026, there is no active MDL litigation for Farxiga ketoacidosis claims, and most attorneys are not currently accepting new cases, though statutes of limitations vary by state. One case that illustrates the nature of these claims involved Betty Barker and Scott Barker, who sued Bristol-Myers Squibb and AstraZeneca on June 27, 2017. Betty was hospitalized for diabetic ketoacidosis and dehydration just four months after starting Farxiga, prompting allegations that the manufacturers failed to adequately warn about this serious risk. This article covers the FDA warnings that prompted litigation, the types of injuries alleged in lawsuits, how the legal proceedings unfolded, and what options may remain for individuals who experienced adverse effects from this SGLT2 inhibitor medication.
Table of Contents
- What Is the Farxiga Ketoacidosis Lawsuit and Why Did It Start?
- FDA Adverse Event Reports That Fueled the Litigation
- How the Multidistrict Litigation Proceeded and Concluded
- Injuries Alleged in Farxiga Lawsuits
- Current Legal Options for Farxiga Patients
- Lessons from SGLT2 Inhibitor Litigation
- Understanding the Claims Against AstraZeneca and Bristol-Myers Squibb
- Future Outlook for SGLT2 Inhibitor Legal Claims
- Conclusion
What Is the Farxiga Ketoacidosis Lawsuit and Why Did It Start?
Farxiga, introduced by AstraZeneca in 2014 for the treatment of type 2 diabetes, belongs to a class of medications called SGLT2 inhibitors. These drugs work by helping the kidneys remove glucose from the bloodstream through urination. While effective for blood sugar control, post-market surveillance revealed a concerning pattern of adverse events that the FDA found significant enough to warrant public warning. In May 2015, the FDA issued a drug safety communication highlighting at least 20 instances of ketoacidosis in patients treated with SGLT2 inhibitors between March 2013 and June 6, 2014.
This was particularly alarming because many cases occurred in type 2 diabetics, who typically do not experience this life-threatening condition. Unlike traditional diabetic ketoacidosis that presents with extremely high blood sugar, SGLT2-related cases sometimes occurred with only moderately elevated glucose levels, making diagnosis more difficult and potentially delaying treatment. The FDA’s warning opened the door for litigation as patients and their attorneys argued that AstraZeneca knew or should have known about the ketoacidosis risk before the drug reached the market. Primary allegations in the lawsuits included failure to warn, defective design, and negligence in marketing. Plaintiffs contended that had they been properly informed of the risk, they would have chosen alternative diabetes treatments or been better prepared to recognize warning signs.
FDA Adverse Event Reports That Fueled the Litigation
The volume of adverse event reports submitted to the FDA provided substantial evidence for plaintiffs’ claims. In a 12-month period from July 2014 to June 2015, 80 cases of diabetic ketoacidosis were reported to the FDA in connection with SGLT2 inhibitors. Additionally, 101 confirmed cases of acute kidney injury were reported between March 2013 and October 2015, expanding the scope of potential injuries beyond ketoacidosis alone. However, these numbers come with important limitations. FDA adverse event reporting is voluntary, meaning actual case numbers may be significantly higher than reported figures.
Conversely, reported cases do not necessarily establish causation””some patients may have developed these conditions due to underlying disease progression or other factors unrelated to the medication. This evidentiary challenge likely contributed to the difficulty plaintiffs faced in achieving favorable outcomes in the litigation. The reported injuries in Farxiga lawsuits extended beyond ketoacidosis to include necrotizing fasciitis (commonly known as Fournier’s gangrene), kidney failure, and heart issues. This range of alleged harms reflected concerns about the systemic effects of SGLT2 inhibitors, though ketoacidosis remained the primary focus of the consolidated litigation. For patients evaluating their own situations, the connection between their specific injury and Farxiga use became a central question that required medical documentation and expert analysis.
How the Multidistrict Litigation Proceeded and Concluded
The legal system’s response to the wave of Farxiga lawsuits followed a familiar pattern for pharmaceutical mass torts. Cases were consolidated into Multidistrict Litigation No. 2776 to streamline pretrial proceedings and prevent conflicting rulings across different federal courts. This consolidation allowed for coordinated discovery, where plaintiffs and defendants could share evidence and conduct depositions more efficiently than if each case proceeded independently. The outcome, however, disappointed many plaintiffs.
The Farxiga MDL was terminated in September 2020, resulting in the closure of 67 cases. No verdicts or settlements were reached””a relatively unusual result for pharmaceutical MDLs, which often conclude with negotiated settlement programs. For comparison, the related Invokana MDL, involving another SGLT2 inhibitor, closed in 2023 similarly without verdicts or settlements. The absence of settlements does not necessarily mean the claims lacked merit. MDL outcomes depend on numerous factors including the strength of scientific evidence linking the drug to specific injuries, the quality of individual case documentation, litigation strategy decisions, and defendants’ willingness to negotiate versus fight cases to verdict. Some individual cases may have been resolved privately outside the MDL structure, though no major settlement announcements have been made public.
Injuries Alleged in Farxiga Lawsuits
Diabetic ketoacidosis, the primary injury alleged in Farxiga litigation, is a serious metabolic emergency. It occurs when the body produces high levels of ketones due to insufficient insulin, causing blood to become acidic. Symptoms include excessive thirst, frequent urination, nausea, abdominal pain, confusion, and fruity-scented breath. Left untreated, it can lead to coma and death. The condition typically requires hospitalization, often in intensive care, with treatment including intravenous fluids, electrolyte replacement, and insulin therapy. What made SGLT2-related ketoacidosis particularly concerning was its atypical presentation.
Traditional diabetic ketoacidosis in type 2 diabetics is relatively rare and usually associated with blood glucose levels above 250 mg/dL. Cases associated with Farxiga sometimes occurred at lower glucose levels, a presentation termed “euglycemic diabetic ketoacidosis.” This atypical presentation could delay diagnosis as neither patients nor healthcare providers expected ketoacidosis without extremely elevated blood sugar readings. Beyond ketoacidosis, lawsuits alleged additional serious injuries. Necrotizing fasciitis of the perineum, known as Fournier’s gangrene, is a rare but devastating flesh-eating bacterial infection requiring emergency surgery and carrying significant mortality risk. Kidney failure allegations connected to the drug’s mechanism of action, which affects kidney function to remove excess glucose. These varied injury claims meant that each plaintiff’s case required individualized medical evidence establishing both the injury and its connection to Farxiga use.
Current Legal Options for Farxiga Patients
As of 2025-2026, the landscape for potential Farxiga litigation has changed significantly. With no active MDL and most sources indicating that attorneys are not currently accepting new Farxiga cases, individuals who experienced adverse effects face limited options. However, some law firms may still evaluate potential cases on an individual basis, particularly for claims involving injuries that may fall outside the statute of limitations considerations. The statute of limitations for filing pharmaceutical injury claims varies by state, typically ranging from one to three years from discovery of the injury. This “discovery rule” means the clock generally starts when a patient knew or should have known that their injury was connected to the medication, not necessarily when the injury first occurred.
For someone hospitalized with ketoacidosis in 2018 who only recently learned of the Farxiga connection, the analysis becomes more complex and state-specific. The tradeoff for potential plaintiffs is significant. Pursuing an individual lawsuit without the support of MDL infrastructure means higher costs, more individualized work, and no benefit from shared discovery with other plaintiffs. Success would require establishing causation through expert testimony, obtaining comprehensive medical records, and convincing a jury””all without the leverage that consolidated litigation provides. For most individuals, the window for meaningful legal action has likely closed, though consultation with a licensed attorney in their state remains the only way to obtain a definitive answer about their specific situation.
Lessons from SGLT2 Inhibitor Litigation
The Farxiga litigation experience offers insights for patients taking any newer medication class. SGLT2 inhibitors reached the market with FDA approval based on clinical trial data, but rare adverse events often emerge only after widespread use exposes the drug to larger and more diverse patient populations. The ketoacidosis risk was not prominently featured in early labeling, and the FDA’s 2015 warning came only after significant adverse event accumulation. For current patients on SGLT2 inhibitors, this history underscores the importance of understanding potential side effects and maintaining open communication with prescribing physicians.
Signs of ketoacidosis””excessive thirst, frequent urination, nausea, abdominal pain, fatigue, and difficulty breathing””warrant immediate medical attention, even if blood sugar readings appear relatively normal. Patients should not discontinue medications without medical guidance, as the benefits of glycemic control must be weighed against potential risks. The litigation also illustrates how pharmaceutical accountability functions in the American legal system. Even when cases do not result in verdicts or settlements, the process of discovery and public attention can influence drug labeling, prescribing practices, and corporate behavior. The FDA has since updated warnings for SGLT2 inhibitors, and healthcare providers have become more attuned to the ketoacidosis risk, potentially preventing future injuries.
Understanding the Claims Against AstraZeneca and Bristol-Myers Squibb
Plaintiffs in Farxiga lawsuits pursued several legal theories against the drug manufacturers. Failure to warn claims alleged that the companies knew or should have known about the ketoacidosis risk and failed to adequately communicate it to physicians and patients. Defective design claims argued that the drug itself was unreasonably dangerous, with risks outweighing benefits for at least some patient populations. Negligence claims focused on the companies’ conduct in developing, testing, and marketing the medication.
The Betty Barker case exemplified these claims. When she developed diabetic ketoacidosis requiring hospitalization just four months after starting Farxiga, her lawsuit contended that proper warnings would have either prevented her from taking the drug or enabled faster recognition and treatment of her condition. The case named both Bristol-Myers Squibb and AstraZeneca as defendants, reflecting the complex partnership arrangements that often exist in pharmaceutical manufacturing and marketing. Defending against these claims, the manufacturers could point to FDA approval, prescribing information that did reference ketoacidosis risks, and the difficulty of establishing that any individual case was caused by the medication rather than underlying diabetes or other factors. The absence of trial verdicts means these arguments were never fully tested before a jury, leaving unanswered questions about how the legal system would have ultimately assessed responsibility.
Future Outlook for SGLT2 Inhibitor Legal Claims
While the organized Farxiga litigation has concluded, the broader SGLT2 inhibitor class may yet generate future legal activity. These medications remain widely prescribed, and continued adverse event monitoring may reveal patterns not yet apparent. New scientific research into the mechanisms by which these drugs cause ketoacidosis or other injuries could potentially revive interest in litigation if evidence of earlier manufacturer knowledge emerges.
For individuals who believe they were harmed by Farxiga, the practical reality is that meaningful legal recourse has become significantly more difficult to obtain. Those who experienced serious injuries within the past few years and have not yet consulted an attorney should do so promptly to understand whether any options remain within their state’s statute of limitations. Documentation including medical records, pharmacy records, and any correspondence with healthcare providers about the medication and subsequent health problems will be essential for any evaluation.
Conclusion
The Farxiga ketoacidosis lawsuit represented an effort by injured patients to hold pharmaceutical manufacturers accountable for what they alleged were inadequate warnings about serious risks. The MDL consolidated 67 cases before terminating in September 2020 without verdicts or settlements, an outcome that left many plaintiffs without the resolution they sought. FDA adverse event data documenting ketoacidosis, kidney injury, and other serious conditions provided the foundation for these claims, though evidentiary challenges in proving causation likely contributed to the litigation’s inconclusive end.
For those affected by Farxiga-related injuries today, options are limited but not necessarily nonexistent. Statutes of limitations vary by state, and some attorneys may still evaluate individual cases despite the absence of active consolidated litigation. Anyone with questions about their specific situation should consult with a licensed attorney in their state who can assess the particular facts and applicable deadlines. The larger lesson from this litigation is the importance of post-market surveillance for newer medications and the value of patients remaining informed and vigilant about potential side effects of any prescribed drug.