Jardiance Lawsuit: Injuries, Warnings, and MDL Status

The Jardiance lawsuit landscape consists of individual product liability claims against Boehringer Ingelheim Pharmaceuticals and Eli Lilly, alleging the companies failed to warn patients and doctors about serious side effects of the type 2 diabetes drug empagliflozin. There is no certified class action, and the federal courts have not created a multidistrict litigation specific to Jardiance. Each plaintiff has to prove Jardiance caused their particular injury. The drug remains FDA-approved and on the market, with no recall.

Injuries Behind the Lawsuits

Plaintiffs have brought claims tied to several conditions they say Jardiance caused or contributed to:

Diabetic ketoacidosis (DKA), a dangerous buildup of blood acids. SGLT2 inhibitors can trigger a form of DKA in which blood sugar looks normal, which can delay diagnosis. The current label acknowledges fatal post-market DKA cases.¹²
Kidney damage and acute kidney injury, sometimes requiring hospitalization or dialysis, which the label attributes to volume depletion.²
Fournier’s gangrene, a rare flesh-eating infection of the genital and perineal area, identified as a known risk in post-approval use.³
Heart attack, stroke, and other cardiovascular complications.
Wrongful death.

One boundary worth noting: amputation claims, which have driven much of the Invokana litigation against a competing SGLT2 inhibitor, have not been a central feature of Jardiance cases. A 2024 meta-analysis of more than 20,000 patients across four major empagliflozin trials found no statistically significant increase in amputation risk versus placebo.⁴ The current prescribing information does note an amputation imbalance in a long-term trial of patients with chronic kidney disease.²

When the Warnings Came

The failure-to-warn theory turns on timing: what the manufacturers knew, and when the label caught up. The FDA approved Jardiance in August 2014.² Key regulatory milestones since then:

May 2015. The FDA issued a safety communication warning that SGLT2 inhibitors, including Jardiance, could cause ketoacidosis, citing 20 cases from its adverse event reporting system between March 2013 and June 2014.⁵
December 2015. The FDA required manufacturers to add label warnings for DKA and serious urinary tract infections. By then it had identified 73 DKA cases, all involving hospitalization or emergency treatment.⁶
August 2018. The FDA warned about Fournier’s gangrene risk with SGLT2 inhibitors. A later database analysis identified 55 cases between March 2013 and January 2019, all requiring surgery, with three deaths.⁷

The current Jardiance label carries warnings for DKA, Fournier’s gangrene, acute kidney injury, lower limb amputation, and serious hypersensitivity reactions.²

The Legal Theory and What Courts Have Said

Jardiance complaints generally allege that Boehringer Ingelheim and Eli Lilly knew or should have known about the drug’s risks and either withheld that information or failed to test adequately before release. Some complaints have added design defect, fraud, and breach of warranty theories, though not all survive early motions.

In Mitchell v. Boehringer Ingelheim, filed in June 2016 in the Western District of Tennessee, Melissa Mitchell alleged she developed DKA after taking Jardiance from February to June 2015, before adequate warnings existed. In November 2017, Chief District Judge S. Thomas Anderson allowed the failure-to-warn claim to proceed, finding Mitchell had presented enough evidence to argue the drug was in a “defective condition or unreasonably dangerous.”⁸ The court dismissed Eli Lilly as a defendant, reasoning that Boehringer Ingelheim developed the drug.⁹

A February 2018 decision in Bell v. Boehringer Ingelheim, from the Western District of Pennsylvania, illustrates how narrowly some theories survive. The court dismissed strict liability and breach of warranty claims outright, citing Pennsylvania law that limits prescription drug manufacturer liability to negligence. It also rejected a standalone gross negligence claim but allowed the plaintiff to replead negligence, fraud, and misrepresentation with more specific facts.¹⁰

Expect three recurring defenses. First, federal preemption: the argument that state failure-to-warn claims conflict with the FDA’s control over drug labeling. Second, Eli Lilly’s position that as a co-marketer rather than the New Drug Application holder, it had no legal authority to change the label. Third, the learned intermediary doctrine, which treats a manufacturer’s duty to warn as satisfied by informing prescribing doctors rather than patients.¹¹

Why There Is No Class Action or MDL

Searches for a “Jardiance class action” turn up a mismatch with the actual court structure. No class has been certified. Cases proceed individually under a mass tort framework, and each plaintiff must independently prove specific causation.¹²

There is also no Jardiance-specific multidistrict litigation. In December 2016, the U.S. Judicial Panel on Multidistrict Litigation declined to fold Jardiance or Farxiga cases into the Invokana MDL (MDL No. 2750), noting only three Jardiance-only federal cases existed at the time and that combining claims against competing manufacturers would complicate discovery and risk exposing trade secrets.¹³ Jardiance litigation has stayed considerably smaller than the Invokana and Farxiga proceedings, both of which reached confidential settlements.

Deadlines and Where Things Stand

Statutes of limitations for a Jardiance claim vary by state, generally running one to six years. Many states use a discovery rule that starts the clock when a patient knew or should have known the drug caused the injury. Some states also impose a statute of repose, an absolute outer deadline of roughly 10 to 15 years after the drug was first used.¹² If you think you have a claim, the deadline analysis is state-specific, and it moves on its own regardless of the litigation’s overall status.

Jardiance cases remain active but limited in number. No public verdicts or settlement figures specific to Jardiance have been reported. Some firms that once accepted these cases have stopped; others continue to evaluate claims, particularly those involving Fournier’s gangrene and DKA requiring hospitalization.¹⁴ The drug itself remains widely prescribed with no recall on the horizon, and emerging safety research, including recent work on perioperative DKA risk in SGLT2 inhibitor users, could shape future filings.¹⁵

1
AboutLawsuits.com. Ketoacidosis Risks and Side Effects of Invokana, Jardiance, and Similar Diabetes Drugs
2
FDA. Jardiance (Empagliflozin) Prescribing Information
3
FDA. Jardiance (Empagliflozin) Prescribing Information
4
PMC. Empagliflozin and Lower Limb Amputation Meta-Analysis
5
AJMC. FDA Warns That SGLT2 Inhibitors May Result in Ketoacidosis
6
Drugwatch. SGLT2 Inhibitors
7
TCTMD. FDA Tallies Cases of Fournier’s Gangrene in Patients Taking SGLT2 Inhibitors
8
AboutLawsuits.com. Jardiance Lawsuit Proceeds
9
vLex. Mitchell v. Boehringer Ingelheim Pharms., Inc.
10
CaseMine. Bell v. Boehringer Ingelheim Pharms., Inc.
11
Moll Law Group. Invokana and SGLT2 Inhibitor Litigation
12
LawFold. Jardiance Lawsuit
13
JPML. MDL-2750 Initial Transfer Order
14
YouHaveALawyer.com. Jardiance Lawsuits
15
JAMA Network. Preoperative SGLT2 Inhibitor Use and Postoperative Diabetic Ketoacidosis