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SGLT2 Inhibitor Lawsuits

Invokana and Farxiga lawsuits account for most of the SGLT2 inhibitor diabetes drug cases filed in federal court. Plaintiffs’ injuries include amputations, kidney damage, diabetic ketoacidosis and a flesh-eating disease called Fournier’s gangrene. As of September 2018, more than 1,100 Invokana lawsuits and more than 50 Farxiga lawsuits were pending in federal courts.

More than a thousand people have filed lawsuits against Type 2 diabetes drugmakers Johnson & Johnson, Bristol-Myers Squibb and AstraZeneca over injuries ranging from a flesh-eating disease called Fournier’s gangrene to life-threatening blood infections.

The U.S. Food and Drug Administration approved Invokana — the first drug in the SGLT2 inhibitor class of Type 2 diabetes drugs — in 2013. Several other drugs in the class, including Farxiga in 2014, followed it.

Lawsuits claim Johnson & Johnson, Bristol-Myers Squibb, AstraZeneca and other manufacturers knew their drugs could injure people but concealed the dangers from patients and their doctors. Despite knowing the dangers, they actively marketed defective and dangerous drugs to the public.

SGLT2 Inhibitors and Manufacturers
Drug Names Manufacturers
Invokana, Invokamet and Invokamet XR Johnson & Johnson, Janssen Pharmaceuticals
Farxiga and Xigduo XR Bristol-Myers Squibb, AstraZeneca
Jardiance, Glyxambi and Synjardy Boehringer Ingelheim, Eli Lilly

SGLT2 Litigation Status

Though there are a few assorted lawsuits for Jardiance and other SGLT2 brands, the bulk of federal litigation focuses on Invokana and Farxiga. The Judicial Panel on Multidistrict Litigation gathered cases from several courts across the country and consolidated them into New Jersey MDL No. 2750 (Invokana) and New York MDL No. 2776 (Farxiga).

Litigation is ongoing in both MDLs. New Jersey Judge Brian R. Martinotti has set the first Invokana bellwether trial date for January 2019.

Meanwhile, New York Judge Lorna G. Schofield issued an order in March 2018 for attorneys to pick Farxiga bellwether trial cases followed by a settlement conference in April 2018. Plaintiffs have voluntarily dismissed some Farxiga cases, but attorneys settled others for confidential amounts in September 2018.

Judge Schofield scheduled a status conference for Nov. 6, 2018 for the remaining cases in the Farxiga MDL.

Why People Are Suing Drugmakers

Lawsuits say SGLT2 manufacturers “negligently, recklessly and carelessly marketed, distributed and sold [each drug] without adequate instructions or warning of its serious side effects and unreasonably dangerous risks.” By the time the FDA released warnings, it was too late for some people who suffered serious health problems and filed lawsuits.

Plaintiffs say if they had known of the dangers, they would never have used the medications. Side effects caused them to endure pain, suffering, loss of quality of life and significant financial losses. Some people lost loved ones because manufacturers failed to warn them about the side effects of SGLT2 Inhibitors.

Did You Know?
From 2013 to 2018, the FDA has released six Safety Communications warning of serious side effects linked to SGLT2 inhibitors.

For example, Raymond Jack’s widow, Loretta, filed a lawsuit against J&J and Janssen Pharmaceuticals after Raymond took Invokana and died of complications. On March 5, 2015, Raymond began taking Invokana. By June, he had suffered a stroke, acute kidney injury, acute renal insufficiency and diabetic ketoacidosis stroke.

Then, in September he was in the hospital again for stroke, renal insufficiency, dehydration, acute kidney injury and acute toxic metabolic encephalopathy. In October, he was hospitalized again with a urinary tract infection and chronic kidney disease Stage III. He died in November 2015 because of his injuries.

Most of the injuries mentioned in lawsuits apply to all SGLT2 inhibitors with the exception of amputations. Invokana is the only drug linked to amputations. In general, people who suffered an injury after taking an SGLT2 inhibitor prior to the FDA warning may be eligible to file a lawsuit. But each case is different, and only an attorney can tell you if you qualify.

SGLT2 Injuries and Lawsuit Eligibility Dates
Injury Date of Injury
Amputations of legs, feet and/or toes (Invokana) Before May 16, 2017
Kidney injury Before June 14, 2016
Urinary tract infections resulting in kidney (pyelonephritis) or blood (urosepsis) infections requiring hospitalization Before Dec. 4, 2015
Fournier’s gangrene, also known as necrotizing fasciitis of the perineum Before Aug. 29, 2018
Diabetic ketoacidosis Before Dec. 4, 2015

Recent Lawsuits & Claims

SGLT2 lawsuits name many different drugs and manufacturers and claim a variety of injuries. These drugs affect older and younger people of both genders across the country. When people first started filing lawsuits, the main injuries were ketoacidosis and kidney injury. Because of expanded FDA warnings, people are filing suits for amputations and Fournier’s gangrene — these are the newest cases.

Polley Dailey
Polley Dailey sued Janssen Pharmaceuticals and J&J on July 6, 2017. She started taking Invokana in December 2014. About a year later, she had to have her right leg amputated. She said the defendants did not warn and mislead the public about the risks, specifically amputation.
Lee Letourneau
Lee Letourneau sued Janssen Pharmaceuticals and J&J on Sept. 8, 2018. He took Invokamet from February 2017 until the end of the year. Doctors diagnosed him with Fournier’s gangrene and removed 60 percent of his scrotum. Letourneau’s lawsuit states, “Nowhere does the [drug] label state that a male patient might suffer Fournier’s gangrene, or lose part of his scrotum.”
Betty Barker
Betty Barker and her husband Scott Barker sued Bristol-Myers Squibb and AstraZeneca on June 27, 2017. Just four months after taking Farxiga, Betty ended up in the hospital for diabetic ketoacidosis and dehydration. Hospital doctors told her to stop taking Farxiga.
Melissa Mitchell
Melissa Mitchell sued Eli Lilly and Boehringer Ingelheim on July 6, 2016. She began taking Jardiance in February 2015, and by June she was hospitalized for ketoacidosis. Defendants tried to get the case dismissed by saying her claims were based on side effects reported before Jardiance hit the market. But the judge let the case proceed and ruled the drugmakers should have changed their label to add warnings.

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics, vaccines and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Kevin Connolly
Kevin Connolly Managing Editor
Reviewed By
Dr. John A. Daller
Dr. John A. Daller American Board of Surgery

7 Cited Research Articles

  1. Barker v. Bristol-Myers Squibb et al. (2017, June 27). In The United States District Court for The Eastern District Of California. Complaint and Demand for Jury Trial. Case No. Case 1:17-at-00496. Retrieved from https://www.pacer.gov/
  2. Dailey v. Janssen Pharmaceuticals et al. (2017, July 6). United States District Court District of New Jersey Trenton Division. Complaint and Demand for Jury Trial. Case No. Case 3:17-cv-04954. Retrieved from https://www.pacer.gov/
  3. Jack v. Janssen Pharmaceuticals et al. (2017, October 27). United States District Court District Of New Jersey. Complaint. Case No. Case 3:17-cv-09809. Retrieved from https://www.pacer.gov/
  4. Letourneau v. Janssen Pharmaceuticals et al. (2018, September 6). United States District Court District of New Jersey. Complaint and Demand for Jury Trial. Case No. Case 1:18-cv-13584. Retrieved from https://www.pacer.gov/
  5. Martinotti, B.R. (2018, February 5). MDL NO. 2750 Master Docket No. 3:16-MD-2750 Case Management Order No. 26. Retrieved from http://www.njd.uscourts.gov/sites/njd/files/CMO26_1.pdf
  6. Mitchel v. Boehringer Ingelheim. (2017, November 21). In The United States District Court For The Western District Of Tennessee Eastern Division. Order Partially Granting and Partially Denying Defendant’s Motion To Dismiss. Case No. Case 1:16-cv-02384-STA-egb. Retrieved from https://www.pacer.gov/
  7. U.S. Food and Drug Administration. (2018, August 29). Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm446852.htm
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