Plaintiff's attorneys argue that manufacturers of Invokana (canagliflozin) and other SGLT2 inhibitors drugs for Type 2 diabetes did not properly warn patients and doctors of the risks of serious and potentially fatal side effects. If doctors or patients had known, they might have chosen another medication or monitored their health for symptoms of complications.
Invokana users filed the first lawsuits, and then lawsuits for other drugs followed. According to lawsuits, manufacturers concealed — and continue to conceal — knowledge of SGLT2 drugs' "unreasonably dangerous risks" from consumers and the medical community. These dangerous risks include diabetic ketoacidosis, blood infections and kidney problems.
The United States Judicial Panel on Multidistrict Litigation (JPML) ordered Invokana cases consolidated in multidistrict litigation (MDL) number 2750 in New Jersey before Judge Brian R. Martinotti. While attorneys are accepting cases for all SGLT2 inhibitors, no other drugs have an MDL yet.
The litigation is still in its early stages, and there are no settlements or jury verdicts. Discovery is still underway and no exact bellwether trial dates are set. Lawyers expect many more plaintiffs to join the Invokana MDL. Attorneys are accepting cases for all SGLT2 drugs.
SGLT2 drugs subject to potential lawsuits include:
- Invokana (canagliflozin), Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson
- Invokamet (canagliflozin and metformin), Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson
- Invokamet XR (canagliflozin and metformin extended release), Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson
- Farxiga (dapagliflozin), AstraZeneca
- Xigduo XR (dapagliflozin and metformin extended-release), AstraZeneca
- Jardiance (empagliflozin), Boehringer Ingelheim and Eli Lilly
- Glyxambi (empagliflozin and linagliptin), Boehringer Ingelheim and Eli Lilly
- Synjardy (empagliflozin and metformin), Boehringer Ingelheim and Eli Lilly
Side Effects Claimed in Lawsuits
Since the U.S. Food and Drug Administration approved the first drug in the class — Invokana — in 2013, it has issued a number of safety communications about these medications.
Manufacturers knew or should have known these drugs could cause potential side effects, according to lawsuits. But the first warnings did not reach the public until December 4, 2015 when the FDA required companies to put warnings on labels.
In the meantime, millions of patients received prescriptions for these drugs and may have suffered severe health problems linked to the medications.
A number of serious health problems are at the center of SGLT2 litigation. In many cases, patients were in critical condition that required hospitalization. Some plaintiffs died from their injuries. Damages claimed include past and future medical bills, pain, suffering, lost wages and funeral expenses.
Lawsuits against SGLT2 manufacturers claim the following injuries:
- Diabetic ketoacidosis requiring hospitalization
- Diabetic ketoacidosis resulting in death
- Renal failure in those with no history of underlying kidney problems
- Acute kidney injury requiring hospitalization in those with no history of underlying kidney problems
- Stroke or other thromboembolic events
- Urinary tract infections resulting in blood infections (urosepsis), requiring hospitalization
- Urinary tract infections resulting in kidney infections (pyelonephritis), requiring hospitalization
Important Dates for Specific Injuries and Filing Lawsuits
In general, people who took one or more SGLT2 drugs and suffered diabetic ketoacidosis, urosepsis and pyelonephritis before December 4, 2015 may have possible claims against drug manufacturers. This is the date the FDA added the official warning for these conditions to drug labels.
Plaintiffs who suffered renal failure, acute kidney injury, a stroke or thromboembolic events before or after December 4, 2015 may still file a claim.
For statute of limitations information or other important deadlines, claimants should contact and attorney immediately to avoid possible disqualification of a claim.
SGLT2 Inhibitor Lawsuits
Plaintiffs who took Invokana, Farxiga and other SGLT2 inhibitors claim the drugs caused several severe side effects, some fatal. According to lawsuits, manufacturers “negligently, recklessly and carelessly marketed, distributed [SGLT2 drugs] without adequate instructions or warning of serious side effects and unreasonably dangerous risks.”
- Michael Cormier – Tennessee resident Michael Cormier took Farxiga and claims the drug caused him to suffer diabetic ketoacidosis after he only took it for a month. He was in critical condition in the ICU at Vanderbilt University Medical Center for about three days. Doctors told him to stop taking Farxiga. His lawsuit alleges AstraZeneca and Bristol-Myers Squibb — who worked together to sell and market Farxiga — knew that the drug increased the risk of diabetic ketoacidosis and kidney damage but did not sufficiently warn consumers or physicians of the risk.
- Adelina Quintanilla – Texas resident Adelina Quintanilla’s lawsuit alleges Farxiga manufacturers AstraZeneca and Bristol-Myers Squibb “willfully deceived” her, her doctors and the general public about the drug’s health risks. She claims Farxiga caused her to suffer diabetic ketoacidosis and is unreasonably dangerous and defective.
- Patricia MacMurray – Patricia MacMurray sued Janssen Pharmaceuticals, Eli Lilly and Boehringer Ingelheim after she took Invokana and Jardiance and developed diabetic ketoacidosis. She was hospitalized for seven days, part of it in intensive care. She says the dangerous drugs caused and will continue to cause her injury and damage. MacMurray said she relied on the claims made by manufacturers that Invokana was safe and effective. Instead, she ended up in the hospital.
- Donna and Terry Royse – Donna Royse filed a lawsuit on behalf of her husband, Terry, after he took an unspecified SGLT2 inhibitor and suffered kidney failure, respiratory failure and death. The lawsuit against Janssen Pharmaceuticals, Eli Lilly, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb and Mitsubishi Tanabe Pharma accuses the manufacturers of “willful and wanton conduct and/or gross negligence,” fraud and negligent design among other allegations.
Litigation Status and Claims against Manufacturers
As of March 22, 2017, about 178 cases were pending before Judge Martinotti in the Invokana New Jersey MDL, according to Case Management Order #8. In addition, Invokana cases pending in the Eastern District of Pennsylvania will transfer to New Jersey.
Martinotti plans to schedule the first Invokana bellwether trial for September 2018. In the meantime, cases will be in discovery. In the discovery phase both sides will exchange information and conduct depositions.
Some of the claims made against SGLT2 manufacturers include:
- Failure to warn of risks
- Manufacturing a defective drug
- Deceptive advertising
- Failure to adequately test drugs
- Misleading physicians and the public by downplaying risks
- Willfully deceiving the public
Other Type 2 Diabetes Drug Settlements
While no SGLT2 drug lawsuits have reached settlement or jury trial yet, these are not the first class-related Type 2 diabetes drugs involved in lawsuits. Other drugs involved in lawsuits include Takeda’s Actos (pioglitazone) and GlaxoSmithKline’s Avandia (rosiglitazone) — both members of the thiazolidinedione (TZD) class.
After studies linked Actos of an increased risk of bladder cancer, lawsuits against Takeda ramped up. Tens of thousands of plaintiffs came forward claiming the drug gave them bladder cancer.
In April 2014, a jury ordered Takeda and Eli Lilly to pay $9 billion to one man who claimed the drug gave him bladder cancer. In 2015, Takeda agreed to pay about $2.37 billion to settle about 9,000 cases.
Patients who took GlaxoSmithKline’s Avandia claimed the drug caused cardiovascular death, liver toxicity and bone fractures. Since 2007, the drug was implicated in more than 50,000 lawsuits. It settled several thousand cases for just under $1 billion from 2010 to 2011. Then, the company set aside about $3.4 billion for future Avandia settlements and litigation.
Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.
- In Re: Invokana (canagliflozin) Products Liability Litigation. (2016, December 7). Transfer order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2750-Initial_Transfer-12-16.pdf
- Cormier v. Bristol-Myers Squibb and AstraZeneca. (2016, December 30). In the United States District Court for the Southern District of New York, Complaint and Demand for Jury Trial. Case 1:16-cv-10046
- Quintanilla vs. Bristol-Myers Squibb and Astra Zeneca. (2016, May 23). In the United States Dustrict Court for the Southern District of Texas Corpus Christi Division, Complaint Jury Trial Demanded. Case 2:16-cv-00172
- Royse v. Janssen Pharmaceuticals et al. (2016, November 28). In the United States District Court for the Eastern District of Kentucky, Jury Trial Demanded. Case: 5:16-cv-00439-JMH
- In Re: Invokana (canagliflozin) Products Liability Litigation. Case Management Order #8. Retrieved from http://www.njd.uscourts.gov/sites/njd/files/InvokanaCMO8.pdf
- Library of Congress Prints and Photographs Division Washington, D.C. 20540 USA http://hdl.loc.gov/loc.pnp/pp.print
Did you experience ketoacidosis after taking Invokana?