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Invokana Lawsuits and Other SLGT2 Cases

Hundreds of SGLT2 inhibitor lawsuits claim the Type 2 diabetes drugs caused amputation, diabetic ketoacidosis and kidney injury. Plaintiffs say drug companies manufactured faulty drugs and failed to warn of the risks.

Complications from taking an SGLT2 Inhibitor?

If you took a diabetes drug like Invokana or Farxiga and suffered from ketoacidosis or kidney injury, you may be eligible for compensation.

Invokana Lawsuit Facts
  1. Number of Lawsuits About 990 in the Invokana MDL; 57 in the Farxiga MDL
  2. Plaintiff Injuries Diabetic ketoacidosis, kidney damage and others
  3. Defendants Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, Bristol-Myers Squibb, AstraZeneca, Boehringer Ingelheim and Eli Lilly
  4. Litigation Status Active

People who say they suffered serious injuries after taking Invokana and other SGLT2 inhibitor diabetes drugs are suing the manufacturers in the U.S. and Canada seeking compensation for what happened to them. The lawsuits are the subject of two federal Multidistrict Litigations, and trials have not yet begun.

Federal, State and Class-Action Lawsuits

SGLT2 drug lawsuits are in their early stages and have not yet proceeded to trial or been part of any large settlements. But the cases involving about 800 plaintiffs who say the drugs caused injuries are proceeding on several fronts:

Cases Consolidated

The U.S. Judicial Panel on Multidistrict Litigation ordered Invokana cases consolidated in multidistrict litigation (MDL) No. 2750 in New Jersey before Judge Brian R. Martinotti. As of Dec. 18, 2017, over 990 cases were involved in the Invokana MDL.

Clarkson S. Fisher Federal Building and United States Courthouse in Trenton, New Jersey.
Clarkson S. Fisher Federal Courthouse, site of the Invokana New Jersey MDL

According to Johnson & Johnson, there are also federal lawsuits over Invokana pending in federal court in California and Missouri. There are also cases in state courts in Pennsylvania, California and New Jersey.

U.S. District Judge Lorna G. Schofield is overseeing a Farxiga MDL in the Southern District of New York. As of Dec. 18, 2017, there were 55 cases pending in the Farxiga MDL.

Bellwether Cases Planned

Bellwether trials involve cases selected by the parties to go to trial first in MDLs and other mass torts. These initial trials are expected to help the parties get an idea how the remaining cases may play out, providing useful information to guide potential settlement negotiations.

Did You Know?
Bellwether trials help parties get an idea how the remaining cases may play out.

For example, if the bellwether trials end with large verdicts, that suggests other cases may warrant large settlements. If, on the other hand, the drugmaker prevails in the initial trials, that would portend a different outcome. The same holds for court rulings on matters of importance, such as whether certain experts will be permitted to give testify about their opinions.

Invokana Bellwether

The first Invokana bellwether trial is planned for September 2018. In this case, the Judge Martinotti has directed plaintiffs’ attorneys and attorneys for the defense to identify a total of six plaintiffs who ingested Invokana and later developed ketoacidosis and six who later suffered kidney injury. This will be a total of 12 potential bellwether cases, with an equal number representing each kind of injury selected by the defense and by the plaintiffs. To be eligible to be a bellwether, plaintiffs must have filed their case before July 31, 2017 and been prescribed Invokana.

“In selecting their respective six cases,” the court order states, “the parties are strongly encouraged to select cases that they have a good faith belief are representative cases that should be robustly discovered and then taken to trial.”

Other Bellwethers

The court will seek another batch of six bellwether cases to be selected in 2018 involving people who ingested Invokana and later developed a cardiovascular injury, such as a heart attack or stroke.

The Farxiga bellwether cases are being selected, and the judge has not yet created a trial schedule.

Lawsuit Deadlines

In general, people who took one or more SGLT2 drugs and suffered diabetic ketoacidosis, urosepsis and pyelonephritis before Dec. 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.

Gangrene Lawsuit
Patients who developed gangrene in the lower limbs and toes as well as amputations in the lower limbs before May 16, 2017, may have a claim.
Renal Failure
People who suffered renal failure or acute kidney injury before Dec. 4, 2015, may file a claim.

For statute of limitations information or other important deadlines, claimants should contact a qualified product liability attorney as soon as possible to avoid disqualification of a claim.

Find out or if you Qualify for compensation for either claims. Free Case Review

Injuries You Can Sue For

People who were prescribed SGLT2 drugs by a doctor and were later injured and had to stay in the hospital overnight as a result may be able to file a lawsuit to get compensated. Family members of people who died from these injuries may also be able to file.

Injuries for which patients and their families ay be able to obtain compensation through a lawsuit include:
  • Diabetic ketoacidosis (if suffered from ingesting a covered drug before Dec. 4, 2015) that resulted in hospitalization or death
  • Urinary tract infections resulting in blood infections (urosepsis) requiring hospitalization (If suffered from ingesting a covered drug before Dec. 4, 2015)
  • Urinary tract infections resulting in kidney (pyelonephritis) or blood (urosepsis) infections requiring hospitalization (If suffered from ingesting a covered drug before Dec. 4, 2015)
  • Below-the-knee amputations before May 16, 2017
  • Renal (kidney) failure in patients with no history of underlying kidney problem

SGLT2 Inhibitor Lawsuit Allegations

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.

Risks Alleged

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, certain amputations and kidney problems.

Public Notification

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 Dec. 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.

Hospitalizations and Deaths

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.

Claims against manufacturers of SGLT2 inhibitor drugs for treatment of type 2 diabetes include:
  • Failure to warn of risks
  • Negligence
  • Manufacturing a defective drug
  • Deceptive advertising
  • Failure to adequately test drugs
  • Misleading physicians and the public by downplaying risks
  • Willfully deceiving the public

Brand Names Involved in Lawsuits

Sodium-glucose cotransporter 2 (SGLT2) drugs are a relatively new class of drugs used to treat Type 2 diabetes. The drugs are designed to prevent the blood from reabsorbing glucose. But they also have been linked to various dangerous side effects, which have precipitated the filing of lawsuits.

SGLT2 Drugs include:
  • Invokana
  • Invokamet
  • Xigduo XR
  • Glyxambi
  • Farxiga
  • Jardiance
SGLT2 lawsuit defendants include:
  • Bristol-Myers Squibb, which makes AstraZeneca
  • Eli Lilly
  • Janssen Pharmaceuticals
  • Boehringer Ingelheim
  • Mitsubishi Tanabe Pharma

Settlements and Cases

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 Diabetes Drug Lawsuits

Other drugs involved in lawsuits include Takeda’s Actos (pioglitazone) and GlaxoSmithKline’s Avandia (rosiglitazone) — both members of the thiazolidinedione (TZD) class.

Actos
Actos being one drug involved in lawsuits
Avandia
Actos being another drug involved in lawsuits

After studies linked Actos to 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.

$9 billion verdict

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.

Settlements, Litigation Fund

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.

SGLT2 Inhibitor Lawsuits

Hundreds of plaintiffs have filed lawsuits saying the suffered serious injuries from taking SGLT2 inhibitors.

Some examples of SGLT2 Inhibitor lawsuits include:
Cormier v. Bristol-Myers Squibb, et al
  • PLAINTIFF: Michael Cormier
  • ALLEGED INJURY: Diabetic ketoacidosis
  • DRUG: Farxiga
  • DATE OF ALLEGED INJURY: January 8, 2016
  • AGE AT INJURY: 43
  • AGE AT FIRST PRESCRIPTION: 43
  • LAWSUIT: Filed Dec. 30, 2016 in United States District Court for the Southern District of New York against Bristol-Myers Squibb Co., AstraZeneca LP and AstraZeneca Pharmaceuticals LP
Quintanilla v. Bristol-Myers Squibb Co., et al
  • PLAINTIFF: Adelina Quintanilla
  • ALLEGED INJURY: Diabetic ketoacidosis
  • DRUG: Farxiga
  • DATE OF ALLEGED INJURY: May 2014
  • LAWSUIT: Filed May 23, 2016, in the United States District Court for the Southern District of Texas against Bristol-Myers Squibb Co., AstraZeneca LP and AstraZeneca Pharmaceuticals LP.
MacMurray v. Janssen, et al
  • PLAINTIFF: Patricia MacMurray
  • ALLEGED INJURY: Diabetic ketoacidosis
  • DRUGS: Invokana and Jardiance
  • DATE OF ALLEGED INJURY: March 2015
  • LAWSUIT: Filed October 10, 2016, in the United States District Court for the Southern District of Indiana against Janssen Pharmaceuticals, Inc., Eli Lilly and Company, and Boehringer Ingelheim Pharmaceuticals Inc.

Canadian Class Action

Kidney Failure Illustration
Potential serious side effects of Invokana include diabetic ketoacidosis, kidney failure and death

At least one class action lawsuit has been filed in Canada over Invokana. A complaint seeking more than $1 billion in special and general damages was filed in Ontario on behalf of everyone in Canada who ingested Invokana. Among other things, the suit against Johnson & Johnson and Janssen Pharmaceuticals alleges the companies failed to warn patients about the potential for serious side effects, including diabetic ketoacidosis, kidney failure and death. The lead plaintiff, Rosalba Joudry, says she discovered the danger when she happened upon a U.S. television commercial. She contacted her doctor and after tests, learned she was experiencing kidney failure.

FDA Warnings About Serious Side Effects

The FDA approved the first drug in the class — Invokana — in 2013, and has since then issued a number of safety communications about these medications. The first warnings did not reach the public until Dec. 4, 2015 when the FDA required companies to put warnings on labels.

Among the more serious warnings required by the FDA:
Black Box Warning: Lactic Acidosis
Invokamet, is a combination of canagliflozin, the active ingredient in Invokana, and metformin. The drug must carry a black box warning – the most serious warning – that it may cause lactic acidosis, which is a potentially fatal buildup of lactic acid in the body.
Black Box Warning: Amputations
Two large clinical trials showed people taking drugs with the active ingredient canaflozin were twice as likely to require leg and foot amputations as people given a placebo. After reviewing these studies, the FDA in May 2017 required a black box warning with Invokana, Invokamet and Invokamet XR.
Acute Pancreatitis
In 2016, the FDA announced it had received reports that some patients who took Invokana and other SGLT2 inhibitors had developed acute pancreatitis, an inflammation of the pancreas, which makes insulin.

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

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6 Cited Research Articles

  1. Clarkson S. Fisher Federal Building and U.S. Courthouse By Niagara (Own work) [CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons. Retrieved From: https://upload.wikimedia.org/wikipedia/commons/9/9d/Clarkson_S._Fisher_Federal_Building_and_U.S._Courthouse.jpg
  2. U.S. Judicial Panel on Multidistrict Litigation (2017, October 16). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-October-16-2017.pdf
  3. 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
  4. In Re: Invokana (canagliflozin) Products Liability Litigation. Case Management Order #8. Retrieved from http://www.njd.uscourts.gov/sites/njd/files/InvokanaCMO8.pdf
  5. Library of Congress Prints and Photographs Division Washington, D.C. 20540 USA; Retrieved from http://hdl.loc.gov/loc.pnp/pp.print
  6. Ontario Superior Court of Justice Between Rosalba Joudry and Janssen Inc., et al. (2015, September 10). Statement of Claim. Retrieved from https://www.documentcloud.org/documents/2426592-statement-of-claim-in-invokana-suit.html
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