Lawsuits are being filed after the manufacturer of Invokana never adequately warned doctors and patients of the harmful side effects associated with SGLT2 inhibitors such as diabetic ketoacidosis (DKA), urinary tract infections (UTI), kidney failure, heart attacks, and bone fractures.

Bellwether Trial Date: Not Yet Set

Injury: kidney, failure, heart attacks, and bone fractures

Cases Filed: 741

Settlement Amounts: EST – $304,000 over $1,000,000

What Is Invokana?

Invokana (canagliflozin) is a new type-2 diabetes medication that helps control the blood sugar levels by forcing the removal of excess glucose through the urine. Originally approved in 2013, the medication immediately proved to be more dangerous than expected when, just two years later, the U.S. Food and Drug Administration issued a new warning about harmful side effects. Patients using the medications were, in fact, at risk for diabetic ketoacidosis (DKA), a potentially fatal condition. Other hazardous adverse reactions included severe kidney damage and failure. Shortly thereafter, a storm of canagliflozin litigations started being filed by patients who suffered these permanent injuries or needed a renal transplant.

Plaintiffs’ lawyers accuse Janssen of releasing a defective drug to the market, inadequately test its safety, and failing to warn the public about its life-threatening dangers. The MDL includes many cases of different injuries, including systemic infections, amputated limbs and bone fractures. This medication may also cause urinary tract infections (UTI) so severe that the regulatory agency added a black box label to warn patients about this risk.

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 Canagliflozin side effects and dangers

Since Invokana’s activity relies on the elimination of substantial quantities of sugar in the urines, it ends up providing a perfect environment for yeast and bacteria to grow and multiply in the upper urinary tract. In December 2015 the Food and Drug Administration (FDA) issued a label change to warn patients about an increased risk of yeast and urinary tract infections (UTI) in the elderly and female patients. These conditions may become chronic, and in some instances, have severe consequences on the kidneys’ health such as pyelonephritis and urosepsis which may lead to renal failure in patients with pre-existing renal issues.

In one of its latest reports, the Institute for Safe Medication Practices (ISMP) provided convincing evidence confirming that canagliflozin’s benefits probably do not outweigh its risks. The independent agency that monitors medications’ safety alleged that the FDA did test this antidiabetic drug for a period that was too short to evaluate it fully and that its approval was rushed.

Additional side effects reported in their Quarterwatch included fluid imbalances, kidney stones, and dehydration. Many diabetic patients treated with Invokana showed a risk of fungal infections that was up to 6 times higher than comparator groups, as well as signs of reduced renal function. On top of that, the FDA found clinical evidence that associated treatment with Invokana with a higher risk of amputations of lower limbs (toes, feet and even legs).

On July 14, 2016, the FDA decided to strengthen the current warning about the risk of acute kidney injury for both canagliflozin and dapagliflozin by adding information and recommendations to minimize this risk on the medications’ labels.

Invokana Illegal off-label marketing

Canagliflozin-induced ketoacidosis may lead to weight loss since a substantial amount of sugar is lost in the urines. This type of slimming is unnatural and unhealthy, though, and may also cause many severe kidney complications. Despite that, according to a lawsuit that has been recently filed in the U.S. Southern District of Alabama, salesmen from Janssen and its parent company Johnson & Johnson were instructed to market Invokana as a weight loss medicine unlawfully. The plaintiff Luana Jean Collie accused the manufacturer of illegally promoting the antidiabetic agent as an off-label slimming drug, and even advertising it to improve glycemic control in type 1 diabetics and lower blood pressure, two indications that were never approved by the FDA.

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Lawsuits Filed

To date, one of the most representative litigations filed so far is the one from Paula Brazil of Dalton, Georgia. The plaintiff took canagliflozin in October 2013, after her doctor prescribed her with this drug to treat her type 2 diabetes. The woman rapidly lost weight and started vomiting shortly after that, until she was admitted to a local hospital in November 2013. According to the case, physicians diagnosed her with diabetic ketoacidosis that is going to cause her a lifetime of suffering and pain. Other, more recent, suits include claims of wrongful death caused by heart attacks and strokes, as well as some cases of amputation.

Update: as per September 2017, a total of 741 claims have been centralized in an MDL Products Liability Litigation No. 2750, which will be held in the U.S. District of New Jersey court, overseen by U.S. District Judge Brian R. Martinotti.

Current Status of the legal proceedings and settlements

So far, no Invokana claim has been settled by Janssen Pharmaceuticals. Contrarily to what happens with class actions, individual lawsuits centralized in mass torts must be handled separately after a series of bellwether trials go before the jury to measure their response. When a verdict is reached for these first few cases, the manufacturer is expected to keep defending its positions, or to settle down cases by paying plaintiffs a monetary reward.

Currently, the discovery process was scheduled between September 1, 2017, and December 15, 2017,  while the bellwether trials have been set to take place in September 2018. Most of the claims allege that the company failed to warn the public about the drug’s dangers, breached its duty to consumers, and misrepresented the safety of Invokana with misleading commercials and marketing campaigns.

The deadline to pursue a civil action is set by each state’s Statute of Limitations, and usually ranges from 2 up to 4 years after the plaintiff suffered the injury for which he or she is seeking compensation. If you want to file an action, call us today. Our lawyers will provide you with a free legal consultation with no obligation.


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