Invokana Lawsuit
(Canagliflozin)
Problem summary
More than a thousand Invokana lawsuits have been filed against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, alleging that the makers of the popular Type 2 diabetes drug failed to provide adequate warnings to patients and healthcare professionals about the potential risk of Invokana side effects, including diabetic ketoacidosis, the need for lower limb amputations, urinary tract infections resulting in kidney or blood infections, and kidney failure in patients with no history of kidney problems.
When Invokana first entered the market in 2013, it was touted as the first of a new class of drugs that would help control Type 2 diabetes in adults. However, it quickly became clear that the drug carried some hidden dangers that patients weren’t informed of, and former Invokana users and their loved ones are now pursuing legal claims against J&J and Janssen, alleging that the blockbuster diabetes medication caused them to suffer severe or fatal complications.
About Invokana
Invokana (canagliflozin) belongs to a class of diabetes drugs known as SGLT2 inhibitors. These medications work by blocking the sodium/glucose cotransporter 2 protein, which normally helps reabsorb glucose into the blood, causing the glucose to instead be expelled in the urine. Invokana was approved by the FDA in 2013, and is commonly prescribed in combination with diet and exercise to control Type 2 diabetes in adults.
In the short time Invokana has been on the market, federal regulators have issued numerous warnings about the potential side effects of the diabetes drug. In May 2015, just over two years after approving the medication, the FDA issued an initial safety alert about the higher-than-expected number of ketoacidosis reports that involved patients taking Invokana. Regulators required multiple Invokana warning label updates later that year, in September, about the increased risk of bone fractures from Invokana treatment, and in December, about the increased risk of ketoacidosis and serious urinary tract infections linked to the drug. At this time, the FDA had received 19 reports of life-threatening blood and kidney infections that began as urinary tract infections in SGLT2 inhibitor patients, all of which required hospitalization and some of which required dialysis.
It wasn’t until May 2016 that the FDA issued its first warning about the potential for patients taking Invokana to require leg or foot amputations, a finding that was based on interim results from an ongoing clinical trial. That same year, after reviewing Invokana adverse event reports submitted to the FDA, the agency warned that people taking Invokana face a greater risk of severe kidney damage possibly requiring hospitalization and dialysis, and that those who already have kidney disease may face an increased risk of death. In May 2017, the FDA issued an updated Invokana amputation warning based on data from two large clinical trials, indicating that, “the type 2 diabetes medication canagliflozin causes an increased risk of leg and food amputations,” which occurred about twice as often in patients treated with Invokana compared to patients treated with a placebo. As a result of these findings, the agency added a black box warning to the Invokana label highlighting the risk of lower limb amputations.
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Invokana Side Effects
- Foot and leg amputations
- Kidney failure
- Diabetic ketoacidosis
- Kidney damage
- Acute pancreatitis
- Heart disease
- Hyperkalemia (high potassium)
- Low blood sugar
- Bone fractures
- Blood infections (urosepsis)
- Kidney infections (pyelonephritis)
- Serious urinary tract infections
- Hospitalization
- The need for dialysis
- Wrongful death
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Invokana Settlements & Litigation
Once believed to be a breakthrough drug in the treatment of Type 2 diabetes, Invokana has been plagued by reports of serious or fatal adverse events and Johnson & Johnson and Janssen Pharmaceuticals now face more than a thousand lawsuits filed over alleged side effects of Invokana. The majority of these Invokana lawsuits were filed in federal courts and have been centralized in New Jersey for coordinated pretrial proceedings as part of a multidistrict litigation (MDL), while others are pending in state courts across the country. The Invokana litigation involves allegations that J&J and Janssen manufactured a defective and unreasonably dangerous drug, hid Invokana’s risks from the public, and was reckless and careless in making the drug available to consumers.
Patients and their loved ones who have required amputations or suffered other serious side effects allegedly caused by their use of Invokana may have grounds to file a product liability lawsuit, seeking compensation for past and future medical expenses, pain and suffering, lost wages, loss of future earning capacity, loss of enjoyment of life, and other injuries. The best way to learn about your legal rights is to contact an experienced Invokana attorney who can help you determine whether you have a case against J&J and Janssen.
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