Invokana Lawsuit Updates
Diabetes patients have been filing Invokana lawsuits against Janssen and Johnson & Johnson over claims the company failed to warn them of the drug’s severe side effects, including amputations, diabetic ketoacidosis (DKA), and kidney problems. While the effects of diabetes can lead to serious health problems if left untreated, many patients claim that this widely prescribed medication is causing as much harm, if not more, than the condition the drug was created to treat.
High Risk of Amputations
According to two large, randomized clinical trials known as CANVAS and CANVAS-R, patients who take Invokana (and other forms of canagliflozin) are about twice as likely to require an amputation than those who took a placebo. Most amputations involved the toes and middle of the foot, but some patients who took Invokana required amputations of the leg, both below and above the knee.
CANVAS and CANVAS-R Amputation Results
|Canagliflozin: 5.9 out of every 1,000 patients||Canagliflozin: 7.5 out of every 1,000 patients|
|Placebo: 2.8 out of every 1,000 patients||Placebo: 4.2 out of every 1,000 patients|
Because the incidence of amputations are so much higher for those who take Invokana, many have begun to wonder why they were not better informed of the risks before taking the drug. This has led to hundreds of lawsuits being filed by people who were prescribed the drug and later lost part of their foot or leg.
Common Invokana Lawsuit Claims
The most common allegations by injured patients claim that Janssen knew or should have known about the risks before the drug went to market, and that they did not properly warn the public.
Serious health problems are at the center of these cases, with many patients ending up in critical condition requiring hospitalization. Claimants seek compensation for past and future medical bills, pain and suffering, lost wages and, in the cases where a patient has died, funeral expenses.
Most of the lawsuits allege that Janssen:
- Withheld critical information from the FDA
- Misrepresented the risks and benefits of taking Invokana
- Failed to conduct proper safety studies
- Failed to warn the public of potential canagliflozin side effects
Janssen and J&J Invokana Cases Dismissed
In October 2015 Paula Brazil sued Janssen and its parent company Johnson & Johnson. after recurrent nausea and vomiting caused by the drug led to extreme weight loss, which required emergency care at Hamilton Medical Center in Dalton, Georgia. In her lawsuit, she accused Janssen of strict liability, negligence, fraud, and misrepresentation, and sought punitive damages for harm.
In December 2015 Wardell Fleming filed a lawsuit against Janssen, Johnson & Johnson, and Mitsubishi Tanabe. Fleming’s kidneys failed after starting treatment with Invokana in 2013. The claimant alleged physical and emotional injuries, economic losses, and a loss of enjoyment of life due to the medication’s adverse effects.
Ultimately, both cases were dismissed for different reasons, but Johnson & Johnson continues to face many more suits over the drug. As of September 2016, there were at least 56 cases in 11 federal district courts across the U.S. with similar claims, and an additional 41 cases pending in the Eastern District of Pennsylvania alone. Motions were filed to treat these cases similarly to other product liability lawsuits using multidistrict litigation (MDL), and in October 2016, Janssen agreed.
As of March 2017, 178 cases were pending under MDL 2750 in the U.S. District Court for the District of New Jersey. The pending cases in Pennsylvania will transfer to the New Jersey MDL. On July 19, 2017, a scheduled “Science Day” will educate the judges about scientific studies that may link or disprove a link between Invokana (and other SGLT2 inhibitors) and the injuries claimed in the lawsuits. The cases remain in discovery until the first bellwether trial, which is scheduled for September 2018.
Current Lawsuit Eligibility
If you or a loved one has suffered adverse effects after taking Invokana, you may be eligible to file a claim. Since these cases are time sensitive, you should contact an attorney specializing in these cases as soon as possible to discuss what’s best for you and your family.
Early Safety Concerns About Invokana
Before the U.S. Food and Drug Administration (FDA) approved Invokana in 2013, panel members debated its cardiovascular (CV) safety, pointing to a clinical study reporting 13 CV episodes in the Invokana group, as opposed to one episode in the placebo group. Of the 15 panel members, eight voiced concern with what they viewed as limited data informing this risk. They also expressed concern over unanswered questions regarding increased stroke incidences and other CV events.
The FDA panel members were not alone. A number of scientific researchers were concerned about Invokana clinical reports that showed dangerous increases in urinary infections and symptoms related to low blood pressure. In 2013, Sydney M. Wolfe, MD, of the renowned consumer watchdog group Public Citizen argued during a congressional testimony against Invokana’s approval, stating that the risks outweighed the drug’s potential benefits.
Other safety groups, including the Institute for Safe Medication Practices (ISMP), have since come forth claiming that Invokana was not adequately tested in clinical trials before the FDA approved it. Meanwhile, millions of people were prescribed the drug and may have suffered severe health problems that could have been prevented. In it’s first year after FDA approval, nearly half a million prescriptions were written, and over 450 injuries were reported.
FDA Issues Warnings About Invokana
The FDA did issue several safety communications about the side effects of Invokana and other SGLT2 inhibitors, but the first warning wasn’t made public until May 2015, two years after the drug was approved for market. In its drug safety announcement, the agency stated that these medications risk the development of a serious health condition called diabetic ketoacidosis that can cause diabetic comas or death. The warning followed the agency’s review of dozens of adverse event reports from patients who were injured or hospitalized due to ketoacidosis after taking SGLT2 inhibitors including Invokana. The warning was not added to the drug’s label until December 2015.
After Janssen published the results of a post-marketing study in September 2015, the FDA further revised Invokana labels with information on the risk of bone fractures and a decrease in bone mineral density. In June 2016, the FDA announced new warnings for Invokana and other SGLT2 inhibitors, reporting that the drugs were linked to acute kidney injuries which, in some cases, required hospitalization.
Invokana Black Box Warning
tIn May 2017, the FDA issued an Invokana black box warning, the most severe alert it can order, for the risk of leg, foot and toe amputations. This followed results from two clinical trials reporting that people with type 2 diabetes were twice as likely to require amputation when taking Invokana as opposed to taking a placebo.
Black Box Warning for Invokana
WARNING: LOWER LIMB AMPUTATION
- An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
- Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
- Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
- Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.