2018 Invokana Lawsuit News: In August 2018, the FDA issued a warning about the increased danger of a rare, serious genital infection for patients who take Invokana and other SGLT2 inhibitors. More than 1,000 Invokana lawsuit trials are expected to begin in September 2018, and others are being filed now. If you have been affected by a side effect of this diabetes drug, talk to a lawyer right away to understand your legal rights.
Invokana is one of a class of type 2 diabetes drugs known as SGLT2 inhibitors that blocks glucose (sugar) from being absorbed into the bloodstream. Made by Janssen Pharmaceuticals (a division of Johnson & Johnson), Invokana has been associated with a number of severe side effects, including an increased risk of lower-limb amputation, a destructive genital disease called Fournier gangrene, ketoacidosis, and kidney injury. As a result, thousands of people have filed lawsuits against Janssen and J&J claiming that they did not properly warn patients about the potential dangers of taking this drug.
Talk to an Invokana lawyer todayGet a free case review
Why Are People Filing Invokana Lawsuits?
Upon the initial approval of canagliflozin, the active ingredient in Invokana, by the U.S. Food and Drug Administration (FDA) in March 2013, many people praised the drug as the first of a new class (SGLT2 inhibitors) that would significantly help people with type 2 diabetes. However, it quickly became clear that the diabetes drug had some hidden dangers that required additional study and warnings added to the label. As people who took Invokana became increasingly ill, and in some cases even passed away, additional questions about the drug’s safety came to the forefront.
Many legal claims refer to results from the CANVAS and CANVAS-R studies cited by the FDA as evidence that Janssen could have done more to warn consumers about the risks of taking Invokana. Instead, the drugmaker continued to promote the medication as safe for diabetes patients, even promoting it for off-label purposes to treat weight loss, reduce blood pressure, and improve cardiovascular function. Since Janssen failed to provide proper warnings, however, consumers were unable to make an informed choice about whether to take the drug.
Lower-Limb Amputations Caused by Invokana
Diabetes can cause people to have severe foot problems due to poor circulation, nerve damage, and peripheral arterial disease, possibly requiring a partial or complete amputation. A study by the FDA found that people who took Invokana required leg and foot amputations twice as often as those who took a placebo.
In May 2016, the FDA issued an initial safety alert informing the public that taking Invokana or Invokamet can increase the need for a leg or foot amputation. Then, about a year later, the agency issued a second safety warning, adding that the risk of amputation when taking Invokana was nearly double the risk of diabetes patients who did not take the drug. As a result, the FDA required a black box warning be added to the drug label.
Many of the Invokana lawsuits against Janssen accuse the company of failing to warn them of the higher risk of amputation. They are seeking compensation for the costs of treatment, pain and suffering caused by amputations, and other related expenses.
Fournier’s Gangrene and SGLT2 Inhibitor
In August 2018, the FDA issued a warning about a newly discovered serious side effect of Invokana and other SGLT2 inhibitors called Fournier’s gangrene (also known as necrotizing fasciitis of the perineum). This rare condition is caused by an infection in and around the genitals in both males and females, and it can lead to serious damage to the body and even death.
Patients who take Invokana and experience any of the following symptoms should contact their healthcare provider immediately:
- Swelling of the genitals
- Swelling of the perineum (area between the genitals and the anus)
While Fournier’s gangrene is relatively rare in the general population, the FDA found a significantly higher risk of developing the condition in those who take Invokana or another SGLT2 inhibitor (including Invokamet, Farxiga, Xigduo, or Jardiance). The regulatory agency discovered 12 adverse events (7 men, 5 women) in patients taking SGLT2 inhibitors over a five year period from May 2013 to May 2018, while only 6 cases had been discovered in the preceding 30 years for other diabetes medications.
Have you had an amputation or Fournier gangrene?Discuss your case for free with a legal expert
Other Severe Side Effects Mentioned in Invokana Lawsuits
In addition to the higher risk of lower body amputations and developing Fournier’s gangrene, other dangerous side effects have been named in Invokana lawsuits against Janssen and J&J.
Diabetic Ketoacidosis – A life-threatening diabetic complication that occurs when high levels of blood acids (ketones) accumulate in the bloodstream. If left untreated, diabetic ketoacidosis can cause dehydration, brain swelling, coma, and even death.
Kidney Failure – A review of reports by the FDA in 2016 showed that people who take Invokana have a higher risk of severe kidney damage (renal failure), which can require hospitalization and dialysis. Those who already have kidney disease could face a higher risk of death when taking the drug.
Acute Pancreatitis – Although rare, taking Invokana can lead to a sudden inflammation of the pancreas, an abdominal organ that produces insulin and other hormones. Researchers believe this happens because of the drug’s diuretic (dehydrating) effect, and it can lead to a variety of other health problems or even death.
Heart Disease – Early studies suggested that Invokana users could experience cardiovascular problems, with 8 of 15 members of the FDA approval panel voicing concerns over clinical data related to the risk of heart attacks.
Invokana FDA Warnings
- May 2015 – Many reports of ketoacidosis and diabetic ketoacidosis (DKA) requiring hospitalization
- September 2015 – Label update warning about increased risk of bone fracture
- December 2015 – Label change for SGLT2 inhibitors about increased risk of ketoacidosis and serious urinary tract infections
- May 2016 – First amputation warning based on interim analysis of CANVAS and CANVAS-R studies
- June 2016 – Communication to doctors with stronger warnings about kidney injury risks
- May 2017 – Second amputation warning, requiring a label update with a boxed warning
- August 2018 – Invokana and other SGLT2 inhibitors may lead to a flesh-eating genital infection (Fournier’s gangrene or necrotizing fasciitis)
According to the most recent quarterly report by Johnson & Johnson, the company is facing approximately 1,100 Invokana lawsuits, and that number is likely to grow. More than 950 of these cases have been filed in various federal district courts throughout the country, but some of them have also been filed in state courts, primarily in California, Pennsylvania, and New Jersey. Your lawyer will be able to help you determine which venue is right for your case.
Federal Invokana Lawsuits (MDL 2750)
Most Invokana lawsuits have been organized into multidistrict litigation (MDL) in the United States District Court for the District of New Jersey under the designation MDL 2750. The MDL process makes it more efficient to handle many legal complaints that are the same or similar, and it has been used frequently to handle defective drugs, medical devices, and consumer products. As of early 2018, cases in MDL 2750 are still going through the pretrial discovery phase, with the first Invokana trial expected to begin in September 2018.
State Invokana Lawsuits
Some plaintiffs may have a better chance at receiving compensation from state courts, depending on the state’s laws and other factors. Pennsylvania has seen more Invokana lawsuits filed than other states, although there are quite a few lawsuits filed in New Jersey and California as well. When considering a state court for litigation, it is important to understand the statutes of limitations, which are effectively deadlines by which individuals must file or risk losing their legal rights to seek compensation.
Invokana Settlements and Verdicts
As of September 2018, there have been no major settlements or verdicts in Invokana cases. However, trials are set to begin soon for MDL 2750, and we could see settlements or favorable verdicts for plaintiffs develop soon.
Invokana Lawsuit FAQs
Get answers to some of the most common questions about Invokana lawsuits below.
Can I File an Invokana Lawsuit?
If you or a loved one has experienced one of the following severe side effects after being prescribed Invokana, you could be eligible to file a legal claim:
- Lower-leg, foot, or toe amputation
- Fournier’s gangrene
To find out if your case is eligible for a lawsuit, you should talk to an Invokana lawyer right away for a free evaluation. Your lawyer will be able to assess your situation and help you determine the best way to move forward.
What Compensation Is Available for Invokana Lawsuits?
Legal compensation for drug-related product liability cases depend primarily on the individual’s experiences. Things that judges and juries take into account include how long the person suffered from the drug’s side effects, how much it cost the patient and their family to treat those effects, and whether the person suffered from any temporary or permanent disability as a result of the drug.
Those who file lawsuits related to Invokana and other canagliflozin-based drugs (such as Invokamet and Invokamet XR) generally seek economic and noneconomic damages in a couple of different areas:
- Medical Bills – The actual costs paid out of pocket for surgery, prescriptions, follow-up appointments, and other health-related activities. Costs of travel and lodging to and from expert medical providers could also be covered.
- Lost Income – If a person had to take a leave of absence or leave their job due to the effects of Invokana, they could get compensation for that lost income. This may also include potential future income, if the individual is permanently disabled.
- Pain and Suffering – This can include both physical pain caused by the direct side effects, as well as mental anguish experienced as a result of the trauma.
- Loss of Companionship – The inability to engage in a full relationship with your spouse or partner (sometimes called loss of consortium) is another type of noneconomic damages that some plaintiffs seek.
- Funeral Expenses – If a patient passes away as a result of the drug, their family could seek expenses related to their loved one’s untimely death.
If you or a loved one wants to know more about the type of damages you could seek when filing an Invokana lawsuit, you should sign up for a free case review today.
Connect with an Invokana Attorney Today