Invokana lawsuits claim the diabetes drug manufacturer failed to warn patients of extreme side effects like a higher risk of lower limb amputation, Fournier’s gangrene, diabetic ketoacidosis and kidney failure. Invokana patients have filed more than 1,200 lawsuits in state and federal courts against Johnson & Johnson, many of which are currently pending lawsuit settlement.
Why Are People Filing Invokana Lawsuits?
In March 2013, when the U.S. Food and Drug Administration (FDA) first approved canagliflozin, the active ingredient in Invokana, the drug was praised as the first of a new class of diabetes medications called sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors). Since then, the drug has helped many people with type 2 diabetes, in combination with diet and exercise, to reduce blood sugar levels, lose weight, and lower blood pressure. However, in some cases, Invokana has also been linked with complications, such as an increased risk of foot and lower leg amputations. As a result, the FDA has required warnings to be added to the label about the potential severe Invokana side effects.
Many legal claims cite results from the CANVAS and CANVAS-R clinical trials as evidence that Janssen could have done more to warn consumers about the risks of taking Invokana. Instead, the drugmaker promoted 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 Increased by Invokana
Diabetes can cause severe foot problems due to poor circulation, nerve damage, and peripheral arterial disease. In some instances, these problems can require a partial or complete amputation of the foot or lower leg. 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. Plaintiffs are seeking compensation for the costs of treatment, pain and suffering caused by amputations, and 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 in rare cases, 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 (such as Invokamet, Farxiga, Xigduo, Xigduo XR, 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.
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 complication that occurs when high levels of blood acids accumulate in the bloodstream. If left untreated, diabetic ketoacidosis can cause dehydration, brain swelling, coma, and death.
Kidney Failure – A review of reports by the FDA in 2016 showed that people who take Invokana have a higher risk of acute kidney injury, which can require hospitalization and dialysis.
Acute Pancreatitis – Although rare, case reports have linked Invokana 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.
Invokana FDA Warnings
- May 2015 – Many reports of ketone buildup leading to 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 Johnson & Johnson’s most recent quarterly report, the company is facing approximately 1,200 Invokana lawsuits. Most 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.
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 July 2019, there were 959 active lawsuits in the Invokana MDL.
State Invokana Lawsuits
Some plaintiffs may have a better chance of 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
In October 2018, Janssen Pharmaceuticals file a motion to settle many of the 1,100 Invokana lawsuits against the company. According to a motion to established a qualified settlement fund filed on October 16, 2018, the Invokana settlement amount is confidential.
Full details of the settlement are still being negotiated as of December 2018.
Invokana Lawsuit FAQs
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 may be able to file a legal claim:
- Lower-leg, foot, or toe amputation
- Fournier’s gangrene
What Compensation Is Available for Invokana Lawsuits?
Legal compensation for an Invokana product liability case will depend primarily on your individual experiences. Judges and juries will take into account include how long you suffered from the drug’s side effects, how much it cost you and your family to treat those effects, and whether you suffered from any temporary or permanent disability as a result of the drug.
When victims file lawsuits related to Invokana and other canagliflozin-based drugs (such as Invokamet and Invokamet XR), they generally seek economic and non-economic 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 Consortium – The inability to engage in a full relationship with your spouse or partner (sometimes called loss of consortium) is another type of non-economic 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.
- Punitive Damages – Juries can also punish pharmaceutical companies for failing to provide safe drugs to its customers.
How Much Does an Invokana Lawyer Cost?
In many drug-related product liability cases, people filing lawsuits are generally not charged any fees upfront. Instead, they are only required to pay legal fees when they receive compensation either in the form of a settlement or favorable verdict.