Invokana Amputation Lawsuits
Nearly 30 million people in the U.S. have diabetes. Invokana is a new kind of medication approved in 2013 to reduce blood sugar in people with type 2 diabetes. Invokana works by blocking the kidneys from reabsorbing sugar into the bloodstream and excess sugar is sent out of the body through urination. The blockbuster drug has brought in billions of dollars for its manufacturer but it has left some patients with serious and life-threatening injuries. The FDA has issued numerous warnings about the drug and lawsuits are now being filed nationwide.
Leg and Foot Amputations
The FDA issued a safety communication in May 2016 after data from an ongoing clinical trial revealed a higher incidence of leg and foot amputations in patients taking Invokana or Invokamet. The amputations affected mostly the toes.
Amputations of the leg and foot are a complication of diabetes, but the trial results suggest that Invokana may increase this risk. However, the FDA said it was still investigating whether Invokana increased the risk for these types of amputations and would issue further guidance when it had more information.
Invokana Ketoacidosis Lawsuits
People with type 2 diabetes who took the drug Invokana and experienced side effects are now filing lawsuits against the drug’s manufacturer. Invokana has been linked to a serious complication of diabetes called diabetic ketoacidosis, as well as kidney failure and acute kidney injury.
If you took Invokana and experienced serious side effects, you may be entitled to financial compensation. There may be significant cash payouts in the form of settlements for those affected by the drug.
Invokana lawsuits accuse the drug’s manufacturer, Janssen Pharmaceuticals Inc., of designing a defective product and failing to warn about its risks. Hundreds of Invokana lawsuits have already been filed in courts nationwide and accuse Janssen of:
- Designing a defective product
- Failing to warn about Invokana’s risks
- Strict liability for designing a defective product
- Breach of express and implied warranties
- Misrepresenting Invokana’s risks and benefits
Invokana Multidistrict Litigation
Federal Invokana lawsuits were consolidated into a multidistrict litigation (MDL) in late 2016. Plaintiffs in over 2 dozen lawsuits petitioned the Judicial Panel on Multidistrict Litigation in October 2016 to coordinate theirs and other federally filed cases for pretrial proceedings.
The MDL Panel ruled in December 2016 to create the Invokana MDL and more than 50 cases were brought together in the District of New Jersey. By the end of March 2017, there were 178 cases pending in the litigation with hundreds more expected to be filed.
More than 100 Invokana cases originally filed in Pennsylvania state court were also waiting to be transferred to New Jersey. Janssen removed the group to federal court in November 2016 — a move fought by plaintiffs. But in February 2017, a federal judge ruled to keep the cases in federal court and set them up to be transferred to the Invokana litigation in New Jersey.
MDLs are often formed when multiple lawsuits alleging similar legal claims are filed against the same corporation. Invokana lawsuits, for example, all claim the diabetes drug was defectively designed and led to their injuries. Coordinating similar cases helps streamline the discovery process, especially in complex pharmaceutical injury lawsuits like Invokana.
A handful of cases are usually chosen from the MDL’s pool of cases to be tried first. These are called bellwether trials and they help lawyers and attorneys on both sides test legal theories in front of a jury. The outcome of these trials can help move both parties in the direction of a global settlement.
Invokana Class Action
Hundreds of people who were injured by Invokana are filing lawsuits against the manufacturer, but so far these lawsuits are not involved in a class action. Invokana lawyers and attorneys are filing lawsuits on behalf of individual patients.
Class actions are filed by one or more people on behalf of others who were affected in the same way by the same corporation. If a settlement or verdict is reached, it is distributed equally among all the plaintiffs.
Federal Invokana cases were consolidated into an MDL, but the cases remain separate. Settlements or verdicts reached in these cases are handed down individually, not split equally like in a class action suit.
Settlements & Verdicts
Invokana lawsuits are still in their early stages. More than a hundred were consolidated in the District of New Jersey and there are dozens more pending in state courts nationwide.
So far, no case has gone to trial and there have been no settlements or verdicts reached.
There is still time to file an Invokana lawsuit, but each state has its own statute of limitations which prevent claims from being filed after a certain period of time. An Invokana attorney can help you determine if your claim qualifies for an Invokana lawsuit.
What is Invokana?
Invokana is a first-in-its-class, prescription medication used to treat type 2 diabetes. It belongs to a new class of diabetes drugs called SGLT2 inhibitors.
Diabetes affects more than 29 million Americans and another 86 million have blood sugar levels high enough to be considered “pre-diabetic.”
Since Invokana’s approval by the U.S. Food and Drug Administration in 2013, the drug has brought in over $3.3 billion dollars in sales. The blockbuster drug brought in more than $1.4 billion in 2016 alone for Janssen Pharmaceuticals and its parent company Johnson & Johnson.
Despite strong sales, the type 2 diabetes medication has come under scrutiny by the FDA for potentially causing a number of unwanted side effects.
People who took the drug say they developed diabetic ketoacidosis, kidney disease, kidney failure and other serious conditions.
The FDA issued a series of warnings about the drug and its potential risks and now lawsuits are being filed against Janssen for failing to adequately warn the public on its own.
How Does Invokana Work?
Invokana is a first-of-its-kind drug that works in the kidneys to treat type 2 diabetes.
People with type 2 diabetes have too much sugar in their blood. Invokana reduces that amount by blocking a key protein found in the kidneys that reabsorbs blood sugar.
Invokana relies heavily on the kidneys to do its job, which could be why so many people say they developed kidney injuries as a result of Invokana.
Invokana & Kidney Function
Invokana blocks a protein found in the kidneys called sodium glucose cotransporter 2, or SGLT2. SGLT2 is responsible for the majority of blood sugar that is reabsorbed by the kidneys.
Invokana reduces blood sugar levels in people with type 2 diabetes by blocking this protein and the excess sugar is then sent out of the body through urination.
Many of the side effects associated with Invokana relate to the kidney, including acute kidney injury, infection and kidney failure. The way Invokana works in the kidneys could affect a person’s kidney function and health.
Invokana has been associated with a number of different side effects that range from mild to severe. These side effects were reported in clinical studies and by patients taking Invokana.
Some of the minor side effects associated with Invokana include:
- Dehydration and thirst
- Yeast infections in both women and men
- Increased urination
Patients taking Invokana have experienced serious side effects, as well. Some of these side effects are severe enough to land patients in the hospital.
Some of the serious side effects associated with Invokana include:
- Diabetic ketoacidosis
- Low blood pressure
- Acute kidney injury
- Hyperkalemia (high potassium levels)
- Urosepsis (blood infection from a urinary tract infection)
- Kidney infection
- Low blood sugar
- Hypersensitivity reactions
- Bone fracture
- Increases in “bad” cholesterol
Since Invokana’s approval in 2013, the FDA has issued a number of safety warnings about the drug. These warnings included risks of serious side effects that can lead to additional medical care and hospitalization.
Ketoacidosis is a serious complication of diabetes that causes too much acid to build up in the blood. Ketoacidosis usually develops in patients with type 1 diabetes, but patients taking Invokana are also at risk of the condition.
Ketoacidosis occurs when the body doesn’t have enough insulin. Insulin plays a major role in helping sugar enter the body’s cells to fuel muscles and other tissues. Without insulin, the body starts to break down fat as fuel instead of sugar. This can cause a buildup of acids in the bloodstream and can develop into ketoacidosis if not treated.
The FDA first warned about Invokana’s potential to cause too much acid in the blood in May 2015, just 2 years after the drug was approved. The following December, the agency issued an updated safety communication with results from its own safety review.
The agency said 73 cases of ketoacidosis were reported by patients taking Invokana between March 2013 and October 2014. In many cases, the patients’ blood sugar levels were much lower than what is usually seen in ketoacidosis. This led to delayed diagnoses in some patients.
The FDA required the manufacturer of Invokana — as well as other SGLT2 inhibitors — to update the drug’s label to include the risks of ketoacidosis. The agency also required a 5-year postmarket study to further investigate the risk.
Patients taking Invokana who develop symptoms of ketoacidosis should stop taking their mediation and seek medical attention right away, the FDA warned.
Symptoms of ketoacidosis include:
- Abdominal pain
- Trouble breathing
Acute Kidney Injury
In June 2016, the FDA announced it was strengthening existing warnings about kidney injuries on Invokana’s label. The agency said the label would now include warnings about acute kidney injury, a serious condition in which the kidneys suddenly stop filtering waste from the blood.
Between March 2013 and October 2015, the FDA said it received 101 reports of acute kidney injury in patients taken Invokana, its sister drug Invokamet and another SGLT2 inhibitor called Farxiga.
The injuries were serious enough to require hospitalization and dialysis treatment in some patients. The FDA also acknowledged that there may have been many more cases of acute kidney injury not reported to the agency.
Patients with chronic kidney insufficiency, low blood volume or congestive heart failure may be at higher risk for kidney problems when taking Invokana or other SGLT2 inhibitors. Patients taking diuretics, NSAIDs or blood pressure medications called ACE inhibitors or ARBS may also be at higher risk.
The FDA warned patients should seek medical treatment right away if they develop symptoms of acute kidney injury. Symptoms may include decreased urine and swelling in the legs and feet.
Severe Blood and Urinary Tract Infections
Invokana carries the risk of severe urinary tract infections that can lead to blood and kidney infections. The FDA warned of this risk in a December 2015 Safety Communication after identifying at least 19 reported cases of blood and kidney infections. In all 19 cases, the infections had started as urinary tract infections.
All 19 patients were hospitalized and some were taken to the intensive care unit because their injuries were so severe. A few of the infections led to kidney failure and required dialysis treatment.
Symptoms of urinary tract infections include:
- A strong, persistent urge to urinate
- A burning sensation when urinating
- Passing frequent, small amounts of urine
- Urine that appears cloudy
- Urine that appears red, bright pink or cola-colored (a sign of blood in the urine)
- Strong-smelling urine
- Pelvic pain, in women
In September 2015, the FDA announced it was updating Invokana’s label to include the risk of bone fractures and decreased bone mineral density. Bone mineral density refers to the strength of a person’s bones.
Results from several clinical trials showed fractures occurred more frequently in patients taking Invokana compared to placebo and could occur as early as 4 months after starting the drug. A mandatory clinical trial conducted by Janssen also found Invokana caused greater bone mineral density loss at the hip and lower spine in patients compared to placebo.
The risk of bone fractures had been included on the Invokana label since it was approved, but the warnings were updated to include the results of the trials. The FDA said it was also investigating the risk of fractures in other SGLT2 inhibitors, like Farxiga.
Black Box Warning
Despite the number of warnings issued by the FDA concerning Invokana, the drug does not carry a black box warning.
Black box warnings are the FDA’s strictest warnings. They are placed on a drug’s label when there is a risk for serious or life-threatening side effects.
Invokana has been linked to both serious and life-threatening side effects and the FDA has issued formal safety communications to warn about these risks. However, the agency has stopped short of issuing a black box warning for Invokana.
Invokana Dosage and Administration
Invokana is available in oral tablets that should be taken once a day before the first meal.
The recommended starting dose is 100 mg a day. For patients who tolerate 100 mg well but need better blood sugar control, the dosage can be increased up to 300 mg a day.
Invokana is only available in 100 mg and 300 mg tablets.
Invokana may interact with a few different types of drugs. These include:
UGT Enzyme Inducers (rifampin) — these drugs can reduce the effect of Invokana, so patients may need to increase their Invokana dosage
Digoxin — the 300 mg dose of Invokana raised the amount of Digoxin in the blood; patients taking the drugs together should be monitored
Insulin — taking Invokana with insulin can lower blood sugar too much; patients taking insulin may need to take a lower dose
Who Should Not Take Invokana?
Some people should not take Invokana because of the risks the drug may pose, especially people with kidney problems, women who are pregnant or nursing, children and the elderly.
People who have kidney problems may be at an increased risk for complications if they take Invokana. Invokana is not approved for use in people with severe kidney impairment or who have a history of diabetic ketoacidosis.
Pregnant Women and Nursing Mothers
Women who are pregnant or nursing should speak with their doctors about how best to manage their diabetes during that time. Animal studies showed a potential risk for kidney problems in mothers, so Invokana is not recommend in the 2nd and 3rd trimester of pregnancy.
Invokana is also not recommended in nursing mothers because it can be passed through the milk.
Invokana has not been tested in kids or teens and is not indicated to treat patients under the age of 18.
People who are 65 years or older may have an increased risk for complications when taking Invokana. Clinical studies showed a higher incidence of side effects, such as low blood pressure, dizziness and dehydration, compared to younger patients.
Other SGLT2 Inhibitors
Invokana was the first SGLT2 inhibitor to hit the market, but since its approval in 2013, other drugs in its class have been cleared by the FDA.
All SGLT2 inhibitors work by blocking the protein in the kidneys responsible for reabsorbing blood sugar. The drugs contain different active ingredients, however, and some are combination drugs. The active ingredient in Invokana is canagliflozin.
Other SGLT2 inhibitors on the market include:
- Farxiga (dapagliflozin)
- Invokamet (canagliflozin and metformin hydrochloride)
- Glyxambi (empagliflozin and linagliptin)
- Jardiance (empagliflozin)
- Synjardy (empagliflozin and metformin HCl)
- Xigduo XR (dapagliflozin and metformin HCl extended release)
Farxiga is an SGLT2 inhibitor manufactured by AstraZeneca in collaboration with Bristol-Myers Squibb. It was approved by the FDA in 2014 to treat type 2 diabetes along with diet and exercise.
Farxiga works similarly to Invokana and blocks the reabsorption of blood sugar by the kidneys. Farxiga is available in 5 mg and 10 mg doses and can be taken with or without food. The recommended dosage is 5 mg once a day.
Farxiga, like Invokana, carries certain risks, including the risk for diabetic ketoacidosis, acute kidney injury, severe UTIs, kidney infection and possibly even bladder cancer.
Lawsuits involving this type 2 diabetes drug are not included in Invokana litigation, but they are being filed individually in state and federal courts across the country. Plaintiffs involved in Farxiga lawsuits petitioned the MDL Panel in February 2017 to consolidate their cases into a multidistrict litigation, much like Invokana patients did in 2016. There were about 18 federal Farxiga cases at the time of the petition.
Invokamet is a sister drug of Invokana and is also manufactured by Janssen Pharmaceuticals. Invokamet is a combination of canagliflozin, the main ingredient in Invokana, and metformin, the first-line treatment of type 2 diabetes.
Invokamet helps reduce blood sugar and is indicated for people who are not responding well to Invokana or metformin alone.
Invokamet carries much of the same risks as Invokana, including diabetic ketoacidosis, severe UTI, kidney problems and bone fractures.
Patients who took Invokamet are also filing lawsuits against Janssen. Invokamet lawsuits are included in the Invokana litigation.
Alternatives to Invokana
People with type 2 diabetes have a number of treatment options they can discuss with their doctors. This includes eating a healthy diet and getting plenty of exercise, as well as treatments with medications.
SGLT2 inhibitors like Invokana are new types of diabetes drugs, but more traditional medications have been on the market longer. All diabetes medications carry risks, so patients should speak with their doctors about what is right for them.
Medications used to treat type 2 diabetes include:
- Thiazolidinediones (Avandia, Actos)
- Biguanides (Metformin)
- Alpha-glucosidase inhibitors
- Dopamine agonist
- DPP-4 inhibitors
- Glucagon-like peptides
IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION (MDL NO. 2750). Case Management Order #8. (March 30, 2017). Retrieved from http://www.njd.uscourts.gov/sites/njd/files/InvokanaCMO8.pdf
Centers for Disease Control and Prevention. Data and Statistics. “Diabetes Latest.” (June 17, 2014). Retrieved from https://www.cdc.gov/features/diabetesfactsheet/
Johnson & Johnson 2016 Annual Report. Retrieved from https://jnj.brightspotcdn.com/88/3f/b666368546bcab9fd520594a6016/2017-0310-ar-bookmarked.pdf
Judicial Panel on Multidistrict Litigation, Pending MDLs by District. (March 15, 2017). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf
Invokana Label. (February 2017). Retrieved from https://www.invokana.com/prescribing-information.pdf
Healthline. “A Complete List Of Diabetes Medications.” (June 16, 2016). Kristeen Cherney. Retrieved from http://www.healthline.com/health/diabetes/medications-list#overview1
FDA. Safety Communication. “SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections.” (Dec. 4, 2015). Retrieved from https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm475553.htm
FDA. Safety Communication. “SGLT2 inhibitors: Drug Safety Communication – FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood.” (May 15, 2015). Retrieved from https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446994.htm
FDA. Safety Communication. “Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication – Strengthened Kidney Warnings.” (June 14, 2016). Retrieved from https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm506554.htm
FDA. Safety Communication. “Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Clinical Trial Results Find Increased Risk of Leg and Foot Amputations.” (May 18, 2016). Retrieved from https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm
FDA. Safety Communication. “FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density” (Sept. 10, 2015). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm461449.htm
Mayo Clinic. Urinary Tract Infection (UTI). “Symptoms.” (Nov. 30, 2016). Retrieved from http://www.mayoclinic.org/diseases-conditions/urinary-tract-infection/basics/symptoms/con-20037892
Farxiga label (March 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf
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Invokana Amputation Lawsuits page updated on August 25, 2017