We have won more than $40 billion in jury verdicts and settlements and have been in business for almost 70 years.
The Invokana amputation lawsuits claim the manufacturers of Invokana failed to warn patients and physicians of the increased risks of severe leg and foot infections.
Our law firm is accepting clients who took Invokana and suffered a lower limb amputation. We have been handling claims against pharmaceutical companies since 1955, and we are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
Thousands of claims have been filed against Johnson & Johnson and Janssen Pharmaceuticals by individuals who have suffered injuries as a result of taking Invokana. The lawsuits are presently combined before a federal judge in New Jersey where all of the national discovery and evidence gathering is taking place.
In the court filings, lawyers argue the following:
The most serious potential side effects and risks caused by Invokana are amputations, acute kidney damage, and ketoacidosis.
Clinical trials have found that patients taking Invokana are twice as likely to suffer a leg or foot amputation as those taking a placebo. Toe amputations and those in the middle of the foot are most common. Individuals taking Invokana should be especially careful to look for signs of increased tenderness, sores, ulcers, and infections in their legs and feet; and to immediately notify their doctors if such symptoms appear.
Researchers at the University of Padova in Italy analyzed reports voluntarily submitted to the United States FDA adverse-event reporting system. The analysis looked at 66 reports of amputations associated with SGLT2-inhibitors.
Among those cases, 86% involved patients who had been taking Invokana. Two-thirds of those patients had no other apparent risk factors associated with amputations, such as nerve damage, injuries, infections and/or a previous history of amputation.
Since May 2017, the FDA has required Invokana to warn of this problem, advising doctors to discontinue Invokana for patients who experience unusual pain, sores or infections in the extremities.
As of this time, there have been no large group settlements involving Invokana and the potential link to amputations. Generally, however, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
We are one of only a very few law firms that have been appointed to the Plaintiffs Executive Committee by the judge overseeing all of the federal claims involving Invokana. This means that we are directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this drug.
Our law firm has been in existence for more than 60 years, and is considered a national leader in this type of litigation. We have received well over 150 jury verdicts throughout the country in the amount of $1 million or more, and achieved verdicts and settlements in excess of $4 billion.
We are the founder of Mass Torts Made Perfect, which is a national seminar attended by approximately 800 lawyers twice per year where we help teach the successful handling of cases against pharmaceutical companies. For more information, please visit our About Us section.
Our lawyers provide absolutely free confidential consultations, and if we are fortunate enough for you to hire us, we never will charge you any fees or costs unless you first recover.
The contingency fee we charge ranges from 20% to 40% depending upon how much we recover for you. To review a summary of our fees and costs, click Fees & Costs.
To contact us for a free confidential consult, you can call us at (800) 277-1193 (toll free). You also can request a confidential consultation by clicking Free & Confidential Consult, which form will be immediately reviewed by one of our attorneys handling the Invokana litigation.
A class action is a type of lawsuit where a few individuals represent the interest of many other individuals. The court rulings are binding on all persons who are considered a member of the class action. All class members are required to accept the settlement approved by the court, even if an individual class member is going to receive little or no compensation.
This is not the type of litigation we will be pursuing for our Invokana clients. Instead, we represent each individual based on his/her specific circumstances, and evaluate the recovery for each client based on his/her facts. Each of our clients always has the option of settling or not settling his/her case.
For a detailed discussion on class actions, mass torts, and multidistrict litigation, please visit our Class Action Mass Torts Page.
Invokana is a prescription medication used in combination with diet and exercise to lower blood sugar and improve glycemic control in adults with type 2 diabetes. It was first approved by the U.S. Food and Drug Administration (FDA) in March 2013, and is manufactured by Janssen Pharmaceuticals, Inc.
When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and a range of other problems. Invokana helps lower a person’s blood sugar by causing the kidneys to remove sugar through the urine.
Invokana is an antidiabetic drug of the subtype 2 sodium-glucose transport (SGLT-2) inhibitors class. It helps improve glycemic control in patients with type 2 diabetes, and it’s often used in combination with other drugs such as metformin or sulfonylureas.
Invokana differs from its competitors by inhibiting the action of SGLT1, which causes glucose to remain in the intestinal tract, making it more effective in controlling blood sugar levels.
Patients affected by type 2 diabetes slowly become more and more resistant to the effects of insulin, a hormone required by cells to properly use glucose (blood sugar). Since cells cannot use sugar anymore, it starts reaching toxic levels in the blood, leading to a condition called hyperglycemia.
Many antidiabetic medications act by reducing the serum sugar levels or by improving the effectiveness of insulin itself. SGLT-2 inhibitors mechanism of action is a quite peculiar one. They block glucose kidney reabsorption, meaning that the sugar that reaches the kidney cannot go back to the blood and is thus eliminated through the urines.
Sugar removed this way amounts to an average of about 119 grams (476 kilocalories) per day. Since the glucose molecule possesses osmotic properties, additional water is excreted through diuresis reducing blood pressure.
Type 1, also known as “childhood onset,” is a genetic condition in which the patient’s pancreas fails to produce insulin. Essentially, the organ does not function.
Type 2 is also known as “adult onset.” While some people are genetically predisposed to this condition, it is largely caused by lifestyle issues, such as obesity, excess consumption of sugar and lack of physical activity. While the pancreas is usually fully functional, the body’s cells have stopped responding to insulin. The condition is known as “insulin resistance.”
FDA warns of foot, leg amputations with J&J diabetes drug:
“Johnson & Johnson is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.” Reported in Reuters – FDA Invokana Amputation Warnings
Perspective: SGLT2 inhibitors may predispose to ketoacidosis:
Based on the physiology of SGLT2 and pharmacology of SGLT2 inhibitors, there are several biologically plausible mechanisms whereby this class of drugs has potential to increase the risk of developing diabetic ketoacidosis. Future research should be directed toward identifying which patients are at greatest risk for this side effect, and also to optimizing pharmacotherapy in order to minimize risk to patients. Reported in The Journal of Clinical Endocrinology & Metabolism – Invokana and Ketoacidosis
“In May 2015, the FDA issued a warning about the risk of developing diabetic ketoacidosis while using SGLT2 inhibitors. That December, the FDA updated the drugs’ labels to include warnings about developing ketoacidosis even with near-normal blood glucose levels.” Reported in Pharmacy Times – Invokana Ketoacidosis Risk
FDA Issues Warning for Type 2 Diabetes Drugs: SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis:
A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns. These prescription drugs are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine. The drugs are sold under the brand names: Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin). Reported in WebMD – FDA Ketoacidosis Warning
For additional information, click Levin Law Invokana News
“Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.” Reported in FDA Invokana Safety – Amputations
“The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).” Reported in FDA Invokana Safety – Kidney Issues
“Patients should stop taking their SGLT2 inhibitor [such as Invokana] and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.” Reported in FDA Invokana Safety – Infections
As of this time, there has not been a recall of Invokana related to amputations, kidney failure or ketoacidosis.
However, the FDA has issued three safety announcements warning patients about these potential injuries, and has mandated that a Box Warning be prominently displayed describing the link between Invokana and amputations.
Beginning in 2017, Sharp HealthCare, Scripps Health, and numerous treating physicans stopped prescribing Invokana in light of the amputation risks.
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