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Invokana Amputation Risk, Surgery

Invokana Amputation Risk Continues Amid Slipping Quarterly Sales

By | Invokana

The risk of Invokana amputation remains a real threat to the increasing number of consumers globally who have been prescribed the type 2 diabetes drug. Manufacturer Janssen (a division of Johnson & Johnson), first received a green light for public sales of the drug five years ago, but even that was only with a confidence vote of 10-to-5, indicating serious safety concerns right from the very start.

National media outlets at the time reported comments from several U.S. Food & Drug Administration members who revealed they didn’t think the drug should be taken at all by patients who suffer even moderate kidney disease. Further, Invokana amputation was almost twice as likely to happen as amputations associated with other similar types of diabetes treatment drugs.

Approximately 7,500 adverse events were reportedly linked to Invokana in just a single recent year. The FDA ordered a black box warning in 2017, specifically for the increased Invokana amputation risk. Black box warnings, you may recall, are those that denote a call to attention for a serious and potentially life-threatening side effect or health risk that has been linked to use of a certain drug or medical device.

But even as hundreds of Invokana amputation injury lawsuits pend in a multi-district litigation action in New Jersey, a recent report by 360 Market Updates reveals investors continue to be concerned about the sharp drop in sales of Invokana over the last year.  Read More


Invokana Amputation Risk Remains High, Even as Study Indicates Lower Cardiac Risk

By | Invokana

The maker of Invokana, the Type 2 diabetes medication that promises to help with low blood sugar, has been the subject of intense scrutiny in recent years, in particular for the potential risk of Invokana amputation, as well as concerns regarding increased risk of heart attacks.Invokana amputation attorney

On the latter issue, pharmaceutical firm Johnson & Johnson is confident it’s going to receive an indication from the U.S. Food an Drug Administration that this top-selling drug lowers the cardiovascular risk (i.e., heart attacks or heart failure). While it’s waiting for that formal nod from the regulator, the company seized an opportunity at the recent American College of Cardiology’s annual scientific session to present an internal study it just completed indicating Type 2 diabetes patients who took Invokana, an SGLT2 inhibitor, were 22 percent less likely to be hospitalized or die due to a heart attack.

However, even if these findings prove verifiable and even if the FDA extends the indication for which the company is vying, there is still the serious and sharply heightened risk of amputations with Invokana.  In 2016, researchers first brought this unique risk to light, reporting Invokana was associated with double the risk of lower extremity amputations than those in the control group. The issue was reported on by several independent data monitoring committees. That spurred the FDA into action, last year releasing a Drug Safety Communication indicating there was an increased risk of both leg and foot amputations with canagliflozin (the generic term for Invokana, Invokamet and and Invokamet XR). Ultimately, this resulted in a black box warning on the drug’s label. Read More

Black Box Warnings on Drugs Like Invokana Alert to Serious Side Effects

By | Invokana

Black Box Warning – Invokana®

Black box warnings, also referred to as “boxed warnings” are listed on drugs like Invokana® by the U.S. Food and Drug Administration to warn doctors, pharmacists and consumers about the potential for serious adverse reactions. It’s the most dire type of warning issued by the FDA, and is featured prominently on the label of the drugs to warn those who prescribe them of possible problems that may have profound negative consequences for users. black box warnings

Although these warnings may be indicated at the time the drug is released, they often aren’t listed until some time after the drug has been on the market.

With Invokana, for example, was approved by the FDA for treatment of type 2 diabetes, but it wasn’t until 2017 that the FDA updated its black box warnings to include Invokana – specifically for the heightened risk of leg and foot amputations.  Read More

First Invokana Injury Trial Alleging Amputation Slated for September 2018

By | Invokana

Invokana Injury – Amputation Lawsuit

Invokana injury lawsuits are mounting in the consolidated multi-district litigation (MDL) in the U.S. District Court, District of New Jersey (MDL 2750), and the first of those trials are expected to begin in September. These initial bellwether cases will give a good indication of how future claims for damages will be resolved by manufacturer Janssen (a subsidiary of Johnson & Johnson), which markets the drug for treatment of Type 2 diabetes.Invokana injury lawyer

Since the MDL was created, more than 1,000 cases have been filed within the federal district court, alleging patients prescribed Invokana are at a markedly higher risk of suffering an amputation of a lower extremity (usually a leg or toe).

Case Management Order # 20 in the MDL outlines the first group of bellwether cases – a total of 12, with six chosen by plaintiffs and six by defendants. Half of those plaintiffs who took Invokana developed a condition known as diabetic ketoacidosis, while the other half suffered kidney injuries. The judge overseeing the MDL encouraged both sides to identify claims that are overall representative of future claims. Discovery in those initial cases will be intense, and findings revealed in those discovery actions can be applied to future cases.  Read More

Invokana® Lawsuit Update

By | Invokana, Personal Injury Attorneys

Invokana® Lawsuit Update

An Invokana lawsuit will move a at a brisk pace thanks to a recent court order. Recently, Judge Brian Martinotti, issued Case Management Order Number 4 regarding the filing of Invokana amputation and ketoacidosis lawsuits. In the order, Judge Martinott granted Invokana victim’s the right to directly file their lawsuit in MDL 2750, In Re: Invokana Products Liability Litigation, Case Number 3:16-md-2750.  To accomplish this, cases directly filed with the MDL court must follow the following:

  •  Cases must utilize a particular caption;
  •  The case must contain a statement indicating that it is being filed in accordance with CMO No. 4;
  •  The case must designate the venue, which will be the place of remand;
  •  The case must be filed electronically.

This is a great development for Invokana plaintiffs as it will substantially reduce the amount of time incurred for the case to be filed and docketed with the MDL. The first bellwether trial is set to start in September 2018.

What is an Invokana Lawsuit Injury Case?

Generally, an Invokana injury lawsuit involves a diabetic who is using Invokana and suffers the loss of a limb, such as a foot, ankle or leg. Also, claims involve diabetic ketoacidosis, kidney failure and death.

The Invokana Timeline

  •  March, 2013: Entered the market; in the March, 2013;
  •  December, 2015: Diabetic ketoacidosis was added to the Warnings & Precaution Section of the label;
  •  June 2016: Kidney failure warning was added to the Warnings & Precaution Section of the label;
  •  August 2016: Diabetic ketoacidosis warning was amended to include reports of “Fatal” Diabetic Ketoacidosis;
  •  May 2017: Black Boxed Warning for amputation was added to the label.
  •  To date Invokana has grossed close to $5 Billion dollars for Janssen Pharmaceuticals.

Questions About Invokana Lawsuits?

The James Esparza Law Firm is here to answer your questions about Invokana lawsuits. Call Now 1-800-745-4050.

Invokana Amputation Victims

By | Invokana, Personal Injury Attorneys

Invokana® Amputation Lawsuit

The FDA is requiring new warnings to be added to the diabetic drug Invokana to explain and emphasize the risk of amputations associated with Invokana use.  As a result physicians are taking action against using Invokana this according to a recent article by Inewsource, with some physicians taking their patients off of Invokana. The prescribing habits of physicians apparently changed after the FDA required the manufacturer, Johnson & Johnson, of Invokana to place a Black Box warning about the doubling of the risk of limb amputation with use of the drug. The most common amputations are toe, foot and lower leg. Invokana is prescribed to people with Type II diabetes.

Patients are urged to contact their doctor if they notice pain, tenderness, sores, ulcers or infections in their limbs. However, patients should not stop using this drug without consulting the doctor that prescribed Invokana.

Many physicians still prescribe Invokana believing that the drug is beneficial to patients. It is estimated that 4.5 million Invokana prescriptions were filled in the United States in 2016, so many patients could be affected by use of this drug.

Other Complications Associated With Invokana

The study that shined a bright light on the serious risk of amputations associated with Invokana also raised the questions about a condition called diabetic ketoacidosis. Other drugs in the same class of medication as Invokana carry a warning about ketoacidosis.

Cardiac risk is also a concern with Invokana. One of the investigators on the Invokana Clinical trial questioned the methods that were used to say that the drug prevented major cardiac events this according the Inewsource article.

We Can Help

If you or loved one has suffered a limb amputation while using Invokana you may have many questions about whether you have a claim against the manufacturer of Invokana. The James Esparza Law Firm can answer your questions. We have helped thousands of individuals and families recover from life altering injuries. We would like to help your too. Call us now at 1-800-745-4050. We will help you obtain full and complete compensation.

Helpful Links.
Doctors debate danger of popular diabetes drug after FDA amputation warning

Invokana Black Box Warning – Leg & Foot Amputations

By | Invokana


The Food & Drug Administration (FDA) is requiring a black box warning to appear for Invokana® and Invokamet® alerting users and physicians of the serious adverse event of an increased risk of Leg, Toes & Foot Amputations with Invokana use.  Black box warnings are reserved for the most serious adverse events.

Doubling of the Risk of Leg & Foot Amputations

Invokana® is manufactured by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. The FDA warning is the result of two large clinical studies that found that Invokana users faced twice the risk of leg and foot amputations with Invokana® compared to placebo users.  The studies were CANVAS (Canagliflozin Cardiovasculare Assessment Study) and CANVAS-R.

According to the FDA, the CANVAS trial showed that over a 1 year period that the risk of amputation was

  •  5.9 out of every 1000 patients treated with Invokana®
  • 2.9 out of every 1000 patients treated with placebo

CANVAS R results showed that over a 1 year period that the risk of amputation was

  • 7.5 out out every 1000 patients treated with Invokana®
  • 4.2 out of every 1000 patients treated with placebo

This is not the first time the FDA has expressed concern over Inovkana®.  In May 2016 the FDA’s review of interim clinical data caused the FDA to further investigate the increased risk of lower limb amputations, mostly toes, with the diabetes medicine Invokana®

The most common type of amputations was of the toe and middle of the foot. Amputations involving the leg, below and above the knee, had occurred as well. In addition, some patients had more than one amputation, some of which involved both limbs.

The FDA warning provides further information about Invokana® in regard to its usage, methodology, and side effects. It’s a prescription medicine used primarily with diet and exercise in order to lower the level of blood sugar in adults with type 2 diabetes. It falls into the drug class of sodium-glucose cotransporter-2 (SGLT2) inhibitors. It reduces the blood sugar by triggering the kidneys to remove sugar in the body through urine.

The FDA recommends “patients taking Invokana® should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet.” This recommendation is further supplemented by emphasizing one shouldn’t stop their diabetes medication without first consulting their health care professional.

We Can Help You.

If you or a loved one has taken Invokana® and sustained an amputation of the foot, toes or leg we would like to help you.  Call for a confidential consultation at 1-800-745-4050.

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Invokana Kidney Injuries – We Can Help

By | Invokana
Invokana Kidney & Heart Attacks

Invokana Kidney Injury

Invokana® Lawsuit News!

A Invokana kidney injury case can proceed according to a federal judge. No preemption exists according to Judge Martin Feldman. The case concerns the plaintiff developing acute kidney damage while using Invokana a Janssen Pharamaceutical product. Janseen is a division of Johnson & Johnson.

The case involved Gloria Guidry who was prescribed Invokana to treat her Type II diabetes.  She took Invokana from approximately 6 months before she was hospitalized for acute kidney injury and acute kidney failure. Guidry alleged that Invokana caused her acute kidney failure.

In the Guidry, Janssen filed a motion to dismiss urging Judge Feldman to dismiss all of the plaintiff’s claims because of preemption.  The were many issues addressed in Judge Feldman’s 45 page opinion.  However, the key issue in the case was whether a defective design claim arising from use of a brand name prescription drug, Invokana®, is preempted.

Judge Feldman ruled that under Louisiana law that a defective design claim against a brand name prescription drug is not preempted. His rational seemed to be focus, in part, on providing Louisiana residents the right to go to court and have their claim heard by a jury.  Further, a key fact the plaintiff alleged was that Janssen knew Invokana’s design posed an unreasonably dangerous risk of kidney injury before it was approved by the FDA.

How Does Invokana Work?

As noted in our Current Investigations, Invokana is designed to help diabetics reduce excess blood sugar by blocking re-absorption of glucose in the kidneys.  Instead glucose is pushed out through urination.  In this process, it is alleged, sugar builds up in the tubes connecting the kidney to the bladder, forcing the kidneys to over work.  This causes the kidneys to stress leading to kidney injury and kidney failure.

Why You Should Select Us?

If you have a serious injury case you need an experienced product liability attorney.  At the James Esparza Law Group we only accept clients who have been harmed from defective products. We provide each client with the personal care and attention they deserve.  If you or a loved one would like to discuss your Invokana injury we are here to answer your questions. We will make no promises to you, but we will investigate your case and answer your questions as best as possible. Call now 1.800-745-4050. Experience law done differently!