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What They Knew

“There is absolutely an increased risk of amputation with canagliflozin,” according to that trial, Mahaffey said. Even so, he said, “We have to put the risk of amputations in perspective with the clear benefits we are seeing”.

While Janssen Pharmaceuticals tested their drug to measure glucose levels, they failed to fully monitor the painful effects that could put patients in harm’s way. This is important to know because canagliflozin is a newer drug that worked in a completely different way than previous diabetes medications (it blocks glucose absorption that takes place in the kidneys and releases the excess glucose through the urine).

When They Knew It

Invokana was approved by the FDA in March 2013. By June 2015, the European Medicines Agency (which is similar to our FDA) started to evaluate the risk of canagliflozin due to the high number of complaints they were receiving. This was almost a full two years before the FDA put out a safety communication warning patients and doctors of the increased potential for amputations.

Millions of patients took Invokana and Invokamet, and hundreds of thousands have experienced painful, life-altering injuries even after many complaints were filed. Brenda Lozano of Texas took Invokana for a little over two years and suffered severe kidney damage which later resulted in a stroke. Brenda has accumulated expensive medical bills and she now has to live with the lifelong physical complications of her injuries.

Polley Dailey of Kentucky took Invokana for just over a year and then had to endure the amputation of her right leg. Brenda, Polley and many others are taking Janssen Pharmaceuticals to court because: 1. the new medication was never fully tested resulting in patients being the guinea pigs and 2. patients and doctors weren’t warned of the true extent of the risks involved with these medications. Janssen Pharmaceuticals misrepresented their drug as a safe option when they fully knew the potential harm that patients might experience.

In fact, in December 2017, over 990 Invokana cases had been consolidated in multidistrict litigation (MDL) in New Jersey. While this number may seem low, who knows how many Polleys or Brendas are out there?

Can I Make a Claim?

Did you take Invokana or Invokamet and suffered from an amputation? You may be able to make a claim if you meet the following qualifications:

  • You started taking Invokana after March 2013 OR
  • You started taking Invokamet after August 2014
  • You or a loved one experienced an amputation (or multiple amputations) involving toes, a foot or a leg.

Maybe you (or someone you know) have endured this horrible situation and now you have overwhelming medical bills, costly medications and you’ve lost time at work. Janssen Pharmaceuticals should have tested their medications thoroughly before putting it on the market to ensure that it was safe for patients and they should have told doctors and patients of the increased risk for amputations. Contact us today to see if we’re able to help you get the compensation that you deserve.

Invokana/Invokamet Warnings In The News

BREAKING (6/18/2018): FDA Requests Invokana Label Review Extension Due to Increased Risk of Amputations

In order to change a drug label, market a new dosage or strength of a drug, or change the way a drug is made, a pharmaceutical company must first submit a supplemental new drug application (sNDA) to the FDA. Johnson & Johnson, the makers of the type 2 diabetes drug Invokana (canagliflozin), recently submitted an sNDA application so that it’s label could add that Invokana reduces the risks of cardiovascular events in type II diabetes patients who are potentially at risk for cardiovascular (CV) disease. Invokana – along with its fixed-dose combinations Invokamet and Invokamet XR – is a sodium-glucose co-transporter-2 (SGLT2) inhibitor that is used for treating type 2 diabetes.

Unfortunately, Invokana currently has a black box warning – the highest warning given by the FDA – for the increased risk of amputations. Do the benefits of reduced cardiovascular complications outweigh the high risk for amputations?

Read Full Article

3/1/2018: Lawsuit Blames Invokana For Toe Amputation

According to a February 14th filing in the U.S. District Court, District of New Jersey, Richard Greenhut was prescribed Invokana in 2016 and took it as directed. On January 12, 2017, he was hospitalized for a swollen, ulcerated and malodorous second right toe, osteomyelitis and renal failure, which he claims were the direct result of his Invokana use. At that time, Greenhut underwent surgical amputation of the affected toe.

The plaintiff was readmitted to the hospital on January 25th due to ongoing ulceration and osteomyelitis. That same day, Greenhut underwent a right second ray partial amputation, which involved the removal of the corresponding metacarpal bones in the foot. He is now permanently disfigured and injured.

Read Full Article

8/31/17: Doctors Debate Danger of Popular Diabetes Drug After FDA Amputation Warning

Many San Diego doctors are taking their patients off of Invokana, a widely used diabetes drug, after a large industry-sponsored trial found it doubled the risk of lower limb amputations compared with those taking a placebo.

Patients are being switched to other medications even though the study’s authors say the drug’s benefits — a reduced risk of cardiovascular events including death, non-fatal heart attacks and non-fatal strokes — outweigh its risk of amputations.

The drug is prescribed for people with Type 2 diabetes. The patients in the trial were already at high risk for heart disease and other diabetes complications including amputations.

Read Full Article

6/12/17: Johnson & Johnson Drug Prevents Heart Attacks At Cost Of Amputated Toes

Invokana, a diabetes drug made by Johnson & Johnson, decreases the risk of heart attacks and strokes, but also increases the risk of amputation, particularly of toes.

The study also deepens the mystery about such drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which prevent the kidney from absorbing sugar from the blood. This lowers blood sugar, is good for the kidney, but leads to more urinary tract infections and weakened bones. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s entirely unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” says Harlan Krumholz, of Yale University.

Read Full Article

5/18/16: Interim clinical trial results find increased risk of amputations with [Invokana]; FDA to investigate

The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

Read Full Article

 

5/15/15: FDA warns that [Invokana] may result in a serious condition of too much acid in the blood

 

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

Read Full Article

 

Filed Invokana Complaints & Damages

7/6/17: Dailey V. Janssen Pharmaceuticals, Inc.
5/26/17: Lozano V. Janssen Pharmaceuticals, Inc Et Al
As a result of the defective nature of INVOKANA, persons who were prescribed and ingested INVOKANA, including Plaintiff, have suffered and may continue to suffer severe and permanent personal injuries, including a stroke. 4. After beginning treatment with INVOKANA, and as a direct and proximate result of Defendants’ actions and inaction, Plaintiff developed kidney failure. Plaintiff’s ingestion of the defective and unreasonably dangerous drug INVOKANA has caused and will continue to cause injury and damage to Plaintiff

Read Full Case

Invokana Settlement Information

GET YOUR FREE Invokana/Invokamet CASE REVIEW TODAY

Invokana/Invokamet settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

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The Step-By-Step Guide To Taking Action

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

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Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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