According to the guidelines published by ADA (American Diabetes Association), Invokana may be considered to reduce major cardiovascular events after lifestyle management and metformin in patients with T2D and established cardiovascular disease.

Over a period of time, Invokana has been linked to aggravating certain medical conditions one of them being 'Ketoacidosis,' a condition in which the body produces high levels of blood acids known as ketones. If left untreated, this condition can be fatal. Since its launch in the U.S. markets, several patients have developed ketoacidosis to the point of needing an emergency room visit or hospitalization.

The most common side effects include genital yeast infections, urinary tract infections, and changes in urination. The side effects listed by the manufacturer is weight loss of between two to three percent. It is also known to lower blood pressure anywhere between three to five mmHg. However, the major side effects mentioned in various lawsuits, are not listed by the manufacturer.

Diabetes causes severe foot problems due to poor circulation, nerve damage, and peripheral arterial disease. In some cases, these problems require a partial or complete amputation of the foot or lower leg. Many lawsuits against Janssen involving Invokana accuse the company of failing to warn them of the higher risk of amputation caused due to the intake of the drug.The most common side effects include genital yeast infections, urinary tract infections, and changes in urination. A weight loss of two to three percent is listed as side effects by the manufacturer. It is also known to lower blood pressure anywhere between three to five mmHg. However, the major side effects mentioned in various lawsuits are not listed by the manufacturer.

Serious Alleged Injuries May Include:

• Ketoacidosis
• Kidney Failure
• Amputation Of Toe Or Part Of Foot

FDA Safety Warnings:

• May 2015: The FDA issued a warning that the type 2 diabetes medicines canagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

• September 2015: The FDA added a new ‘Warning and Precaution' and revised the ‘Adverse Reactions' section of the Invokana and Invokamet drug labels regarding the increased chance of bone fractures and decreased bone mineral density.

• December 2015: Label change for SGLT2 inhibitors about increased risk of ketoacidosis and serious urinary tract infections

• May 2016: FDA issued an initial safety alert stating 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, stating Invokana doubles the risk of amputation.

• June 2016: The FDA strengthened the existing warning about the risk of acute kidney injury information about acute kidney injury and added recommendations to minimize this risk.

• May 2017: Based on new data from two large clinical trials, the FDA required a black-box warning about an increased risk of leg, toe, and foot amputations.

• September 2018: The FDA issued a strong safety warning about the link between a “rare but serious” infection called Fournier's gangrene within and around the genital area in people with diabetes taking these medications.

• October 2018: The FDA approved Invokana as the first and only oral diabetes treatment approved to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease.

As of January 2019, there has not been a recall of Invokana related to kidney failure, amputations, myocardial infarction or ketoacidosis.

Legal Updates:

Defendants: Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc.

Defendant Law Firm: Tucker Ellis, Cleveland/ Drinker Biddle & Reath LLP

Counsel For Defendants:

John Q. Lewis -Tucker Ellis LLP- Cleveland

Mollie F. Benedict - Tucker Ellis LLP- Los Angeles

Allegations: Diabetic Ketoacidosis (DKA), Leg Amputation / Foot or Toe(s) Amputation; failure to adequately test the drug and warn of its risks.

Plaintiff Steering Committee

US District Judge Brian Martinotti appointed the plaintiff's steering committee

• Christopher A. Seeger (Co-Lead Counsel): Seeger Weiss LLP

• Michael A. London (Co-Lead Counsel): Douglas & London, P.C.

• James E. Cecchi (Liaison Counsel): Carella, Byrne, Cecchi, Olstein, Brody & Agnello

• Ellen Relkin (Executive Committee): Weitz & Luxenberg, P.C.

• Hunter J. Shkolnik (Executive Committee): Napoli Shkolnik, PLLC

• Timothy O'Brien (Executive Committee): Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.

• Ashley Brittain-Landers - Schlichter Bogard & Denton LLP

• John Gomez - Gomez Law Firm

• Anthony D. Irpino - Irpino, Avin & Hawkins

• Holly H. Dolejsi - Robins Kaplan, LLP

• Danielle Ward Mason - Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

• Frank M. Petosa - Morgan & Morgan, P.A.

• Jason C. Webster - The Webster Law Firm

• David S. Stellings - Lieff Cabraser Heimann & Bernstein, LLP

Lawsuit Status:

December 2016: Invokana cases were coordinated before U.S. District Judge Brian Martinotti of the District of New Jersey. MDL No 2750: IN RE: Invokana (Canagliflozin) Products Liability Litigation with a count of more than 1,000 cases as of October 2018.

Invokana cases are also pending in state courts in Pennsylvania, California, and New Jersey.

Important Legal Proceedings, Verdicts & Settlements:

A schedule for bellwether cases was selected; the first set of trials were to begin in September 2018. However, the defendants entered into negotiations to settle a large number of Invokana lawsuits pending in court.

Jul 2017: The FDA required a serious boxed warning to be highlighted in the labels about the increased risk of leg and foot amputations.

August 2017: J&J's Janssen Pharmaceuticals confirmed in its quarterly financial filing with the Securities and Exchange Commission (SEC) that it has more than 800 product liability cases across the nation for its anti-diabetic drug Invokana.

Jan 2018: According to the fourth quarter 2017 sales earnings report released by J&J, Invokana made $262 million, which was a 29% dip when compared to the previous reports. The low figures are reasoned to be due to the growing competition and awareness of the side effects associated with this Type 2 diabetes medication.

May 2018: The FDA warned the manufacturers of Invokana, Invokamet, and Invokamet XR to speed track the process to include a Black Box Warning Label to warn about the increased risk of leg and foot amputations.

August 2018: A hand amputation case was filed by a plaintiff who developed severe tissue necrosis, dry gangrene, and blackening of the fingers when she was under Invokana treatment in 2015.