Invokana

  • Invokana Medical Record Review and Outsourcing Services

Invokana (Canagliflozin) is a drug used for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson in the United States. The U.S. Food & Drug Administration (FDA) approved Invokana on March 29, 2013, for the treatment of type 2 diabetes. It belongs to the class sodium-glucose cotransporter 2 (SGLT2) inhibitor. Glucose is reabsorbed from urine by the action of SGLT2, which is an enzyme in the kidney tubule; by inhibiting the action of SGLT2, Invokana helps the kidneys get rid of glucose from the bloodstream.

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.

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

  • 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 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 Invokana lawsuits pending in court.

October 16, 2018:  A New York-based, firm Douglas & London, P.C., requested New Jersey federal court to establish a qualified settlement fund to administer the settlement of certain claims against the defendants. Attorney Michael London of D&L also the co-lead plaintiffs’ counsel representing nearly 142 plaintiffs expects that the settlement should resolve all of his cases out of the 1,000 plus lawsuits pending as consolidated litigation in the US District Court of New Jersey.

More settlement agreements are likely on the way. Judge Martinotti had scheduled jury selection to begin in January 2019, but “in light of the tremendous efforts of the parties to achieve resolution for the various injuries claimed in this complicated multidistrict litigation,” Martinotti stayed discovery in the cases, essentially stopping their progress toward trial to provide more time for concerted settlement negotiations. Discovery was stayed until October 30.

Evidence:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake
  • Any other SGLT2 inhibitors used

Medical Record Review and claim validation of Invokana case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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