Johnson & Johnson entered its drug, Invokana, into the pharmaceutical marketplace seven years ago. From its auspicious beginnings as an approved diabetes treatment, the drug soon faced legal challenges after the U.S. Food and Drug Administration (FDA) issued serious warnings about its risks and side effects.
What is Invokana?
Invokana is a prescription drug used to treat Type 2 (T2) diabetes. It is part of a class of drugs known as SGLT-2 inhibitors, meaning it is a sodium-glucose co-transporter that acts to control high blood sugar for non-insulin-dependent T2 diabetics. Invokana blocks reabsorption of sugar by the kidneys and helps expel excess sugar through urine production.
However, Invokana has been the subject of lawsuits due to many serious side effects that came to light aftermarket. The more common side effects include urinary tract infections, vaginal itching, nausea, fatigue and bone fractures. Rare side effects include gangrene, lower leg amputations, diabetic ketoacidosis (DKA) and kidney problems.
A timeline reveals Invokana’s transformation from a wonder drug to its current status: the subject of multidistrict litigation (MDL) 2750.
- 2013 – Invokana (Canagliflozin) Goes to Market. In January 2013, the FDA’s Food and Drug Advisory Panel voted to approve Janssen Research and Development LLC to go to market with Invokana for use in the treatment of T2 diabetic patients. Invokana becomes the first SGLT-2 inhibitor sold in the U.S.
- 2015- FDA Revised Advice to Include Warning of Risks. In December 2015, the FDA revises its advice on Invokana to warn of serious risks associated with the drug, including DKA and urinary tract infections. The warning notes that DKA can occur while taking SGLT-2 inhibitors even if the patient’s blood sugar level is not very high. The FDA finds that emergency room personnel or other medical providers may not immediately recognize DKA symptoms, which can result in the delay of appropriate treatment. The FDA cites 19 cases of life-threatening blood infections and kidney infections that result in intensive care and dialysis treatments during the previous two-year period. As a result, FDA warnings about the inhibitors are added to prescription labels, and the FDA institutes a five-year reporting period for DKA in patients taking SGLT-2 inhibitors.
- 2016 – The Creation of MDL 2750. By October 2016, plaintiffs have filed 57 personal injury cases against Janssen Pharmaceuticals and Johnson & Johnson in 11 United States district courts. The parties agree to consolidate and transfer the cases to a single U.S. district court for coordinated pretrial proceedings. The cases — known collectively as “In Re: Invokana (Canagliflozin) Products Liability Litigation” — transfer to Judge Brian Martinotti of the District of New Jersey as Multidistrict Litigation (MDL) 2750. As of October 2018, MDL 2750 includes more than 1,000 cases.
- 2017 – Major CANVAS Study. In June 2017, the American Diabetes Association publishes an article on the long-awaited results from the CANVAS (Canagliflozin Cardiovascular Assessment Study) showing that Invokana provides significant benefits for preventing cardiovascular events and results in a reduced risk in the decline in kidney function in patients with T2 diabetes. At the same time, however, the study shows Invokana presents a significant risk of diabetes-related amputations in the lower limbs. The reason for this risk is unknown. Individuals taking Invokana are twice as likely to need amputations at the toe or metatarsal. The amputation risk applies to all SGLT-2 inhibitors.
- 2017 – FDA Confirms CANVAS/CANVAS-R’s Negative Results. In May 2017, the FDA issues a safety announcement confirming the amputation risk for patients taking Invokana. The safety warning originates from two large clinical trials (CANVAS and CANVAS-R) that indicate the increased risk in lower leg amputations and result in new prominent box warnings on the product labeling. CANVAS-R studied the effects of Canagliflozin on renal endpoints in patients with T2 diabetes.
- 2018 – FDA Finds Invokana Can Lead to Fournier’s Gangrene. At the end of August 2018, the FDA issues another safety warning with regard to SGLT2 inhibitors. Patients taking this class of drugs are susceptible to a rare infection of the genitals and genital area called Fournier’s Gangrene, a necrotizing fasciitis, which results in dead tissue in the affected area.
- 2018 – Janssen Pharmaceuticals Offers a Settlement. In October 2018, Johnson & Johnson agrees to a settlement of a big part of the cases consolidated under MDL 2750. This is the first settlement of substantive cases under MDL 2750. MDL 2750 Judge Martinotti cancels bellwether trial jury selection to allow settlement talks to continue.
- 2019 – Gangrene cases added to MDL 2750. In June 2019, the panel on Multidistrict Litigation transfer the Goodwin and Lo Re gangrene cases to MDL 2750 because they find enough common factors to justify consolidation for pretrial coordination.
- 2019 – CREDENCE Study. The CREDENCE study shows Canagliflozin superior to placebo in the treatment of diabetic kidney disease. It is now the only SGLT2 inhibitor approved for treating diabetic kidney disease and reducing hospitalization risk for heart failure in patients with T2 diabetes and diabetic kidney disease.
- 2019 – FDA approves Invokana. After the CREDENCE study, the FDA approves Invokana as the only SGLT2 inhibitor to slow diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with T2 diabetes and diabetic kidney disease.
MDL 2750 remains ongoing in New Jersey under judges Martinotti and Goodman. If your firm is interested in finding clients to join MDL 2750, you must access quality leads and perform intake on a large scale. The most efficient way is to outsource to a legal call center, like Alert Communications. Alert features customizable intake procedures that can qualify and convert leads on your law firm’s behalf, often on the very first contact.