Invokana’s Deadly Side Effects Create the Opportunity for Major Recovery Posted on December 15, 2015 by Larry Bodine Invokana, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals, is a “blockbuster” drug that has been prescribed to millions of Americans with type 2 diabetes in the two short years it’s been on the market. Johnson & Johnson promoted Invokana as a “much-needed” breakthrough in diabetes research. Invokana was designed to help control blood sugar by forcing the kidneys to purge glucose from the bloodstream through urination, but when Janssen began promoting it off-label for weight loss, deadly side effects occurred, according to a letter from Public Citizen to the FDA (see page 6 of the letter). Blockbuster Drug With Deadly Side Effects The host of alarming side-effects Invokana has been linked to include: hypotension urinary tract infections yeast infections ketoacidosis (a potentially-fatal rise in blood acidity) decreased bone strength increased risk of broken bones heart attack stroke kidney failure “Blockbuster drugs” like Invokana are extremely popular drugs that generate annual sales of at least $1 billion for the company that creates it. Examples of blockbuster drugs include Vioxx, Lipitor and Zoloft. Janssen heavily promoted Invokana for both the on-label and off-label use. The FDA described Invokana as creating “an imbalance in early cardiovascular events” observed in the CANVAS trial. This trial involved a 4,300-subject study assessing the cardiovascular effects of Invokana. In the first 30 days of use, Invokana had a cardiovascular events “Hazard Ratio” of 6.9, which means that patients who were taking Invokana at the time had a 690% higher likelihood of suffering a cardiovascular event than the patients who were taking a placebo. Janssen has opened itself up to failure-to-warn suits because the Invokana label does not warn of dangerous side effects, including: heart attack, stroke, kidney failure, and diabetic ketoacidosis. See Also: Is It Time to Rethink the MDL for Mass Tort Cases? While most personal injury attorneys are not currently pursuing bone fracture side effects Invokana cases because cases with hospitalization and prolonged injuries are generally preferred. Generally, Invokana clients must have taken an SGLT2-inhibitor, such as Invokana, Jardiance, or Farxiga (or one of the combination products Invokamet, Glyxambi or Xigduo). Additionally, the most commonly pursued injuries include: Heart attack (must be within 15 days of last use). Stroke (must be within 15 days of last use). DKA (must be within 15 day of last use). Kidney Failure (must be within 45 days of last use). Current Invokana Lawsuits and Potential MDL Rosalba Joudry, a resident of Ontario, Canada, filed an Invokana class action on September 10, 2015—the first Invokana lawsuit ever filed. Joudry and her lawyers filed her case with the Ontario Superior Court. The lawsuit contains accusations that the manufacturer: Failed to perform “proper design, development and testing of its drug” before proceeding to advertise and sell it on the Canadian market. Failed or refused to ensure that doctors and patients had access to a “clear, complete, and current” list of side effect warnings. Ignored, either on purpose or through neglect, vital information on the risks of Invokana, which it should have been aware of “based on Invokana’s [kidney-facilitated] mechanism of action, the class of drugs Invokana belongs to, and numerous studies, trials, and medical journal articles”. Persists in portraying Invokana as a safe product while “downplaying the seriousness of [its] potential side effects”. Chose to value profits over consumer health and safety, exercising “unfair business practices” by concealing any information that might hinder sales. Joudry requested more than $1 billion in damages from Janssen, Inc. for herself and for other claimants who may later join the suit. Due to its widely-prescribed status, the number of lawsuits that could arise due to Invokana’s side effects may reach staggering numbers. Similar plaintiffs may elect to consolidate their cases with group litigation methods such as Joudry’s class action or multi-district litigation (MDL), which expedites the legal process. Because of differences between U.S. and Canadian law,individual lawsuits consolidated in multi-district litigation will likely offer more compensation and flexibility for similarly situated Invokana plaintiffs. To compare the potential compensation that could arise from Invokana MDL, consider Takeda Pharmaceuticals, the manufacturer of the diabetes drug Actos. Takeda recently agreed to pay $2.37 billion in settlements to plaintiffs alleging the drug causes bladder cancer (much like the kidney failure caused by Invokana). This settlement agreement was drawn up to resolve an estimated 9,000 individual lawsuits that demanded compensation for significant damages to health, quality of life, and financial well-being. Mass torts attorneys should contemplate the benefits of marketing geared toward those injured by Invokana.