Janssen Asks FDA For Use Expansion Despite Invokana Litigation
April 8th, 2019
The Johnson & Johnson subsidiary Janssen now claims that its troubled anti-diabetes drug can reduce the risk of end-stage kidney disease in some patients, so it will seek expanded government approval for Invokana.
This latest announcement comes on the heels of a new clinical trial. Janssen claims that in the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) phase three study, people who suffered from CKD (Chronic Kidney Disease) and received Invokana along with standard treatments had much better outcomes than patients who received placebos. The CREDENCE study was so successful that Janssen was able to end it early, according to company officials.
“Today, millions of people living with type 2 diabetes and chronic kidney disease are at high risk of experiencing kidney failure, and unfortunately, we have not seen treatment innovation for these patients in almost 20 years. Janssen’s application is a significant step toward bringing a much-needed, new standard of care for those living with these serious conditions,” remarked Dr. James List, who is Janssen’s Global Therapeutic Area Head in the Cardiovascular & Metabolism division.
Invokana and its Side-Effects
Canagliflozin (Invokana), Farxiga, and Jardiance are all Sodium-Glucose Co-Transporter-2 inhibitors. SGLT2 inhibitors stop the kidneys from reabsorbing excess glucose into the bloodstream. Instead, this sugar passes out of the body through the urine. The big drug companies make billions of dollars off this new class of anti-diabetes drugs.
But there are issues. The higher concentration of glucose in urine may cause urinary tract and genital infections, particularly in women. If not treated properly, the infection can spread to neighboring organs.
Diabetic Ketoacidosis (DKA) is an even more serious problem. This kidney disease can be life-threatening if not diagnosed early and properly treated. There are many invokana lawsuits filed against Johnson and Johnson and their subsidiary, Janssen Pharmaceuticals, Inc. pending in a Federal Court Multi-District Litigation (MDL) that allege that the manufacturers failed to warn doctors of the risk of developing diabetic ketoacidosis. DKA symptoms include dehydration, abdominal pain, fruit-scented breath, and excessive urination. Many DKA victims also have non-physical symptoms, such as sleeplessness and confusion.
The Flawed FDA Approval Process
The Food and Drug Administration’s roots go back to about 1900. Back then, it was legal to sell anything to anyone for any reason. One large drug company even sold bottles of heroin and marketed them as children’s cough syrup. Lawmakers formed the FDA to prevent abuses like that. For many years, the agency was an effective consumer watchdog.
But things change. Today, the FDA receives 75 percent of its funding from drug companies. Since so much of its money comes from the industry that it’s supposed to regulate, FDA inspectors may be reluctant to veto new drug developments.
Furthermore, the FDA is somewhat reliant upon the drug companies to disclose the bad as well as the good when it comes to the approval process. If a company fails to disclose a known side-effect or risk to the FDA, a drug may be approved that simply should not have been. While the FDA can come back and recall drugs or require new warning labels be added, it may already be too late for consumers who had no notice of these risks and no warning to alert them to watch for symptoms. The bottom line is that just because the FDA approves a drug does not mean the drug is safe for all uses.
Your Claim for Damages
As mentioned above, during the approval and sales process, drug companies sometimes fail to disclose to the public pertinent information regarding harmful contaminants within and/or side-effects of their product. The allegations in the talcum powder litigation are a good example of yet another product that Johnson and Johnson is alleged to have withheld information about.
When companies put profits before people by not disclosing known risks, substantial punitive damages are often available. Texas jurors can award these damages if there is clear and convincing evidence that the tortfeasor (negligent company) intentionally disregarded a known risk and put people at risk.
The aforementioned kidney and blood disease problems linked to Invokana and other SGLT2 inhibitors also lead to significant medical bills. Victims must often go to two or three doctors before they receive a correct diagnosis. Because of that delay, their medical problems get worse. Compensation is available for these losses, as well as for the pain and suffering, loss of enjoyment in life, and other noneconomic damages these victims experience.
Invokana is a dangerous drug that causes serious side effects. For a free consultation with an experienced personal injury attorney in Houston, contact Simmons & Fletcher, P.C.
Paul Cannon has practiced personal injury trial law since 1995. He is Board Certified in Personal Injury Trial Law (2005). He has earned recognition as a Super Lawyer by Thompson Reuters in 2017 & 2018, and as a Top 100 Trial Lawyer by the National Trial Lawyers Association in 2017. He is a Shareholder, trial lawyer and online marketing manager at Simmons and Fletcher, P.C. His legal writings have been published by the Texas Bar Journal, Business.com, Lawyer.com HG Legal Resources, Lawfirms.com, and others. He has been asked to give education talks and media interviews on dog bite law.