Invokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give you a history of key dates in the life-cycle of the drug, from its market release through the latest developments in the multidistrict litigation, where currently 1,000 lawsuits have been filed.

May 31, 2012. On this date Janssen Pharmaceuticals, a drug company owned by Johnson & Johnson, submitted an application to the FDA for approval of Invokana.

March 29, 2013. The FDA approves Invokana for sale. Janssen and J&J begin selling the drug.

May 15, 2015. The FDA issues its first warning about possible injury from taking Invokana. The FDA announces that the drug can cause ketoacidosis, which occurs when a person’s body produces high levels of acids called ketones. Ketoacidosis can cause extreme thirst, nausea, pain, weakness, and other conditions. It is considered a serious condition.

September 10, 2015. The FDA issues new warnings regarding Invokana. In this warning, the FDA states that decreased bone density and bone fractures have been reported by some patients taking the medication.

October 2015. The first lawsuit against Janssen and J&J is filed over injuries caused by taking Invokana. The plaintiff alleges that the drug caused her to develop ketoacidosis. The case is filed in California. Many lawsuits will follow.

December 14, 2015. Yet another safety communication is announced by the FDA. This time, the FDA warns about the public the potential for elevated blood acid levels and urinary tract infections in patients who take Invokana.

June 29, 2016. The FDA announces that patients taking Invokana have an increased risk of bone fractures, particularly with patients who use the medication for longer periods of time. Which is to say, the longer you take Invokana, the higher your the risk of bone fractures.

December 7, 2016. The JPML designates a multidistrict litigation (MDL) site for plaintiffs suing the makers of Invokana. The venue is the federal court in New Jersey, with Judge Brian Martinotti presiding. I have written quite a lot about MDLs on this site, but for now, just know that MDLs permit hundreds or thousands of plaintiffs to have their cases managed in one court through the initial stages of litigation. If a settlement is not reached, eventually each individual case is transferred to the district court in the state where it should have originally been filed. Please note: multidistrict litigation is not a class action lawsuit. Each MDL case is ultimately handled individually, on its own merits. The MDL is used simply to consolidate litigation work on discovery and certain key motions before the cases are returned to their home districts for trial.

January-December 2016. Janssen and J&J earn approximately one billion dollars on the sale of Invokana in 2016.

May 16, 2017. The FDA warns about a higher risk for leg and foot and toe amputations associated with the use of Invokana. The FDA orders that Invokana’s “boxed warning,” which is the highly visible warning on the label inside a black box or border, should include language about the increased risk for amputations.

August 31, 2017. On this date the FDA releases its latest assessment of injuries from patients taking Invokana. On its “FAERS” website, which stands for FDA Adverse Events Reporting System, the FDA notes that 14,072 “adverse events” have been reported since the drug was first sold in 2013. Of these, 1,988 were cases of diabetic ketoacidosis, 714 were incidents of urinary tract infections, 641 were kidney injuries, 594 were kidney failure, 58 were toe amputations, and 17 were leg amputations. There have been 169 reported deaths associated with taking Invokana. Keep in mind that the FAERS will not have every adverse event associated with any drug. Some injuries are not reported to the FDA. Still, this site gives you an overview of the kinds of injuries being reported in patients taking Invokana (or any other drug).

Let me say that I think the FDA “FAERS” website is very useful for consumers. If you have concerns about a certain drug, the FAERS site will provide a ton of collected information. I would educate yourself on the prescription drug you may be taking, and then ask your doctor about all the risks in taking the medication. You can access FAERS here.

November 7, 2017. In a Case Management Order in the Invokana MDL, it is reported that 943 cases have been filed through this date.

September 2018. The first Invokana bellwether trial is scheduled. I will keep you posted on on this bellwether case and in MDL 2750.

If you are currently taking Invokana, I would suggest you have a conversation with your doctor about the risks in taking the drug. And if you have been injured by the drug, perhaps in one of the ways discussed above, give me a call to discuss your legal options.

Diabetes is a serious condition that affects the way the body metabolizes sugar. Over 29 million Americans currently suffer from the disease. Of the newly diagnosed cases of diabetes in adults, around 95% are for Type 2 diabetes. Type 2 diabetes occurs when the body produces enough insulin but cannot use insulin properly. Type 2 diabetes results in high blood sugar levels which can cause long-term health problems. So what does all this mean? From the perspective of pharmaceutical companies, it means there is a massive market for Type 2 diabetes drugs. Enter the latest diabetes “wonder drug,” Invokana. more Invokana

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a diabetes medication sold by Janssen Pharmaceuticals and Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by preventing the kidneys from reabsorbing blood glucose. The blood glucose is removed with the body’s urine. Unfortunately, many patients who took Invokana suffered side effects they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include diabetic ketoacidosis, stroke, renal failure and other kidney injuries, urinary tract infections, and leg and foot amputations.

After its approval and release in the United States, canagliflozin was the subject of several safety announcements and warning label updates. In May 2017 there was another FDA Drug Safety Communication which confirmed an increased risk of leg and food amputations for those patients taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk.

So what should you do if you suffered an injury while taking Invokana? Here are six helpful steps:

1. Don’t Stop Taking Invokana Until You Speak with Your Doctor.

The FDA currently recommends that patients taking Invokana to contact their doctor if they’re experiencing problems with the medication. The FDA has also recommended that patients should not stop taking Invokana until they meet with their doctor first.

I would go a step further and recommend that even if you have no injuries or symptoms, you should ask your doctor if Invokana poses an unnecessary risk to your health. There may be safer medication options for you.

2. See Your Doctor Immediately.

This is the most important thing to do if you are suffering injuries or side effects while taking Invokana. Your health issues must come first. Ask your doctor if Invokana is simply too risky to continue taking. If your doctor insists that you should continue taking Invokana, ask your doctor why (and write down the answers). Also ask your doctor if there are safer alternative medications. Gather as much information as you can. If your doctor does not give the issue the attention you think it deserves, seek a second opinion.

3. Keep a “Symptoms Journal.”

It is simple enough: when you first begin to notice symptoms which seem abnormal or unexpected or troubling, jot down these sensations on a piece of paper or a notes “app” on your smart phone. The more detail the better. This journal may well provide critically important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A person who has been injured by a harmful drug can recover money “damages” in a category known as pain and suffering. A symptoms/pain/well-being journal can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a potentially dangerous drug like Invokana.

4. Keep Careful Record of Medical Bills, Out-of-Pocket Expenses, and Time Missed from Work.

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to injuries suffered from Invokana, including inpatient treatment, surgeries, recovery, rehabilitation, other medications, etc. In some cases, drug companies will pay the out-of-pocket expenses of a victim of a failed prescription medication. Finally, keep detailed records of all time missed from your employment, including sick days you were forced to spend, and days out of work for which you lost compensation.

5. Find an Attorney You Trust.

This step is very important and not easy. Do your research on the attorney and take your time with this important decision. If the first lawyer you call is not a good fit, you can easily move on to the next lawyer. Of course, you can always call me (919.830.5602).

6. File a Lawsuit Against the Makers of Invokana.

The primary legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of the risks associated with taking Invokana. Had these injured people been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pretrial litigation process and perhaps facilitate a potential settlement. The cases are currently in the “discovery phase,” which will take several months to complete. The pretrial work must run its course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants like Janssen and J&J, the discovery process can be the most time consuming and expensive part of the lawsuit.

In the Invokana MDL, the judge intends to have three bellwether trial cases chosen by January 2018, with the first bellwether trial beginning in September 2018.

Note: I am not a doctor. As a product liability lawyer, I can’t diagnose your health issues and cannot connect any injury you may have suffered to Invokana or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to Invokana or another drug).