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).

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk. more Black Box Warnings

A boxed warning is serious business. A “boxed warning” or “black box warning” is a warning that appears on the package insert for certain prescription drugs. It is given this name because the FDA requires that the warning be presented with a box or notable border around the text. The boxed warning is designed to call attention to serious or life-threatening risks that are possible when using the prescription drug.

In July 2017, the FDA required a boxed warning for the diabetes drug Invokana, which included these bullet points:

“Warning: Lower Limb Amputation”

• A 2-fold increased risk of lower limb amputations was observed in two studies of patients taking Invokana.
• Amputations of the toe and midfoot were most frequent; amputations of the leg were also observed. Some patients had multiple amputations.
• Before taking Invokana, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving Invokana for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

See FDA Website for the complete boxed warning.

The bottom line: if you are taking Invokana for treatment of Type-2 diabetes, talk to your doctor about the risks and whether you should remain on the medication. For more information, consult the FDA website.

Originally touted as a wonder drug, a new class of medications based on SGLT2 inhibitors promised to help those suffering from Type 2 diabetes by increasing their ability to lower and control their blood sugar, while also lowering body weight and blood pressure. Pharmaceutical companies were hoping that these new products could potentially become blockbuster drugs. Invokana and Farxiga are two examples of SGLT2 inhibitors.

But just a few years after the release of these drugs in the United States, the drug companies started facing stiff competition among themselves. Additionally, the public learned of the serious risks of taking SGLT2 inhibitors. The purpose of this blog post is to provide a quick overview of SGLT2 inhibitor drugs and the status of their litigation.

What Is a SGLT2 Inhibitor?

SGLT2 is short for sodium/glucose co-transporter 2, which is a type of protein found in the human body. The SGLT2 protein plays a major role in the body’s ability to reabsorb blood glucose through the kidneys.

Drug makers created a new class of medications called gliflozins. These were recently approved by the FDA. Gliflozins are SGLT2 inhibitors, which mean they restrict the SGLT2’s role in the human body. This results in lower blood sugar, since glucose that would normally be retained by the body is now eliminated in the urine.

What Gliflozin Medications Are Currently on the Market?

There are a number of SGLT2 inhibitor medications currently sold in the United States. They include:

• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin)
• Farxiga (dapagliflozin)
• Xigudo XR (dapagliflozin and metformin extended release)
• Jardiance (empagliflozin)
• Glyxambi (empagliflozin and linagliptin)

What Are Some Problems with Taking an SGLT2 Inhibitor?

One of the above drugs that has been in the news lately is Invokana. We recently discussed some of the problems associated with Invokana and the lawsuits that resulted. Some of the problems with Invokana and other SGLT2 inhibitors include:

• Acute kidney injury, resulting in sudden kidney (renal) failure
• Diabetic ketoacidosis, where the blood contains high levels of ketones, a blood acid
• Urinary tract infections
• Stroke
• Yeast infections
• Increased risk of foot and leg amputations

The exact side effects will vary depending on the specific gliflozin a patient is taking. For example, the FDA has only issued a Safety Announcement regarding amputation risks for the drugs using canagliflozin. However, the FDA has issued a Safety Announcement concerning diabetic ketoacidosis for SGLT2 inhibitors in general and a Drug Safety Communication concerning acute kidney injuries for both canagliflozin and dapagliflozin-based medications.

Due to the severity of these problems, along with the high number of individuals taking them, a number of lawsuits have been filed.

SGLT2 Inhibitor Lawsuits

Currently, the number of lawsuits is relatively limited. There are several hundred lawsuits involving Invokana which are still in the early stages of litigation. However, they have reached multi-district litigation, or MDL status. The cases are in the discovery stage, with the first bellwether trial scheduled for early in 2018.

But Invokana isn’t the only drug that’s in litigation. Farxiga is also in MDL before Judge Lorna G. Schofield in the Southern District of New York. As of April 2017, there were only eighteen cases in the Farxiga MDL, although this number will likely be higher by the time you read this. The plaintiffs’ allegations center around Farxiga causing diabetic ketoacidosis and acute kidney injuries, as well as the drug maker’s failure to adequately test the medication and warn patients of Farxiga’s risks.

What Now?

Both the Invokana and Farxiga MDLs are early in their life-cycles. I am currently investigating new cases involving Invokana, Farxiga and other SGLT2 drugs. Feel free to give me a call if you have been injured by SGLT2 inhibitors. When there are any notable developments concerning SGLT2 drugs or the litigation, I will provide updates on this website. Stay tuned.

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

Invokana: Diabetes Drug

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a subtype 2 sodium-glucose transport inhibitor marketed by Janssen, a subsidiary of Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

Problems and Side Effects of Invokana

All drugs have side effects and Invokana is no different. However, many patients who took Invokana suffered many side effects that 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
• Renal failure and acute kidney injuries, even in those without a history of kidney problems
• Stroke
• Urinary tract infections, resulting in either blood or kidney infections
• Increased risk of leg and foot amputations

After its approval and release in the United States, drugs containing canagliflozin, including Invokana, were the subject of several safety announcements and warning label updates.

For example, in May 2015, the FDA issued a Drug Safety Communication telling the general public that there was a risk of diabetic ketoacidosis.

In September 2015, the FDA issued another Drug Safety Communication declaring increased safety warnings concerning the risk of bone fractures due to decreased bone density.

In December 2015, the FDA released yet another Drug Safety Communication requiring that drugs containing canagliflozin have warning labels that listed diabetic ketoacidosis and urinary tract infections.

And in May 2017 there was another Drug Safety Communication released by the FDA confirming an increased risk of leg and food amputations in those taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk. The FDA’s decision was based on two clinical studies which found that individuals taking medications containing canagliflozin had twice the risk of having a foot or leg amputated.

With all these newly discovered problems with a popular medication, it’s no wonder there is currently a flurry of lawsuits pending in the courts.

People Injured by Invokana Filing Suit

As of April 27, 2017, there were 295 Invokana product liability lawsuits in federal court. By the time you read this, that number is very likely to be higher.

Because of the varied side effects and problems with taking Invokana, the lawsuits set forth a variety of physical injuries, including stroke, diabetic ketoacidosis, urinary tract infections, kidney failure and death.

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

Invokana Litigation Status

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 pre-trial litigation process and facilitate a potential settlement.

The cases are currently in the discovery phase, which will take many months to complete. The Judge overseeing the Invokana MDL hopes to have three bellwether trial cases selected by January 2018, with the first bellwether trial beginning in September of 2018.

What Happens Next?

The pretrial activities, such as discovery, will need to run their 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, the discovery process can be the most time consuming and expensive part of the lawsuit.

The FDA currently recommends patients taking Invokana and other medications containing canagliflozin to contact their doctor immediately if they’re experiencing any problems with the medication. The FDA has also told patients not to stop taking Invokana until they speak with their doctor first.

When there are additional updates to the Invokana litigation, I will post them on this blog.