If you or someone you love have suffered side effects such as Diabetic Ketoacidosis, Kidney Disease, Acute/Kidney Failure, Heart Attack, Stroke or Amputation after starting Invokana, Invokamet, Farxiga, Jardiance, Xigduo XR or Glyxambi, you may be eligible for compensation through a defective drug lawsuit against the manufacturer. Our Invokana attorneys are standing by, waiting to assist.
Lawsuits allege that Janssen / Johnson & Johnson, manufacturer of Invokana, a popular type two diabetes drug, failed to warn both the medical community and consumers of serious potential side effects including heart attacks, stroke, amputation, kidney failure, kidney disease and diabetic ketoacidosis. Ketoacidosis is a serious condition, usually requiring hospitalization due to the possibility of fatal brain swelling, coma, and severe dehydration. It’s also been alleged that had the public been properly warned, doctors and patients may have chosen something other than Invokana for diabetes management or at the very least, monitored for health issues more frequently.
New Lawsuit Accuses Johnson & Johnson, Janssen Pharmaceuticals of Failure to Adequately Research Invokana and Failure to Warn of Health Risks
July 13, 2017 – In a lawsuit filed July 3, 2017, plaintiff Martha Williams of Tennessee accuses Janssen Pharmaceuticals and parent company Johnson & Johnson of failure to adequately research all potential health risks of its new generation diabetes drug Invokana as well as failure to warn the public and medical community of such risks. The lawsuit blames an onset of acute renal failure, a urinary tract infection, dehydration and hypokalemia suffered by Williams just one month after starting the medication.
“Consumers of Invokana and their physicians relied on the Defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, stroke, and the life-threatening complications thereof,” the lawsuit states. “The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”
Read the entire complaint here.
United States District Court, District of New Jersey, Case 3:17-cv-4891
Invokana Linked to Amputations of the Toe, Foot, Leg
May 16, 2017 – The U.S. Food & Drug Administration (FDA) has issued an update citing clinical trials that found an increased risk of amputation in diabetes type two patients taking canagliflozin (Invokana, Invokamet), most involving the legs and feet.
The safety announcement states:
“based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type two diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”
They advise that anyone taking the medication consult with their doctor immediately should they experience any pain or tenderness, sores, ulcers or infections in the lower limbs. They do not recommend stopping the medication without first consulting with a physician or other healthcare provider.
Healthcare professionals are advised to consider any factors that may predispose a patient to amputations before starting the medication, which may include issues such as:
- Any prior amputations
- Peripheral vascular disease
- Diabetic ulcers in the feet
The two clinical trials referenced in the FDA safety announcement include results from the Canagliflozin Cardiovascular Assessment Study (CANVAS) and A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R). Both studies published findings that indicated “leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 9 out of every 1,000 patients treated with canagliflozin
- 8 out of every 1,000 patients treated with placebo
The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
- 5 out of every 1,000 patients treated with canagliflozin
- 2 out of every 1,000 patients treated with placebo”
The most common amputations were of toe or middle foot but also included the leg and knee areas. Some patients required amputations involving more than one area, or more than one surgery.
Invokana Heart Attack, Stroke
Cardiovascular side effects have been a concern since early on in the drug’s approval process. On January 10, 2013, Dr. Sidney Wolfe, of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, expressed reservation concerning clinical trial outcomes citing abnormalities in the number of red blood cells in proportion to plasma, or “hemoconcentration” in patients who were taking the drug.
The drug is in a class of SGLT2 inhibitors that flush blood glucose through urine. At the same time, increased urination can also increase the concentration of red blood cells to a level that causes thickening of the blood, possibly increasing the risk of blood clots, stroke, and heart attack.
Wolfe noted that within the clinical trial data canagliflozin showed to increase hematocrit more than another SGLT2 inhibitor, dapagliflozin. He estimated that 25% of patients taking the drug could suffer hemocontrations that he called “a very dangerous range.”
Invokana Bellwether Trial Scheduled to Begin September, 2018
May, 2018 – The first bellwether trial for Invokana (canagliflozin) has been scheduled to begin September 2018, per a Case Management Order signed by the Court on May 1, 2017. Currently, over 230 Invokana and Invokamet personal injury lawsuits have been filed alleging Johnson & Johnson withheld critical information about the drugs’ link to ketoacidosis and other life threatening side effects.
In a bellwether trial, test cases are selected from the filed complaints to go before a jury in order to gauge responses to the issue. As it is not practical to bring every case to trial, these results will help shape the process in dealing with the remaining cases and ascertain value.
The discovery process is to take place between September 1, 2017 and December 15, 2017 with four case-specific depositions permitted per side. Recommendations for the bellwether trial pool are due by January 5, 2018, with the Court making final decisions of three bellwether cases for trial and order by January 19th.
The cases have been consolidated in New Jersey as part of a federal multidistrict litigation before U.S. District Judge Brian Martinotti.
It is expected that thousands of claims will ultimately be filed as attorneys continue to receive consumer complaints and file claims across the United States.
Read the entire order, here.
The drug is used to improve glycemic control in combination with diet and exercise modifications and belongs to a class of Type 2 diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. The SGLT2 inhibitor works by decreasing blood sugar levels and encouraging the release of excess sugar into the urine.
Diabetic Ketoacidosis (DKA)
DKA is a serious condition and patients who notice symptoms should contact a doctor or emergency room immediately.
DKA occurs when the body cannot use sugar (glucose) as a fuel source because there is either too little or no insulin. Instead, the body breaks down fat for energy. The breakdown of fat produces ketones which can build up in the body. When these waste products build in the blood, they become toxic.
Symptoms of diabetic ketoacidosis can onset quickly and include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Hyperglycemia (high blood sugar)
- Keytones in urine
If you or someone you love have suffered diabetic ketoacidosis since starting Invokana, you may be eligible for compensation through a defective drug lawsuit.
Acute Kidney Injury (AKI)
Kidney injury is a serious condition where the kidneys suddenly stop working and allow waste to build up in the body. In some cases, AKI may not have symptoms and healthcare providers may have to run tests to diagnose it. The FDA recommends that patients who have signs of kidney injury stop taking Invokana immediately.
Symptoms of AKI include:
- Decreased urine output
- Fluid retention
- Shortness of breath
- Chest pain
If you or someone you love have suffered a kidney related injury since starting Invokana, you may be eligible for compensation through a defective drug lawsuit.
FDA SAFETY WARNINGS
FDA Issues Safety Warnings
The drug was approved by the FDA in March, 2013 but in May, 2015 issued a drug safety warning to patients and the medical community that the drug could cause diabetic ketoacidosis after reviewing 20 adverse event reports of ketoacidosis in patients taking the drug from the time period March, 2013 – June, 2014. They found that all 20 incidents required emergency room visits or hospitalization for treatment.
In December, 2015, the FDA required manufacturers of the drug add warning labels citing the risk of ketoacidosis and urinary tract infections. Lawsuits were filed by patients who developed the side effects, also alleging the drug caused strokes, kidney injuries requiring hospitalization, and blood clots.
The warning for acute kidney injury was strengthened by the FDA in June, 2016 when more than 100 people had experienced the side effect between March, 2013 – October, 2015. They also state there could be even more cases that have gone unreported. Reports indicated that half or so cases experienced kidney troubles within one month of starting the medication.
To date the medication has not been recalled and the FDA says they are continuing to investigate.
What Is a Defective Drug Lawsuit?
A defective drug lawsuit is a lawsuit against the drug manufacturer alleging insufficient warnings or improper testing of the medication before it was released to the public. The law allows for remedies when someone has been injured in this way. Often times the injuries suffered are more significant than what led the person to take the medication in the first place. Manufacturers are required by law to test products and make sure they are safe. They are also required to adequately warn people of any risks or potential side effects they may experience by taking the drug. If the drug manufacturer fails to do this, they are liable for the injuries suffered because they neglected their duties.
What Will an Attorney Cost Me?
We represent our clients on a contingency fee basis. This means that you pay no attorney fees until we win your claim. If we are unable to successfully resolve your claim, you are not obligated to pay attorneys’ fees.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers, or surgical instruments can harm patients when the product is defective in the manufacturing process, design, or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
Nationally recognized as a leading plaintiff’s law firm, we handle cases in all 50 states and Puerto Rico.
Read more about our attorneys here.