- Numerous claims have been filed against Janssen Pharmaceuticals for producing and selling Invokana, a medication for people with type 2 diabetes, which resulted in them experiencing severe side effects.
- Patients who had been prescribed the medication and suffered from severe side effects are eligible to file a claim against the company in order to recover compensation for their losses.
- Several users around the country were admitted to the hospital or passed away from serious complications, which Janssen Pharmaceuticals failed to mention on the drug’s warning labels.
- The most common complaints filed against Janssen Pharmaceuticals include their failure to warn of risks, downplaying risks, manufacturing a defective drug, failure to perform adequate tests, deceptive advertising, among others.
- Janssen Pharmaceuticals is currently facing around 1,200 lawsuits with 878 active lawsuits filed in different federal courts and state courts.
Invokana, also known by its generic name canagliflozin, is manufactured by Janssen Pharmaceuticals, which is a division of Johnson & Johnson, and is used for the treatment of type 2 diabetes. The medication belongs to the category of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors.
Mitsubishi Tanabe Pharma Corporation, formerly known as Tanabe Seiyaku Ltd. is a pharmaceutical company that developed the drug first and then licensed it to Janssen Pharmaceuticals to continue its development and market it worldwide.
The U.S. Food and Drug Administration (FDA) conducted clinical testing to prove its efficacy and in March 2013, they approved a new drug application for Invokana. The European Medicines Agency also authorized the drug for distribution.
Janssen Pharmaceuticals released a press release, claiming Invokana as a revolutionary drug for individuals diagnosed with diabetes. A lead officer employed at Janssen Pharmaceuticals stated that Invokana lowered blood glucose levels or performed similarly as other existing drugs available for the treatment of diabetes during clinical trials. The manufacturer also said that the drug was generally well tolerated and reported seeing mild to moderate side effects.
In 2014, sales for the drug were $586 million, which later grew to $1.3 billion in 2015. The drug surpassed two newly FDA-approved drugs for the treatment of diabetes, Jardiance and Farxiga. Millions of patients were prescribed to take Invokana since then.
At the same time, the FDA released a warning that SGLT2 inhibitors like Invokana could lead users to develop diabetic ketoacidosis (DKA). Diabetic ketoacidosis occurs due to the build-up of high levels of acid in the blood. The FDA further stated that SGLT2 inhibitors can cause kidney injuries and bone fractures.
When the side effects of the drug came to light, its sales decreased. Despite that, Johnson & Johnson continued to generate hundreds of millions of dollars each year from the sale of the drug. Even though several precautions were taken before prescribing this drug, reports of users experiencing severe side effects after taking Invokana surfaced.
There are around 1,200 Invokana personal injury lawsuits filed in both state and federal courts against Johnson & Johnson by Invokana patients — most of which are still pending in courts. According to the lawsuits for Invokana, the affected individuals claim that Johnson & Johnson failed to warn them of the serious side effects associated with the drug.
Those include a higher risk of Fournier’s gangrene, lower limb amputation, kidney failure, and diabetic ketoacidosis. Most lawsuits cite results from the CANVAS-R and CANVAS clinical trial as evidence that the manufacturer could have emphasized slightly more than they did about the side effects associated with the drug use.
Instead, the manufacturer chose to promote the drug as a safe option for people with diabetes and even promoted it for off-label use to reduce blood pressure, treat weight loss, and improve cardiovascular function. Since the manufacturer failed to release proper warnings of using the drug, users were incapable of making an informed decision on whether to use the drug or opt for an alternative.How Does the Drug Work?
Invokana is an oral medication taken by patients with type 2 diabetes. The drug reduces blood glucose levels in the body by filtering out excess glucose from the blood and excreting it via the urine. The drug helps users reduce blood sugar levels without increasing their risk of gaining weight, given they follow a healthy and balanced diet combined with regular exercise.
Invokana has shown to be more effective in lowering blood glucose levels than DPP-4 inhibitors in clinical trials. The antidiabetic drug is categorized as a SGLT2 inhibitor, which increases the amount of glucose that exits through the urine.
The kidneys function to filter glucose from the blood while the SGLT proteins reabsorb glucose into the blood. SGLT2 proteins block the action, resulting in decreased glucose reabsorption and increased glucose excretion through the urine.
Even though this drug has been touted as an effective treatment for type 2 diabetes, several users around the country have been admitted to the hospital or passed away from serious side effects, which the manufacturer failed to mention on the drug’s warning labels.
The manufacturer is responsible for warning users of possible life-threatening side effects and due to their failure, patients and loved ones of patients who died after taking Invokana have filed personal injury lawsuits against them, seeking compensation and justice.
Some of the most common complaints lodged against the manufacturer include their failure to warn of risks, downplaying risks, manufacturing a defective drug, failure to perform adequate tests, deceptive advertising, among others. Some of the injuries mentioned in the lawsuit claims are lower limb amputations and diabetic ketoacidosis.Uses of the Drug
Invokana is primarily used as a drug to reduce blood sugar levels in patients with type 2 diabetes. The drug can also be used to treat the following medical conditions:
Diabetic Kidney Disease: Diabetic kidney disease (DKD) is caused by diabetes. The kidneys function to filter waste and excess water from the blood and excrete it via the urine. Kidneys control blood pressure and create hormones that the body requires to stay healthy.
When kidneys can no longer perform their function of filtering blood, waste builds up in the body. The risk of developing diabetic kidney disease is higher in people with diabetes. Increased blood glucose levels can damage the blood vessels in the kidneys, causing them to lose function. Invokana is claimed to be the only antidiabetic drug to reduce the risk of diabetic kidney disease, as well as end-stage kidney disease (ESKD)in diabetic patients.
Heart Disease: Diabetes increases the risk of people developing heart disease. It also increases their chances of experiencing a stroke or heart attack. People with diabetes are at a higher risk of developing high blood pressure or high cholesterol, thus increasing their risk of experiencing a stroke or heart attack.
People with diabetes need to manage their blood glucose levels, along with their blood pressure and cholesterol. High blood glucose levels can damage a person’s blood vessels and nerves that control the blood vessels and heart. Invokana can lower the risk of hospitalization for heart failure in people with type 2 diabetes and diabetic kidney disease.Who is at Risk?
The risk of experiencing side effects from Invokana is higher in the following instances:
- People with heart problems
- People with liver disease or kidney disease
- People who have or have experienced bladder infections or urination problems
- People with nerve problems or circulation problems in their legs or feet
- People with pancreas disorder
- People with diabetic ketoacidosis
- People on a low salt diet
- People with a diabetic foot ulcer or amputation
- Pregnant women or those trying to conceive
- Women who are breastfeeding
- People who are under the age of 18
- People with a history of alcohol abuse
- People with low blood volume (hypovolemia)
- People with low blood pressure
People using Invokana should seek medical help immediately if they experience any of the following symptoms:
- Genital infection (burning, odor, itching, tenderness, pain, redness, or swelling of the rectal or genital area)
- Light-headedness (feel as if they may faint)
- Little to no urination
- Burning or pain when urinating
- New pain, sores, tenderness, infections, or ulcers in the feet or legs
- High potassium levels (irregular heartbeats, nausea, loss of movement, or weakness)
- Ketoacidosis, which is the presence of high levels of acids in the blood (vomiting, nausea, stomach pain, unusual drowsiness, confusion, or difficulty breathing)
- Dehydration (weakness, dizziness, or feeling light-headed as if about to faint)
Invokana increases the likelihood of people having a broken bone. Older adults are at a higher risk of experiencing severe symptoms associated with taking Invokana. People who have experienced side effects or close family members who have lost a loved one due to the negligence of the manufacturer should contact the attorneys from Frankl Kominsky for information on their eligibility to pursue a lawsuit against Invokana. A lawyer can try to help the victims get compensated for their medical expenses, lost wages, household bills, loss of future earnings, and pain, suffering, and emotional turmoil.Who Can File an Invokana Lawsuit?
People with type 2 diabetes who were prescribed Invokana and suffered from serious complications after taking the medication are eligible to file a personal injury lawsuit. Here is a list of the serious side effects that people experienced after taking Invokana:
Lower Limb Amputation: Those diagnosed with diabetes are at a higher risk of lower limb amputations. Two clinical trials conducted on a larger scale confirmed that people taking the drug are twice as likely to undergo lower limb amputations than people taking a placebo.
The researchers stated that the most likely part of the lower limb to be amputated the toe and middle of the foot. However, several others also underwent leg amputations with some undergoing amputation of both legs. This led the FDA to issue a black box warning to be placed on all drugs with canagliflozin.
Diabetic Ketoacidosis: Diabetic ketoacidosis occurs when the blood contains high levels of ketones due to a breakdown of fatty acids. High levels of ketones in the body can lead to a diabetic coma or death. This life-threatening medical condition occurs when the cells do not receive the glucose required for energy, the body starts to utilize fat for energy, which produces ketones.
The FDA released a safety communication to warn people that Invokana, along with other SGLT2 inhibitors, can cause a person to develop diabetic ketoacidosis. The FDA received 20 confirmed reports of people developing diabetic ketoacidosis after taking the class of drugs with every patient hospitalized or taken to the emergency room.
Kidney Injuries: SGLT2 inhibitors also increase the risk of acute kidney injuries with the FDA receiving 73 confirmed cases of acute kidney injury among people taking Invokana. In half of the lawsuits, people experienced an acute kidney injury within a month of taking it.
Infections: Urinary tract infections and yeast infections are the most common side effects in both men and women. Even though these infections are usually manageable, people taking SGLT2 inhibitors are at an increased risk of developing recurring urinary tract or yeast infections.
Serious urinary tract infections can cause urosepsis or kidney infection known as pyelonephritis. Several patients needed to be admitted to the hospital for the treatment of kidney infection due to contracting a urinary tract infection after taking the drug.
Anyone who has suffered from any one of these side effects should consult with an attorney. It is important to speak to a lawyer who will strive to negotiate a favorable outcome and settlement for them on their behalf. They can examine the case in detail and work to try and build a successful case, on behalf of their client, who suffered from the ill side effects of Invokana.
Anyone who has lost a loved one due to Invokana can also try to pursue legal action against the manufacturer of the drug. The family can try to fight to receive compensatory damages for the loss of parental guidance, loss of companionship, and financial support. Any individual affected mentally and/or physically should consult with lawyers on the different options available to pursue a lawsuit against the manufacturer of the drug.How Long Do I Have to File an Invokana Lawsuit?
Since the FDA’s approval of Invokana in 2013, several patients have come forward to file a lawsuit for compensation against the manufacturer. It quickly became apparent that the SGLT2 inhibitor drug was defective and caused serious side effects.
With more and more people coming forward, the manufacturer of the drug will have to be in court for several years to settle several product liability cases against them. However, people only have a limited time to file a lawsuit against them.
The Statute of Limitations to file a lawsuit against Invokana, Canagliflozin, or Janssen Pharmaceuticals, which is a division of Johnson & Johnson will vary from state to state. If you fail to file your lawsuit within the Statute of Limitations, it is likely your case will be dismissed. However, due to the severity of your injuries, we encourage you to consult with an injury firm that is available to investigate these types of claims.How Many Lawsuits Have Been Filed Against the Manufacturer of Invokana?
Janssen Pharmaceuticals is currently facing around 1,200 lawsuits with 878 active lawsuits filed in different federal courts and state courts, mainly in New Jersey, Pennsylvania, and California. Here are three prominent cases filed against the manufacturer of Invokana:
Case 1: Wardell Fleming vs. Janssen Pharmaceuticals, Inc.
The plaintiff claimed that he suffered from kidney damage, kidney failure, and reduced kidney function after taking the drug. The plaintiff also alleged to suffer from economic losses, emotional injuries, and loss of enjoyment of life. He further stated that he would not have taken the drug if the manufacturer had properly warned of its side effects. The court granted the manufacturer’s request to dismiss the case and asked the plaintiff to re-plead his case within 30 days of the verdict.
Case 2: Wardell Fleming vs. Janssen Pharmaceuticals, Inc.
The plaintiff argued that the manufacturer marked and advertised the drug improperly. After taking the drug, the plaintiff suffered from permanent injuries, including heart attack, severe kidney disease, stroke, diabetic ketoacidosis, and severe kidney disease. The plaintiff sought compensatory and punitive damages and monetary restitution. The plaintiff demanded a jury trial on all the grievances.
Frankl Kominsky Injury Lawyers have helped many injured clients receive the compensation they deserve. They can try to help you too. If you are a victim of Janssen Pharmaceuticals, our lawyers will try to pursue compensation for the following:
- Duration and extent of your injuries after taking the drug.
- Medical expenses related to treating your medical condition caused by the drug.
- Amount of salaries and wages lost due to your inability to work.
- Damages caused to your mental and physical health after suffering from injuries due to your medical condition.
- Non-economic damages, such as the suffering, pain, mental anguish, and emotional distress caused in the past and future.
- Decreased enjoyment of life, both in the present and future, due to your declining medical condition caused by a long-term injury after taking the drug.
Frankl Kominsky lawyers will stand with you and try to hold these big pharmaceutical companies responsible for their negligence and wrongdoing. We will try to evaluate the evidence and circumstances in your case to determine the value of your lawsuit. We will offer a detailed consultation and are available to review your medical records.
Presently, most people who have filed a case against the manufacturer are looking to obtain compensation for lost wages, medical bills, future medical costs, pain and suffering, and wrongful death. Do not hesitate to contact us for a free initial consultation.
You can fill out this free evaluation form on our website or contact us at 855-800-8000.