2018 Invokana Lawsuit News: According to the latest update from the U.S. District Court for the District of New Jersey, Invokana lawsuit trials are expected to begin in September 2018. If you have been affected by a side effect of this diabetes drug, talk to a lawyer today to understand your legal rights.
Invokana is a drug used to treat type 2 diabetes. However, recent studies have shown that patients who take Invokana and other drugs containing canagliflozin (such as Invokamet) have a higher risk of below-the-knee amputations, leading to more than a thousand lawsuits filed against Janssen Pharmaceuticals – a division of Johnson & Johnson.
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What Is Invokana?
Invokana is one of a class of drugs known as SGLT2 inhibitors that blocks glucose (sugar) from being absorbed into the bloodstream. Canagliflozin, the active ingredient in Invokana, is the first of four SGLT2 inhibitors approved in the U.S., though other drugs in the class are used elsewhere in the world.
How SGLT2 Inhibitors Work
Invokana and other SGLT2 inhibitors work by blocking the sodium/glucose cotransporter 2 (SGLT2) protein, which helps reabsorb glucose into the blood. Reabsorption normally happens in the kidneys, but SGLT2 inhibitors prevent that process from taking place, causing glucose to be expelled in the urine.
Invokana and other SGLT2 inhibitors are prescribed with a low-sugar diet and exercise. It is not meant to control diabetes on its own – patients still need to maintain a healthy lifestyle while taking the drug. Also, the drug is only effective against type 2 (adult onset) diabetes; it is not prescribed to treat type 1 diabetes.
FDA-Approved SGLT2 Inhibitor Diabetes Drugs
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While some other SGLT2 drugs have been developed and are currently in use in other countries, only the four listed above have been approved by the U.S. Food & Drug Administration.
Invokana Side Effects
Many people who were prescribed canagliflozin to treat their diabetes experienced severe, and sometimes fatal, side effects, including:
- Lower Body Amputation – Diabetes can cause people to have severe foot problems due to poor circulation, nerve damage, and peripheral arterial disease, possibly requiring a partial or complete amputation. A study by the FDA found that people who took Invokana required leg and foot amputations twice as often as those who took a placebo.
- Diabetic Ketoacidosis – A life-threatening diabetic complication that occurs when high levels of blood acids (ketones) accumulate in the bloodstream. If left untreated, diabetic ketoacidosis can cause dehydration, brain swelling, coma, and even death.
- Kidney Failure – A review of reports by the FDA in 2016 showed that people who take Invokana have a higher risk of severe kidney damage (renal failure), which can require hospitalization and dialysis. Those who already have kidney disease could face a higher risk of death when taking the drug.
- Acute Pancreatitis – Although rare, taking Invokana can lead to a sudden inflammation of the pancreas, an abdominal organ that produces insulin and other hormones. Researchers believe this happens because of the drug’s diuretic (dehydrating) effect, and it can lead to a variety of other health problems or even death.
- Heart Disease – Early studies suggested that Invokana users could experience cardiovascular problems, with 8 of 15 members of the FDA approval panel voicing concerns over clinical data related to this risk.
Invokana has a range of other, more common side effects as well.
Most Common Invokana Side Effects
- Abdominal pain
- Allergic reactions
- Bone fractures
- Hyperkalemia (high potassium)
- Hypersensitivity reactions
- Increased cholesterol
- Increased urination
- Kidney problems
- Low blood pressure
- Low blood sugar
- Urination discomfort
- Urinary tract infections
- Vaginal itching
Why Are People Filing Invokana Lawsuits?
Upon the FDA’s initial approval of Invokana in March 2013, many people praised the drug as the first of a new class that would significantly help people with type 2 diabetes. However, it quickly became clear that the diabetes drug had some hidden dangers that required additional study and warnings added to the label.
As people who took Invokana became increasingly ill, and in some cases even passed away, additional questions about the drug’s safety came to the forefront. Now, more than a thousand lawsuits have been filed alleging that Janssen should have warned users about the drug’s risks.
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Amputation and Other Adverse Effect Claims
Final results from two clinical trials…showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo.FDA
In May 2016, the FDA issued an initial safety alert informing the public that taking Invokana or Invokamet can increase the need for a leg or foot amputation. Then, about a year later, the agency issued a second safety warning, adding that the risk of amputation when taking Invokana was nearly double the risk of diabetes patients who did not take the drug. As a result, the FDA required a black box warning be added to the drug label.
Many claims refer to results from the CANVAS and CANVAS-R studies cited by the FDA as evidence that Janssen could have done more to warn consumers about the risks of taking Invokana. Instead, the drugmaker continued to promote the medication as safe for diabetes patients, even promoting it for off-label purposes to treat weight loss, reduce blood pressure, and improve cardiovascular function.
In particular, Invokana lawsuit complaints say that patients would have avoided taking the drug had they known about the increased risk of amputation ahead of time. Since Janssen failed to provide proper warnings, however, consumers were unable to make an informed choice on the matter.
Similar legal complaints have arisen around other serious side effects of Invokana, as well. These are related to the FDA’s various warnings around ketoacidosis, renal failure, bone fractures, and serious urinary tract infections.
Timeline of Invokana FDA Warnings
- May 2015 – Many reports of ketoacidosis and diabetic ketoacidosis (DKA) requiring hospitalization
- September 2015 – Label update warning about increased risk of bone fracture
- December 2015 – Label change for SGLT2 inhibitors about increased risk of ketoacidosis and serious urinary tract infections
- May 2016 – First amputation warning based on interim analysis of CANVAS and CANVAS-R studies
- June 2016 – Communication to doctors with stronger warnings about kidney injury risks
- May 2017 – Second amputation warning, requiring a label update with a boxed warning
Pain and Suffering
Those who have experienced a severe side effect of Invokana claim in their lawsuits that the drug caused them to experience additional pain and suffering beyond what was expected, based on the marketing and warning labels provided by the manufacturer. While the specific suffering might differ from patient to patient – amputation, kidney disease, ketoacidosis, etc. – the common link between them is that Invokana caused or exacerbated those conditions.
In addition to physical pain and discomfort caused by Invokana, many patients who took the drug have suffered mentally, as well. For example, amputation can lead to a number of psychological effects, including phantom limb syndrome, depression, and post-traumatic stress disorder. These are all mental health conditions that the patient would not have experienced had they not taken Invokana.
Medical Bills and Other Costs
In addition to seeking compensation for physical and mental pain and suffering, many people who file Invokana lawsuits attempt to recover costs related to medical bills. This can include hospitalization, surgery, post-operative care, and ongoing medical needs, as well as related costs like traveling to see a specialist, lodging near treatment centers, and expenses that may not be covered by insurance.
Invokana lawsuits often include claims to recover these costs that victims otherwise would not have needed to pay. For those who pass away from Invokana complications, their families may also ask for funeral and burial expenses, and lost income that their loved one might otherwise have earned.
Can I File an Invokana Lawsuit?
If you or a loved one has received an amputation or experienced another serious side effect after taking Invokana, you may be eligible to file a lawsuit. The best way to learn about your legal rights is to discuss your case with an Invokana lawyer who can give you more information specific to your case.
Types of Invokana Lawsuits
According to the most recent quarterly report by Johnson & Johnson, the company is facing approximately 1,100 Invokana lawsuits, and that number is likely to grow. More than 950 of these cases have been filed in various federal district courts throughout the country, but some of them have also been filed in state courts, primarily in California, Pennsylvania, and New Jersey.
Federal Invokana lawsuits have been organized into multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey under the designation MDL 2750. The MDL process makes it more efficient to handle many legal complaints that are the same or similar, and it has been used frequently to handle defective drugs, medical devices, and consumer products. As of early 2018, cases in MDL 2750 are still going through the pretrial discovery phase, with the first Invokana trial expected to begin in September 2018.
State Invokana lawsuits may give some plaintiffs a better chance at receiving compensation, depending on the state’s laws and other factors. Pennsylvania has seen more Invokana lawsuits filed than other states, although there are quite a few lawsuits filed in New Jersey and California as well. When considering a state court for litigation, it is important to understand the statutes of limitations, which are effectively deadlines by which individuals must file or risk losing their legal rights to seek compensation.
Do I Need an Invokana Lawyer?
There are two important things that an experienced Invokana lawyer can help you with:
Assessing your case: A free case review will help you understand the strength of your case and what to expect if you wind up filing a lawsuit. There’s no upfront payment or commitment, and you will be able to ask all the questions you have about your legal rights.
Fighting back against big drug companies: Corporations like Johnson & Johnson have well paid, highly trained lawyers who spend all their time looking for ways to fight legal claims against their products and services. Having someone who knows how to fight back will give you the best chance at receiving compensation.
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