One of the recent pharma litigations creating turbulence in America is the Invokana lawsuit. Have you heard about Invokana? Before knowing what it is, let’s glance through a little intro.
A hundred years have passed since the discovery of insulin, and many new diabetic medications were invented in the meantime. However, we couldn’t find any successful methods to prevent the number of people affected by it.
According to the National Diabetes Statistics Report, in 2020, there were around 37.3 million Americans with diabetes, which is equal to one in ten people.
Among them, around one in five people with diabetes were not even aware of having that. The 2022 National Diabetes Statistics Report was recently made available by the Centers for Disease Control and Prevention (CDC).
According to this study, there are more than 130 million people in the U.S who have diabetes or prediabetes. The two data show how fast the number is growing, and it is highly alarming.
Are you wondering what the connection is between Invokana and diabetes? There is a connection- Invokana is a diabetes medication introduced to the medical field as the greatest invention in the management of diabetes in the 2000s.
Like every medication, Invokana® also had some side effects. But when the side effects greatly overshadowed the benefits, the patients started pursuing Invokana lawsuits.
You may know that chronic diabetic patients are already at risk of amputation. However, if such a diabetic medication leads to amputation, then it is a very serious matter of concern. That’s what happened in the case of Invokana®.
Have you encountered a similar situation? Contact an experienced Invokana lawyer to know the prospects of your claim. A medical record review expert can identify the strengths and weaknesses of your claim to help you win the case.
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Through this blog, you are going to get familiarized with the drug, its detailed side effects, and the status of Invokana lawsuits in 2022 in the United States. Come on, let’s plunge deep…
What is Invokana®?
Canagliflozin is marketed under the brand name Invokana®. It is a third-line medication used to treat type 2 diabetes in adults after metformin has been tried. It belongs to the sodium-glucose cotransporter-2 (SGLT2) inhibitor class of drugs. Invokana® should be used in conjunction with exercise and a healthy diet.
Type 2 diabetes, if left untreated, can cause blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and various other complications. Invokana® lowers blood sugar levels and lowers the risk of cardiovascular problems, and prevents death.
It is claimed to work with the kidneys to prevent some excess sugar from being absorbed back into the body and to aid in the loss of approximately 100 grams of sugar per day through urination.
History of Invokana®
Canagliflozin is a synthetic version of a chemical separated in the 1830s from the bark of apple trees. In the early 2000s, Mitsubishi Tanabe Pharma Corp invented the initial compound, which was later sold to Janssen Pharmaceutical for manufacturing and marketing.
Invokana® was marketed by Janssen Pharmaceuticals, Inc. and was given FDA approval as the first SGLT2 inhibitor on March 29, 2013, to be used as a supplement to diet and exercise to enhance glycemic control in individuals with type 2 diabetes mellitus.
It came to the market as a great boon to patients with type-2 diabetes. However, within a short span, patients started reporting adverse effects of the drug, which ruined its savior image.
At the close of 2015, the FDA sought to demand that the maker of Invokana®, Janssen Pharmaceuticals, should add a warning label stating that there was an increased risk of ketoacidosis and urinary tract infections.
In 2017, the FDA reviewed two clinical studies done on Invokana® and a placebo to investigate the adverse effects of the drug. According to the CANVAS trial, 5.9 amputations out of every 1,000 patients received canagliflozin, compared to 2.8 out of every 1,000 patients who received a placebo.
According to the CANVAS-R experiment, there were 7.5 amputations per 1,000 patients who received canagliflozin as opposed to 4.2 per 1,000 patients who received a placebo.
The study did not, however, explain why Invokana has a higher risk of amputation. According to a Forbes story from June 2017, experts believe Invokana may thicken blood, which could obstruct blood flow. This can cause it to gather in the feet and lead to amputations.
It demonstrated that Invokana® increases the risk of leg and foot amputations, and its risk percentage is higher when compared to the placebo. As a result, the FDA urged manufacturers to add new warnings, including a boxed warning, to drug labels.
Patients were advised to see a physician if they experienced new pain or tenderness, sores or ulcers, or infections in their legs or feet.
Before prescribing the drug, physicians were instructed to look for the following conditions in their patients. A history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers are among the risk factors.
Physicians were advised to monitor patients receiving canagliflozin for the above-mentioned signs and symptoms and discontinue canagliflozin if any adverse signs are seen.
The black box warning on the drug box:
In August 2018, the FDA issued a warning that Invokana and other SGLT2 inhibitors could cause flesh-eating genital infection.
A report notes that from 2013 to 2020, the manufacturers paid more than 100,000 US doctors $104 million to promote the drug. Invokana-related adverse events that were reported to the FDA between 2013 and 2020 totaled about 23,000 cases.
Over 450 deaths connected to Invokana have been reported to the FDA during that time. However, the deaths reported were not proven entirely to be linked to Invokana.
Reports clearly prove that the manufacturers were warned of the side effects of ketoacidosis by one of their researchers early in 2014. However, the researcher’s warning was not given any due respect, and instead, the researcher was warned of being fired. This clearly stands as proof that the manufacturers marketed the drug even after knowing its pernicious side effects.
Is Invokana still on the market? Yes, of course, it is still on the shelves, but the sales have declined considerably.
Invokana® Side Effects
The given side effects are just a few of the more common side effects reported by Invokana® study participants. These side effects can vary depending on the condition being treated by the drug. The most common side effects are yeast infection in the penis, vaginal and urinary tracts, constipation, nausea, and vomiting. However, it also could cause some adverse side effects, as noted below.
- Abnormal weight loss: Losing weight without any reason.
- Bone fractures: Weak bones tend to break easily.
- Dehydration: The low fluid level can lead to low blood pressure. The other symptoms can be light-headedness and weakness while standing.
- Hypoglycemia: The low blood sugar level can cause sleepiness, headache, confusion, weakness, hunger, irritability, nervousness, sweating, rapid heart rate, and significant allergic response
- Lower limb amputation: According to research, up to 3.5% of those who used Invokana experienced an amputation. Invokana increased the chance of amputation by twofold when compared to those who did not take the medication. The most often amputated limb parts were the toe and the midfoot (area of the arch). There were also some reports of leg amputations.
- Diabetic ketoacidosis: It means increased ketone levels in blood and urine. This condition occurs when your body’s cells do not receive the glucose (sugar) they require for energy. Without it, your body turns to fat for energy. This can result in high levels of acidic chemicals known as ketones in your blood. The American Diabetes Association lists the following as the symptoms of ketoacidosis abdominal discomfort, breathing trouble, confusion or difficulty concentrating, dry or flushed skin, nausea, unusual weariness or sleepiness, and vomiting.
- Fournier’s gangrene: It is a severe infection near the genitals. The symptoms include fever, an overall feeling of discomfort, pain, tenderness, swelling, or reddening in the genital or rectal area. It is also known as necrotizing fasciitis of the perineum.
- Damage to the kidneys: It can cause kidney diseases like kidney failure, fluid imbalances, and kidney stones. The symptoms of kidney damage can be less frequent urination than usual, swelling in the ankles, feet, or legs, confusion, exhaustion (lack of energy), nausea, chest pressure or pain, inconsistent heartbeat, and seizures.
- Loss of balance: The weakness due to the drug makes the patients face frequent fall incidents.
- Allergic reactions: Rashes, itching, and redness.
Invokana Lawsuits
Janssen started facing lawsuits on behalf of their canagliflozin-based drugs (such as Invokana, Invokamet, and Invokamet XR). In September 2015, the first set of Invokana lawsuits was filed in the United States and a class-action lawsuit in Canada.
Janssen had to face a lot of Invokana lawsuits all over the U.S. Despite the fact that New Jersey and California have also seen a significant number of Invokana lawsuits filed against them, Pennsylvania has seen the most as a single state.
Since Janssen was based out in New Jersey, all claims were moved to the United States District Court for the District of New Jersey and consolidated as MDL no. 2750. 2019 saw the start of the first Invokana bellwether trial, handled by New Jersey Judge Brian R. Martinotti.
The MDL procedure has been commonly utilized to manage a number of legal complaints that are the same or similar, and it makes it more efficient to handle these types of cases.
A substantial chunk of the 1,000 Invokana claims brought against Johnson & Johnson alias Janssen in the New Jersey Invokana MDL No. 2750 were resolved confidentially in October 2018 itself after the parties reached an agreement. However, in the New Jersey MDL, there was still 878 active Invokana litigation outstanding as of September 2019.
After 2018, there were no other Invokana Lawsuit Settlements in the U.S. If Invokana lawsuit payouts or another resolution for the cases are not reached during the MDL process, the case and others involved in the litigation may be remanded to U.S. District Courts across the country for separate trial dates. The Invokana attorneys hope 2024 will see at least some settlement.
Allegations in Invokana Lawsuits
Janssen faced allegations listed below from the plaintiffs of all the Invokana lawsuits.
- Invokana risks were not adequately communicated.
- Invokana’s risks and benefits were misrepresented in product advertising.
- A defective and unreasonably dangerous product was manufactured and brought to market negligently.
- Patients are at risk of amputation, kidney damage, and ketoacidosis as a result of this medication, and Janssen Pharmaceutical failed to warn consumers about these known risks.
- Janssen did not thoroughly test Invokana for all potential side effects.
- The company also had in-house data from the FDA and consumers that indicated the drug’s dangers.
Glimpses of a Few Invokana Lawsuits
In 2015, Rosalba Joudry was the Canadian woman who filed an Invokana class action complaint against Johnson & Johnson seeking more than $1 billion in damages. She claimed that after using Invokana for eight months, she experienced kidney failure. In the same class-action lawsuit, Joudry submitted her claim on behalf of everyone else affected in Canada.
According to her class action Invokana lawsuit, the manufacturer neglected to adequately design and test the medication to guarantee its safety before releasing it onto the Canadian market. In the lawsuit, it is also claimed that the business failed to disclose the potential side effects, which included acute renal injury.
One of the plaintiffs was not even aware that the medication could be related to her renal damage until she saw a television commercial that mentioned it. The woman was taken aback by this information because neither her doctor nor the labels had made any mention of kidney failure as one of the possible side effects.
On November 13, 2015, a woman from Texas sued Invokana for $13 million, including punitive damages. She claimed that after only one month on the drug, she developed ketoacidosis and severe kidney damage. She sued Janssen for misrepresentation, fraud, failure to warn, and negligence.
Charles Maddox filed an Invokana lawsuit in Louisiana in February 2016, claiming that he developed diabetic ketoacidosis after taking Invokana. He sued for negligence, failing to warn patients of dangerous complication risks, misrepresentation, breach of warranty, fraud, and liability for a defective drug.
On March 16, 2017, the plaintiffs Charles Pinkston, Pamela Gideon, Elia Lopez, Marie Luera, Opal Louise Simon, Anita Martinez, and Janice Brana filed a complaint in the United States District Court for the District of New Jersey. All Invokana lawsuits claim that the manufacturers failed to warn users and the medical community about the risk of serious health problems associated with the use of Invokana.
Invokana Settlements Update
Invokana lawsuits failed in a way that the plaintiffs’ side could not provide scientific proofs to establish the side effects. Janssen pharmaceuticals had resolved some of the claims pertaining to failure to warn the risks for around $120 million.
For illegally marketing the drug for off-label uses, it reached another settlement of $300 million in 2019 with the U.S. Department of Justice (DOJ). This included $285 million to resolve civil liabilities under the Food, Drug and Cosmetic Act and $15 million to resolve False Claims Act allegations. In 2020, it settled some claims for $10 million foe illegally marketing Invokana.
Damages Claimed in Invokana Lawsuits
Like all other mass tort claims, the plaintiffs of the Invokana tort lawsuits can claim the following damages- economic as well as non-economic damages.
- Past and present medical expenditure
- Medication bills, surgical costs
- Future assistive care
- Future medical care expenses
- Punitive damages
- Pain and suffering
- Emotional distress
- Disability benefits in case of amputation
- Wrongful death damages, if the victim died due to the negligence
- Loss of consortium
If you are affected by the Invokana medication and underwent serious health issues, immediately contact an Invokana attorney to find out if there is any valid case in 2022 and proceed with your Invokana lawsuit.
When contemplating litigation in a state court, it is critical to understand the statutes of limitations, which are effectively deadlines by which individuals must file or risk losing their legal rights to seek compensation. Consider the statute of limitations in your state to file the claim.
Collate all your medical records, including the proof of your start date for the medication and the progressing symptoms. The imaging studies, lab reports, and the doctor’s chart notes are all can be influential in winning your litigation.
Even if your medical records are hefty, a medical records review company can sift through them for vital information. LezDo has an expert crew to help the mass tort attorneys to help in medical record reviews.
Maximize your case potential with expert record analysis!
To wind up,
Since many of the lawsuits against the pharma sharks are used to be settled out of the court confidentially so as not to affect their reputation, it is also applicable in the case of Invokana lawsuits.
Therefore, the details of this Fournier’s gangrene lawsuit settlement amounts too, are not available. However, if your claim is valid, you have a bright possibility of winning your reparation.
Leading a life after amputation will be extremely difficult. The compensation may not make you whole again. However, it can at least give you solace from your financial worries. Hope 2024 may bring some relief to the plaintiffs of the pending Invokana lawsuits.
Dear Invokana plaintiffs, if interested, share your stories with us…
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1/6 Can a medicine that’s supposed to prevent amputation cause it?
Invokana, the diabetic medication caused such a devastating side effect on those who used.#invokanalawsuits #invokanalawsuitsettlement #invokanasettlementNupdate2022 #lezdomedlegal pic.twitter.com/PahmIDELHP— LezDo MedLegal (@LezDoMedLegal) November 1, 2022
