Invokana Lawsuits Filed Over Lower Limb Amputations
Invokana Lawsuits Filed Over Lower Limb AmputationsSarah2018-11-07T12:18:15-05:00
Did you or a loved one undergo a lower limb amputation after taking Invokana? You may have powerful legal options. Some patients may be eligible to secure financial compensation.
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Invokana, one of Johnson & Johnson’s new “blockbuster” drugs, has been prescribed to millions of Americans with type 2 diabetes since its U.S. debut in 2013. Promoted as a “much-needed” breakthrough in diabetes research, Invokana was designed to help control blood sugar by forcing the kidneys to purge glucose from the bloodstream through urination.
But Invokana has also been linked to a host of alarming side effects, including an increased risk for lower limb amputations, diabetic ketoacidosis (a potentially-fatal rise in blood acidity), decreased bone strength and increased risk of broken bones, heart attack, stroke, and kidney failure.
Injured Patients Seek Justice In Invokana Lawsuits
Across the country, patients who suffered harm after taking Invokana are filing personal injury lawsuits. In their complaints, these plaintiffs say that the drug’s manufacturers failed to properly disclose the drug’s side effects, especially in light of recent FDA-issued public safety warnings about Invokana and related drugs. Dozens of patients claim to have undergone debilitating and costly amputation procedures.
Johnson & Johnson Settles Chunk Of Invokana Claims
At present, nearly 1,200 Invokana lawsuits have been consolidated as Multidistrict Litigation (MDL) in the U.S. District Court for New Jersey. There are significant signs that the litigation, which has been centralized for coordinated pre-trial proceedings, is heading toward a wave of financial settlements. Johnson & Johnson and subsidiary Janssen Pharmaceuticals have already agreed to settle a slate of over 140 cases prosecuted by attorney Michael London, who is serving as co-lead plaintiffs’ counsel for the litigation. US District Judge Brian Martinotti has stayed discovery in the cases, providing both sides in the dispute more time to devote their undivided attention to settlement negotiations.
Legal experts believe a wave of settlements could be on the way. Time may be limited for additional plaintiffs to join the litigation. If you or a loved one suffered injuries after taking Invokana, it is essential that you reach out to an experienced attorney immediately. Without prompt action, your chance to pursue justice could slip away. Don’t wait to learn more about your legal options. Contact our compassionate legal team today for a free consultation.
In addition to the New Jersey MDL, additional Invokana cases are currently pending in state courts in Pennsylvania, California and New Jersey. An Invokana class action was filed in September 2015 in Canada.
FDA Warns Of Link To Foot & Leg Amputations
In May 2017, FDA researchers warned patients and health care professionals that Invokana and sister drug Invokamet can increase the risk for lower limb amputations. Diabetes patients already live at an increased risk for amputation, but Invokana’s active ingredient, canagliflozin, appears to increase the risk even further.
Two large clinical trials found that Invokana patients are substantially more likely to undergo leg, foot and toe amputations than diabetes patients who do not take an SGLT-2 inhibitor. As a result of these studies, the FDA has gone out of its way to make clear that Invokana and Invokament “cause” an increase in the rate of amputation.
The FDA has decided to slap a new “black box” warning on packages of Invokana to warn patients and doctors of the amputation risk. A “black box” warning is the FDA’s strongest form of warning.
Study Finds 100% Increase In Amputations
The decision comes in the wake of two clinical trials – CANVAS and CANVAS-R. In both studies, clinical researchers noticed a doubling in the risk of leg and foot amputations. Over the course of a single year, Invokana patients in the CANVAS trial required amputations at a rate of 5.9 in 1,000. The risk for patients who were administered a placebo was just 2.8 in 1,000.
CANVAS-R turned up similar results – 7.5 in 1,000 Invokana patients underwent amputation procedures during the study period. People who took the placebo underwent amputations at a rate of 4.2 in 1,000.
Patients Say Janssen Lied About Invokana Risks
The patients who have filed lawsuits against Invokana’s manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) feel that they have been gravely wronged and misled. In a new wave of lawsuits, patients accuse Janssen of concealing Invokana’s link to lower limb amputations for years.
Invokana was heralded by its manufacturer, the press, and even the FDA, as a promising new alternative to more-established diabetes drugs. But rather than benefiting significantly from their prescription, many patients instead developed serious health problems that caused them extreme stress, pain, and financial hardship from medical expenses and lost wages.
Several of the complications associated with Invokana can even become severe enough to cause death – diabetic ketoacidosis can lead to fatal consequences; limb amputations can result in severe blood infections; kidney failure is often a tragic death sentence. And yet, some of these risks aren’t even mentioned on the product’s labeling or in its full Prescribing Information, a document which is supposed to provide comprehensive guidelines that doctors can use to help them write safe, appropriate prescriptions for their patients.
This is one reason why many patients are now fighting back and demanding compensation from manufacturers—they feel unfairly subjected to suffering that they say could have been prevented.
Plaintiff In First Invokana Lawsuit Suffered Kidney Failure
Rosalba Joudry, a resident of Ontario, Canada, filed an Invokana class action on September 10, 2015—the very first Invokana lawsuit filed.
Joudry describes first taking Invokana in October 2014 as prescribed by her doctor. 8 months later, she happened upon an American television commercial informing viewers that Invokana users may develop ketoacidosis and kidney damage. She was shocked by this information and alleges that she’d been given no prior indication of these possibilities by her doctor or from the drug’s label. Her lawsuit states that she would never have taken Invokana if she’d known about such side effects.
Immediately after seeing the commercial, Joudry notified her doctor, who advised her to stop taking the drug and to come see him for diagnostic tests. The test results showed that she was suffering from kidney failure, a critical condition that sometimes occurs with few or no obvious symptoms.
Outraged that Janssen Pharmaceuticals had “denied [her and other affected patients] the ability to make an informed decision” about starting an Invokana prescription, Joudry and her lawyers filed her case with the Ontario Superior Court.
The lawsuit contains accusations that the manufacturer:
Failed to perform “proper design, development and testing of its drug” before proceeding to advertise and sell it on the Canadian market
Failed or refused to ensure that doctors and patients had access to a “clear, complete, and current” list of side effect warnings
Ignored, either on purpose or through neglect, vital information on the risks of Invokana, which it should have been aware of “based on Invokana’s [kidney-facilitated] mechanism of action, the class of drugs Invokana belongs to, and numerous studies, trials, and medical journal articles”
Persists in portraying Invokana as a safe product while “downplaying the seriousness of [its] potential side effects”
Chose to value profits over consumer health and safety, exercising “unfair business practices” by concealing any information that might hinder sales
Joudry requests more than $1 billion in restitution from Janssen, Inc. for herself and for other claimants who may later join the suit.
With Joudry’s lawsuit in mind, we can take a look at 3 main categories of allegations that are commonly raised in claims involving prescription drugs like Invokana:
Product Liability. Many “dangerous drug” lawsuits, including Joudry’s, are primarily comprised of product liability allegations, which focus on the drug manufacturer’s responsibility to provide consumers with products that are reasonably safe, especially when used for their intended purpose as instructed. At the very least, it’s expected that the manufacturer should thoroughly inform consumers of possible health threats. Such allegations frequently scrutinize the degree to which the manufacturer took measures to safely design, develop, manufacture, and distribute the drug of interest, as well as how accurately the drug was portrayed in advertising materials and product labeling.
Medical Malpractice. Plaintiffs in drug lawsuits may level claims against their doctors or medical institutions if they feel that their injuries were largely caused by a breach of the “medical standard of care.” This refers to a level of care/consideration expected of reasonably proficient, qualified medical professionals in a given situation. When doctors or other medical staff violate this standard by endangering patient safety, either on purpose or through negligence, their actions can be considered medical malpractice. Joudry did not blame her doctor or clinic for her unexpected kidney failure because she believed they did the best they could with the information provided by Janssen, Inc. But if for example, Joudry thought that her doctor had incorrectly prescribed the drug in some way, she might have included medical malpractice claims.
Wrongful Death. In some tragic cases, prescription drug side effects can prove fatal. When this happens, a wrongful death lawsuit can be filed on behalf of the deceased patient by a spouse or other close family member. Such lawsuits expound on defendant actions or negligence that may have contributed to the patient’s untimely death and request compensation for medical expenses, funeral costs, and any other relevant financial losses incurred by surviving family members.
Will Invokana Litigation Proceed as Class Action?
When widely-prescribed drugs like Invokana are suspected of harboring dangerous side effects, the number of lawsuits that arise can reach staggering numbers. In situations like these, plaintiffs may elect to consolidate their cases with group litigation methods such as class action or multidistrict litigation (MDL), which can expedite legal processing.
Though Rosalba Joudry is seeking class action status for her case, class action is not necessarily the optimal choice for American Invokana lawsuits, due to differences between U.S. and Canadian law. Actually, the experienced attorneys at Banville Law believe that individual lawsuits consolidated via multidistrict litigation can offer much more flexibility and possible compensation for Invokana plaintiffs.
Most Class Action Claimants Have Limited Rights and Compensation
In class action, one or a few plaintiffs file a lawsuit that is meant to represent a multitude of other claims with significant similarities, such as common allegations, similar case details, or a shared list of defendants. The “representative” or “lead” plaintiffs are the only “class members” who actually go through the process of filing the class action lawsuit, while any other potential claimants are either automatically included as members if they fit eligibility requirements or are invited to join by submitting a claim form.
Though it may seem that attaching your Invokana claim to an existing class action would be a simple, hassle-free way to take legal action against manufacturers, class action harbors several major disadvantages for potential participants:
Lack of Influence Over the Case. Any important decisions regarding the lawsuit are made by the lead plaintiff(s) and their legal counsel. All other class members have no say in whether or not the class action will be canceled, go to trial, or enter a settlement agreement, nor can they contribute in trial or settlement negotiations except under special circumstances.
Little or No Compensation. Any restitution awarded in a class action lawsuit is divided up among the class members by court decision, with the majority typically allocated to the lead plaintiff(s). Frequently, individual class members receive only a small amount of compensation, if they end up receiving anything at all.
Barred from Filing On Your Own. Being part of a class action requires you to sign over the right to file your own lawsuit. This means that if you are dissatisfied with the outcome of the class action and want to file an individual claim later on, you would no longer be allowed to.
Case Outcomes In Multidistrict Litigation Are Decided Individually
By contrast, plaintiffs who file individual claims are afforded complete control over their cases and will likely have a greater chance of receiving fair compensation than those who become members of a class action. And when a large number of similar individual lawsuits are pending in various districts throughout the country, they can be centralized for efficiency by multidistrict litigation (MDL).
To initiate an MDL, plaintiffs must petition the Judicial Panel on Multidistrict Litigation (JPML) and request that their claims be grouped together for pre-trial. The Panel deliberates on whether or not the cases are similar enough to merit consolidation. If MDL status is awarded, all of the cases are sent to a single “transferee” court for pre-trial proceedings such as “discovery,” in which defendants and plaintiffs formally extract information from one another.
The constituent cases in an MDL are only handled together for events that take place before trial. After this, cases are either “remanded”—sent to their home courts for trial—or settled out of court individually.
In other words, the cases remain separate lawsuits. This is advantageous for plaintiffs because they will retain all legal rights for their claims and will receive the full amount of compensation awarded.
Diabetes Drug Suits Can End In Billion Dollar Settlements
Though it’s too early to make any predictions on the course of Invokana litigation, it can be useful to review the outcomes of other drug lawsuits to get an idea of how such claims can be resolved.
If you are thinking of filing an Invokana lawsuit, you may be heartened to learn that many plaintiffs harmed by diabetes treatment drugs have obtained significant restitution from the manufacturers responsible.
For example, Takeda Pharmaceuticals, the manufacturer of the diabetes drug Actos, recently agreed to pay $2.37 billion in settlements to plaintiffs alleging the drug causes bladder cancer. This settlement agreement was drawn up to resolve an estimated 9,000 individual lawsuits that demanded compensation for significant damages to health, quality of life, and financial well-being.
Learn About Your Legal Options—Before It’s Too Late
If Invokana has negatively impacted your health or that of someone you love, you may be able to obtain restitution by filing a lawsuit.
The best way to find out if you have a workable claim is to schedule a free case evaluation with the defective drug lawyers at Banville Law. Our seasoned legal team has successfully obtained compensation for many clients while navigating the intricate New York legal system. There are no upfront fees so you can focus on your health without the added stress of legal fees on top of medical bills. You won’t be charged a dime unless we win a settlement or court award for you.
However, keep in mind that the window of time in which you can file a claim is constrained by your state’s “statute of limitations.” Call today to avoid losing your right to seek justice for harm that may have been caused by Invokana.