The U.S. release of Invokana, a new drug for type 2 diabetes, was highly anticipated in the medical community and among healthcare investors. According to the press, the drug would usher in a “revolution” in blood sugar management, with an active ingredient from a newly-designed drug class that operates by modifying kidney function.
Why Patients Are Filing Invokana Lawsuits
Yet even before its release, early clinical trials suggested that Invokana use could have significant adverse effects, including heart attack, stroke, and kidney damage.
The FDA approval committee was concerned over the data but ended up giving the green light – on condition that the manufacturer conduct a host of long-term studies to establish the drug’s safety.
Consolidated MDL In New Jersey Federal Court
Currently, these required safety studies are still in progress, but consumers are already falling victim to serious ailments that may have been caused by Invokana. The FDA was forced to issue two major safety alerts regarding the widely-prescribed drug in 2015 alone. 2017 saw yet another huge revelation, as researchers at the federal agency confirmed a causal link between Invokana and an increased risk in lower limb amputations.
Now, patients who experienced severe Invokana side effects are filing lawsuits against Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that manufactures Invokana and Invokamet (a combination drug with older diabetes drug metformin).
More than 900 of these product liability lawsuits are now consolidated in the US District Court of New Jersey, where the claims will undergo pre-trial proceedings together. In their claims, patients and grieving families say Invokana caused significant health problems, extreme stress, pain, and anxiety, as well as financial hardship from numerous medical expenses and lost wages.
3 Types of Drug Lawsuits
The Invokana lawsuits are being developed as product liability claims, one of the three main categories that prescription drug cases commonly fall into (a single lawsuit can be in multiple categories):
The law holds drug manufacturers responsible for taking efforts to offer medications that are reasonably safe when used for approved purposes. Additionally, manufacturers are supposed to provide accurate documentation with their products to ensure that consumers will be properly informed of any possible health risks.
In forming product liability suits, attorneys typically focus on any failures in safely formulating and manufacturing the drug of interest as well as on inaccuracies from product advertisements and labels.
A patient whose drug injuries were directly caused by medical professionals can file a malpractice suit against individual doctors or medical staff, as well as associated hospitals, clinics, and medical offices.
Those working in the healthcare industry are expected to uphold the “medical standard of care.” This refers to a reasonable level of competence and consideration for patients that one would presume a properly-trained doctor or other medical staff member to be capable of. Medical malpractice is when this standard is breached through an error, act of negligence, or deliberate action that threatens patient health.
In drug lawsuits, for example, doctors can be accused of writing unsound prescriptions—such as an unsafe amount of a drug or an off-label purpose. Pharmacies may also come under fire if employees administer incorrect prescriptions or fail to properly inform and instruct patients on how to take their medications.
When adverse effects from a prescription drug end up claiming a patient’s life, surviving family members can file a wrongful death lawsuit on behalf of the deceased patient. Wrongful death allegations scrutinize any acts or negligence committed that could have led to an untimely or otherwise unnatural death.
Damages listed in lawsuits involving a wrongful death include expenses and financial losses related to the death, such as any relevant medical costs, funeral expenses, and loss of spousal support.
Could Plaintiffs See Settlements?
When defendants wish to resolve a lawsuit out of court, whether before the case goes to trial or while a trial is in progress, they can try to do so by offering a settlement to the plaintiff(s). If the plaintiff(s) are open to the possibility of settling, then the two parties can enter negotiations to pinpoint an appropriate settlement amount.
Why would a drug manufacturer opt to settle rather than have a case resolved by trial? For one thing, trials can be expensive and time-consuming even for corporate defendants, and especially in situations where there are hundreds or even thousands of complaints, offering settlements may actually save considerable time and resources for them.
Another common reason is that trials can open up a company to intense public scrutiny that many manufacturers would prefer to limit or completely avoid if possible to preserve their reputations.
Invokana litigation is still at a very early stage, but outcomes from recent cases involving similar prescription drugs suggest that settlement is a distinct possibility.
GSK Resolves Thousands Of Avandia Cases In Settlements
Avandia, a type 2 diabetes medication released in 1999, was strongly linked with increased heart attack risk. The FDA administered its strictest “black box” warning and severely restricted sales of the drug. More than 50,000 patients who had allegedly suffered heart attacks after taking Avandia filed lawsuits against GlaxoSmithKline, and the manufacturer ended up settling most of these by 2010 with more than $750 million in settlement payments.
Actos Bladder Cancer Lawsuits End In $2 Billion Settlement
Actos, another type 2 diabetes drug, has been linked to heightened risks of bladder cancer, kidney disease, congestive heart failure, bone fractures, and lactic acidosis. The drug was alleged in more than 9,000 individual lawsuits to have caused patients to develop bladder cancer after a year or more of use.
To settle most of these lawsuits, the manufacturer, Takeda Pharmaceuticals, promised $2.37 billion in restitution to plaintiffs in April 2015—one of the largest prescription drug settlement agreements in U.S. history.
When Should I File?
If you or a family member developed health problems that may have been caused by an Invokana side effect, you may be able to file a claim and obtain fair compensation for your hardship and loss.
However, it’s best to explore your legal options as soon as possible to avoid losing the right to file. The time period in which you are allowed to take legal action pertaining to a particular injury is restricted by a state-imposed “statute of limitations.”
Contact Banville Law today and speak to a seasoned attorney within 24 hours. Our firm offers free Invokana case evaluations and can work for you on a contingency fee basis—we won’t accept payment until we secure a court award or settlement for your case.
Latest Invokana News
By Laurence P. Banville
February 22, 2018 – Florida Woman Files Invokana Lawsuit Over Kidney Failure
On February 16, a Florida woman filed an Invokana lawsuit in the U.S. District Court for the District of New Jersey claiming that some of the side effects of the diabetes drug were that she developed kidney problems and kidney failure. According to the complaint filed against drug manufacturers Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, the woman began taking Invokana in June 2014 and in August 2015 she began suffering from the serious side effects directly related to the medication. The lawsuit claims that the manufacturers failed to adequately warn consumers and the medical community of the risks associated with taking the medication.
January 22, 2018 – Invokana Lawsuit Filed Alleging Risk Of Kidney Failure
A lawsuit was filed in the U.S. District Court for the District of New Jersey in the beginning of January 2018 regarding the diabetes drug Invokana. The suit alleges that the defendants, drugmakers Johnson & Johnson and it’s subsidiary Janssen Pharmaceuticals, failed to warn consumers of the risk of kidney failure when taking the drug. The plaintiff, in this case, began taking Invokana in February 2015 and alleges that his diagnosis of kidney failure was due to his use of the diabetes drug. There are currently close to 1,000 Invokana lawsuits which have been centralized into an MDL.
December 27, 2017 – Iowa Man Files Invokana Lawsuit Over Amputation
A lawsuit was filed on December 13, in the Superior Court of New Jersey alleging that the side effects of the diabetes drug, Invokana, caused an Iowa man to partially lose one of his legs to amputation below the knee. The complaint states that the man began taking his prescription of Invokana in April 2015 and by December of the same year he underwent surgery for the partial amputation. The complaint names Johnson & Johnson and its subsidiary Janssen Pharmaceuticals as defendants.
November 16, 2017 – Wrongful Death Suit Filed Over Diabetes Drug Invokana
A new complaint was filed by a Georgia family on October 27 in the U.S. District Court for the District of New Jersey against drugmakers Johnson & Johnson and its subsidiary Janssen Pharmaceutical. The wrongful death suit was filed on behalf of a man who died in November 2015 after suffering a stroke, kidney disease, diabetic ketoacidosis, and several other ailments which were allegedly caused by the diabetes drug Invokana. The man was first prescribed Invokana in March 2015 and was hospitalized in June 2015 after suffering an acute stroke. He was hospitalized again in October of the same year before passing away in November.
October 4, 2017 – Invokana Lawsuit Filed Over Toe Amputation By Texas Man
A new Invokana complaint was filed against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, by a Texas man on September 29 in the U.S. District Court for the District of New Jersey. According to the suit, the man was prescribed Invokana in May of 2015 but by October of 2015 he developed a severe diabetic ulcer on his left foot and needed to be hospitalized. Due to the ulcer, his toe needed to be amputated and a second surgery occurred to remove additional bone. The suit claims that the amputation has left him permanently disabled and that it was a side effect of the diabetes medication.
September 6, 2017 – Kentucky Man Files Invokana Lawsuit After Amputation
On August 18, a Kentucky man and his wife filed a lawsuit against drugmaker, Janssen, a subsidiary of Johnson & Johnson, over alleged side effects of their diabetes drug Invokana. According to the complaint, the man began taking Invokana in 2015 and was hospitalized in August 2016 for diabetic ketoacidosis and severe cellulitis of his left foot. Amputation of his leg, below the knee, was required, resulting in a need to use a wheelchair or prosthesis for the rest of his life. The lawsuit claims the manufacturers knew or should have known of the risks Invokana poses prior to putting it on the market. In May of 2017, the FDA required the Invokana label to be updated with a warning regarding the risk of leg or foot amputation.
August 30, 2017 – New Invokana Lawsuit Filed After Plaintiff Suffers Stroke
On August 18, an Alabama man filed an Invokana lawsuit against drugmaker Johnson & Johnson and its subsidiary Janssen in the U.S. District Court for the District of New Jersey. In his suit, the man alleges that he suffered a stroke only 1 month after beginning to take the drug and that the makers of Invokana withheld safety information from consumers and the medical community by failing to provide adequate label warnings regarding the risks of potential side effects. The plaintiff had started taking Invokana in July of 2015 and suffered an ischemic stroke in August of the same year. In December of 2015 the FDA required drugmakers to add new warnings for diabetic ketoacidosis to the Invokana label due to several health problems being linked to the diabetes drug and more warnings were added to the label in June 2016 and May 2017 regarding kidney risks and the risk of leg and foot amputation.
July 28, 2017 – Lawsuit Filed Claiming Diabetic Ketoacidosis As Invokana Side Effect
A new Invokana lawsuit was filed by a plaintiff in the U.S. District Court for the District of New Jersey on July 21 claiming that drugmaker Johnson & Johnson subsidiary Janssen Pharmaceuticals failed to warn consumers and the medical community of the risk of possible life threatening side effects that could occur when taking diabetes drug Invokana. The Texas man indicates in his suit that he began taking the drug in late March 2015 and after only a few weeks of using the drug was hospitalized with diabetic ketoacidosis. He claims that his condition was caused by side effects of Invokana which at the time he was using the drug did not provide warnings on the label for such side effects. His case joins a large number of Invokana lawsuits filed across the country with similar claims against the makers of the drug.
June 6, 2017 – Invokana Receives Black Box Warning
Two clinical trials, named CANVAS, revealed there is a higher risk of foot and leg amputation when taking the type 2 diabetes drug Invokana. Due to this data, the FDA issued a black box warning on May 16, 2017. There are other concerns with Invokana that have caused controversy with Invokana being linked to instances of kidney failure, diabetic ketoacidosis, and cardiovascular injuries. The CANVAS results that prompted the black box warning revealed that leg and foot amputations occurred almost twice as often in those taking canagliflozin (generic Invokana) compared to those who took a placebo. The FDA warns Invokana users to contact a healthcare provider if they develop new pain, sores, ulcers, tenderness, or infections in feet or legs.
May 2, 2017 – Invokana Lawsuit Filed Alleging Failure To Warn Of Side Effects
A new Invokana lawsuit was filed on April 21 in the U.S. District Court for the District of New Jersey. The suit alleges that Johnson & Johnson and its subsidiary Janssen did not properly warn consumers of the serious risks associated with their diabetes drug, Invokana. According to the complaint, a woman began taking Invokana in April 2015 and by April 29 until May 1, 2015, she was hospitalized. Following that hospitalization, the plaintiff was hospitalized again for renal failure from May 27 to May 29, 2015. This lawsuit will be consolidated as a part of the federal Invokana litigation.
April 10, 2017 – Lawsuit Filed Over Alleged Invokana Side Effects
A new Invokana lawsuit was filed in the U.S. District Court for the District of New Jersey on March 29 by an Indiana woman. The suit alleges that the side effects of Invokana caused the woman to suffer serious health problems as a result of severe dehydration and starvation ketosis. According to the complaint, the plaintiff was prescribed Invokana in September 2013 and developed starvation ketosis in late March 2015, which resulted from her use of the drug. This suit is one of many lawsuits filed against the makers of Invokana, which claim that there was a failure to warn the medical community and consumers of the risk of potential side effects of Invokana.
March 6, 2017 – New Warnings Issued In The EU For Invokana Patients
On February 24, the European Medicines Agency stated that type 2 diabetes patients who use SGLT2 Inhibitors such as Invokana have an increased chance of lower limb amputation. They released a statement that patients that use these drugs should “check their feet regularly and follow their doctor’s advice on routine preventative foot care.” A new warning will be included in the prescribing information for SGLT2 Inhibitors which will list lower limb amputation as an uncommon side effect.
February 9, 2017 – Invokana Lawsuit Plaintiffs Fight To Keep Cases In PA
Janssen Pharmaceuticals recently filed to move over 100 cases pending in Pennsylvania federal court into the newly created Invokana MDL located in New Jersey. Plaintiffs are fighting to keep the cases in PA which they had previously sought to consolidate into a mass tort in Philadelphia. Over 100 plaintiffs in 106 cases now argue that a transfer would go against the rules in the Class Action Fairness Act.
January 13, 2017 – First Case Management Conference For Invokana MDL Held
The official case management order that was released last month stated that the first case management conference will be held by Judge Martinotti for the Invokana MDL on January 12. During this conference plaintiffs and defendants were to discuss the organizational structure and current litigation status, possible amendments for pleadings, and a proposed discovery plan in order to prepare the cases for trial. Judge Martinotti was also expected to appoint plaintiffs to different leadership roles such as liaison counsel.
December 19, 2016 – JPML Consolidates Invokana Cases Into MDL Housed In New Jersey
After a motion was filed by plaintiffs in September requesting to consolidate the Invokana litigation against Janssen in New Jersey, the Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate 55 suits into a Multidistrict Litigation (MDL). The panel found many similarities within the suits which allowed the cases to be consolidated and noted that the centralization will serve as a convenience for both parties allowing litigation to progress efficiently. Similar diabetes drugs such as Farxiga and Jardiance, which are manufactured by various different companies, were excluded from the MDL to avoid complications which could significantly delay proceedings. U.S. District Judge Brian R. Martinotti has been assigned to the MDL.
November 17, 2016 – Motion To Remove Invokana Lawsuit From Philadelphia Is Denied
Several lawsuits have been filed against Janssen Pharmaceuticals and its parent company regarding the new generation diabetes drug Invokana. One such suit was filed by a Texas man in Pennsylvania who claims to have suffered diabetic ketoacidosis while taking the drug. J&J filed a motion earlier in the year for the suit to be sent back to Texas and removed from Pennsylvania court where the company alleged would be more convenient for both parties. The plaintiff disagreed, and Judge Denis Cohen agreed with the plaintiff. The motion to remove the lawsuit was denied and it will proceed in the Philadelphia County Court of Common Pleas.
October 28, 2016 – Extended Release Version Of Invokamet, A Diabetes Drug, Approved By The FDA
Type 2 diabetes drug, Invokamet, has just recently been approved by the FDA for an expanded use. The new Invokamet XR is an extended release combination drug for the treatment of type 2 diabetes. The original form was FDA-approved in 2014. The drug is an SGLT2 inhibitor, the same as Invokana, which is meant to help manage blood sugar levels in type 2 diabetes patients by eliminating excess glucose via kidney filtration and excretion in the urine. The prescribing information warns of the risk of lactic acidosis and states that the drug is not intended for the treatment of type 1 diabetes.
September 23, 2016 – JPML Files Motion To Consolidate Invokana Lawsuits
On September 20 the Judicial Panel on Multidistrict Litigation filed a motion to centralize all pending Invokana lawsuits into MDL. These cases all contain similar allegations against the same defendants, Janssen Pharmaceuticals, and Mitsubishi Tanabe Pharma Corp., that the medical community and users of the drug were not adequately warned of the dangerous potential side effects that could occur while taking the drug. The consolidation would seek to transfer all pending cases before a single judge to avoid duplicative discovery, conflicting pretrial rulings, and generally, make the judicial process smoother and less expensive for those involved. It was suggested in the motion that the litigation be transferred to newly appointed U.S. District Judge Brian R. Martinotti in the District of New Jersey, who previously presided over cases of injury related to several different drugs and medical devices.
August 3, 2016- Invokana Lawsuits Are Growing In Pennsylvania
The number of people filing lawsuits alleging that they experienced severe side effects from using Invokana is growing in Pennsylvania. More lawsuits are being filed in Philadelphia as safety concerns increase. Other plaintiffs have also filed wrongful death cases. In the cases filed it is being stated that Invokana manufacturers did not give adequate warning about the serious side effects associated with the drug.
June 2, 2016- New Invokana Trial Links Invokana To High Risk Of Diabetic Ketoacidosis
A new clinical trial suggests that Invokana, which is used to treat Type 2 diabetes might also be useful to treat people with Type 1 diabetes by controlling blood sugar. However, the trial also revealed that the drug may increase the risk of diabetic ketoacidosis (DKA). DKA can be a life-threatening condition that occurs when too much acid develops in the blood.
May 31, 2016- FDA Reviewing Risk Of Amputation Linked To Invokana
From the time Invokana was released on the market in 2013, the FDA has given warnings associated with the use of the drug such as ketoacidosis, kidney failure, infections, sepsis, fractures, and the latest one is now amputations. One of the common side effects of using Invokana is dehydration caused by excessive urination. The other problem is the fact that diabetes creates a serious risk factor for amputations.
April 7, 2016- New J & J Lawsuits Increase New Jersey Filings In Federal Court
The end of March saw two new lawsuits filed against Johnson and Johnson with allegations that its popular diabetes drug Invokana, led to kidney damage and heart disease. These two lawsuits bring the number of Invokana cases filed in federal court in New Jersey to three. One of the plaintiffs alleges that he experienced a stroke and kidney damage after he had been prescribed Invokana for diabetes. The other plaintiff stated that he used Invokana for 19 months and ended up suffering from kidney damage.
March 18, 2016- Invokana Lawsuit Filed In Canada Seeks $1 Billion In Damages
An Invokana lawsuit filed at the end of 2015 at the Ontario Superior Court of Justice in Canada, is seeking $1 billion in damages against the makers of the drug- Janssen Pharmaceuticals. This lawsuit seeks class-action status, and it is due to be determined in the space of six to seven months. One of the allegations in this Canadian lawsuit, is that Janssen did not perform enough long-term studies to determine the effects the drug has on kidney health.
February 4, 2016- Invokana DKA & Urinary Tract Infection Warnings Requested By FDA
The FDA in May 2015 released a drug safety communication to doctors and patients stating that drugs like Invokana can cause diabetic ketoacidosis (DKA). Now the FDA has updated this safety warning stating that they require manufacturers of drugs like Invokana to include warnings to their product labels. Product label warnings must alert users to the risks of DKA as well as severe urinary tract infections. The warning states that “both conditions can result in hospitalization”.