The type 2 diabetes medication Invokana has been widely promoted by its manufacturer and by the press as a valuable new approach to blood sugar management. Introduced to the U.S. market in March 2013, the drug quickly gained popularity, with an estimated 4 million prescriptions written each year.
But recently, the FDA has called Invokana’s safety into question by sending out side effect warnings—one about adverse effects on bone health and the other about the possibility of developing ketoacidosis, a form of blood poisoning that can prove fatal. Invokana has also been linked to kidney failure and severe cardiovascular events such as blood clots, heart attack, and stroke.
Shockingly, these dangerous complications were not mentioned anywhere on Invokana’s Prescribing Information. This “oversight” has led many Invokana patients afflicted with kidney-related ailments to take legal action.
In Prescription Drug Litigation, Seasoned Legal Counsel Is Key
As part of the healthcare industry, pharmaceutical companies are supposed to put patient health and safety first. But as history shows, these corporations don’t always follow the basic Hippocratic oath that says “first, do no harm.” Many drug manufacturers are so focused on increasing their profits that matters of drug efficacy and safety fall by the wayside, and some end up endangering patients by “pushing” drugs that harbor serious side effects.
Fortunately, injured patients have the right to fight back against manufacturers who have wronged them by filing civil lawsuits. But winning a suit against a powerful corporation is a daunting task. Drug manufacturers often have vast resources that allow them to employ teams of aggressive corporate defense lawyers to bolster their cases.
This is why hiring an experienced personal injury lawyer can make all the difference to the outcome of your legal claim. Lawsuits against drug corporations are full of potential pitfalls, and not every lawyer will have the experience, resources and strong disposition needed to take on such a challenge.
The Experienced Attorneys At Banville Law Put Your Needs First
The legal team at Banville Law has extensive experience with litigation against large companies.
Even better, Laurence Banville, Esq., Banville Law’s founder and managing partner, worked in the past as a corporate defense attorney for companies facing asbestos lawsuits. His familiarity with the defense strategies commonly used by big corporations is a valuable asset, one he now applies in helping our clients achieve justice against manufacturers who jeopardize consumer safety.
You can learn more about how Banville Law was established on our About page.
At Banville Law, clients come first. We want you to feel completely comfortable in working with us and we always go the extra mile to ensure you feel confident about the status of your case. We will fight tirelessly for your rights – you deserve nothing less.
Frequently Asked Legal Questions About Invokana
With Banville Law, you’ll never be left in the dark. We place high importance on making sure that clients are thoroughly informed about matters relevant to their cases. Here, we provide a brief FAQ comprised of Invokana legal questions:
What Makes Invokana So Different From Other Diabetes Drugs?
Invokana’s release in the U.S. was highly anticipated because its active ingredient hails from a brand new drug class called sodium-glucose co-transporter2 (SGLT2) inhibitors. The mechanism of action behind SGLT2 inhibitors is insulin-independent, a distinct departure from the way most other diabetes pills work. Rather than modifying the body’s use or production of insulin, SGLT2 inhibitors act on the kidneys, causing them to flush glucose from the bloodstream through the urine, instead of saving the glucose as they normally would.
After Johnson & Johnson’s Janssen Pharmaceuticals unit obtained approval for Invokana, other SGLT2 inhibitor-containing medicines were approved in the U.S., including:
- Farxiga. Active ingredient dapagliflozin, manufactured by Bristol-Meyers Squibb Co. and AstraZeneca.
- Jardiance. Active ingredient empagliflozin, manufactured by Boehringer Ingelheim
- Invokamet. Active Ingredients canagliflozin and metformin, manufactured by Janssen Pharmaceuticals
- Glyxambi. Active Ingredients empagliflozin and linagliptin, manufactured by Boehringer Ingelheim
Many in the healthcare community were hopeful that Invokana and other medicines containing SGLT2 inhibitors could help open up new avenues for diabetes treatment, such as the combination of insulin therapy with pill medications. However, while Invokana’s popularity booms, evidence of unexpected possible side effects has been growing.
Do The Benefits Outweigh The Risks?
Though proponents of Invokana defend the drug against side effect warnings by saying that its “risk-benefit ratio” must be considered, consumer advocates are also pointing out that the drug’s efficacy, when compared to older medications, is far from spectacular.
Invokana’s Prescribing Information reveals that the drug’s tested effect on blood sugar, when monitored by A1C tests (which indicate average blood sugar over 3 months) is only a 0.79% A1C decrease for the 100 mg tablet and a 0.94% decrease for the 300 mg tablet.
On the other hand, the more established diabetes treatment drug metformin (trade name Glucophage) lowers blood sugar by 1.4% according to its label. In sharp contrast to Invokana, metformin harbors no serious side effects and can be obtained cheaply in generic form.
Why Are Patients Filing Lawsuits?
Many potential side effects associated with Invokana are severe and can result in ruinous consequences for patients. Worse yet, several of these adverse effects, such as heart attack and ketoacidosis, are not even mentioned on Invokana’s Prescribing Information, nor are they detailed in the drug’s promotional materials.
Such omissions, whether intentional or accidental, may unfairly expose patients to risk without giving them or their doctors the choice to avoid it. Patients suffering from Invokana side effects can face irreparable damage to their health, as well as financial hardships due to lost wages and exorbitant medical expenses.
Some of these patients are planning to demand compensation from manufacturers for their pain and loss, claiming that their ordeals could have been avoided if manufacturers had only taken the necessary precautions to properly design, test, and label Invokana to ensure consumer safety.
Is There A Class Action Suit?
So far, one lawsuit has been filed in Canada by a woman who unknowingly suffered kidney failure only 8 months after starting her Invokana prescription. She and her lawyers are requesting class action status for the case, as they’ve been given cause to believe that many more patients who suffered kidney damage from Invokana will likely join the suit.
Here in the U.S., Banville Law is now offering free case evaluations to patients harmed by Invokana, and many lawsuits have been filed claiming Janssen failed to warn consumers of the possible side effects associated with the drug. And with an estimated 4 million Invokana prescriptions written each year, we expect many more patients to step forward.
Has The FDA Recalled Invokana?
No. But the agency has issued 2 major safety warnings regarding Invokana and related drugs and is constantly monitoring adverse patient reports and ongoing clinical trials to assess the drug’s safety. In fact, Invokana’s manufacturer was only granted approval if it agreed to conduct an extensive set of post-market studies including:
- “a cardiovascular outcomes trial;
- an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes;
- a bone safety study; and
- two pediatric studies.”
However, the FDA allowed Janssen Pharmaceuticals a generous amount of time to complete the studies–for example, the clinical trials focusing on cardiovascular effects is slated to wrap up sometime in 2017.
In the meantime, patients continue to be exposed to the potential risks. But even if the post-market studies reveal substantial evidence supporting the existence of serious Invokana side effects, the FDA may still decide not to recall the drug.
This is exactly what happened in the case of Avandia, another type 2 diabetes drug associated with adverse cardiovascular effects. Through an extensive analysis of clinical studies suggested a whopping 43% increase in heart attack risk, the FDA never recalled Avandia, opting only to require label edits and to restrict the drug’s availability.
How Much Does An Attorney Cost?
At Banville Law, you won’t need to pay anything to get our attorneys started on your claim. Because we feel that your success should always come first, we accept no fees until after we’ve secured compensation for you in the form of a settlement or court award.
Am I Eligible to File?
The only way to know for sure is to schedule a free case evaluation with our lawyers. Prescription drug cases tend to be highly individual and we would need to know your unique circumstances in order to gauge the viability of your case.
However, because the time period for filing a lawsuit regarding a given situation is constrained by New York‘s statute of limitations, it’s best to explore your legal options as soon as possible to avoid losing the right to your Invokana claim. Contact Banville Law and you will speak with an experienced attorney within 24 hours, at no risk and no obligation.