Invokana and Diabetic Ketoacidosis
Updated December 8, 2016
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How Invokana Causes Kidney Problems And Diabetic Ketoacidosis
For decades, diabetics have treated with metformin or, if that doesn’t work, insulin. Recently, however, drug companies have seen diabetes as a potential goldmine, and so have started pushing new types of diabetes drugs, including SGLT2 inhibitors, like Invokana. (Read more about the differences between Invokana, metformin, and Januvia.) Invokana was approved by the FDA as a diabetes treatment in March 2013. Since then, the FDA has issued six “safety labeling changes” and five “drug safety communications.”(1) The National Diabetes Education Initiative, too, has said that SGLT2 inhibitors have “limited long-term experience,” and so are not recommended as an initial treatment.(2)
One of the biggest side effects of diabetes is having too much glucose in the bloodstream (hyperglycemia). Invokana works by blocking SGLT2, an enzyme in the kidneys that causes the kidneys to reabsorb glucose. Thus, when a patient takes Invokana, their kidneys process and excrete more glucose, which causes the patient to have lower blood sugar levels, like HbA1c.
But any drug that changes the way the kidneys work has the potential to cause kidney injury. Moreover, Invokana does not just inhibit SGLT2, but also inhibits SGLT1, which is found in the kidney, intestines, and brain. Unfortunately, Invokana doesn’t just change how the kidneys process glucose. Invokana also causes the blood vessels in the kidneys to contract, and it causes elevated creatinine levels, which are a signal of impaired kidney function.(3)(4)
In May 2015, the FDA issued a warning that Invokana and other SGLT2 inhibitors “may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”(5) A year later, in May 2016, the warning label for Invokana was updated to include “acute kidney injury and impairment in renal function,” as well as “ketoacidosis.”(6) The warning label also now says that Invokana is not approved for treatment of type 1 diabetes.
In many of the cases of ketoacidosis caused by Invokana, the doctors treating the patients weren’t aware that ketoacidosis could be the problem, and so the patients didn’t receive the correct treatment right away. Although the patients had signs of metabolic acidosis, like nausea, vomiting, abdominal pain, and shortness of breath, the doctors were put off their guard because diabetic ketoacidosis usually only happens after a patient has reached high blood glucose levels, but the patient’s blood glucose levels were fine. As the American Diabetes Association says, diabetic ketoacidosis “is rare in people with type 2” diabetes, especially if their blood glucose levels were not too high.(7)
The Status of Invokana Lawsuits
We believe that the manufacturers of Invokana should have, at a minimum, updated the warning label for Invokana long ago. As described above, the connection between Invokana and kidney dysfunction is obvious given how the drug functions. Our review of the FDA’s adverse event database, which tracks injuries reported by doctors, reveals that reports have been filed for years indicating that patients were having a variety of kidney problems, including diabetic ketoacidosis (over 500 reports), dehydration, pollakiuria (excessive daytime urination), acute kidney injury, renal failure, ketoacidosis, dysuria, hyperkalaemia, renal impartment, nephrolithiasis, metabolic acidosis, renal disorder, polyuria, ketonuria, and ketosis.
In December 2015, the first lawsuits were filed in Philadelphia, Pennsylvania, where our law firm is based, against the manufacturers of Invokana, Johnson & Johnson and Janssen Pharmaceuticals. Since then, other cases have been filed in Philadelphia, Pennsylvania and in other courts. The manufacturers have filed motions to dismiss the cases, raising typical arguments, but we expect the court to overrule them. As of November 23, there are 106 lawsuits pending in federal courts across the country, most of which are in the District Court for New Jersey.
When prescription drug lawsuits are filed, the courts typically “consolidate” them. That isn’t the same thing as a class action, where a handful of plaintiffs and their lawyers control the case. Rather, the cases are all individually filed, but they’re all handled by the same court. Usually, in drug prescription cases, there will be one “consolidated” litigation for the federal courts and one “consolidated” litigation in a state court where the defendants do business. That hasn’t happened yet for Invokana, but there are several motions pending with the federal “Judicial Panel on Multidistrict Litigation” that would create such a litigation. The original petition sought to consolidate the litigation in the federal court for New Jersey, and Janssen has agreed to that. A separate petition sought to move the litigation to the federal court in Chicago, Illinois, and add Farxiga and Jardiance lawsuits, but that petition has been opposed. On December 7, 2016, the federal panel ordered that all cases be consolidated in the federal court for New Jersey.
There have been no jury trials or settlements in the Invokana lawsuits. That, too, is typical at this early stage.
Why Hire Our Invokana Lawyers?
Because of our results and our expertise.
Results: Our nationwide product liability law firm negotiated the $2.4 billion Actos settlement, the largest settlement ever for claims against a diabetes drug manufacturer. We also negotiated the $650 million Pradaxa settlement, one of the few nationwide drug lawsuit settlements ever reached without the need for a trial, and within less than two years of the lawsuits first being filed.
Defendants settle with us because they know we can take the cases to trial and win. We have won jury trials for millions, even tens of millions, of dollars, in fields as diverse as medical malpractice, wrongful death, and occupational injuries.
Experience: Our lawyers have an unmatched depth of experience, which is why, for example, several of our lawyers were appointed by the federal court overseeing the Januvia and Victoza litigation to serve on the Plaintiffs’ Steering Committee, which fights the case on behalf of everyone who has filed a claim. Cases like the Invokana lawsuit require the plaintiff’s lawyers review millions of pages of documents, assess thousands of scientific studies, navigate a complex world of legal doctrines, and bring onboard world-class expert doctors and researchers.
We have years of experience with every part of that process. We use cutting-edge “big data” techniques for finding and investigating everything the drug company has, down to individual emails sent among their own employees. We have on-call epidemiologists and biostatisticians to work through data from clinical trials and real-world drug use. Our lawyers are often called in to argue before the court the legal issues in these cases, and even to discuss these issues on Capitol Hill. We have brought to court some of the world’s leading experts, including former FDA officials and prize-winning biologists, biochemists, and physicians.
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm400577.htm and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm446852.htm
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