The new type 2 diabetes drug Invokana has been linked to multiple severe health complications, including ketoacidosis. In two major Safety Communications, the US Food & Drug Administration has warned patients taking the drug to monitor for symptoms of abnormally high blood acid concentrations, a new, and potentially life-threatening, side effect.
In response to these stunning developments, former Invokana patients have begun to file personal injury lawsuits, seeking compensation from a drug manufacturer they say actively concealed evidence from the public.
Reviewing adverse event reports filed between 2013 and 2014, the FDA identified 20 patients in whom Invokana was linked to a form of elevated blood acidity; all required emergency medical intervention.
As a result, the FDA cautioned patients taking Invokana and other SGLT2 inhibitors to monitor for difficulty breathing, nausea and vomiting, excessive fatigue, abdominal pain and disorientation, all early warning signs of ketoacidosis.
The agency continued to monitor incoming reports, eventually identifying 73 cases of ketacidosis from 2013 to 2015 - all of which required hospitalization. For the FDA, those warning signs were clear enough to warrant a label change. As of December 4, 2015, Invokana's label reads:
"Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance with type 1 and type 2 diabetes mellitus receiving [fusion_builder_container hundred_percent="yes" overflow="visible"][fusion_builder_row][fusion_builder_column type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"][...] SGLT2 inhibitors, including Invokana [...] Patients treated with Invokana who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels [...] If ketoacidosis is suspected, Invokana should be discontinued."
That warning may be enough to save future patients, but critics say it's come too late for many people.
Consumer advocate groups, including the Institute for Safe Medication Practices, have been warning about Invokana's link to ketoacidosis for more than a year. As we've seen, the FDA publicly announced the possibility in May of 2015. The drug's manufacturer, however, did nothing, according to plaintiffs in a series of new Invokana lawsuits. Rather than warn the public, Janssen Pharmaceuticals, a subsidiary of corporate giant Johnson & Johnson, actively defended its product, patients claim.
The FDA's labeling revision came on December 4, 2015, and only 6 days would pass before the first Invokana lawsuit was filed. Brought by Arthur Portnoff, a former Invokana patient, the lawsuit claims Janssen Pharmaceuticals was well-aware of the drug's serious risks, but failed to warn doctors. Shockingly, Portnoff says he began taking Invokana in November of 2014 and was diagnosed with diabetic ketoacidosis only three months later. His lawsuit, filed in the Philadelphia Court of Common Pleas, was registered under the case number 15-12-00653.
On December 8, 2015, Luana Jean Collie added her own voice to what legal experts believe will become a major litigation. Collie, a resident of Orange Beach, Alabama, says she began taking Invokana in December 2014, believing the drug a "safe and effective" choice to treat her type 2 diabetes. But only months later, she was suffering the severe consequences of ketoacidosis.
Shocked to learn that numerous red flags were seemingly ignored by the drug's manufacturer, Collie took action, filing a lawsuit in the US District Court for the Southern District of Alabama. She accuses Janssen of failing "to properly assess and publicize alarming safety signals" and suppressing "information revealing serious and life threatening risks."
Portnoff and Collie will not be alone in their calls for justice. In the first three months of 2015 alone, Invokana sales raked in $278 million for Janssen Pharmaceuticals. The drug has proved a blockbuster, among health care professionals and alike, many of whom are still unaware of its substantial risks. As public awareness grows, and more patients come forward, the legal community expects numerous Invokana lawsuits to be filed in the coming months.
Any patient who was prescribed Invokana and then suffered from ketoacidosis may be eligible to file a personal injury lawsuit against the drug's manufacturer. Attorneys are also investigating claims that Invokana may be linked to kidney failure, cardiovascular complications and bone fractures.
In a lawsuit, harmed patients may be able to claim damages for:
Banville Law's experienced dangerous drug attorneys are currently providing free consultations to patients who believe they may have a potential Invokana claim. Case evaluations come at no charge and no obligation.
We've developed a number of resources for patients interested in learning more about Invokana lawsuits. Follow the links below for more information:
Our attorneys are following the development of Invokana litigation closely. For breaking legal news and information on the latest SGLT2 inhibitor studies, click here.
Approved on March 29, 2013, Invokana is one of several "new generation" type 2 diabetes drugs known as "SGLT2 inhibitors." All drugs within this class have been found to increase the risk of ketoacidosis:
SGLT2 inhibitors (or "sodium-glucose cotransporter-2 inhibitors") block the kidney's natural ability to filter blood glucose from urine. Rather than returning the body's main energy source to the blood stream, Invokana forces glucose to be excreted. In light of the drug's mechanism of action, health experts have said that the newly-identified dangers could have been "reasonably expected."
The drug is approved only for use in patients with type 2 diabetes, who suffer from "insulin resistance." In these patients, the body's cells are unable to convert glucose into energy, leading to dangerously high blood sugar levels and long-term organ degeneration. And while Invokana may increase the body's ability to dispose of excess glucose, the drug seems to increase blood acids, or "ketones," as well.
That is the troubling suggestion made by QuarterWatch, a publication of the Institute for Safe Medication Practices, in a report released in March 2015.
Independently reviewing serious adverse event reports filed in April, May and June of 2014, QuarterWatch's analysts identified more than 50 reports in which patients taking Invokana suffered symptoms of impaired kidney function, including total kidney failure. Dehydration, kidney stones and urinary tract infections were other commonly reported adverse events. In conclusion, QuarterWatch questioned whether or not Invokana's benefits truly outweighed its potential risks.
On December 4, 2015, the FDA released new information, and a new warning, on Invokana, implicating the drug in a rash of severe urinary tract infections, many of which seem to have spread quickly to the kidneys. From March 2013 to May 2015, the agency identified 19 reports of such infections - all 19 patients required hospitalization. In fact, several required dialysis to forestall the onset of kidney failure.
Only two months prior to Invokana's approval, members of an FDA advisory committee raised serious concerns about the drug's link to another class of severe complications: cardiovascular events.
Contrasting data from an Invokana clinical trial to the results of a study involving another SGLT2 inhibitor, Dr. Sidney Wolfe, co-founder of the Public Citizen's Health Research Group, found that patients taking Invokana presented marked elevations in hematocrit, the concentration of red blood cells. He noted that increases in hematocrit can lead to "thrombotic events," or blood clots, and may in turn result in heart attack and stroke. Wolfe pointed out that thirteen patients in the Invokana trial had experienced "cardiovascular events."
Doctor Hyon Kwon, an FDA official, backed up Wolfe's concerns with his own observations of increased cardiovascular risks.
The attorneys handling SGLT2 lawsuits, which include Invokana lawsuits, are lead by attorney Laurence P. Banville, Esq. Mr. Banville has extensive experience in the area of mass torts and is active in several mass tort litigations including:
Our lawyers are licensed to practice law in the state of New York, however we work with other firms on jointly representing cases outside of New York.
Invokana is a type 2 diabetes drug that has been associated with numerous critical health complications. These complications suffered by patients have led to several lawsuits being filed. Below you will find information about Invokana latest updates as well as lawsuits that are being filed all over the country.
A female plaintiff filed a lawsuit on July 25th in the U.S. District Court for the District of New Jersey. Her complaint alleges that the defendants, the manufacturers of the diabetes drug Invokana, were negligent in that they failed to warn or concealed from consumers the potential side effects of the drug. The plaintiff claims to have developed diabetic ketoacidosis while using Invokana and continues to suffer from injuries as a result. The Arizona resident is one of many who have filed suit claiming they were not warned of the life-threatening risks the new-generation diabetes drug posed, and that the manufacturers should have included warnings on the label. The FDA has released several safety communications since their approval of the drug in 2013 but did not require a warning about ketoacidosis on the label until December of 2015.
A California woman is suing Janssen Pharmaceuticals and Johnson & Johnson for injuries she allegedly suffered due to the use of the type 2 diabetes drug Invokana. She is seeking over $75,000 in damages for kidney failure she alleges Invokana caused. The plaintiff stated she was taken to hospital in April 2014 and May 2015 for acute kidney injury and acute kidney failure after she had started taking the drug. She alleges that had the defendants fully disclosed the risks associated with the drug, she would not have used it.
A woman from Texas filed a lawsuit against the manufacturers of Invokana, alleging that she suffered serious injuries after she took the drug for type 2 diabetes. The woman is seeking over $10 million for compensatory and punitive damages. Her lawsuit was filed in the U.S. District Court for the District of New Jersey.