Diabetes drug Invokana is used in conjunction with a modified diet to treat low blood sugar in adults with type 2 diabetes. While the effects of diabetes can lead to serious health problems if left untreated, many patients claim that this widely prescribed medication is causing as much harm, if not more, than the condition the drug was created to treat.
As a result, a number of lawsuits have been filed against Invokana’s manufacturer, the Janssen Pharmaceutical Companies of Johnson & Johnson, on behalf of patients who experienced adverse effects. At this time, dozens of cases are still pending.
Early Safety Concerns About Invokana
Before the U.S. Food and Drug Administration (FDA) approved Invokana in 2013, panel members debated its cardiovascular (CV) safety, pointing to a clinical study reporting 13 CV episodes in the Invokana group, as opposed to one episode in the placebo group. Of the 15 panel members, eight voiced concern with what they viewed as limited data informing this risk. They also expressed concern over unanswered questions regarding increased stroke incidences and other CV events.
The FDA panel members were not alone. A number of scientific researchers were concerned about Invokana clinical reports that showed dangerous increases in urinary infections and symptoms related to low blood pressure. In 2013, Sydney M. Wolfe, MD, of the renowned consumer watchdog group Public Citizen argued during a congressional testimony against Invokana’s approval, stating that the risks outweighed the drug’s potential benefits.
Other safety groups, including the Institute for Safe Medication Practices (ISMP), have since come forth claiming that Invokana was not adequately tested in clinical trials before the FDA approved it. Meanwhile, millions of people were prescribed the drug and may have suffered severe health problems that may have been prevented.
FDA Issues Warnings About Invokana
The FDA did issue several safety communications about Invokana and other SGLT2 inhibitors, but the first warning wasn’t made public until May 2015, two years after the drug was approved for market. In its drug safety announcement, the agency stated that these medications risk the development of a serious health condition called diabetic ketoacidosis that can cause diabetic comas or death. The warning followed the agency’s review of dozens of adverse event reports from patients who were injured or hospitalized due to ketoacidosis after taking SGLT2 inhibitors including Invokana. The warning was not added to the drug’s label until December 2015.
After Janssen published the results of a post-marketing study in September 2015, the FDA further revised Invokana labels with information on the risk of bone fractures and a decrease in bone mineral density. In June 2016, the FDA announced new warnings for Invokana and other SGLT2 inhibitors, reporting that the drugs were linked to acute kidney injuries which, in some cases, required hospitalization.
In May 2017, the FDA issued a black box warning, the most severe alert it can order, for the risk of leg, foot and toe amputations. This followed results from two clinical trials reporting that people with type 2 diabetes were twice as likely to require amputation when taking Invokana as opposed to taking a placebo.
Patients Start Filing Invokana Lawsuits
Many patients have filed lawsuits against Invokana’s manufacturer after experiencing adverse effects while taking the drug. Other claims have been filed on behalf of patients who died from complications after taking Invokana. Among the allegations, claimants say Janssen knew or should have known about the risks before the drug went to market, and that they did not properly warn the public.
Serious health problems are at the center of these cases, with many patients ending up in critical condition requiring hospitalization. Claimants seek compensation for past and future medical bills, pain and suffering, lost wages and, in the cases where a patient has died, funeral expenses.
Most of the Invokana lawsuits allege that Janssen:
- Withheld critical information from the FDA
- Misrepresented the risks and benefits of taking Invokana
- Failed to conduct proper safety studies
- Failed to warn the public of Invokana’s potential side effects
In October 2015, Paula Brazil sued Janssen and its parent company Johnson & Johnson after recurrent nausea and vomiting caused by the drug led to extreme weight loss, which required emergency care at Hamilton Medical Center in Dalton, Georgia. In her lawsuit, she accused Janssen of strict liability, negligence, fraud, and misrepresentation, and sought punitive damages for harm.
Wardell Fleming filed a lawsuit against Janssen, Johnson & Johnson, and Mitsubishi Tanabe in December 2015. Fleming’s kidneys failed after starting treatment with Invokana in 2013. The claimant alleged physical and emotional injuries, economic losses, and a loss of enjoyment of life due to the medication’s adverse effects.
Ultimately, both cases were dismissed for different reasons, but Janssen and Johnson & Johnson face many more litigation over the drug. As of September 2016, there were at least 56 cases in 11 federal district courts across the U.S. with similar claims, and an additional 41 cases pending in the Eastern District of Pennsylvania alone. Motions were filed to treat these cases similarly to other product liability lawsuits using multidistrict litigation (MDL), and in October 2016, Janssen agreed.
As of March 2017, 178 cases were pending under MDL 2750 in the U.S. District Court for the District of New Jersey. The pending cases in Pennsylvania will transfer to the New Jersey MDL. On July 19, 2017, a scheduled “Science Day” will educate the judges about scientific studies that may link or disprove a link between Invokana (and other SGLT2 inhibitors) and the injuries claimed in the lawsuits. The cases remain in discovery until the first bellwether trial, which is scheduled for September 2018.
If you or a loved one has suffered adverse effects after taking Invokana, you may be eligible to file a claim. Since these cases are time sensitive, you should contact an attorney specializing in Invokana lawsuits as soon as possible to discuss what’s best for you and your family.