INVOKANA or canagliflozin is an oral drug administered to patients with type 2 diabetes over the last four years to reduce blood sugar glucose levels. The drug works as a sodium-glucose cotransporter 2 inhibitor, increasing the release of sugar into the urine. Other brand names of the drug include Invokamet and Invokamet XR.
Since its release in 2013, many diabetic patients switched over to using INVOKANA from other diabetes medications. According to one company’s estimation, approximately 4.5 million INVOKANA prescriptions were filled in 2016 in the U.S. alone.
However, in May 2017, the Food and Drug Administration (FDA) issued a black box warning, concluding that the drug caused an increased risk of leg and foot amputations, and required new warnings be placed on all drugs containing canagliflozin, describing the risks. Other known side effects include kidney failure, heart attacks, diabetic ketoacidosis, and related injuries.
Trials & Side Effects: Amputations & Ketoacidosis
The FDA knew of the diabetic ketoacidosis risk, and required that Johnson & Johnson add warnings to INVOKANA, highlighting this especially dangerous risk, in December 2015. Diabetic ketoacidosis can be fatal if left untreated. In June 2016, the company was required to add additional warnings concerning other kidney injuries, including the risk of acute kidney injuries.
It was recently reported that many doctors are deciding to take their patients entirely off INVOKANA after the industry-sponsored trials found that the drug specifically doubled the risk of lower limb amputations. In the trial, approximately half of the amputations occurring were of toes, while the rest were at the ankle, across the foot, below the knee, or right above the knee. Some hospital pharmacies are also now keeping canagliflozin entirely off its list of drugs safe for use on hospitalized patients.
In fact, one doctor calculated that one patient out of 69 who takes canagliflozin for five-years will likely suffer from a drug-induced amputation. Other doctors and diabetes researchers have also questioned the methodology relied upon to demonstrate that INVOKANA prevents major cardiac events, noting that the FDA would never approve the drug to prevent these events based on current data.
Within months of the FDA’s announcement, people who’d taken the drug and had to receive amputations as a result filed personal injury and product liability claims against the makers of INVOKANA—Johnson & Johnson—as well as its subsidiary, Janssen Pharmaceuticals, and Mitsubishi Tanabe Pharma Corp—arguing that the companies knew or should have known about the dangers associated with the drug, yet failed to provide this information to doctors and patients. Specifically, that they concealed and continel to conceal their knowledge of the drug’s unreasonably dangerous risks to consumers and the medical community. These actions were brought under product liability, design defect, failure to warn, negligence, fraud, misrepresentation, and breach of warranty claims against the producers of INVOKANA. Companies that manufacture drugs like these owe consumers a duty to exercise reasonable care when designing, manufacturing, marketing, advertising, distributing, and selling these drugs, including taking any and all reasonable steps to ensure that the products are not unreasonably dangerous to consumers, and to warn them of any known dangers.
The litigation also claims that the defendant companies marketed and continue to market INVOKANA not only for use in patients suffering from type 2 diabetes, but for off-label purposes such as weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetes.
Companies marketing drugs like these have a duty to conduct proper safety studies, assess any safety signals that come along, and reveal any information related to serious and life threatening. Failing to do so constitutes a willful and wanton failure to provide adequate instructions, as well as a willful misrepresentation concerning the safety and nature of their product; particularly when this conduct brings about and/or exacerbates consumer injuries; injuries that are a reasonably foreseeable consequence of the companies’ conduct and their products’ defects.
But-for these actions, those harmed would not have used the drug, or been harmed by the drug. In other words, the harm suffered was the direct and proximate result of the companies’ acts, omissions, and misrepresentations.
What about Doctors?
Now that the FDA has released numerous warnings about the drug, physicians owe a responsibility to their patients to be aware of any factors that might predispose a patient to developing a condition that requires amputation as a result of taking INVOKANA. Some of those factors include prior amputations, peripheral vascular disease, diabetic foot ulcers, and neuropathy. Failure to be aware of and follow these protocols could also open up a physician to liability, in addition to Johnson & Johnson and Janssen Pharmaceuticals. Prescribing physicians have a duty to learn about risks like these through reasonable diligence.
Anyone currently taking INVOKANA or any other drug containing canagliflozin should contact their doctor right away if they start to experience sores, ulcers, infections or any pain or tenderness in their legs and feet.
If you or a loved one has been injured or killed after and as a result of taking INVOKANA, contact our experienced personal injury and product liability attorneys right away for a free legal consultation. As a leading Marietta faulty product attorney, Roger Ghai has the skills and experience to provide you with the aggressive representation you need to obtain the compensation to recover. Anyone harmed by the drug can not only seek compensatory damages, but also punitive damages, monetary restitution, and other remedies as a result of their injuries and loss. Those who are harmed by drugs like these not only suffer severe and permanent physical injuries, but emotional injuries as well; pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical costs.