Lawsuits continue to be filed against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals for injuries suffered by those taking the drug Invokana, a drug used to treat Type 2 diabetes. Those who have suffered severe injury due to the use of Invokana have filed claims in state court in New Jersey—where J & J is based—as well as a federal multidistrict litigation which is also based in New Jersey. Multidistrict litigation is used by federal courts to streamline the process of managing large numbers of lawsuits which have been filed across the country involving the same issues.
How MDLs Are Used in Dangerous Drug and Defective Medical Device Claims
MDLs are frequently utilized in dangerous drug and defective medical device lawsuits, as many of the plaintiffs have the same injuries and are asserting the same claims against the manufacturer. An MDL places all the cases before a single judge so the time and expense of mass lawsuits can be coordinated. Bellwether trials on typical cases are held first in an MDL to allow both sides to get a good idea of how the future trials may go, and to give the manufacturer the opportunity to offer a settlement in the remaining cases. The bellwether cases are chosen from all the filed lawsuits as those being most representative of the cases as a whole.
Black Box Warning on Invokana
In the case of Invokana, as of December, 2017, 952 complaints were pending, with the majority of those cases involving injuries other than amputations (kidney injuries, stroke, serious ketoacidosis, and infections). The Invokana MDL was created on December 7, 2016, and it was not until May 2017 that the FDA highlighted the link between Invokana and amputations, subsequently requiring the manufacturer to include a black box warning—the most serious type of warning the FDA can issue—regarding the risk of amputation. The FDA made this decision after two large Invokana clinical trials concluded those who took the drug had twice the risk of leg and foot amputations as those given a placebo.
Most Recent Invokana Amputation Cases
A Tennessee resident filed a recent lawsuit linking Invokana to amputations. She began taking Invokana in May 2016; a month later, her doctor prescribed Invokamet, which combines the active ingredient of Invokana (canagliflozin) with metformin. About seven months later, she underwent surgery to amputate the first toe of her right foot. Her lawsuit, filed on December 26, 2017, alleges Janssen failed to adequately warn physicians and patients about the potential risks of taking Invokana.
Two lawsuits were filed in New Jersey Superior Court in Middlesex County on behalf of patients who also experienced amputations after taking Invokana. A man from Alabama was prescribed Invokana in January 2015, undergoing left foot and below-the-knee amputations a year later. Another began taking Invokana in April 2015, then little more than eight months later he had his right leg amputated below the knee. Four more Invokana amputation lawsuits were filed in October 2017 in federal court.
Invokana On the Market for Four Years Before Adverse Event Reports Submitted
Invokana had only been on the market for four years when the FDA announced the drug could potentially increase the risk of toe amputations, mid-foot amputations, below-the-knee amputations, above-the-knee amputations and even multiple amputations involving both limbs. Patients were advised to speak to their doctor about the potential risks of Invokana amputations, and to immediately seek medial assistance if they developed an infection, ulcer, sore, or any area which was tender to the touch.
Invokana Clinical Trials
The first Invokana clinical trial reported that 5.9 out of 1,000 patients being treated with Invokana suffered an amputation, while only 2.9 out of 1,000 who received a placebo during the clinical trial suffered an amputation. The second clinical trial returned even higher numbers, with 7.5 out of every 1,000 patients receiving Invokana suffering an amputation, and only 4.2 out of 1,000 patients receiving a placebo suffering an amputation. In addition to the serious risk of amputation for those taking Invokana, by June 2014 there had been at least 20 patient reports of ketoacidosis which required hospitalization and emergency treatment. More adverse event reports continued to come in to the FDA, claiming kidney failure, heart attack and diabetic ketoacidosis as a direct result of taking Invokana.
Where to Turn for Help if You Have Been Injured by Invokana
The lawsuits currently filed against Johnson & Johnson & Janssen for amputations and other serious injuries allege the manufacturers knew—or should have known—about the serious side effects of the drug prior to releasing it to consumers, and that since some of the side effects of the drug are deadly, there was a definite failure to warn. If you or a loved one has suffered injury as a result of taking Invokana, it could be very beneficial for you to speak to an experienced, knowledgeable Pennsylvania product liability attorney who can help you determine your best course of action.
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