WASHINGTON — A significant number of lawsuits have been filed against pharmaceutical giant Johnson & Johnson, along with its subsidiary Janssen Pharmaceuticals, alleging that the diabetes medication Invokana is linked to severe leg and foot amputations. Patients and legal advocates argue that the companies failed to adequately warn users about the risks associated with the drug.
Invokana, approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of type 2 diabetes, has been under scrutiny after research showed an increased risk of amputations, particularly involving the toes and middle of the foot. Medical studies, including one prominent piece of research conducted at the University of Padova in Italy, have indicated that patients using Invokana could be twice as likely to suffer from amputations compared to those on other diabetes medications or a placebo.
The legal challenges currently consolidate numerous individual claims into multidistrict litigation, overseen by a federal judge in New Jersey. This judicial process is designed to accelerate the handling of complex cases that involve large numbers of plaintiffs across different federal courts who have similar allegations.
Central to the lawsuits are accusations asserting that Johnson & Johnson and Janssen Pharmaceuticals were negligent in how they developed and marketed Invokana. Plaintiffs claim that the drug is defective and unreasonably dangerous. Besides negligence, the complaints list failure to perform adequate tests, insufficient warnings regarding the elevated risks of amputations, and allegedly misleading marketing practices.
In response to emerging data, the FDA intervened in May 2017, mandating that all Invokana packaging include a prominent warning about the amputation risk. This federal action followed reports linking Invokana not only to amputation risks but also to potential kidney damage and diabetic ketoacidosis, a serious complication that occurs when the body produces high levels of blood acids called ketones.
Added precautions recommended by health care regulators include advising doctors to discontinue prescribing Invokana for patients who develop significant foot complications, such as tenderness, sores, ulcers, or infections. The FDA has also advised caution in prescribing the drug to patients with a history of prior amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers.
Despite these warnings, no recall of Invokana has been issued as of this report. Some health systems like Sharp HealthCare and Scripps Health, perceiving the risks, have ceased prescribing the medication.
As the legal processes unfold, the outcomes of these cases could influence future regulatory and manufacturing practices within the pharmaceutical industry, particularly concerning how side effects are researched and disclosed. The ongoing litigation and its ramifications continue to be closely watched by medical professionals, patients, and legal experts alike, highlighting a critical discourse on patient safety and corporate accountability in the healthcare sector.