Farxiga and Invokana Lawsuits

With cases of type 2 diabetes increasing at an alarming rate, it should come as no surprise that pharmaceutical giants have been working to develop effective new treatments for the condition over the past several years. This push has led to the introduction of SGLT2 inhibitors, drugs designed to cause the release of excess blood sugars into the urine. Popular versions of the drugs, AstraZeneca’s Farxiga and Invokana from Johnson & Johnson have achieved widespread appeal, in part because they have been observed to help reduce blood pressure and facilitate weight loss in addition to controlling the effects of diabetes.

However, the safety of these purportedly revolutionary treatments for type 2 diabetes has recently come into question, with adverse event reports submitted to the FDA by patients and physicians. Some people who experienced health complications during or after SGLT2 inhibitor use are considering filing lawsuits, alleging that the medications cause side effects such ketoacidosis, hypotension, cardiovascular complications and even stroke.

FDA safety communication about SGLT2 inhibitors

The potential link between the use of Farxiga, Invokana, and/or Jardiance and the development of ketoacidosis is particularly worrisome, because of the impact the condition has on the body. Ketoacidosis results in dangerously elevated levels of acids (ketones) in the bloodstream. Patients afflicted by this condition are at risk of falling into a diabetic coma or death. Onset symptoms of ketoacidosis include extreme thirst, frequent need to urinate, excessive fatigue, abdominal pain, nausea, vomiting and difficulty breathing.

The U.S. Food and Drug Administration issued a safety communication in May 2015 concerning SGLT2 inhibitor drugs which stated that these medications “may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.” The agency discussed adverse event reports it had received in which patients suffering from ketoacidosis following use of the diabetes drugs required emergency treatment and hospitalization. The FDA advised patients taking these drugs to stay alert to diabetic ketoacidosis (DKA) symptoms so that they can seek prompt medical treatment should they appear.

The FDA stated in the safety communication that, “we are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.”

SGLT2 inhibitors include:

• Invokamet (canagliflozin and metformin)
• Xigduo XR (dapagliflozin and metformin extended-release)
• Glyxambi (empagliflozin and linagliptin)
• Farxiga (dapagliflozin)
• Invokana (canagliflozin)
• Jardiance (empagliflozin)

European health regulators publish SGLT2 inhibitor alert

Not long after the FDA drug safety communication was released in the U.S., the European Medicines Agency (EMA) published their own review of SGLT2 inhibitor risks, urging health care providers to be on the lookout for symptoms of DKA in patients. The EMA cautioned doctors that Type 2 diabetes patients may develop the life-threatening condition and yet present with atypical symptoms such as normal blood glucose levels. Patients who are taking Invokana, Edistride, Ebymect, Jardiance, Farxiga, Synjardy, Vokanamet or Xigduo — all sold in the EU — are urged to be aware of early onset signs of diabetic ketoacidosis including confusion, vomiting, stomach pain, heavy breathing, rapid weight loss and a sweet or metallic taste in the mouth, and to seek prompt medical attention. If ketoacidosis is confirmed, treatment with SGLT2 inhibitors should be halted immediately until blood acid levels have stabilized.

Possible Farxiga and Invokana lawsuits

For any future SGLT2 inhibitor lawsuits brought against drug makers like AstraZeneca and Johnson & Johnson to be successful, plaintiffs will have to prove that the diabetes drugs were the direct and exclusive cause of ketoacidosis and resulting complications such as coma, heart attack, kidney failure, and death. Plaintiffs will also seek to prove that the drug manufacturers negligently sold and marketed products that were not subjected to sufficiently lengthy or meaningful clinical tests, that the safety of the drugs was misrepresented to physicians and the public, that the drug makers placed a defectively designed and manufactured product on the market, and that warranties of fitness were breached.

Though no Invokana lawsuits have yet been filed, typically in drug injury litigation, plaintiffs claim that had they been aware of the threats posed by medications they were taking, they would have opted to use an alternative treatment available on the market.

Any lawsuits that are ultimately filed will likely demand damages for:

• Current, past and future medical expenses
• Lost wages
• Lost earning capacity
• Pain and suffering
• Emotional distress
• Rehabilitation expenses
• Funeral costs
• Punitive damages

The future of Farxiga and Invokana litigation

Farxiga and Invokana attorneys across the country are currently reviewing potential cases of individuals who took SGLT2 inhibitors and claim to have suffered ketoacidosis and related complications.

Though the eventual scope of litigation surrounding these drugs remains to be seen, if a large number of cases is ever filed, it is possible that federal multidistrict litigation or state-level mass torts would be instituted to manage pretrial discovery. Consolidation of this type is useful in providing consistency of early-stage rulings, economical use of judicial resources and often helps the parties assess how juries are likely to respond to their respective legal theories and evidence. Ultimately, this can lead to resolution of a large number of cases and allow plaintiffs to settle claims without the need for time-consuming trials.

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