Genital Infection Lawsuit
A genital infection lawsuit may be an option for people who have developed a genital infection or the area surrounding the genitals. Following a warning issued by the FDA, lawyers are looking into possible connections between genital infections and the use of several drugs used to treat type 2 diabetes, including Invokana, Jardiance and Farxiga.
The infection, known as Fournier’s gangrene, is an extremely rare but life-threatening bacterial infection that quickly spreads and destroys the infected tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Genital Infections Linked to Invokana
On August 29, 2018, the FDA issued a safety announcement warning patients and health care professionals that 12 cases of rare but serious genital infections linked to Invokana and other sodium-glucose cotransporter-2 (SGLT2) inhibitors were reported between March 2013 and May 2018. The rare infection is known as necrotizing fasciitis of the perineum or Fournier’s gangrene.
According to the FDA’s announcement, Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery, and some patients required multiple disfiguring surgeries, some developed complications and one patient died.
In their announcement, the FDA advised patients to seek medical attention if they begin to experience:
- tenderness, redness or swelling of the genitals or area around the genitals;
- a fever above 100.4 degrees; or
- general feeling of being unwell
Symptoms of the infection may worsen quickly, and it is important that patients seek medical attention as soon as possible.
Type 2 Diabetes
Type 2 diabetes is a disease that occurs when a person’s blood glucose (also called blood sugar) is too high. Blood glucose is your main source of energy and comes mainly from the food you eat, and those who have type 2 diabetes aren’t able to make enough insulin to help glucose get to your cells. Type 2 diabetes is the most common type of diabetes, and millions of Americans are diagnosed with diabetes each year.
Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
What are SGLT2 Inhibitors?
Sodium-glucose cotransporter-2 SGLT2 inhibitors are a class of FDA-approved prescription medicines that are used to lower blood sugar in adults with type 2 diabetes in addition to diet and exercise. Medicines in the SGLT2 inhibitor class include th active ingredients canagliflozin, dapagliflozin, and empagliflozin.
How Do They Work?
SGLT2 inhibitors are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. They lower blood sugar by causing the kidneys to remove sugar from the body through the urine. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.
FDA-Approved SGLT2 Inhibitors
FDA-approved SGLT2 inhibitors include medications manufactured by Johnson & Johnson’s, Eli Lilly & Co, Bristol-Myers Squibb, AstraZeneca Plc, Merck & Co, and Pfizer Inc.
- Invokana (canagliflozin)
- Invokamet & Invokamet XR (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin and metformin)
- Qtern (dapagliflozin and saxagliptin)
- Glyxambi (empagliflozin and linagliptin)
- Synjardy & Synjardy XR (empagliflozin and metformin)
- Steglatro (ertugliflozin)
- Segluromet (ertugliflozin and metformin)
- Steglujan (ertugliflozin and sitagliptin)
Fournier’s Gangrene Linked to SGLT2 Inhibitors
Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. According to the FDA, the bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect.
In addition to early signs associated with Fournier’s gangrene, including tenderness, redness or swelling of the genitals or area around the genitals; severe pain; and fever, later symptoms of the infection, according to the Centers for Disease Control and Prevention, may include:
- Ulcers, blisters or black spots on the skin
- Changes in the color of the skin
- Pus or oozing from the infected area
- Dizziness
- Fatigue or tiredness
- Diarrhea or nausea
Although the infection most commonly affects men, it can develop in women and children as well. Out of the 12 cases identified from March 2013 and May 2018, seven were men and five were women. Having diabetes is a risk factor for developing Fournier’s gangrene; however, this condition is still rare among diabetic patients. According to information gathered by the FDA, “an estimated 1.7 million patients received a dispensed prescription for an SGLT2 inhibitor” from retail pharmacies in the United States.
Lauren A. on May 16, 2016
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Other SGLT2 Side Effects
Common side effects of SGLT2 inhibitors include yeast infections, urinary tract infections, and low blood sugar when combined with other prescription diabetes medicines.
According to the FDA, SGLT2 inhibitors can also cause local genital fungal infections, also known as yeast infections. Yeast infections are different from necrotizing fasciitis of the perineum (Fournier’s gangrene) because they cause limited local symptoms like vaginal or penile discharge, itching, or redness.
Patients with yeast infections do not experience fever or a general feeling of being unwell.
Has There Been a Recall Due to Genital Infections Linked to Invokana?
Since the drug’s approval in December 1994, the FDA has not notified the public of any drug recall issued because of the risk of genital infections linked to Invokana or similar drugs, such as Jardiance or Farxiga.
Drug recalls are usually conducted by the drug manufacturer, by FDA request, or by FDA order.
Potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Has a Class Action Lawsuit Been Filed Due to Genital Infections Linked to Invokana?
At the time of this article’s publication, a class action lawsuit has not been filed on behalf of patients who suffered serious complications due to genital infections linked to Invokana or similar drugs in its class. Affiliated attorneys are unsure if a class action will be certified for patients who are adversely affected by the drug or other SGLT2 inhibitors.
Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by Invokana, Jardiance, or Faxiga and similar diabetes drugs, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding.
MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by dangerous drugs.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments.
After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Genital Infection Lawsuit News
- August 2018FDA issues a safety announcement warning patients and health care professionals of a rare but serious infection of the genitals and area around the genitals reportedly linked to a class of type 2 diabetes medicines known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
How a Genital Infection Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Invokana, Jardiance, Faxiga or other SGLT2 inhibitor, may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
