SGLT2 class inhibitors refer to a class of FDA-approved prescription medication used to treat diabetes mellitus. The FDA recommends the use of the medication alongside a proper diet and adequate exercise to manage diabetes. The SGLT2 class inhibitors are available as single-ingredient medications and can also be used alongside other diabetes drugs. The SGLT2 inhibitors are among the newest oral antihyperglycemic agents used in the treatment of diabetes.

The past few years have seen tremendous improvement in the efficacy and safety of this class of medication. However, despite the significant improvements in the SGLT2 class inhibitors' safety, the drugs still have adverse effects. If you suffer adverse side effects after using SGLT2 class inhibitors, Consumer Alert Now can help you file a mass tort claim to seek compensation.

SGLT2 Class Inhibitors and Treatment of Diabetes

There is a significant prevalence of diabetes in the United States. Diabetes affects a sizable portion of the US population. Type 2 diabetes is a progressive disease that calls for continuous medication to help control glucose levels in the blood. The inhibitors work through a new technique by inhibiting the renal tubular glucose absorption. The other benefits of the SGLT2 inhibitors include favorable effects on weight and high blood pressure.

Given the benefits and efficacy of SGLT2 inhibitors, they have assumed a central role in the treatment of diabetes. Patients who suffer from type 2 diabetes but are not ready to start insulin injection may benefit from these medications.

The inhibitors prevent the reabsorption of glucose from the blood filtered through the kidney, enhancing the excretion of glucose through urine. The removal of excess glucose through urine helps lower glucose blood sugar levels.

The common types of SGLT2 approved by the FDA are:

  • Invokana (canagliflozin)
  • Farxiga ( dapagliflozin)
  • Jardiance (empagliflozin)
  • Glyxambi
  • Synjardy
  • Xigduo

The SGLT2 inhibitors are oral medications available in the form of pills. If your doctor prescribes an SGLT2 inhibitor, they will probably advise you to take it once or twice a day. Your doctor may recommend other medication alongside the SGLT2 medications to help keep your blood sugar low. You should ensure that you take all the prescribed medications as advised by the doctor.

The Potential Side Effects and Risks of Taking SGLT2 Inhibitors

Even if the SGLT2 inhibitors are generally considered safe, they have some adverse side effects under certain circumstances. The potential risks posed by SGLT2 inhibitors are:

  • Genital illnesses that are not sexually transmitted, including yeast infections
  • Urinary tract infections
  • Low blood sugar or hypoglycemia
  • Blood acidity which results from diabetic ketoacidosis

On some rare occasions, severe genital infections, Fournier's gangrene, has resulted from SGLT2 inhibitors. Invokana may also raise the risk of bone fractures. However, other SGLT2 inhibitors do not have reported instances of causing bone fractures. You should consult your doctor regarding the potential side effects of the SGLT2 inhibitors. This way, you will know what to expect and how to manage the side-effects. You should contact your doctor right away if you suspect that you have severe side effects after consuming an SGLT2 inhibitor.

SGLT2 Inhibitors and Fournier's Gangrene

Fournier's gangrene is a severe medical condition that kills body tissues, including muscles, blood vessels, and nerves. Fournier's gangrene is a rare health condition, but it is often a medical emergency when it occurs. This condition mostly affects men mainly in the penis or the scrotum. A variety of organisms often grow and infect the affected tissues. In severe Fournier's gangrene cases, a doctor may have no option but to remove the affected tissue. The doctor may have to remove part of your testicles or your penis.

The condition involves infection in the scrotum, penis, and perineum. Perineum refers to the area between the anus and the scrotum for a man. For a woman, the perineum is the area between the vulva and the anus. For people suffering from Fournier's gangrene, the dead tissue is found in the genitals. However, the dead tissue may also spread to the stomach, thighs, and chest.

Fournier's gangrene is a rare condition, usually more common in men but can also occur in women and children. However, the side effects of SGLT2 Inhibitors may cause Fournier's gangrene in both men and women.

Given the severity and the adverse effects of Fournier's gangrene, most mass torts involve customers suing SGLT2 inhibitors' manufacturers after developing the condition due to the drugs' side-effects. Other than the side-effects of SGLT2 inhibitors, Fournier's gangrene may also occur due to other risk factors, including:

  • Diabetes
  • A compromised immune system due to HIV
  • Morbid obesity
  • Diabetes

A significant percentage of the people who develop Fournier's gangrene have diabetes mainly due to the side effects of diabetes medication.

The Common Symptoms of Fournier's Gangrene

How can you tell that you are suffering from Fournier's gangrene? What are the leading side effects of the condition? In most cases, Fournier's gangrene manifests through a feeling of being generally unwell. The typical symptoms are:

  • Moderate pain in the genital area
  • Malaise
  • Swelling in the genital area

If you do not seek immediate treatment, the condition continues to worsen, and the associated pain becomes worse. You may also notice a foul smell from your genitals due to the dead and rotting tissue therein. If you rub the affected area, you will notice a popping sound commonly known as crepitus. The sound results from the friction that occurs as gas and tissues move against each other.

The presence of Fournier's gangrene could lead to additional symptoms that may eventually be deadly. The severe infection may spread to your body's deeper tissues and lead to inflammation of the blood vessels' linings. The inflammation of the blood vessels is known as obliterative endarteritis.

The inflammation further causes the formation of small blood clots. When the tissues do not receive ample blood supply, they begin to die. At times, the dead tissues may release necrotic tissue byproducts and bacteria into the bloodstream leading to an inflammatory response in the body. A septic shock may result whereby the body cannot maintain its blood pressure, making the body organs begin shutting one by one. A septic shock could lead to death. It is advisable to seek timely treatment when you notice the symptoms of Fournier's gangrene. This helps to prevent the worsening of the symptoms.

FDA's Warning Regarding Fournier's Gangrene and SGLT2 Inhibitors

In 2018, the FDA issued a warning regarding the development of a rare but severe infection in the urinary tract and the area around the genitals in people with type 2 diabetes. The condition occurred in patients who rely on SGLT2 inhibitors as a treatment for diabetes mellitus.

The FDA advised patients to seek immediate medical treatment if they experience tenderness, swelling, and redness around the genitals while on SGLT2 Inhibitors. You may also experience similar symptoms in the area surrounding the genitals to the rectum. You may experience a feeling unwell and a fever of up to 100.4F. The FDA advised patients to seek prompt treatment after experiencing these symptoms because the symptoms may worsen rapidly.

Health practitioners should also assess patients for Fournier's gangrene if they notice the symptoms mentioned above. Upon the confirmation of the conditions, patients should start immediate treatment.

According to study results published in the Annals of Internal Medicine, clinicians should be aware of Fournier's gangrene's increased risk in diabetes patients receiving SGLT2 Inhibitors. To understand the risk of Fournier's disease in patients with type 2 diabetes, researchers reviewed cases documented in FAERS between March 2019 and January 2019. The majority of Fournier's gangrene cases occurred among patients in the United States. The condition occurred within nine months after starting the SGLT2 Inhibitors therapy.

The research revealed that all the patients who developed Fournier's gangrene were severely ill and hospitalized. Several had complications like sepsis and diabetic ketoacidosis. In some cases, amputation occurred due to necrotizing fasciitis of the lower extremity during hospitalization. Certain hospitalized patients had to undergo procedures for fecal diversion, and some died.

The researchers noted that the Fournier's gangrene cases occurred in patients who used the SGLT2 inhibitors approved by the FDA. However, there was an exception for the patients who consumed ertugliflozin. The researchers concluded that ertugliflozin's low association with Fournier's gangrene was due to the drugs' limited time in the market. The drug was introduced into the market in December 2020.

Understanding Mass Tort Litigations in the US.

A mass tort is a part of personal injury law that can be litigated in various practice areas. This law can be litigated in insurance law, product liability law, employment discrimination law, defective drug law, and antitrust law, among others. A mass tort is a civilian action involving few defendants in a federal or state court or numerous plaintiffs against one defendant.

A mass tort arises from the defendants injuring plaintiffs through the same or similar act of harm like a drug prescription. In order to be fair and efficient to the defendants and plaintiffs, the courts handle all the victims' claims collectively.

There are two ways that a mass tort action can be coordinated in the federal court system. First, the lawsuits can be consolidated as multidistrict litigation procedures established in 1968 by Congress Statute, which is now codified as 28 USC 1407. It can also be done as a class action under Federal Rule of Civil Procedure 23(6). However, mass torts often fall under three smaller categories:

  • True mass torts
  • Toxic tort cases
  • Mass accident cases

A true mass tort needs innovative and new procedures for the collective treatment of claims, which can be found in multidistrict litigation and class actions. There could be hundreds or even thousands of individual claims that are often referred to as constituent claims of a mass tort, but the courts handle them collectively in a process called aggregation. The true mass torts give rise to numerous claims, but the tortious incidences that the claims are based on could disperse widely in space and time. Even though they arise from defective drugs or medical devices, they cause intense harm that could have lasting implications throughout the country and beyond.

Though the harmful effects may take long periods before discovery, the actions are geographically confined in toxic tort cases. All the claims arising from toxic tort must be directed in the same State court or Federal District because the toxic tort has a geographic center.

Mass accident cases arise from a tragic event that injures numerous people or causes damage to different parties. What defines such a case is that the actual harm the victims suffered arose from a distinct event at a specific time in a specific place, even if they may be found in different parts of the country. Therefore, their claims focus on one point in time and are centered in one place. Though the victims may be scattered across the world and there may be many such claims, the event that elicits the claims differs from other tortious activities.

Collective Treatment

It is common in the United States for courts to handle collective or aggregated way claims arising from mass torts. Litigating each constituent claim separately would bankrupt the defendants if there were no way to treat the claims collectively. The legal costs and other resources needed to challenge the cases could leave the defendants with no money to pay the claims, and the courts could be overwhelmed.

Filing a Mass Tort Due to the Adverse Effects of SGLT2 Class Inhibitors

There are specific steps to follow when filing a mass tort case, just like any other personal injury case. Typically, a mass tort attorney cannot file suit until he or she is sure that you have a valid claim. It all begins with the plaintiffs receiving treatment for any illnesses and injuries they suffered after using a drug. After receiving treatment and having your injuries recorded by medical professionals, you need to consult a competent mass tort attorney. You will have to give the attorney a medical report and determine the options you have when getting involved in the mass tort litigation process. The main stages in mass tort litigation are:

Reviewing Records by a Mass Tort Attorney

A mass tort attorney must review various records to determine if you have a case. He or she must review your statements along with the claims of injuries sustained. The attorney may also review the years' worth of medical records.

The defense attorney goes back about ten years in an ordinary personal injury case. They will comb through your entire medical history with mass tort litigation. This is important because it helps them determine if you had a pre-existing condition. It also helps them establish a timeline when you allegedly discovered your injuries. The consistencies amongst the plaintiffs must be determined. For instance, if you allege that a particular drug caused your injuries, the attorney must find similarities amongst the other plaintiffs' claims.

Identifying Injury Consistencies by Mass Tort Attorney

Your attorney will have to identify injury consistencies for your case to qualify for a mass tort. Plaintiffs often claim identical or similar damages in almost all mass tort cases. Each victim may have their lawsuit, and a mass tort attorney may build one case against a defendant. However, the suits must have a similar structure because only a few cases will determine the other cases' path. Mass tort attorneys may group the cases in different ways. They may categorize them based on injuries duration or the severity of injuries. The attorney will determine the damages once the case settles and assign damages based on where your case falls.

Federal Lawsuit Filing

In the United States, mass torts are filed in federal courts. It is good to file mass torts together even though you live in different parts of the region or country. This is what aggregating or consolidating mass tort claims means. You need a competent mass tort attorney because these cases are tried in federal courts. An experienced attorney knows the filing procedures and understands the structure of a mass tort case. The reason behind consolidating these cases is to make it faster and more convenient for every individual affected. Since the courts do not need their dockets clogged up with individual cases, they prefer consolidation to streamline them.

Trial of Bellwether Cases

The courts often try a handful of cases before handling the entire group case. The attorney handling the mass tort litigation usually chooses the most severe cases. This could include individuals facing imminent death or have passed away or those involving victims with severe damages. Mass tort cases are usually a test run for juries and judges. It determines the path other cases will go, and if the mass tort cases find a defense, other cases cannot proceed to trial. Therefore, the mass attorney must handle the cases seriously.

Settlement

It may take years or months, but most of the mass tort cases do settle. There is always an opportunity to appeal, and trials are expensive and time-consuming, making these cases take more extended periods. This is why the judges and attorneys prefer to have these cases settled out of court.

How Long Does a Mass Tort Claim Take?

Compared to an individual personal injury claim, which moves faster through the court system in months or weeks, mass torts are much more complicated.  This is because mass torts have vast numbers of plaintiffs. It takes a long time to investigate and gather sufficient evidence to prove an individual claimant's injuries. It could take years to investigate a single mass tort.

Mass torts also have unique processes that consume money and time. There are many status and case management conferences, selection of bellwether trial cases, sharing of motions and documents between parties. The factors that may influence the time a mass tort case could take include:

  • Collection of evidence and investigation- substantial evidence is needed in a mass tort claim like company documentation, medical records, and more, which can last months to organize, locate, collect, and analyze.
  • Locating and deposing expert witnesses- The attorney may contact several expert witnesses like drug company developers or researchers, economists, scientists, marketers, and physicians, depending on the case.
  • The need to travel- Like when required to conduct other case investigations or to locate and depose witnesses

Statutes of limitations are available in dangerous drug and medical device cases; you only need to contact an attorney immediately for a free case evaluation if you have a claim.

Improvement of Mass Tort Litigations in the US.

Practitioners in charge of improving the process of mass torts have made many innovative suggestions. They allege that the civil justice system is not well suited for mass tort litigation. Proposals include new forms and compensation mechanisms, adaptations of the current consolidation rules, and revisions in the current class actions or multidistrict rules.

The majority of the suggestions focus on procedure instead of substantive doctrine. Most aim to increase the judges' ability to achieve global resolutions of mass tort litigation. None of the proposals deals directly with the legal and factual complexity of the cases but addresses the problems related to future plaintiffs or the litigation conflicts.

Typically, the suggestions ignore the peculiar risk profile that drives mass tort litigation. The proposals aim to rationalize what courts are already doing while failing to deal with the equity and difficult ethical issues intertwined with mass tort litigation. The proposals also aim to expedite settlement and reduce transaction costs.

If a mass tort is resolved by creating a compensation fund and aggregation, the fund can be paid out, and the remaining litigation resolved in a claims facility. Typically, claims facilities offer a combination of jury trials, alternative dispute resolution, and administrative compensation schedules, with procedures aiming to meet the defendants', plaintiffs', and attorneys' requirements in certain cases.

Find a Mass Tort Attorney Near Me

If you have suffered Fournier's gangrene due to the adverse side-effects of SGLT2 Class Inhibitors, you need an experienced mass tort attorney. Mass tort litigations are complicated and require legal expertise. An attorney will guide you through the states of filing a mass tort claim. At Consumer Alert Now, we will evaluate your case and help you join or initiate mass tort litigation. Contact us at 800-511-0747 and speak to one of our attorneys.