Pharmaceutical companies dealing with dangerous drugs make more than one trillion dollars every year. Thousands of innocent Americans turn to drugs such as DPP-IV Inhibitors Bullous Pemphigoid to relieve their pain/suffering. Our commitment at Consumer Alert Now is to provide consumers across the country with information on potentially dangerous medical products. We will discuss DPP-IV Inhibitors Bullous Pemphigoid below and discuss how you can join a mass tort for this dangerous drug.
DPP-IV Inhibitors: An Overview
Inhibitors of dipeptidyl peptidase 4 (also known as DPP-IV inhibitors/gliptins) are a type of oral hypoglycemics used in treating diabetes mellitus type 2. DPP-IV inhibitors work by blocking enzyme dipeptidyl peptidase-4 (commonly referred to as DPP-IV). The FDA approved the first agent of DPP-IV inhibitors, sitagliptin, back in 2006.
Technically, glucagon raises blood glucose levels in the human body. DPP-IV inhibitors are usually administered to lower glucagon, thus lowering blood glucose levels. They are designed to raise the levels of incretin (GIP and GLP-1), which prevent glucagon release and help increase insulin secretion. Abundant secretion of insulin decreases the gastric emptying and lowers blood glucose levels.
Diabetes Mellitus Type 2 and DPP-IV Inhibitors
Diabetes mellitus type 2 is the most common type of diabetes caused by the resistance of insulin by the cells. Unlike type 1 diabetes, which is caused by the deficiency of insulin, type 2 diabetes is a milder form of diabetes. Treatment of Diabetes Mellitus type 2 includes agents known to raise the amount of pancreas-secreted insulin. The condition is also treated with agents known to make target organs more sensitive to insulin.
Once nutrients are ingested in the body, the gastrointestinal tract produces hormones known as incretins. These hormones usually stimulate the secretion of glucose-dependent insulin once they act on the pancreatic beta cells. GLP-1 (glucagon-like peptide) and GIP (glucose-dependent insulinotropic polypeptide) are the two predominant incretin hormones that help in insulin secretion. DPP-IV inhibitors help enhance incretin activity, thus managing type 2 diabetes.
Examples of Drugs Marketed and Sold as DPP-IV Inhibitors
More than ten critically-acclaimed drugs belong to this class. They include FDA-approved drugs such as Sitagliptin, Lingaplitin, Saxagliptin, and Alogliptin. Others include Japan-approved Anagliptin, Omarigliptin, and Trelagliptin, EU-approved Vildagliptin, Korea-approved Gemigiptin and Evogliptin, Russia-approved Gosogliptin and Dutogliptin. Berberine, an alkaloid extracted from plants belonging to genus Berberis, is also known to inhibit dipeptidyl peptidase-4.
Marketed and sold under the name "Onglyza," Saxagliptin is an anti-diabetic drug of the DPP-IV inhibitor class. Though Bristol-Myers Squibb was the first company to develop the drug, AstraZeneca partnered with the company later in 2007 in developing and marketing Saxagliptin. Onglyza helps in the treatment of diabetes Type 2 diabetes single-handedly or in combination with other drugs. The drug is more powerful in treating Type 2 diabetes when consumed together with metformin.
Vildagliptin, which is traded as Galvus, Gliptus or Vildagluse, is an anti-diabetic drug belonging to the DPP-IV inhibitor drug class. The drug prevents the inactivation of incretin hormones (GIP and GLP-1), allowing them to increase the secretion of insulin in the pancreatic beta cells. Vildagliptin also helps suppress glucagon released by the alpha cells in the Langerhans, found in the pancreas. Multiple studies found the drug effective in reducing hyperglycemia in Diabetes Type 2.
Sold under the name “Januvia” Sitagliptin is a medication for treating Type 2 Diabetes Mellitus. Besides being administered as a single drug, it is also available as a pill combined with metformin. Merk & Co is the first company to develop the drug and sell it after its FDA-approval in 2006. With over 9 million prescriptions, Januvia ranked at number 82 in the 2016 list for the most prescribed medication in the US.
Branded as “Tradjenta,” Linagliptin is a medication used in the treatment of Type 2 Diabetes Mellitus. The FDA approved the drug for medical use in the US back in 2011. Findings of a 2010-Phase 3 clinical trial of Linagliptin suggested that the medication is effective in reducing blood sugar levels.
Negative Side Effects of DPP-IV Inhibitors
Patients taking sulphonylureas together with DPP-IV inhibitors are at a high risk of experiencing low blood sugar levels. The adverse effects of taking DPP-IV inhibitors include skin reactions, hypersensitivity, heart failure, nasopharyngitis, nausea, and headache. The FDA added warnings to the labels of alogliptin and Saxagliptin following a 2014-review that revealed heart failure as one of the adverse effects of the drugs.
The FDA continues to warn consumers against taking medicines such as alogliptin, linagliptin, Saxagliptin, and sitagliptin since they are likely to cause severe joint pain. Labels warning consumers against DPP-IV inhibitors are increasingly being added on drugs belonging to this class. A 2018-study even suggested that patients using DPP-IV inhibitors are at a 58 percent risk of experiencing acute pancreatitis. In the same year, a separate observational study revealed an increased risk of patients developing ulcerative colitis, which is an inflammatory bowel disease.
Bullous pemphigoid is a rare autoimmune skin condition characterized by large, fluid-filled blisters. The blisters tend to develop on the armpits, upper thighs, and lower abdomen. As a condition that is common in older adults, Bullous pemphigoid develops once your immune system starts attacking the thin tissue layer below your outer skin layer. While the reasons for this immune response are unknown, trigger factors include taking various medications.
The disorder can be life-threatening for older people with terminal illnesses. Treatment, which may include drugs such as prednisone, help suppress the immune system, ease the itching, and heal the blisters. You should see a doctor when you notice blisters on your eyes and unexplained reddish/dark blisters on your skin.
Does the Use of DPP-IV Inhibitor Increase the Risk of Developing Bullous Pemphigoid (BP)?
A recent population-based study suggests that DPP-IV inhibitors put patients at risk of developing BP. The study relied on Korean insurance claims data dating from 1st January 2012 to 31st December 2016. It included 670 patients newly diagnosed with both diabetes and BP and 670 patients with only diabetes. The number of patients suffering from BP and diabetes increased more than twice from 77 (in 2012) to 206 in 2012.
The proportion of individuals with diabetes among those with BP increased from 0.18 (in 2012) to 0.33 (in 2016). The study found out that patients with diabetes were at a higher risk of developing bullous pemphigoid. Based on the findings, the highest adjusted odds ratio (AOR) of developing BP was linked to the consumption of Vildagliptin. Further subgroup analyses showed that male patients were at a higher risk of suffering from the disorder than their female counterparts. These population-based results conducted in Korea served as a basis for offering insights on how DPP-IV inhibitors lead to the development of bullous pemphigoid.
Mass Torts Against Manufacturers of DPP-IV Inhibitors
Anti-diabetic drugs such as Victoza, Januvia/Janumet, Byetta, and Onglyza have attracted over a thousand lawsuits across the country. Numerous reports indicate that people taking these medications to treat Type 2 Diabetes Mellitus suffer adverse effects such as joint pain and BP. Details regarding these lawsuits are discussed below:
Amylin Pharmaceuticals, LLC was among the defendants in a product liability lawsuit for damages caused by the use of Byetta/Bydureon. In the lawsuit, the plaintiffs allege that they suffered injuries such as kidney cancer, thyroid cancer, pancreatic cancer, and pancreatitis from the use of the drug. The Southern District of California court heard alleged pancreatic cancer cases.
The District Court granted a summary judgment motion to the defendants on November 2015. In the same month, the court also dismissed claims alleging that pancreatic cancer was among the injuries caused by the use of Byetta/Bydureon. The plaintiffs appealed to the Ninth Circuit U.S Court of Appeals following this ruling. The appeal court remanded further discovery into the case after vacating the District Court's ruling. An appeal of the same motion, granted in May 2016 to the defendants, remains pending.
Approximately 282 plaintiffs filed a product liability lawsuit against Novo Nordisk for the adverse effects caused by the use of Victoza. In the suit filed in California state and federal courts, the plaintiffs claimed damages for suffering pancreatic cancer. Cases pending in California state and federal courts were dismissed in November 2015 on the grounds of federal preemption.
The U.S Court of Appeals for the 9th Circuit reversed and vacated the District Court's ruling in November 2017 after the plaintiffs appealed it. Following this appeal, the case was sent back to the California Federal District Court for further hearings. The California State Appeals Court is currently examining the preemption ruling made by the district court judge.
Merck, the manufacturer of Januvia/Janumet, was involved in a product liability lawsuit brought by about 1,260 product users. The product user claims allege that they developed pancreatic cancer among other injuries from the use of Janumet and/or Januvia. The users filed the complaints in several different state and federal courts. Most of the claims formed part of "In re Incretin-Based Therapies Products Liability Litigation," which was filed in the Southern District of California Court.
The plaintiffs appealed the lawsuit and the preemption rulings made by the California State Court. The U.S Court of Appeals for the 9th Circuit reversed the ruling of the trial court. In the ruling, the Ninth Court suggested that the district court made multiple errors during the discovery stage of the trial. Though consumers continue to file claims against Merck, the company has pledged to defend against these civil actions.
Besides being an FDA-approved drug, Onglyza is allegedly known to cause heart failure. Some of the patients who suffered adverse side effects from taking the drug filed a lawsuit against the drug manufacturers. Defendants involved in the lawsuit include McKesson Corporation, Bristol-Myers Squibb Company, and AstraZeneca Pharmaceuticals. The pretrial proceedings for the case began in February 2018 in the Eastern District of Kentucky Court with about 80 Kombiglyze and Onglyza lawsuits.
Judge Karen K. Caldwell split the Onglyza heart failure cases into two phases for discovery purposes. The first one focused on the general causation, while the second one focused on whether the plaintiffs could establish that the drug causes heart failure. The proposed trials are expected to begin in October 2020.
How Mass Torts are Conducted
A mass tort is a type of civil action pursued by several plaintiffs against one or several defendants. The lawsuits, which can be filed in a federal or state court, usually arise out of injuries caused by defendants. Most mass torts are pursued to seek damages caused by a defective product, a medical device, a prescription drug, a construction disaster, or a train/car/plane crash.
Unlike other personal injury lawsuits, mass torts have about three unique characteristics defining them. First, they focus on the participation of large groups of people affected by a device or product. Second, the underlying issues and facts in dispute are the same regardless of a large number of victims involved. Third, the various claims in the lawsuits are interdependent in terms of value.
While products are designed to offer consumers numerous benefits, manufacturers may ignore accuracy matters and produce products that are compromised in terms of safety. Defective products are not safe for use since they can cause adverse effects and death. Thousands of individuals have suffered injuries, and many more have lost their lives after using these products. It is sad to note that most products that undergo insufficient lab testing are deceptively marketed to consumers.
Mass Torts: The Process
When an individual sustains injuries or dies because of taking/using dangerous/defective products, the recourse is to file a product liability claim against the manufacturer. The lawsuit will automatically qualify as a mass tort when several individuals have suffered the same injuries from using/taking the product. Product liability is a complex field of law that ensures that manufacturers are held accountable for releasing defective/dangerous products to the public.
A mass tort usually involves several plaintiffs filing a product liability lawsuit against one or several companies. The goal of the lawsuit is to help the victims get compensated for the damages and injuries caused by the dangerous/defective product. As a plaintiff, you can claim pain and suffering, lost wages, and diminished quality of life. You can also seek compensation for loss of companionship, the death of your loved one, hospitalization costs, and ongoing treatment.
The type of product liability claims pursued in a mass tort largely depends on the facts of the case. In every claim, the injured individuals or the surviving family members should show that they suffered an injury or a loss while using the product as intended. They should also show that the product was defective, and the loss/injury was a direct consequence of using the product. The types of claims a plaintiff can pursue are as follows:
With this claim, you will be alleging that there was an error or negligence when the product was being manufactured. Your claim will show that the problem arose at the factory level. Manufacturing problems arising at the factory level may result in a product or a product bundle being made different or being contaminated.
Failure to Warn
A "failure to warn" claim is focused on holding the manufacturer accountable for knowing the adverse effects caused by a product. The manufacturer must give adequate warning/instructions about the proper use of the product and the potential problems. You can file this claim if the notice of potential danger is not indicated on the product's label.
Defective Device Design
You can file this type of claim if the design of a particular product makes it inherently dangerous or defective. There is a higher possibility of the entire product line being defective or dangerous if one of the products is affected. For instance, if a drug is designed for patients with high blood pressure, the patients may file this claim if it fails to work as expected.
Ways You Can Join a Mass Tort
Mass torts offer a new and increasingly developing area of litigation stemming from modern advances in technology, production, and distribution. When multiple parties suffer injuries from a single product, their situation is referred to as a mass tort. The goal of this civil action is to enable the victims to have their collective injury claims heard and effectively tried. Mass tort litigation may encompass large antitrust claims pursued against businesses, product liability claims, and artificial disasters such as car/plane crashes and plant explosions.
While it involves many different factors, mass tort features various elements for multiple victims to be included. The basis of this lawsuit is established when a defective product puts the lives of numerous individuals in danger. These individuals come together and agree to pursue a mass tort against a particular company to recover losses/damages. Each person can contribute to the entire case and increase the number of potential damages by involving a lawyer.
The affected individuals can file the suit against a hospital, healthcare facility, or a pharmaceutical company if the claim involves injuries suffered from defective medical devices/products. Dissimilar claims may arise if there are different types of injuries suffered by the victims. The mass tort will begin with a team of lawyers communicating the fact of the case with the individual or organization that should be part of the lawsuit. Witness statements and other pieces of evidence will be presented in the courtroom, just like other trials.
Joining a Mass Tort
You can start by contacting an attorney or attorneys working with the mass tort when you want to join a mass tort. Once the lawyer receives your request, you should wait until you are summoned for an interview. The details of your injury from the dangerous/defective product should be relevant to the lawsuit. You will have to sue the person/company responsible separately if your circumstances or injuries do not correlate with the case.
Once you are listed as one of the plaintiffs in the mass tort, be cooperative when asked to present pieces of evidence proving your injuries or damages. The lawsuit will also be backed by experts and other professionals who provide witness testimonies. If the case involves physical harm, the pieces of evidence must suggest the defects in the design or materials used in the product.
Lawyers involved in mass torts tend to investigate the case thoroughly before it proceeds to court. The investigation may involve interviewing each victim and witness to confirm the facts of the case. Identifying the responsible party in the lawsuit helps ensure that the suit is directed to the person/company whose product caused harm to others.
Mass Tort Trial Lawyers
The line-up of mass tort trial lawyers usually comprises of a team of legal experts working with a shared goal. The attorneys serve families and individuals looking for legal help on mass tort claims. They possess superior leadership, influence, performance, and reputation qualities in their specialty area. The lawyers network with other legal experts/law firms and explore legal education opportunities to further their skills in their line of work.
Since they require a huge amount of financial resources to pursue, mass torts are not for every tort or a personal injury lawyer. The financial resources are geared towards travel expenses, copying costs, discovery costs, and technology expenses. Lawyers participating in the lawsuits must shoulder these expenses unless a contractual arrangement made with the plaintiffs advises them not to do so. Besides finances, the cases require a large support staff comprising of junior associates, paralegals, and legal assistants to handle the work involved.
Join a Mass Tort Near Me
Have you experienced any injuries from taking DPP-IV Inhibitors Bullous Pemphigoid? Consumer Alert Now is a nationwide watchdog team against dangerous drugs and defective medical devices working with legal and medical experts. We help consumers seek insights on the side effects of prescription drugs and medical device complications. Call us now at 800-511-0747 to join us in our nationwide fight against deceptive pharmaceutical companies.