Complera is a drug commonly used for the treatment of HIV-1 in adults with no prior antiviral therapies. The drug offers a comprehensive treatment of HIV. Therefore, you should not take the medication alongside other medications. As much as Complera is effective in treating HIV, it has numerous side effects. If you experience adverse side effects after consuming Complera, you may join other consumers in a mass tort who may have experienced the adverse effects. Consumer Alert Now can guide you on how to join other plaintiffs in filing a mass tort, contact us if you have suffered complications using this drug.

Overview of Complera

Complera is a combination of three main components. Each tablet of the drug contains a portion of tenofovir disoproxil fumarate, emtricitabine, and rilpivirine. The right dose of Complera is one tablet daily. You should only take the drug with a meal. Complera needs fat in the meal for better absorption. The drug helps control an HIV infection as it suppresses HIV in the body enabling your immune system to work better. Complera helps improve the quality of your life by curbing the adverse effects of HIV. It is important to note that Complera is not a cure for HIV but only controls the disease.

Complera is an effective antiretroviral therapy (ART). It can increase your CD4+ cell counts and can also decrease the viral load in your blood (amount of HIV in your blood). The drug may thus prevent you from developing other life-threatening conditions commonly associated with HIV.

If you are on antiretroviral therapy and your viral load is low, you are less likely to transmit HIV to other people. Studies reveal that people who are on ART and have undetectable viral load are not expected to carry HIV to their sexual partners.

Side Effects of Complera

As much as Complera is effective in controlling HIV, it has some negative side effects. Different users of Complera may experience varying side effects depending on how their bodies react to the compounds contained in the drug. Some mild effects may include changes in body shape. People using Complera often experience excessive weight gain, especially in the first few years after commencing the drug use. Some of the adverse side effects of Complera include the following.

Psychological/ Mental Effects

Drugs that contain rilpivirine, including Complera, may lead to depressive illnesses. Studies reveal that around 5% of patients who use Complera experience some mental illnesses. The symptoms experienced may be mild and, in some cases, life-threatening. Many people continue taking the drug despite the negative mental effects. Only about 1% of Complera users stop using the drug due to mental effects.

 

While using Complera, you may experience some problems with your thoughts and feelings. You can become irritable and experience feelings of discouragement and hopelessness. It is also common to experience unexpected feelings of sadness, anger, and depression. Complera users may also lose the pleasure of taking part in the day to day activities. It is also common to have thoughts of self-harm or thoughts of inflicting harm on other people. Other effects of Complera on your mental health include experiencing suicidal thoughts, lack of energy, difficulty falling asleep, and constant strange thoughts.

Abnormal Heart Rhythms

A study conducted on Complera users revealed that users were likely to experience abnormal heart rhythms. This side effect is mainly due to the rilpivirine contained in the drug. People who have cardiovascular heart problems such as poor circulation of blood to the heart and heart failure should be cautious while using Complera.

What are the symptoms of abnormal heart rhythms? How can you tell that you are experiencing an abnormal heart rhythm?  If you have a feeling that your heart is pumping fast even while you are resting (heart palpitations). Other symptoms of abnormal heart rhythms may include fainting, dizziness, and seizures. 

Swollen Pancreas Glands

Tenofovir, which is a compound found in the Complera drug, may cause painful swollen pancreas glands. A study conducted on people taking Complera revealed that they had abnormally high levels of the enzyme amylase in their blood. Amylase is an enzyme produced by the pancreas. The very high levels of amylase in the blood are commonly an indication of inflammation in the pancreas.

Some of the symptoms of an inflamed pancreas include excessive sweating, nausea, vomiting, and fever. You are also likely to experience unexplained abdominal pain, especially when lying down.

Higher-than-normal levels of Lactic Acid in the Blood

Upon using Complera, you may experience a condition known as lactic acidosis. This condition is characterized by very high levels of lactic acid in your blood. People who are overweight, especially overweight women, are at a higher risk of experiencing this condition. High levels of lactic acid in the blood may be exposed to some other medical conditions, including a swollen liver due to fatty deposits.

If you are suffering from lactic acidosis, you may experience some persistent signs that may include vomiting, feeling light-headed, or dizzy. You may also experience cold on the legs and arms, or experience unexpected fatigue. Some of the additional symptoms of lactic acidosis include diarrhea, abdominal pain, muscle pain, and nausea.

Thinning Bones

Due to the compound tenofovir DF contained in Complera, many HIV patients using the drug commonly experience thinning bones. A study conducted on some patients using Complera revealed thinning bones in the spine area. Patients who portrayed this side effect also complained of pain in the bones.

However, it is essential to note that the people who have HIV may have thinner than healthy bones even if they are not using tenofovir DF. For most patients, bone density decreases when they commence antiretroviral therapy. Their bone density often stabilizes one or two years into the ART. 

Kidney Dysfunction

Complera contains the compound tenofovir DF that has to be broken down by the kidney once consumed. Some people using tenofovir DF have reported instances of kidney dysfunction. While assessing your kidney health while using Complera, it is advisable to undergo regular urine and blood tests.

Cases of Fanconi syndrome (renal tubular injury with severe hypophosphatemia) and acute renal failure may result from the continued use of tenofovir DF.

Skin and Hypersensitivity Reactions

For drugs containing rilpivirine, including Complera, it is common for users to experience severe skin and hypersensitivity reactions. Other symptoms, like fever, may accompany skin reactions. In some instances, patients may report organ failure alongside skin irritations. Most patients experience grade one or grade two rashes in the first four to six weeks after starting the Complera therapy.

What are some of the symptoms of skin hypersensitivity that you should look out for? It is advisable to discontinue using the drug if you notice a severe rash on your skin. Commonly, other symptoms may accompany the rash, including facial edema, conjunctivitis, angioedema, or mucosal involvement.

When to Avoid Complera

The side effects of Complera may be detrimental to some classes of people. For instance, if you are pregnant, it is advisable to avoid using the drug. You should only use Complera if the benefits exceed the negative impacts the drug may have on the unborn child.

For older individuals who are above the age of 65 years, it is important to be careful while using Complera due to the associated side effects.

People suffering from Hepatitis B or C or people with liver health problems should be careful while using Complera. People suffering from severe liver injury should not use Complera at all. On the other hand, people suffering from mild liver injury may use Complera but with great caution. HIV patients co-infected with Hepatitis B or C recorded increased levels of liver enzymes in the blood. The enzymes levels were much higher than in patients not infected with Hepatitis.  The high levels of enzymes may be an indication of liver dysfunction or liver inflammation. 

Measures to Observe While Using Complera

Complera is not a cure for HIV but helps reduce the effects of HIV. Due to the severe side effects of Complera, it is advisable to remain under the supervision of a health practitioner while you are using Complera.

As much as studies indicate that people on ART are less likely to spread HIV, it is advisable to continue using protection while practicing sex even if you are using Complera. This will help minimize contact with body fluids such as blood, vaginal secretions, or semen.

Breastfeeding mothers should not take Complera and breastfeed at the same time. Breastfeeding may expose the baby to risks as some components of Complera may be passed to the baby, and this could be risky.

Complera should be taken with food. It is important for patients to realize that protein drinks are not a substitute for food.

It is important to be aware of the side effects of Complera that you should look out for a while using the drug.

What Should You Do In The Case of Negative Side Effects of Complera?

If you suffer adverse side effects after using Complera, you can sue the manufacturer. For instance, you may join a mass tort and join other consumers who may have suffered similar adverse side effects and together sue the drug's manufacturer. 

What is a Mass Tort?

A mass tort is litigation, which is often launched if products such as prescription drugs or defective medical equipment cause harm to a large number of consumers. It is a civil action that involves many plaintiffs suing one or several corporate entities for defective products. Consumers file a mass tort if they have suffered similar injuries after using the same products or a class of products by a common manufacturer. 

In a mass tort, a single judge handles a case involving similar products and injuries. This results in well-coordinated pretrial proceedings. This helps to prevent inconsistent rulings from different judges when handling similar effects of a defective product. Mass torts also help to prevent duplicative discovery into common issues.

Mass Torts Against Complera's Manufacturer

Consumers have filed numerous lawsuits against Gilead Sciences, Inc., the manufacturer of Complera for the adverse effects of the drug. Almost 20,000 people with HIV experience develop kidney disease after using TDF-based antiretroviral drugs. Studies indicate that most of the consumers of the drugs also develop bone problems. Nearly 6,000 yearly bone breaks in the United States are often associated with the consumption of TDF-based antiretroviral drugs.

Most lawsuits against Gilead Sciences, Inc. is based on the fact that the company failed to disclose the adverse side effects of the drug in the warning label. In order to bolster its profits, it was evident that Gilead Sciences, Inc. has come up with a safer version of Complera but withheld it from consumers.

It is the responsibility of every drug manufacturer to warn doctors and patients about the adverse effects and common side effects of the drugs they manufacture. Patients can use this information when making tough decisions about medical products to use. Doctors can also use the warning from manufacturers when making professional prescriptions and recommendations. However, most drug companies fail to disclose the side effects of the drugs they manufacture as they fear to deter patients from using the products. 

When filing lawsuits against Gilead Sciences, Inc., consumers claim that Gilead Sciences, Inc. was aware of the adverse effects of Complera. It is out of this knowledge that Gilead Sciences, Inc. developed a safer version of the drug. However, the company withheld it from consumers and continued distributing Complera.

The safer version of the drug developed by Gilead Sciences, Inc. was more reliable and did not have adverse effects on the renal unit and the bones. Most of the drug was absorbed into the body. The plaintiffs claimed that it was when Complera was about to lose protection from generic alternatives that Gilead Sciences, Inc. revealed its safer drug. The company went on to advise patients who were on TDF-based Complera HIV drugs to immediately stop using the drug and instead use the safer version. 

Establishing a Mass Tort

In establishing a mass tort, the plaintiffs' attorneys file a petition in court or motion the court to bring together similar lawsuits. When determining whether to combine several lawsuits into one mass tort, the court may consider some factors. The court determines whether the litigation has the potential to involve a large number of plaintiffs. The court also examines the lawsuits by various plaintiffs and determine if the damages suffered by the plaintiffs have a similar cause. Upon the creation of a mass tort, the court transfers all pending eligible claims to the established mass tort.

Additional Lawsuits Against Gilead Sciences, Inc.

In 2018, two men from South California filed a lawsuit against Gilead Sciences, Inc. The lawsuit similar to other mass torts outlined that Gilead Sciences, Inc. was aware of the adverse effects of its HIV drugs from the year 2000. It was then that the company's scientists developed a safer alternative to its HIV medicine tenofovir. The latter drugs did not have severe effects on a patient's kidneys and bones.

However, Gilead Sciences, Inc. discontinued the production of the safer drug and instead continued to earn billions of dollars by supplying HIV medicine tenofovir despite its adverse effects on the consumers.

A spokesperson from Gilead Sciences, Inc. claimed that he would not comment on the issue until the investigations were complete. In the lawsuit, it is evident that many patients had suffered for many years as the company withheld the safer drug.

The AIDS Healthcare Foundation funded the attorneys representing the plaintiffs in the 2018 lawsuit. AIDS Healthcare Foundation, a nonprofit organization headquartered in Los Angeles, filed a parallel case in May 2018 seeking compensation for all Californian victims who consumed the HIV drug from October 26, 2001, to the time of filing the claim. The organization had earlier filed a lawsuit seeking to invalidate the drug's patents.

Are You Eligible to Join a Mass Tort?

You may be eligible to join a mass tort if you have experienced severe side effects after consuming an HIV treatment drug such as Complera. You may enter a mass tort after suffering bone injuries, including bone fractures, osteoporosis, and osteopenia after consuming the drugs.  You may also be eligible to join a mass tort in case, you experience declining kidney function after consuming the drug, and if you develop chronic kidney disease. Other kidney ailments that may prompt you to join a mass tort include tubular dysfunction, acute kidney injury or renal failure, or Fanconi syndrome.

Compensation for Complera Victims

Upon joining a mass tort and filing a lawsuit against a drug manufacturer, victims may receive compensation for several factors. The victims may receive compensation for:

Past, Current, and Future Medical Costs

You may suffer from medical conditions such as renal failure or bone fractures after consuming Complera. You would need constant medical treatment to handle the conditions. Treatment may be costly and recurring. For instance, kidney failure may call for recurring dialysis while damaged bones may call for continuous physiotherapy. In seeking compensation for medical costs, you should not only focus on the current costs but also the past and the future medical costs as well. Although the victims of adverse effects of drugs file a lawsuit as a group, compensation is accorded on an individual basis depending on the type and extent of the injury suffered by each plaintiff.

Lost Income

Professional ramifications also form part of the compensation for mass torts' plaintiffs. People whom consumer Complera may have income-generating activities from which they earn a living. After suffering the adverse side effects of medicines like Complera, patients may not be in a position to continue working and earning an income.  The victims may receive compensation for the time spent away from work while receiving treatment for the adverse effects of Complera drugs. Business people may receive compensation for the lost business opportunities due to the impacts of Complera.  Victims who were not working at the time of suffering injuries but would have joined employment in the future may receive compensation for lost earning capacity.

Pain and Suffering

The adverse side effects of Complera usually consist of extraordinarily deliberating and excruciating medical conditions. Often, victims of Complera drug may receive compensation for the medical torture and suffering they have to endure.  For people who have suffered bone loss and extensive bone fractures, the extent of pain can be detrimental.  The compensation is also meant to comfort victims for having to deal with life-threatening conditions such as kidney failure due to the mistakes of manufacturers. 

Loss of Companionship and Consortium

Other than the victims of Complera, the families and friends of the victims are likely to suffer as well. Due to Gilead's failure to warn patients and doctors of the adverse effects of Complera, the associated family members and friends suffer along with the victims. Therefore, the mass torts may demand compensation for loss of consortium and companionship as well. 

On top of seeking compensatory damages, mass torts may also seek punitive damages. This is aimed at punishing the manufacturer of Complera for covering up the potential risks of using TDF HIV drugs and for withholding the safer version of the drug from consumers.  Most mass tort claims demand punitive damages. If the lawsuits can successfully prove that Gilead withheld safer drugs from users, it can be easy to get paid for punitive damages. 

Any Payouts for Complera Lawsuits Yet?

It is only recently that victims of adverse side effects of HIV drugs began seeking compensation. Therefore, most of the mass tort lawsuits are yet to conclude. The earliest batch of TDF lawsuits against the manufacturer or Complera, Gilead commenced in mid-May 2018.  Due to the complexity of the mass tort claims against Gilead, the trials may take longer to conclude. However, if the consumers' allegations against Gilead are correct, the settlements for victims could be substantial.  The compensation to the victims is likely to be significant, considering the billions of money Gilead has made from selling the drugs. Drugs are said to have been making an average of $18 billion every year from selling Complera and other TDF HIV drugs.

Contact a Mass Tort Expert Near Me

If you or your loved one have developed adverse side effects after using Complera, it may be time to act. At Consumer Alert Now, we are committed to assisting you seek the compensation you deserve. We can assist you to join other victims and together file a mass tort against the manufacturer of Complera. Contact us at 800-511-0747 and speak to one of our experts today.