Hepatitis C Lawsuit

Manufacturers of certain direct-acting antiviral (DAA) medications used to treat Hep C virus (HCV) infections are facing Hepatitis C lawsuits after the FDA warned that these medications may increase the risk of reactivation and recurrence of the Hepatitis B virus (HBV). Companies are being accused of not testing the DAAs effectively since they did not use individuals with HBV during the clinical trials. Additionally, many companies were assumed to know about the dangers of these DAAs but failed to inform patients and doctors beforehand.

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Why Have People Filed Hepatitis C Lawsuits?

Several hepatitis C lawsuits were filed soon after the FDA issued a black box warning, its most serious warning, for 9 direct-acting antiviral (DAA) medications in October 2016. Patients who have taken DAA medications and seen a reemergence of their hepatitis B, experienced liver damage, or suffered liver failure, may be eligible to file a lawsuit against the drug manufacturers. According to the FDA, this reemergence usually occurs within 4-8 weeks of receiving DAA treatment drugs. During clinical trials, this potentially deadly side effect was not discovered because researchers only recruited patients with hepatitis C and no co-infections.

What Are the Plaintiffs’ Claims?

Plaintiffs claim that the reactivation of hepatitis B (HBV) comes from the drugs they use to treat their hepatitis C. These drugs are made to help treat the effects and syndromes that come with chronic hepatitis C. This link was not shown during testing because individuals with HBV were not included in the clinical trials. 

What Drugs Are Associated with Hepatitis C Lawsuits?

As of 2023, the following DAA medications were a part of the black box warning: 

  • Daklinza
  • Epclusa
  • Harvoni
  • Olysio
  • Sovaldi
  • Technivie
  • Viekira Pak
  • Viekira Pak XR
  • Zepatier

The FDA advises that individuals who have hepatitis C and are considering DAA drug treatment should contact their doctor if they also have a history of HBV. Doctors should also screen patients for HBV before starting them on hepatitis C drug treatment. They should also monitor their HBV patients closely for signs of liver failure, liver damage, or any other adverse reactions. 

What Hepatitis C Lawsuit Settlements Were There?

There have been many lawsuits associated with hepatitis C. There have been lawsuits about insurance coverage for hepatitis C drugs as well as lawsuits with prisoners not being properly tested and treated for hepatitis C while in prison. The settlement, in excess of $2.5 million, secures comprehensive testing of inmates and treatment for those suffering from the deadly, but curable virus.

The FDA was sued by public health groups, The Global Health Justice Partnership at Yale University and Treatment Action Group, for the release of clinical trials on Sovaldi. Both groups filed the suit on June 25, 2015, in a federal district court in Connecticut to enforce their Freedom of Information request and seek prompt disclosure of the clinical trial data, the release said. There has been no recorded update since 2015.

As a result of the companies’ failure to provide adequate warnings regarding the risk of liver damage from Viekira Pak, it was estimated that many users would receive compensation for their suffering. However, the litigation remained in the early stages and there has been little to no record of settlements or compensation provided to victims. 

What Hepatitis Lawsuit Settlements Have There Been?

There have been a multitude of settlements involving the virus hepatitis C, but as of 2023, there are no known lawsuit settlements associated with the link of DAAs to hepatitis B. 

Are There Active Hepatitis C Lawsuits?

There are no recorded lawsuits as of 2023 associated with DAAs and the link to hepatitis B.

What Is Chronic Hepatitis C?

Chronic hepatitis C is a contagious liver disease that affects nearly 4 million Americans in the United States. Of every 100 people infected with the hepatitis C virus, 70% will develop chronic liver disease, 20% will develop cirrhosis, and up to 10% will die. In 2014, however, all of that changed with the emergence of direct-acting antiviral (DAA) drugs.

How Does Hepatitis C Occur?

People can become infected with the Hepatitis C virus due to sharing infected needles, or needle sticks in the healthcare setting, or being born to a mother with Hepatitis C. Before 1992, it was most commonly contracted through blood transfusions and organ transplants. 

How Is Hepatitis C Treated?

Before 2014, chronic hepatitis C patients could take medications to manage their condition. These medications would not cure the disease, but they would reduce the amount of the virus in the patient’s body, thereby reducing the complications. 

DAA drugs, however, can effectively wipe out the hepatitis C virus – providing a true cure. In fact, it is estimated that DAA drugs have a 90% cure rate and newer treatment drugs can even treat less common strains in a shorter amount of time.

What Is the Difference Between Hepatitis B and Hepatitis C?

Both hepatitis B and C are attacks on the liver, weakening the immune system. The difference between them is that hepatitis C is more deadly, leading to more chronic cases. Acute cases of hepatitis B can fade away after 6 months whereas people who contract hepatitis C are more likely to develop into chronic hepatitis.

What Are the Symptoms of Hepatitis B and C?

Most people who contract hepatitis B don’t exhibit any symptoms for a while. However, when they do show up, they’re similar to the symptoms exhibited by patients with hepatitis C.

These symptoms may include: 

  • Fever
  • Fatigue
  • Loss of appetite
  • Nausea
  • Vomiting
  • Dark urine
  • Pale feces
  • Joint pain
  • Jaundice

What Are DAAs?

DAA stands for direct-acting antiviral agents. These DAAs were created and approved by the FDA to help treat the effects of hepatitis C. DAAs are expensive, leaving these drugs being exclusively used by those who can afford them. This is similar to other HCV treatments where treatment becomes limited to those who can afford to pay the price.

What Are the Side Effects of DAAs?

Side effects of DAAs can include: 

  • Anemia 
  • Diarrhea 
  • Fatigue
  • Headaches
  • Nausea
  • Vomiting
  • Slow heart rate
  • Raised liver markers indicative of liver problems

What Side Effects Should DAA Users Be Wary of?

The main side effects DAA users should look out for are any symptoms that may show the reactivation of HBV. Patients who have signs of liver damage or liver failure should notify their physician immediately.

Some of those signs include: 

  • Jaundice
  • Yellow eyes and skin
  • Nausea
  • Vomiting
  • Fatigue
  • Loss of appetite
  • Light colored stool

What Are the FDA’s Warnings About DAAs?

On Tuesday, October 4, 2016, the FDA announced that it would require manufacturers of certain DAA drugs to place a black box warning on the label warning. This warning states that these drugs could reactivate the dormant hepatitis B virus (HBV) in people who were infected with both. Of the 24 cases that were previously reported to the FDA, two patients required liver transplants and one patient died as a result.

Healthcare professionals should screen all patients for evidence of current or prior infection before prescribing DAAs and monitor them as they take them. Patients should inform healthcare professionals of their medical history associated with hepatitis B or liver problems and always consult with their doctor. 

Are DAAs Still on the Market?

Despite the link, the FDA only advises caution and has not required the medications to be taken off the market. The black box warning on the medications and the urged caution are the preventative measures the FDA has taken. Additionally, they have not recommended patients stop using DAAs, as DAAs are the only effective treatment of hepatitis C.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.