Provigil and Nuvigil Lawsuits
and Other Legal Options
Provigil and Nuvigil, two sleep-disorder medications, are known to cause birth defects when taken during or right before pregnancy. The lack of notice to consumers put many fetuses at risk of injury, which is why many victims consider Provigil and Nuvigil lawsuits.
Who Manufactures Provigil and Nuvigil?
Cephalon is the original manufacturer of Provigil and Nuvigil. Provigil, which is the brand name for the stimulant drug modafinil, first received approval from the United States Food and Drug Administration (FDA) in 1998. The FDA approved Nuvigil, which is the brand name for armodafinil, in 2007.
In 2011, Teva Pharmaceuticals bought the company. Cephalon remains a subsidiary of the parent company.
Mylan is another manufacturer of a modafinil pill medication. In 2019, Mylan and Teva Pharmaceuticals were accused of and sued for price-fixing the market for this sleep-disorder medicine. Numerous states and attorneys general initiated the suit against the companies.
Lack of Notice Given to Consumers About Provigil and Nuvigil Side Effects
Teva Pharmaceuticals issued a statement in 2019 summarizing the dangers of these drugs. The company cited an ongoing Provigil and Nuvigil Pregnancy Registry that found use of modafinil-containing drugs can cause “congenital malformations.”
Nuvigil was marketed the same way and provided the same risks to fetuses for a little more than a decade. Both drugs are particularly harmful to the fetus during the first or second trimester, as most defects occur during this time.
Following the statement from Teva Pharmaceuticals, Health Canada and the European Medicine Agency mandated a label change to Provigil and Nuvigil (brand name Alertec in Canada). Both agencies warned consumers that these sleep-disorder medications could cause birth defects.
In the United States, the FDA requires labels for Provigil and Nuvigil. Both claim there is not enough data to determine a definitive risk of adverse pregnancy outcomes. Both labels cite animal studies showing evidence of “developmental toxicity” for the fetuses.
Despite this warning, many consumers used Provigil and Nuvigil without knowing the side effects. For two decades, Provigil was marketed and available to pregnant women, or soon-to-be-pregnant women.
Fetuses were put at risk of Provigil birth defects such as:
- Cleft lip
- Cleft palate
- Congenital heart defects
- Hypospadias
- Microcephaly
Nuvigil was marketed the same way and provided the same risks to fetuses for a little more than a decade. Both drugs are particularly harmful to the fetus during the first or second trimester, as most defects occur during this time.
Following the statement from Teva Pharmaceuticals, Health Canada and the European Medicine Agency mandated a label change to Provigil and Nuvigil (brand name Alertec in Canada). Both agencies warned consumers that these sleep-disorder medications could cause birth defects.
In the United States, the FDA requires labels for Provigil and Nuvigil. Both claim there is not enough data to determine a definitive risk of adverse pregnancy outcomes. Both labels cite animal studies showing evidence of “developmental toxicity” for the fetuses.
Provigil and Nuvigil Claims for Birth Defects
Provigil and Nuvigil claims are available to victims of birth defects caused by these drugs. The companies responsible did not provide an adequate warning to consumers about the risks to a fetus.
Many people suffering from injuries have sought Provigil and Nuvigil compensation to help pay for multiple post-birth surgeries and treatment to address birth defects. This financial help can come from Provigil and Nuvigil claims, such as Provigil lawsuits and Nuvigil lawsuits.
Provigil and Nuvigil Lawsuits
Provigil lawsuits and Nuvigil lawsuits are available to people affected by either drug. Lawyers are accepting cases where pregnant or soon-to-be-pregnant women took either medication, resulting in birth defects for their child. Since the consumers were not warned before taking these drugs, they were put in danger.
Provigil lawsuits, also called modafinil lawsuits, are legal actions taken due to alleged injuries caused by using this sleep-disorder medication. Many victims have sought Provigil compensation due to the drug causing birth defects.
Nuvigil lawsuits, also called armodafinil lawsuits, are legal claims made due to alleged injuries caused by using Nuvigil. This sleep-disorder medicine can cause birth defects if taken during or right before pregnancy, and victims can seek Nuvigil compensation.
There are two types of Provigil lawsuits and Nuvigil lawsuits: individual claims and class action lawsuits.
What Are Class Action Lawsuits?
A class action lawsuit is a type of lawsuit where the plaintiff is a group of people or entities. In Provigil class action lawsuits and Nuvigil class action lawsuits, the group is usually people who allegedly were affected by these two sleep-disorder medications.