Provigil and Nuvigil Lawsuits

Lawyers are accepting cases involving birth defects in children whose mothers took Provigil (modafinil) or Nuvigil (armodafinil) while pregnant. Cephalon Inc. and Teva Pharmaceutical Industries Ltd. could face lawsuits that claim Provigil or Nuvigil use during pregnancy caused microcephaly, cleft lip or palate, hypospadias, congenital heart defects and deaths from these birth defects.

Provigil and Nuvigil Lawsuit Facts
  1. Injuries Microcephaly, cleft lip or palate, hypospadias, congenital heart defects, death from birth defects
  2. Manufacturers Cephalon Inc. and Teva Pharmaceutical Industries Ltd.
  3. Litigation status Initial stages, no settlements or trials yet

The Food and Drug Administration approved Provigil and Nuvigil to improve wakefulness in adults with excessive sleepiness because of narcolepsy, obstructive sleep apnea or shift work disorder, a condition that affects people who work night shifts or other irregular hours.

On June 7, 2019, Teva Pharmaceuticals Ireland, in agreement with the European Medicines Agency (EMA) and Health Products Regulatory Authority (HPRA), issued a warning to health care providers that modafinil use during pregnancy may cause congenital malformations.

Modafinil and armodafinil are similar drugs and have similar side effects, so lawyers are accepting cases for both drugs.

Birth Defects Caused By Provigil or Nuvigil

According to Teva’s warning, the rate of major congenital malformations with modafinil is approximately 15 percent. In the general population, the rate of defects is 3 percent. That means babies whose mothers take modafinil while pregnant are five times more likely to have a birth defect than babies whose mothers don’t take the drug.

Lawyers are accepting cases of children and young adults exposed to Provigil and Nuvigil in utero and born with birth defects, including, but not limited to: cleft lips or palate, various heart defects, hypospadias, microcephaly and death due to any of these defects. Mothers must have taken at least one dose of Provigil or Nuvigil while pregnant.

These birth defects affect the face, heart, genitals and head. Compensation may include medical expenses from surgeries and treatments, pain and suffering, and lost wages.

Was your child born with birth defects after you used Provigil or Nuvigil during pregnancy? Get a Free Case Review

Cleft Lip or Palate (Orofacial Clefts)

Cleft lips and palates occur when a baby’s body tissue and cells don’t come together properly to form the lips and mouth in utero. This causes an opening in the lip or upper roof of the mouth, or both.

These gaps in the lip and mouth make it difficult for children to eat and talk. The defects can also lead to hearing problems, teeth problems and ear infections, according to the Centers for Disease Control and Prevention.

Children typically need several surgeries to repair these defects. They may also suffer self-esteem problems. People with these defects may require services related to the clefts into adolescence and adulthood to lead healthy lives.

baby with cleft lip
Provigil may cause a cleft lip or palate. Children born with these defects have difficulties eating and talking.

Congenital Heart Defects

Children whose mothers took Provigil or Nuvigil during pregnancy may have congenital heart defects. In general, congenital heart defects are the most common types of birth defects.

Many heart defects affect the way the heart works. They can range from holes in the heart to missing parts of the heart. Additionally, one in four babies born with a heart defect has critical congenital heart disease and needs surgery before turning 1 year old, according to the CDC.

Congenital heart defects that may be mentioned in lawsuits include:
  • Atrial septal defects
  • Atrioventricular septal defects
  • Coarctation of the aorta
  • Double-outlet right ventricle
  • D-transposition of the great arteries
  • Ebstein anomaly
  • Hypoplastic left heart syndrome
  • Interrupted aortic arch
  • Pulmonary atresia
  • Single ventricle
  • Tetralogy of Fallot
  • Total anomalous pulmonary venous return
  • Tricuspid atresia
  • Truncus arteriosus
  • Ventricular septal defects

Some children with these defects don’t have any symptoms. But others may suffer from trouble breathing, tiredness, sleepiness and blue-tinted nails or lips. Treatment often includes surgery.

It is possible for children with congenital heart defects to grow into independent adults, but some children may develop disabilities and require care for the rest of their lives.

Hypospadias: Genital Birth Defects

Some cases of birth defects in children whose mothers took modafinil or armodafinil while pregnant involve genital defects. Hypospadias is a birth defect in boys that occurs when the opening of the urethra doesn’t form correctly and isn’t at the tip of the penis.

The urethral opening can form near the head of the penis (subcoronal), on the shaft of the penis (midshaft) or where the penis and scrotum meet (penoscrotal). This causes problems urinating and problems with sexual function later in life.

According to the CDC, medications a mother takes during pregnancy may be a cause of hypospadias. Treatment is typically surgery.

Microcephaly

Another birth defect lawyers are investigating in Provigil and Nuvigil cases is microcephaly. Microcephaly is a condition that makes a baby’s brain and head smaller than they should be.

Children born with this condition may suffer seizures, learning disabilities, and problems walking, talking, sitting or standing. They may also have problems eating, hearing or seeing.

Microcephaly is a lifelong condition and has no standard cure or treatment. Minor issues with head size may not affect development, but children with severe microcephaly need lifelong care.

microcephaly illustration
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Mothers who take modafinil or armodafinil while pregnant may give birth to a child with an underdeveloped head and brain.

No Pregnancy Warnings in the United States

Shortly after Teva alerted the European Medicines Agency about the suspected risk of birth defects with modafinil, Health Canada released a safety alert for modafinil, known by the brand name Alertec. The agency said the drug is contraindicated in pregnant women or women who may become pregnant.

Despite the fact that Teva used preliminary data from its U.S. Nuvigil and Provigil Pregnancy Registry to flag the birth defect risks, there have been no formal warnings or drug label changes involving the drugs in the United States as of July 2019.

The FDA had placed Provigil and Nuvigil in the pregnancy category C when it approved the drugs. This meant there was a potential for fetal harm in animals, but there weren’t enough human studies to prove the risks because pregnant women were excluded from clinical trials.

Teva Pharmaceutical Industries Ltd. established the pregnancy registry in the United States to gather data on how modafinil and armodafinil affect pregnant women and their babies. According to the registry’s page on ClinicalTrials.gov, manufacturers established the registry in 2009 but won’t have the results until 2027.

Is There a Provigil or Nuvigil Class Action?

So far, there have been no Provigil or Nuvigil class action lawsuits involving birth defect claims. Lawyers are accepting individual injury cases at this time.

But multiple antitrust class action lawsuits have accused the drugs’ manufacturers of paying generic drugmakers to delay generic versions of Provigil. Cephalon, Teva, Mylan NV, Barr Pharmaceuticals Inc. and Ranbaxy Laboratories Ltd. were involved in the lawsuits, Reuters reported.

Teva paid $1.2 billion to settle claims by the Federal Trade Commission, and the company — along with Barr Pharmaceuticals — agreed to pay $35 million to consumers in 48 states and the District of Columbia as part of a settlement with attorneys general from those states.

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

16 Cited Research Articles

  1. Centers for Disease Control and Prevention. (n.d.). Facts about Cleft Lip and Cleft Palate. Retrieved from https://www.cdc.gov/ncbddd/birthdefects/cleftlip.html
  2. Centers for Disease Control and Prevention. (n.d.). Facts about Hypospadias. Retrieved from https://www.cdc.gov/ncbddd/birthdefects/hypospadias.html
  3. Centers for Disease Control and Prevention. (n.d.). Facts about Microcephaly. Retrieved from https://www.cdc.gov/ncbddd/birthdefects/microcephaly.html
  4. Centers for Disease Control and Prevention. (n.d.). What are Congenital Heart Defects? Retrieved from https://www.cdc.gov/ncbddd/heartdefects/facts.html
  5. ClibicalTrials.gov. (2013, February 15). The Nuvigil and Provigil Pregnancy Registry. Retrieved from https://clinicaltrials.gov/ct2/show/study/NCT01792583
  6. DailyMed. (2018, November 7). Nuvigil. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d878aed0-ddbf-8fa1-abf7-d3e480260845
  7. DailyMed. (2018, November 7). Provigil. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e16c26ad-7bc2-d155-3a5d-da83ad6492c8&audience=consumer
  8. Federal Trade Commission. (2015, May 28). FTC Settlement of Cephalon Pay for Delay Case Ensures $1.2 Billion in Ill-Gotten Gains Relinquished; Refunds Will Go To Purchasers Affected By Anticompetitive Tactics. Retrieved from https://www.ftc.gov/news-events/press-releases/2015/05/ftc-settlement-cephalon-pay-delay-case-ensures-12-billion-ill
  9. Health Canada. (2019, June 20). Alertec (modafinil) and the Risk of Congenital Anomalies. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php
  10. New Jersey Division of Consumer Affairs. (n.d.). Settlement Agreement. Retrieved from https://www.njconsumeraffairs.gov/ocp/Legal%20Filings/08042016-Provigil-Settlement-Agreement.pdf
  11. Pierson, B. (2017, February 6). Mylan agreed to pay $96.5 million in Provigil antitrust class action. Retrieved from https://www.reuters.com/article/us-mylan-nl-provigil-settlement-idUSKBN15L22D
  12. Teva Pharmaceuticals Ireland. (2018, June 7). Modafinil: potential risk of congenital malformations when administered during pregnancy. Retrieved from http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---modafinil99170c2697826eee9b55ff00008c97d0.pdf?
  13. Teva Pharmaceuticals. (n.d.). Nuvigil Pregnancy Registry. Retrieved from http://www.nuvigilpregnancyregistry.com/patients.aspx
  14. Teva Pharmaceuticals. (n.d.). Provigil Pregnancy Registry. Retrieved from http://provigilpregnancyregistry.com/patients.aspx
  15. U.S. Food and Drug Administration. (2019, July 26). FDA Adverse Event Reporting System (FAERS) Public Dashboard. Retrieved from https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
  16. United States District Court for the Eastern District of Pennsylvania. (n.d.). If You Paid for Provigil or Generic Versions of Provigil You Could get Money from a State Attorney General Settlement. Retrieved from https://www.albertsonsmarket.com/Media/Albertsonsmarket/PDFs/Provigil-Notice%20021417.pdf
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