Zofran Lawsuit

As far back as 1999, GlaxoSmithKline was warned by the FDA for illegal marketing practices regarding Zofran.  The manufacturer was accused of failing to adequately disclose potential risks while aggressively promoting the benefits of Zofran.

In 2012, the Department of Justice announced the settlement of charges against GSK relating to improper marketing of thee medication to physicians for use in pregnant women and for paying kickbacks to physicians for using the medication.  Glaxo was required to pay a total of $3 billion in civil and criminal fines to dismiss these allegations.

Despite the DOJ settlement, GSK has not been absolved of any legal responsibility for damages or injuries caused by Zofran.  Families, mothers and their children who have had birth defects or been injured by Zofran use may be eligible to receive monetary compensation for medical costs, lost wages or pain and suffering.

In addition in some lawsuits regarding medication injuries or birth defects, victims have also received punitive damages (to punish the company for improper practices) which can be much higher than compensation for actual damages.

Lawsuits have already been filed against GSK regarding birth defects and injuries caused by Zofran use and many more are expected.

About Zofran

Zofran, also known by its generic name, odansetron hydrochloride is approved by the Food and Drug Administration to treat or prevent nausea and vomiting caused by chemotherapy and radiation therapy treatment for cancer and for post-operative nausea.

Zofran is manufactured by GlaxoSmithKline, one of the largest global manufacturers in the world with an estimated yearly revenue of $35 billion.  The medication is available in injectable formulations for intravenous use and in oral tablets, disintegrating tablets and oral solution.

Zofran works by blocking one of the Serotonin receptors, specifically the 5HT3 receptors present in the brain and along the vagus nerve which travels along the throat to the stomach.

Zofran is not approved for use during pregnancy, but many women have received the medication as an “off-label” prescriptions.  Doctors may prescribe medication for off—label uses if the benefits of the drug outweigh the risk.  Manufacturers, however are not allowed to market the medication for unapproved uses.

GSK has been accused of improperly marketing Zofran to physicians for use during pregnancy and paying kickbacks to physicians to use the medication and unfortunately, several studies, including one conducted by the Centers for Disease control have linked Zofran to a number of birth defects in women who took the medication while pregnant.

Many women or families of affected children may be filing lawsuits related to birth defects caused by Zofran use and may be eligible for significant compensation for those injuries.

Zofran Birth Defects

Up to 15 percent of pregnant women may experience nausea and vomiting that is severe enough to need medication for treatment.  Zofran is not approved for use during pregnancy but many women have taken the medication, particularly during the first trimester when nausea is more severe and the fetus is most vulnerable to damage caused by medications.

A 2012 report issued by the Centers for Disease Control (CDC) indicated that when used in pregnant women, Zofran may double the risk of cleft palate or cleft lip birth defect.  A 2013 report also indicated that the medication may increase the overall risk of any birth defect by as much as 34 percent and also double the risk of congenital heart defects.

Cleft palate and cleft lip are a result of incomplete formation of the upper portion of the roof of the mouth and front of the upper jaw.  This essentially results in a hole which leaves the sinuses open to the mouth and may create significant difficulties for the infant or child in eating and breathing.  In addition to these difficulties, cleft lip and palate often cause significant facial deformity and may result in social ostracization.  Cleft palate and lip will require surgery or a series of surgeries to reconstruct the bone but many children are still left with disfigurement.

Congenital heart defects such as Atrial Septal Defect (ASD) or Ventral Septal Defect (VSD).  ASD is incomplete closure of the wall between the two upper heart chambers while VSD involves a similar defect in the lower two heart chambers.  In both cases, the infant is born with a “hole in the heart” which must be surgically repaired.  Some children require multiple surgeries to correct the defect and will experience long-term physical and mental disability due to inadequate blood circulation and oxygen supply to the body and brain.

Heart murmur may also result from pregnancy related Zofran use.  Heart murmur can be mild to severe and involves improper heart beat conduction and contraction.  This birth defect is usually not operable and depending upon severity may pose lifetime limitations on the child’s physical and mental development and on future activities as the child matures.

Other birth defects caused by Zofran may include:

  • Skeletal abnormalities
  • Kidney malformation
  • Low fetal birth weight
  • Spontaneous abortion
  • Stillbirth

Children who have been born with birth defects caused by Zofran, or their families, may be eligible for legal damages issued following a lawsuit regarding pregnancy related Zofran use.

Other Zofran Side Effects

Zofran has also been shown to cause heart arrhythmia, known as QT prolongation.  In rare cases, QT prolongation may cause a much more significant cardiac problem known as Torsades de Point, which may be fatal.  Cardiac symptoms caused by Zofran may include weakness, fainting, heart palpitations, swelling or edema.

In 2011, GSK was required to conduct cardiac studies to identify specific heart risks and was subsequently required to recall a high concentration dose after the FDA issued warnings regarding the risks of taking over 16 mg of the medication.

Zofran may also cause less significant side effects such as itching, redness, rash and constipation.

View Sources
  1. Anderka, M., et al, (19 November 2012), Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects, Birth Defects Research Part A: Clinical and Molecular Teratology, Accessed on 12 February 2015 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/
  2. Andersen, JT, et al, Ondansetron use in early pregnancy and the risk of congenital malformations, Department of Pharmacology, Bispebjerg Hospital, Accessed on 12 February 2015 http://clin.au.dk/fileadmin/www.ki.au.dk/forskning/forskningsenheder/gyn__kologisk-obstetrisk_afd__y/logistics/sandbjerg_m__der/sandbjerg_2012_Obstetrisk_Sandbjerg-moede_2012/Sandbjerg_2013/130227_Ondansetron_use_in_early_pregnancy_and_the_risk_of_congenital_malformations.pdf
  3. Barnato, K., (04 February 2015), GSK revenue falls, but firm upbeat on respiratory business, CNBC.com, Accessed on 12 February 2015 http://www.cnbc.com/id/102395839
  4. Centers for Disease Control, (2015), Facts about cleft lip and palate, CDC, Accessed on 12 February 2015 http://www.cdc.gov/ncbddd/birthdefects/CleftLip.html
  5. Department of Justice, (02 July 2012), GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, U.S. Department of Justice, Accessed on 12 February 2015 http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
  6. Food and Drug Administration, (09 March 1999), FDA DDMAC Warning: ondansetron (Zofran), U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166133.pdf
  7. Food and Drug Administration, (29 June 2012), FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran), U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm
  8. Food and Drug Administration, (15 September 2012), FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron), U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
  9. Food and Drug Administration, (04 December 2012), FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products, U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm330049.htm
  10. GSK, (2015), Zofran Injection Prescribing Information, GlaxoSmithKline, Accessed on 12 February 2015 https://www.gsksource.com/gskprm/htdocs/documents/ZOFRAN-INJECTION.PDF
  11. GSK, (2015), Zofran Oral Prescribing Information, GlaxoSmithKline, Accessed on 12 February 2015 https://www.gsksource.com/gskprm/htdocs/documents/ZOFRAN-ORAL.PDF
  12. GSK, (2015), About Us, GlaxoSmithKline, Accessed on 12 February 2015 http://www.gsk.com/en-gb/about-us/McLean, J., et al, (25 June 2014), Birth defects blamed on unapproved morning sickness treatment, thestar.com GTA, Accessed on 12 February 2015 http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
  13. Mayo Clinic, (2015), Types of Congenital Heart Defects, mayoclinic.org, Accessed on 12 February 2015 http://www.mayoclinic.org/diseases-conditions/congenital-heart-defects/multimedia/congenital-heart-defects/sls-20076059
  14. SOGC, (2015), Nausea and Vomiting During Pregnancy, The Society of Obstetricians and Gynaecologists of Canada (SOGC), Accessed on 12 February 2015 http://sogc.org/publications/nausea-and-vomiting-during-pregnancy/