24/7 | Se habla español Call 516.741.5252

Zofran Lawsuits Unveiled

Zofran Lawsuits

Studies reveal the anti-nausea drug Zofran (ondansetron) increases the risk of birth defects by THIRTY PERCENT when expectant mothers take it during pregnancy. Zofran also doubles the chance infants will gain a heart defect, and risk rates triple for cleft lip and cleft palate defects arising at newborn birth. 

GlaxoSmithKline (GSK) Disregards Warnings to Capture Profits

The FDA rejected Zofran for treating morning sickness.

In the early 80s, pregnant women had no effective medical treatment to manage their morning sickness symptoms. At the same time pharmaceutical company, GSK, was developing a drug to deal with nausea and vomiting in cancer patients undergoing chemotherapy.

The FDA approved GSK’s Ondansetron in 1991, but the Agency explicitly limited its application to treat outpatients enduring specific radiology therapies. A few OB-GYN physicians ignored FDA warnings and prescribed Zofran to prenatal patients suffering from nausea. The medicine relieved symptoms successfully; and as Ondansetron became popular, doctors began calling it the morning sickness drug.

GSK soon detected anti-nausea-and-vomiting medicine missing in antenatal markets, and it also believed clinical trials proving Zofran was prenatal-safe were redundant because the FDA had previously approved Zofran for cancer patients.

These niche factors incited GSK to advertise and lobby their new morning sickness drug vigorously to help expectant mothers. Zofran sales hit their peak in 2002; revenue further jumped to two billion dollars after GSK resolved to sell the medicine for “off-label use,” despite warnings from the FDA, two years prior, not to do so.

GSK’s marketing success was nonetheless short-lived after scientist bombarded the medical community with evidence that proved Ondansetron provokes birth defect risks.

The FDA Reigns In

Government officials took preemptive action, but GSK ignored it.

After Zofran became an off-label medicine, more than a million pregnant women were using the morning sickness drug to treat their symptoms.

The FDA found, during this time, GSK (formerly Glaxo Wellcome) was participating in misleading advertising; Zofran promos had violated FDA regulations because GSK’s marketing efforts didn’t warn consumers about the drug’s prenatal side effects.

In response to the findings, the Agency issued GSK a warning letter in 1999 that ordered GSK to stop using Ondansetron propaganda that lacks risk of harm information

The FDA later established a “Category A” grade for pregnancy medication that promotes fetal safety; the Agency accordingly disallowed Zofran from taking part in this class.

GSK Knew Zofran Passes from Mother to Fetus

Ondansetron remains in fetuses even after the mother’s system dispels it.

GSK discovered in the early 80s that ondansetron transfers through placental barriers in pregnant rats and rabbits, exposing animals’ fetuses to the drug’s active ingredient; still, the company declined to pass on this knowledge to the FDA and consumers.

In 2006, the Chinese University at Hong Kong injected mothers seeking abortions with low Zofran doses right before surgery and encountered considerable volumes of the medicine inside the embryonic cells of over forty aborted fetuses; this was the first proof of placental transference in humans.

Ondansetron concentration in these fetal tissues was significantly higher than doses found in women’s amniotic systems, indicating the drug’s active ingredient was “trapped” inside fetuses just after the medicine crossed placentas.

Scientists later proved the data, in 2015, after publishing research that demonstrated ondansetron crosses rapidly into human placentas and remains active in the womb two times longer than in the mother’s body. The study also claimed five percent of trial patients who ingested Zofran delivered babies with birth defects, compared to the four percent of women who did not.

Still, GSK has recalled Zofran only once (in 2012); and the company has refused to recognize their morning sickness drug causes birth defect risks, despite forty years of data proving otherwise.

Zofran Birth Defect Research

Continuing scientific investigation establishes ondansetron causes birth defects.

Heart Defects

In 2012, Swedish doctors found congenital malformations in over a thousand infant hearts whose mothers took ondansetron from 1998 to 2012. This data drove the doctors to conclude the medicine increases risk of heart defects by over sixty percent. 

Twenty Canadian women who took ondansetron during pregnancy also had babies with diverse heart defects in 2014.

Cleft Palate and Cleft Lip

A 2012 study linked Zofran to increase risk of cleft palate formation. The Slone Epidemiology Center at Boston University gathered statistics from over nine thousand pregnant women and found specific embryologic systems developed malformations due to toxic exposure of ondansetron; the newborns in the study consistently experienced a double risk increase of obtaining cleft palates and cleft lips during the first trimester.

Mental and Cognitive Defects

Serotonin syndrome in infants is a potentially life-threatening defect that arises when chemicals in the brain react with specific drugs. In 2017, the FDA linked Zofran to serotonin syndrome after newborns, whose mothers ingested the morning sickness drug during prenatal care, experienced rapid pulses, muscle rigor, and convulsions at birth and later expressed cognitive and behavioral changes and loss of consciousness after leaving hospitals.

Kidney Defects

In 2013, Australian researchers concluded expectant mothers who take Zofran to treat nausea and vomiting run a six hundred percent chance of their child developing kidney defects compared to pregnant women who don’t take ondansetron.

The FDA Recalls Zofran and Fines GSK

GSK admits it misled doctors and consumers.

Government officials forced GSK to conduct ondansetron cardiac effect research in 2011; third-party scientists later found Zofran doses over 16 mg increased an expectant mother’s risk of contracting potentially fatal heart rhythm disorders.

The Agency then forced GSK to withdraw all 32 mg ondansetron products from markets in 2012. Soon after, the US Justice Department, sued GSK, alleging the company marketed Zofran for unapproved uses and made fraudulent representations that ondansetron was safe for pregnancy-related nausea; the US Attorney further claimed GSK paid illegal kickbacks to healthcare professionals to promote prescribing Zofran to patients.

GSK subsequently pleaded guilty to the fraud that same year and settled to pay three billion dollars in fines to the federal government and to numerous states.

Morning Sickness Lawsuits Explained

GSK knew or should have known Zofran evokes birth defects risk.

GSK never investigated scientific data linking Zofran to birth defects, nor did the company take affirmative action after learning nearly one thousand newborns inherited ondansetron-related birth defects since the FDA approved Zofran in 1991.

Company omissions and inactions prompted victims to file personal injury and products liability lawsuits in both federal and state courts. Cases ranged from individual filings to class actions and consolidated multidistrict litigation (MDL).

Typical pleadings included the following allegations:

  • Breach of Duty: GSK failed in its duty to make sure Zofran was safe before placing it in healthcare markets.
  • Breach of Duty: GSK failed to conduct pretrial ondansetron tests on pregnant women.
  • Failure to Warn: The company hid Zofran’s dangerous adverse effects from the public after learning about them from animal testing in the 80s.
  •  Fraud: GSK executives sold ondansetron as a harmless drug for treating morning sickness without FDA approval.
  • Products Liability: Zofran is an inherently defective morning sickness drug because it causes damage to women and their fetuses when applying the medication to treat nausea and vomiting.

Notable Zofran Litigation

February 2015 — Cheri Flynn files the first Zofran-related lawsuit in federal court for her two children were born with serious heart defects that required corrective surgery.

February 2015 — Tomisha LeClair of Massachusetts sues GSK, claiming ondansetron gave her daughter congenital heart defects and limb deformities.

April 2015 — Ashley Davis claims Zofran left her child with a cleft palate and cleft lip that later contributed to his latest speech and slow cognitive development.

April 2015 — Julie Hunter files a claim, alleging ondansetron gave her son severe chromosomal birth defects.

June 2015 — The Regan family sues GSK after their infant son dies from a heart defect; Mrs. Regan took Zofran during her first trimester of pregnancy.

July 2015 — The Kutzer family sues GSK for paying doctors to prescribe Zofran to Angela Kutzer who gave birth to a boy with urethra birth defects; their son also arrived without kidneys.

July 2015 — GSK petitions the courts for MDL consolidation for hundreds of tort lawsuits filed in over sixteen states. The court granted GSK’s motion.

July 2015 — A heart defect in Jamie Burcher’s son spawns a highly publicized Zofran lawsuit.

September 2015 — The Turnages file a morning sickness lawsuit for their son born with a cleft palate.

December 2015 — GSK motions to dismiss hundreds of MDL Zofran lawsuits for lack of evidence; the following month, the motion is struck down, and the lawsuits were allowed to move forward.

Modernly — Approximately nine hundred MDL actions against GSK are at trial, pending or in discovery.

ATTORNEY ADVERTISING. Past results do not guarantee future outcome.