ZofranAnti-nausea Medicine Linked to Birth Defects

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Zofran

CASE UPDATE: Federal Judge Denies GSK's Motion to Dismiss Zofran Lawsuit Cases

February 7, 2019 - A federal judge denied GlaxoSmithKline PLC's request to dismiss hundreds of lawsuits filed by women who allege Zofran, an anti-nausea medication, caused birth defects. In his decision, U.S. District Judge F. Dennis Saylor said it was unclear if GSK "compiled with the FDA's letter of regulations and whether GSK had presented expert backing for its argument about the data's authenticity."

Read More Updates

Manufactured by GlaxoSmithKline, Zofran (also known as Ondansetron) was approved for use by the U.S. Food & Drug Administration in 1991 to treat nausea and vomiting associated with cancer chemotherapy, surgery, and radiation therapy. It has also been used off-label to treat morning sickness during pregnancy, even though the Food and Drug Administration (FDA) never approved the use of Zofran for morning sickness during pregnancy.

By 2009, Zofran became the most prescribed morning sickness medication in the United States.

 

Zofran Side Effect Injuries We’re Accepting Cases For

TorHoerman Law is currently accepting cases for a Zofran lawsuit for the following injuries associated with the use of Zofran:

  • Structural heart defects
  • Cleft lip/palate
  • Cranial defects

 

Birth Defects and Zofran

The Center for Disease Control (CDC) knew of these potential birth defects, as a 2011 study completed with grant money from the CDC reported that Zofran doubled the risks of birth defects, but the drug continued to be promoted to pregnant women. Dr. Gideon Koren’s study, published in the American Journal of Obstetrics and Gynecology, points out that about 1 million pregnant women are exposed to Zofran or its generic every year. This off-label use is at the heart of the current controversies and court battles: there is solid, public evidence that Zofran may be the cause of serious and potentially deadly side effects in babies. Side effects for mothers can include swelling, constipation, irregular heartbeat, dizziness, fainting, rashes, hives, and itching.

In 2012, the Center for National Birth Defects Research and Prevention found that the chances of developing a cleft lip and cleft palate increased 2.4 times when a mother took Zofran in the first trimester. Approximately, 9,000 pregnant women participated in the study.

In February 2013, the New England Journal of Medicine published a Danish study which reported that Zofran usage was not associated with increased malformation, i.e. birth defects. That very study was conducted on 608,835 pregnant women in Denmark between the years of 2004 and 2011. However, nearly six months after the initial study by Pasternak, a different analysis of that same data was conducted by another group of researchers who studied a larger pool of pregnant women (897,018 versus the initial 608,835) and a broader time range between 1997-2010. This second study of that same data found statistically significant risks associated with usage. More specifically, the second evaluation of that data showed a doubled risk of heart defects for babies whose mothers used Zofran, with an overall increased risk of defects about 30% among the 897,018 pregnant women studied. The fact that the same data yielded such varying results when conducted by different groups is quite startling.

The second study of that same data, conducted in August 2013, was not the only study demonstrating increased risk with Zofran usage.

Another significant health risk is the development of serotonin syndrome in expectant mothers. The syndrome can result when two or more prescription drugs affect the body’s natural serotonin levels simultaneously.

Serotonin, a neurotransmitter, is a natural chemical produced that allows brain cells and other nervous system cells to communicate with one another. It is a necessary chemical, but too little or too much can cause severe side effects. Too little contributes to depression and too many causes serotonin syndrome, a potentially life-threatening disease.

Zofran, in combination with a specific class of antidepressants known as serotonin reuptake inhibitors (SSRIs), can cause serotonin syndrome to occur. SSRIs are a type of drug that increases serotonin levels to prevent depression. If taken in conjunction with Zofran, a drug that also increases serotonin, the syndrome could occur. Symptoms of serotonin syndrome can include confusion, agitation, headache, changes in behavior, heavy sweating, and in extreme cases, seizures, irregular heartbeat, or unconsciousness. Don’t hesitate to reach out to TorHoerman Law if you have any SSRI lawsuit questions.

 

Zofran Lawsuit

The current Zofran lawsuit alleges that GlaxoSmithKline actively marketed the drug off-label as a safe and effective treatment for a common side effect of normal pregnancy (pregnancy-related nausea and vomiting, or morning sickness). The Zofran lawsuit makes allegations that the company engaged in unethical practices by promoting Zofran to pregnant mothers while failing to undertake a single study on the effects of Zofran on pregnant mothers or their unborn children, arguably because conducting these studies would have delayed the marketing of Zofran and associated profits. In this sense, pregnant mothers and their unborn children were arguably the test subjects for the drug.

Plaintiffs also allege that GlaxoSmithKline was actually aware that Zofran was unsafe for ingestion by pregnant women based on animal studies done in the 1980s, which revealed evidence of toxicity, intrauterine deaths, and malformations in offspring. Plaintiffs also assert that this evidence was supported by reports of birth defects submitted to GlaxoSmithKline in the 1990s and 2000s.

In February 2015, two Zofran lawsuits were filed in federal courts alleging that the use of Zofran during pregnancy increases the risk of birth defects. These lawsuits are aimed at GlaxoSmithKline LLC, the maker of Zofran, and seek compensatory and punitive damages, equitable relief, and other relief deemed just and proper arising from the injuries as a result of prenatal exposure to Zofran.

Currently, the Zofran lawsuit is still on-going.

In 2012, GlaxoSmithKline pled guilty to criminal charges lodged by the United States Department of Justice for its off-label promotion of Zofran for uses never approved by the FDA. GlaxoSmithKline also entered civil settlements and had to pay a $3 billion settlement for the company’s unlawful promotion of several prescription drugs, including Zofran, as well as paying doctors to prescribe the drug. The settlement will compensate plaintiffs who allege that they were encouraged to use these drugs, but it does not compensate them for alleged injuries resulting.

 

Contact TorHoerman Law

TorHoerman is interested in speaking with you regarding any drug you believe may have harmed you or your baby. Contact our personal injury lawyers for a free no-obligation consultation today.


Litigation Updates

Lawsuit Moving Forward

February 2019 - General discovery is moving forward in the MDL.  The judge just denied the defendants' attempts to dismiss the case under a theory of preemption, so the cases will be allowed to proceed towards trial.

 

The Lawsuit is Proceeding with Discovery and Bellwether Trial Cases

August 2018 - General discovery is proceeding. Potential bellwether trial cases will be selected before the end of 2018.

 

Discovery and Bellwether Selection Proceeding

April 2018 - General discovery is proceeding, and the parties are regularly appearing before the MDL judge as disagreements arise. GSK has not made settlement offers in any pending cases at this time.

The defendants have made another push to have recently-filed generic-use cases dismissed. The judge previously dismissed earlier-filed generic-use cases. We are hopeful that a recently-amended master complaint will allow the judge to allow us to proceed in generic-use cases, but the majority of the current law on the subject weighs against us.

The lawsuit, which has reached multidistrict litigation (MDL) status, alleges, amongst other allegations, that the defendant, pharmaceutical manufacturer GlaxoSmithKline (GSK), used targeted marketing to advertise Zofran to pregnant women without warning these women of the adverse health effects associated with the drug. The first Zofran lawsuits were filed in February 2015 on behalf of a mother whose two daughters were born with congenital heart defects. More complaints followed suit in multiple districts.

In October 2015, the judicial panel issued an order centralizing twelve Zofran lawsuits to the U.S. District Court of Massachusetts.

In January 2016, the judge rejected GSK's motion for dismissal of more than 200 pending cases. Since then, more than 500 total actions have been filed.

The discovery phase of litigation began in February 2016. No trial date has been scheduled at this time.

Defense Files to Dismiss Generic-use Cases

2018 - The defense filed a motion to dismiss generic-use cases.

 

Request for Dismissal is Rejected

2016 - A judge rejected GlaxoSmithKline's request for dismissal of the Zofran lawsuit.

 

Individual Filed First Zofran Lawsuit

2015 - A Minnesota mother filed a lawsuit, the first Zofran lawsuit to be filed after her two daughters were born with congenital heart defects.

 

FDA Placed Zofran on Adverse Event Reporting System (FAERS)

2013 - The FDA placed Zofran on the Adverse Event Reporting System (FAERS) over concerns about the link between the drug and serotonin syndrome. FAERS, an FDA database, is a way to monitor drugs that may have significant health risks.

 

Manufacturer Plead Guilty

2012 - GlaxoSmithKline pleads guilty to criminal charges for promoting off-label use of Zofran.

 

Whistleblower Filed Lawsuit

2003 - A whistleblower filed a lawsuit alleging GlaxoSmithKline marketed Zofran for off-label use such as treating morning sickness in pregnant women.

 

FDA Issues Warning Letter to Manufacturer

1999 - The FDA issued GlaxoSmithKline a warning letter for marketing Zofran to consumers in a misleading way, such as marketing the drug for purposes other than what it was approved for.

See More

References

Anderka, Marlene, et al. “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, U.S. National Library of Medicine, Jan. 2012, www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/.

“GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data.” The United States Department of Justice, 2 July 2012, www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report.

Koren, Gideon. "Treating Morning Sickness in the United States—Changes in Prescribing Are Needed." American Journal of Obstetrics & Gynecology, vol. 211, no. 6, Dec. 2014, pp. 602–606., doi:http://dx.doi.org/10.1016/j.ajog.2014.08.017

Pasternak, B, et al. “Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes.” The New England Journal of Medicine., U.S. National Library of Medicine, 28 Feb. 2013, www.ncbi.nlm.nih.gov/pubmed/23445092

“What Is Serotonin Syndrome?” WebMD, WebMD, www.webmd.com/depression/guide/serotonin-syndrome-causes-symptoms-treatments#1.

“Zofran Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” WebMD, www.webmd.com/drugs/2/drug-30/zofran-oral/details.

Last Modified: October 17th, 2019 @ 05:49 pm

What is Zofran?

Zofran is an anti-nausea drug for use after chemotherapy, radiation, or after surgery to prevent nausea and vomiting. The drug has been commonly used as a treatment for morning sickness in pregnant women, but it has not been approved to treat that particular illness. Multiple studies have found a correlation between the drug and birth defects which could lead to a birth defect lawsuit. A Zofran lawsuit has been filed on behalf of the women and children affected by the potentially-deadly side effects of Zofran.