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ZofranAnti-nausea Medicine Linked to Birth Defects

Zofran Lawsuit: Anti-nausea Medicine Linked to Birth Defects

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.

Litigation Updates

Discovery and Bellwether Selection Proceeding

April 2018: The parties are proceeding with general discovery and with a bellwether selection process. https://www.torhoermanlaw.com/zofran-lawsuit-update/

Defense Files to Dismiss Generic-use Cases

2018: Defense files motion to dismiss generic-use cases.

Request for Dismissal is Rejected

2016: A judge rejects GlaxoSmithKline's request for dismissal of the Zofran lawsuit.

Individual Files First Zofran Lawsuit

2015: A Minnesota mother files a lawsuit, the first Zofran lawsuit after two daughters are born with congenital heart defects.

FDA Places Zofran on Adverse Event Reporting System (FAERS)

2013: The FDA places 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 Pleads Guilty

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

Whistleblower Files Lawsuit

2003: A whistleblower files 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 issues 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.

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What is Zofran? What Does It Treat?

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 on the risks, 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.

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.

 

 

+ - 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.

“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.

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