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Michael Monheit
Michael Monheit
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Massachusetts Mother Claims Zofran Caused 9 Birth Defects


On February 16, 2015, a woman living in Massachusetts became America’s second parent to allege that anti-nausea drug Zofran caused her child’s severe birth defects. Her personal injury lawsuit, a claim brought against GlaxoSmithKline, Zofran’s manufacturer, was filed in the United States District Court of the District of Massachusetts. It is filed under case number 1:15-cv-10429.

Plaintiff Alleges That Prenatal Exposure To Zofran Caused Congenital Heart Defects, 6 Other Major Abnormalities

After becoming pregnant in 2000, plaintiff claims she was prescribed Zofran as treatment for the nausea and vomiting that commonly accompanies early pregnancy.

She notes that Zofran has never been approved as a treatment for morning sickness. As her complaint details, the drug was developed and approved “to treat only those patients who [are] afflicted with the most severe nausea imaginable – that suffered as a result of chemotherapy or radiation treatments in cancer patients.”

Federal Government Brought Charges Against GlaxoSmithKline For Promoting Zofran “Off Label”

Notwithstanding federal laws that prohibit pharmaceutical manufacturers from promoting their products for unapproved purposes, she says that GlaxoSmithKline “marketed Zofran ‘off label’ as a safe and effective treatment for […] ‘morning sickness.’ ”

In support of this allegation, her complaint references a series of civil and criminal charges filed against the drug company by the federal government in 2012. The US Department of Justice claimed that GlaxoSmithKline had:

  • “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)
  • made and / or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning [the drug’s use for] pregnancy-related nausea
  • offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”

While GlaxoSmithKline continues to deny the government’s claims, plaintiff notes that the company “entered civil settlements with the United States that included more than $1 billion in payments to federal government for its illegal marketing of various drugs, including Zofran specifically.”

Plaintiff Says GlaxoSmithKline Used “Expectant Mothers & Unborn Children As Human Guinea Pigs”

The plaintiff in case 1:15-cv-10429 states that Zofran’s manufacturer has “never once undertaken a single study on the effects of this powerful drug on a pregnant mother or growing child in utero.” This fact has never been disputed. Neither before the drug’s approval, nor after multiple epidemiological studies found an increased incidence of major birth defects among babies exposed to Zofran prenatally, has GlaxoSmithKline conducted controlled studies to investigate the drug’s effects during pregnancy.

In light of the company’s alleged “off label” promotion, plaintiff claims that GlaxoSmithKline’s “conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.” According to the plaintiff, pregnant women, including herself, “had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

Atrial septal defect

Atrial septal defects occur when barriers fail to form completely between chambers of the heart.

Plaintiff’s Child Born With 9 Major Birth Defects

After birth, plaintiff’s child was diagnosed via echocardiogram with three separate congenital heart defects:

  • atrial septal defect
  • right ventricular hypertension
  • aortic arch hypoplasia

You can find details on congenital heart defects that have been linked to Zofran exposure here.

At least three large-scale epidemiological studies have found an increased risk of congenital heart defects associated with Zofran.

Among their findings, these studies have linked Zofran to an increased incidence of cardiac septal defects, a category that includes the atrial septal defect from which plaintiff’s child suffers.

Further diagnoses would find that plaintiff’s child suffers from:

  • facial dysmorphia
  • low set ears
  • hearing loss
  • sensitivity to light
  • inguinal hernia, a condition in which weakened abdominal muscles allow organs and soft tissue to protrude
  • webbed toes

Over twelve years of life, plaintiff’s daughter “has had to undergo ten surgeries” to repair these congenital defects, which “impair her development and enjoyment of a normal life at home and at school due to substantial developmental delays.”

Did GlaxoSmithKline Know That Zofran Presented An “Unreasonable Risk Of Harm” In Pregnant Women?

Plaintiff claims that her daughter’s birth defects were caused by Zofran.

But beyond alleging that GlaxoSmithKline unlawfully promoted the drug for unapproved use during pregnancy, she says that the company actually knew of Zofran’s dangers for fetal development.

Studies In Pregnant Animals: Zofran Passes Placental Barrier, Produces Signs Of Toxicity

Conducted during the 1980s, prior to Zofran’s approval, studies in pregnant rats and rabbits demonstrated that the drug’s active ingredient, ondansetron, is able to cross the placental barrier in mammals. In other words, ondansetron can pass from a pregnant female’s blood to that of her unborn offspring. While animal studies are never assumed to predict results in human patients, mammalian physiology is remarkably similar across species. The medical community accepts as fact that this is how harmful substances are able to affect fetal development.

GlaxoSmithKline submitted the results of these animal studies to the FDA in support of Zofran’s initial application for approval in 1991. According to the plaintiff, the company said that the results “show[ed] no harm to the fetus, but the data also revealed clinical signs of toxicity, premature births, intrauterine fetal deaths, and impairment of ossification (incomplete bone growth).”

Plaintiff does not argue that these study results, allegedly concealed by GlaxoSmithKline from regulatory authorities, are evidence that Zofran can cause fetal harm in humans. As we just mentioned, the results of animal studies are never assumed to imply that similar effects will be experienced by humans. But the company continues to categorize Zofran in Pregnancy Category B, which indicates that “animal reproduction studies have failed to demonstrate a risk to the fetus.” According to plaintiff, this is a gross misrepresentation of the study’s actual results, one that GlaxoSmithKline has used to minimize Zofran’s potential risks in its alleged off label promotion of the drug for morning sickness.

At Least 200 Birth Defect Reports Associated With Zofran To Date

Plaintiff states that as early as 1992, one year after Zofran’s initial approval, GlaxoSmithKline “began receiving reports of birth defects associated with the use of Zofran by pregnant women.” These reports included congenital heart defects, like those with which her daughter was diagnosed, intrauterine death and orofacial anomalies, like cleft lip and palate.

As of her complaint’s filing, plaintiff claims that GlaxoSmithKline has received “more than 200″ such reports. She says that the company “has failed […] to disclose these severe adverse events to healthcare providers or expectant mothers.”

In addition, plaintiff notes that pharmaceutical companies have the ability, under provisions of federal law, to “add or strengthen – without prior approval from the FDA – a contraindication, warning, precaution, or adverse reaction.” Plaintiff claims that receiving hundreds of birth defect reports, as well as being aware of multiple post-marketing studies finding significant associations between birth defects and Zofran, obligated GlaxoSmithKline to inform the medical community and public.

Despite what plaintiff calls “positive evidence of human fetal risk posed by Zofran,” the drug’s warning label has included the same pregnancy-related language since 1993:

“Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits […] and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”

You can read Zofran’s full prescribing information packet here.

Can Other Parents Bring Claims Against GlaxoSmithKline?

Yes. If these allegations are true then any mother who took Zofran during the first trimester for symptoms of nausea and vomiting and delivered a child with major birth defects may be eligible to file a lawsuit against the drug’s manufacturer.

Monheit Law has joined forces with plaintiffs’ attorneys across the nation to investigate similar claims. We are offering free consultations to any parent or birth defect survivor who believes they may have suffered damages due to Zofran exposure. Our experienced attorneys are available 24 / 7 to answer your questions. Call 1-877-620-8411 or click here to complete an online contact form.

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