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Michael Monheit
Michael Monheit
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Parents In California Allege Zofran Caused Heart Defect


On March 5, 2015, parents from San Francisco filed the nation’s third lawsuit in a litigation that involves the anti-nausea drug Zofran and its potential to increase the risk of major congenital defects.

To date, at least six other American families have brought legal claims against GlaxoSmithKline, Zofran’s manufacturer.

San Francisco Family Claims Zofran Caused Child’s Bicuspid Aortic Stenosis

Filed under case number CGC-15-544524 in the Superior Court for the State of California, County of San Francisco, this is the first Zofran birth defect lawsuit to name two parents, both mother and father, as plaintiffs. The two claims previously filed were brought by mothers individually.

According to the complaint, the family’s child was born in 2009, and has been diagnosed with a congenital heart defect known as bicuspid aortic stenosis. Parents claim that prenatal exposure to Zofran, prescribed during the first trimester as an “off label” morning sickness treatment, caused their child’s birth defect.

Bicuspid Aortic Stenosis: A Potentially Life-Threatening Heart Defect

The aortic valve rests between the heart’s left ventricle and the body’s most crucial artery, the aorta. When properly functioning, the aortic valve allows pressurized blood to flow from the heart to the rest of the body, where the fluid can nourish body tissues and organs with oxygen and nutrients.

In healthy human hearts, the aortic valve has three “leaflets,” flaps that open to allow blood into the aorta and close to prevent it from flowing backward into the left ventricle.

In this case, plaintiff’s child was born with only two aortic valve leaflets. This condition, commonly referred to as a bicuspid aortic valve, makes it extremely difficult for the valve to perform its proper function.

Complications Of A Bicuspid Aortic Valve

With only two leaflets, blood can flow backwards through the valve, forcing a strain on the left ventricle which must work harder to pump an adequate amount of blood out to the body. The ventricle can even thicken, losing its strength and normal shape. Eventually, this condition can lead to heart failure or aneurysm.

Over time, calcium deposits can build up on the improperly functioning valve, causing its pathway to narrow and become stiff. This condition, known as stenosis, does not necessarily occur in all patients with a bicuspid aortic valve. But in referring to their child’s birth defect as bicuspid aortic stenosis, plaintiffs imply that his condition has progressed to an advanced stage of degeneration.

They say that their child “will require continued monitoring and future surgeries to repair or replace his damaged valve.”

Plaintiffs Claim GlaxoSmithKline Promoted Drug As Morning Sickness Treatment

As with most congenital heart defects, bicuspid aortic stenosis can only occur during early fetal development. This stage of pregnancy is also the time during which pregnant women are most likely to experience symptoms of nausea and vomiting.

Plaintiff claims that she was prescribed Zofran early in her first trimester, “to alleviate the symptoms of morning sickness.” The complaint notes that Zofran has never been approved for use during pregnancy, and is not an FDA-approved treatment for morning sickness.

But according to plaintiffs’ allegations, Zofran’s manufacturer “launched a marketing scheme to promote Zofran to obstetrics and gynecology […] healthcare practitioners, among others, as a safe treatment alternative for morning sickness in pregnant women” soon after the drug was approved in 1991 for a limited number of indications.

Zofran is only approved to treat severe nausea and vomiting in cancer patients receiving chemo- and radiotherapies, as well as surgical patients who experience nausea and vomiting after undergoing anesthesia.

In 2012, the US Department of Justice made notably similar allegations, claiming that GlaxoSmithKline had unlawfully promoted several drugs to doctors for unapproved use. In its case, the federal government explicitly charged the company for promoting Zofran as a “safe and effective” morning sickness treatment, without having ever conducted a single clinical trial to investigate the drug’s effects in pregnant women or on their unborn children.

As plaintiffs note, GlaxoSmithKline ultimately “agreed to […] pay $3 billion to resolve its criminal and civil liability.” A significant amount of this settlement resolved the federal allegations involving Zofran, although GlaxoSmithKline continues to deny that it promoted the drug as a safe morning sickness treatment.

Plaintiffs Say Glaxo Knew Of Zofran’s “Unreasonable Risk Of Harm”

If GlaxoSmithKline did in fact promote Zofran for use during pregnancy, the company did so without any evidence of the drug’s safety in pregnant women or during fetal development. But plaintiffs make an even more serious allegation. They say that since at least 1992, GlaxoSmithKline has received mounting evidence of Zofran’s potential to cause birth defects. According to their complaint, the company failed to disclose this evidence to the health community or public.

More Than 200 Reports Of Birth Defects Associated With Exposure To Zofran, According To Plaintiffs

The family who filed case CGC-15-544524 claims that GlaxoSmithKline “began receiving reports of birth defects associated with the use of Zofran by pregnant women” more than two decades ago.

At present, they allege that the company has received more than 200 of these reports, and that the most commonly-reported defects are congenital heart defects, like the bicuspid aortic valve with which their son was born.

Plaintiffs say that “GSK has failed […] to disclose these severe adverse events to healthcare providers or expectant mothers.”

Researchers Find Link Between Zofran & Increased Risk For Congenital Heart Defects

Next, plaintiffs turn to the results of epidemiological studies that have found an increased association of congenital heart defects among children exposed to Zofran during early pregnancy.

They cite three studies:

In 2014, a team of Swedish researchers found that women who took Zofran during the first trimester “had a 62% increased risk of having a baby with a cardiovascular defect.” These women were also more than twice as likely to deliver children with a septal cardiac defect than mothers who had not been exposed to Zofran.

In 2013, two teams of Danish medical researchers independently studied hundreds of thousands of birth and prescribing records.

According to plaintiffs’ complaint, the first study’s supplemental materials “indicated that women taking Zofran during the first trimester, compared to women who did not take Zofran, were 22% more likely to have offspring with a septal defect, 41% more likely to have offspring with a ventricular septal defect and greater than four-times more likely to have offspring with atrioventricular septal defect.”

Using Danish birth records that spanned from 1997 to 2010, the second study concluded that women prescribed Zofran’s active ingredient during the first trimester were more likely to have babies with congenital heart defects. Specifically, mothers exposed to Zofran were at anywhere from a two- to four-time greater risk of delivering babies with a septal cardiac defect.

Detailed summaries of these studies, along with ones that have linked Zofran to cleft palate and kidney defects, can be found here.

Plaintiffs Say Glaxo Failed To Warn Public & Health Community

In the face of this mounting evidence of risk, GlaxoSmithKline has remained silent according to plaintiffs.

The parents note that in a drug’s labeling information, pharmaceutical companies are required to “describe serious adverse reactions and potential safety hazards,” as well as include any “limitations in [a drug’s] use” recommended as a result of those hazards. Under federal law, this information must be included, and drug companies are not required to check with the FDA before strengthening or altering a drug’s warning label.

Plaintiffs claim that GlaxoSmithKline has failed to revise Zofran’s warning label with information on its association to an increased risk of birth defects. They say the company did nothing to strengthen labeling information, and made no effort to discourage Zofran’s “off label” use during pregnancy.

Other Parents May Be Eligible To File Zofran Birth Defect Lawsuits

Case number CGC-15-544524 was filed through two law firms. The parents’ attorneys include Ms. Elizabeth Graham, Esq., a plaintiffs’ lawyer with more than 26 years of trial experience and leader of the complex pharmaceutical and device litigation practice at Grant & Eisenhofer, P.A.

Ms. Graham has now joined with Monheit Law to investigate similar claims and represent families and birth defect survivors who believe they have been damaged by GlaxoSmithKline’s alleged actions.

Along with a national alliance of attorneys, Ms. Graham and Monheit Law sponsor an informational website at http://zofran.monheit.com, which serves as a resource center for parents and members of the public who would like to learn more about Zofran and the scientific research that has associated it with increased risks of major birth defects.

Monheit Law is currently offering free consultations to any parent or birth defect survivor who believes they may be eligible to bring a legal claim against GlaxoSmithKline. Interested parties can call 1-877-620-8411 or visit the website linked above to fill out a contact form.

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