In the most recent Zofran lawsuit to surface, parents living in Texas claim the anti-nausea drug caused their unborn child to develop a “secondary” cleft palate.
The couple’s complaint, filed on July 23, 2015, was registered under case number 5:15-cv-02090-EEF-KLH. While the family now resides in Texas, they have brought their claim against GlaxoSmithKline in the US District Court for the Western District of Louisiana. The mother’s pregnancy, as well as the birth of their daughter E.M. occurred in the state.
In court documents, the mother writes that she was prescribed Zofran, a common “off label” treatment for morning sickness, “on or about November or December of 1997,” during the first trimester of pregnancy. She delivered E.M. on July 28, 1998, and the child was quickly diagnosed with a cleft palate, her parents claim.
Now 17, E.M. was forced to undergo three surgeries before turning 5, and according to her family, needed “years of intensive speech therapy.”
Three Years After Harvard Researchers Find Link Between Zofran & Cleft Palate, Families Continue To Come Forward
In 2012, a team of public health researchers at Harvard and Boston Universities reviewed more than 10,000 birth records. In their study, the academics separated these pregnancies into two groups: women who had been prescribed Zofran as an “off label” morning sickness treatment and women who had not.
Their findings would be the first to demonstrate an association between the drug and major birth defects.
For women who had taken Zofran, their children were 2.37 times more likely to be born with a cleft palate. Due to the study’s large sample size, the researchers were able to ascribe statistical significance to their results.
In the wake of these results, and widespread allegations that GlaxoSmithKline promoted Zofran unlawfully for use during pregnancy, families have begun to file lawsuits. At least 34 legal claims have been brought in US Federal Courts; at a minimum, 3 have named a form of cleft palate or lip.
The newest to come to public attention claims Zofran caused “secondary” cleft palate, a form of the birth defect that may sound unfamiliar.
What Is “Secondary” Cleft Palate?
While the phrase “secondary cleft palate” isn’t often heard in conversation, it’s usually used by medical professionals to describe the condition with which most of us are accustomed.
The palate, or roof of the mouth, can be divided into two parts. One, the primary palate, sits directly behind our front teeth; it’s hard, often craggy and rests far lower than what we usually consider the “palate.”
Behind the primary palate is a high shelf of bone that eventually becomes a soft, flexible membrane before ending right before the throat. As a whole, this structure is called the “secondary palate,” and it’s the organ that is split, or separated, in children born with an isolated cleft palate. The condition is called “isolated” because the lip is not split as well.
In children born with a cleft lip and palate, on the other hand, the cleft affects the primary palate, but generally leaves the secondary palate untouched. This form of the condition is far more common than an isolated cleft palate; estimates from the Centers for Disease Control suggest that 1 out of every 1,509 US babies are born with an isolated cleft palate annually, while 1 out of every 900 babies are born with both a cleft palate and lip.
Families Can Still File Zofran Lawsuits
While long-term prognoses are favorable, cleft palate is difficult, and costly to treat. Many children require multiple surgeries; if her parents claims are true, E.M. has already undergone three, and it’s not uncommon for some affected children to require as many as 10 individual, invasive procedures.
Speech therapists, hearing experts and an entire team of medical practitioners are often employed to ensure children born with cleft palate flourish well into adulthood. Expenses can run high, and since cleft repairs are often categorized as “plastic surgery,” some insurance companies won’t cover these necessary treatments.
But families like E.M.’s, parents who were unaware of Zofran’s potential link to cleft palate and delivered children with the condition, may have another option.
More than 30 families have already filed Zofran birth defect lawsuits, claiming compensation for past and future medical expenses, pain and suffering and other associated damages. More may be eligible.
To learn whether or not your family is entitled to bring a claim against GlaxoSmithKline, contact our experienced lawyers today. We offer a free consultation, with no obligations, and always work on a contingency-fee basis: you pay nothing until we secure compensation in your case.