Fill out my online form.
We are pleased to announce that our Zofran litigation team has expanded to better serve families and individuals on the island of Hawaiʻi through joining forces with local personal injury lawyers from the law offices of Wayne Parsons.
With local offices at 1406 Colburn St #201, Honolulu, HI 96817, the attorneys at Wayne Parsons are ready and available to offer local Hawaiʻi families free consultations about potential zofran birth defect lawsuits.
A series of recent epidemiological studies have associated ondansetron, the active ingredient in the anti-nausea drug Zofran, with an increased prevalence of birth defects. As of April 2015, at least five families have filed lawsuits against Zofran’s manufacturer, all claiming that exposure to Zofran during early pregnancy caused their children’s birth defects.
Joined by an international alliance of experienced attorneys, Monheit Law has begun investigating the claims of families who believe that their own child’s congenital defects may have been the result of exposure to Zofran in the first trimester.
We are working with local counsel in Hawaii to help families explore their legal options and file child birth defect claims against Zofran’s manufacturer.
Zofran is FDA approved as a treatment for severe nausea and vomiting, but only in patients undergoing chemotherapy, radiotherapy and surgical operations. While the FDA has never approved Zofran as a treatment for morning sickness, the common nausea and vomiting that can accompany early pregnancy, doctors have been prescribing the drug to pregnant women for as long as two decades.
Physicians do so, in a practice known as “off-label” prescription, at their own discretion. Actual instances of off-label use are not regulated by the FDA. But under US law, pharmaceutical manufacturers are prohibited from marketing their products for “off-label” use. In a litany of civil charges filed in 2012, the US Department of Justice alleged that Zofran’s manufacturer had done just that: promoted the drug directly to physicians as a “safe and effective” treatment for unapproved use as a morning sickness treatment.
While Zofran’s manufacturer continues to deny claims that it marketed Zofran for use during pregnancy, the company settled the DOJ’s case for a record-breaking $3 billion.
Zofran has quickly become one of America’s leading morning sickness treatments. As a result, multiple research institutions have conducted studies to determine its potential effects on fetal development.
In 2012, researchers at Harvard University found that women who were prescribed ondansetron during the first trimester were more than twice as likely to deliver babies with a cleft palate than women who did not seek treatment for the nausea and vomiting that commonly accompanies early pregnancy.
A team in Western Australia concluded that babies exposed to ondansetron during the first trimester were born with kidney malformations six times more often than babies who were not.
In Sweden and Denmark, researchers reviewed national birth records that spanned more than a decade. Both teams found an increased incidence of congenital heart defects among babies who had been exposed to ondansetron during early development.
In the five lawsuits that have now been filed against Zofran’s manufacturer, US families claim compensation for a wide range of birth defects, including:
Zofran, which became available on the US market in 1991, is believed to have captured 99% of market share by as early as 1995. Soon after, the anti-nausea drug became one of America’s most-prescribed medications.
According to estimates made by the Centers for Disease Control, around one out of every 33 babies in the US is born with a birth defect. Birth defects can be caused by a number of factors, including genetic mutations and fetal exposure to harmful chemicals. As of 2014, the US Census Bureau estimated Hawaii’s total population at 1,419,561. On the island of Oahu, the state capital of Honolulu was home to an estimated 991,788 in 2014.
Using those population figures, along with birth defect incidence rates found in the four Zofran studies, we’ve calculated a series of estimates. The numbers below represent how many Hawaiian children born with birth defects may have had Zofran exposure as a contributing factor since 1991.
Based on Hawaiʻi’s total population of 1,419,561, we estimate that there have been approximately 700 Hawaiian babies, born with birth defects, for whom Zofran may have contributed to their congenital conditions. Breaking that down, our estimate includes approximately 150 children born with orofacial clefts, a category that includes cleft lip and cleft palate, and approximately 600 babies born with congenital heart defects.
Our calculations estimate that in Honolulu, a city of around 991,788 inhabitants, exposure to Zofran potentially resulted in approximately 500 babies born with congenital defects. We estimate that 100 of these babies have been born with orofacial clefts, and the remaining 400 with congenital heart defects.
If you were prescribed Zofran as a morning sickness treatment during early pregnancy, and then delivered a child with birth defects, you may be eligible to bring a legal claim for compensation against the drug’s manufacturer.
Our team of distinguished plaintiffs’ attorneys includes counsel licensed to practice law in Hawaiʻi. Our attorneys offer a free initial consultation, and work on a contingency-fee basis, which means that you owe us nothing until we win your case. To learn more about our attorneys admitted to practice in Hawaii, click here.
If you would like to learn more about Zofran birth defect lawsuits, call 1-877-620-8411 or complete our online contact form.
Home » Hawaii Attorneys From Wayne Parsons Filing Zofran Birth Defect Lawsuits