A Pennsylvania mom claims that her son’s first few days of life were a nightmare, all because of a cleft palate he allegedly developed due to Zofran.
“Struggling, sitting up, wondering and crying every night if your baby is going to make it through the next night,” Ashley Wright recently told Pittsburgh’s WPXI-TV.
Ten years ago, when she was expecting Kaleb, Wright was prescribed Zofran to treat the nausea and vomiting associated with her pregnancy. Following his birth, her son was diagnosed with a severe cleft palate that, in conjunction with reflux, prevented him from eating. When little Kaleb did manage to eat, he experienced frightening episodes of choking.
While Kaleb is better today, he still suffers some lingering effects from his birth defect. His mother, like hundreds of other parents, is now suing the drug’s manufacturer, GlaxoSmithKline. Wright also wants to educate other women about the risks allegedly associated with Zofran.
“I just don’t think it’s fair that you’re giving us stuff that hasn’t been tested and you don’t know what it’s going to do for us,” she told WPXI.
Zofran was brought to market in the 1990s. While it has long been used to treat morning sickness in pregnant women, the medication has never actually been approved by the U.S. Food & Drug Administration (FDA) for this purpose. In 2012, Glaxo paid a $3 billion fine to the federal government for “unlawful promotion and failure to report safety data” of several drugs, including Zofran. Among other things, the government had accused the pharmaceutical company of improperly marketing the anti-nausea drug as an appropriate treatment for pregnancy-related nausea and vomiting.
More than 230 Zofran lawsuits have now been filed in federal court on behalf of children who, like Kaleb Wright, allegedly developed serious birth defects due to their mother’s use of medication in early pregnancy. Their complaints cite the 2012 Zofran settlement, as well as a number of studies which suggest that pre-natal exposure to the drug might increase the risk or certain birth defects, including cleft lip and cleft palate.
The majority of Zofran birth defects cases have been filed in a centralized litigation now underway in the U.S. District Court, District of Massachusetts. Late last year, Glaxo attempted to convince the federal court to dismiss all of the cases pending in the proceeding, asserting that clear evidence indicates federal regulators would have rejected any Zofran warning label update pertaining to birth defects. However, the court ruled that the company’s Motion to Dismiss was not ripe for consideration at such an early stage in the litigation, and denied it without prejudice.