UMATILLA, Fla. – One local mother is warning other parents after she said she wishes she'd known the possible side effects of a commonly prescribed medication she took while she was pregnant.
Michelle Kinkead said her 10-month-old daughter, Jazmyne, is her miracle baby.
[WEB EXTRA: Ruling affecting generic drugs | Ondansetron studies | Another Study | GlaxoSmithKline Response]
"I had less than a 2 percent chance of having another child and that was eight years ago," said Kinkead.
Jazmyne may look like any other healthy little girl at first glance, and Kinkead said for the most part she is, except for one thing.
"The cleft gum," said Kinkead. "She's on the verge of a cleft palate."
It's more obvious in photos from when Jazmyne was born.
"It almost looked like she had teeth to begin with because her gum is so grooved," said Kinkead. "Her top flap comes where most people's are, only connected a little bit. Her top flap is actually connected all the way to the bottom of her gum. It may affect her speech later on, so once she gets a little older the orthopedic specialist will have to surgically cut that for her."
Kinkead said cleft palates or gums don't run in her family, and although she knows they can occur naturally, she believes in Jazmyne's case, it was all caused by a drug she was prescribed for severe morning sickness: Zofran.
"Probably by the eighth, ninth week, I was sick all day every day," said Kinkead. "It took losing about 5 pounds at the doctor's office before I finally asked them if there was something I could take with it, because being high risk, I was really worried about taking anything with her whatsoever."
Kinkead was given Zofran, which she said she took every morning until the day before she was induced. It's a medication that's Food & Drug Administration-approved for use in cancer patients and in other cases, but is not FDA-approved for use with nausea in pregnant women. But it's still being prescribed as what the FDA said is called off-label.
"You go to the doctor and you're supposed to be able to believe what your doctor tells you," said Kinkead. "They assured me there was minimal side effects, that it was safe to take with her."
But Morgan & Morgan attorney Laura Yaeger said data shows that's not the case.
"What we are finding and seeing is many families experiencing their children being born with various birth defects," said Yaeger. "One is heart defects, and there's a long list of heart defects. The two main ones we're seeing are what we would call holes in the heart and then we're also seeing cleft palate and cleft lip birth defects in children."
Local 6 News found thousands of comments on different Facebook pages, mothers all over the country saying their babies were born with defects after taking the medication.
"Families have been very negatively affected," said Yaeger. "Unfortunately, there have been some infants that have died. If they do survive the side effects of having a hole in the heart, they can have trouble feeding and growing, and a number of times they have to have multiple surgeries to correct the problem."
Yaeger said the problem is that the company that makes Zofran, GlaxoSmithKline, isn't being honest about those risks.
"What we have here is a drug company that's not willing to give us the true picture of the risk," said Yaeger. "The doctors haven't been told the truth."
Yaeger said in 2012, GlaxoSmithKline agreed to plead guilty and was fined $3 billion by the U.S. Justice Department. The settlement was to resolve the company's criminal and civil liability after it was sued for several allegations, including the illegal promotion of several of its drugs off label, and providing kickbacks to doctors for prescribing them.
In a recently filed lawsuit against the company, that settlement agreement is mentioned specifically referencing Zofran:
"9. GSK's written agreement with the United States reports GSK's settlement of claims that GSK:
(a) "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)"
(b) "made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]"
(c) "offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran"
Local 6 News reached out to GlaxoSmithKline for comment on the prior settlement.
"GSK reached a settlement with the government regarding Zofran to avoid the delay, expense, inconvenience and uncertainty of protracted litigation," said a representative in an email. "Notably, as the public record makes clear, there were no findings that GSK illegally marketed Zofran at any time, and GSK never admitted wrongdoing with respect to its marketing of Zofran."
The drug's warning label indicates Zofran should only be used during pregnancy if clearly needed. Local 6 News found some studies that say there's no evidence the drug causes birth defects, but others say the drug may increase risks by double.
Yaeger said the problem is even worse if a woman was prescribed and took the generic form, Ondansetron.
"Most consumers have no idea that if they are harmed by a generic drug, it's going to be a much harder case to prove," said Yaeger.
That goes for any generic drug.
It's all because of a 2011 U.S. Supreme Court ruling that Yaeger said protects generic drug makers against legal claims because they're using the same formula and warning labels as the brand name.
"We think it's a very unfair current state of the law," said Yaeger.
And she said that doesn't mean you can sue the company that created the brand name version either.
"There's a theory called innovator liability, where you can go after the brand name manufacturer and hold them responsible because their label is being copied by all these manufacturers," said Yaeger. "But Florida does not allow that liability to move forward."
Kinkead said the nausea she experienced was so severe that she couldn't eat if she didn't take her Zofran, potentially putting her baby at risk.
Still, she said she wouldn't take it again.
"I wish they told me the risks so I could make that decision," said Kinkead. "Not, 'It's OK to take, here, go ahead and take it.' Even if your doctor says it's OK, it's well worth looking into on your own."
Local 6 also spoke to a representative for Orlando Health, who declined to go on camera. However, he said most doctors prescribe Zofran for severe nausea in pregnant women, and that many women benefit from the drug. He further stated plenty of medical literature supports the use of the drug, and said at worst, may indicate further study is needed to determine whether birth defects can be linked to Zofran use during pregnancy.