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Michael Monheit
Michael Monheit
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Two New Zofran Lawsuits Filed By Monheit Law Clients


More than 60 lawsuits have been filed against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran causes birth defects. In the wake of a federal panel’s decision to send the claims to Boston, these families await new developments in their cases with a mix of anxiety and hope.

Many are being guided by the attorneys at ZofranLegal.com, a website founded by an alliance of trial attorneys who have played an instrumental role in the Zofran litigation. But Michael Monheit, Esq., the site’s lead sponsor, says the country is home to numerous eligible parents who have yet to come forward.

Two Families Say Zofran Caused Oral Cleft Defects

Indeed, clients of Monheit’s personal injury firm, Monheit Law, continue to file new lawsuits. While the claims against GlaxoSmithKline have related mainly to heart defects, two of Monheit Law’s most recent clients say Zofran caused a child’s orofacial defects.

Copies of their court documents can be found at ZofranLegal.com.

Boy Underwent Bone Graft To Repair Cleft Gum Line, Parents Claim

The first of these new complaints was filed on August 14, 2015 in the US District Court of Idaho, Southern Division. The claim was brought by the parents of Z.E., a child now 8 years old. Z.E. lives with his mother in Boise, Idaho; the boy’s father is currently a resident of Aberdeen, Maryland. The lawsuit has been logged as case number 1:15-cv-00319-BLW.

Generic Zofran Manufacturer May Share In Blame

Plaintiff claims she was prescribed Zofran as an unapproved morning sickness treatment near the beginning of a 2007 pregnancy. But notably, Plaintiff has also named Sandoz, Inc. as a Defendant alongside GlaxoSmithKline.

Sandoz, a Colorado company, manufactured and sold a generic version of Zofran as GlaxoSmithKline’s authorized distributor. The product is no longer listed on Sandoz’s website.

Plaintiff claims she was administered both brand name Zofran (intravenously upon being admitted to a hospital) and Sandoz’s generic ondansetron. Both drugs, she claims, were taken during the first trimester of fetal development.

Born With A Cleft Alveolus & Ear Defects

But the drug’s alleged effects were already apparent before Z.E.’s birth. Via ultrasound, physicians diagnosed the boy with a craniofacial defect:  cleft alveolus.

This gap or opening in gum tissue and bone is often accompanied by a cleft in the palate or lip. The complaint says that Z.E. was also born with an “ear deformity.”

Multiple Surgeries, & More To Come

Z.E.’s challenges began early, his parents claim. The boy has undergone multiple surgeries, they say, including a recent bone graft intended to level his uneven gum-line. These treatments, however, have not been entirely successful, and Z.E. continues to live with breathing difficulties. His parents say more surgeries are expected in the future, including a “possible rhinoplasty.”

California Mother Says “Off-Label” Drug Caused Cleft Palate

The second parent represented by Monheit Law filed her lawsuit more recently, on September 25, 2015. In a claim brought in the US District Court for the Central District of California, a mother from Huntington Beach says her son J.S. was born with a cleft palate after being exposed to Zofran.

The family’s lawsuit was registered as case number 8:15-cv-01552.

Surgery At Nine Months, But Difficulties Remain

Plaintiff’s pregnancy-related nausea was so severe that she continued taking Zofran, now America’s leading “off-label” morning sickness, from her first trimester through the third. She says J.S. was born in September of 2009, but only diagnosed with cleft palate four days after delivery.

J.S. underwent surgery at the extremely young age of nine months, his mother claims. While additional procedures are likely, the boy “struggles every day due to his condition,” according to court documents. J.S. “constantly chok[es]” on the fluids allowed to flow between his nasal passages and mouth. The cleft has inhibited his ability to speak, and his mother says he will need speech therapy in the near future.

Zofran And Cleft Palate

In their lawsuits, many families have noted a 2012 study that linked Zofran to an increased risk for cleft palate. In fact, researchers at Harvard and Boston Universities found that mothers who ingested Zofran were more than twice as likely to have babies with the birth defect, a gap in the roof of the mouth.



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  1. S says:
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    How can a drug manufacturer be to blame when a doctor makes a medic decision to use a product for an unapproved/unlabeled use?

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      According to the parents who are filing these lawsuits, doctors were just as deceived by GlaxoSmithKline’s marketing of Zofran as pregnant women were. Many of them allege that the company actively suppressed research results and birth defect reports, while promoting the drug as an “established” treatment for morning sickness.

  2. khassan says:
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    Just because her son had cleft palate, does not equate to having defects, As she admitted to taking the drug despite the warning. Theres not enough research to prove the correlation, though it may exist more research needs to be done. Furthermore, it could be that they see zofran an easy target to be sued.

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      I urge you to read (or re-read) the complaints for yourself; nowhere can I find an admission that Plaintiff received a “warning” regarding Zofran’s safety but chose to take the drug anyway. Regardless of whether or not Plaintiff “admitted to taking the drug” after receiving such a warning, I certainly think being born with a cleft palate “equates” to having a birth defect.

      Further research would be a welcome development, and we can expect more studies in the near future. Federal law, however, doesn’t require proof of a causal relationship before obligating drug companies to disclose certain things about their products. As Plaintiffs note, the Code of Federal Regulations clearly states that manufacturers must “include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” Plaintiffs claim such “reasonable evidence” exists. At least three studies ascribe statistical significance to their conclusions that Zofran increases the relative risk for cleft palate or congenital heart defects. Whether or not that constitutes “reasonable evidence” is now for the courts and juries to decide.

      Drug companies may be an “easy target,” but only insofar as they routinely demonstrate, time and time again, their own willingness to violate federal law and ethical consideration in the search for profit. It would be more appropriate to say that, for drug companies, patients are the “easy target.”

  3. Lisa Muchnick says:
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    My daughter was prescribed Zofran in her first trimester for morning sickness. No one warned us of any problems. She was very sick and could not keep food down so she took the prescribed dose. At 5 months we were referred to a specialist because the baby was diagnosed with Disposition of the great arteries and will need open heart surgery at birth.

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      Lisa, I am sorry to hear what you have been through. Thank you for sharing what happened. These injuries sound similar to those in cases we currently are representing involve children who have suffered a variety of heart birth defects. Feel free to call me if you have specific questions.

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