Court documents have surfaced indicating that a couple from Brazoria, Texas, an hour south of Houston, recently filed a Zofran birth defect lawsuit against GlaxoSmithKline on July 24, 2015.
In a complaint filed in the US District Court for the District of Delaware, the family claims their two children, B.H. and H.H., were both born with congenital defects as a result of prenatal Zofran exposure.
Their lawsuit, one among at least 34 claims to draw a causal link between Zofran and major birth defects, was filed under case number 1:15-cv-00637-UNA. A copy of the complaint can be found below:
Two Children, Born With Heart & Kidney Defects, In Texas
Zofran, an anti-nausea drug commonly prescribed “off label” as a morning sickness treatment, caused the unborn B.H. to develop severe congenital heart defects that would prove fatal upon her birth, Plaintiffs write.
According to the complaint, their second child, also exposed to Zofran during the first trimester, was born with kidney defects of a “permanent and lasting […] nature” only three years after the death of their first child.
Family Says First Child, Less Than One Month Old, Died Of Severe Congenital Heart Defects
Plaintiff claims she became pregnant with her first child in November of 2000. After an “early” ultrasound exam, she was told that her unborn child was developing properly, with no sign of congenital abnormalities.
But suffering from the symptoms of nausea and vomiting common during early pregnancy, she was prescribed Zofran and says she started taking the drug on January 12, 2000. Plaintiff notes that her prescription began during the first trimester, when the risk of a child developing birth defects is highest.
At 20 weeks, diagnostic testing revealed that her child, named H.H. in court documents, “had developed severe physical malformations, including severe and life-threatening heart defects.” These defects, she alleges, were caused by the child’s prenatal exposure to Zofran, a drug known to cross the “placental barrier,” entering fetal tissues via a mother’s circulatory system.
H.H. was born in July of 2000; determined to be a “high risk birth,” plaintiff’s daughter was delivered by cesarean section, the family writes. A “team of pediatric cardiac specialists” waited nearby during the delivery.
After her birth, H.H. was immediately transferred to Texas Children’s Hospital, away from her mother’s arms, where she was “placed on a ventilator.” Suffering from difficulty breathing, their daughter would stay in the hospital’s neonatal intensive care unit (NICU) for the rest of her short life, parents write.
Less than one month after her birth, H.H. passed away on August 2, 2000. Her death, plaintiffs claim, was the result of several severe heart malformations, including “a heart whose left side was one-fifth of its normal size and an aorta that was severely malformed.”
It is likely that H.H. was born with hypoplastic left heart syndrome, a condition in which the heart’s left chambers are severely underdeveloped.
Second Child Lives With Kidney Defects, The Result Of Zofran, Parents Claim
Two years after the death of H.H., plaintiff became pregnant with her second child. Around July of 2002, she was again prescribed Zofran to alleviate the symptoms of morning sickness, an indication she notes for which Zofran has never been approved.
The mother claims GlaxoSmithKline unlawfully promoted Zofran as a “safe and effective” drug during pregnancy, despite having never studied its effects in pregnant women. In the words of her complaint, physicians were “deceive[d]” into believing that Zofran had been determined safe for pregnant women by “a fraudulent scheme” of off-label marketing.
This allegation was first leveled by the US Department of Justice, in a 2012 case eventually settled for $3 billion.
GlaxoSmithKline’s alleged deception extended to Plaintiff’s physician, the mother claims, and she began taking Zofran during the first trimester of her pregnancy with daughter B.H.
Another high-risk birth, B.H. was delivered on February 18, 2003 at a Houston hospital. Upon delivery, the child experienced “excessive vomiting and reflux,” her parents write. Unable to retain adequate amounts of nutrition, B.H. was kept in the hospital for an extended period of time and underwent “extensive testing.”
Parents say B.H. continues to suffer from reflux, along with “urinary and kidney maladies,” including unspecified congenital kidney defects.
Families & GlaxoSmithKline Lobby For Zofran Lawsuit Consolidation, At Odds Over Venue
With at least 34 Zofran birth defect lawsuits now filed in Federal Courts, GlaxoSmithKline has asked the US Judicial Panel on Multidistrict Litigation (JPML) to consolidate the claims in the US District Court for the Eastern District of Pennsylvania.
If Glaxo’s request is granted, all Federally-filed Zofran claims would be transferred to the Pennsylvania court for consolidated pretrial information gathering. But Plaintiffs have strongly opposed the company’s chosen transfer venue, and it remains to be seen whether the JPML will consolidate Zofran lawsuits at all.
You can find more information on how consolidation would affect current and future Zofran birth defect lawsuits here.
The JPML has scheduled a hearing session for October 1, 2015 in New York, in which the Panel will hear oral arguments on GlaxoSmithKline’s motion to transfer.