In a new lawsuit filed against GlaxoSmithKline, a family from Arkansas claims that the company’s anti-nausea drug Zofran caused their son to be born with a cleft lip.
The family filed their claim on May 21, 2015 in the US District Court for the Eastern District of Arkansas, Western Division.
You can read a copy of their complaint, filed under case number 4:15-cv-00284-BRW, by clicking the button below:
Prenatal Exposure To Zofran Caused Partial Cleft Lip, Arkansas Family Claims
Plaintiff says that she was prescribed Zofran in the fall of 2011 as a treatment for morning sickness “early in the first trimester of her pregnancy.” She writes that she “was prescribed Zofran because GSK promoted the drug as a way to prevent morning sickness,” asserting the allegation shared by all plaintiffs, that GlaxoSmithKline promoted Zofran unlawfully for use during pregnancy. Zofran has never been approved for use during pregnancy, and federal law prohibits drug companies from promoting their products for unapproved uses.
Her son was born on June 1, 2012 with a partial cleft lip, plaintiff writes. Children born with partial clefts have openings, or “clefts,” that separate the upper lip in some location, but unlike a complete cleft lip this opening does not extend upwards to the nose.
After three months, the couple’s infant underwent surgical repair, plaintiffs write, and he now suffers a “permanent scar from the repair that is often red and inflamed.” They note that the bottom of their child’s lip “is not symmetrical.”
Beyond undergoing a corrective procedure, plaintiffs say that their son “has also had developmental delays from the sedations” administered prior to his cleft lip’s repair. They write that
“it took him longer to speak and walk than the average infant, and he has visited a speech therapist, a developmental therapist, and a physical therapist. These therapist visits are unduly burdensome on the [plaintiff] family.”
GSK Promoted Zofran As Morning Sickness Treatment In Violation Of Federal Law, Plaintiffs Claim
The couple accuses GlaxoSmithKline of promoting Zofran as a safe morning sickness treatment during pregnancy “without testing it [to] determine whether or not Zofran was safe for this use.”
This allegation was first leveled in 2012 by the US Department of Justice. A milestone in the prosecution of alleged health care fraud, the federal government charged GlaxoSmithKline for “promot[ing] the sale and use of Zofran for […] conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea).” The charges relating to Zofran are summarized here, in a settlement agreement that GlaxoSmithKline entered in July of 2012.
Plaintiffs Say GSK “Failed To Warn” Patients & Physicians In Face Of “Reasonable Evidence” Of Birth Defect Risks
Plaintiffs allege that GlaxoSmithKline “failed to conduct adequate testing,” while simultaneously marketing Zofran to doctors as a safe remedy for nausea during pregnancy, thereby placing a drug with unknown effects on fetal development into the hands of unsuspecting pregnant women.
But beyond allegedly misrepresenting the safety of Zofran, plaintiffs claim that GlaxoSmithKline failed to adequately act upon “the existence of reasonable evidence associating Zofran use with the increased risk of birth defects.”
At least four major epidemiological studies have now found an association between prenatal exposure to Zofran and increased risks of birth defects. One of these studies, published in 2012 and funded by the US Centers for Disease Control (CDC), found that women who were prescribed Zofran’s active ingredient were 2.37 times more likely to have babies with a form of orofacial cleft.
You can read an abstract of that study, “Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects,” here.
Plaintiffs claim that GlaxoSmithKline has “failed to include any warning disclosing any risks of birth defects arising from Zofran use during pregnancy in Zofran’s prescribing information or other product labeling.” The mother claims that if she had known of Zofran’s association to birth defects, “she would not have taken Zofran during pregnancy, and [her son] would not have been born with a congenital malformation.”
The family claims damages for pain and suffering, medical and hospital expenses, financial losses incurred in caring for their son as well as punitive damages.
Zofran Birth Defect Lawsuits In Arkansas
While this is the first Zofran lawsuit filed in the state of Arkansas, other families may be eligible to pursue claims against GlaxoSmithKline. In fact, any parent who was prescribed Zofran as an “off label” morning sickness treatment and then delivered a child with major birth defects, including orofacial clefts like cleft lip and cleft palate and congenital heart defects, may be able to file a lawsuit.
ZofranLegal.com is sponsored by an alliance of plaintiffs’ attorneys devoted to pursuing justice for families and birth defect survivors. Our lawyers are currently providing free consultations and case eligibility evaluations. To learn more, call 1-877-620-8411 or fill out our online contact form.