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On April 17, 2015, a mother from Texarkana, Texas filed suit against GlaxoSmithKline, manufacturer of the anti-nausea drug Zofran. Plaintiff claims that Zofran, often prescribed “off-label” to treat morning sickness, caused her unborn child to develop multiple congenital defects. Continue reading
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Apr 28, 2015 /prREACH/ -- To date, at least six families have filed personal injury lawsuits against pharmaceutical giant GlaxoSmithKline. These parents claim that the company’s popular anti-nausea drug Zofran caused their children’s major birth defects.
Echoing charges originally filed by the US Department of Justice, plaintiffs allege that GlaxoSmithKline promoted Zofran as a “safe and effective” treatment for morning sickness, a use for which it has never been approved. Noting that the company has never studied Zofran’s effects during pregnancy in clinical trials, claimants say that GlaxoSmithKline has been aware of Zofran’s potential to adversely affect fetal development for decades. Plaintiffs claim that the company has only continued its alleged off-label promotion of Zofran, failing to report mounting evidence of the drug’s possible risks to the US Food & Drug Administration, health community and public.
In the most recent claim, filed under case number 5:15-34 in the United States District Court of Texas, Texarkana Division, a mother alleges that after she was prescribed Zofran to alleviate the nausea and vomiting common during early pregnancy, her child was born with “numerous birth defects.” Plaintiff claims that prenatal exposure to Zofran caused these congenital abnormalities, which include “heart murmur, fluid on the brain [hydrocephaly], thickened arteries and multiple developmental delays.” She says that her child, now eight months old, “anticipates a long road of multiple surgeries” that will attempt to correct the birth defects from which he suffers.
Zofran is approved to treat severe nausea and vomiting in patients being treated for cancer through chemotherapy or radiotherapy, as well as in patients who experience nausea and vomiting after surgery. GlaxoSmithKline has never sought the drug’s approval as a treatment for morning sickness, or even studied its effects on pregnant women and their developing babies. But physicians across the world have prescribed Zofran “off-label” to treat nausea and vomiting of pregnancy for years. While “off-label” prescription is not regulated by the FDA, US law prohibits drug manufacturers from promoting their products for unapproved use.
In 2012, the US Department of Justice charged GlaxoSmithKline with doing just that: promoting Zofran to doctors as a “safe and effective” treatment for pregnant women, without ever performing the clinical trials required to make such claims. The federal government also accused the company of violating the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b), by paying physicians to promote and prescribe Zofran themselves. GlaxoSmithKline eventually resolved the government’s allegations in a settlement of $3 billion, but continues to deny all claims that it unlawfully promoted Zofran for off-label use.
Of at least six lawsuits now filed for Zofran-related birth defects, case 5:15-34 is the first to note a simultaneous investigation of GlaxoSmithKline’s business practices in China. According to the complaint filed in Texas, GlaxoSmithKline was “also under investigation for bribing doctors in China to prescribe its products and using travel agencies to cover up the practice.” Ultimately, five managers from the company’s Chinese operation pleaded guilty to the charges, and GlaxoSmithKline itself acknowledged what the New York Times called “a spree of bribe-giving and illicit sales tactics.”
In docket 5:15-34, plaintiff alleges that “between 1992 and 2011, [GlaxoSmithKline] avoided conducting studies or trials [of Zofran’s effects during pregnancy] because they would have hampered its marketing of Zofran and decreased profits.” She claims that the company chose not to investigate Zofran’s potential risks for pregnant women and unborn children “because it had knowledge of the drug’s toxicity.” The claimant alleges that GlaxoSmithKline has been aware of evidence that Zofran has the potential to cause birth defects for more than 20 years, saying “at least as early as 1992, [GlaxoSmithKline] began receiving reports of birth defects associated with the use of Zofran by pregnant women.” She alleges that GlaxoSmithKline has received at least 200 such reports to date, and then claims that the company failed to disclose these reports to “the FDA or any representative body of the United States government.”
Claimant also cites three recent studies, performed independently by researchers in Denmark and Sweden, that all found an elevated risk of congenital heart defects, like those suffered by plaintiff’s child, in babies exposed to Zofran’s active ingredient during early gestation.
If these allegations against GlaxoSmithKline are true, other mothers who were prescribed Zofran “off-label” as a treatment for morning sickness, and then delivered babies with birth defects, may be eligible to bring claims for compensation against the pharmaceutical company. Monheit Law has joined with a multi-state alliance of plaintiffs’ lawyers to investigate claims involving birth defects that may have been caused by exposure to Zofran. Parents and birth defect survivors can visit http://zofran.monheit.com/ to learn more, or schedule a free legal consultation.