Did you see a commercial on TV about Zofran? These commercials have focused on a series of lawsuits filed against GlaxoSmithKline, and serious allegations that the company’s anti-nausea drug Zofran may cause birth defects. Commercials urge women who were prescribed Zofran for morning sickness, and then delivered children with birth defects, to seek legal counsel.
The legal team sponsoring Zofran.Monheit.com does not produce TV commercials, but we are offering free consultations to all families interested in learning more about the ongoing Zofran litigation.
If the commercial you saw seemed to describe your own situation, our attorneys are ready to answer your questions. To speak with an experienced lawyer 24 / 7, just call 1-877-620-8411 or fill out our contact form.
What Are Zofran TV Commercials Saying About Birth Defect Lawsuits?
Parents across the country are pursuing legal claims against GlaxoSmithKline (GSK), an international pharmaceutical manufacturer and the company behind Zofran. These mothers delivered children with birth defects, all after taking Zofran as a treatment for morning sickness.
Zofran is not approved for use during pregnancy, and GSK has never conducted a single study to investigate the drug’s effects on pregnant women or developing babies. Zofran was approved in the 1990s for the prevention of three, very specific types of nausea and vomiting:
- in cancer patients undergoing chemotherapy
- in cancer patients undergoing radiotherapy
- in surgical patients undergoing anesthesia
Experts have found that many doctors are also prescribing the drug to pregnant women as an “off label” treatment for morning sickness. This common practice, when physicians prescribe drugs for uses that haven’t been approved in the US, is not regulated by the FDA. But under federal law, drug companies are not allowed to promote their products for unapproved uses.
In 2012, the federal government charged GlaxoSmithKline with doing just that: marketing drugs to doctors for “off label” uses. One of the drugs cited in the government’s complaint was Zofran. The US Department of Justice alleged that GSK “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” GSK eventually pled guilty to three of the government’s criminal charges, but continues to deny all wrongdoing in connection with Zofran. Even so, the company entered a settlement agreement for $3 billion, making it the largest case of alleged health care fraud in US history.
What Allegations Do Zofran Lawsuits Make?
Plaintiffs in the recent Zofran birth defect lawsuits insist that GSK marketed Zofran unlawfully, and then continue to make other troubling allegations. These parents say that for more than two decades, GSK has been aware of Zofran’s potential to increase the risk of major birth defects.
According to their complaints, the company began receiving reports of birth defects with suspected ties to Zofran’s use as a morning sickness treatment in 1992, only one year after the drug hit the market. They say that GSK has received more than 200 such reports to date, but underreported the number to the FDA.
The Commercial I Saw Mentioned Scientific Research. Do Studies Really Link Zofran To Major Birth Defects?
The commercial you saw on TV probably mentioned that significant scientific studies have found an association between Zofran and birth defects.
These epidemiological studies lie at the heart of the lawsuits that have been filed against GSK. Four independent teams of researchers have found an increased incidence of birth defects among children born to women who took Zofran during early pregnancy.
You can find more information on these studies here.
Which Birth Defects Have Been Associated With Zofran?
Studies have found an association between Zofran ingested during the first trimester of pregnancy and an increased risk of:
- Cleft palate
- Congenital heart defects, including atrial septal defect, ventricular septal defect and atrioventricular septal defect
- Kidney malformations
In addition to those abnormalities, the TV commercial you saw may have mentioned the following:
- Cleft lip
- Hydrocephaly (fluid on the brain)
- Abdominal defects, like gastroschisis
- Right ventricular hypertension
- Aortic arch hypoplasia
- Bicuspid aortic stenosis
- Supraventricular tachycardia
- Hearing loss
- Low set ears
- Webbed toes
- Inguinal hernia
Plaintiffs have claimed damages for all of the congenital abnormalities listed above, birth defects they say were caused by prenatal exposure to Zofran.
At least seven US families have now brought legal claims against GlaxoSmithKline, alleging that the company failed to disclose vital safety information about Zofran’s potential to increase the risk for major birth defects from the public and health community.
Considering Legal Action After Seeing A Zofran TV Commercial?
If you were prescribed Zofran during the first trimester and delivered a child with birth defects, you may be eligible to file a lawsuit against GSK.
Monheit Law has joined forces with a multi-state alliance of plaintiffs’ attorneys to investigate Zofran-related birth defect claims. Our lawyers have been holding pharmaceutical giants accountable for decades.
To learn more about your case eligibility, call 1-877-620-8411 or complete our online contact form.