Making its first appearance on the American market in the early 1990s, Zofran (ondansetron) is an anti-nausea drug manufactured by pharmaceutical giant GlaxoSmithKline (GSK). The medication is approved by the U.S. Food and Drug Administration (FDA) as a treatment for nausea and vomiting often experienced by chemotherapy and surgery patients.
Though the medication has never been granted FDA approval for use in pregnant women suffering from morning sickness, this particular so-called “off-label” use has gained widespread popularity in the Unites States. However, a wave of concerns and allegations have arisen with regard to potential links between Zofran use during pregnancy and several serious birth defects.
If you are among those whose children were born with a heart defect, cleft palate or other abnormality, and you suspect the anti-nausea medication may have been to blame, product liability attorneys at The Sanders Firm can offer the help you need to pursue a Zofran lawsuit and seek compensation.
Even though Zofran was not an FDA-approved morning sickness drug, GSK marketed its anti-nausea med for this off-label purpose. In fact, GSK’s marketing activities relating to several drugs, including Zofran, ultimately led the company to enter into a $3 billion settlement with the United States Department of Justice as a means to resolve potential civil liability. The company has yet to admit any wrongdoing in regards to its promotion of Zofran or other medications.
Some women are troubled with this fact, especially in light of research and recent allegations suggesting a link between Zofran and congenital birth defects. As a result of these developments, Zofran litigation is beginning to emerge with new lawsuits expected in the coming months.
Research sparks some concern regarding Zofran
Researchers recently studied data related to Zofran use during pregnancy as a potential cause of birth defects. In 2013, a study which appeared in the New England Journal of Medicine evaluated information taken from the Danish Medical Birth Registry during the years 2004-2011. Though a hard link between the use of Zofran by expectant mothers and increased rates of birth defects was not clearly established, critics of the data analysis point to the fact that Zofran exposure occurred after 10 weeks gestation, a point at which the risk of most birth defect risks has already passed.
Another study utilizing Danish Medical Birth Registry data was conducted, though with an expanded sample. In this case, researchers analyzed 900,000 births occurring between 1997-2010 and came to a contrary conclusion to that of the first study. This time around, scientists found an increase in the number of heart defects in babies born to mothers who used Zofran while pregnant. The study reported that 4.7% of the expectant mothers who were given Zofran gave birth to infants with defects, while only 3.5% of mothers who did not use the medication had a child with a defect.
Among the birth defects allegedly linked to Zofran use during pregnancy are:
- Cleft palate
- Artial septal heart defects
- Kidney trouble
- Heart murmur
- Skull deformities
- Fetal growth restriction
These types of defects can be very serious and pose real threats to the welfare of impacted children. In addition, they can require highly involved, expensive surgeries, therapy and other kinds of interventions most parents are ill-equipped to afford without assistance.
Attorneys at The Sanders Firm do not believe families affected by dangerous drugs should ever have to face these challenges alone, and that is why we fight for every dollar of compensation available.
Expected uptick in Zofran lawsuits
Roughly 80% of all pregnant women experience the discomfort and inconvenience of morning sickness, but for some, the condition is crippling. Those diagnosed with hyperemesis gravidarum, the most serious form of morning sickness, may suffer from dangerous levels of dehydration, nutritional deficiencies, muscle wasting and loss of 5% of their body weight.
As a result, many have turned to Zofran as a way to alleviate the effects and facilitate a return to daily functions. Because such large numbers of pregnant women may have used the drug in this way, more cases may soon be filed. Here at The Sanders Firm, we fight to secure the largest possible compensation award for the victims we represent and hold negligent parties accountable.
Why consider litigation?
Though the idea of filing a Zofran lawsuit may seem intimidating to mothers of children with birth defects, it may prove to be the best hope of securing the financial recovery necessary for raising a special needs child.
Successful litigation can help claimants recover damages for:
- Medical bills – past, present and future
- Therapy and rehabilitation expenses
- Lost wages
- Reduced earning capacity
- Pain and suffering
- Emotional distress
Dangerous drug cases are complex matters involving expert testimony from medical professionals, economic loss analysts and others able to build a persuasive case on a plaintiff’s behalf. The Sanders Firm has cultivated an impressive network of professionals and support staff, all of whom are skilled at assembling the evidence necessary for victims to have the best possible change of prevailing against drug giants such as GSK.
Potential allegations leveled in Zofran lawsuits
Mothers who suspect that their child’s birth defects were caused by the use of Zofran during pregnancy will likely level common allegations in suits against the drug maker.
Potential allegations include:
- GSK’s failure to conduct a clinical trial among expectant mothers prior to marketing Zofran to pregnant women was negligent and unreasonably dangerous;
- GSK concealed its awareness of animal studies revealing a link between Zofran and malformations, toxicity and intrauterine death in test subjects;
- GSK failed to disclose to physicians the reports it received about birth defects possibly caused by exposure to Zofran
- GSK failed to disclose or promote awareness that Zofran’s active ingredient was found to cross the placental barrier in mammals to their fetuses.
While the FDA has not issued any specific safety communications or warnings about Zofran use by expectant mothers, it has issued an alert about the drug’s safety in adult individuals with prior heart conditions. Some view this as lending additional credence to arguments about the overall dangers the medication may pose.
It is expected that future plaintiffs in Zofran lawsuits will make claims to include negligence, fraudulent misrepresentation and concealment, strict products liability, breach of warranties, negligent misrepresentation and deceptive trade practices.
Who should consider filing a Zofran lawsuit?
Not all women who used Zofran to treat morning sickness will necessarily have a strong case.
The strongest candidates for securing a financial recovery in a lawsuit are women who:
- Can show that their infant was in fact harmed. Countless pregnant women use Zofran for morning sickness each year and go on to have perfectly healthy babies. Just because Zofran may have the potential to cause harm, that does not mean everyone who took it should file suit.
- Are unable to pinpoint any other possible causes for the specific birth defect(s) which occurred. A lawsuit may be seriously compromised if other possible cause for the defects, including risky behaviors during pregnancy or intervening genetic factors, can be identified.
- If defense lawyers are able to prove actual awareness of Zofran pregnancy risks on the part of the mother, recovery may be elusive.
Expert legal advice from product liability attorneys
The first lawsuits pertaining to Zofran use and birth defects are beginning to appear in courts across the country, with the eventual scale of litigation yet to be determined. If you are among those women who believe your child’s injury was caused by GSK’s anti-nausea medication, enlisting the help of the right team of dangerous drug attorneys can make all the difference in your ability to prevail in your case.
The Sanders Firm has developed a reputation as one of the nation’s preeminent product liability and personal injury firms, building a track record of million-dollar verdicts and settlements for our clients. Our experience is evident at every stage of drug litigation, from discovery to settlement talks to trial, should that be necessary. Deep-pocketed drug makers recognize us as being tireless advocates for the injured, possessing the resources needed to win. To schedule a free consultation and case evaluation, contact us by calling 1-800-FAIR-PLAY.