Hundreds of families have filed suit against GlaxoSmithKline, the British pharmaceutical giant and manufacturer of the anti-nausea drug Zofran. In their claims, parents say the drug causes major birth defects, and accuse Glaxo of hiding the evidence – for decades.
Mothers from across the nation believe they were deceived into taking an unapproved morning sickness drug that ended up harming their unborn children. Burdened by rising medical expenses, these parents say their only option – to support the children they love – is through legal action.
Families Are Filing Zofran Lawsuits. Should You?
Multiple major scientific studies have identified an association between Zofran, which is frequently prescribed during pregnancy, and birth defects like:
- Cleft Palate
- Heart Defects
- Atrial Septal Defect
- Ventricular Septal Defect
- Atrioventricular Septal Defect
In their lawsuits, parents say GlaxoSmithKline actively concealed evidence of these possible risks from doctors and pregnant women. Plaintiffs say the company failed to submit birth defect reports to the US Food & Drug Administration (FDA), and note with pointed urgency that none of the studies are mentioned on Zofran’s warning label.
While their allegations will only be tested in court, there’s already good evidence, including damning details unearthed by a government investigation, to support many of their assertions.
Can My Family Get Compensation?
Any one who was prescribed Zofran as a morning sickness treatment and delivered a child with birth defects may be eligible to file a claim. But time could be running out.
In many states, a strict statute of limitations prevents parents who have suffered harm from filing suit after a certain period of time. While some families have been able to extend their time limits, others have been prevented from exercising their rights. Immediate action, always a good idea in legal matters, may be necessary in this case.
In fact, the Judicial Panel on Multidistrict Litigation (JPML) has already recognized the Zofran lawsuits – deciding to “consolidate” the claims in Boston. With Multidistrict Litigation (MDL) 2657 officially formed in the US District Court for Massachusetts, families who have already filed suit will be able to pursue the evidence needed to hold GlaxoSmithKline accountable, but they’ll do so together.
Lawyers Can Help
In pursuing huge corporations, strong, dynamic legal counsel is a must.
Throughout this evolving litigation, Zofran attorneys have served as vocal advocates for the rights of parents and birth defect survivors everywhere.
The best way to protect your best interests is by finding an experienced, knowledgeable lawyer. But not any experience will do. Each area of the law is dramatically different, so look for an attorney with experience fighting large corporations over cases involving dangerous drugs.
Zofran lawyers don’t think families should be forced to face these challenges alone. They’ll be thoroughly committed to justice, one child at a time.
Has Zofran Been Linked To Birth Defects?
While Zofran was initially approved in 1991, it’s prevalence as a morning sickness drug has only come to the attention of medical researchers recently. Startled by the fact that Zofran has never been approved for use in pregnancy, teams from across the globe began investigating the drug’s effect on unborn children.
With their preliminary results in, some critics are already calling for Zofran to be banned from the offices of obstetricians and gynecologists. In any event, the drug appears far from a risk-free option, unlike another currently-available medication approved to treat pregnancy-related nausea.
While Zofran lawsuits have named numerous birth defects, no congenital abnormality is more frequently listed than heart defects.
In their complaints, parents rely on a series of European studies, performed between 2013 and 2014, as evidence of Zofran’s damaging effect on fetal heart development.
Danish Study: Hole In The Heart Defects 2 To 4 Times More Likely
In Denmark, researchers analyzed every Danish birth record filed between 1997 and 2010. Eventually, their study would include more than 900,000 pregnancies. Using hospital and prescription records, the team identified every woman who was prescribed Zofran during that time-period, and then determined which women had delivered children with birth defects.
Overall, babies exposed to Zofran during the first trimester were 20% more likely to be born with congenital abnormalities. But the risk for selected heart defects was far higher. Women prescribed Zofran were:
- 2.1 times more likely to deliver children with atrial septal defect
- 2.3 times more likely to deliver children with ventricular septal defect
- 4.8 times more likely to deliver children with atrioventricular septal defect
This group of heart conditions, commonly known as “hole in the heart” defects, can be life-threatening. Each disorder involves a hole in cardiac tissue, an opening that allows blood to flow outside its normal path, drastically affecting the body’s ability to absorb oxygen.
Swedish Team Replicates Study, Finds Doubling Of Heart Defect Risk
One year later, a team from Sweden’s government repeated the study and came to similar conclusions. Reviewing more than 1 million Swedish birth records, the researchers found that children exposed to Zofran in the womb were 2.05 times more likely to be born with “hole in the heart” defects.
In the lawsuits, costly medical procedures with life-preserving outcomes are a recurring feature. Many parents say their children were forced to undergo multiple surgeries, often as newborns. Beyond the trauma and anxiety of watching their babies operated on, the families say they’re now burdened by mountains of debt and uncertain futures.
Cleft Palate Linked To Morning Sickness Drug Early On
Along with genetics, many parents are now calling Zofran one of the causes of cleft lip. In their complaints, families say the anti-nausea drug drastically increases the risk for orofacial clefts, like cleft palate and cleft lip.
To learn more about one of the families who have filed a Zofran cleft palate lawsuit, click here.
Notably, cleft palate was the very first birth defect linked to Zofran. Many parents have cited the 2012 study performed at Harvard and Boston University that found children exposed to the drug were more than twice as likely to be born with cleft palate. This research has become central to the growing litigation, and it’s one of the reasons the JPML decided to consolidate Zofran lawsuits in Boston.
Latest Lawsuit Updates
December 16, 2015 – 5 Attorneys Appointed To Lead Zofran MDL
With almost 200 lawsuits now consolidated in Boston, it looks like the Zofran MDL is getting underway. On November 18, 2015, the US District Court for Massachusetts released its third MDL Order, appointing three trial attorneys to serve as lead counsel for the consolidated lawsuits.
As lead counsel, Kimberly Barone Baden, Elizabeth Graham and Tobias Millrood will chair the Plaintiffs’ Steering Committee, a group of attorneys selected to develop core legal strategies and identify crucial evidence. Two other lawyers, Robert Jenner and Kimberly Dougherty, have been appointed liaison counsel, and will be tasked with coordinating administrative efforts.
Why Do Doctors Prescribe Zofran To Pregnant Women?
Zofran has never been approved for use during pregnancy. It’s actually meant to treat cancer patients, who often suffer from nausea and vomiting after chemotherapy, and surgery patients who feel sick after anesthesia. But approval has little to do with how doctors actually prescribe drugs.
While many of us assume that doctors maintain rigorous safety standards, that’s not always the case. Recent studies suggest that medical professionals frequently prescribe drugs off-label, even ones without any scientific research demonstrating their safety or effectiveness.
In fact, Zofran is now America’s leading drug for the treatment of morning sickness. Some opinion makers have tried to explain the drug’s success among pregnant women by pointing out that between 1980 and 2013, no drug was approved for morning sickness. By that logic, doctors had to prescribe something for severe cases and so they turned to Zofran.
Did Glaxo Market An Unproven Drug For Morning Sickness?
The federal government has a different explanation.
In a landmark case, the US Justice Department charged GlaxoSmithKline for promoting drugs “off-label,” for unapproved uses. One of those drugs was Zofran. Federal investigators presented a wealth of evidence all leading to one conclusion: Glaxo had been pushing Zofran directly to obstetricians and gynecologists, misrepresenting the drug as “safe and effective” for pregnant women. That’s illegal, since the company had never even studied Zofran’s effects on unborn babies.
Glaxo never admitted to the charges. Instead, the company settled the government’s case for $3 billion. They continue to deny any fraudulent marketing. But Plaintiffs aren’t buying that denial; they maintain that GlaxoSmithKline promoted a drug with unknown (or dangerous) effects on fetal development to unwitting OB / GYNs.
Much of the evidence they cite was gathered by state prosecutors in Massachusetts, who started the investigation into Glaxo’s potentially unlawful marketing practices. That’s another reason why the JPML decided to send Zofran lawsuits to Boston, rather than Pennsylvania like GlaxoSmithKline wanted.
Contact An Attorney Who Believes In Your Case
With Zofran lawsuits “fast-tracked” as an MDL, we believe it’s only a matter of time before hundreds of families bring legal claims of their own.
Dedicated lawyers are committed to helping you and your family pursue justice. If you took Zofran and delivered a child with major birth defects, you may be entitled to significant financial compensation.