Zofran, a powerful nausea drug made by GlaxoSmithKline, may increase the risk for major birth defects. Recent scientific research has found an association between the popular “off label” morning sickness treatment and congenital heart defects and cleft palate.
Families across the country have already begun to file lawsuits against GlaxoSmithKline, a company the US Justice Department says promoted its nausea medication for unapproved use during pregnancy.
Is Zofran Safe During Pregnancy?
Zofran was approved in 1991 to treat the most severe nausea and vomiting imaginable: in cancer patients undergoing chemotherapy and radiation therapy. Blocking the action of serotonin, a neurotransmitter scientists believe triggers our impulse to vomit, Zofran’s active ingredient quickly and effectively prevents sickness in many patients who rely on it.
But by 2006, it became clear that doctors were prescribing Zofran for a very different condition. The drug’s sales skyrocketed as it became America’s most popular pharmaceutical morning sickness treatment.
GlaxoSmithKline’s revenues skyrocketed, too, until the company’s patent on Zofran’s active ingredient expired in 2006:
- 2003 – $463 million
- 2004 – $495 million
- 2006 – $645 million
The drug’s safety during pregnancy, however, was far from certain. Zofran was never approved for morning sickness and GlaxoSmithKline has never even studied its effects on developing babies.
Despite the recent availability of Diclegis, an FDA approved morning sickness treatment, Zofran remains the preferred choice for physicians hoping to treat pregnancy-related nausea with drugs.
How Did Use During Pregnancy Become Common?
In explaining Zofran’s amazing rise in “off label” popularity, many medical professionals have looked no further than the decades-long drought in viable morning sickness treatments.
In 2012, the US Federal Government proposed its own theory: GlaxoSmithKline had been marketing Zofran for unapproved use during pregnancy. That’s illegal under federal law, and the Department of Justice charged the company with multiple civil and criminal counts of unlawful “off label” promotion.
In its landmark case, the government claimed Glaxo had marketed Zofran directly to obstetricians and gynecologists, making unsubstantiated, and quite possibly false, claims about the drug’s safety during pregnancy. The company even paid doctors illegal kickbacks to prescribe more Zofran, and promote the drug’s off label uses themselves, federal prosecutors alleged.
The company eventually settled the government’s case for $3 billion. It remains the largest settlement for alleged health care fraud in US history.
To date, GlaxoSmithKline has never admitted any wrongdoing. But the government hasn’t backed down either, and maintains that its allegations are “well-founded.”
Today, more than 1 million women are prescribed Zofran during pregnancy every year, and teams across the globe have scrambled to study its effects.
In 2012, a team of public health researchers from Harvard and Boston University investigated the effects of Zofran on fetal development. Using birth records and maternal interviews, the scientists identified women who had been prescribed Zofran during the first trimester.
These women were 237% more likely to deliver children with cleft palate.
In 2013, a team from Sweden’s Copenhagen University reviewed more than 900,000 Swedish birth records. Cross-referencing those records to prescription logs, the researchers concluded that women prescribed Zofran were:
- 60% more likely to be born with heart defects
- 210% more likely to be born with an atrial septal defect
- 230% more likely to be born with a ventricular septal defect
- 480% more likely to be born with an atrioventricular septal defect
Conducting a similar study in 2014, researchers at Sweden’s National Board of Health & Welfare came to a disturbingly similar conclusion. Analyzing every birth record filed in Sweden between 1998 and 2012, more than 1.5 million pregnancies, they found that women prescribed Zofran were:
- 62% more likely to have children with heart defects
- 205% more likely to have children with cardiac septal defects
Medical experts worldwide continue to investigate Zofran’s potential risks for unborn babies. But the early findings have already spurred a wave of litigation, as parents from across the country claim the off-label morning sickness treatment caused their children’s birth defects.
Zofran Lawsuits: 3 Major Allegations
As of December 16, 2015, nearly 200 families have sued GlaxoSmithKline. Like the US Department of Justice, these families claim GSK promoted the drug directly to obstetricians and gynecologists, in violation of federal law.
But their allegations go much further.
Plaintiffs say GlaxoSmithKline concealed decades of evidence associating Zofran to birth defects.
1. Glaxo Hid Early Trial Results From FDA, Plaintiffs Allege
In the early 1980s, the company conducted a series of studies involving pregnant rats and rabbits. According to Plaintiffs, the trials revealed evidence that Zofran is toxic. The animals experienced increased rates of intrauterine death as the dosage of Zofran was increased, parents claim, and the offspring showed signs of developmental retardation.
But in submitting the study results to the FDA, GlaxoSmithKline reported no evidence of Zofran’s teratogenicity, its ability to alter fetal development.
2. Zofran Penetrates Fetal Tissue At “High Concentrations”
In 2006, a team in Hong Kong found that Zofran’s active ingredient easily crosses the placental barrier in humans. After ingestion, Zofran is absorbed by a mother’s blood and quickly transmitted to the tissues of her developing fetus.
Plaintiffs claim GlaxoSmithKline was obligated to inform patients and physicians of this information, but failed to do so.
3. Birth Defect Reports Went Unsubmitted, Parents Say
GlaxoSmithKline began receiving reports of birth defects with suspected ties to Zofran exposure as early as 1992, the families write in their lawsuits. They say that to date, the company has received more than 200 of these reports.
But many went “missing,” lost on the way from Glaxo’s headquarters to the FDA, plaintiffs claim.
Monheit Law Finds Hundreds Of Birth Defect Reports
In a Freedom of Information Act (FOIA) request to the FDA, a Pennsylvania-based firm called Monheit Law asked for every adverse event report implicating Zofran as the potential cause of serious harm.
Combing through more than 3,800 pages of data, the attorneys found:
- 475 reports linking Zofran to congenital anomalies and adverse fetal outcomes
- 170 references to congenital heart defects
- 52 references to craniofacial defects, including cleft palate
- 86 references to congenital respiratory defects and abnormalities
- 55 reports of stillbirth, fetal death and abortion
Plaintiffs allege that GlaxoSmithKline has failed to notify doctors and patients of these reports, and failed in its obligation to update Zofran’s warning label and include the drug’s link to birth defects.
Heading For MDL, More Cases Expected
With dozens of lawsuits filed, Plaintiffs and GlaxoSmithKline have both agreed that Multidistrict Litigation (MDL) is the best path forward.
Through this legal mechanism, all the claims filed in Federal Court can be “transferred,” sent to a single court and presided over by a single judge. Experienced Zofran lawyers will lead the charge, coordinating their evidence-gathering efforts and developing strong legal arguments together.
The Judicial Panel on Multidistrict Litigation has elected to send Zofran lawsuits to the US District Court for Massachusetts. Now officially consolidated as MDL 2657, the litigation will be presided over by the Honorable F. Dennis Saylor IV. Hundreds of birth defect claims have already been transferred to Boston, in preparation for the beginning of pre-trial proceedings.
Settlements Possible: How MDL Works
Common when multiple plaintiffs file similar lawsuits against a Defendant, MDL is meant to make the legal process more efficient for everyone involved.
Since each lawsuit shares a similar set of allegations, the Discovery phase, in which parties exchange information, can be conducted in common. The single judge can make rulings that apply to each claim equally.
After pre-trial proceedings are complete, a number of “bellwether” claims can be selected for trial. These “test cases” help both sides of the dispute gauge a jury’s likely reaction to witness testimony and evidence.
Zofran settlements may become more likely if juries find in favor of plaintiffs. Any lawsuits that don’t reach resolution in the MDL can be “remanded,” sent back to their original courts.
Is MDL The Same As Class Action?
No, multidistrict litigation isn’t the same as class action, although both mechanisms involve numerous claims against the same defendant.
In a class action, one or more “representative” plaintiffs file suit on behalf of a wider group. But members of this wider class are tied to the decisions made by their representatives, including whether to accept a settlement or proceed to trial. Studies have found that as few as 12% of class members ever receive compensation.
MDL, on the other hand, respects the individuality of each Plaintiff’s particular situation, allowing them to fully guide the course of their own lawsuit.
Can My Family File?
Any woman who delivered a child with major birth defects after taking Zofran may be eligible to file a claim against GlaxoSmithKline.
- were prescribed Zofran as a morning sickness treatment
- during the first trimester of pregnancy
- delivered a child with major birth defects
- have suffered increased medical expenses and emotional hardship
may be entitled to financial compensation.
Latest Zofran News
By Laurence P. Banville
September 26, 2017 – In-Utero Therapy Might Be Possible To Prevent Common Birth Defect
According to Centers for Disease Control and Prevention, about 2,650 babies are born in the U.S. with cleft palate each year and it is one of the most common birth defects in the world. Now scientists believe they may have found an in-utero treatment that could prevent the deformity from occurring at all. Scientists at the University of Utah Health were planning to study 2 sets of genes to see how they affect the formation of teeth and discovered that these genes also work to ensure that the palatal shelves grow and develop during fetal formation. The treatment still needs more testing but the current results look promising.
August 14, 2017 – Families Filing Zofran Lawsuits Request Release Of GSK Documents
Families involved in Zofran lawsuits against GSK (GlaxoSmithKline) regarding birth defects requested that the federal court make the company turn over regulatory files from Japan, Canada, and the United Kingdom. The documents, the plaintiffs say, will show that GSK did not disclose to U.S. regulators that Zofran could cause birth defects. A similar discovery request had been made by plaintiffs in the past and denied. However, when the request was denied the judge added that if the plaintiff could make a request for correspondence with health officials from specific countries that required drug labeling acknowledging possible issues with pregnant women using Zofran they would likely have more success.
July 27, 2017 – Some Antibiotics May Increase Birth Defect Risks According To New Study
A new study performed in Canada has found that a certain type of antibiotics in a class called quinolones are especially dangerous and need to be avoided during pregnancy due to the risk of unborn babies developing birth defects. The British Journal of Clinical Pharmacology published the study results. The study followed over 100,000 mothers of babies born in Quebec from 1998 to 2008 and tracked their antibiotic use during their first trimester as well as tracking their babies’ birth defects through the first year of their life. While infections in mothers need to be treated pregnant women and doctors need to be aware of the dangers that certain antibiotics could present.
June 30, 2017 – New Research Links Obesity During Pregnancy To Risk Of Birth Defects
In a new study, researchers used data from Sweden between the years of 2001 to 2014 from over 1.2 million live births. They found evidence which linked obesity in pregnancy to an increased risk of birth defects. In the British Medical Journal researchers urged women to maintain a healthy weight prior to becoming pregnant. Obesity is currently considered a growing health problem globally and some of the risks of severe obesity during pregnancy include diabetes, stillbirth, and preeclampsia.
May 31, 2017 – New York City Has 25% Of Babies Born With Zika-Related Birth Defects
City health officials announced on Thursday, May 25, that 25% of the babies born with Zika-related birth defects in the U.S. were born in New York City. There were almost 1,500 pregnant women identified across the country as having been infected. Sixteen babies were identified has to have birth defects related to Zika in NY out of 64 affected babies nationwide. The city health commissioner stated that unprecedented efforts were made to raise awareness of the risk of Zika transmission. While Zika is not making headlines this summer it is still imperative that travelers, especially pregnant women, take the proper precautions. Health officials announced this information last week, and this week a new study was published in BMJ which brought birth defects back into the spotlight. The study highlights the need for more research on the cause of birth defects because currently only one-fifth of birth defects are explained.
April 28, 2017 – Judge Will Allow Fraud-Based Claims To Remain In Zofran MDL
Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts released an order on Monday, April 24. In the order, he has refused to dismiss the claims against GlaxoSmithKline alleging that the company misrepresented Zofran’s labeling regarding the risk of birth defects. The judge did, however, find the allegations against the company’s marketing campaign too broad.
March 30, 2017 – Drug Testing For Different Genders Could Change With New Device
A new device called EVATAR has been developed and is located in a laboratory in Chicago. The device has replicated a full menstrual cycle for the first time. The device contains a bit of mouse ovary and pieces made from a human uterus, cervix, vagina, fallopian tubes, and liver. It was created in order to help scientists better understand how medications affect women in comparison to men. Until only recently medications were not tested on women which caused many complications when doctors assumed medicine would affect women the same way it affects men. Hopefully, this new device will make it easier to test drugs on a system that mimics a woman’s body so that complications such as those associated with Zofran will be a problem of the past.
February 28, 2017 – Some Women Opt For Marijuana Rather Than Zofran
The New York Times recently published an article which stated that the number of women who opted to use marijuana during their pregnancy was increasing. They released a follow-up piece which interviewed several women, 5 of which allowed their names to be used. Of these five women, two chose to use marijuana to control morning sickness instead of an off-label prescription for Zofran. The women expressed concern over the effect that Zofran or other prescription drugs could have on their unborn children, and decided after much contemplation that marijuana would be a better option for them.
January 27, 2017 – Plaintiffs Respond To GSK Request To Dismiss Fraud Allegations In Zofran MDL
GlaxoSmithKline has been arguing that the fraud claims alleged in the master complaint for the Zofran MDL should be dismissed due to lack of details needed under Rule 9.The master complaint alleges fraud by GSK by misrepresenting the safety risks to pregnant women and aggressively promoting the drug off-label. In response to the manufacturer’s filing to dismiss the fraud allegations, plaintiffs stated to the federal judge that they adequately laid out what is needed at this stage of the MDL process and will later provide more details such as the who, what, and when further on in the litigation.
December 28, 2016 – Judge Allows Five Zofran Lawsuits To Proceed
Five families who have missed discovery deadlines for the Zofran litigation argued that they were in need of more time in order to be able to obtain the necessary medical records. Since September, GlaxoSmithKline has argued that the cases should be dismissed due to not meeting the deadlines set in place, but the presiding judge, Judge F. Dennis Saylor IV, has allowed the cases to proceed stating that “dismissal is not appropriate under the circumstances.” There are 350 lawsuits consolidated in a Zofran MDL in the U.S. District Court for the District of Massachusetts. The litigation has made progress despite being slow moving and plaintiffs are hopeful that the litigation will move forward much further in 2017.
November 25, 2016 – Discovery Phase Continues In Zofran MDL
There are currently about 350 lawsuits pending in the Zofran MDL which claim the anti-nausea drug caused babies in utero to develop various birth defects when their mothers were prescribed the drug to treat symptoms of morning sickness. It is expected that hundreds more claims will be filed nationwide. Judge Saylor who presides over the MDL, has established five phases of discovery which were outlined in an order issued on November 10. Many of the phases outlined are already underway and the fourth phrase it is set to begin in February 2017. The start of the fifth phase will be determined at a later date.
October 26, 2016 – Two Lawsuits Added To Zofran Litigation
Over 300 Zofran lawsuits are already consolidated into a multidistrict litigation on Boston, Massachusetts claiming the anti-nausea drug caused babies to develop birth defects while in utero. Two more lawsuits have just been added, one from Mississippi and another from Texas. The plaintiff in Mississippi claims her baby suffers several congenital abnormalities, an enlarged heart and more than 10 other defects due to her use of Zofran while pregnant. The Texas plaintiff also claims Zofran is the cause of her child’s cardiac septal defects. These plaintiffs and others in the MDL allege that GlaxoSmithKline was negligent in failing to warn consumers of the risks associated with the drug.
September 28, 2016 – Wrongful Death Suit Filed By Woman Who Used Zofran During Pregnancy
A female plaintiff has filed a wrongful death lawsuit after being prescribed Zofran to combat her morning sickness during pregnancy. Her suit claims that the anti-nausea medication caused severe birth defects to develop in her twin babies, which led to the death of one child. The surviving baby was diagnosed with severe heart defects that may require future surgeries and medical treatment. Her case will join the more than 250 other federally-filed cases which allege the manufacturers failed to adequately warn consumers and the medical community of the risks involved with taking Zofran during pregnancy.
August 3, 2016- Pregnancy Terminated Because Of Zofran Malformations
A Zofran lawsuit that was recently filed alleged that Zofran, which was used during pregnancy led to side effects that caused an unborn baby to suffer malformations. The malformations were so extreme that the pregnancy needed to be terminated. The lawsuit states that GlaxoSmithKline did not do enough to warn pregnant women and the medical community about the dangers associated with Zofran use during pregnancy.
June 10, 2016- Pregnant Women Underrepresented In Clinical Research
A women’s health expert has stated that when it comes to drug safety, pregnancy is mostly a research-free zone. The consequence of this is being seen through the effects of drugs like Zofran that are prescribed to pregnant women suffering from extreme nausea. Most drugs like Zofran, that are prescribed during pregnancy in the United States are considered “off label”, which means they have not gone through the clinical trials required by the Food and Drug Administration before being approved for a specific use.
May 4, 2016- Zofran Lawsuits Being Filed In Canada
Canadian women are filing Zofran lawsuits stating that their children were born with birth defects after they were exposed to Zofran in utero. These Canadian lawsuits are similar to the suits being filed in the United States, where women used Zofran for their nausea and vomiting which was associated with morning sickness. Zofran warning labels in Canada state that the drug’s safety for use in human pregnancy has not been established, but there is no mention of the risks associated with using the drug while pregnant.
April 12, 2016- Zofran Master Complaint To Be Filed By April 14th, 2016
On April 14th, 2016, a Master Complaint for MDL 2657 will be filed in the ongoing Zofran lawsuit. Plaintiffs involved in this litigation will further provide the defendant, GlaxoSmithKline, with a Short Form Complaint. The purpose of the Short Form Complaint is so that they can provide the company with all the plaintiffs names and the type of Zofran they used, that is whether it was oral or I.V., state the drug script was written, state that the alleged harmed child was born in, and the types of injuries the child suffered from due to Zofran intake. Provision of a Master Answer is being requested by the plaintiffs no later than May 17th, 2016.
March 11, 2016- Protective Order Crafted By Zofran Lawsuit Parties
Zofran parties, Plaintiffs, and GlaxoSmithKline have collaborated to craft a protective order that is designed to keep certain documents private. This negotiated proposal is meant to protect internal corporate documents and the patients’ information which is found in the course of discovery. This document was put forth to the US District Court of Massachusetts on March 7, 2016. Approval from the federal judge is now being waited upon.
February 11, 2016- Boston MDL Sees 9 New Zofran Lawsuits
Nine more Zofran lawsuits were added to the Multi-District Litigation that has now combined into the U.S. District Court of Massachusetts. The lawsuits were brought to court between February 2nd and 5th alleging that the anti-nausea drug Zofran, caused birth defects. Eight of the nine cases were filed for the first time directly in the U.S. District Court of Massachusetts.