Paul Miller is a partner at Will Davidson LLP, a law firm based in Ontario, Canada. Mr. Miller is an experienced trial lawyer having appeared before all levels of Appeals courts in Ontario. Mr. Miller’s practice is wide ranging and he has experience in working on defective medical devices and cases involving negligent manufacturing of pharmaceuticals.
Along with an alliance of US plaintiffs’ attorneys, Monheit Law is currently working with local counsel based in Ontario to help Canadian families investigate child birth defect claims against GlaxoSmithKline
Several recent studies have linked the pharmaceutical giant’s anti-nausea drug Zofran to an increased incidence of birth defects, including cleft palate and congenital heart defects. At least 4 US families have filed lawsuits, alleging that GlaxoSmithKline was aware of Zofran’s risks during pregnancy, and claiming that the company did nothing to warn the public, health community or regulatory agencies.
Zofran Birth Defect Lawsuits In Canada
Zofran, a powerful anti-emetic drug manufactured by GlaxoSmithKline, was approved by Health Canada in 1996 for the prevention of severe nausea and vomiting in two specific situations:
- patients undergoing chemotherapy or radiotherapy for the treatment of cancer
- patients undergoing surgical anesthesia.
Health Canada has only approved Zofran, as well as generic equivalents with the same active ingredient (ondansetron), for these two indications.
But many Canadian doctors have found another use for ondansetron: treating the often severe symptom of early pregnancy, morning sickness.
In the US, more than thirty years passed without an approved treatment for morning sickness. But in Canada, a medication called Diclectin has been approved by Health Canada to prevent nausea and vomiting of pregnancy since 1983. Even so, ondansetron has become a leading treatment for morning sickness in Canada and across the world.
GlaxoSmithKline’s Allegedly Fraudulent Zofran Marketing
Health Canada does not regulate this practice: the prescribing of drugs for unapproved purposes, and there is no law that would prevent doctors from doing so. Drug manufacturers, on the other hand, are barred from marketing their products for unapproved, or “off-label,” uses.
In 2012, the US Department of Justice (DOJ) brought a host of criminal and civil charges against GlaxoSmithKline. Among the civil allegations, the US federal government claimed that the manufacturer had promoted Zofran to doctors as a safe and effective treatment for nausea and vomiting of pregnancy. America’s DOJ also alleged that GlaxoSmithKline had paid kickbacks to physicians for prescribing several drugs, including Zofran, in violation of US law.
GlaxoSmithKline continues to deny these allegations, despite having reached a $3 billion settlement agreement to “resolve” its civil and criminal liabilities.
According to an investigative report in the Toronto Star, GlaxoSmithKline also denies that its sales representatives promote drugs for off-label purposes in Canada. However, the report concluded by saying that “Health Canada has never investigated or even asked the company about its ondansetron sales practices.”
Zofran’s Potential Link To Birth Defects
Drug manufacturers must first conduct clinical trials (studies involving human subjects) to determine the potential side effects of a product, before receiving approval from Health Canada. Notably, they are only required to do so in relation to the specific indications for which they intend to sell the drug.
Since GlaxoSmithKline never sought Zofran’s approval as a morning sickness treatment, the company has never investigated the drug’s effects in pregnant women when prescribed for morning sickness. Studies were conducted on pregnant rabbits and rodents in the late 1980s. After these tests, GlaxoSmithKline reported to the US Food & Drug Administration (FDA) that “no evidence of impaired fertility or harm to the fetus” was found. Even if that claim is true, animal studies are never assumed to predict similar results in humans.
But due to the increase in Zofran’s off-label prescription to pregnant women, several independent large-scale research studies have now been completed, all investigating Zofran’s possible effects on fetal development.
Studies Find A Possible Association Between Zofran & Severe Birth Defects
In 2012, researchers at Harvard University reviewed the birth records of more than 10,000 pregnant women. Comparing those women who had been exposed to ondensatron during the first trimester to those who had not, they found that women who had taken the drug were 2.37 times more likely to have babies with a cleft palate.
Danish researchers compiled data from every birth record filed in Denmark between 1997 and 2010, which totaled more than 900,000 births. After determining which women had been prescribed Zofran or a generic equivalent in the first trimester, they found that pregnancies exposed to ondansetron were 4.8 times more likely to result in babies born with atrioventricular septal defect, a congenital heart abnormality that involves holes in cardiac tissue.
Using similar methods, a team in Sweden found a lower, but statistically significant, increase of cardiac septum defects among babies born to women prescribed ondansetron.
You can learn more about these studies, along with additional research conducted on Zofran, here.
Reports Of Birth Defects Among Canadian Women
After analyzing the US Food & Drug Administration’s public database of side-effect records, which includes reports made by Canadian patients, journalists from the Toronto Star found at least 20 Canadian women who had been prescribed ondansetron and then “experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations.”
Distinguished pediatrician, and founder of the Hospital for Sick Children’s Motherisk program in Toronto, Gideon Koren was quoted as saying: “Here is a drug not meant for pregnancy, given in pregnancy, with no data. So how do you know it’s safe for a baby?”
Koren was actually the first researcher to investigate Zofran’s effects during pregnancy, publishing a study in 2004 that found no apparent association between ondansetron and “an increased risk for major malformations.” But after reviewing the latest research, Koren has revised his position. He now considers reports of serious side-effects among women and babies exposed to ondansetron a “signal that should be looked into.”
Health Canada’s Response
While Health Canada has released two updated drug warnings for Zofran, these safety announcements make no mention of the drug’s potential association with birth defects.
In regard to pregnancy, Zofran’s Canadian label reads:
“the safety of ondansetron for use by pregnant women has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.”
In regard to the recent research findings, the agency has been relatively silent. A spokesperson for Health Canada told the Toronto Star: “currently, no emerging safety issues requiring further assessment related to ondansetron use in pregnant women have been identified.”
Families Have Begun To File Zofran Lawsuits
Several American mothers have now filed personal injury lawsuits on behalf of their children. Each woman claims that she was prescribed Zofran during the first trimester, and then gave birth to a child with birth defects.
According to court documents, filed under docket numbers:
- CGC-15-544524 and
four women have raised a similar set of allegations against GlaxoSmithKline.
Like the US Department of Justice, plaintiffs claim that GSK fraudulently marketed Zofran to physicians as a safe morning sickness treatment, without any clinical evidence to substantiate that assertion.
Moreover, they allege that GlaxoSmithKline had received multiple reports of birth defects with suspected links to Zofran exposure as early as 1992, and that the company has received at least 200 such reports to date. In regard to the early studies involving pregnant animals, the mothers claim that those tests actually revealed “evidence of toxicity, intrauterine deaths, and malformations in offspring.” The complaints allege that GlaxoSmithKline failed to disclose any of this information to pregnant women, physicians or the US FDA.
If these allegations prove true, other mothers who were prescribed Zofran and then delivered babies with birth defects may be entitled to bring claims against GlaxoSmithKline themselves.
Can I File A Lawsuit?
Monheit Law has joined forces with a law firm based in Ontario to investigate potential claims against GlaxoSmithKline.
If you took Zofran as a treatment for morning sickness during the first trimester, and then gave birth to a child with congenital defects, we urge you to contact us for a free consultation.
You may be eligible to pursue compensation for your family’s pain and suffering, past and future medical expenses and loss in quality of life. Call 1-877-620-8411 or complete our online contact form to speak with an experienced attorney today.