Partner at Will Davidson, LLP, Paul Miller is an experienced trial lawyer based in Ontario. Mr. Miller’s legal experience encompasses a wide variety of matters, including cases involving dangerous medical devices and negligent pharmaceutical manufacture. He has appeared before every level of Appeals court in Ontario.
Along with Will Davidson, LLP, Mr. Miller has joined Monheit Law and our US-based litigation alliance to investigate claims of major birth defects that may have been caused by Zofran. Mr. Miller will guide the investigation of Zofran-related birth defect claims in Canada.
Joined by a coalition of distinguished US-based attorneys, Monheit Law has now aligned with counsel in Ontario to assist families from Canada in pursuing legal claims against GlaxoSmithKline, international pharmaceutical giant and manufacturer of the anti-nausea drug Zofran.
Can Canadian Families File Zofran Lawsuits?
At least four large-scale studies have begun to establish an association between Zofran, its active ingredient ondansetron, and an increased prevalence of severe congenital defects, including heart abnormalities and orofacial clefts.
Now, nine families from the US have brought legal claims against Zofran’s producer. Their complaints allege that GlaxoSmithKline marketed the anti-nausea drug directly to physicians as a safe and effective treatment for morning sickness, despite having never established Zofran’s safety for pregnant women or their developing babies.
These families also allege that GlaxoSmithKline was aware of Zofran’s potential risks for fetal development as early as 1992, but failed to warn US and Canadian regulatory authorities, the health community or the public.
Zofran & Health Canada
Health Canada approved Zofran in 1996 for the treatment of severe nausea under limited circumstances:
- to prevent nausea and vomiting in cancer patients treated through chemotherapy or radiotherapy
- to prevent post-operative nausea and vomiting
To date, neither Health Canada nor the US Food & Drug Administration have approved Zofran for the treatment of morning sickness in pregnant women.
Nonetheless, Zofran has become one of Canada’s leading medications prescribed to alleviate the symptoms of nausea and vomiting in pregnancy. According to an investigative report published on June 25, 2014 in the Toronto Star, this practice of prescribing Zofran for unapproved purposes, frequently referred to as “off-label” use, has become “common” in Canada.
In 2012, researchers at McGill University reviewed a total of 253,347 prescriptions written by Canadian physicians between 2005 and 2009. A full 11% of these prescriptions were for unapproved indications, and 79% of off-label uses “lacked strong scientific evidence” as to their safety or efficacy.
Off-label prescription is not regulated by Health Canada, and there are currently no Canadian laws prohibiting physicians from prescribing drugs for unapproved uses.
US Department Of Justice Claims That GlaxoSmithKline Marketed Zofran For Off-Label Uses
While doctors may prescribe medications “off-label” at their own discretion, pharmaceutical manufacturers are held to strict ethical standards. As in the US, Canadian statute forbids drug companies from marketing or promoting their products for unapproved uses.
The US Department of Justice (DOJ) began scrutinizing GlaxoSmithKline’s promotional practices as early as 2004. Their investigation included the marketing initiatives for 10 different drugs, including Zofran. In 2012, the DOJ filed a multitude of charges, both criminal and civil, against GlaxoSmithKline.
Two civil charges were filed in relation to Zofran and GSK’s marketing of the drug. The US Department of Justice alleged that:
- GlaxoSmithKline had promoted Zofran to physicians as a safe and effective treatment for morning sickness during pregnancy
- GlaxoSmithKline had paid kickbacks to doctors who prescribed Zofran
While GlaxoSmithKline denied, and continues to challenge, both claims, the company settled the DOJ’s case for a total of $3 billion. It remains the largest single settlement for alleged health care fraud in US history.
When prompted by journalists from the Toronto Star, GSK denied that company representatives promote any drugs, including Zofran, for unapproved use to Canadian physicians. When the question was brought to officials at Health Canada, Star reporters were told that the regulatory agency “has never […] even asked the company about its ondansetron sales practices.”
Studies Find Potential Link Between Ondansetron & Birth Defects
In response to the rapid rise in Zofran’s off-label prescription during pregnancy, multiple teams of researchers from across the globe have sought to establish the drug’s potential consequences for prenatal development.
In Denmark, a team from Copenhagen University reviewed every birth record filed from 1997 to 2010. During that 14 year period, Danish mothers gave birth to a total of 903,207 babies. By identifying those mothers who had been prescribed ondansetron during the first trimester, and then reviewing records of birth outcomes, the researchers were able to determine whether or not ondansetron exposure was associated with any adverse natal effects.
They found that women who had taken ondansetron in early pregnancy were almost 5 times more likely to deliver babies with atrioventricular septal defects (AVSD), a condition in which the heart’s chambers fail to form properly. Among other abnormalities, babies born with AVSD have large holes directly at the center of their hearts. These children almost always require immediate surgical intervention.
Researchers from Sweden investigated a wide swath of national birth records as well, and found a statistically significant increased incidence of congenital heart defects in babies whose mothers had been prescribed ondansetron during the first trimester.
In the US, a team of public health experts at Harvard and Boston Universities compiled birth outcome reports from more than 10,000 pregnancies. Looking back in time, they ascertained which women had been prescribed ondansetron, and then compared those pregnancies to a group of women who had not sought medical treatment for morning sickness. Ultimately, they concluded that women prescribed ondansetron were more than twice as likely to deliver children with a cleft palate.
You can find details from these studies here.
Did GlaxoSmithKline Study Zofran’s Effects In Pregnant Women?
In order to receive approval from Health Canada, pharmaceutical companies are obligated to study a drug’s effects in clinical trials first. These trials, which involve human subjects, are intended to determine:
- that a drug is effective in treating the conditions for which it will be marketed
- whether a drug is associated with adverse side effects
But critically, manufacturers must only perform clinical trials that involve patients experiencing the specific medical conditions for which approval is being sought. As we’ve mentioned, GlaxoSmithKline never submitted Zofran to Health Canada as a prospective morning sickness treatment. As a result, neither the drug’s safety nor its efficacy were ever studied in clinical trials that included pregnant women.
In short, GlaxoSmithKline has never established that Zofran is safe for pregnant women to take. Nor has the company ever investigated whether or not the drug presents potential adverse consequences for fetal development.
In seeking Zofran’s approval from the US Food & Drug Administration (FDA), GlaxoSmithKline did perform a series of studies using pregnant animals. The company reported that these trials revealed no evidence of fetal harm or impaired fertility. But even if those claims were accurate, the results of studies in animals are never taken to indicate that similar results will occur in human subjects.
Toronto Star Investigates Multiple Birth Defect Reports With Possible Link To Ondansetron
As part of their investigation into ondansetron’s off-label prescription in Canada, the Toronto Star’s journalists reviewed a huge database of adverse event reports collected by the US FDA. While this database is nominally American, Canadian physicians and patients are allowed to file their own reports as well.
Andrew Bailey, the paper’s data analyst, unearthed the accounts of “at least 20 Canadian women treated with ondansetron for vomiting in pregnancy [who] experienced serious suspected side-effects.”
Among these adverse events were:
- “two infant deaths”
- multiple “heart defects and kidney malformations”
- one “musculoskeletal anomaly”
There was also one record in which “a doctor reported that ondansetron was the suspected cause of a baby’s mouth deformity, jaundice, heart murmur and two heart defects, including ‘atrial septal defect,’ otherwise known as a hole in the heart.”
Has Health Canada Responded To These Reports?
After the Toronto Star brought these adverse event records to Health Canada’s attention, the regulatory agency reportedly stated that “there is no reason to probe the reported birth deformities.”
Nor has Health Canada responded in any way to the recent research studies that have begun to establish an association between ondansetron and an increased incidence of birth defects. Across Canada, Zofran’s warning label continues to state that:
“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.”
Likewise, Zofran’s US label reads: “this drug should be used during pregnancy only if clearly needed.”
Allegations Made In The First Zofran Birth Defect Lawsuits
In at least nine recent personal injury lawsuits, US families have brought claims for compensation against GlaxoSmithKline. In each complaint, plaintiffs allege that they were prescribed Zofran as a morning sickness treatment during the first trimester, and then delivered babies with birth defects.
Their claims include those made by the US Department of Justice, but go further. In addition to fraudulently marketing Zofran to physicians as a safe and effective method of treating nausea and vomiting during pregnancy, the plaintiffs allege that GlaxoSmithKline became aware of Zofran’s potential to cause fetal harm in 1992.
Plaintiffs allege that GlaxoSmithKline’s Zofran studies in pregnant animals did, in fact, present “evidence of toxicity,” including adverse alterations to both maternal and fetal physiology. They claim that after being given ondansetron, multiple animals gave birth to malformed offspring, and several of the animal fetuses died in utero.
In addition, each plaintiff claims that GlaxoSmithKline began receiving reports of birth defects with suspected links to Zofran more than a decade ago. They allege that the manufacturer has received at least 200 similar reports to date.
Plaintiffs allege that GlaxoSmithKline failed to report any of this information to US and Canadian regulatory authorities.
Can My Family File A Zofran Lawsuit?
If you took Zofran as a morning sickness during early pregnancy, and delivered a child with a birth defect, you may be entitled to pursue a claim against GlaxoSmithKline.
In order to help Canadian families, Monheit Law has joined with local counsel in Ontario. We urge families interesting in learning more about this ongoing litigation to contact our experienced attorneys for a free consultation.
Call 1-877-620-8411 or fill out our contact form today.