Hundreds of families have filed Zofran lawsuits against GlaxoSmithKline, claiming the company’s anti-nausea drug causes birth defects. Despite having never been approved for use during pregnancy, Zofran is currently the top-selling morning sickness drug in the US. More than 1 million women are prescribed the drug every year, many in their first trimester, when developing fetuses are most susceptible to harm.
Here’s how we got here.
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How Zofran Became America’s Leading Morning Sickness Drug
Zofran was approved by the US Food & Drug Administration in 1991. Initially, the drug was designed and cleared for the treatment of nausea and vomiting caused by potent cancer treatments like chemotherapy. Its approval would be further extended to cover patients suffering from nausea during rounds of radiation therapy and for patients who experience nausea after going under anesthesia. It was never, and is still not, approved for the treatment of morning sickness. But no sooner had Zofran been released onto the US market than physicians across the country began using it to treat the nausea and vomiting of pregnancy.
By 2009, Zofran was America’s most popular pharmaceutical treatment for morning sickness. In that year, the drug overtook promethazine, its closest competitor. GlaxoSmithKline never looked back. In 2013, more than twice as many women were being prescribed Zofran during pregnancy as promethazine, according to numbers from IMS Health, the nation’s largest aggregator of prescription data.
How did that happen? How was Zofran able to capture an entire population of patients for whom it wasn’t even approved? Here are two theories:
1. With No Other Treatment, Doctors Had To Choose Something. They Chose Zofran.
Before Zofran came along, there weren’t any drugs approved to treat morning sickness in the US. Bendectin, the last nausea medication approved for use during pregnant, was withdrawn from the market way back in 1983. That had huge effects.
For one, Bendectin’s removal from use led to a drastic increase in pregnant women being hospitalized for severe nausea. The year after Bendectin’s withdrawal, hospital admissions for excessive vomiting among pregnant women increased by 50%, according to an article published in the Canadian Journal of Public Health. Bendectin’s effective recall left a huge hole in the market; millions of women were getting pregnant, most suffered from morning sickness, but there was no drug to treat them.
Then Zofran, a new option for nausea, was approved. Of course, it wasn’t approved for pregnant women, but that’s never stopped physicians from trying drugs out in new patient populations. Researchers at Dartmouth have found that 1 out of every 5 prescriptions is “off-label,” written for an indication that the drug was never approved for. Perhaps more troubling, at least 15% of those off-label prescriptions have no medical science to back up either their safety or effectiveness. Be that as it may, doctors began trying Zofran out on their patients with morning sickness, and it worked. Word spread, and soon 1 million pregnant women were getting the drug every year.
2. GlaxoSmithKline Illegally Promoted Zofran For Use During Pregancy (At Least That’s What The Justice Department Thinks).
The other theory to explain Zofran’s unprecedented popularity was first floated by the US Department of Justice. It’s a lot simpler: GlaxoSmithKline was marketing Zofran to doctors as a safe and effective morning sickness drug. That, as you might expect, would be illegal.
While doctors have every right to prescribe drugs off-label, pharmaceutical manufacturers are only allowed to promote their products for approved uses. GlaxoSmithKline, however, had been telling obstetricians and gynecologists to try Zofran in their pregnant patients, going so far as to imply that the drug had been demonstrated safe during early fetal development, federal prosecutors alleged. According the Justice Department, the company had even set up a system of illegal kick-backs to compensate physicians who sold a lot of Zofran.
In 2011, the US government took GlaxoSmithKline to court, in part for unlawfully promoting Zofran. After a year-long legal battle, the company’s attorneys hammered out a settlement agreement, one that didn’t require GlaxoSmithKline to accept any liability for its alleged off-label promotion of Zofran. Despite never claiming responsibility, the company agreed to pay the government $3 billion. It remains the largest settlement for alleged health care fraud in US history.
You can read more about the government’s case against GlaxoSmithKline, and the two whistleblowers who started it, here.
Zofran & Birth Defects: Studies Find Troubling Link
But the Justice Department’s case didn’t have anything to do with whether or not Zofran was actually safe for pregnant women to take. The government’s lawsuit only looked into how GlaxoSmithKline had marketed the drug, not whether it could cause birth defects in children.
That difficult task would be left to medical researchers who, at the end of 2011, began investigating Zofran’s effects on fetal development.
Harvard Study Shows Increased Risk For Cleft Palate
In January of 2012, a team of researchers from Harvard University and Boston University’s Slone Epidemiology Center published “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects” in the journal Birth Defects Research. The study took an exhaustive look at common morning sickness treatments and their potential links to fetal harm.
Using patient interviews and hospital records, the team realized that women who were prescribed Zofran seemed to have more babies with cleft palate than women who weren’t. Far more, actually. The risk of delivering a child with cleft palate jumped by 237% when Zofran was added to the equation.
In Denmark & Sweden, Congenital Heart Defects Rise With Zofran
Troubled by the widespread use of Zofran during pregnancy, Danish researchers from Copenhagen University dove into their own country’s health records to investigate the drug’s potential effects. Analyzing prescription and birth records from more than 900,000 pregnancies, the team discovered a shocking association between Zofran and congenital heart defects.
Women taking Zofran were:
- 60% more likely to have a child with any heart defect
- 2.1 times more likely to have a child with atrial septal defect
- 2.3 times more likely to have a child with ventricular septal defect
- 4.8 times more likely to have a child with atrioventricular septal defect
Notably, the researchers only looked at women who had taken the drug during their first trimester, when a baby’s cardiac tissues are beginning to form. Their results were released in 2013, and followed quickly by a similar study from Sweden.
Swedish government researchers reviewed every birth record filed in Sweden between 1998 and 2012, a total of more than 1 million pregnancies. As in Denmark, women prescribed Zofran were more likely to have babies with heart defects. The team noted a 60% increase in the rate of all heart defects, and a more than two-fold rise in the risk for “cardiac septal defects,” a category of abnormalities that includes atrial, ventricular and atrioventricular septal defects. The study, ultimately published in the December 2014 edition of Reproductive Toxicology, provided damning corroboration for the findings in Denmark, sparking a wave of litigation that experts say has only begun.
Hundreds Of Zofran Lawsuits Say Drug Caused Birth Defects
Parents are now filing civil lawsuits against GlaxoSmithKline, claiming its potent anti-nausea drug caused their children to be born with birth defects. Families across the nation say the company treated expectant mothers like “human guinea pigs,” promoting an unproven drug with devastating consequences. The first lawsuit was filed in February of 2015, and a steady stream has followed since.
While these lawsuits were initially filed in federal courts across the country, they have been formally transferred to the US District Court of Massachusetts in Boston. Now consolidated as a “Multi-District Litigation,” the lawsuits will head through all-important pre-trial proceedings together. But prominent members of the legal community say the fact that the Zofran litigation has been consolidated doesn’t restrict the rights of other families. Parents who gave birth to children with birth defects after being prescribed Zofran may still be able to file suit.
Breaking Zofran Lawsuit Updates
By Michael Monheit
June 30, 2017 – New Study Finds Strong Link Between Maternal Weight & Birth Defects
A new study from researchers in Sweden (joined by teams in Denmark and the United States) has found compelling evidence that a mother’s weight can increase the risk of her child being born with birth defects. You can read more about the research, along with its implications and limitations, here.
June 1, 2017 – Washington State Still Can’t Explain Strange Cluster Of Neural Tube Birth Defects
A region of Washington State has been struck by a strange rash of rare birth defects. Children are being born with anencephaly, a congenital disorder that inhibits the growth of a fetus’ head, leaving portions of the brain, skull and scalp undeveloped. While anencephaly is exceedingly rare, occurring in only around 2 of every 10,000 American pregnancies, it’s not so rare in Washington State. In fact, the birth defect is around four times more likely to occur in three counties of Eastern Washington than the nation overall. Researchers, however, have struggled to explain the drastic increase in birth defect rates afflicting Benton, Franklin and Yakima Counties.
It’s not from lack of trying. As Crosscut reports, state health officials have called in experts from the US Centers for Disease Control & Prevention and established an advisory committee to investigate the problem. Thus far, their inquiry has come to naught. No cause for the congenital anomalies has yet been identified, though a number of potential answers have been ruled out. More accurately, every potential answer has been ruled out, from exposure to radiation from a nearby nuclear weapons facility to any of the pesticides commonly-used in the area.
Scientists have been grappling with Eastern Washington’s peculiar anencephaly rate for six years now, but in the absence of any plausible leads, the State is running out of patience – and money. Washington’s Department of Health plans to track anencephaly cases for another eight months, with a proposed end date for the project looming in January 2018.
May 3, 2017 – Boston Federal Judge Allows Fraud-Based Zofran Claims To Stand
A Massachusetts federal judge has denied GlaxoSmithKline’s petition to strike allegations that the company fraudulently advertised its anti-nausea drug Zofran for off-label use during pregnancy, according to Law360.
Hundreds of families say the drug, which is approved for use in chemotherapy patients, causes major birth defects. Their lawsuits have been consolidated in the US District Court of Massachusetts under the guidance of Judge F. Dennis Saylor. Several months ago, GlaxoSmithKline presented Judge Saylor with a proposal: dismiss the plaintiffs’ fraud-based allegations, claims the company called unsupportable and vague.
Judge Saylor delivered his answer to Glaxo’s suggestion on April 24, 2016, saying that plaintiffs could continue to argue their allegations of fraud – where those allegations touched on Zofran’s labeling. While Judge Saylor considered allegations of a general, fraudulent marketing campaign “too broad,” he allowed that plaintiffs’ had pled their labeling-related claims with adequate specificity. As Judge Saylor wrote in his official order:
“Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling.” Whether or not any prescribing physicians actually relied on the labeling’s language, the Judge wrote, is “a question for another day.”
April 12, 2017 – Families Win Right To Examine Justice Department Investigation Of Zofran Marketing
In a court order released on April 6, 2017, US Magistrate Judge Judith Dein has sided with plaintiffs in the Zofran litigation, allowing the families to discover “documents and communications” between GlaxoSmithKline and the US Department of Justice.
The pharmaceutical manufacturer came under federal investigation nearly a decade ago over allegations of unlawful marketing practices. In part, the government accused GSK of promoting Zofran for unapproved use among pregnant women, a contention that plaintiffs have revived in their individual birth defect lawsuits against the company. With Judge Dein’s recent order now official, the families will soon be able to learn crucial details from the government’s investigation.
March 21, 2017 – Marijuana For Morning Sickness? Potential Risks To Fetus Give Researchers Pause.
To date, 29 states and the District of Columbia have legalized marijuana for medical purposes, sanctioning the drug’s use by patients with cancer, glaucoma, HIV / AIDS and certain seizure disorders. Marijuana’s benefits for treating pain and nausea have received considerable attention, although the research to support the drug’s therapeutic potential remains spotty and, for some inconditions, non-existent.
Thus it was with some surprise that researchers identified a new and expanding patient population who have begun to lean on marijuana as a medical therapy: pregnant women dealing with morning sickness. Marijuana is already the most-frequently used illegal drug among pregnant, the Washington Post reports, but now we have compelling evidence to suggest that more and more pregnant are turning to the drug for its reported therapeutic benefits. Indeed, reports out of Hawaii have found that women experiencing severe forms of morning sickness are over 60% more likely to use marijuana than other pregnant women.
This trend isn’t good, researchers say, in a new editorial published by the Journal of the American Medical Association. While the medical literature is still developing, scientists have found troubling evidence that marijuana use during pregnancy, especially during the first trimester, may harm a developing fetus. Exposure to marijuana has been linked to increased rates of anemia and low birth weight in infants. Children born to women who used marijuana while pregnant also appear more likely to be admitted to neonatal intensive care units. Long-term research has found a correlation between prenatal marijuana exposure and impaired impulse control during a child’s school years.
February 21, 2017 – Drug Company-Funded Studies Might Not Detect Safety Risks, German Researchers Say
Studies funded by pharmaceutical companies are often too small to uncover rare side effects, according to a new German study published in the British Medical Journal.
Conducted after a drug has been released to the market, post-marketing studies are often used to evaluate potential issues, most notably long-term risks, that may not have been caught during clinical trials. But in analyzing the results of 558 such post-marketing studies, all funded by drug manufacturers, a group of German researchers found that a majority of studies enrolled too few patients to turn up evidence of rare risks.
The problem is even worse, however. When a study’s data suggests that a company’s drug may cause harm, that information is usually considered proprietary business information. Bankrolled by drug manufacturers, researchers themselves are often bound by contract to keep their results out of the public eye. “The fact that many physicians are obliged by contracts to handle adverse drug reactions as confidential business information rather than reporting them is very disturbing,” lead author Dr. Angela Spelsberg told Reuters.
“In light of the indispensable role of general practitioners and clinicians in detecting, diagnosing and publicly reporting adverse drug reactions,” Spelsberg told reporters, “this means a very big threat to public safety.”
January 19, 2017 – GlaxoSmithKline & Families Grapple Over Off-Label Fraud Allegations In Generic Zofran Lawsuits
Dozens of families have sued GlaxoSmithKline over child birth defects that parents believe were caused by generic versions of ondansetron, the active ingredient in GlaxoSmithKline’s brand name Zofran drug. Families accuse the multi-national healthcare conglomerate of fraudulently promoting Zofran for off-label use in pregnant women. This alleged illegal marketing, parents say, allowed even generic drug manufacturers to profit, placing an unproven anti-nausea drug in the hands of millions of pregnant women nationwide.
But in an ongoing legal battle, GlaxoSmithKline argues that lawsuits filed over generic versions of ondansetron should be dismissed entirely for a lack of detail on the company’s alleged off-label marketing, Law360 reports. In a new court filing, parents have struck back, telling a federal court in Massachusetts that that their claims have been adequately established.
Multiple generic manufacturers currently produce their own versions of ondansetron, the active ingredient in Zofran.
December 12, 2016 – Zofran Oral Solution Discontinued
On November 17, 2016, the US Food & Drug Administration announced that the oral solution for Zofran, a popular anti-nausea drug linked to major birth defects, has been discontinued. The agency says that the oral solution’s discontinuation is not due to “manufacturing product quality, safety or efficacy concerns.” No reason for the product’s withdrawal has yet been announced.
November 17, 2016 – GSK Requests Dismissal Of Generic Zofran Lawsuits
GlaxoSmithKline has asked a Massachusetts federal court to dismiss 27 lawsuits filed over generic versions of the company’s anti-nausea drug Zofran. The pharmaceutical corporation’s motion to dismiss, filed on October 13, 2016, was followed only hours later by a second request, asking the Court to strike all “fraud-based claims” from the more than 200 Zofran lawsuits that have been consolidated in a Boston MDL. The Court has not yet ruled on either issue, but has instructed Plaintiffs to file their responses in January 2017.
October 19, 2016 – GlaxoSmithKline Requests Confidentiality For Affidavit Of Electronic Evidence Expert
As discovery in the Zofran MDL continues, GlaxoSmithKline has asked the court to make confidential an affidavit from John H. Jessen, one of the world’s leading experts on electronic evidence. Jessen has been called “the nation’s foremost authority on secret or deleted computer files.” His company, Electronic Evidence Discovery Inc., was founded to “help companies under subpoena identify, locate, retrieve, and review electronic documents,” according to Wired Magazine.
Electronically-stored documents have become a primary source of evidence in legal proceedings. GlaxoSmithKline has thus far opposed plaintiffs’ attempts to discover “what GSK knew as it [allegedly] marketed [Zofran] to pregnant women,” according to court filings, hoping to limit discovery to regulatory and science topics.
September 20, 2016 – Zofran Lawsuit Discovery Moves Forward
Discovery in the Zofran MDL is well underway. In June, GlaxoSmithKline produced approximately 500,000 documents related to approval applications for its anti-nausea drug, which hundreds of families say can cause birth defects. Attorneys are now scouring the documents for information on the drug’s early clinical trial testing and development history.
August 22, 2016 – French Health Organization Accused Of Concealing Epilepsy Drug’s Birth Defect Risk
A French newspaper has accused the country’s national health organization of concealing a study on the continued use of an epilepsy drug, known to cause birth defects, in pregnancy.
France’s Le Canard Enchaine usually focuses on satirical humor about French culture and politics. But the paper occasionally runs investigative pieces, using a network of government and corporate insiders. On August 10, the publication reported claims that France’s health ministry suppressed a study finding evidence that over 10,000 pregnant women had been prescribed sodium valproate between 2007 and 2014, despite the drug’s known link to severe congenital malformations.
French officials have denied the allegations. In the US, valproate is sold as Depakote. The US Food & Drug Administration has strongly warned against the use of Depakote during pregnancy for more than a decade.
July 25, 2016 – In 277th Zofran Lawsuit, Texas Parents Say Nausea Drug Caused Cleft Palate, Kidney Defects
Nearly 300 families have filed lawsuits in the US District Court of Massachusetts, accusing multinational pharmaceutical giant GlaxoSmithKline of hiding scientific evidence about its nausea drug Zofran. Parents say the drug causes child birth defects, and that years of medical research supports their allegation.
In the most recent case, parents from Longview, Texas claim that prenatal exposure to Zofran caused their unborn child to develop cleft palate and kidney defects. In 2012, researchers at Harvard University found that children exposed to Zofran’s active ingredient were more than twice as likely to develop cleft palate, an orofacial defect.
The lawsuit was filed on July 25, 2016 under the case number 1:15-md-02657-FDS. The parents used a new, simplified “Short Form” Complaint to file suit.
June 22, 2016 – Zofran Litigation Sees Major Progress
To date, more than 260 families have filed suit against GlaxoSmithKline, claiming the company’s anti-nausea drug causes major birth defects. In some ways, this would not be a problem, since Zofran is not specifically approved for use during pregnancy. But in their complaints, parents say GlaxoSmithKline marketed the drug as a morning sickness treatment, putting thousands of unborn children at significant risk. GlaxoSmithKline denies this allegation, one that was first raised by the US Department of Justice. The truth, in any event, will likely come to light in the course of litigation.
That litigation, however, is speeding up. After months of negotiation, Plaintiffs have now finalized a set of standardized documents, so-called “Master” complaints that will bring every one of their shared allegation together in one place. There is one Master Complaint (PDF) for parents who claim to have been prescribed Glaxo’s brand name Zofran product, and another for people who say they were prescribed generics. Along with a Short Form Complaint, in which families will be able to outline their own individual circumstances, these documents will set the stage for the Zofran litigation’s progress through pre-trial proceedings.
May 24, 2016 – MDL Status Conference Finds Zofran Plaintiffs, GlaxoSmithKline In Agreement
Reports from the US District Court of Massachusetts suggest that a recent Zofran MDL status conference, held before Judge F. Dennis Saylor, IV on May 17, resolved several issues of dispute between GlaxoSmithKline and more than 200 families who say the company’s anti-nausea drug Zofran causes major birth defects.
A court order, issued the following day, confirms that Saylor has finalized a timeline for the filing of “master pleadings.”
Plaintiffs are required to file and serve on GlaxoSmithKline their Master Complaint by May 31, 2016. This standardized document will gather together every allegation leveled against the pharmaceutical giant by hundreds of parents, who will then be required to file individual Short Form Complaints, adopting the specific allegations they wish to endorse. On June 21, 2016, Defendants will file their Master Answer, another standardized document that will respond to each of the allegations listed on Plaintiffs’ Master Complaint. Once a Short Form Complaint has been served, Defendants will have 30 days to file a motion to dismiss that individual case. If they do not, their Master Answer will be deemed a legally-binding response to the Short Form Complaint, along with those portions of the Master Complaint that the Plaintiff has adopted.
An order that will protect confidential information during the course of discovery was also issued on May 18, 2016.
April 20, 2016 – Plaintiffs Submit Proposed Fact Sheet For GlaxoSmithKline
On April 1, 2016, legal representatives of the more than 200 families who have filed Zofran lawsuits submitted their proposed “Defendant Fact Sheet” to the Massachusetts federal court in which their claims have been consolidated.
In essence, the fact sheet serves as a standardized list of questions that, upon approval, GlaxoSmithKline will be required to answer for each individual plaintiff. Plaintiffs themselves will need to fill out a similar “Plaintiff Fact Sheet,” providing information for the company to use during litigation.
Most of the fact sheet submitted by Plaintiffs is concerned with physicians, primarily those who prescribed Zofran during pregnancy, and whether or not GlaxoSmithKline contacted those doctors about the nausea drug. Plaintiffs have raised a number of questions about the financial relationships, if any, maintained between specific physicians and the company behind Zofran. Plaintiffs also ask whether or not GlaxoSmithKline tracked the amount of Zofran these doctors prescribed, a common practice among pharmaceutical companies hoping to “boost” their sales.
While GlaxoSmithKline has agreed that many of these questions are appropriate, and can be asked in the fact sheet, several areas of dispute remain unresolved. The company has taken issue with the scope of several inquiries, including Plaintiffs’ hope to learn particular details about sales representatives, including their level of education.
Negotiations between the two parties, Plaintiffs and GlaxoSmithKline, have thus far proven unsuccessful in settling these differences, and the final word will come from the Honorable F. Dennis Saylor IV.
March 29, 2016 – Plaintiffs & GlaxoSmithKline Debate “Product Identification”
With GlaxoSmithKline’s anti-nausea drug Zofran having surpassed its 25th birthday, it may come at no surprise that the company no longer holds a patent on the drug’s active ingredient, ondansetron. In fact, at least 30 different generic drug companies currently manufacture ondansetron. GlaxoSmithKline, in an effort to identify those plaintiffs who may have ingested generic forms of the drug, petitioned the US District of Massachusetts on February 22, 2016, asking the court to require “product identification” immediately.
Many observers have noted that GlaxoSmithKline’s request is likely meant to separate generic from brand name cases, in hopes that lawsuits involving generic ondansetron will be dismissed. In previous lawsuits, courts have ruled that brand name drug companies cannot be held liable for the injuries caused by generic equivalents, despite the fact that generic companies are prevented by federal law from altering their warning labels until a brand name company does so first.
In a vigorous response, filed on March 8, 2016, Plaintiffs argue that the Zofran case is different. But before doing so, they write that product identification, while certainly important, should take place during discovery, not before the fact-finding process has begun. Both sides in the dispute are currently drafting “fact sheets,” documents with a standardized set of questions that will allow for initial discovery in an efficient manner. Those fact sheets are the appropriate place for “product identification” to occur, Plaintiffs argue.
Beyond procedural concerns, Plaintiffs say that even generic cases should be allowed to stand. In the course of their lawsuits, Plaintiffs intend to prove that GlaxoSmithKline marketed Zofran illegally as a morning sickness treatment, they write, citing allegations first raised by the US Department of Justice, ones which the company continues to deny. As a result of this allegedly unlawful promotion, however, GlaxoSmithKline effectively “set the stage” for numerous generic drug companies, Plaintiffs claim. The generic companies only came along afterwards to exploit the market among pregnant women, they allege, a market Plaintiffs say was illegitimately created by GlaxoSmithKline. Thus GlaxoSmithKline should be held accountable for all the injuries that may have been caused by ondansetron, Plaintiffs write, whether or not the company had a hand in manufacturing a particular pill or infusion.
Judge F. Dennis Saylor IV has yet to rule on the issue.
February 1, 2016 – Zofran Judge Denies GlaxoSmithKline Motion To Dismiss All Lawsuits
On January 22, 2016, GlaxoSmithKline’s first attempt to have every Zofran lawsuit dismissed was stymied. The Honorable F. Dennis Saylor IV, the federal judge selected to preside over more than 200 lawsuits claiming Zofran causes birth defects, opted to give plaintiffs more time to “develop the facts” of their case against GlaxoSmithKline.
Families have accused GlaxoSmithKline of failing to warn the public about Zofran’s potential link to birth defects, which would be illegal under state law. But some state laws that conflict with federal laws don’t apply to drug manufacturers all the time. That’s called “federal preemption,” and GlaxoSmithKline argued that plaintiffs’ demand to have Zofran’s warning label change was preempted, since a citizen’s petition to have the warning label changed was rejected by the FDA, a federal agency, in October of 2015.
Saylor disagreed, allowing the claims to proceed through pre-trial steps like discovery.
Latest Zofran Updates
Below you will find a listing of the most recent lawsuits filed against GSK seeking compensation for the severe child birth defects sustained by the plaintiffs from ingesting Zofran during the first trimester of pregnancy.
Please check back regularly for updates as our Zofran lawyers will keep this listing up to date.