First Bellwether Trial Over Zofran Birth Defects Set To Begin October 2021

The U.S. District Judge presiding over all Zofran birth defect lawsuits pending throughout the federal court system has scheduled the first bellwether trial to go before a jury in October 2021, which will help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of lawsuits filed by families nationwide.

GlaxoSmithKline currently faces more than 400 product liability complaints filed in U.S. District Courts throughout the country, each involving allegations that women and the medical community were not adequately warned about the potential pregnancy risks with Zofran, an anti-nausea medication that has commonly been marketed for use to treat morning sickness. However, families allege use of the medication during pregnancy caused children to be born with severe birth defects and congenital malformations, such as cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems.

Given the similar questions of fact and law presented throughout the Zofran litigation, cases filed throughout the federal court system have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.

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As part of the coordinated proceedings before Judge Saylor, a small group of representative cases have been prepared for a series of Zofran “bellwether” trials, which were expected to begin in January 2020. However, the first trial was delayed after GlaxoSmithKline filed a Citizen’s Petition sought to change the drug’s warning label, to give the agency time to respond to the petition.

Following a status conference last week, Judge Saylor reset the first jury trial, which is now tentatively set to begin on October 18, 2021, and is expected to last four weeks. Judge Saylor also set another conference for March 24, 2021, at which time the court will consider arguments over whether some cases should be dismissed, based on a claim by GlaxoSmithKline that plaintiffs have failed to provide causation evidence linking Zofran to septal defects and other heart defects.

In addition, the Court indicated discovery proceedings have temporarily stalled because Novartis is waiting on communications from the FDA regarding proposed labeling changes for the anti-nausea drug. Novartis acquired Zofran from GlaxoSmithKline in 2015. The FDA rejected a proposal for new birth defect warnings proposed by Novartis in November.

GlaxoSmithKline has attempted to defend against the lawsuits by arguing that the plaintiff’s failure to warn claims should be preempted by federal law. However, Judge Saylor has previously rejected this argument, finding there was no clear evidence the drug maker was prevented from strengthening the Zofran warnings. In addition, the court found there was not clear evidence the FDA would have rejected such efforts.

While the outcomes of any early “bellwether” trials will not be binding on other claims, they may greatly influence any Zofran settlement negotiations that would be necessary to avoid the need for hundreds of individual cases to go to trial in courts nationwide, if the drug maker is unable to otherwise bar the claims.

8 Comments

  • AmberJanuary 22, 2022 at 2:29 pm

    I took zofran from week 7 or 8 to 10 or 11. My son was born in 2013. He had dulpicating collective system and a blocked ureter. Surgery at 3 months old and 9 months. I've had 5 pregnancies and 6 children. None of them have kidney issues. I looked into it a little bit back then but thought I was crazy. Until now. A friend of mine is pregnant. Took the same meds at around the same time. Her son ha[Show More]I took zofran from week 7 or 8 to 10 or 11. My son was born in 2013. He had dulpicating collective system and a blocked ureter. Surgery at 3 months old and 9 months. I've had 5 pregnancies and 6 children. None of them have kidney issues. I looked into it a little bit back then but thought I was crazy. Until now. A friend of mine is pregnant. Took the same meds at around the same time. Her son has similar issues.

  • ShekaDecember 15, 2021 at 4:32 pm

    I TOOK ZOFRAN DURING MY PREGNANCY. MY SON DEVELOPED CLEFT PALATE. AFTER ALL MY PREGNANCY I NEVER REALLY NEED ZOFRAN BUT WITH MY SON I DID BECAUSE I HAD A BAD MORNING SICKNESS.

  • KodyNovember 7, 2021 at 6:03 pm

    I was on zofran in 2015 due to Hypermesis Gravidarum. My son was born with heart disease. I was never made aware that there could have been serious birth defects.

  • CarleneSeptember 26, 2021 at 2:24 am

    I was on zofran my entire pregnancy with my first daughter and she was very slow with her mental development. She is eleven years old and has IEP since she started public school at 5 years old. She struggles with all school work and I am in the strong belief that it is due to the use of Zofran during my pregnancy

  • TaaSeptember 12, 2021 at 1:26 pm

    My grand daughter was born early with a cleft lip, club foot & some brain issues. She 3 years old & can't walk or talk or hold up her head.

  • LisaJuly 29, 2021 at 8:25 am

    My child and I were on for my who pregnancy. I had hyperemesis gravidarum. I threw up 24/7

  • FatimaJune 29, 2021 at 3:09 pm

    I had Hyperemesis gravidarum in 2003 with my first pregnancy and had a Pic line put in to administer Zofran any time I needed. My 17 year old daughter was born with a slight hear murmur that cleared up but I think she’s on the autism spectrum now. Something is off and has been off with her. She developed late. Talking only till 4 years old, walked late started before 2 years old. She has learning [Show More]I had Hyperemesis gravidarum in 2003 with my first pregnancy and had a Pic line put in to administer Zofran any time I needed. My 17 year old daughter was born with a slight hear murmur that cleared up but I think she’s on the autism spectrum now. Something is off and has been off with her. She developed late. Talking only till 4 years old, walked late started before 2 years old. She has learning disabilities and it has to be the Zofran.

  • MarthaApril 26, 2021 at 12:39 pm

    I have a son who was born with bilateral club foot a text so friend throughout my pregnancy

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