GlaxoSmithKline Says FDA Rejection of Petition to Review Zofran Pregnancy Data Should Provide Company Liability Protection
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Birth Defect Lawsuits Over Zofran Dismissed After Summary Judgment Granted on Federal Preemption June 7, 2021 Irvin Jackson Add Your Comments The U.S. District judge presiding over pretrial proceedings in all federal Zofran birth defect lawsuits granted a motion for summary judgment filed by the drug maker last week, determining the failure to warn claims are preempted by federal law, resulting in the dismissal of several hundred lawsuits brought by families nationwide. Since late 2015, the litigation has been centralized in the U.S. District Court for the District of Massachusetts, where U.S. District Dennis Saylor has presided over discovery and pretrial proceedings in claims brought by more than 400 families of children born with severe birth defects or congenital malformations following exposure to Zofran during pregnancy, including cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems. Each of the complaints raise similar allegations, indicating GlaxoSmithKline withheld important warnings about the pregnancy risks with Zofran, an anti-nausea medication which has commonly been marketed for “off-label” use to treat morning sickness. Learn More About Zofran Lawsuits Use of Zofran in Pregnancy May Increase the Risk that Children Suffer Cleft Palate, Cleft Lip, Heart Defects or Other Malformations. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Zofran Lawsuits Use of Zofran in Pregnancy May Increase the Risk that Children Suffer Cleft Palate, Cleft Lip, Heart Defects or Other Malformations. Learn More SEE IF YOU QUALIFY FOR COMPENSATION While the first “bellwether” trials were expected to begin later this year, to help gauge how juries may respond to certain evidence and testimony that would be repeated throughout the claims, the litigation came to an abrupt end last week, when Judge Saylor granted a renewed motion for summary judgment brought by the drug makers. A a similar motion was rejected in February 2019, after the Court found there was not clear evidence the FDA would have rejected an attempt by the drug makers to add new pregnancy warnings to the drug label. However, Judge Sayler agreed to reconsider the decision after a U.S. Supreme Court decision issued a few months later clarified that a judge, not a jury, must determine whether there is clear evidence a drug maker fully informed the FDA about the justifications for adding such warnings, and that such warnings were rejected. In a 68-page memorandum and order (PDF) issued on June 1, Judge Saylor determined the state-law based claims for failure to warn were preempted by federal law, after finding the FDA had ample opportunity to change Zofran’s warning label, and has refused to do so. Therefore, since the FDA’s judgment has priority, the Court determined GlaxoSmithKline cannot face failure to warn claims regarding Zofran, regardless of whether it provided the agency with all the necessary information to make that decision. “In short, even assuming that GSK did, in fact, fail to make complete disclosures to the FDA in 1991, and at various later points, there is no question that the FDA is now fully informed of all relevant information concerning the safety of the drug. And the FDA has made the determination that a label change is not warranted,” Judge Saylor wrote. “Thus, the FDA, acting pursuant to the duty imposed on it by federal law, has rejected the pregnancy warning label that plaintiffs insist was required by state law at the time of the alleged injuries.” Judge Saylor issued an official judgment (PDF) in favor of GlaxoSmithKline on June 2. resulting in the dismissal of all claims, which is likely to be appealed by plaintiffs’ lawyers. Tags: Birth Defects, GlaxoSmithKline, Novartis, Pregnancy, Zofran, Zofran Birth Defects More Zofran Lawsuit Stories Trial Court Dismissal of Zofran Birth Defect Lawsuits Upheld on Appeal Before First Circuit January 10, 2023 First Bellwether Trial Over Zofran Birth Defects Set To Begin October 2021 March 5, 2021 GlaxoSmithKline Says FDA Rejection of Petition to Review Zofran Pregnancy Data Should Provide Company Liability Protection January 21, 2021 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermNameThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: 2 days ago) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. MORE ABOUT: HAIR RELAXER LAWSUITHair Relaxer Cancer Lawsuits Continue To Be Filed as Lawyers Prepare First Cases for Trial (06/24/2025)Replacement Hair Relaxer Lawsuit To Be Selected for MDL Bellwether Pool (06/12/2025)Hair Relaxer Lawsuits and Talcum Powder Lawsuits Designated as New Mass Torts in Philadelphia (05/30/2025) Lawyers Ordered To Engage in Talcum Powder Settlement Talks in MDL (Posted: 2 days ago) A special mediator has been appointed to oversee negotiations between Johnson & Johnson and tens of thousands of women who say its talcum powder products caused them to develop reproductive system cancers. 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Trial Court Dismissal of Zofran Birth Defect Lawsuits Upheld on Appeal Before First Circuit January 10, 2023
GlaxoSmithKline Says FDA Rejection of Petition to Review Zofran Pregnancy Data Should Provide Company Liability Protection January 21, 2021
Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: 2 days ago) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. MORE ABOUT: HAIR RELAXER LAWSUITHair Relaxer Cancer Lawsuits Continue To Be Filed as Lawyers Prepare First Cases for Trial (06/24/2025)Replacement Hair Relaxer Lawsuit To Be Selected for MDL Bellwether Pool (06/12/2025)Hair Relaxer Lawsuits and Talcum Powder Lawsuits Designated as New Mass Torts in Philadelphia (05/30/2025)
Lawyers Ordered To Engage in Talcum Powder Settlement Talks in MDL (Posted: 2 days ago) A special mediator has been appointed to oversee negotiations between Johnson & Johnson and tens of thousands of women who say its talcum powder products caused them to develop reproductive system cancers. MORE ABOUT: TALCUM POWDER LAWSUITSTalcum Powder Ovarian Cancer Lawsuit Selected for First Federal Bellwether Trial (07/01/2025)Retired Talcum Powder Judge May Be Appointed To Address Renewed Expert Motions (06/20/2025)Talc Safety To Be Subject of New Independent Scientific Expert Panel Led by FDA (05/22/2025)
Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (Posted: 3 days ago) A wrongful death lawsuit claims a woman’s sister died of a Depo-Provera brain tumor which was not discovered until after her death. MORE ABOUT: DEPO-PROVERA LAWSUITLawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)Ortho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)