A federal appeals court on Monday declined to revive hundreds of lawsuits by women who claim that GlaxoSmithKline Plc failed to warn them that taking the anti-nausea drug Zofran during pregnancy could cause birth defects.
that federal law preempts the plaintiffs' state-law claims that GSK failed to warn doctors and pregnant women that animal studies found a link between birth defects and taking Zofran.by U.S. District Judge F. Dennis Saylor that marked the end of 425 lawsuits consolidated before him in long-running multidistrict litigation.
The plaintiffs' lawyers contended that Japanese animal studies they claimed GSK had withheld from the FDA would have justified a change on the drug's warning label indicating the studies revealed adverse effects on the fetus. Without any newly acquired information, GSK could not legally change the label without the FDA's blessing, Kayatta wrote.
The 2021 update was in response to a request by Novartis AG, which was not a party to the litigation but had acquired Zofran from GSK in 2015 and proposed warning of the risks of harm to fetuses.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
How To Watch Monday’s College Football Playoff Championship Game On TV & OnlineUndefeated and defending national champion Georgia takes on TCU in the College Football Playoff national championship game Monday, with kickoff set for 7:30 p.m. ET/4:30 p.m. PT at SoFi Stadium in …
Weiterlesen »
Clouds And Rain Sunday, Dry With Sunshine Monday - Alabama NewsSunday's forecast looks much different. Clouds increase Saturday night. Rain falls from a mainly cloudy sky at times Sunday. However, Sunday does not look like a washout. Rain amounts could be in the ballpark of one quarter inch.
Weiterlesen »
Black Monday promises to turn up NFL head coaching carousel with more firingsSaturday’ s news that the Denver Broncos have requested and received permission from the New Orleans Saints to interview Sean Payton, per ESPN, was the latest reminder that more dominoes are …
Weiterlesen »
LAUSD urges students to get tested for COVID before returning to classes MondayThe Los Angeles Unified School District is encouraging parents to get students tested for COVID-19 before they return to classes tomorrow after winter break.
Weiterlesen »