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Pharmaceutical Industry › Food and Drug Administration (FDA) › Birth Defects

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Faegre Drinker Biddle & Reath LLP on

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Console and Associates, P.C. on

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

Steptoe & Johnson PLLC

WV Supreme Court Kicks Failure to Warn Case Under Michigan Law

Steptoe & Johnson PLLC on

The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more

Shook, Hardy & Bacon L.L.P.

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

Shook, Hardy & Bacon L.L.P. on

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Morrison & Foerster LLP - Class Dismissed

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Morrison & Foerster LLP - Class Dismissed on

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

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