STORY FROM: Drugs & Medical Devices

Del. Federal Magistrate Judge Says Claims in GE GBCA Case Preempted

WILMINGTON, Del. — A Delaware federal magistrate judge has opined that a failure-to-warn claim against GE Healthcare in a gadolinium-based contrast agent case is preempted because the plaintiff failed to identify any newly acquired information that would have supported a label change via the Changes Being Effected regulation.

In a May 29 report and recommendation, Magistrate Judge Sherry R. Fallon of the U.S. District Court for the District of Delaware further found the plaintiff’s negligent design and manufacturing claim is preempted because GE could not alter the product’s FDA-approved design and manufacturing practices.

Debra Javens alleges she had normal kidney ...

Associated Documents
Report & Recommendation



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