Texas Federal Judge Allows IFU Expert Opinions in Ethicon Pelvic Mesh Case

HOUSTON — A Texas federal judge has refused to exclude a case-specific expert’s testimony in an Ethicon pelvic mesh case to the extent he opines that the device’s Instructions for Use is factually incorrect and does not address the likelihood of adverse events.

In a Dec. 3 order, Senior Judge Gray H. Miller of the U.S. District Court for the Southern District of Texas further held that expert Dr. Niall Galloway may opine that the IFU does not provide sufficient information regarding potential medical issues such as “frequency, severity, lack of responsiveness to treatment, and permanence of complications associated …