In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010). There’s nothing particularly interesting about the affirmance as to the manufacturing defect claim. But what the court had to say about plaintiff’s allegations concerning off-label promotion is music to our ears. First, there’s nothing improper about off-label (more…)

We had to comment on the most intriguing case of Hughes v. Boston Scientific Corp., 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009). Hughes involved a PMA device, something called a “HydroTherm Ablator,” that allegedly malfunctioned and injured the plaintiff. Thereafter, the defendant (1) changed its adverse event reporting algorithm in response to FDA concerns, and (2) still later, instituted a Class II recall of the device.
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