We just learned about Pinsonneault v. St. Jude Medical, Inc., No.0:12-cv-01717-PJS-JSM, slip op. (D. Minn. June 13, 2013). We think the court's preemption analysis would be of interest to our readers, but since the defendant is a Reed Smith client (although not in the Pinsonneault case), our description is bare bones, with no commentary:
Product involved: PMA approved pacemaker leads.
Procedural posture: Plaintiffs' motion to amend largely denied (all newly alleged causes of action denied).
- Failure to warn claim predicated on allegations of failure to report adverse events to FDA denied as "futile" because: (a) there is no parallel state-law claim because post-sale duty to warn involves warnings to product users, not federal agencies; (b) adverse events reported to the FDA are not necessarily public, so a report to the FDA does not equal a warning to implanting physicians; (c) the alleged claim is thus not genuinely parallel; and (d) because there is no recognized state-law cause of action for failure to report to any federal agency the claim is also impliedly preempted as an improper private attempt to enforce the FDCA. Slip op. at 14-20.
- Express warranty claims alleging that the defendant warranted that the product was "safe, fit, and proper" for its "intended use" were expressly preempted because no particular express language not part of the product's FDA-approved labeling was specified in the proposed amendment. Slip op. at 20-23.
- Certain factual amendments, but no causes of action, were permitted because their causal relationship to the plaintiffs' alleged injuries could not be determined on the pleadings. Slip op. at 23-24.