Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp. 2d 1006

Plaintiffs in three civil actions against St. Jude allege defects in Riata leads and resulting injuries.
Plaintiffs claim defects include insulation abrasion risking lead failure and device malfunction.
St. Jude issued two Dear Doctor letters (2010 and 2011) stating abrasion rates but no recalls at that time.
FDA issued a Class I recall on December 21, 2011 for Riata leads, highlighting insulation failure concerns.
Plaintiffs seek to amend complaints to add Count V (negligence—failure to warn) and Count VI (breach of express warranty).
Court grants amendment limited to additional factual allegations but denies Counts V and VI due to preemption analyses.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Count V is preempted under § 360k(a).	Plaintiffs contend state duty to warn parallels federal MDR duties.	St. Jude argues failure-to-warn claims are preempted as they would impose requirements different from or in addition to FDA rules.	Count V preempted (express and implied).
Whether Count VI is preempted under § 360k(a).	Breach-of-express-warranty claims based on voluntary statements are not preempted; some labels/statements may be FDA-approved.	Express warranty claims based on FDA-approved label statements are preempted; voluntary warranties may be not.	Count VI preempted to extent based on FDA-approved label; not preempted for voluntary statements—but court finds claims insufficiently pled and thus preempted.
Whether the Court should grant the amendment as to additional factual allegations.	Additional facts regarding FDA inspections and PMA history are relevant to claims and not unduly prejudicial.	Allegations unrelated to pleaded claims lack linkage and should be denied.	Additional factual allegations granted.
Whether amended claims would survive a Rule 12(b)(6) dismissal based on preemption.	Amendments are not futile because they could state parallel state duties to warn.	Amendments alleging MDR reporting claims are futile due to express/implied preemption and lack of equivalent state duties.	Amendments as to Counts V and VI denied; futile due to preemption.

Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs preempt state claims that add to federal requirements)
In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (parallel claims must be genuinely equivalent to FDA duties to avoid preemption)
In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) (district court preemption analysis on MDR reporting claims)
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (FDCA preemption of private enforcement actions)
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) (express warranty claims based on FDA-approved statements often preempted)
Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517 (D. Minn. 1989) (post-sale duty to warn not tied to FDA reporting requirements)
Hodder v. Goodyear Tire & Rubber Co., 426 N.W.2d 832 (Minn. 1982) (post-sale duty to warn concept; state duties must parallel federal requirements)
Kinetic Co., Inc. v. Medtronic, Inc., 2011 WL 1485601 (D. Minn. 2011) (not included due to WL; referenced for preemption discussion)