Carrelo v. ADVANCED NEUROMODULATION SYSTEMS, INC.
777 F. Supp. 2d 303
D.P.R.2011Background
- Plaintiffs allege gross negligence by St. Jude Medical Puerto Rico, LLC and product liability against Advanced Neuromodulation Systems and St. Jude related to the EON IPG.
- EON IPG is a Class III device subject to FDA PMA; the device implanted February 12, 2008, and charging equipment was provided the day after surgery.
- February 10, 2009 charging and programming occurred after a later Puerto Rico visit; diagnostic testing showed lead impedance issues on April 1, 2009.
- Plaintiffs claim failure to warn, manufacturing defect, and design defect, and contend claims are not preempted by federal law.
- Defendants moved for partial summary judgment under 21 U.S.C. § 360k(a); the court deemed the motion unopposed due to lack of timely response.
- The court partially grants and partially denies the motion, denying SJ as to failure to warn and granting SJ as to manufacturing and design defects.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does MDA preempt state-law claims for Class III devices? | Jimenez argues parallel claims remain despite PMA compliance. | Defendants contend § 360k(a) broadly preempts certain state-law claims. | Class III preemption applies; some claims may proceed as parallel claims. |
| Is the failure to warn claim preempted or parallel to federal requirements? | Warning failures not aligned with PMA stand as parallel claims. | Failure to warn is preempted if it imposes different federal requirements. | Failure to warn claim survives as a parallel, not preempted claim; genuine issue of material fact exists. |
| Are manufacturing defects preempted by § 360k(a)? | Manufacturing defect claim premised on CGMP/Quality System violations not preempted. | Manufacturing defect claim is preempted as it would impose different federal requirements. | Manufacturing defect claim preempted; granted summary judgment. |
| Are design defects preempted by § 360k(a)? | Design defect not preempted if based on federal regulatory violations. | Design defect claims would impose requirements different from PMA. | Design defect claim preempted; granted summary judgment. |
| Should the court grant summary judgment given the unopposed status? | Court granted partial summary judgment where appropriate; failure to warn unresolved. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMAs preempt state-law claims for Class III devices)
- Medtronic Leads v., 592 F. Supp. 2d 1147 (D. Minn. 2009) (parallels and preemption discussion for device claims)
- Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) (FDA violations and recalls; parallel claim requirement)
- Parker v. Stryker Corp., 584 F. Supp. 2d 1298 (D. Col. 2008) (parallel claim analysis with federal regulatory violations)
- Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp. 2d 222 (D.P.R. 2008) (Puerto Rico law recognizing strict liability for manufacturing, design, warnings)
- Bausch v. Stryker Corp. Inc., 630 F.3d 546 (7th Cir. 2010) (Quality System Regulations as binding; CGMPs relevant to preemption analysis)
- Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) (parallel claim standards regarding CGMP/CGMP claims)