Pearsall v. Medtronics, Inc.
147 F. Supp. 3d 188
E.D.N.Y2015Background
- Plaintiff Furman Pearsall received a Medtronic Virtuoso ICD with a Sprint Fidelis Lead (model 6949) in December 2006; the lead later malfunctioned in May 2012, causing an unexpected shock and emergency replacement.
- The Sprint Fidelis Lead model 6949 was approved via the FDA PMA process (supplement approved June 8, 2004); Medtronic later issued a recall and the FDA classified it as a Class I recall.
- Pearsall sued under New York common law for strict liability (manufacturing defect), negligent manufacturing, and failure to warn, alleging (among other things) unauthorized manufacturing changes (e.g., spot welding), CGMP violations, and delayed or incomplete adverse-event reporting to the FDA.
- Medtronic moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing the Medical Device Amendments (MDA) to the FDCA preempt state-law claims for PMA-approved devices (Riegel) and that there is no private enforcement of FDA reporting requirements (Buckman).
- The court applied the two-step Riegel inquiry (existence of federal requirements via PMA; whether state claims impose requirements different from or in addition to federal ones) and dismissed the complaint with prejudice as preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are manufacturing-defect claims based on CGMP violations parallel (non-preempted)? | Pearsall: CGMPs create minimum manufacturing duties; Medtronic violated them, causing defects. | Medtronic: CGMPs are flexible, not specific federal ‘‘requirements’’ that state law can parallel; allowing claims would add state requirements. | Dismissed: CGMP-based manufacturing claims are preempted because CGMPs are generic and do not create a parallel state duty. |
| Are claims based on failure to submit PMA supplements parallel? | Pearsall: Changes were reported only in annual reports; state law provides similar duties. | Medtronic: No New York law parallels the federal PMA-supplement regime; private suit would enforce federal duties reserved to FDA. | Dismissed: Preempted and impliedly preempted (enforcement rests with FDA). |
| Are manufacturing claims based on specific plant practices (e.g., spot welding, Villalba violations) parallel? | Pearsall: Specific manufacturing practices caused lead fractures and were not disclosed/approved. | Medtronic: FDA approved design and manufacturing process; such claims would second-guess FDA’s PMA decisions. | Dismissed: Preempted as they would substitute jury judgment for FDA approval. |
| Is the failure-to-warn claim (based on delayed/omitted FDA reporting) parallel to New York duty to warn medical professionals? | Pearsall: Failure to report adverse events prevented timely warnings to physicians; New York imposes a continuing duty to warn the medical profession. | Medtronic: New York’s duty to warn does not parallel the federal reporting duty to FDA; private enforcement of FDA reporting is precluded. | Dismissed: Preempted — state duty differs from federal reporting duties and the reporting enforcement is for FDA alone. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA-approved device claims preempted if state requirements are different from or in addition to federal requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (private suits cannot be used to enforce FDCA requirements; FDA has exclusive enforcement authority)
- In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (MDL court dismissal affirmed; CGMP and related claims preempted)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (failure-to-warn claim not preempted where state law duties paralleled federal reporting duties)
- Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296 (11th Cir. 2011) (PMA approval imposes federal requirements sufficient to preempt state law claims)