921 F. Supp. 2d 1374
N.D. Ga.2012Background
- Plaintiff Sheryl D. Cline received an implantable spinal cord stimulator (IPG) in 2009, Model 3788, designed, manufactured, marketed, and sold by the Defendant.
- The IPG ceased functioning in 2010 and was surgically removed; the device was analyzed and deemed defective due to a faulty IPG battery.
- Plaintiff filed suit in state court; Defendants removed to federal court based on diversity.
- Plaintiff amended to assert Breach of Express Warranty and Violation of FDA Regulations; the Court later allowed one prior amendment and dismissed the second count as preempted.
- Plaintiff sought leave to amend a second time to cure deficiencies in count II (a parallel claim) and requested limited discovery on PMA-related issues.
- The Court granted leave to file the Second Amended Complaint and ordered limited discovery on PMA specifications, with a deadline for a Third Amended Complaint if the parallel claim is to proceed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Should leave to amend be granted to add count II? | Cline can cure deficiencies and proceed with a parallel claim. | Amendment would be futile due to preemption and pleading flaws. | GRANTED |
| Is count II impliedly preempted by the FDCA §337(a)? | Count II is a non-preempted state negligence claim, not fraud-on-the-FDA. | Count II is impliedly preempted as a FDCA-based private action. | Not impliedly preempted |
| Does count II adequately plead a parallel claim under MDA standards? | CGMP-specific allegations tied to the device and causal link support a parallel claim. | CGMP alone is insufficient; needs device-specific FDA violations with causation. | Sufficiently pleaded |
| Did the motion to lift stay render moot the discovery issue, and how should discovery proceed on count II? | Discovery should proceed to obtain PMA-related information to flesh out count II. | Limited discovery appropriate but contingent on PMA specifications; broader discovery later. | MOOT as to lift stay; limited discovery ordered for count II; broader discovery to await Third Amended Complaint |
| What procedural steps govern timing for a Third Amended Complaint and subsequent discovery? | File a Third Amended Complaint within a set period to continue parallel claim discovery. | Without timely amendment, parallel claim should be abandoned; otherwise, justify scope of discovery. | Deadline set; Third Amended Complaint due by Feb 5, 2013; limited discovery through 75 days after confidentiality order |
Key Cases Cited
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA preemption principle)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (parallel claim concept under MDA preemption)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (pleading requirements for parallel FDA-regulation claims)
- Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582 (E.D.N.Y. 2009) (CGMPs not sufficient alone; device-specific allegations required)
- Medtronic, Inc. Sprint Fidelis Leads Products Liability Litig., 623 F.3d 1200 (8th Cir. 2010) (discusses pleading standards for PMA/CGMP in parallel claims)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (parallel claim viability and complexity in FDA-regulated devices)