535 F.Supp.3d 1157
N.D. Ala.2021Background
- Synvisc‑One is a Class III, PMA‑approved hyaluronic acid knee injection manufactured by Genzyme; Lot 7RSL021 was later found to be uniformly contaminated with Methylobacterium thiocyanatum and voluntarily recalled.
- Ralph Lowery received an injection from that Lot on November 1, 2017 and developed knee pain; clinicians noted a thick yellow fluid and considered septic arthritis but medical opinions were not uniform.
- Genzyme’s release sterility and endotoxin testing initially passed; retrospective testing of retained bulk samples in November–December 2017 showed endotoxin and sterility failures leading to recall.
- Plaintiff sued for product liability (AEMLD/strict‑liability‑style claim), negligence/wantonness, breach of implied and express warranties, and failure to comply with GMPs.
- Genzyme moved for summary judgment arguing (1) Plaintiff lacks admissible expert proof of general and specific medical causation and (2) Plaintiff’s state‑law theories are preempted by the federal Medical Device Amendments and related FDA requirements; the court granted summary judgment for Genzyme.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Medical causation (diagnosis and causation by device) | Lowery’s clinicians, company investigation documents, and plaintiff experts show septic arthritis caused by contaminated Lot | Plaintiff’s causation experts were excluded or unreliable; treating physician testimony equivocal and insufficient as expert causation | Plaintiff failed to establish general or specific causation; summary judgment for defendant |
| Admissibility/necessity of expert proof | Documentary admissions and internal reports suffice to show causation | Complex medical/technical causation requires admissible expert testimony under Rule 702/Daubert | Court excluded key expert opinion(s) and held that admissible expert proof was required and absent |
| Warranty notice requirement (express & implied) | Plaintiff contends notice not required or inapplicable | No notice was pleaded or given; Simmons does not eliminate notice for buyers; Eleventh Circuit precedent controls | Warranty claims dismissed for failure to plead/produce required notice; summary judgment for defendant |
| Preemption under MDA (PMA/GMP/guidance) | State claims parallel federal requirements; deviations from testing/good practice and PMA/specification violations support claims | Plaintiff relies on nonbinding guidance, inapplicable drug GMPs, or fails to identify specific PMA/GMP violations and a causal link to injury; claims would impose different/additional requirements | In the alternative, claims preempted: plaintiff did not point to specific federal requirements violated and causally connected to Lowery’s injury; many allegations rest on nonbinding guidance or pharmaceutical regs not applicable to device |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (2008) (PMA approval process and express preemption of state requirements that 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 FDA’s statutory duties; implied preemption)
- Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017) (explaining narrow gap for parallel claims and requirement to connect federal violations to injury)
- Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018) (a plaintiff must identify specific federal regulations violated to plead a parallel claim)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (discussing preemption analysis for PMA and GMP‑based state claims)
- McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005) (expert proof of causation required in complex toxic‑exposure/product cases)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (summary judgment burden‑shifting principles)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (standard for genuine issue of material fact at summary judgment)