159 F. Supp. 3d 1085
N.D. Cal.2016Background
- Plaintiff Tanya De La Paz (S.C. resident) underwent implantation of the Essure permanent contraceptive in 2012 and later suffered perforation, pain, bleeding, and removal surgeries for the device.
- Defendants (Bayer and related entities, including predecessor Conceptus) designed, manufactured, marketed, and trained physicians in use of Essure; Essure is a Class III device that received FDA premarket approval in 2002 subject to conditions.
- Plaintiff filed a diversity personal-injury action in N.D. Cal. asserting ten state-law claims (manufacturing defect, design defect, negligence, failure to warn, strict liability, implied and express warranty, negligent and fraudulent misrepresentation, fraudulent concealment).
- Defendants moved to dismiss claiming express preemption under 21 U.S.C. § 360k(a), implied preemption (Buckman), failure to plead causation, failure to plead fraud with particularity (Rule 9(b)), and California’s two-year statute of limitations.
- The complaint relied in part on FDA Form 483 inspection findings (2008, 2011) alleging manufacturing irregularities and unreported adverse events; plaintiff sought leave to amend several claims.
- Judge Alsup granted the motion to dismiss in full but allowed limited leave to amend on certain theories (manufacturing, negligent-training limited to hysteroscopic equipment or deviations from FDA-approved training, failure-to-warn-the-FDA if plaintiff can plead causation, certain warranty/fraud claims outside FDA-approved statements); design-defect claims were dismissed with no leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under MDA §360k(a) | De La Paz: claims allege FDA violations or parallel state duties, so they are not preempted | Bayer: Essure is PMA-approved Class III device; state-law duties that conflict are preempted | Most safety/effectiveness tort claims preempted unless they allege parallel duties or conduct outside PMA scope; plaintiff failed to fit within narrow gap for most claims |
| Implied preemption (fraud-on-FDA) | Plaintiff: alleges FDA reporting failures and adulteration based on Form 483s | Bayer: claims that exist solely by virtue of federal requirements are impliedly preempted (Buckman) | Fraud-on-FDA claims are impliedly preempted; plaintiff’s adulteration allegations, absent causal link to injury, also fail |
| Manufacturing-defect / adulteration causation | De La Paz: Form 483s show nonconforming materials/adulteration causing defects | Bayer: Form 483s do not show device-level defect or causation; allegations are conclusory | Dismissed for failure to plead how alleged manufacturing irregularities caused plaintiff’s injuries; leave to amend permitted to plead specific regulatory violations and causal link |
| Design-defect claim | De La Paz: Essure defective as designed | Bayer: design conforms to FDA-approved design; design claims conflict with PMA | Dismissed and not amendable — design-defect claims preempted because they would require deviation from FDA-approved design |
| Failure-to-warn-the-FDA | De La Paz: Bayer failed to report adverse events (perforations) to FDA, so state parallel duty exists | Bayer: FDA already knew and had not required further warnings; plaintiff cannot show reporting would have led to different warnings or prevention | Dismissed for failure to plausibly plead causation (that timely FDA reporting would have reached physicians in time to prevent injury); leave to amend allowed if plaintiff can plausibly allege FDA would have required enhanced warnings |
| Fraud / warranty / misrepresentation | De La Paz: marketing, website, blog and other statements induced reliance | Bayer: most statements were FDA-approved labeling or descriptions (preempted); fraud claims lack particularity and reliance | Dismissed: express warranty and misrepresentation claims preempted where tied to FDA-approved statements; fraud claims also fail Rule 9(b) and for lack of pleaded reliance (except a poorly-pled blog theory) — leave to amend for particularized allegations only |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (state tort claims preempted where they impose requirements different from or additional to PMA federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (fraud-on-the-FDA claims impliedly preempted because enforcement of FDCA is federal)
- Perez v. Nidek Co., Ltd., 711 F.3d 1109 (Ninth Circuit: narrow gap for state-law claims must allege MDA violations yet not be claims that exist solely because of the MDA)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (Ninth Circuit en banc: duty to warn the FDA can be a parallel state duty that survives express preemption in narrow circumstances)
- McClellan v. I-Flow Corp., 776 F.3d 1035 (Ninth Circuit: negligence-per-se claim based on failure to comply with FDA labeling can avoid preemption where state law imposes independent duty)