LAUREL BEELER, Magistrate Judge.
This is a products liability case about defective contact lenses.
The Acuvue Oasys contact lenses are a Class III medical device under the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act.
The PMA contains information bearing on the contact lenses and their production.
In May 2013, Mr. Money "purchased a package of Acuvue Oasys contact lenses manufactured, stored, distributed and sold by [the] Defendants."
Mr. Money returned to the hospital three more times.
Mr. Money sues the defendants because of his experience with the lenses. He filed his Second Amended Complaint ("SAC") after the court dismissed the First Amended Complaint.
After the pleadings are closed "but early enough not to delay trial," a party may move for judgment on the pleadings. Fed. R. Civ. P. 12(c). "[T]he same standard of review applicable to a Rule 12(b) motion applies to its Rules 12(c) analog" because the motions are "functionally identical." Dworkin v. Hustler Magazine, Inc., 867 F.2d 1188, 1192 (9th Cir. 1989). A Rule 12(c) motion may thus be predicated on either 1) the lack of a cognizable legal theory or 2) insufficient facts to support a cognizable legal claim. See Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir. 1990). When considering a motion to dismiss under Rule 12(c), the court "must accept all factual allegations in the complaint as true and construe them in the light most favorable to the non-moving party." Fleming v. Pickard, 581 F.3d 922, 925 (9th Cir. 2009). "A judgment on the pleadings is proper if, taking all of [the plaintiff]'s allegations in its pleadings as true, [the defendant] is entitled to judgment as a matter of law." Compton Unified School Dist. v. Addison, 598 F.3d 1181, 1185 (9th Cir. 2010).
The defendants argue that the MDA expressly and impliedly preempts Mr. Money's state-law claims.
The MDA expressly and impliedly preempts certain claims sounding in state-law tort. See Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (express preemption); Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (implied preemption).
First, the MDA expressly preempts state safety and effectiveness requirements that are different from, or add to, federal requirements:
21 U.S.C. § 360k(a). The subsection (b) exception, which allows the FDA to exempt state laws from preemption, is inapplicable here. See De La Paz v. Bayer Healthcare LLC, No. C 15-03995 WHA, 2016 WL 392972, at *4 (N.D. Cal. Feb. 2, 2016).
Two conditions must be met for express preemption to apply: 1) the federal government must have established requirements applicable to the device at issue and 2) the state law must impose safety and effectiveness requirements "different from, or in addition to," the federal requirements. Riegel, 522 U.S. at 321-22. The first element — the existence of applicable federal requirements — is satisfied where, as here, a device was approved through the PMA process. Id. at 322-23 (holding that the PMA process "imposes `requirements' under the MDA"). The second element — different or additional state-law safety and effectiveness requirements — may be satisfied by state common law duties. Id. at 323-24.
Section 360k(a) will not, however, preempt state duties that "`parallel,' rather than add to, federal requirements." Id. at 330. To properly plead a parallel claim, "a plaintiff must allege facts (1) showing an alleged violation of FDA regulations or requirements related to [the device], and (2) establishing a causal nexus between the alleged injury and the violation." Edison v. Medtronic, Inc., 981 F.Supp.2d 868, 880 (N.D. Cal. 2013) (quoting Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085, 1092 (C.D. Cal. 2011)).
Second, the MDA impliedly preempts claims that exist "solely by virtue" of federal requirements. Buckman, 531 U.S. at 352-53. "The FDCA provides that enforcement of its requirements (including the MDA) `shall be by and in the name of the United States[,]'" and so, "the Federal Government rather than private litigants . . . [is] authorized to file suit for noncompliance with the medical device provisions." De La Paz, 2016 WL 392972 at *4 (quoting 21 U.S.C. § 337(a); Buckman, 531 U.S. 349 n.4). Thus, only "claims that rely on `traditional state tort law' may proceed (to the extent they can overcome express preemption)." De La Paz, 2016 WL 392972 at *4.
Between the MDA's express and implied preemption, there is a "narrow gap through which a state-law claim must fit to escape preemption by the [MDA]." Perez, 711 F.3d at 1120. To fit, "[t]he plaintiff must be suing for conduct that violates the [MDA] (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the [MDA] (such a claim would be impliedly preempted under Buckman)." Id. (quoting In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)). Mr. Money's manufacturing defect and implied warranty claims "squeeze through" this gap to the extent based on the PMA.
The court considers separately Mr. Money's state-law claims to determine if they are preempted. See Funke v. Sorin Group USA, Inc., No. SACV 15-01182-CJC(ASx), 2015 WL 7747011, at *3 (C.D. Cal. Nov. 24, 2015) ("The second prong of Riegel . . . must be addressed separately for each of [the plaintiff's] claims.") Because the parties did not discuss (or cite to) authority addressing specifically the preemption of battery claims, the court does not now determine if Mr. Money's battery claim is preempted.
Mr. Money brings claims for manufacturing defect in both negligence and strict liability.
Here, the MDA does not preempt Mr. Money's manufacturing defect claims. First, § 360k(a) does not expressly preempt his claims because he alleges specific violations of the PMA, ties them to his manufacturing defect claim, and establishes a causal nexus between the federal violation and his injuries. He alleges that the PMA establishes the maximum chemical concentrations for the lens coating and cleaning solution.
Second, and for similar reasons, the MDA does not impliedly preempt his claims. The defendants argue that Mr. Money's "claims impermissibly attempt to enforce federal law" because they rely "solely on federal-law violations."
Mr. Money also brings claims for breach of the implied warranties of merchantability and fitness for a particular purpose, both under California law.
For the same reasons stated above, Mr. Money's claims for breach of California implied warranties survive preemption. He identifies specific federal requirements (the PMA's purity, stability, and manufacturing procedures), alleges the violation of those requirements, and thereby establishes a connection between the federal violation and his state-law claims (i.e. the impurity or instability rendered the lenses unfit for the ordinary purpose and unfit for the particular purpose of placing them on his eyes). These claims therefore parallel, rather than add to, the federal requirements, and are premised on state-law warranties, avoiding preemption.
In sum, excluding from consideration his battery claim, Mr. Money asserts claims for conduct violating federal requirements (avoiding express preemption), but not because the conduct violated those requirements (avoiding implied preemption). Even though he does not currently cite to precise provisions of the PMA — which the defendants may prefer
The defendants also move for judgment on the pleadings for Mr. Money's failure to state plausible claims for relief. The court considers the sufficiency of his claims in turn.
"In order to prove facts sufficient to support a finding of negligence, a plaintiff must show that the defendant had a duty to use due care, that he breached that duty, and that the breach was the proximate or legal cause of the resulting injury." Hayes v. Cnty. of San Diego, 57 Cal.4th 622, 629 (2013) (alterations omitted). "In California, negligence per se is not a separate cause of action but is the application of an evidentiary presumption[.]" Carson, 365 Fed. Appx. at 815. There are four elements: "(1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect." Id. (citing Alejo v. City of Alhambra, 75 Cal.App.4th 1180, 1184-85). As for manufacturing defects, the requirements for stating a negligence and strict liability claim are the same. See Fender v. Medtronic, Inc., 887 F.Supp. 1326, 1333 (E.D. Cal. 1995). In both cases, the plaintiff must show that: "(1) he has been injured by the product; (2) the injury occurred because the product was defective; and (3) the defect existed when the product left the hands of the defendant." Tucker, 2013 WL 1149717 at *10 (citing Fender, 887 F. Supp. at 1333).
Here, Mr. Money's allegations state a plausible claim for negligent and strict liability manufacturing defect. His allegations support a claim for negligence per se: he alleges that the defendants violated the PMA's purity, stability, and manufacturing procedural requirements which caused his pain, blindness, and other eye injuries. These allegations plausibly support a conclusion that the PMA requirements were meant to protect against injuries to lens-wearers' eyes, including Mr. Money. His allegations also plausibly show that his eye injuries were caused by the lenses: after putting the lenses in at 6:30 a.m., he experienced pain during the day, followed by extreme pain and blindness when he took them out.
The defendants challenge Mr. Money's implied warranty claims on two bases: 1) there is no privity between Mr. Money and defendants Johnson & Johnson and Vision Care and 2) he fails to state a claim against defendant Luxottica.
A "breach of the implied warranty of merchantability means the product did not possess even the most basic degree of fitness for ordinary use." Moce. v. Alfa Leisure, Inc., 114 Cal.App.4th 402, 406 (2003). "A product which performs its ordinary function adequately does not breach the implied warranty of merchantability merely because it does not function as well as the buyer would like, or even as well as it could." General Motors Corpo. v. Brewer, 966 S.W.2d 56, 57 (1998). "In order to state a claim for breach of implied warranty of fitness under . . . the California Commercial Code, a plaintiff must allege that (1) the seller has reason to know of a particular purpose for which the goods are required, and (2) that the buyer relies on the seller's skill or judgment to select or furnish suitable goods." Marcus, 2015 WL 151489 at *8.
Here, Mr. Money alleges that he purchased the contact lenses from a "store owned and operated by Defendant Luxottica."
Mr. Money's final claim is for battery.
Here, Mr. Money fails to plausibly state a claim for battery. First, he has not plausibly alleged that the defendants made contact with his person within the meaning of the claim. See Huntman v. Danek Medical, Inc., No. 97-2155-IEG RBB, 1998 WL 663362, at *3 n.8 (S.D. Cal. July 24, 1998) (dismissing with prejudice the plaintiff's claim that the manufacturer-defendant's illegal marketing of bone screws, and the plaintiff's subsequent screw implantation, amounted to battery because the plaintiff could not show that the defendant touched him). Second, he has not plausibly shown that whatever contact there was (i.e. his placing of the contacts on his eyes) was "unlawful" — "[a] contact is `unlawful' [only] if it is unconsented to." Ashcraft, 228 Cal. App. 3d at 611. He instead pleads that he purchased and placed the contacts in his eyes, showing his consent to their use.
The court dismisses Mr. Money's claim for battery and his implied warranty claims against Johnson & Johnson and Vision Care. The implied warranty claims are dismissed without leave to amend. The battery claim is dismissed with leave to amend within 21 days of this order. That said, given the battery claim's deficiencies, and given that the other claims fairly encompass the alleged harm, the court cannot see how amendment would cure the defects and thinks that the SAC is sufficient. His other claims survive.