Ko v. Mutual Pharmaceutical Company, Inc

Filing 63

ORDER by Judge Whyte granting 40 Motion to Dismiss. (rmwlc2, COURT STAFF) (Filed on 10/18/2013)

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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United States District Court
For the Northern District of California

SAN JOSE DIVISION
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JOSIE C. KO,
Plaintiff,

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Case No. C-13-00890-RMW
ORDER GRANTING DEFENDANT
MUTUAL PHARMACEUTICAL
COMPANY, INC.’S MOTION TO
DISMISS

v.
MUTUAL PHARMACEUTICAL
COMPANY, INC.,

[Re: Docket Nos. 37 and 40]
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Defendant.

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Plaintiff Josie C. Ko brings state law products liability claims and unfair competition claims

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against defendant Mutual Pharmaceutical Company (“Mutual”), alleging injuries caused by

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defendant's product sulindac, a generic anti-inflammatory medication. Am. Compl. 2, Dkt. No. 37.

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Mutual moves to dismiss, asserting that Ko's claims are preempted by federal law and fail to state a

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claim for which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). Mutual

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further objects to the joinder of Ko’s husband, Antonio Ko, on the grounds that he was not properly

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added as a plaintiff to the action per Federal Rule of Procedure 15(a) and moves to dismiss his loss

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of consortium claim on the basis that it fails to state a claim. As explained below, the court

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GRANTS Mutual's motion to dismiss all claims in the action.

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ORDER GRANTING MOTION TO DISMISS
Case No. C-13-00890-RMW
FMP / SW

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I. BACKGROUND

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United States District Court
For the Northern District of California

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On January 17, 2013, plaintiff Josie C. Ko, proceeding pro se, filed a form complaint in the
Santa Clara County Superior Court, alleging "products liability" for injuries suffered following her
prescribed use of sulindac, a generic anti-inflammatory medication manufactured by defendant
Mutual Pharmaceutical Company. Compl. 1, Dkt. No. 1, Ex. 1. Mutual removed the case to federal
court on the basis of diversity jurisdiction. Notice of Removal ¶¶ 7–9, Dkt. No. 1. On March 6,
2013, Mutual filed a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). Mot.
Dismiss, Dkt. No. 8. The court granted Mutual’s motion to dismiss for failure to state a claim
without prejudice on July 1, 2013, allowing Ko thirty days to amend her complaint in good faith.
Order, Dkt. No. 32. Ko filed an amended complaint on July 31, 2013, alleging design defect
products liability claims and state unfair competition claims arising from Mutual’s alleged
inadequate warning label. Am. Compl. 2–4. On the same day, Ko’s husband filed a joinder
declaration to add himself as a plaintiff, alleging loss of consortium based on Ko’s underlying
products liability claims. Joinder Dec. 1, Dkt. No. 38.
Mutual moves to dismiss Ko’s amended complaint on the basis that Ko’s claims are
preempted by federal law under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual
Pharmaceutical, Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). Mutual further moves to dismiss the
amended complaint for failure to state a claim; and finally, objects to the joinder of Ko’s husband on
procedural grounds and moves to dismiss his loss of consortium claims for failure to state a claim.
II. ANALYSIS

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Although pro se litigants are “held to less stringent standards than formal pleadings drafted
by lawyers[,]” Castro v. U.S., 540 U.S. 375, 386 (2003) (quoting Haines v. Kerner, 404 U.S. 519,
520 (1972)), here, the law is clear. Despite Ko’s sympathetic situation, the court is bound by
Supreme Court precedent in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual
Pharmaceutical, Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). With regard to Ko’s argument that
current preemption law is unjust, this is beyond this court’s power. The court is bound to apply the
law as it is. The Supreme Court in Bartlett said it “would welcome Congress’ ‘explicit’ resolution
of the difficult preemption questions that arise in the prescription drug context[,]” but it was bound
ORDER GRANTING MOTION TO DISMISS
Case No. C-13-00890-RMW
FMP / SW

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to follow the current law. Bartlett, 133 S. Ct. at 2480. Accordingly, this court must dismiss Ko’s

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products liability claims and state unfair competition claims.

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A. Preemption

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Mutual contends that Ko’s claims, as alleged, are based on allegedly inadequate warnings on

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the sulindac label and fail as a matter of law because state law tort claims against generic drug

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manufactures are preempted by federal law.

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The court agrees, finding the claims are preempted. As explained in the court’s prior order,

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“federal law preempts state law failure-to-warn claims.” Order 5. Because generic drug

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manufacturers are required by federal law to use the same FDA approved labeling as the

United States District Court
For the Northern District of California

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manufacturers of the brand-name drug, and because generic manufacturers cannot legally change

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their labels even to add additional warnings, any state law claims based on failure-to-warn would

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conflict impermissibly with federal FDA regulations, and are therefore preempted. PLIVA, Inc. v.

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Mensing, 131 S. Ct. 2567, 2570 (2011); see also Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466

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(2013) (reaffirming Mensing and finding that state law design defect claims based on inadequate

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warnings are also preempted).

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Ko's state law strict liability, negligence, and breach of express and implied warranty claims,

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and unfair competition claims, which rest on Mutual’s alleged inadequate labeling of sulindac, are

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based on a failure-to-warn theory and consequently preempted by federal law. See Gaeta v. Perrigo

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Pharm. Co., No. 09-15001, 2012 WL 605678 (9th Cir. 2012), aff'g 562 F. Supp. 2d 1091 (N.D. Cal.

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2008) (granting summary judgment in favor of defendant because plaintiff's state law claims for

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negligence, breach of express warranty, and breach of implied warranty based on inadequate

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warning were preempted); see also Phelps v. Wyeth, Inc., 857 F. Supp. 2d 1114, 1123-24 (D. Or.

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Apr. 24, 2012) (holding that all warnings-based claims, including claims for negligence, strict

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liability, and breach of warranty are preempted); Moretti v. PLIVA, Inc., No. 08-00396 2012 WL

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628502 (D. Nev. Feb. 27, 2012) (holding that state law claims for strict liability, negligence, breach

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of express and implied warranties, consumer fraud, and deceptive trade practices based on

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inadequate warning are preempted); see also Caouette v. Bristol-Myers Squibb, Co., No. C–12–

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ORDER GRANTING MOTION TO DISMISS
Case No. C-13-00890-RMW
FMP / SW

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