stating it “is axiomatic that the complaint may not 12 amended by the briefs”
How later courts described this case
- stating it “is axiomatic that the complaint may not 12 amended by the briefs”
Written by the judges who cited it.
The opinion
|| P|
3 | | NOV 29 2029 |
4 Pod
CLERK US grag FS □□□
5 . | SOUTHERN SIBIRICT OF GALIFOSMIA
BY ee _ DEPUTY |
6
4
8 UNITED STATES DISTRICT COURT
9 SOUTHERN DISTRICT OF CALIFORNIA |
10
1i || ROBIN HOGG-JOHNSON, Case No.: 3:20-cv-00884-BEN-BLM
12 Plaintiff,
ORDER GRANTING MOTION TO
Vv. □ DISMISS □
14 || MERZ NORTH AMERICA, et al.,
15 Defendants.| [ECF No. 14]
16
17 Before the Court is Defendant Merz North America’s (“Merz”) Motion to Dismiss
18 || Plaintiff Robin Hogg-Johnson’s First Amended Complaint (“FAC”). ECF No. 14. For .
19 || the reasons that follow, the motion is granted.
20 BACKGROUND!
21 Plaintiff Robin Hogg-Johnson was prescribed Belotero Balance, a prescription
22 dermal filler manufactured by Merz that is intended to smooth moderate to severe
23 ||nasolabial folds. FAC, ECF No. 12, 414. After using Belotero Balance, Hogg-Johnson
24 |! suffered a severe adverse reaction, which included “granulomatous hypersensitivity as a
26 . .
27 The following overview of the facts is drawn from Plaintiff's FAC, ECF No. 14, which
5 the Court assumes true in analyzing Merz’s motion to dismiss. Erickson v. Pardus, 551
8 US. 89, 94 (2007). The Court is not making factual findings.
1 reaction to the modified hyaluronic acid found in [Belotero Balance.]” Jd. at 9 5-6. Thi
2 || adverse reaction caused a “breakdown of her immunity” and required at least three
3 |jemergency room visits. Id. at 17. She continues to suffer adverse reactions to the
4 ||Belotero Balance injections that have required her to meet with numerous medical
5 || specialists. Id. at q18.
6 Hogg-Johnson’s FAC alleges a strict products liability claim on a failure to warn
7 theory and a negligence claim arising from the “preparation, design, research,
8 || manufacture, inspection, label[ing], marketing, and sale of the dermal fillers.” Id. at 1
9 |) 10,
10 Hogg-Johnsons’s failure to warn claim alleges Belotero Balance’s labeling “did
11 {|not contain sufficient warnings to alert consumers, including Plaintiff, of the dangerous
12 |Irisks involved in the product, including but not limited to the risk of a granulomatous
13 || hypersensitivity reaction to hyaluronic acid.” Jd. at 710. She alleges Merz knew of these
14 | defects, nonetheless failed to warn her or members of the medical community, and that
15 || had Merz provided adequate warnings she would not have used the product. Jd. at 11-
16 || 13. She further alleges that Merz “had a continuing duty to warn Plaintiff and physicians
17 of the dangers associated with Belotero Balance.” Jd.
18 _ Hogg-Johnson’s negligence claim alleges Merz “had a duty to warn health care
19 | providers and consumers of the risks, dangers, and adverse side effects of the dermal
20 fillers.” Id. at § 22. Her claim specifically cites Belotero Balance’s “use of artificial
21 cross-linking to modify the hyaluronic acid used in dermal fillers” as the potential source
22 || of her adverse reactions. Jd. at { 23. Hogg-Johnson alleges Merz breached this duty by
23 ||“unreasonably and carelessly failing to properly warn of the potential risks associated
24 || with the dermal fillers, specifically with its potential adverse reaction with the immune
25 system.” Id. at 925.
26 Merz asks the Court to take judicial notice that the Food and Drug Administration
27 ||(FDA) approved Belotero Balance through the premarket approval process in 2011.
28 || Pursuant to Federal Rule of Evidence 201, the Court may take judicial notice of matters
□
I || of public record when ruling on a motion to dismiss. Lee v. City of Los Angeles, 250.F.3«
2 668, 688-89 (9th Cir. 2001). The Court may also take judicial notice of documents wher
3 the plaintiff's complaint necessarily relies on those documents and the documents’ |
4 authenticity is not questioned. Id. at 688. Merz has provided an authenticated copy of
||Belotero Balance’s premarket approval documentation and its FDA approved labels.
6 || Decl., ECF No. 14-1, Exs, A-C. Hogg-Johnson does not question the authenticity of
7 these documents. Moreover, the Court finds the FAC necessarily relies on these
8 |/documents because Hogg-Johnson alleges Belotero Balance’s warning labels were
9 inadequate. FAC, ECF No. 12,910. Accordingly, the Court takes judicial notice of the
10 || FDA’s premarket approval of Belotero Balance and the FDA approved label for the
11 j|product. See Bryant v. Apotex, Inc., Case No. 12-CV-1377-LJO, 2013 WL 394705, at *6
12 ||(£.D. Cal. Jan 30, 2013) (taking judicial notice of prescription drug warning labels) and
13 re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282,
14 || 1286 (C.D. Cal. 2008) (same).
15 |. LEGAL STANDARD
16 _ A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal
17 ||theory or on the absence of sufficient facts alleged under a cognizable legal theory.
18 || Johnson v. Riverside Healthcare Sys., F.3d 1116, 1121 (9th Cir. 2008); Navarro Vv.
19 || Block, 250 F.3d 729, 732 (9th Cir. 2001). When considering a Rule 12(b)(6) motion, the
20 || court “accept[s] as true facts alleged and draw[s] inferences from them in the light most
21 || favorable to the plaintiff.” Stacy v. Rederite Otto Danielsen, 609 F.3d 1033, 1035 (9th
22 || Cir. 2010). A plaintiff must not merely allege conceivably unlawful conduct but must
23 |! allege “enough facts to state a claim to relief that is plausible on its face.” Bell □□□□ Corp.
24 Twombly, 550 U.S. 544, 570 (2007). “A claim is facially plausible ‘when the plaintiff
25 pleads factual.content that allows the court to draw the reasonable inference that the □
26 || defendant is liable for the misconduct alleged.” Zixiang Li v. Kerry, 710 F.3d 995, 999
27 || (9th Cir. 2013) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). “Threadbare
28 j/recitals of the elements of a cause of action, supported by mere conclusory statements, do
suffice.” Igbal, 556 U.S. at 678.
2 Ifa court dismisses a complaint, it may grant leave to amend unless “the pleading
3 {| could not possibly be cured by the allegation of other facts.” Cook, Perkiss & Liehe, Inc.
4 |lv. N. Cal. Collection Serv. Inc., 911 F.2d 242, 247 (9th Cir. 1990).
ANALYSIS =~
Merz argues Hogg-Johnson’s claims are “preempted by federal law and also still
7 || fail to include sufficient factual allegations to make her claims plausible.” Mot., ECF No
. 8 1. The Court does not reach the second argument, as it finds the claims as pleaded to
9 Ibe preempted. .
10 | Hogg-Johnson’s FAC contains one products liability claim alleging Merz failed to
Il || warn of known defects, as well as one generalized negligence claim. ECF No. 12, □□ 10,
12 ||21-26. Merz argues these claims are preempted because “Belotero Balance is a Class III
13 prescription injection that was approved via the premarketing approval process,” which |
14 ||“impose[s] specific requirements on Merz, including that Merz must use the design and
15 || labeling approved as part of that [premarket approval].” Mot., ECF No. 14,6. □□□□
16 | reasons that if it used FDA approved labeling and otherwise obtained premarket approval
17 || for Belotero Balance, Hogg-Johnson’s state law claims for failure to warn and negligence
18 | are preempted and thus must fail. Id.
19 The Supreme Court established a two-part test for whether a claim is preempted by
20 the Medical Device Amendment to the Federal Food, Drug; and Cosmetic Act. Riegel v.
21 || Medtronic, Inc., 552 U.S. 312, 321-22 (2008). First, the Court must determine whether
22 Federal Government . . . established requirements applicable to [the medical
23 || device].” Jd. at 321. If so, it then determines whether the common law claims are “based
upon [state] requirements with respect to the device that are ‘different from, or in
25 || addition to’ the federal ones, and that relate to safety and effectiveness.” Jd. at 321-22
26 (quoting 21 U.S.C. § 360k(a)). if these conditions are met, the state law claim is
27 || preempted and is dismissed. Id. at 330.
28
. : 4 .
1 Here, the first element is met. Hogg-Johnson’s FAC alleges that Belotero
2 ||Balance’s label “did not contain sufficient warnings to alert consumers, including
3 Plaintiff, of the dangerous risks involved with the Product.” FAC, ECF No. 12, □□□
4 ||She also alleges Merz was negligent “in their preparation, design, research, manufacture,
5 inspection, label[ing], marketing, and sale” of the product. Id. at 21. However, Hogg-
6 || Johnson does not dispute that Belotero Balance was accepted by the FDA through the
7 || premarket approval process. Opp’n, ECF No. 15, 2.
The premarket approval process is “rigorous.” Riegel, 552 U.S. at 317. During the
9 |/process, the FDA conducts a “risk-benefit assessment of the device and an analysis of the
10 || adequacy of the manufacturer’s label.” Weber v, Allergan, Inc., 940 F.3d 1106, 1110
11 Cir. 2019). Once a device receives premarket approval, the FDA must sign off on
12 || any changes “in design specifications, manufacturing processes, labeling, or any other
13 |/ attribute that would affect safety or effectiveness.” Riegel, 552 U.S. at319.
14 Accordingly, Belotero Balance’s labeling, manufacture, and sale were clearly subject to
15 federal requirements through the premarket approval process.
16 The question then is whether Hogg-Johnson’s claims are based on state
17 ||requirements that are “different from, or in addition to” the FDA’s requirements. 21
18 ||U.S.C. § 360k(a)(1). The Court concludes the claims are, causing them to be preempted.
19 Hogg-Johnson alleges that Belotero Balance “did not contain sufficient warnings,”
20 ||FAC, ECF No. 12, 10, but the product’s warning labels were approved by the FDA and
21 could not be changed without FDA’s approval. Riegel, 552 U.S. at 319. Merz could not
22 comply with both federal law through the FDA’s approved labeling for Belotero Balance
23 || and provide the allegedly appropriate warnings Hogg-Johnson seeks to impose. This
24 || claim presents a classic case of preemption, and thus is dismissed.
25 Hogg-Johnson’s negligence claim suffers the same fate. Her negligence claim -
26 ||references a standard of “reasonable care” and alleges breach of that standard. Congress,
27 || however, through the Medical Device Amendment and the FDA’s premarket approval
28 || process, imposes its own requirements on medical device manufacturers before a new
. . 5 ,
1 || product can be introduced into the market. Weber, 940 F.3d at 1110. The FAC flatly
|lignores those requirements in favor of common law negligence standards. ECF No. 12,
3 21-26. Accordingly, as pleaded, the common law negligence claim is preempted. See
4 Riegel, 352 U.S. at 327-28 (also finding medical device negligence claim preempted).
5 To state a claim that is not preempted, Hogg-Johnson would have to allege Merz
6 || violated an FDA requirement, not a common law duty of care. Weber, 940 F.3d at 1111.
7 || The FAC does not do so. Hoge-I ohnson seemingly acknowledges this in her opposition,
8 || where she argues that Merz failed to notify the FDA of adverse incidents that occurred
9 after Belotero Balance received premarket approval. Opp’n, ECF No. 15, 5. However,
10 || Hogg-Johnson cannot amend her FAC in her opposition. See Doe v. Wolf, 432 F. Supp.
1] 3d 1200, 1215 (S.D. Cal. 2020) (stating it “is axiomatic that the complaint may not
12 amended by the briefs”). The Court therefore declines to consider these arguments.
13 The Court finds Hogg-J ohnson’s negligence claim is preempted because the
14 ||FDA’s premarket approval process regulates the activity at issue and because her claims
15 || would impose different requirements than those imposed by federal law. Accordingly, it
16 || grants the motion to dismiss this claim. .
IV. CONCLUSION |
18 _ For the foregoing reasons, Defendant’s Motion to Dismiss is GRANTED. ECF
19 |INo, 14. Plaintiff has once again requested leave to file an amended complaint and the
20 Court, considering the above, will grant the request. See Fed. R. Civ. P. 15(a)(2).
21 || Accordingly, Plaintiff may file a Second Amended Complaint within fourteen (14) days
22 || of this Order. a .
23 IT IS SO ORDERED.
24
95 || DATED: Novenbsr/f, 20020 □□□ lp UA ;
HON-RUGER T. BENITEZ
26 / United States District Judge
27 ||
28