Judge David S. Cunningham, Case JCCP4962 2022-08-02 Tentative Ruling

Defendants’ motion for summary judgment/adjudication is denied in full without prejudice.

“After a person contracts chickenpox, the Varicella Zoster Virus (‘wild-type’ virus) remains in a person’s nervous system for life. When a person’s immune competence declines, usually with advancing age, the virus can reactivate . . . in the form of” herpes zoster, more commonly known as shingles. (Plaintiffs’ Response Separate Statement, UMF[1] 1.)

Defendants manufacture Zostavax, a vaccine utilized to prevent shingles. In 2005, they applied to the Food and Drug Administration (“FDA”) for approval. “The FDA’s Vaccine and Related Biological Products Advisory Committee unanimously determined that Zostavax is safe and effective for use in preventing shingles in adults over the age of 60.” (Defendants’ Separate Statement, UMF 4 [adding that “the FDA extended the eligible population to adults over the age of 50” on 3/24/11].)

“When the FDA approved Zostavax as safe and effective,” it “also approved the vaccine’s labeling, including warnings and adverse reactions.” (Id. at UMF 5.) “That label included the following FDA-approved language: ‘Zostavax significantly reduced the risk of developing [shingles] when compared with placebo.’” (Ibid.) “As to adverse events, the initial label identified ‘noninjection-site [shingles]-like rashes’ as well as chicken-pox like rashes, and explained that the vaccine-strain of the virus was detected in ‘two subjects who reported’ chickenpox ‘like rashes.’” (Ibid.)

“Administration of Zostavax does not guarantee protection against shingles.” (Plaintiffs’ Response Separate Statement, UMF 7.) “Since approval, the Warnings and Precautions section of the Zostavax label has stated: ‘Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients. The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown.’” (Ibid.) “It has also stated that that efficacy ‘decline[s] with increasing age.’” (Ibid.)

“Zostavax is approved for administration only in individuals with a healthy immune system because Zostavax ‘may result in a more extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed.’” (Id. at UMF 8.)

Defendants “submitted a Changes Being Effected (‘CBE’) application to the FDA” on 2/26/14 “to add ‘[h]erpes zoster (vaccine strain)’ under ‘Infections and infestations’ in the ‘Post-marketing Experience’ section of the Zostavax labeling.” (Id. at UMF 11.) On 8/28/14, “after reviewing the data, the FDA approved [Defendants’] CBE application for a labeling change, agreeing that ‘[h]erpes zoster (vaccine strain)’ should be placed in the Postmarketing Experiences section of the label.” (Ibid.)

The parties appear to agree that the operative complaint contains claims for failure to warn. (See Motion, p. 1; see also Opposition, p. 1.) Plaintiffs contend the Zostavax label is defective. They assert that Zostavax can cause shingles and that Defendants should have amended the label to provide this information.

A defendant or cross-defendant has met his or her burden of showing that a cause of action has no merit if the party has shown that one or more elements of the cause of action, even if not separately pleaded, cannot be established, or that there is a complete defense to the cause of action.

“The ‘tried and true’ way for defendants to meet their burden of proof on summary judgment motions is to present affirmative evidence (declarations, etc.) negating, as a matter of law, an essential element of plaintiff's claim.” (Weil & Brown, Cal. Prac. Guide: Civ. Proc. Before Trial (The Rutter Group 2022) ¶ 10:241, emphasis in original.) “A cause of action ‘cannot be established’ if the undisputed facts presented by defendant prove the contrary of plaintiff's allegations as a matter of law.” (Id. at ¶ 10:241.10, emphasis in original.) “The moving party's declarations and evidence will be strictly construed in determining whether they negate (disprove) an essential element of plaintiff's claim ‘in order to resolve any evidentiary doubts or ambiguities in plaintiff's [opposing party's] favor.’” (Id. at ¶ 10:241.20.)

A second way to meet the initial burden “is to ‘show’ that an essential element of plaintiff's claim cannot be established.” (Id. at ¶ 10:242.) “Defendant does so by presenting evidence that plaintiff ‘does not possess and cannot reasonably obtain, needed evidence . . . .” (Ibid., emphasis in original.) The moving party must present evidence of discovery admissions and/or factually devoid “all facts” discovery responses. (See id. at ¶¶ 10:244-10:245.27.)

The third way is to show a complete defense. (See id. at ¶ 10:246.) “To ‘show’ a complete defense, defendant must present admissible evidence of each essential element of the defense upon which it bears the burden of proof at trial.” (Id. at ¶ 10:247, emphasis in original.) “Thus, where a defense has several elements, lack of substantial evidence on any element bars relief, ‘even if the plaintiff failed to introduce a scintilla of evidence challenging that element.’” (Ibid., emphasis in original.)

Once one of these burdens is met, “the burden shifts to plaintiff to prove the existence of a triable issue of fact regarding that element of its cause of action or that defense. If plaintiff is unable to do so, defendants are entitled to judgment as a matter of law.” (Id. at ¶ 10:240, emphasis in original.)

“A motion for summary adjudication asks the court to adjudicate the merits of a particular cause of action, affirmative defense, issue of duty or claim for damages, including a punitive damage request.” (Id. at ¶ 10:1, emphasis in original.)

A defendant (or cross-defendant) moving for summary [adjudication] must “show” that either:

* one or more elements of the “cause of action … cannot be established”; OR

This means that where plaintiff has the burden of proof at trial by a preponderance of evidence, defendant “must present evidence that would require a reasonable trier of fact not to find any underlying material fact more likely than not—otherwise, he [defendant] would not be entitled to judgment as a matter of law, but would have to present his evidence to a trier of fact.” [Citation.]

The import of “more likely than not” in the foregoing quote is that a moving defendant must generally present evidence that, if uncontradicted, “would constitute a preponderance of evidence that an essential element of the plaintiff's case cannot be established … The same is true when a moving defendant seeks to secure dismissal of the complaint based on an affirmative defense.” [Ciation.]

. . . Once defendants meet this burden, the burden shifts to plaintiff to prove the existence of a triable issue of fact regarding that element of its cause of action or that defense. If plaintiff is unable to do so, defendants are entitled to judgment as a matter of law. [Citations.]

. . . If defendants fail to meet their burden, their motion must be denied; plaintiff need not make any showing at all. [Citation.]

Preemption Re: Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. Section 301 et seq.

“The federal government regulates the manufacture, labeling, and sale of pharmaceuticals pursuant to the FDCA.” (Gibbons v. Bristol-Myers Squibb Co. (2d Cir. 2019) 919 F.3d 699, 707.) “To bring a drug to market, a manufacturer must file a new drug application, which must explain the drugmaker's tests and studies, demonstrate that the drug is ‘safe for use under the conditions prescribed,’ and include proposed labeling language.” (Ibid.) “The [Food and Drug Administration’s (‘FDA’)] premarket approval of a new drug application includes the approval of the exact text in the proposed label.” (Ibid.)

“The FDA can direct a pharmaceutical manufacturer to change a drug's label after it has entered the market, [citation], but ‘manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times,’ [citation].” (Ibid.) “Nevertheless, drug manufacturers are limited in their ability to unilaterally change the labels on their products. Specifically, to make a change on their own, a manufacturer must comply with the ‘changes being effected’ (‘CBE’) regulation, set forth at 21 C.F.R. [section] 314.70(c)(6)(iii).” (Ibid.) The CBE “allows drug manufacturers to change [a label] without the FDA’s preapproval if the changes ‘add or strengthen a contraindication, warning, precaution, or adverse reaction,’ or ‘add or strengthen an instruction about dosing and administration that is intended to increase the safe usage of the drug product,’ in order to ‘reflect newly acquired information.’” (Ibid.) “‘Newly acquired information’ can include either new data or new analyses of previously submitted data.” (Ibid.) “The rule accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments[.]” (Wyeth v. Levine (2009) 555 U.S. 555, 569 [“[I]f the sponsor submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to FDA, the sponsor meets the requirement for ‘newly acquired information.’”].)

“The Supremacy Clause establishes that federal law ‘shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.’” (PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 617.) “Where federal and state law conflict – that is, where it is impossible for a party to follow both federal and state law – state law must give way.” (Gibbons, supra, 919 F.3d at 708.) “Because manufacturers may unilaterally update a drug's label if the change complies with the CBE regulation, a state law failure-to-warn claim that depends on newly acquired information – information that Defendants could have added to their label without FDA approval – is not preempted.” (Ibid. [citing Wyeth, supra, 555 U.S. at 568-572 and In re Celexa & Lexapro Mktg. & Sales Practices Litig. (1^st Cir. 2015) 779 F.3d 34, 40-41].)

“[T]he Courts of Appeals have synthesized the requirements to properly plead and then prove a state law failure-to-warn claim based on post-drug-release information.” (Ibid.) “Thus, to state a claim for failure-to-warn that is not preempted by the FDCA, a plaintiff must plead ‘a labeling deficiency that [Defendants] could have corrected using the CBE regulation.’” (Ibid.) “If the plaintiff meets that standard, the burden shifts to the party asserting a preemption defense to demonstrate that there is ‘“clear evidence that the FDA would not have approved a change” to the [prescription drug's] label.’” (Ibid.)

As noted above, Defendants’ motion is based on a preemption defense. Defendants bear the initial burden to “present admissible evidence of each essential element of the defense . . . .” (Weil & Brown, supra, at ¶ 10:247, emphasis in original.)

In addition to presenting such admissible evidence, they have the obligation to satisfy all procedural requirements.

One defect relates to the operative complaint. “[T]he pleadings play a key role in a summary judgment motion.” (Id. at ¶ 10:51.) They “serve as the ‘outer measure of materiality’ in a summary judgment motion, and the motion may not be granted or denied on issues not raised by the pleadings.” (Id. at ¶ 10:51.1.) Despite the rules, and despite the fact that this is a coordinated proceeding involving more than 20 underlying actions, Defendants fail to identify the particular underlying case and the particular operative complaint to which their motion applies. Without these details, the Court cannot determine what the operative causes of action are, whether Defendants’ preemption defense covers each of them, and whether the preemption defense is sufficient to dispose of the entire action, which is necessary to grant summary judgment. (See, e.g., id. at ¶ 10:26 [“When the court grants summary judgment, the action is terminated”], emphasis added; see also id. at ¶ 10:27 [“A summary judgment may be granted where it is shown that the ‘action has no merit”], bolding added, italics in original; id. at ¶ 10:28 [“[S]ummary judgment lies only where the opponent has no case at all”], emphasis in original; id. at ¶ 10:33 [“Summary adjudication must completely dispose of the cause of action, defense, damages claim or duty issue”], emphasis in original.) Specifically, Defendants argue that Plaintiffs’ failure to warn claims are preempted (see Motion, p. 1), but does the operative complaint also include non-failure to warn claims? Defendants did not submit the operative complaint with their moving papers, did not ask the Court to judicially notice the operative complaint, and fail to identify the operative causes of action, so the Court cannot answer the question and, thus, cannot determine whether summary judgment is warranted. This is reason enough to deny Defendants’ motion.

An example illustrates the point. The cover page of Defendants’ memorandum of points and authorities identifies lead case Gregory v. Merck & Co., Inc. (BC658499). It is the only underlying case identified, and no other underlying case appears to be mentioned anywhere else in the brief (nor does the brief state that it is an omnibus motion applicable to all underlying cases). (See Motion, pp. i-18.) Assuming arguendo that Defendants’ motion is meant to apply to Gregory, the Court notes that, according to eCourt, the Gregory Plaintiffs filed the original complaint on 4/19/17. The original complaint is unscanned, and it is not posted on Case Anywhere; the Court cannot see it. Defendants apparently posted their answer to the Gregory complaint on Case Anywhere on 1/7/19. The answer states:

Following the Court’s November 16, 2018, order (a) sustaining Defendants MERCK & CO., INC. and MERCK SHARP & DOHME CORP.’s (collectively, “Merck”) demurrer to Plaintiffs’ causes of action for design defect and unjust enrichment, and (b) granting Merck’s motion to quash service of the non-resident Plaintiffs’ claims because the Court does not have jurisdiction over those claims against Merck, Merck answers the California-resident Plaintiffs’ unverified Complaint in the above-captioned case as follows . . . .

(1/7/19 Gregory Answer, p. 1, emphasis added.) The only 11/16/18 order that the Court could find is Judge Carolyn Kuhl’s minute order addressing Defendants’ demurrer in Bell v. Merck & Co., Inc. (BC695789). The minute order indicates that the Bell complaint asserted ten causes of action:

(1) negligence; (2) strict products liability – defective design; (3) strict products liability – failure to warn; (4) breach of express warranty; (5) breach of implied warranty; (6) fraudulent misrepresentation; (7) negligent misrepresentation; (8) unjust enrichment; (9) violation of Business and Profession Code section 17200; and (10) violation of Business and Professions Code section 17500.

(11/16/18 Bell Minute Order, p. 2.) Judge Kuhl sustained the demurrer without leave to amend as to the second and ninth causes of action and noted that “Plaintiff is to file a request for dismissal as to the two causes of action in the underlying cases where the demurrer was sustained within 20 days.” (Id. at pp. 2, 5.) Her minute order fails to reveal the causes of action asserted in the Gregory complaint before the Bell hearing and, more importantly, the causes of action that remain in the Gregory complaint after the Bell hearing. The Court cannot presume that the Bell complaint and the Gregory complaint are the same in terms of claims alleged; consequently, the Court cannot tell whether the Gregory complaint contains non-failure to warn causes of action that are not subject to Defendants’ preemption defense and that preclude summary judgment.[2]

To the extent Defendants contend the preemption defense applies to all remaining causes of action, well, again, which underlying case (cases?) is at issue? What are the remaining causes of action? Do the remaining causes of action involve issues or claims that necessitate compliance with Code of Civil Procedure section 437c(t)? (See Weil & Brown, supra, at 10:44.25 [listing requirements to “move for summary adjudication of any legal issue or a claim for damages” that “would not completely dispose of a cause of action, an affirmative defense or an issue of duty”], emphasis in original.) For example, is a there a remaining Unfair Competition Law cause of action that contains failure to warn allegations and manufacturing defect allegations?[3]

This problem is compounded by Defendants’ failure to provide any procedural history in their moving brief (Plaintiffs’ opposition brief also lacks procedural history).

And, to reiterate, Defendants did not ask the Court to judicially notice the operative complaint or any other relevant order. The Court decided on its own to conduct research to find an example to demonstrate the significance of this procedural defect.

Defendants’ notice of motion is defective for similar reasons. It fails to state which underlying case(s) it applies to, and it fails to list the targeted causes of action.

Another defect concerns the separate statement. Defendants request summary judgment and summary adjudication, yet the separate statement fails to include “a separate section heading indicating the issue number and specifying the issue.” (Weil & Brown, supra, at ¶ 10:96.6.) In fact, there is no separate section for summary adjudication at all, just 13 UMFs for summary judgment. (See Defendants’ Separate Statement, pp. 1-5; see also Weil & Brown, supra, at ¶ 10:96.7 [“Where ‘undisputed facts’ pertain to more than one claim, issue or defense, these facts (together with the supporting evidence) should be repeated for each issue”].) “Failure to comply with the separate statement requirement constitutes ground for denial of the motion.” (Id. at ¶ 10:97.)

Moreover, it is useful to remember the “Golden Rule”: “If it is not set forth in the separate statement, it does not exist.” (Id. at ¶ 10:95, emphasis in original.) Defendants submitted 38 exhibits but cite just 17 of them in the separate statement. (See Defendants’ Separate Statement, UMFs 1-3 [citing Exhibits 1, 2, 3, 4, 5, 7, 9, 10, 11, 15, 16, 17, 18, 19, 20, 21, and 22].) While California law instructs moving parties to only include “those facts which are truly material to the claims or defenses involved” (Weil & Brown, supra, at ¶ 10:95.1, emphasis in original), courts have discretion to decline to “consider evidence omitted from the . . . separate statement[.]” (Id. at ¶ 10:95.4.)

[1] “UMF” means undisputed material fact.

[2] Defendants fail to discuss whether the Gregory Plaintiffs filed an amended complaint.

[3] Consider Sanders v. Merck & Co., Inc. (18STCV06629). The Court located a minute order by Judge Kuhl sustaining the demurrer to the third cause of action for “Strict Liability – Manufacturing Defect” with leave to amend in Sanders. (5/23/19 Minute Order, pp. 1, 3.) It appears that the Sanders Plaintiffs filed an amended complaint on 7/9/19. The amended complaint includes at least two manufacturing defect causes of action (strict liability and negligence), which, presumably, would survive regardless of whether Defendants’ preemption defense is meritorious as to failure to warn claims. The record here is undeveloped and unclear as to whether the same is true of Gregory.