Judge David S. Cunningham, Case Number: JCCP4962, Date: 2023-11-06 Tentative Ruling

Moving Party: Merck & Co., Inc., et al. (jointly “Defendants” or “Merck”)

Defendants’ moving and reply requests for judicial notice (“RJN”) are granted in full. The Court judicially notices the existence of the documents.

Defendants’ motion in limine is granted as to Dr. Pinghui Feng’s new report and opinions.

Defendants’ motion in limine is denied without prejudice as to testimony, arguments, and opinions regarding the 7/10/03 company memorandum (“Mixed-Sample Memo” or “Memo”).

“Merck manufactures a vaccine utilized to prevent shingles branded as Zostavax.” (3/24/23 Order Re: Motion for Summary Judgment/Adjudication, p. 2 (“3/24/23 Order”).) “Shingles is a viral infection that causes a painful rash. It is undisputed that the varicella zoster virus (“VZV” or ‘wild-type’ virus) causes chickenpox and shingles.” (Ibid.)

“This action involves claims that Merck failed to warn that Zostavax, a vaccine approved and licensed to prevent shingles, could cause shingles. Plaintiffs are individuals diagnosed with shingles.” (Ibid.)

“The instant action is a coordinated proceeding with 23 underlying cases designated as JCCP 4962.” (Ibid.) “In September 2020, Judge Ann Jones bifurcated the JCCP to address generally applicable motions before hearing case-specific issues.” (Ibid.) “All of the claims in the JCCP turn on the adequacy of Zostavax’s label warning.” (Ibid.)

On 8/2/22, Defendants’ first motion for summary judgment/motion for summary adjudication (“MSJ/MSA”) came on for hearing. The Court denied it “without prejudice due to procedural defects.” (Ibid.)

“On 1/24/23, the Court heard Defendants’ second MSJ/MSA and ordered supplemental briefs (the motion concern[ed] preemption and applie[d] to all causes of action remaining in the operative complaints).” (Id. at p. 3.)

“On 2/21/23, the Court heard oral arguments regarding the supplemental briefs and took the matter under submission.” (Ibid.)

On 3/24/23, “the Court announce[d] its decision.” (Ibid.) Despite making several findings against Plaintiffs, the Court denied the second MSJ/MSA in part and informed the parties of its intention to hold a bench trial on whether Zostavax clinical trial data generated by Merck from 2005 through 2009 is “newly acquired information.”[1]

Here, Merck moves to exclude (1) Dr. Feng’s new report and analysis and (2) testimony, arguments, and opinions concerning the Mixed-Sample Memo.

To begin, the Court incorporates the 3/24/23 Order. As to the Protocol 022 evidence, the AN1030166 evidence, the 2008 European Medicines Agency (“EMA”) report, the 2014 EMA report, the Varicella Zoster Virus Identification Program evidence, the recombination evidence, the 2014 label change, the Mixed-Sample Memo, and the submitted 2002 through 2004/2005 clinical trial data, the Court found that Defendants shifted the burden and that Plaintiff failed to raise triable issues. (See 3/24/23 Order, pp. 11-25.) Those findings stand, and the Court declines to reconsider them.

The subject of the bench trial is the unsubmitted 2005 through 2009 clinical trial data. As to this issue, the 3/24/23 Order states:

. . . the Court shares Defendants’ concerns. It was Plaintiffs’ counsel who performed the reassessment, along with their experts, like Dr. Feng, who are not included in the record. [Citations.] They did rely on their own interpretation of the Mixed-Sample Memo to reassess the data. [Citations.] The Court agrees that these facts tend to show “a classic instance of litigation-driven analysis” [citation], and, because the Memo study utilized “lab-created non-human” samples, the reliability of Plaintiffs’ analysis is questionable. [Citation.]

Nevertheless, the Court finds that the MSJ/MSA should be denied. Plaintiffs filed several Excel-type charts. The charts contain columns with myriad numbers and other data points. [Citations.] Neither side submitted expert evidence explaining the numbers. [Citations.] It is appropriate to deny the motion under these circumstances because both sides’ analyses amount to attorney arguments rather than evidence. [Citations.] More evidence is needed to make a prima facie showing and to determine, as a matter of law, what the ¿Ct values ranging from 5 to 10 mean independent of the parties’ competing interpretations of the Mixed-Sample Memo (it might be useful, for example, to hear from the researchers who originated the data or a person most knowledgeable). Consequently, while the Court shares Defendants’ concerns, the current record is deficient, Defendants fail to shift the burden, and, alternatively, a triable issue exists.

Preemption is a legal issue for the Court to decide. [Citation.] To resolve this issue, the Court is inclined to hold a bench trial on whether the unsubmitted 2005-2009 clinical trial data constitutes “newly acquired information.” No other issues and no other types of claimed “newly acquired information” will be considered or reconsidered. The bench trial shall be limited to analysis of the unsubmitted data only.

The subject of Defendants’ motion in limine is Plaintiffs’ expert, Dr. Feng. On 8/2/23, Plaintiffs responded to Defendants’ interrogatories, stating that there are 20 samples from the 2005 through 2009 clinical trial data that have “¿Ct values below 5, indicative of the presence and contribution of vOka VZV to the herpes zoster[.]” (Beamer Decl., Ex. 2, p. 4; see also id. at Ex. 3, p. 29 [reducing the number to 16 samples].) One of the samples came from the already adjudicated Protocol 022. (See id. at Ex. 2, p. 4.) The other samples were found by Dr. Feng. Apparently, he utilized a process called “beta-globin normalization” to determine the values:

. . . these 19 out of 20 patient samples require[] Ct value normalization using internal beta-globin control. It is imperative that the amplification efficiency between experiments (runs with either wildtype primers or vOka primers) is consistent with each other and the Ct values of beta-globin, a housekeeping gene, serve this goal. Normalization is an integral step to the proper performance and interpretation of real-time PCR assay. . . .

(Ibid.) On 9/19/23, Dr. Feng submitted a new report that details his findings based on his use of the “beta-globin normalization” method. (See id. at Ex. 1.)[2]

Defendants contend Dr. Feng’s new report and opinions should be excluded because they constitute litigation-generated analysis (see Motion, pp. 8, 10-11), do not qualify as rebuttal evidence (see id. at pp. 8, 11-13), and are unreliable (see id. at pp. 13-14).

Plaintiffs assert that Dr. Feng’s new analysis is rebuttal evidence and that the Court invited them to submit it. (See Opposition, pp. 2-4.)

In reply, Defendants claim the 3/24/23 Order prohibits new expert opinions, Dr. Feng’s new analysis is not rebuttal evidence, and Plaintiffs fail to show that his new analysis is reliable. (See Reply, pp. 3-6.)

The Court agrees with Defendants. The Cout finds that Dr. Feng’s new report and opinions should be excluded because:

* His new analysis appears to be litigation-generated analysis. He admitted at his deposition that he had not “identified these samples or expressed this opinion in any prior Zostavax expert report” and that he did the analysis “for the first time” for his new report. (Beamer Decl., Ex. 3, pp. 14-15, 29-30.) He admitted that Plaintiffs’ counsel selected and provided the data that he analyzed. (See id. at Ex. 3, p. 56; see also Motion, p. 13 n.8 [noting that Dr. Feng only evaluated “a portion of . . . data from two Zostavax sub-studies” and “ignored . . . “hundreds of samples that were tested in other Zostavax clinical trials conducted between 2005 and 2009”].) His understanding was that no one at Merck used the “beta-globin normalization” method during the 2005 through 2009 period, and he did not know of “any other person or organization” that performed “beta-globin normalization” on the samples. (Id. at Ex. 3, pp. 17-19) He also admitted that “the use of beta-globin was never validated for this purpose.” (Motion, pp. 12-13; see also Beamer Decl., Ex. 3, p. 21.) Bottom line, the facts suggest that he did the analysis at Plaintiffs’ counsel’s direction for trial, using a previously unused methodology, 15 years or more after Merck created the data.[3]

* His “beta-globin normalization” analysis is not rebuttal evidence. As Defendants note, Plaintiffs gave notice of Dr. Feng’s new analysis in their August 2, 2023 responses to Defendants’ interrogatories. (See id. at Ex. 2, p. 4.) Dr. Feng testified that, prior to August 2^nd, he helped Plaintiffs’ counsel prepare the responses. (See id. at Ex. 3, pp. 65-66.) Necessarily, this means he and Plaintiffs’ counsel “devised and advanced” the “beta-globin normalization” theory before the depositions of Merck’s witnesses took place. (Motion, p. 12; see also Beamer Decl., Ex. 4 [attaching the August 9, 2023 deposition of Beth Arnold]; id. at Ex. 5 [attaching the August 15, 2023 deposition of Dr. Maria Nagel].)

* Even if it were rebuttal evidence, it still would need to be excluded because it is litigation-generated analysis as opposed to testimony from “the researchers who originated the data or a person most knowledgeable[.]” (3/24/23 Order, p. 24.) The Court requested evidence from people with personal or institutional knowledge to explain “what the ¿Ct values ranging from 5 to 10 mean independent of the parties’ competing interpretations of the Mixed-Sample Memo[.]” (Ibid., emphasis in original.) Dr. Feng does not have personal or institutional knowledge. He conceded that he partly based his opinions on the Mixed-Sample Memo. (See Beamer Decl., Ex. 1, p.. 20 [stating that “consideration of the [Memo] is unavoidable”]; see also id. at Ex. 3, pp. 26-27, 47.) Simply put, his new analysis exceeds the scope of the 3/24/23 Order.

Defendants’ argument – the new analysis is unreliable – is unpersuasive at this point, but it does not change the outcome. If reliability was the only question, the Court would be inclined to hold an Evidence Code section 402 hearing instead of deciding the matter on the papers. However, regardless of reliability, the new analysis is litigation-generated, so it needs to be excluded.

Last, Defendants ask the Court to exclude all testimony and arguments related to the Mixed-Sample Memo. (See Motion, p. 15; see also Reply, p. 6.)

. . . Dr. Feng states in his Report that “consideration of the [constructed sample] study is unavoidable.” [Citation.] Thus, discussion of Ct values relies upon its definition, which is based on the Constructed Sample Study. Dr. Feng points out that “samples with ¿Ct values between 5 and 10 likely contain the Oka vaccine strain VZV up to 5%, using their constructed sample as a reference.” [Citation.] The meaning of ¿Ct values between 5 and 10 is precisely what the Court has ordered be addressed at the bench trial.

Without the results and conclusions of the Constructed Sample Study, Plaintiffs will be required to make a legal argument without being able to reference the definition of the main subject matter. Therefore, it will be impossible for Plaintiffs to explain fully and properly the meaning of Ct values without being able to discuss the origin and foundation of those values.

The Court denies Defendants’ request without prejudice. Defendants fail to highlight particular testimony or evidence that they seek to prohibit. This is a prophylactic motion. The Court cannot rule in a vacuum. (See Kelly v. New West Federal Savings (1996) 49 Cal. App. 4th 659, 670.)

The remedy for Defendants is to make objections to specific evidence at trial. It is well known that the Court previously adjudicated the Mixed-Sample Memo in Defendants’ favor. (See 3/24/23 Order, pp. 21-22, 25.) It is well known that the Court held that the trial evidence should explain the meaning of the 2005 through 2009 data “independent of the parties’ competing interpretations of the Mixed-Sample Memo[.]” (Id. at p. 24, emphasis in original.) In June 2023, the Court stated, clearly, that it will not “rely[] on any litigation expert’s analysis” of the Memo. (Merck’s Moving RJN, Ex. 2, p. 32.) With these guidelines in mind, Defendants should feel free to raise objections at trial, which will allow the Court to evaluate the evidence in context.

[2] At the MSJ/MSA stage, the Court excluded an earlier report by Dr. Feng because Plaintiffs filed it late, and it amounted to “litigation-triggered analysis.” (3/24//23 Order, p. 21.)

[3] Are Plaintiffs changing their theory? In their MSJ/MSA supplemental brief, Plaintiffs claimed “[t]here were over 100 samples that had ¿Ct values between 5 and 10 to indicate the presence of vOka strain.” (3/24/23 Order, p. 23, emphasis added.) Now, they claim Dr. Feng identified “20 patient samples with ¿Ct values below 5, indicative of the presence and contribution of vOka VZV to the herpes zoster.” (Beamer Decl., Ex. 1, p. 4, emphasis added.) Is this a material difference? The Court will give Plaintiffs’ counsel an opportunity to answer this question during oral arguments. For now, though, it appears different and seemingly lends support to the conclusion that Plaintiffs’ theory is new and, as a result, that Dr. Feng’s new analysis is litigation-generated. (See, e.g., Motion, p. 8 n.3.)

[1] “Newly acquired information” means “data, analyses, or other information not previously submitted to” the Food and Drug Administration (“FDA”), “which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” (21 C.F.R. § 314.3, subd. (b).)

[2]At the MSJ/MSA stage, the Court excluded an earlier report by Dr. Feng because Plaintiffs filed it late, and it amounted to “litigation-triggered analysis.” (3/24//23 Order, p. 21.)2[ At the MSJ/MSA stage, the Court excluded an earlier report by Dr. Feng because Plaintiffs filed it late, and it amounted to “litigation-triggered analysis.” (3/24//23 Order, p. 21.)

Opposing Party: Merck & Co., Inc., et al. (jointly
“Defendants” or “Merck”)

Defendants’ opposition request for judicial notice is granted in
full. The Court judicially notices the
existence of the documents.

“Merck
manufactures a vaccine utilized to prevent shingles branded as Zostavax.” (3/24/23 Order Re: Motion for Summary
Judgment/Adjudication, p. 2 (“3/24/23 Order”).)
“Shingles is a viral infection that causes a painful
rash. It is undisputed that the varicella zoster virus (“VZV” or ‘wild-type’
virus) causes chickenpox and shingles.” (Ibid.)

“This action involves claims that Merck failed to warn
that Zostavax, a vaccine approved and licensed to prevent shingles, could cause
shingles. Plaintiffs are individuals diagnosed with shingles.” (Ibid.)

“The instant action is a coordinated proceeding with 23
underlying cases designated as JCCP 4962.”
(Ibid.) “In September 2020, Judge
Ann Jones bifurcated the JCCP to address generally applicable motions before
hearing case-specific issues.” (Ibid.) “All of the claims in the JCCP turn on the
adequacy of Zostavax’s label warning.”
(Ibid.)

On 8/2/22, Defendants’ first motion for summary judgment/motion for
summary adjudication (“MSJ/MSA”) came on for hearing. The Court denied it “without prejudice due to
procedural defects.” (Ibid.)

“On 1/24/23, the Court heard Defendants’ second MSJ/MSA and ordered
supplemental briefs (the motion concern[ed] preemption and applie[d] to all
causes of action remaining in the operative complaints).” (Id. at p. 3.)

“On 2/21/23, the Court heard oral arguments regarding the supplemental
briefs and took the matter under submission.”
(Ibid.)

On 3/24/23, “the Court announce[d] its decision.” (Ibid.)
Despite making several findings against Plaintiffs, the Court denied the
second MSJ/MSA in part and informed the parties of its intention to hold a
bench trial on whether Zostavax clinical trial data generated by Merck from
2005 through 2009 is “newly acquired information.”[1]

Here, Plaintiffs request an order allowing the experts to utilize the 7/10/03
company memorandum (“Mixed-Sample Memo” or “Memo”) in offering opinion
testimony.

The Court incorporates the
tentative ruling on Defendants’ motion in limine. As explained there, Dr. Pinghui Feng’s new
report and opinions are excluded because they constitute litigation-generated
analysis and, accordingly, do not constitute “newly acquired information.” (See, e.g., 3/24/23 Order Re: Motion for
Summary Judgment/Adjudication, p. 20 [holding that “[l]itigation-generated
opinions by attorneys and experts do not constitute ‘newly acquired
information’”] (“3/24/23 Order”).)

Incorporating the tentative
ruling arguably renders Plaintiffs’ motion in limine moot. The Court’s understanding is that Dr. Feng is
Plaintiffs’ sole expert for the bench trial.
Since his new analysis is excluded, it seems unnecessary here to make a
blanket ruling on whether experts may utilize the Mixed-Sample Memo.

In case Plaintiffs’ motion is not
moot, the Court finds that it should be denied without prejudice. Defendants’ motion in limine includes a
request to exclude all testimony,
arguments, and opinions regarding the Mixed-Sample Memo. In the tentative ruling, the Court denies the
request without prejudice because it is too broad and vague. (See Kelly v. New West Federal Savings (1996) 49 Cal. App. 4th
659, 670 [prohibiting prophylactic motions that fail to target particular
testimony or evidence and that force courts to rule in a vacuum].) Plaintiffs’ motion, which seeks a general
order permitting unidentified experts to use the Memo in undefined ways,
appears similarly broad and vague.

But more analysis is needed. In the tentative ruling, the Court grants
Defendants leave to object to specific evidence at trial. The same rationale applies to Plaintiffs. The Court already adjudicated the
Mixed-Sample Memo in Defendants’ favor.
(See 3/24/23 Order, pp. 21-22, 25.)
The Court already held that the trial evidence should explain the
meaning of the 2005 through 2009 data “independent of the
parties’ competing interpretations of the Mixed-Sample Memo[.]” (Id. at p. 24, emphasis in original.) In June 2023, the Court stated that it will
not “rely[] on any litigation expert’s analysis” of the Memo. (Merck’s Moving RJN, Ex. 2, p. 32.) Keeping these guidelines in mind, Defendants and
Plaintiffs are free to proffer specific evidence and to raise specific
objections. It may turn out, for
example, that using the Memo for the limited purpose of defining a term is
admissible whereas a wider use is inadmissible.
The key is to give the Court an opportunity to evaluate the evidence in
context.