1

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

)

IN RE ZANTAC (RANITIDINE) )

LITIGATION ) 

)

) C.A. NO. N22C-09-101 ZAN

)

)

Submitted: March 7, 2024

Decided: May 31, 2024

Corrected: June 3, 2024

OMNIBUS ORDER

ON MOTIONS TO EXCLUDE EXPERT OPINIONS

I. INTRODUCTION

Nearly 75,000 Plaintiffs seek to be heard in Delaware for claims alleging that 

their cancer was caused due to the ingestion of a heartburn medication commonly 

known as Zantac. In this early stage of these proceedings, before the Court for 

disposition are the parties’ competing motions to exclude expert testimony pursuant 

to Rule 702 of the Delaware Rules of Evidence and Daubert v. Merrell Dow Pharm. 

Inc.,

1

(the “Motions”). 

The Motions were the subject of discovery, a three-day “Daubert” hearing, 

multiple layers of briefing, and post-hearing submissions all supported by more than 

1

509 U.S. 579 (1993).
2

forty volumes of exhibits. Having considered the pleadings, oral arguments, 

supplemental submissions, and the full record herein, for the reasons now stated, the 

parties’ Motions are DENIED.

II. FACTUAL AND PROCEDURAL HISTORY2

This case involves a molecule known as ranitidine. Ranitidine is marketed 

under the label name of Zantac. N-Nitrosodimethylamine (“NDMA”) is found in 

ranitidine.3 NDMA causes cancer.4 

Zantac is a part of a class of medications known as Histamine-2 Receptor 

Antagonists (“H2Ras”).5 Ranitidine is a histamine-2 receptor blocker used to “treat 

heartburn and many other gastro-intestinal disorders, including duodenal ulcers, 

gastroesophageal reflux disease (“GERD”) and esophagitis.”6 

In 1983, based on extensive testing, including humans, the FDA approved 

ranitidine for prescription use to treat ulcers and later approved it to treat other 

2 The recitation of the history and facts in this section are for context only.

3

See Plaintiffs’ Opposition to Defendants’ Motion to Exclude General Causation Experts’ 

Opinions at 14, Trans. ID 71670509 (Dec. 20, 2023) (herein “Pls.’ Opp’n to Defs.’ Mot. to Exclude 

Gen. Causation Experts’ Op.”).

4

Id.

5 Defendants’ Brief in Support of Brand Defendants’ and Patheon’s Motion to Exclude 

Plaintiffs’ General Causation Experts’ Opinions at 3, Trans. ID 71408977 (Nov. 15, 2023) (herein 

“Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op.”).

6

In re Zantac, 644 F. Supp.3d 1075, 1095 (S.D. Fla. 2022).
3

stomach and esophageal conditions.7 In 1995, the FDA authorized ranitidine for overthe-counter (“OTC”) use.8

 By 2004, the FDA had further approved higher dosages of 

ranitidine for OTC use.9 

Zantac was on the market for more than 35 years.10 During approximately four 

decades of marketing, there were four brand pharmaceutical companies and generic 

manufacturers that sold versions of the product.11 GlaxoSmithKline (“GSK”) 

developed the medication and initially marketed it in prescription form.12 In 1995, 

GSK marketed it as an OTC in a joint venture with a predecessor of Pfizer.13 In 1998, 

GSK transferred its rights to sell OTC Zantac in the U.S. to that Pfizer predecessor.14 

In 2006, Defendant Boehringer Ingelheim (“BI”) acquired the rights to sell OTC 

Zantac.15 In 2017, Defendant Sanofi began selling OTC Zantac after acquiring the 

brand from BI.16 

7 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 4.

8

Id.

9

Id.

10 Id.

11 Id.

12 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 4, n1.

13 Id.

14 Id.

15 Id.

16 Id.
4

In September of 2019, Valisure, an online pharmacy submitted a citizen petition 

to the FDA claiming detection of “extremely high levels of N-Nitrosodimethylamine 

(NDMA)” in ranitidine.17 Valisure reported NDMA at levels in excess of three million 

nanograms per tablet. This far exceeded the limit of 96 nanograms per day that the 

FDA had set for NDMA ingestion in the context of an unrelated class of medications.18

After reviewing Valisure’s petition, the FDA raised concerns about the testing 

methodology.19 FDA and ranitidine manufacturers studied NDMA in ranitidine and 

examined whether ranitidine use increases cancer risks in patients.20 Over the next 

month, some tests revealed amounts lower than what Valisure reported, and some lots 

tested revealed amounts below the acceptable daily intake (ADI).21 

In September and October of 2019, then-existing ranitidine manufacturers

recalled their products. And by April 2020—after further testing confirmed NDMA 

levels in some samples continued to exceed ADI—the FDA requested manufacturers

initiate a market withdrawal of all remaining batches then remaining on the market.22 

After the recall of ranitidine-containing Zantac, litigation ensued around the country. 

17 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 5.

18 Id. 

19 Id. 

20 Id.

21 Id. (citing FDA, FDA Statement: Statement on new Testing Results, Including Low Levels of 

Impurities in Ranitidine Drugs (2019) (Brown Decl. Ex. 89) at 1).

22 Id. at 8.
5

A. NATIONAL PROCEDURAL HISTORY - THE “MDL”23

To address these claims, on February 6, 2020, the United States Judicial Panel 

on Multidistrict Litigation established a multidistrict litigation process (the “MDL”) 

in the U.S. District Court for the Southern District of Florida in West Palm Beach for 

all pretrial purposes. The Panel ordered federal lawsuits for personal injury and 

economic damages from the purchase or use of Zantac to be transferred to the MDL. 

As part of MDL management, a Census Registry (“The Registry”) was created 

to allow the parties and the Court to “understand the nature of the unfiled claims that 

are a part” of the MDL.24 The MDL Court held a Daubert hearing in early 2022. 

On December 6, 2022, the MDL Court issued its opinion on Daubert and 

summary judgment motions (“MDL Order”).25 In its 200-page opinion, the MDL 

Court, in pertinent part, excluded those plaintiffs’ experts’ general causation opinions

and granted summary judgment for Defendants.

26

 

B. LITIGATION IN OTHER STATES

Similar suits were also proceeding in state courts throughout the United States.

The largest one, other than here, was a coordinated proceeding in California, the 

23 See generally, In re Zantac, 644 F.Supp.3d at 1095.

24 Id. at 1096.

25 As of the date of this ruling, it appears that the MDL decision is on appeal in the Eleventh

Circuit Court of Appeals. 

26 See generally, id.
6

Judicial Council Coordinated Proceeding (“JCCP”). In the California state court, 

several thousand cases were being coordinated in the JCCP, with sixteen bellwether 

trials scheduled for 2024. The JCCP Plaintiffs were pursuing their claims for the same 

cancers claimed here. Those cases advanced beyond the general causation phase.27 

C. THE PARTIES AND PROCEDURAL HISTORY HERE

Plaintiffs in this litigation were not before the federal MDL Court. Nor are the 

experts the same. Plaintiffs here are pursuing ten cancers—bladder, esophageal, 

gastric, liver, pancreatic, breast, colorectal, kidney, lung and prostate. Notably, in the 

MDL, Plaintiffs’ Leadership (also not present here) notified that Court that it had 

decided not to pursue general causation expert reports for breast and kidney cancers 

and initially narrowed their list from ten to eight cancers.28 In January of 2022, they 

again notified the MDL Court that they were not moving forward with certain cancers, 

and again, narrowed the list to five cancers. Thus, five of the cancer claims here were 

not before the MDL Court.29

In September of 2022, nearly 75,000 complaints were filed in this Court. 

27 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex 75.

28 In re Zantac, 644 F.Supp.3d at 1098.

29 Id. (The MDL noted in its final disclosure that the plaintiffs in the MDL intended to “prove 

that ranitidine causes bladder, esophageal, gastric, liver, and pancreatic cancers (the ‘Designated 

Cancers’), as opposed to other cancers (‘Non-Designated Cancers.’). The Defendants do not 

address Non-Designated Cancers in the Daubert motions, so individual cases in which Plaintiffs 

allege their ranitidine use caused their Non-Designated Cancers remain pending at this time and 

are not the subject of this Order.”).
7

Plaintiffs allege Defendants collectively bear responsibility for their cancer 

diagnoses, and the related injuries or deaths caused from their ingestion of the 

medication known as Zantac. 

The Defendants are GlaxoSmithKline LLC (“GSK”), Boehringer Ingelheim 

Pharmaceuticals, Inc., Boehringer Ingelheim Corporation, and Ingelheim U.S.A. 

Corporation (collectively, B.I.), Sanofi US Services Inc., Sanofi-Aventis U.S. LLC, 

and Chattem, Inc. (collectively, “Sanofi), Pfizer Inc. (“Pfizer”) (together with all 

those just mentioned are referred to as the “Brand Defendants”) and Patheon, (all 

collectively “Defendants”).30

In these initial proceedings, the first phase addresses “general causation,” 

which involves the question of whether the ingestion of this product is capable of 

causing cancer as alleged. To carry their burden at this stage, Plaintiffs have retained 

ten experts to offer opinions on general causation for the ten mentioned cancers. 

Defendants move to exclude them all.31 Plaintiffs also move to exclude certain 

opinions proffered by Defendants’ sole General Causation Expert, William C. 

30 Brand Defendants’ and Patheon’s Motion to Exclude Plaintiffs’ Expert Dr. Charles Jameson, 

Trans. ID 71409144 (Nov. 15, 2023) (herein “Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ 

Expert Dr. Jameson”). 

31 Defendants move to exclude all of Plaintiffs’ General Causation Experts: Drs. Charles William 

Jameson, PhD; William Sawyer, PhD; Alfred I. Neugut, M.D., PhD; Vinod K. Rustgi M.D., MBA; 

Ioannis Hatzaras, M.D. MPH, PhD, F.A.C.S.; Dan J. Raz, M.D.; Bruce J. Trock, MPH, PhD; 

George Miller, M.D.; Pablo Leone, M.D.; and Vitaly Margulis, M.D. (collectively “Plaintiffs’ 

General Causation Experts”). 
8

Zamboni, Pharm.D., PhD.

III. APPLICABLE LEGAL STANDARDS 

As in any products liability case, each party bears the burden of proof on the 

admissibility of their expert opinion testimony.32 Delaware Rule of Evidence 702 

addresses the admissibility of expert testimony. It provides: 

A witness who is qualified as an expert by knowledge, 

skill, experience, training, or education may testify in the 

form of an opinion or otherwise if: 

(a) the expert’s scientific, technical, or other specialized 

knowledge will help the trier of fact to understand the 

evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and 

methods; and

(d) the expert has reliably applied the principles and 

methods to the facts of the case.33

This rule is nearly identical to Federal Rule of Evidence 702.34 Our Supreme 

Court has interpreted Federal Rule of Evidence 702, addressed the admissibility of 

expert testimony,35 and adopted the holdings of Daubert v. Merrell Dow Pharm., 

32 Minner v. Amer. Mort. & Guar. Co., 791 A.2d 826, 843 (Del. Super. 2000).

33 D.R.E. 702.

34 Barrera v. Monsanto Co., 2019 WL 2331090, at *3 (Del. Super. May 31, 2019).; see also

Minner, 791 A.2d at 833 n.2.

35 See Tumlinson v. Advanced Micro Devices, Inc., 81 A.3d 1264, 1269 (Del. 2013) (herein 

“Tumlinson”).
9

Inc. (“Daubert”) and its progeny as the correct interpretation of Delaware Rule of 

Evidence 702.36 

A. THE DAUBERT STANDARD

Decided in 1993 by the United States Supreme Court, Daubert is a name 

well-known to most lawyers. Even so, the Court has urged litigants to appreciate 

“the perspective from which this Court will view so-called Daubert motions, and the 

process by which such motions will be addressed.”37 This encouragement merits 

respect, as Daubert at first blush may seem contradictory, expanding the power of 

the trial court by rejecting the “general acceptance” requirement for admissibility 

while at the same time emphasizing the limitations on the court’s role in deference 

to the role of the jury.38 And although Daubert rejected the exclusivity of the 

“general acceptance” requirement, an expert’s “access to the courtroom is not 

unfettered.”39 

A few factors can be implicated in Daubert reviews. Some are enumerated in 

Rule 702; others, some identified in Daubert, are deemed nonexclusive.40 But even 

the expanded list is not exclusive. None of the Daubert factors, specific or 

36 See M.G. Bancorporation, Inc. v. LeBeau, 737 A.2d 513, 522 (Del. 1999).

37 In re Asbestos Litig., 911 A.2d 1176, 1197 (Del. Super. 2006).

38 Minner, 791 A.2d at 841.

39 In re Asbestos Litig., 911 A.2d at 1197.

40 Daubert, 509 U.S. at 590.
10

otherwise, is binding on the trial court.41 The trial court also has broad discretion to 

consider factors not articulated by Daubert.

42

 

B. THE GATEKEEPER AND THE JURY

Predominant among Daubert’s holdings is the recognition of the trial court’s 

role as gatekeeper. In that role, the “Trial Judge...insure[s] that the scientific 

testimony is not only relevant but reliable.”43 While Daubert may require trial courts 

to dive deeper into certain preliminary facts than had historically been the case, it 

was not intended to abrogate the jury’s constitutionally protected role as the ultimate 

fact-finder; a role the courts of this State defend vigorously.44 Daubert and its 

progeny have repeatedly emphasized the importance of the trial system and the role 

of juries as the ultimate arbiters in expert evidentiary issues. 

Therefore, “[a]s a threshold matter, Daubert neither requires nor empowers 

Trial Courts to determine which of . . . competing scientific theories has the best 

performance.”45 Daubert “requires only that the trial court determine whether the 

41 Tumlinson, 81 A.3d at 1269.

42 Id. at 1272–73; Long v. Weider Nutrition Group, 2004 WL 1543226, at *5 (Del. Super. June 

25, 2004) (citing Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 150 (1999)).

43 Minner, 791 A.2d at 843 (citations omitted).

44 In re Asbestos Litig., 911 A.2d at 1199; see. e.g., Kaur v. Bos. Sci. Corp., 2022 WL 1486178, 

at *3 (Del. Super. May 11, 2022) (an expert’s investigations and assumptions “are readily subject 

to cross examination and to evaluation by the fact finder . . .”).

45 Minner, 791 A.2d at 848 (citation omitted).
11

proponent of the evidence has demonstrated that scientific conclusions have been 

generated using sound and reliable approaches.”46 But “the judge is not a scientist 

and the courtroom is not a science laboratory.”47 Indeed, 

“[i]t would be unreasonable to conclude that the subject of 

scientific testimony must be ‘known’ to a certainty . . . . 

[N]ot knowing the mechanism whereby a particular agent 

causes a particular effect is not always fatal to a plaintiff’s 

claim. Causation can be proved even where we do not 

know precisely how the damage occurred if there is 

sufficiently compelling proof that the agent must have 

caused the damage somehow.”48 

As such, to determine the admissibility of scientific evidence consistent with 

Daubert, the trial judge must determine whether:

(1) the witness is qualified as an expert by knowledge, 

skill, experience, training or education;

(2) the evidence is relevant;

(3) the expert’s opinion is based upon information 

reasonably relied upon by the experts in the 

particular field;

(4) the expert testimony will assist the trier of fact to 

understand the evidence or to determine a fact in 

46 In re Asbestos, 911 A.2d at 1201; see also Minner, 791 A.2d at 842 (citations omitted).

47 Daubert, 509 U.S. at 596–97 (quoting “Introduction to Reference Manual on Scientific 

Evidence”, Fed. Jud. Ctr. at 2 (2000)).

48 Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1314 (9th Cir. 1995) (emphasis in 

original); accord, Bowen v. E.I. Du Pont de Nemours and Co., 2005 WL 1952859, at *9 (Del. 

Super. June 23, 2005) (herein “Bowen”), aff’d 906 A.2d 787 (Del. 2006) (explaining that the trial 

court need not “decide the admissibility of scientific evidence with the degree of certainty required 

in scientific circles”). 
12

issue; and

(5) the expert will not create unfair prejudice or confuse 

or mislead the jury.49

The gatekeeper must apply these particular “factors in a flexible manner that 

takes into account the particular specialty of the expert under review and the 

particular facts of the underlying case.”50 “Where the question of admissibility is a 

close one, exclusion of the evidence is not appropriate where cross examination, the 

presentation of contrary evidence and careful instruction regarding the burden of 

proof will insure that the jury is not misled or confused.”51 Restated, “[t]he reliability 

requirement is not a tool for the Court to use to exclude questionably reliable 

evidence.”52 This Court’s refusal to establish a bright line rule for proving causality 

has previously been considered.53 And no doubt, “the requisite proof necessary to 

establish causation will vary greatly case by case.”54

The Supreme Court in Daubert was more direct: “Vigorous crossexamination, presentation of contrary evidence, and careful instruction on the burden 

of proof are the traditional and appropriate means of attacking shaky but admissible 

49 Bowen v. E.I. DuPont de Nemours & Co., Inc., 906 A2d 787, 795 (Del. 2006) (herein “Bowen 

I”).

50 Id.; Scaife v. Astrazeneca LP, 2009 WL 1610575, at *14 (Del. Super. June 9, 2009).

51 Bowen, 2005 WL 1952859, at *8, aff’d sub nom. Bowen II, 906 A.2d at 787.

52 Barrera, 2019 WL 2331090, at *10.

53 Id. at *5 (citing In re Zoloft, 858 F.3d 787, 783 (3d Cir. 2017)).

54 In re Zoloft, 858 F.3d at 787.
13

evidence.”55 Thus guided, courts confronted by “shaky but admissible evidence” 

conduct their Daubert analyses “with a ‘liberal thrust’ favoring admission.”56 

C. DAUBERT AND GENERAL CAUSATION CONSIDERATIONS

As the preliminary question concerns general causation, this Court finds the 

federal district court’s approach in In re Roundup Products Liability Litigation57

instructive:

The question at this early phase in the proceedings - the 

‘general causation phase - is whether a reasonable jury 

could conclude that glyphosate . . . can cause Non 

Hodgkins Lymphoma (“NHL”) . . . . There are two 

significant problems with the plaintiffs’ presentation, 

which combine to make this a very close question. 

* * *

The evidence, viewed in its totality, seems too equivocal 

to support any firm conclusion that glyphosate causes 

NHL. This calls into question the credibility of some of 

the plaintiffs’ experts, who have confidently identified a 

causal link. 

However, the question at this phase is not whether the 

plaintiffs’ experts are right. The question is whether they 

have offered opinions that would be admissible at a jury 

trial. And the case law - particularly Ninth Circuit case 

law - emphasizes that a trial judge should not exclude an 

expert opinion merely because he thinks it’s shaky, or 

55 Daubert, 509 U.S. at 596.

56 Messick v. Novartis Pharmaceuticals Corp., 747 F.3d 1193, 1196 (9th Cir. 2014) (quoting 

Daubert, 509. U.S. at 588); M.G. Bancorporation, Inc., 737 A.2d at 522.

57 390 F.Supp.3d 1102 (N.D. CA 2018) (herein “In re Roundup”).
14

because he thinks the jury will have cause to question the 

expert’s credibility. So long as an opinion is premised on 

reliable science principles, it should not be excluded by the 

trial judge; instead, the weaknesses in an unpersuasive 

expert opinion can be exposed at trial, through crossexamination or testimony by opposing experts.58

In Kennedy v. Collagen Corp., the Ninth Circuit emphasized that, while 

competing experts, science, experiments, and publications “may increase or lessen 

the value of the expert’s testimony . . . their presence should not preclude the 

admission of the expert’s testimony—they go to the weight, not the admissibility.”

59

 

Also important in Daubert proceedings is the gravity of the decision to be 

made. This Court in In re Asbestos Litig. placed particular emphasis on the risks 

attending expert opinion decisions:

In the products liability context, an incorrect decision can 

either deprive a plaintiff of warranted compensation while

discouraging other similarly situated individuals from 

trying to obtain compensation, or it can improperly impose 

liability in a manner that will cause the abandonment of an 

important product or technology. Either result is 

unacceptable. The Court must tread carefully.60

Notably, in Long v. Weider Nutrition Group, Inc.,

61 this Court likewise 

counseled judicial restraint from a different, but equally compelling, perspective: 

58 Id. at 1108–09; see also Kennedy v. Collagen Corp., 161 F.3d 1226, 1229–31 (9th Cir. 1998).

59 161 F.3d at 1230–31 (italics in original) (quoting McCullock v. H.B. Fuller Co., 61 F.3d 1038, 

1044 (2d Cir. 1995). Accord, In re Asbestos Litig., 911 A.2d at 1180.

60 In re Asbestos Litig., 911 A.2d at 1200.

61 2004 WL 1543226, at *1.
15

The first of several victims of a new toxic tort should not 

be barred from having their day in court simply because 

the medical literature, which will eventually show the 

connection between the victims’ condition and the toxic 

substance, has not yet been completed.62

The cautions urged in In re Asbestos and Long seem self-evident even where 

the plaintiffs are few. Here, where there are nearly 75,000 plaintiffs, the implications 

are much more profound. Therefore, this Court proceeds cautiously.

IV. DISCUSSION

A. THE DISCRETIONARY MDL ORDER

Defendants extol the MDL Court’s decision with great fervor.

63

 Several issues 

confound that reliance. First, the Delaware Supreme Court has made plain that 

issues of admissibility, as procedural questions, are governed by Delaware law.64 

Therefore, Delaware evidentiary decisions control here.65

For example:

• that an expert may change her opinion goes to the 

weight, not the admissibility, of the expert 

opinion;66

• the use of animal studies in the course of an expert 

62 Id. at 6 (quoting Turner v. Iowa Fire Equip. Co., 229 F.3d 1202, 1208–09 (8th Cir. 2000)). 

63 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 13–37.

64 Tumlinson, 81 A.3d at 1270.

65 Id. at 1273 (stating that it is improper to consider the law of a foreign forum when the 

admissibility of evidence is a Delaware issue).

66 Barrera, 2019 WL 2331090, at *11.
16

analysis does not bar admissibility of the expert 

opinion on human disease;

67

• Delaware law holds that statistical significance is 

“not necessary to prove causality”;68

• Delaware does not recognize a “threshold dose” 

requirement as part of the general causation 

analysis; an issue discussed below;69 

• epidemiological studies are not required as a 

threshold for the admission of an expert opinion on 

general causation.70

Second, the MDL Order concerned the exclusion of different experts; none of 

whom are designated nor challenged here.

71

Third, similar to other state courts that considered and opted not to be bound

by the MDL Order (e.g., the California JCCP Court) so, too, here, this Court views

the MDL Order as a “discretionary decision on the exclusion of evidence.”

72

“Two 

different trial judges can review the same evidence, weigh the evidence differently, 

67 Id. at *14.

68 Id. at *4; see In re Zoloft, 858 F.3d at 793.

69 Barrera, 2019 WL 2331090, at *5.

70 Long, 2004 WL 1543226, at *6; see also Tumlinson v. Advanced Micro Devices, Inc., 2013 

WL 7084888, at *9 (Del. Super. Oct. 15, 2013) (herein “Tumlinson II”), aff’d, 81 A.3d 1264 (Del. 

2013) (stating that the Bradford Hill factors are not all-inclusive and only establish a framework 

to establish causation).

71 See Index of Exhibits in Support of Plaintiffs’ Opposition to Defendants’ Motion to Exclude 

Plaintiffs’ General Causation Experts’ Opinions, Trans. ID 71666233 (Dec. 20, 2023) (herein the 

exhibits will be cited in reference to the corresponding motion, such as “Pls.’ Opp’n to Defs.’ Mot. 

to Exclude Gen. Causation Experts’ Op., Ex. _”) Ex. 75 at 8.

72 Id. at 6. 
17

and make different decisions . . . .”

73 This is especially true where the evidentiary 

law governing some of the salient issues differs. Defendants’ praise of the MDL 

Court’s rationale breathes not a whisper to the differences in Delaware law 

implicated here.

Fourth, as the preceding discussion reflects, Delaware courts approach 

Daubert decisions cautiously and with deep deference for the role of juries as the 

ultimate fact finders. To that end, our trial courts need not definitely “resolve” every 

expert query posed, even those that might present “close calls” or “shaky opinions.” 

When experts disagree, or credibility or other questions confound the reliability 

issue, resolution of those issues rests with the jurors.74 Delaware courts are loath to 

step into the heart of technical debate between opposing scientists. In that regard, 

the jurisprudence reflected in the Floridian Zantac differs from Delaware’s. This 

Court—with great respect for the hard judicial work done there—distinguishes that 

ruling from what was presented here.75

73 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 34; Ex. 75, at 6. 

74 In re Asbestos Litig., 911 A.2d at 1207.

75 The post-Daubert briefing here followed adjournment of the three-day Daubert

hearing. Defendants’ submissions are noteworthy only for their zealous endorsement yet again of 

In Re Zantac and ask this Court to agree that “[the] MDL Decision is a Roadmap for this Court.” 

Of the 18 pages of argument in their Opening Post-Daubert brief, 14 pages are devoted to the 

MDL Order, which this Court has already addressed. Defendants also again cite to Long v. Weider 

Nutrition, 2004 WL 1543226 (Del. Super. June 25, 2004). See id., at 5. This Court affords great 

deference to the Long decision: in a case of this legal and medical gravity, the Court should 

proceed cautiously. See Long, 2004 WL 1543226, at *6; see also In re Asbestos, 911 A.2d at 

1200.
18

B. GENERAL CAUSATION FOCUSES ON NDMA

The discrete issue before the Court at this stage is whether NDMA can cause 

cancer. Both sides disagree as to how to frame the general causation question. 

Plaintiffs cast the issue directly:

It is undisputed that N-Nitrosodimethylamine (“NDMA”) 

is found in ranitidine and that NDMA causes cancer. That 

is why the U.S. Food and Drug Administration ordered an 

immediate recall after independent testing showed 

unacceptable levels of NDMA in the drug. In turn, it 

would seem obvious then, that if a person ingested 

ranitidine with NDMA, they could develop cancer.76 

Plaintiffs maintain that the issue is not whether ranitidine, untethered to 

NDMA, can cause cancer because the cancer-causing agent is NDMA, and its route 

of exposure to NDMA is through the ingestion of ranitidine.77 

Conversely, Defendants frame the general causation question as turning on 

“the consensus of the scientific community that ranitidine use does not increase the 

risk of cancer, and the unreliable methodologies employed by Plaintiffs’ experts [] 

to avoid that reality.”78 In support, Defendants cite the “largest and highest quality 

healthcare databases,” “leading medical journals,” “40 medical institutions, research 

76 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 14 (emphasis in original). 

77 Id. at 40 (emphasis in original).

78 Brand Defendants’ Opposition to Plaintiffs’ Motion to Exclude Certain Opinions of 

Defendants’ Expert William C. Zamboni at 1–2, Trans. ID 71683862 (Dec. 22, 2023) (herein 

“Brand Defs.’ Opp’n to Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Zamboni”) (emphasis 

added).
19

topics” and “15 peer-reviewed studies” addressing “whether ranitidine causes 

cancer.”79 Defendants add that these “studies of ranitidine necessarily account for 

any exposure to NDMA contained in ranitidine products.”

80

Yet, Defendants do not dilate on how the studies “necessarily account” for 

any exposure to NDMA contained in ranitidine products. Whether describing source 

documents, like those above, or setting the predicate for a point of advocacy, 

Defendants speak in terms of ranitidine: “patients who took ranitidine,”

81

 “whether 

ranitidine causes cancer,”

82

 “studies of ranitidine,”

83 “exposure to NDMA contained 

in ranitidine,”

84 “‘no demonstrable association’ between ranitidine use and any 

cancer types[,] ranitidine patients,”

85 and “real-world ranitidine data in humans.”86

At the same time, Defendants concede that in September and October of 2019, 

“as a precautionary public health measure, then-existing ranitidine manufacturers 

voluntarily recalled their ranitidine products pending further investigation into the 

79 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 9–13 (emphasis added).

80 Id. at 10 (emphasis added).

81 Id. at 9.

82 Id. at 10.

83 Id.

84 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op.

85 Id.

86 Id. at 11 (quotation marks in original); see also id. at 12 (“[N]o evidence of a causal association 

between ranitidine therapy and . . . cancer . . . none of these organizations has concluded that 

ranitidine use increases the risk of any type of cancer.”).
20

potential root-causes of NDMA found in some lots” of ranitidine.87 Defendants 

likewise acknowledge that, in April 2020, after “further investigation” confirmed 

that NDMA levels in some samples continued to exceed the ADI, the “FDA 

requested that manufacturers initiate a market withdrawal of any batches remaining 

in the market.”

88

 The recall was based on the FDA’s conclusion that NDMA is a 

“substance that can cause cancer.”89 

Since the FDA recall, ranitidine is no longer sold in the United States and 

many other parts of the world.90 Plaintiffs emphasize that no evidence has been 

offered that the FDA ever stated that ranitidine is safe to be returned to the market 

or that any Defendant has sought to do so.91 And although Defendants place little 

significance on the recall, they also do not challenge that assertion.

Instead, they rely on an FDA July 2021 study (Florian) to suggest that its 

findings “do not support that ranitidine is converted to NDMA in a general, healthy 

population.”92 This does little to advance their arguments. If that were the only 

87 Id. at 8 (emphasis added).

88 Id. (emphasis added); In re Zantac, 644 F.Supp.3d at 1095–96.

89 Plaintiffs’ Brief in Support of Plaintiffs’ Motion to Exclude Certain Opinions of Defendants’ 

Expert Dr. William C. Zamboni, Trans. ID 71466806 (Nov. 21, 2023) (herein “Pls.’ Br. in Supp. 

of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni”) at 2. 

90 In re Zantac, 644 F.Supp.3d at 1091–92; see also Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude 

Certain Op. of Defs.’ Expert Dr. Zamboni at 4.

91 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 19.

92 Id. at 11 (emphasis added) (referring to the Florian study). 
21

issue here, that study might have some utility. 

Zantac was not marketed to serve a generally healthy population. It was 

intended to treat persons with heartburn, and many other gastro-intestinal disorders, 

including duodenal ulcers, gastroesophageal reflux disease (“GERD”) and 

esophagitis. Notably, the record suggests that at least one defendant understood the 

importance of marketing it to this population. The record suggests that Defendant 

GSK’s marketing efforts, from day one, focused on the off-label promotion of 

Zantac for long-term use, despite the drug’s approved indication only for short-term 

use. One GSK executive expressed that very sentiment in 1983.93 

Nevertheless, Defendants insist that the inquiry should focus on ranitidine, not 

NDMA.94 That focus is understandable, but the Court cannot turn a blind eye to the 

focus on NDMA, especially where the record suggests that Defendants 

acknowledged the dangers of it: 

On September 25, 2019, GSK’s scientists prepared a 

Hazard Assessment Report on NDMA (“Hazard 

Assessment”) to “protect the scientists and anybody 

handling” NDMA in the laboratory.95 Some of its 

93 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 33, at 2 (“The sheer 

size of this opportunity and the potential rewards from it dwarf anything we’ve done so far. It’s 

not just that Zantac is bigger than all our other products put together . . . It’s bigger than the whole 

company. You’ve all heard the numbers. My mind finds it difficult to absorb all those zeroes . . 

.”).

94 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 9–10.

95 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 12, at 16:1–17 

(emphasis added).
22

conclusions:

[NDMA] is reasonably anticipated to be a human 

carcinogen based on sufficient evidence of carcinogenicity 

from studies in experimental animals.

 * * *

There is overwhelming evidence that NDMA is mutagenic 

and clastogenic . . . Positive results have been observed in 

human as well as rodent cells.

* * *

Qualitatively, the metabolism of NDMA appears to be 

similar in humans and animals; as a result, it is considered 

highly likely that NDMA is carcinogenic to humans, 

potentially at relatively low levels of exposure.

* * *

NDMA is a genotoxic carcinogen, and exposure should be 

reduced to the extent possible.

N-nitrosamines such as NDMA [] are considered 

carcinogens and have been implicated in human cancers 

such as bladder, esophagus, stomach and naso-pharynx.96

This fundamental dispute of whether the science should focus on ranitidine 

versus NDMA lies at the heart of every challenge mounted in the Motions. This 

Court was confronted with a similar issue in In re Asbestos Litig. The Court’s ruling 

there speaks to Defendants’ ranitidine premise:

Plaintiffs must establish that their experts can reliably 

conclude that exposure to friction products increases the 

risk of contracting an asbestos-related disease. This does 

96 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 19–20; Ex. 13, at 2.
23

not, however, preclude the plaintiffs from attempting to 

carry this burden by presenting competent evidence that 

friction products, in certain circumstances, release 

respirable products [that can cause cancer].97

Similarly, in Kennedy, the Ninth Circuit rejected the trial court’s refusal to 

consider collagen in a general causation analysis, emphasizing that “the body breaks 

down the collagen into amino acids, which are then absorbed into the body.”98 The 

Kennedy court reversed the trial court’s ruling, finding that such evidence will assist 

the trier of fact and is therefore admissible under Daubert and Rule 702.99 At this 

stage, the particular facts here compel the same conclusion. 

For these reasons, this Court cannot constrain its gatekeeping function solely 

to the studies related to ranitidine. NDMA’s dangers, the science, the studies, and 

the opinions therein must be given due consideration. 

The Court now considers the specific challenges as to each expert.

C. PLAINTIFFS’ DAUBERT CHALLENGE

Defendants have disclosed William C. Zamboni as their sole causation expert. 

Dr. Zamboni will opine, in part, that Defendant GSK’s Tanner study, discussed 

below, is the type of study “often not submitted to FDA nor requested by the 

97 In re Asbestos Litig., 911 A.2d at 1202 (emphasis added); see also Kennedy, 161 F.3d at 1229.

98 Kennedy, 161 F.3d at 1229 (emphasis added).

99 Id. at 1231; see also Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 

75 at 33–34 (holding that cases in California “do not suggest that experts cannot consider studies 

on NDMA and must rely on epidemiology studies regarding ranitidine.”).
24

FDA.”100 Dr. Zamboni bases that conclusion on his “experience with drug 

development.”101 Plaintiffs move to exclude that one sentence opinion as wholly 

speculative, citing, inter alia, Dr. Zamboni’s lack of relevant experience in FDA 

drug applications and his failure to review or consider documents relevant to the 

FDA’s request of GSK for data on ranitidine studies.102 Plaintiffs do not move to 

exclude the “majority” of Dr. Zamboni’s opinions.103

Instead, they urge that “an expert is not permitted to opine on the FDA’s state 

of mind,” which, they claim, is exactly what Dr. Zamboni is doing.104 Defendants 

do not quarrel with that proposition.

The Court is constrained to pause on the context in which Plaintiffs’ Motion 

arises. Plaintiffs dedicate considerable argument to what it characterizes as GSK’s 

concealment of material science pertaining to NDMA beginning in 1982. Plaintiffs’ 

100 Brand Defs.’ Opp’n to Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 3 

(citing Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni Ex. 2,

at 28).

101 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 28; Ex. 

2 at 1–2. 

102 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 29 

(“Dr. Zamboni’s opinion regarding what the FDA would not want to know was rendered without 

reference to the very document summarizing what [information] the FDA requested.”).

103 Id. at 2 n.1.

104 Plaintiffs’ Reply in Support of Plaintiffs’ Motion to Exclude Certain Opinions of Defendants’ 

Expert Dr. William C. Zamboni, Trans. ID 71806319 (Jan. 12, 2024) (herein “Pls.’ Reply in Supp. 

of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni”) at 1.
25

effort is detailed and grounded in quotations from GSK and FDA documents.105

By way of background, Plaintiffs allege that as early as 1982, before Zantac 

was approved by the FDA, GSK conducted tests that directly linked ranitidine to 

NDMA formation. A 1982 series of tests, called the Tanner study, named for the 

scientist who performed and reported on the tests, has become a focus of the parties 

here.106 Plaintiffs assert that the Tanner study found that “molecules . . . like 

ranitidine, can react with nitrite under certain conditions to yield [NDMA].”107 

Therefore, NDMA “was already a well-established genotoxic and mutagenic 

nitrosamine.”108

The Tanner Study was only “circulated internally at GSK.”109 Beginning in 

1980, prior to FDA Approval of Zantac, the FDA had voiced concerns about the 

nitrosation potential of ranitidine.110 It is alleged that GSK met with the FDA in 

May 1982, to discuss ranitidine’s mutagenicity and nitrosation. Neither the Tanner 

Study nor NDMA was raised by GSK.111 The meeting never reached those topics

105 See Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 4–

24.

106 Id. at 11.

107 Id. (internal quotes omitted).

108 Id. (emphasis omitted).

109 Id.

110 Id. at 5 (quotation omitted).

111 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 12–13.
26

and the Tanner Study was not made public until 2019.112 

In the intervening years, Zantac went through the FDA pre-approval process. 

The FDA requested of GSK specific information relative to nitrosation and 

ranitidine. Despite various interactions with the FDA, and additional internal testing 

and reports, GSK did not disclose the Tanner Study until 2019. 

Plaintiffs allege that for almost four decades GSK “concealed the fact that 

ranitidine degrades into NDMA.”113 Defendants dispute Plaintiffs’ allegations, 

emphasizing both that 1) substantively, that the Tanner Study addresses whether 

ranitidine “reacts with nitrite within the human stomach to form NDMA”, that is, 

endogenously;

114 and 2) procedurally, that the Tanner study was a type of study 

“often not submitted to FDA nor requested by the FDA.”115 Dr. Zamboni bases that 

conclusion on his “experience with drug development.”116 

The potential implications of the Tanner Study were compounded by a 1984

report—the Preliminary Results of an Investigation into the Thermal Degradation of 

Ranitidine Hydrochloride (“Preliminary Results”)—where GSK reported that 

112 Id. at 2, 23.

113 Brand Defs.’ Opp’n to Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Zamboni at 2; 2 n.5.

114 Id.

115 Id. at 1 (quoting Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. 

Zamboni Ex. 2, at 28).

116 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni Ex. 2, at 

28.
27

ranitidine would rapidly degrade in the presence of moisture and heat, yielding 

“unidentified, breakdown products . . . within the liquid mass formed as a result.”117 

Plaintiffs allege that, despite the Tanner Study, the Preliminary Results report and 

numerous other inquiries and opportunities to do so, GSK did not test the 

unidentified breakdown products for NDMA.118 The Tanner Study remained 

internal.

Furthermore, when ranitidine breaks down to NDMA, discoloration can 

indicate that this degradation process has begun.

119

 It is alleged that after concluding 

that discoloration could not be avoided, GSK scientists recommended changing the 

color of the tablets to “mask any potential discoloration.”120 That recommendation 

was accepted.121 Plaintiffs point to these issues to support the notion that GSK had 

knowledge of the dangers associated with NDMA as early as 1982.122 

Defendants devote the majority of their opposition contesting Plaintiffs’ 

history.123 The one sentence in Dr. Zamboni’s opinion which Plaintiffs move to 

117 Id. at 19; Ex. 27, at 2.

118 Id.

119 Id. at 20–21 (responding to the discoloration problem, one GSK scientist asked, “surely [the 

discoloration] begs the question, ‘if it changes with time, is it safe to use?’ . . . which we do not 

have sufficient information on.”) (quoting Ex. 33 at 5); Ex. 28–31. 

120 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 20; Ex. 

28, at 1; Ex. 29, at 1; Ex. 30, at 6. 

121 Id.

122 Pls.’ Br. in Supp. of Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Dr. Zamboni at 2–3.

123 Brand Defs.’ Opp’n to Pls.’ Mot. to Exclude Certain Op. of Defs.’ Expert Zamboni at 6–15.
28

exclude seems intended to support Defendants’ challenge of GSK’s failure to 

disclose the Tanner Report, and any other data, until 2019. The potential 

implications of Plaintiffs’ history are disturbing. But it is not for the Court to plumb 

their depths at this time.

It may be more than generous to call Dr. Zamboni’s opinion “shaky.”124 But, 

as Daubert and progeny teach us, “[t]he reliability requirement is not a tool for the 

Court to use to exclude questionably reliable evidence.”125 The one sentence opinion 

of Dr. Tanner targeted by Plaintiffs’ Motion will not be excluded. Dr. Zamboni can 

testify to that assertion, though his testimony on that issue should be limited to the 

discrete issue which Plaintiffs move to exclude. Plaintiffs are not without recourse. 

His opinion can be properly measured by cross examination.

126

 Plaintiffs’ Motion 

to Exclude Certain Opinions of Defendants’ Expert William C. Zamboni is 

DENIED.

D. DEFENDANTS’ BROAD DAUBERT CHALLENGES

Defendants muster several broad challenges to general causation. Most of 

these are asserted in the context of Defendants’ Motion to exclude certain experts 

124 In re Roundup, 390 F.Supp.3d at 1109. 

125 Barrera, 2019 WL 2331090, at *10.

126 In re Roundup, 390 F.Supp.3d at 1109 (“[T]he weaknesses [in an] unpersuasive expert opinion 

can be exposed at trial, through cross-examination or testimony by opposing experts”); see also

Kaur, 2022 WL 1486178, at *3 (“[C]hallenges to the ‘factual basis of an expert opinion go to the 

credibility of the testimony, not the admissibility, and it is for the opposing party to challenge . . . 

the expert opinion on cross-examination.’”).
29

and are addressed below. 

One challenge merits discussion at the outset: Plaintiffs’ alleged failure to 

offer satisfactory proof of threshold dose.127 Plaintiffs rely on In re TMI Litig.,

128

where the Third Circuit Court recognized that “it is currently believed that there is 

no threshold dose below which the probability of cancer induction is zero.”

129

Defendants point to Tumlinson II130 in support.131 

In Tumlinson II, this Court was confronted with a causation question 

involving ten possible airborne, causative agents. Plaintiffs’ expert did not rely on 

a dosage in her causative analysis “but instead on atmospheric concentration ranges 

as a surrogate.”132 Tumlinson recognized that no black letter requirement for 

threshold dose exists. To the contrary, the Court discussed those cases excusing 

threshold dose, emphasizing that “[i]n each case, however, the substance in question 

127 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 32; see Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 79–84; see 

also Reply Brief in Support of Brand Defendants’ and Patheon’s Motions to Exclude: (1) 

Plaintiffs’ General Causation Experts’ Opinions; and (2) Dr. Charles Jameson, Trans. ID 71797654 

(Jan. 12, 2024) (herein “Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. & Dr. Jameson”) at 32–35.

128 193 F.3d 613 (3d Cir. 1999), amended, 199 F.3d 158 (3rd Cir. 2000).

129 Id. at 642. In re TMI is not mentioned in Defendants’ Opening or Reply brief, and Defendants 

do not discuss threshold dose in their Reply.

130 Tumlinson II, 2013 WL 7084888, at *7.

131 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation 

Experts’ Op. at 32–36; Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. & Dr. Jameson at 32–35.

132 Tumlinson II, 2013 WL 7084888, at *7.
30

is known to be harmful at some level and the plaintiff suffered the precise harm 

connected to that exposure.”133 

The first prong of Tumlinson II’s comment goes to general causation; the 

second to specific causation.134 Ostensibly, Defendants’ focus on “precise harm” is 

intended to require something more than cancer.135 The Court rejects such a precious

reading, at least at the general causation phase, especially given the conclusions of 

GSK’s 2019 Hazard Assessment, quoted at length above. Daubert counsels against 

black letter standards. Like general acceptance and statistical significance, threshold 

dose is another factor to be considered in the Daubert analysis, but its presence or 

absence is not outcome determinative. 

Moreover, the record suggests that Defendants, particularly GSK, have been 

on notice of the harm that can result from NDMA in their product since the Tanner 

Study in 1982. The Hazard Assessment reflects GSK’s own conclusions about 

carcinogenicity and NDMA.136 Defendants’ expert testified that threshold dose is a 

133 Id.

134 See id. at *5, 8 (“General causation does not consider the likelihood that a certain exposure 

caused a certain harm. Rather, it only considers the possibility.”); see also Pls.’ Opp’n to Defs.’ 

Mot. to Exclude Gen. Causation Experts’ Op. at 84 nn.271–273; Reply Br. in Supp. of Defs.’ Mot. 

to Exclude Pls.’ Gen. Causation Experts’ Op. & Dr. Jameson at 33.

135 See Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. & Dr. 

Jameson at 33.

136 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 12, at 16:1–17.
31

“somewhat meaningless statement [] scientifically.”

137 Defendants debate the 

meaning of that concession.138 Resolution of that debate awaits the jury’s attention. 

But Daubert supports broad, flexible consideration at this stage. 

Also, the parties do not dispute that the FDA has established an ADI limit for 

NDMA based on cancer risk.139 Plaintiffs maintain the testing evidence shows “that 

ranitidine products expose consumers to levels in excess of that ADI.”140 The 

Hazard Assessment provides strong evidence that GSK admits the carcinogenic 

threat in NDMA.141 

Notwithstanding Defendants’ vigorous quarrel with the implications drawn 

from the Tanner history, it can fairly be inferred that GSK delayed revealing the 

cancer-causing potential of NDMA into the science marketplace. Plaintiffs should 

also be able to argue inferences that the collective delays by all Defendants

forestalled development of the science of NDMA exposure.142 At this stage, it does 

137 Id. at 81; id. at 81 n.264.

138 Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. & Dr. Jameson 

at 32.

139 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 83, 83 n.265; Ex. 84, at 

8 (stating that the ADI “is a level that approximates an increased cancer risk”).

140 See id. at 83, 92.

141 Id. Ex. 11 (e.g., “There is overwhelming evidence that NDMA is mutagenic and clastogenic . 

. . Qualitatively, the metabolism of NDMA appears to be similar in humans and animals; as a 

result, it is considered highly likely that NDMA is carcinogenic to humans, potentially at relatively 

low levels of exposure.”).

142 See Long, 2004 WL 1543226, at *6 (“[V]ictims of a new toxic tort should not be barred from 

having their day in court simply because the medical literature, which will eventually show the 

connection between the victims’ condition and the toxic substance, has not yet been completed.”).
32

not lie in the mouths of Defendants to assert a defense based on lack of threshold 

dose. That issue awaits a specific causation finding by the jury.

This is not a case where the imposition of a bright line rule is appropriate. 

That is not to suggest that [threshold dose] is irrelevant.”143 It remains, like general 

acceptance and statistical significance, one of the factors enumerated by Daubert

and its progeny to be considered in the general causation analysis. But it is not, and 

should not, be deemed, alone, outcome determinative. That consideration belongs 

to the jury. 

The Court now considers the specific challenges against Plaintiffs’ experts.

E. DEFENDANTS’ SPECIFIC DAUBERT CHALLENGES

1. Dr. Charles Jameson

Dr. Jameson has been asked to provide expert testimony on ranitidine’s ability 

to form NDMA endogenously and exogenously and to provide “background 

information about the mechanism through which NDMA causes cancer.”144 

Dr. Jameson is a chemist and toxicologist specializing in carcinogenesis. He 

began his career as a senior chemist at the National Institute of Health (“NIH”)’s 

National Cancer Institute. Later, Dr. Jameson was responsible for the National 

Institute of Health’s Environmental Health Services division of Toxicology 

143 In re Zoloft, 858 F.3d at 793.

144 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 90. 
33

Research and Testing. For 18 years, he served as a director on the National 

Toxicology Program’s Report on Carcinogens.145 He has authored or co-authored 

over 80 peer-reviewed scientific publications.146 Dr. Jameson’s methodology, when 

called upon to provide expert testimony, has been upheld by this Court,147 as well as 

the California court overseeing the JCCP, where he provided expert testimony on 

NDMA and ranitidine.148 In both cases, Dr. Jameson’s testimony was admitted. 

Defendants do not challenge Dr. Jameson’s qualifications to consider and opine on 

the questions before him. Dr. Jameson offers four opinions here:149

• ranitidine produces NDMA exogenously (outside the 

body);

• ranitidine produces NDMA endogenously (inside the

body);

• NDMA “meets 5 characteristics of the generally 

accepted characteristics of a carcinogen; and, 

145 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 19.

146 Id., see also id. at 88–90 (providing a complete summary of Dr. Jameson’s qualifications).

147 See Barrera, 2019 WL 2331090, at *14.

148 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 88; Ex. 75.

149 The scope of Dr. Jameson’s opinion is specifically defined. Yet defendants challenge his 

failure to opine “that NDMA in ranitidine can cause cancer in any of the ten cancers at issue,” a 

topic on which he is not offering an opinion. Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ 

Gen. Causation Experts’ Op. & Dr. Jameson at 5. Calling that the “central issue at this stage” of 

the case, defendants argue that Dr. Jameson’s expert testimony is “irrelevant.” Id. at 6. The Court 

rejects that conclusion. Endogenous and exogenous formation of NDMA are a part of plaintiffs’ 

case, as are the carcinogenic characteristics of NDMA and the generally accepted opinion among 

science researchers that NDMA is capable of causing cancer in animals, and humans; topics on 

which Dr. Jameson has been proffered, based on his review of scientific, chemical and medical 

data.
34

• “It is generally accepted among cancer science 

researchers that NDMA is capable of causing cancer in 

animals, including cancer in humans.”150

In support of his expert opinion, Dr. Jameson opines that “the level of NDMA 

found in ranitidine upon its storage reaches levels that exceed the daily intake 

limit.”151 In its root cause analysis, GSK likewise concludes that degradation of 

ranitidine, which begins from the point of manufacture, increases NDMA levels, a 

point confirmed by the FDA.152 This conclusion was also confirmed by independent, 

peer-reviewed testing.153 

In preparing his opinions, Dr. Jameson reviewed data about “exogenous 

NDMA formation from ranitidine,” including testing by FDA, Australia’s TGA, 

GSK, Sanofi, and Emery Pharma, among others.154 He considered GSK’s root cause 

analysis which “concludes, definitively, that ranitidine decomposes into NDMA on 

150 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 19, at 3; see id. at 90–

91.

151 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 19, at 11–12 (emphasis 

added).

152 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 15, at 9 (“NDMA levels 

in drug substances start to increase at a slow rate from the point of manufacture; both elevated 

temperatures and RH contribute to an increase in the rate of degradation”) (emphasis added); id.

Ex. 19, at 7; id. Ex. 8, at 2 (“NDMA levels increase in ranitidine even under normal storage 

conditions...and may raise the level of NDMA in the ranitidine product above the acceptable daily 

intake limit”) (emphasis added); see also id. Ex. 19 at 7.

153 See id. Ex. 30, at 1.

154 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 91, 91 nn.292–93.
35

standing, exacerbated by heat and humidity.”155 Dr. Jameson holds a PhD in organic 

chemistry, and opines as to the molecular reaction beneath the instability of the 

ranitidine molecules.156 His opinion, which is confirmed by independent, peerreviewed testing, “strongly suggest[s] that environmental factors such as heat and 

oxygen are involved in the formation of NDMA.”157

Dr. Jameson concludes that the “evidence is very strong that ranitidine 

decomposes to NDMA which is formed because of an intermolecular degradation 

reaction of the ranitidine molecules that occurs primarily in ranitidine formations” 

and that the “level of NDMA formed in ranitidine upon its storage reaches levels 

that exceed the daily intake limit.”158 This is the same conclusion reached in GSK’s 

root cause analysis and by the FDA, as evidenced by Defendants’ recalling their 

products from the market.159 

Dr. Jameson reviewed in vitro and in vivo data, including numerous in vitro

studies prepared by Defendants and independent laboratories, and peer-reviewed 

literature that, inter alia, support the formation of NDMA from ranitidine within the 

155 Id. at 91–92, 92 n.294.

156 Id. at 92, 92 n.295.

157 Id., 92 n.296.

158 Id., 92 n.297.

159 Id. at 92–93, 92 nn.298–99.
36

human stomach when exposed to sodium nitrite.160 The in vitro data “demonstrates 

that NDMA forms in conditions found in the human stomach.”161 Dr. Jameson also 

relied on an Emery Pharma simulated food study designed to explore how ranitidine 

interacted with nitrite to form NDMA.

162 Using the food tests, Emery was able to 

show that in simulated gastric fluid ranitidine reacts to form NDMA.163 In his 

opinion and in his deposition, he explained his acceptance of or disagreement with 

literature he reviewed or pressed upon him by Defendants’ counsel.164

Dr. Jameson also considered conclusions and recommendations from a litany 

of federal and international agencies, as well as GSK’s internal studies, that NDMA 

“should be regarded for practical purposes as if it were carcinogenic to humans.”165

Conclusions with which he agrees. Some of the agencies reaching that conclusion 

include the FDA, the EPA, The Department of Health and Human Services’ Report 

on Carcinogens, the U.S. Department Health and Human Services’ Agency for Toxic 

160 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 19, at 7–9, 10–18; see

id. at 93–94, 93–94 nn.300–311.

161 Id.

162 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 95, 95 nn.315–18.

163 See id. at 95–100.

164 See id. at 115–21. Beyond the ranitidine issue, Defendants challenge the science of the Hidajat

study: the duration of the study, measurements of “actual NDMA” available, and estimates and 

imputations of NDMA detected and to which workers were exposed. These critiques go to weight 

and, as a consequence, fail to support the Motion.

165 See id. at 16–22 (quoting Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. 

Ex. 1, at 36).
37

Substances and Disease Registry (“ATSDR”), and the World Health Organization 

(“WHO”).166 It cannot be suggested that Dr. Jameson “neglected the core facts of 

the case.”167 Upon completion of his review, he performed a Bradford Hill 

analysis.168 Plaintiffs offer a brief comment on Bradford Hill analysis, none of which 

is remarkable or cause for debate, but three points merit repetition:

(1) methods used by experts in forming opinions as to 

causation substantially rely on the expert’s judgment in 

selecting and weighing their sources;

(2) Daubert does not prescribe a specific weight that 

evidence should be given; and,

(3) it is not the Court’s role to weigh that evidence, second 

guess researchers or pass judgment on substantive 

issues.169

Dr. Jameson’s review supports his conclusion that ranitidine produces NDMA 

endogenously and exogenously, meets five characteristics of the generally accepted 

characteristics of a carcinogen, and is generally accepted among cancer science 

researchers that NDMA is capable of causing cancer in animals, including cancer in 

166 Id. at 16–19.

167 Kaur, 2022 WL 1486178, at *3.

168 Defendants do not voice challenges to Dr. Jameson’s Bradford Hill analysis, either in their 

Opening Brief (filed separately) in support of their Motion to Exclude certain of his opinions, or 

in their Reply Brief. Defendants include three pages on alleged failings they ascribe to Defendants’ 

Bradford Hill analyses, collectively, referring in that argument to “Plaintiffs’ experts” and “some” 

of them. This does not give fair notice of specific challenges to Plaintiffs, their experts, or the 

Court. Defendants in their arguments directed at specific experts do raise Bradford Hill, which 

arguments are addressed later in this ruling.

169 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 67–68.
38

humans.170 

Defendants’ challenges to the reliability of Dr. Jameson’s methodology are as 

follows: he cherry picked his evidence;171 did not rank or weigh his studies;172 the 

tests do not imitate conditions in humans;173 his reliance on non-peer reviewed 

studies;

174 reliance on bad science and improperly rejecting or favoring unreliable 

studies;

175 and, generally, relying on unreliable exogenous studies.176 These 

challenges are for the jury.

The Court finds he utilized sound scientific methodology in formulating his 

opinions. His opinion is generally admissible.177 The science with which Dr. 

Jameson approached his task here, detailed in Plaintiffs’ Opposition, commends that

170 Id. at 90–91.

171 Brief in Support of Brand Defendants’ and Patheon’s Motion to Exclude Plaintiffs’ Expert Dr. 

Charles Jameson, Trans. ID 71409144 (Nov. 15, 2023) (herein “Defs.’ Br. in Supp. of Brand Defs.’ 

& Patheon’s Mot. to Exclude Pls.’ Expert Dr. Jameson”) at 15. 

172 Id. at 16; see Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 100, 100 

n.321 (stating that regulatory and scientific bodies do not rank studies but simply assess their 

strengths and weaknesses); see also id. at 116–117 (responding to questions from counsel, Dr. 

Jameson explains his methodology and explains the strengths and weaknesses of pertinent studies).

173 Id. at 16; but see id. at 101, 101 nn.323–326 (rebutting the assertion that the tests do not imitate 

conditions in humans and relying in part on the Braunstein study).

174 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Expert Dr. Jameson at 

16.

175 Id. at 17; but see Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 103–

20.

176 Id. at 18.

177 In re Asbestos Litig., 911 A.2d at 1204–06; In re Roundup, 390 F.Supp.3d at 1150–51 

(admitting expert opinion where the expert “conducted a literature review and evaluated the quality 

of each of the studies”); See Barrera, 2019 WL 2331090, at *14, 17.
39

methodology.178 Defendants may reject that science and the conclusions Dr. 

Jameson derives from it. But that makes for a battle of the experts; it does not make 

Dr. Jameson’s opinion inadmissible.179 This dispute presents a classic battle of the 

experts.180 Defendants’ Motion to exclude the expert opinions of Dr. Charles 

Jameson is DENIED.

2. William Sawyer, PhD

Plaintiffs offer Dr. William Sawyer for one purpose: to “convert the inhalation 

doses of NDMA observed in the Hidajat study into an equivalent oral dose.”181 Dr. 

Sawyer was not proffered, and will not offer, an opinion on causation; similarly he 

does not intend to discuss the “merits or demerits of any epidemiological study.”182

The express limits of Dr. Sawyer’s opinion notwithstanding, Defendants criticize 

Sawyer for not opining on issues not within his specific task.183

178 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 103–120.

179 McCullock, 61 F.3d at 1044 (“Disputes as to the strength of [an expert’s] credentials, faults in 

his use of [a particular] methodology, or lack of textual authority for his opinion, go to the weight, 

not the admissibility of his testimony”) (parentheticals added); see also Karlo v. Pittsburgh Glass 

Works, LLC, 849 F.3d 61, 83 (3d Cir. 2017) (“The question of whether a study’s results were 

properly calculated or interpreted ordinarily goes to the weight of the evidence, not to its 

admissibility”) (citation omitted).

180 Long, 2004 WL 1543226, at *6.

181 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 121. 

182 Id. at 122; Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. & 

Dr. Charles Jameson at 87, 89 (“Plaintiffs acknowledge Dr. Sawyer is not offering a general 

causation opinion”).

183 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 126–127; Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. 
40

Defendants’ challenges are several, but they focus on one primary issue: Dr. 

Sawyer’s reliance on the 2019 Hidajat study. Defendants attack the Hidajat study 

because, they say, it “did not involve ranitidine at all,”184 and stand on the limiting, 

mechanistic distinction they draw on ranitidine’s role. But Dr. Hidajat did testify 

that “[her] study provided important evidence of. . . the association between NDMA 

exposure and cancer.”185 Thus, at this juncture, her study “fits” the facts of the case.

The science behind the Hidajat study, and Dr. Sawyer’s use of it, merits pause. 

Beyond the ranitidine issue, Defendants challenge the science of the Hidajat 

study:186 the duration of the study,187 measurements of “actual NDMA” available,188

and estimates and imputations of NDMA detected and to which workers were 

exposed.189 These critiques go to weight and, as a consequence, fail to support the 

Motion.190

The Hidajat study “followed 36,441 rubber workers for 49 years—the longest 

& Dr. Charles Jameson at 89 (stating that Dr. Sawyer’s analysis “could not bridge the analytical 

gap” on cancer causation).

184 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 124, 126.

185 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 78–79.

186 Id. at 124–126.

187 Id. at 125.

188 Id.

189 Id. at 125–26. 

190

 Kaur, 2022 WL 1486178, at *4; Bowen, 2005 WL 1952859, at *8; McCullock, 61 F.3d at 1038.
41

follow-up (by 25 years) of any other study in this case.”191 The length of the followup period allowed “near-complete dataset, with 94% of the cohort diseased.”192 To 

estimate exposure to NDMA, the authors “developed a peer-reviewed matrix based 

on the fumes at various locations in the rubber factories...[where workers were] 

‘divided into quartiles of exposure,’ each quartile being compared to the first to see 

whether greater NDMA exposure was associated with specific cancers.”193 The 

Hidajat study documented a “clear dose-response relationship between NDMA 

exposure and the development of bladder, esophageal, liver, lung, pancreatic, 

prostate, and stomach cancer.”194 Because exposure in that study “was through 

inhalation,” Dr. Sawyer “calculated what the equivalent lifetime oral dose would be 

in each quartile.”195

Defendants protest that Dr. Sawyer’s method is “flawed because the amount 

of bioavailable NDMA can depend on dose.”196 When challenged at his deposition, 

he explained that “this was the appropriate method used by forensic 

191 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 74, 74 nn.242–247.

192 Id.

193 Id.

194 Id. at 74–77 (noting Dr. Sawyer offers no opinions on these findings. His opinion is limited to 

“convert[ing] the inhalation doses of NDMA observed in the Hidajat study into an equivalent oral 

dose.”

195 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 74, 74 n.247.

196 Id. at 121–122; see Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. 

Causation Experts’ Op. at 124–26.
42

toxicologists.”197 He further stated that “by using bioavailable data based on higher 

doses, he actually made a more conservative estimate of how much NDMA exposure 

is occurring in the Hidajat study.”198 That is, that he was erring “on the side of 

caution,” as, Plaintiffs note, is “customarily done in toxicological dose 

assessments.”199 This challenge, like the various challenges Defendants assert 

against the Hidajat study, fails under Daubert and its progeny. 

Dr. Sawyer’s opinion is limited, plainly so. He is not testifying on causation, 

but instead on his conversion of inhalation dose to oral dose.200 Defendants reject 

his science. Perhaps, as presented during oral arguments, hisscience may be a bridge 

too far. But at this juncture, the criticisms go to weight and do not preclude 

admission.201 Defendants’ Motion to exclude Dr. Sawyer is DENIED.

3. Alfred I. Neugut, M.D., PhD.

As his CV makes plain,202 Dr. Neugut is an accomplished epidemiologist at 

Columbia University. Dr. Neugut received his MD and PhD from Columbia 

197 Id. at 122, 122 n.409.

198 Id.

199 Id., 122 nn.409–411 (citing to deposition testimony); Pls.’ Opp’n to Defs.’ Mot. to Exclude 

Gen. Causation Experts’ Op. Ex. 136.

200 Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. & Dr. Jameson 

at 89.

201 See Kaur, 2022 WL 1486178, at *4; see also Bowen, 2005 WL 1952859, at *8; see also 

McCullock, 61 F.3d at 1038.

202 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 54.
43

University and a fellowship in Medical Oncology at Sloan-Kettering Cancer Center 

as well as Columbia. Dr. Neugut has published over 800 peer reviewed chapters and 

papers and received over $60 million in funding from the National Cancer Institute, 

American Cancer Society, Department of Defense, and various foundations. Dr. 

Neugut has taught cancer epidemiology at Columbia for over 40 years.203

Here, he was tasked to “assess whether the ingestion of ranitidine, 

contaminated with NDMA, is causally associated with the development of urinary 

bladder cancer.”204 Dr. Neugut was disclosed by plaintiffs in the JCCP litigation to 

offer general causation opinions on carcinogenicity and ranitidine.205 The JCCP 

Court reviewed his methodology, found it to be reliable and denied defendants’ 

motion to exclude his opinions.206 The California Court of Appeals has also 

acknowledged Dr. Neugut as “an expert in the areas of medical oncology and cancer 

epidemiology.”207

His opinions were excluded in In re Roundup Products Liability Litig.,

208 and 

the Barrera Court—then relying on In re Roundup—also excluded his opinions.209 

203 Id.

204

 Id. at 5. 

205 See id. Ex. 75, at 34–38. 

206 See id.

207 Johnson, 266 Cal.Rptr.3d at 118, modified on denial of reh’g (Aug. 18, 2020).

208 390 F.3d at 1144–46.

209 Barrera, 2019 WL 2331090, at *15, 15 nn.199–200.
44

The Roundup court noted that Dr. Neugut was “eminently qualified and refreshingly 

candid,” and lauded his reports as “high quality.”

210

 But that court was disturbed by 

Dr. Neugut’s presentation, commenting on issues with his testimony, not reflected 

in the written transcript.211 The Roundup Court quite correctly noted that “[e]ach 

problem with Dr. Neugut’s testimony is not sufficient, on its own, to justify 

exclusion.”212 The cases discussed cited herein confirm that point. As to statistical 

significance, neither Delaware nor the Third Circuit requires “statistical significance 

to prove causality.”213

In preparing his opinion on the question before him here, Dr. Neugut looked 

at peer-reviewed literature on NDMA, ranitidine, and bladder cancer, and considered 

the strengths and weaknesses of each study.214 He then prepared a forest plot 

synthesizing the studies,215 which revealed a consistent increased risk of cancer.216 

Dr. Neugut’s approach “reflects a sound methodology consistent with Daubert’s 

210 In re Roundup, 390 F.Supp.3d at 1144.

211 Id. (The Roundup Court listed its reasons for its findings that Dr. Neugut’s opinion was not 

sufficiently reliable to be admissible. Two related to his conclusions: one to his characterization 

of glyphosate as something other than a hazard assessment, the other about an IARC conclusion 

as to the meaning of “a probable carcinogen,” and Dr. Neugut’s agreement in his deposition 

regarding associations between glyphosate and NHL). None of those issues present here.

212 Id. at 1146.

213 Barrera, 2019 WL 2331090, at *5, 5 n.56 (citing In re Zoloft, 858 F.3d at 793).

214 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 54, at 15–26; compare 

In re Roundup, 390 F.Supp.3d at 1144.

215 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 54, at 33.

216 Id.; see also id. at 126.
45

‘reliability’ component.”217 Dr. Neugut’s review and synthesis of the data and his 

creation of the forest plot make his opinion generally admissible. 

Dr. Neugut then synthesized the literature using the Bradford Hill factors: 

After reviewing the data and studies described above with 

regard to the association between ranitidine and bladder 

cancer and weighing the evidence in the light of the 

Bradford Hill criteria, it is my expert opinion, within a 

reasonable degree of medical certainty, that there is a 

causal association between ranitidine and urinary bladder 

cancer. 

Again, there is good biological plausibility that supports 

this conclusion. Human epidemiologic studies address this 

finding, and many are large, well done, and present 

reasonable strong associations for the finding. Also, 

several studies of NDMA exposure support an association 

with bladder cancer.218

In response to Dr. Neugut’s review and opinion, Defendants pursue an 

“unreliable methodology” analysis, which they begin with the suggestion that Dr. 

Neugut applies a lower standard of proof in litigation than in his professional 

work.219 Defendants do not make clear if they mean to say that Dr. Neugut’s opinion 

217 In re Asbestos Litig., 911 A.2d at 1206. Accord, In re Roundup, 390 F.Supp.3d at 1150–51 

(admitting expert opinion where the expert “conducted a literature review and evaluated the quality 

of each of the studies”). Compare id. at 1148 (excluding expert where the expert report “did not 

demonstrate that he engaged in his own objective analysis” of the medical literature on which he 

relied).

218 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 126.

219 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 105; Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 126–27. 
46

is not made to a “reasonable degree of medical certainty.”220 If so, Dr. Neugut 

declares directly that his opinion is provided to that degree of certainty.221

If Defendants’ challenge goes to Dr. Neugut’s call of the question, it is still 

not a proper basis for excluding his opinions. “Disputes as to the strength of [an 

expert’s] credentials, faults in his use of [a particular] methodology, or lack of textual 

authority for his opinion, go to the weight, not the admissibility of his testimony.”222

That notwithstanding, Dr. Neugut applied the same “generally accepted scientific 

and medical principles and methodologies” used by cancer epidemiologists.223 Any 

challenge to his application of those methodologies goes to the jury.

Defendants also charge that Dr. Neugut’s analysis is “blatantly resultsoriented,”224 uses “cherry picked” data,225 “outcome driven reasoning,”226 and is 

“flatly contradict[ed] by his prior [deposition] testimony.”227 These criticisms attack 

the expert’s credibility, the bases and calculations underlying his opinion, or seek to 

220 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation 

Experts’ Op. at 105.

221 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 127; see id. Ex. 54, at 

35; Ex. 193, at 143:17–25, 144:2–19.

222 McCullock, 61 F.3d at 1044 (parentheticals added).

223 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 127.

224 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 110.

225 Id. at 109.

226 Id.

227 Id. at 107–08. 
47

elevate Defendants’ science over that of Dr. Neugut.228 These are all arguments that 

Daubert and its progeny reserve to the jury.229 

As the gatekeeper, the Court has spent considerable effort in considering Dr. 

Neugut’s opinion and Delaware’s jurisprudence on point. The Court is not bound 

by the rulings made in RoundUp and Barrera excluding him, particularly given the 

comments of the Court on the merits of his opinion, and the presentation of the

science presented here.

Every case is different. In this early phase of the litigation, the Court is more 

compelled to its conclusion by the legal concepts that animate Daubert proceedings, 

especially as they recognize and uphold the distinct roles of the Court as gatekeeper 

and that of the jury as the ultimate fact finder, and by the encouragement of In re 

Asbestos Litig. and Long to allow the jury to consider debatable scientific 

approaches. Defendants can take up their challenges before the jury on cross 

examination. Defendants’ Motion to exclude Dr. Neugut’s expert testimony is 

DENIED. 

228 Id. at 101–13.

229 See McCullock, 61 F.3d at 1038; see also Karlo, 849 F.3d at 83 (“The question of whether a 

study’s results were properly calculated or interpreted ordinarily goes to the weight of the 

evidence, not to its admissibility.”) (citation omitted); see also In re Roundup, 390 F.Supp.3d at

1150–51 (“different interpretations of [carcinogenicity] studies are not necessarily evidence of 

unreliability . . . plaintiffs may raise their concerns via cross-examination . . .”).
48

4. Dr. Vinod K. Rustgi

Plaintiffs ask Dr. Vinod Rustgi to provide “an expert opinion regarding the 

role of high levels of NDMA found in ranitidine products in the risk of development 

of Hepatocellular carcinoma” (“HCC”).230 Defendants do not challenge his 

qualifications or his actual methodology of conducting a review of peer-reviewed 

literature and applying the Bradford Hill factors.231

In conducting his analysis, Dr. Rustgi relied on in vitro data, in vivo data, 

tissue culture and animal models, as well as epidemiological evidence in humans.232

Following a review of this data, and a Bradford Hill analysis, Dr. Rustgi concluded 

that “NDMA-contaminated Ranitidine can cause the development of HCC.”233 This 

base of analysis supports admissibility of Dr. Rustgi’s opinion.234

Yet Defendants challenge Dr. Rustgi’s opinion on several fronts. As 

predicate, they argue that Dr. Rustgi concedes that “ranitidine or NDMA” is not 

generally accepted by the community of liver specialists as a cause of liver cancer.235

230 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 138.

231 Id.

232 Id.

233 Id. (quoting Ex. 62, at 1).

234 In re Asbestos Litig., 911 A.2d at 1205–06; In re Roundup, 390 F.Supp.3d at 1150–51 

(admitting expert opinion where the expert “conducted a literature review and evaluated the quality 

of each of the studies.”).

235 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 117.
49

But Daubert disposed of the general acceptance requirement for admissibility.236

Defendants urge that only one of seven epidemiological studies reported a 

significant association between ranitidine and cancer. But Defendants note that 

those “results have not been replicated in subsequent studies, and so could be due 

to change.”237 Defendants cite the MDL Order from In re Zantac238 in support of 

these arguments. For the reasons discussed above, this Court is not guided by that 

ruling on these issues. Defendants’ qualification undermines the value of this point. 

More directly, the record reflects that Defendants’ assertion misses the mark. 

Dr. Rustgi testified that it is generally accepted that NDMA causes liver damage and 

liver tumors, and that this is the “preponderance of the evidence going back 

decades.”239 With respect to ranitidine, Dr. Rustgi opines that “exposure to NDMA 

from ranitidine can cause the development of liver cancer.”240 Dr. Rustgi’s Bradford 

Hill analysis, which he conducted, supports this opinion.241

This Court will not inject itself into a dispute over which party has the better 

236 Minner, 791 A.2d at 841.

237 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 117 (emphasis added). 

238 644 F.Supp.3d at 1258–59.

239 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 139 (citing Ex. 141, at 

332:1–10, 331:1–2).

240 Id. (citing Ex. 53, at 35).

241 Id. (citing Ex. 141, at 331:9–18); In re Roundup, 390 F.Supp.3d at 1150–51.
50

science.242 Defendants’ quarrel with Dr. Rustgi’s reading of the Wang study is also 

unavailing, as the balance of Defendants’ challenges to admissibility sound in areas 

reserved in the first instance to the expert witness’s discretion and, ultimately, the 

jury’s wisdom (i.e., cherry picking evidence, improper rejection of relevant data, 

vagueness in describing methodology, inconsistent testimony, etc.)

243 These issues 

present a classic battle of the experts. Resolution of those disputes lies with the jury. 

Defendants have failed to satisfy the Daubert requirements to exclude Dr. 

Rustgi. The Motion is DENIED. 

5. Dr. Ioannis Hatzaras

Plaintiffs identified Dr. Ioannis Hatzaras to evaluate whether NDMA 

exposure from ranitidine can cause esophageal, stomach and colorectal cancer.244 In 

conducting his evaluation, Dr. Hatzaras reviewed studies “demonstrating that 

NDMA is a carcinogen” and reviewed “clinical studies looking into the relationship 

between ranitidine containing NDMA. . . and development of foregut/colorectal 

242 See McCullock, 61 F.3d at 1038; Karlo, 849 F.3d at 83 (“The question of whether a study’s 

results were properly calculated or interpreted ordinarily goes to the weight of the evidence, not to 

its admissibility”) (citation omitted); In re Roundup, 390 F.Supp.3d at 1150–51 (“different 

interpretations of [carcinogenicity] studies are not necessarily evidence of unreliability...plaintiffs 

may raise their concerns via cross-examination.”).

243 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation 

Experts’ Op. at 116–22; compare Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ 

Op. at 139–46.

244 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 149; Ex. 194, at 1.
51

cancer.”245 Dr. Hatzaras “examined 36 particular studies in detail in his report. . . 

and catalogued [their] strengths and weaknesses over 30 pages.”246 His report 

“dissect[s] each study’s merits and drawbacks” to understand whether any 

association is, in fact, causal.247 

Upon completing his review of the literature, Dr. Hatzaras performed a 

Bradford Hill analysis.248 He then conducted a separate Bradford Hill analysis for 

esophageal, gastric, and colorectal cancer.249 Based on his review, evaluation and 

analyses, Dr. Hatzaras concludes to a “reasonable degree of scientific certainty” that 

“NDMA in ranitidine causes foregut/colorectal carcinoma.”250 His Bradford Hill 

analysis confirms that opinion. Dr. Hatzaras’ analysis supports admissibility of his 

opinion.251 Defendants present several challenges, notwithstanding.

Relying again on the MDL Order, Defendants contend that Dr. Hatzaras

employed “an inconsistent, results-driven approach” that “turn[s] science on its 

head,” cherry picked his data, altered his opinion “mid-way through his deposition,” 

245 Id.

246 Id. 

247 Id. at 149–50.

248 Id. at 150.

249 Id. 

250 Id.

251 In re Asbestos Litig., 911 A.2d at 1204–06; see In re Roundup, 390 F.Supp.3d at 1150–51 

(admitting expert opinion where the expert “conducted a literature review and evaluated the quality 

of each of the studies.”). 
52

and applied flawed methods, or none through a “standardless” approach.252 For the 

reasons previously stated, the Court is not bound by that ruling.

Moreover, Plaintiffs’ comprehensive presentation of Dr. Hatzaras’ testimony 

sufficiently addresses Defendants’ challenges,

253 including but not limited to an 

explanation of the science behind Dr. Hatzaras’ rejection of the “binary approach to 

statistical significance extolled” by Defendants.254 Defendants’ arguments may 

undermine Dr. Hatzaras’ opinion and be fodder for cross examination, but they 

cannot exclude that opinion. These expert battles are to be fought before the 

factfinders. This Motion is DENIED. 

6. Dr. Dan J. Raz

Dr. Dan J. Raz, a thoracic surgeon and scientist specializing in lung cancer, 

was asked by Plaintiffs to give opinions as to the causal relationship between 

ranitidine and lung cancer.255 As with all of Plaintiffs experts, Defendants do not 

challenge Dr. Raz’ qualifications to offer the opinion sought.256

Dr. Raz used a “comprehensive review of electronic databases to provide 

sources for his opinions. He also looked to public health authorities, including the 

252 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 76–78.

253 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 150–62.

254 Id. at 151–52.

255 Id. at 163.

256 See id. at 163–64 (detailing recitation of Dr. Raz’ CV).
53

FDA, WHO, and IARC. He carefully considered the strengths and weaknesses of 

each source.”257 Upon completing his review, Dr. Raz performed a Bradford Hill 

analysis to determine whether ranitidine causes lung cancer. He opined that 

“NDMA exposure from ranitidine use is capable of causing lung cancer.”258

Dr. Raz’ methodology supports admission of his opinion.259 His 

methodology appears to mirror that of Defendants’ lung cancer expert, Anil 

Vachani, M.D., M.S.260 Though they reach different conclusions, “different 

interpretations of these [sources] are not necessarily evidence of unreliability[.]”261 

This is, literally, a battle of the experts.

Nonetheless, Defendants advance several challenges to Dr. Raz’ opinion. 

They begin with the charge that his opinions are not generally accepted.262

Defendants conflate acceptance of methodology with acceptance of expert 

conclusions.263 As noted above, while Daubert gives great latitude to the gatekeeper 

in evaluating what factors may be implicated in these disputes, none of those 

factors—including general acceptance of medical conclusions—is determinative in 

257 Id. at 165.

258 Id. at 164–65.

259 See In re Asbestos Litig., 911 A.2d at 1205–06; In re Roundup, 390 F.Supp.3d at 1102.

260 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 165 n.614.

261 In re Roundup, 390 F.Supp.3d at 1150.

262 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 166.

263 See Daubert, 509 U.S. at 580; Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ 

Op. at 166.
54

the trial court’s analysis. Indeed, Daubert holds that methods, not conclusions, are 

to be tested.264 Each factor is but one among many that this Court may consider. 

Importantly, Plaintiffs’ experts point to several public, private, and 

governmental medical and regulatory entities that have studied NDMA and 

concluded that NDMA is capable of causing cancer in humans. The record suggests 

that GSK conceded as much in 2019.265 Also, the Wang study specifically showed 

a “statistically significant association between exposure to ranitidine and lung 

cancer.”

266

 The Habel study found an “overall increased cancer risk,” but fell just 

short of statistical significance for lung cancer. But a positive association may still 

be relied upon by experts; Daubert does not preclude it. It permits it.267 

Defendants’ remaining challenges echo those cited in other expert challenges 

discussed above, such as improper weighing/cherry picking studies on which to rely, 

reliance on NDMA dietary studies, failing to consider/elevating Defendants’ science 

over the witnesses. For example, Defendants complain that Dr. Raz’ opinion should 

264 Daubert, 509 U.S. at 580; see Tumlinson, 81 A.3d at 1272 (noting that “an expert may also 

rely on techniques that have gained widespread acceptance in the scientific community.”) 

(emphasis added).

265 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 12, at 16:1–17

(“[P]rotect the scientists and anybody handling” NDMA in the laboratory.) (emphasis added); see 

also Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 11.

266 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 169; Ex. 146, at 119:7–

8.

267 Barrera, 2019 WL 2331090, at *5 (permitting expert to testify where opinions were based on 

some studies showing statistically significant associations or positive associations).
55

be excluded because he improperly weighed seven epidemiological studies on 

ranitidine and lung cancer, and that his analysis of the studies was flawed.268 In his 

report and deposition, Dr. Raz went into detail explaining that he considered all 

seven of the studies and his reasons for giving more weight to two of them: Wang 

and Habel.269 

Yet, Defendants offer a one-page challenge to Dr. Raz’ Bradford Hill analysis 

on three points: consistency, temporality, and strength of association.270 

Defendants claim that the analysis is “unreliable’ because he relied upon only two 

data points cited in those two studies of Wang and Habel. As discussed previously, 

Dr. Raz’ reliance upon these studies is reasonable. Any quarrel with the application 

of his methodology is for the fact finder.

271

Evaluation of Bradford Hill factors turns on the “expert’s judgment in 

selecting and weighing her sources.”272 “[E]xperts operating on reliable scientific 

268 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 59–62.

269 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 167–71.

270 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 62–63. 

271 Karlo, 849 F.3d at 83 (“The question of whether a study’s results were properly calculated or 

interpreted ordinarily goes to the weight of the evidence, not to its admissibility”); see also In re 

Roundup, 390 F.Supp.3d at 1150–51 (“different interpretations of [carcinogenicity] studies are not 

necessarily evidence of unreliability...plaintiffs may raise their concerns via cross-examination.”).

272 Barrera, 2019 WL 2331090, at *4.
56

principles could weigh the studies differently[.]”273 Any disputes about those 

judgments are not for the Court to resolve. These decisions, made within the 

framework constructed by Daubert and progeny, are reserved to the jury. Therefore, 

Defendants’ Motion as to Dr. Raz is DENIED.

7. Dr. Pablo Leone

Dr. Leone is expected to offer a general causation opinion as to whether 

NDMA exposure from ranitidine causes breast cancer based upon the 

epidemiological evidence.274 Defendants do not challenge Dr. Leone’s 

qualifications.275 To answer the general causation question, Dr. Leone reviewed the 

“available scientific evidence regarding, Zantac (ranitidine) and NDMA”276 He used 

a method “consistent with what is followed by cancer research scientists when 

evaluating whether a chemical agent is a carcinogen and whether individuals are at 

risk of developing cancer based on exposure.”277 His methodology involved:

• a review and evaluation of extensive medical 

scientific literature, including epidemiological, in 

vivo animal, in vitro studies and reviews of all 

relevant topics;

• research on publicly available information related to 

ranitidine and NDMA, their safety and association 

273 Id. at *8.

274 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 200. 

275 See id. at 200–04 (providing summary of Dr. Leone’s credentials).

276 Id. at 203.

277 Id.
57

with cancer generally via articles and references 

from Dr. Leone’s personal library of journals and 

textbooks, as well as PubMed and other relevant 

literature searches; 

• a review and analysis of publications from scientific 

and governmental agencies, including WHO, 

IARC, FDA, and the EPA. and,

• a review and analysis of documents produced by 

Defendants in this litigation.278

Dr. Leone then assessed the totality of the evidence using a weight of the 

evidence methodology in the context of Bradford Hill and different etiology 

concepts, where he concluded to a reasonable degree of medical and scientific 

certainty that “Zantac/ranitidine can cause breast cancer in humans, [and that] the 

causal association is strongest for invasive ductal carcinoma.”279 Dr. Leone’s 

methodology tracks that of many of the experts herein, including Defendants’ lung 

expert, Anil Vachani.280 

As noted, application of this methodology generally supports the admissibility 

of the opinions at issue.281 To overcome this presumption, Defendants assert four 

challenges to Dr. Leone’s opinion beyond the mechanics of the methodology: (1) his 

278 Id. at 203–04.

279 Id. at 204. 

280 Id. at 165.

281 See In re Asbestos Litig., 911 A.2d at 1204–06; In re Roundup, 390 F.Supp.3d at 1150–51 

(admitting expert opinion where the expert “conducted a literature review and evaluated the quality 

of each of the studies.”). See also Barrera, 2019 WL 2331090, at *14, 17.
58

conclusions are not generally accepted;

282 (2) he cannot explain the formulation of 

his opinion;

283 (3) he committed “several methodological errors that are red flags 

under Daubert,” such as ignoring the principle of statistical significance and 

applying an inappropriate substitute;

284 and (4) he perform[ed] an “unreliable 

Bradford Hill analysis.”285 The Court addresses these briefly, seriatim.

General acceptance. In considering this issue, one must bear in mind that the 

Daubert analysis, rejecting the general acceptance requirement, focuses on “the 

principles and methodology used in formulating an expert’s testimony, not the [] 

resulting conclusions.”286 Defendants assert that Dr. Leone concedes no other 

agency or government has concluded that ranitidine can cause breast cancer and that 

Dr. Leone has made “an analytical leap from available data that no other scientist 

outside this litigation has made.”287 Not so. In the findings of the Mathes study,288

the authors reported a “2.2-fold increased risk of ductal type breast cancer, 

representing a 120% increase in the risk of developing breast cancer associated with 

282 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 41.

283 Id.

284 Id. at 43.

285 Id. at 46.

286 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 205 (quoting Bowen, 

906 A.2d at 794). 

287 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 41 (quoting In re Zantac, 644 F.Supp.3d at 1187). 

288 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 205 n.757; Ex. 117.
59

current use of ranitidine.”289 Therefore, the general acceptance argument does not 

advance Defendants’ cause.

Second, Defendants argue that Dr. Leone cannot explain how he formulated 

his opinion. Yet, he testified that he did not ascribe an individual weight to each 

element of his data set, but instead that all of the data “informed [his] opinion.”290 

Dr. Leone’s notes on the strengths and weaknesses of each study were taken into 

account in his Bradford Hill analysis.291 He lays out in detail the various bases for 

his opinion.292 To the extent Defendants dislike the explanations, they can present 

their protestations to a jury.

Defendants also give a short shrift to Dr. Leone’s reference to the Braunstein 

study, asserting that it has not been “subject to the rigors of peer-review.”293 

Although Braunstein was posted on a pre-print online database, the underlying 

epidemiological data in the study had already been peer-reviewed.294 The effort to 

get the Braunstein study published does not impact the admissibility of Dr. Leone’s 

289 Id.

290 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 41 (quoting Dr. Leone’s Tr.).

291 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 206; Ex. 155, at 23.

292 See id. at 206. 

293 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 42.

294 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 206; Ex. 113, Ex. 142, 

at 8–9.
60

opinion, especially since general acceptance is not a requirement under Daubert.

295

 

Moreover, the reasonableness of Dr. Leone’s reliance on Braunstein is for the jury’s 

consideration.

Defendants’ challenges to Dr. Leone’s opinion assert also that he “cherrypicks” favorable evidence, fails to consider contrary evidence,296 and ignores the 

principle of statistical significance.297 These allegations have been held repeatedly 

to be reserved for cross examination.298 Moreover, Plaintiffs rebut each of these 

allegations.299 At this early stage, there is more than enough evidence to overcome 

Defendants’ challenge to Dr. Leone’s formulation of his opinion.

Defendants’ final challenge is that Dr. Leone has performed an unreliable 

Bradford Hill analysis.300 They assert Dr. Leone’s consistency conclusion is 

unsupported, as the studies are noteworthy for their “consistent finding of no 

295 See id. at 206–07.

296 Id. at 208–09.

297 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 43. 

298 See Karlo, 849 F.3d at 83 (“The question of whether a study’s results were properly calculated 

or interpreted ordinarily goes to the weight of the evidence, not to its admissibility”); see also In 

re Roundup, 390 F.Supp.3d at 1150–51 (“different interpretations of [carcinogenicity] studies are 

not necessarily evidence of unreliability...plaintiffs may raise their concerns via crossexamination.”).

299 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 208–11.

300 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 46.
61

statistically significant association.”301 They declare his dose-response analysis 

“unscientific” in part due to his failure to use the “generally accepted definition of a 

“dose-response study.”302 They further reject Dr. Leone’s explanations defending 

the applications and conclusions drawn on this issue, including his inability to 

identify any threshold dose of exposure.303 Delaware law does not impose a bright 

line threshold dose requirement, as discussed above. Moreover, none of these 

challenges rises above the credibility-oriented questions that Daubert and progeny 

for years have reserved to the jury. Defendants’ Motion as to Dr. Leone is DENIED.

8. Dr. Vitaly Margulis

Dr. Margulis has been asked to opine on whether it is likely that the NDMA 

in ranitidine can cause cancer.304 Defendants do not challenge Dr. Margulis’s 

qualifications.

305

 Dr. Margulis reviewed publicly available literature on ranitidine, 

NDMA and renal cancer, including both primary studies and “publications from 

scientific and governmental authorities, such as WHO, TARC, FDA and others.306 

In his report, Dr. Margulis discusses how ranitidine breaks down into NDMA 

301 Id.

302 Id.

303 Id. at 47, 47 n.85. 

304 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 212.

305 See id. (providing Dr. Margulis’ professional education and practice).

306 Id. at 213.
62

and the mechanism by which NDMA can cause cancer.307 Relying on in vitro and 

animal studies, he explains that, in the human body, NDMA metabolizes into “DNA 

adducts,” which induce “carcinogenic point mutations.”

308

 Based on his review, Dr. 

Margulis concludes that NDMA is a “potent carcinogen in every species tested” at 

“single doses and after long-term exposure to smaller doses.”309 The animal studies 

found animals were particularly likely to develop kidney tumors.310

Dr. Margulis then analyzed ranitidine-specific epidemiology. Six studies 

reported a kidney cancer result.311 He analyzed each, finding some strong and others 

seriously flawed.312 Overall, Dr. Margulis found that every study had “nondifferential misclassification of exposure” which “likely biased risk estimates 

toward the null;” that is, the studies “were particularly likely to report a false 

negative result.”313 In Dr. Margulis’s expert opinion, none of the epidemiological 

studies could measure “important data points,” which led to “limitations” impossible 

to overcome. 

After consideration of the literature, Dr. Margulis conducted a Bradford Hill 

307 Id.

308 Id.

309 Id. at 213–14.

310 Id. at 214. 

311 Id.

312 Id.

313 Id.
63

analysis, which led him to opine that “the NDMA in ranitidine can cause cancer.”314

Thereafter, Dr. Margulis authored a peer-reviewed article describing the background 

of NDMA and ranitidine and proffering—as a specific mechanism for 

carcinogenesis—his conclusions as to the harmful metabolization of NDMA.315 The 

mechanism is based on human in vitro studies and animal studies.316 

In both his expert report and his peer-reviewed article, Dr. Margulis “explains 

that animal and in vitro studies can be applied to humans. . . based on the similarities 

in NDMA metabolism seen in animal studies and in vitro human cellular 

experiments.”317 Dr. Margulis included in his article ranitidine epidemiological 

studies, including the same criticisms he raised in his expert report, one of which 

noted that “any conclusions drawn from these observational studies, whether 

supporting or challenging. . . should be interpreted with caution.”318

Defendants challenge Dr. Margulis’s opinion much as they have many of the 

others; he is inconsistent in his approach to statistical significance;

319 his conclusion 

314 Id. at 215.

315 Id. at 215–16. 

316 Id. at 216.

317 Id. (internal quotation marks omitted).

318 Id. (emphasis omitted).

319 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 50.
64

is not accepted by the scientific community;

320 he “cherry-picks” his evidence;321

and his “principal” reliance on dietary and worker NDMA studies is not 

appropriate.322

The extended discussion of Dr. Margulis’s methodology and findings make 

plain the detailed nature of his statistical analysis.323 He is not a poseur.

324

 

Defendants admit he is qualified to offer his opinion, and at this stage, his methods 

confirm as much. 

As to “principally” relying on NDMA dietary and worker studies, in his report 

Dr. Margulis spends one paragraph each on dietary and occupational studies, 

summarizing them, and emphasizes that the role those studies played in his 

conclusion was “not significant.”325 He further considered the contrary statistical 

findings in the six ranitidine studies.326 Plaintiffs emphasize that “[t]here is nothing 

inconsistent about accurately reporting the actual results from these studies.”327 

Defendants pause on these mixed results as “the definition of inconsistent

320 Id. at 49.

321 Id. at 50–53.

322 Id. at 53–55.

323 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 214, 217–19.

324 In re Asbestos Litig., 911 A.2d at 1207.

325 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 218.

326 Id. at 214, 217–18. 

327 Id. at 217.
65

results,”328 although they point out Dr. Margulis’s conclusion that the six studies 

broke evenly, three showing an increased risk and three a decreased risk. At this 

level of science, any characterization of these numbers would do the data a 

disservice. And asking this Court to do the math is not a good idea. Numerically, 

the results, inconsistent or otherwise, do not tip the scale in either direction.329 

Defendants further throw several accusations at Dr. Margulis’s report. While 

the Court considers many herein, review of the Opposition gives a more fulsome 

recitation of Dr. Margulis’ rebuttal in defense of his opinion.330 Some, Plaintiffs 

suggest, mischaracterize his opinions.331 Some, they claim, ignore his testimony.332 

These challenges, along with claims of cherry-picking and flawed reliance on certain 

NDMA studies, fall victim to the wisdom of Daubert: they belong to the jury.333

The Motion to exclude Dr. Margulis’s opinion is DENIED.

9. Dr. George Miller

Plaintiffs have asked Dr. Miller to provide opinions regarding whether 

328 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation 

Experts’ Op. at 51; Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 217. 

From a non-scientist’s perspective, that the six studies broke evenly on the point 3 to 3 does not 

seem to fit the definition of inconsistent.

329 Barrera, 2019 WL 2331090, at *17 (stating that opposing experts interpreted the same studies 

differently “does not render [their] opinions inadmissible.”).

330 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 216–21.

331 See, e.g., id. at 217–19.

332 Id. at 219.

333 Karlo, 849 F.3d at 83; In re Roundup, 390 F.Supp.3d at 1150–51.
66

NDMA exposure from ranitidine causes pancreatic cancer.334 Defendants do not 

challenge Dr. Miller’s qualifications to opine on that question.335 Defendants would 

exploit Dr. Miller’s lack of formal epidemiological training, but they have not voiced 

objection to the expert’s qualifications to offer those opinions. Dr. Miller may testify 

on epidemiological issues implicated in his report.336

Dr. Miller is expected to opine within a reasonable degree of medical certainty 

that there is a causal link between ranitidine and pancreatic cancer.337 In preparing 

that opinion, Dr. Miller first analyzed “whether ranitidine contains a cancer-causing 

agent” and—relying in part on GSK’s root cause analysis—found that NDMA is a 

toxic degeneration byproduct of ranitidine.338 Dr. Miller also relied upon testing 

outlined in the expert report by Emery Pharma.339 He analyzed studies that showed 

a link between dietary sources and pancreatic cancer. Dr. Miller then compared the

studies with others that did not show an association between ingestion of nitrates and 

pancreatic cancer, finding serious flaws with those that did not show an 

association.

340

 

334 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 184.

335 See id. at 185–87 (providing summary of Dr. Miller's educational and professional 

background).

336 See Barrera, 2019 WL 2331090, at *13.

337 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 187.

338 Id.

339 Id. at 187–88. 

340 Id. at 188.
67

Dr. Miller also analyzed studies showing a link between occupational 

exposure to NDMA and pancreatic cancer, and weighed the strengths and 

weaknesses of each study to determine if the peer-reviewed studies supported such 

a link. Dr. Miller then analyzed peer-reviewed studies regarding the link between 

NDMA exposure from ranitidine use and pancreatic cancer. After weighing the 

strengths and weaknesses of each study, Dr. Miller then analyzed the Bradford Hill 

criteria, and concluded the existence of a causal link between ranitidine and 

pancreatic cancer.341 And added that “[t]here is considerable biologic plausibility to 

support this conclusion and lend support to the well-conducted human 

epidemiological studies.”342

Defendants argue that Dr. Miller’s methodology is unreliable. Pointing to a 

number of alleged deficiencies across the breadth of his opinion, the gist is that the 

augmentation of his opinions are evidence of the “results-oriented nature of his 

analyses.”343 These allegations do not support exclusion of his opinion.344 Nor does 

what Defendants characterize as Dr. Miller’s “inconsistent application of power and 

341 Id. at 189.

342 Id.

343 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 63.

344 Barrera, 2019 WL 2331090, at *11 (changing opinion goes to the weight, not admissibility).
68

follow-up to the studies.”345 Their rejection of his analysis and application of followup time,

346 does not compel exclusion. Likewise, the arguments that Dr. Miller made 

a “faulty assumption” and improperly “flipped the burden” of proof,347 or turned 

“limitations in the ‘negative’ studies into strengths in the studies he preferred,”

348 go 

to weight, not admissibility.349 

In a broader attack, Defendants accuse Dr. Miller of providing no 

methodology for how he evaluated studies. First, this claim is rebutted by the 

extensive background review Dr. Miller performed as part of his preparation. Miller 

testified that he “conducted a systematic review of the literature and evaluated the 

science to arrive at his conclusions.”350 Second, Dr. Miller dedicates eleven pages 

of his report discussing the various studies and their strengths and limitations.351

345 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 93–94; see Reply Brief in Support of Brand Defendants’ and Patheon’s Motions to Exclude: 

(1) Plaintiffs’ General Causation Experts’ Opinions; and (2) Dr. Charles Jameson, Trans. ID 

71797654 (Jan. 12, 2024) (herein “Reply Br. in Supp. of Defs.’ Mot. to Exclude Pls.’ Gen. 

Causation Experts’ Op. & Dr. Jameson”) at 63–64.

346 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 194–95; see Defs.’ Br. 

in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ Op. at 94–

95.

347 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 91.

348 Id. (emphasis in original). 

349 McCullock, 61 F.3d at 1038; Karlo, 849 F.3d at 83.

350 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 91.

351 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 192. 
69

Defendants accuse Dr. Miller of not ranking the studies by quality.352 But Dr. 

Miller wrote extensively in his report regarding the strengths and weaknesses of each 

study.353 They complain that Dr. Miller was not able to identify the key criteria he 

used to determine a study’s reliability. Yet, he testified that the most critical factors 

for him in evaluating studies were “median age to study an appropriate population 

and follow-up time.”

354 Defendants discredit Dr. Miller’s Bradford Hill analysis, 

although he testified at length about same.

355

 

Dr. Miller’s conclusions are reliable.356 At this stage, it cannot be said that 

the scope of his review and the science used to formulate his opinions do not support 

admissibility.357 Defendants may have succeeded at times in making this a close 

call. But close calls go to the jury. The Motion to exclude his opinion is DENIED.

10. Bruce J. Trock, MPH, PhD

Dr. Trock has been disclosed to give general causation opinions regarding 

whether NDMA exposure from ranitidine causes prostate cancer.358 Dr. Trock is a 

352 Id. at 193. 

353 Id.

354 Id.

355 See id. at 198–99. 

356 Barrera, 2019 WL 2331090, at *14.

357 In re Asbestos Litig., 911 A.2d at 1205–06; In re Roundup, 390 F.Supp.3d at 1150–51 (expert 

opinion admitted where the expert “conducted a literature review and evaluated the quality of each 

of the studies.”); accord, Barrera, 2019 WL 2331090, at *14, 17.

358 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 174.
70

cancer epidemiologist at Johns Hopkins University, with 37 years of experience in 

cancer research, 21 of which were focused on prostate cancer.359 He has authored, 

or co-authored, over 320 peer-reviewed publications, 201 of which focus on prostate 

cancer.360 Defendants do not challenge Dr. Trock’s qualifications to testify here.

361

In preparing his opinions, Dr. Trock reviewed and analyzed “the entirety of 

the relevant scientific and epidemiological literature concerning the association 

between ranitidine and prostate cancer.”362 In doing so, Dr. Trock “assessed the 

strength of the relevant evidence derived from animal and occupational studies, and 

Dr. Trock used his review and analysis of the medical literature, including the 

strengths and weaknesses of the pertinent studies, to perform a Bradford Hill 

analysis.363 Based on his reviews and his Bradford Hill analysis, Dr. Trock 

concluded, to a reasonable degree of scientific certainty, that exposure to ranitidine 

can cause prostate cancer in humans.364 His opinions are based on sound, reliable 

scientific methodology, and are generally admissible.365 

359 Id.

360 Id.

361 See id. at 174–75 (providing a more complete summary of Dr. Trock’s qualifications).

362 Id. at 175; Ex. 147, at 24–38.

363 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 175.

364 Id. at 176.

365 Id.; see In re Asbestos Litig., 911 A.2d at 1205–06; see also In re Roundup, 390 F.3d at 1150–

51 (expert opinion admitted where the expert “conducted a literature review and evaluated the 

quality of each of the studies.”); accord, Barrera, 2019 WL 2331090, at *14, 17.
71

Defendants interpose several challenges to that admissibility. Their initial 

challenge argues that relevant epidemiological studies “reported no statistically 

significant positive associations between ranitidine use and prostate cancer.”366

Plaintiffs counter that, in fact, Dr. Trock noted that of the nine relevant 

epidemiological studies concerning ranitidine, three actually observed “increases in 

the incidence of prostate cancer.”367 Dr. Trock further distinguished five of the 

remaining six studies as considerably flawed (i.e., they used inadequate follow up 

periods, had short durations of exposure to ranitidine, and failed to adjust for 

potential confounders).

368

 Several studies “lacked data on duration or cumulative 

dose of ranitidine, and recorded only at baseline,” and were therefore susceptible to 

misclassification.369 

Defendants first reject Dr. Trock’s analysis and conclusions. That is, of 

course, their prerogative, but does not support exclusion. Similarly, Defendants 

raise again the charge that his opinion is inadmissible because his conclusions are 

not generally accepted in the medical community.370 

366 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 64. 

367 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 177. 

368 Id. 

369 Id.

370 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 64–65. 
72

As noted, Daubert rejected the general acceptance requirement. Defendants 

nonetheless urge that general acceptance is still an indicator of unreliable 

methodology.371 But, the record establishes that Dr. Trock analyzed the relevant 

data, and his opinions align with three of the relevant studies. This evidence is to be 

used flexibly when evaluating reliability. Again, Daubert does not charge the trial 

court to pick one expert’s science over another’s.372 

Defendants next argue that Dr. Trock’s conclusions are unreliable because he 

“ignores epidemiological ranitidine studies and takes the novel approach of drawing 

conclusions about ranitidine based on studies” of rubber workers and animals.373

Defendants point to the MDL Order and its rejection of the Hidajat study as 

flawed.

374 Those may have been appropriate conclusions for that court to draw. But 

as presented through these experts, in Delaware, it is not the role of this Court to 

substitute its scientific conclusions for those of an expert scientist. 

Dr. Trock analyzed the Hidajat study and compared it to a second rubber 

worker study, which he rejected as marred by speculation.375 Dr. Trock did not rely 

371 Id. at 65.

372 In re Asbestos Litig., 911 A.2d at 1207.

373 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 65–67; Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 179. 

374 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 66.

375 Id.
73

on animal studies alone. He considered their import along with his evaluation of the 

six epidemiological studies available. Defendants acknowledge that Dr. Trock 

analyzed the epidemiological ranitidine studies and dismissed them as “severely 

flawed.”376 That approach is consistent with the proper methodology applied in such 

circumstances.377 Delaware law “does not require that evidence of general causation 

take the form of epidemiological evidence . . . Evidence such as animal studies, in 

vivo studies, in vitro studies, toxicology, and case studies can be used to show 

causation.”378 These factors are to be applied flexibly.379

Defendants’ final charge is that Dr. Trock’s Bradford Hill analysis is 

unreliable.380 They argue that an expert must address epidemiological evidence that 

is inconsistent with his opinion.381 As discussed above, Dr. Trock did that. Their 

argument about dose response, which is another of the Bradford Hill criteria that 

may be considered, does not suffice to compel exclusion of Dr. Trock’s opinion. 

376 Id. at 65–66. 

377 See, e.g., Barrera, 2019 WL 2331090, at *14.

378 Id.

379 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 182 (discussing Dr. 

Trock’s selection of studies on which he relied); see, e.g., id. (“Dr. Trock’s analysis, placing more

weight on NDMA occupational [and animal] studies, is entirely reasonable in light of the 

significant limitations in the nine epidemiological studies of ranitidine.”); see also id. at 180 

(discussing Dr. Trock’s use of animal studies, emphasizing that “in considering the weight of the 

evidence, Dr. Trock considered NDMA animal studies - but not to the exclusion of the relevant 

epidemiological literature.”).

380 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Pls.’ Gen. Causation Experts’ 

Op. at 68–69. 

381 Id. at 69. 
74

Defendants can take up these challenges before the jury. The Motion to exclude Dr. 

Trock is DENIED.

11. Emery Pharma 

Plaintiffs retained Emery Pharma (hereinafter “Emery”) to “conduct further 

testing on the levels of NDMA in ranitidine provided by Defendants and specifically 

the levels in Plaintiffs’ own pills and opine on the nature of ranitidine’s ability to 

degrade and transform into NDMA.”382 

Emery is a “full-service contract research laboratory, specializing in 

analytical, bioanalytical chemistry, microbiology and cell biology services, custom 

synthesis, [] general research and development and [] the standards employed in the 

manufacture of drugs, not in research.”383 Defendants characterize Emery as a 

“litigation support lab.”384 Emery counters that “only approximately twenty percent 

of Emery’s revenues are from litigation consulting.”385 Emery describes the 

majority of its clients as pharmaceutical companies that reach out to Emery for 

“isolation characterization work;” that is, to analyze and identify “an impurity in a 

382 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 223.

383 Id. at 224. 

384 Brief in Support of Brand Defendants’ and Patheon’s Motion to Exclude Plaintiffs’ Expert, 

Emery Pharma, Trans. ID 71408808 (Nov. 15, 2023) (hereinafter “Defs.’ Br. in Supp. of Brand 

Defs.’ & Patheon’s Mot. to Exclude Emery Pharma”) at 14 n.23. The Court notes Defendants’ 

Brief to Exclude Emery Pharma is devoid of pagination, as such the Court references the 

corresponding PDF page numbers.

385 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 221 n.829.
75

drug that is being marketed.”386

Defendants do not challenge Emery’s qualifications to render the opinions 

requested of it.387 Yet, the parties devote nearly 150 pages of briefing to the 

admissibility of the Emery opinion alone. The somewhat more aggressive and 

pejorative rhetoric in the briefs suggests the Emery opinion lies at the heart of the 

Daubert debate, for both sides. 

Defendants offer nine challenges to the admissibility of the Emery Opinion:

(1) Plaintiffs’ use of HILIC methodology is unvalidated 

and unreliable;

(2) Plaintiffs’ opinion of manual integration, without 

proper protocols, is unreliable;

(3) Plaintiffs failed to keep proper documentation;

(4) Dr. Najafi left all operational decisions in the testing 

process to the discretion of his assistants, who did 

not follow preset protocols;

(5) the Emery opinion has not been published or 

submitted for peer review;

(6) the Emery opinion does not “fit” the parameters of 

the issue here;

(7) Emery’s simulated studies fail to meet the Daubert

standards;

386 Id.

387 See id. at 224–28 (providing a more complete recitation of Emery qualifications and its 

representatives).
76

(8) Emery’s simulated gastric fluid study is not reliable; 

and

(9) Emery’s “miscellaneous tests” do not “fit” the case 

and are not reliable.388

The Court addresses briefly each of Defendants’ challenges separately. The 

Court prefers not to get into the weeds of the science, but some digging is required. 

a. Emery’s Use of HILIC

Emery used Hydrophilic Interaction Chromatography (“HILIC”) to test for 

the presence of ranitidine. Defendants argue that HILIC is unvalidated, and 

therefore unreliable. Defendants also charge that the increased measure of ranitidine 

when HILIC was used supports their charge that HILIC’s use was a litigation-driven 

decision, made to skew the numbers in Plaintiffs’ favor.

HILIC is a technique for separation of polar compounds. Plaintiffs explain 

that HILIC was used in the first part of Emery’s separation processes “to improve 

sample identification and quantification.”389 Plaintiffs further indicate that Emery’s 

method known as LC-MS/MS (the combination of liquid chromatography (“LC”) 

and mass spectrometry (“MS”)) “uses the same underlying technology the FDA 

used, with the difference being the type of initial column used for separation of the 

388 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 21–22.

389 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 236. 
77

analyte.”390 

Plaintiffs further assert that HILIC is a well-established, accepted column for 

use in chromatography with polar compounds, which NDMA is.391 They quote from 

a monograph by Defendants’ expert, Bernard Olsen, in support:

The popularity of [HILIC] has grown rapidly in recent 

years. The HILIC mode can provide retention and 

separation of polar compounds that are difficult to analyze 

by reversed-phase high-performance liquid 

chromatography (RPLC) or other means. HILIC has been 

utilized in a variety of applications including drugs and 

metabolites in biological fluids, biochemicals, 

pharmaceuticals (from drug discovery to quality control), 

foods and environmental.392

The Olsen monograph notes that HILIC “can be particularly suited in the 

determination of specific impurities, including polar compounds,”

393 of which 

NDMA is one. 

Emery explains its reasons for preferring HILIC columns over reverse-phase 

columns.394 Emery also showed that its protocol, including use of an HILIC column, 

was “fully validated.”395 Notably, the JCCP court rejected this same Daubert 

390 Id.

391 Id. at 237.

392 Id.

393 Id. at 237, 237 n.878.

394 Id. at 236–38. 

395 Id. at 239.
78

challenge.396 Emery’s efforts notwithstanding, Defendants reject their science and 

stand on the MDL Order.

397

 Following Delaware jurisprudence, this Court finds that 

HILIC has been validated and determined reliable, and its use in measuring 

ranitidine constitutes sound methodology to survive a Daubert challenge.

b. Manual Integration

Defendants’ challenge of Emery’s use of manual integration involves data 

integrity. They claim Plaintiffs did not follow a Standard Operating Procedure 

(SOP) to guide when “analysts perform manual integrations.”398 They further accuse

Emery of performing manual integrations “unreliably, arbitrarily, and following no 

set standards.”399

Emery explained that “all decisions regarding when and how to conduct 

manual integrations, along with the integrations themselves, were done using the 

same scientific principles as written in Emery’s Standard Operating Procedure 

(“SOP”) for chromatography analysis [] that was in effect at the time.”400 It appears 

396 Id. at 254; see also Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 75,

at 23.

397 Brand Defendants’ and Patheon’s Reply in Support of their Motion to Exclude Plaintiffs’ 

Expert, Emery Pharma (herein “Defs.’ Reply Br. in Supp. of Mot. to Exclude Emery Pharma”) at 

9–11.

398 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 29. 

399 Id.; Ex. 15, at 1. 

400 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 241. 
79

that Defendants’ expert, Dr. Olsen, also relied on the same scientific principles.401

“[W]hether performed automatically or manually. . . integration must be 

scientifically justifiable.”402 Defendants concede that an “analyst must exercise 

professional judgment in deciding when use of a manual integration is 

appropriate.”403 Emery performed manual integrations only when the default 

integration was scientifically unsound.404 To the extent that Defendants rely on the 

Agilent monograph in support of this argument, this Court accepts the reasons set 

for by Plaintiffs that any data manipulation that was focused on FDA compliance is 

not at issue here.

405

 

Defendants further argue that Emery “left manual adjustments to the 

unfettered discretion of its staff,” and that performing manual engagements “may” 

be a sign of a “flawed method.”406 For several reasons, this argument is insufficient 

to warrant relief. 

Emery makes the point that “Dr. Cheu,” one of the primary representatives of 

Emery on the opinion, “did these manual integrations.”407 In their Reply, Defendants 

401 Id.

402 Id. at 240.

403 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 29.

404 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 240.

405 Id. at 255–56.

406 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 30 (quoting 

In re Zantac, 644 F.Supp.3d at 1123)) (emphasis added).

407 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 240–41.
80

equivocate on this point while doubling down: “Emery allowed its analysts, 

including Dr. Cheu, to perform manual integrations in their sole judgment and 

discretion.”408 Further, Dr. Najafi testified that he supervised the work being done 

at Emery and double-checked the work being done by his staff scientists to make 

sure [he was] confident of the numbers.”409 Dr. Najafi reviewed the lab results, the 

lab notebooks, and synthesized that data in formulating his opinion.410 

Manual versus electronic integration turns on the scientist’s assessments of 

the accuracy and utility of each in a particular circumstance. As the discussion 

illustrates, these are complicated questions well beyond the wisdom of this trial 

judge, who, consistent with Daubert and its progeny, will not pick a winner. The

answer rests with the jury.

c. Lack of Documentation of Lab Results

Defendants allege that Plaintiffs’ protocols and test results fail the reliability 

requirement of Daubert due to their failure to “describe the methods they used as 

fully and accurately as possible.”411 Defendants emphasize that “[w]ithout 

408 Defs.’ Reply Br. in Supp. of Mot. to Exclude Emery Pharma at 12.

409 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 260.

410 Id.

411 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 32 n.51; 

see also id. Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma Ex. 

35, at 48.
81

documentation the process is meaningless; essentially there has been no study.”412

The initial challenge focuses on Emery’s failure to adequately document its 

testing.413 In response, Plaintiffs have sufficiently explained that Emery designed 

and created protocols for each experiment, each of which was validated and the 

results of that validation produced.414 Plaintiffs add that, beyond those “standalone 

validations, each analytical run includes a series of calibrations and quality control 

injections to further validate the process in run,” and each test “was documented in 

a lab notebook contemporaneously maintained by the analyst conducting the 

experiment and counter signed by “another researcher who validated the 

experiment.”415

Defendants next attack Emery’s lack of protocols for baseline testing, 

emphasizing that “none was ever created.”416 The straight-forward response is that 

that “Emery’s task regarding baseline testing [] was simply to determine what levels 

of NDMA were detectible, if any, in the pills and API [active pharmaceutical 

ingredients] produced to Plaintiffs by Defendants. There was no hypothesis to be 

tested. There was no need for a ‘study design’ outside that of testing protocol and 

412 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 32 n.51.

413 Id. at 35; Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 257. 

414 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 256. 

415 Id. at 256–57.

416 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 34 n.54.
82

method. Emery tested the pills and API and reported the results. . . .”

417

 

As to the adequacy of the lab notebooks, Plaintiffs explain that “[m]ost raw 

and processed data for LC-MS/MS simply cannot be recorded in lab notebooks, as 

it is maintained electronically.418 The lab notebooks, however, “contain a reference 

to exactly where on Emery’s system (by folder path) that data was stored.”419 All of 

the written validated protocol, underlying raw and processed data from the conduct 

of the testing was provided to Defendants in [the relevant] format, with printed 

versions in the form of PDFs, and also stored electronically in the [relevant] system, 

where it remains to this day, and all of it was produced to the Defendants.”

420

Plaintiffs further indicate they provided Defendants with “all of [the test] 

results along with the corresponding test names, lot numbers, etc., in Excel format,” 

noting that Defendants can “conduct their own data analysis to come up with 

whatever statistical calculations they wish,” something, Plaintiffs note, Defendants 

have not done.421 If Plaintiffs failed to describe their methods as fully and accurately 

as possible, any such failing is reserved as a topic for cross examination.422 

417 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 257–58 (emphasis in 

original). 

418 Id. at 257.

419 Id.

420 Id.; see Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 202. 

421 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 258.

422 See, e.g., McCullock, 61 F.3d at 1043–44; Karlo, 849 F.3d at 81–84.
83

d. Dr. Najafi’s Reliance on the Work of His Team

Defendants take the position that Dr. Najafi, individually, should be excluded 

because he relied “entirely” on the work of his team. They impugn Dr. Najafi with 

the statement that he is “merely parroting” work done by others.423 Not so.

Dr. Najafi testified on his role in the preparation of Emery’s testing 

conclusions.424 Defendants do not take that testimony on directly. Rather, they rely 

on the MDL Order and deposition testimony that contradicts Dr. Najafi’s own

testimony. With that, they argue that Emery analysts conducted testing without 

“guiding principles from Dr. Najafi” or without written procedures or instructions.425

They highlight the inclusion of three signatures on the Emery Report as “tacit 

acknowledgement of his lack of firsthand knowledge.”

426

The fact that several scientists signed the Report may be weighed as a 

testament to each scientist’s involvement in its preparation, and their certification of 

its accuracy and validity. Dr. Najafi’s testimony supports that conclusion. The 

Defendants are free to argue that the actions of the signatories somehow implicate 

Dr. Najafi. But not at this juncture. Their allegations on this score present a 

423 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 40. 

424 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 259–61.

425 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 39 (citing 

In re Zantac, 644 F.Supp.3d at 1138).

426 Id.
84

credibility issue for the jury.

e. Lack of Publication or Peer Review

Defendants cite lack of peer review or publication as a “pertinent 

consideration” of whether a theory or technique is valid.427 At the outset, Defendants 

offer no authority in support, beyond the MDL Order in Zantac.

428

 Moreover, the 

lack of peer review or publication presents an issue for the jury. Nor is Emery’s 

science an orphan child.429 And as previously mentioned, even Defendants’ expert,

Dr. Bernard Olsen, extolls the LS-MS/MS technique used by Plaintiffs.430 As 

Plaintiffs’ point out, when Defendants’ experts were asked about publication, they 

refused to suggest lack of publication as evidence of unreliability.431 If lack of peer 

review or publication has any utility here, it is fodder for cross-examination, not 

exclusion.

f. Emery’s Baseline Testing “Does Not Fit”

Defendants next challenge the so-called “fit” of Emery’s baseline testing to 

427 Id. at 40.

428 Id.

429 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 261 (“[T]he use of 

LC-MS/MS to detect and quantify impurities in drug substances, and the methodology used to 

validate the specific protocol applied by Emery are both not only widely accepted and published 

in peer reviewed literature but have been available and in use for decades.”).

430 Id. at 237.

431 Id. at 262.
85

the facts of the case.432 The challenge rests on the premise that the amount of 

ranitidine in active pharmaceutical ingredients (API) is different than in a pill that a 

user ingests.433 Testing API alone, Defendants argue, “skews testing results high 

and does not reflect what individuals actually ingest.”434 Plaintiffs argue that this is 

a faulty premise via this explanation:

[N]one of the steps involved in creating the final dosage 

form . . . is supposed to change the included [active 

pharmaceutical ingredient] API. Thus, any NDMA 

contained in the API will be, perforce, also included in the 

finished pill. This is why, for example, GSK also tested 

and reported the NDMA in API when it conducted its root 

cause analysis.435

That is, “the NDMA contained in the API at the time the finished dose is 

manufactured will get transferred to the pill itself.”436 Defendants do not counter 

this analysis in their Reply. Emery’s testing of API fits the facts of the case and will 

not be excluded.

g. Emery’s Simulated Environmental Tests

Emery conducted three “simulated consumer experience” tests to measure 

432 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 41; see

Daubert, 509 U.S. at 591. 

433 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 41.

434 Id.

435 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 263. 

436 Id.
86

how NDMA might form in ranitidine.437 Plaintiffs suggest the simulations show the 

breakdown of ranitidine “into NDMA in various real-world scenarios, and produces 

high levels of NDMA, [which is] relevant to Defendants’ argument that there is 

minimal NDMA exposure from taking ranitidine.”438 Plaintiffs suggest that such 

testing shows “that NDMA could reasonably form under specific instances—

instances that would apply to all plaintiffs.”439 Thus, their argument follows, the 

simulations are relevant at the general causation stage.440 This Court agrees.

Defendants’ challenge to the simulations follows a common path. They each 

begin with a general acceptance attack, which they support in the main with a 

quotation from the MDL Order.

441

 Citing to that ruling, they argue that “no other 

laboratory in the world has used these tests to measure drug stability; no agency 

requires or recognizes them [;] [and no] paper has ever been published validating 

their reliability.”442

As to the car simulation, Defendants note that “Emery did not study Zantac 

stored in real-life cars,” instead making “a series of unsupported assumptions about 

437 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 42. 

438 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 263.

439 Id.

440 Id.

441 See Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 44

(quoting In re Zantac, 644 F.Supp.3d at 1150).

442 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 42.
87

consumer behavior and car conditions” to simulate that experience.443 They criticize 

Dr. Najafi’s reliance on the Vanos 1028 study, and urge that “even if modeling an 

experiment for a drug stability study. . . were a reliable methodology,” Emery’s car 

simulation did not comport with such a model.444 

But the Vanos report outlines three bases for its data—Vanos, Grunstein, and 

the Assessment of the Common Carrier Shipping Environmental General Technical 

Report.445 Defendants concede that Plaintiffs cited a few studies in support of their 

data.446 And further concede they missed key data points from the Grunstein study 

pertaining to the average air temperature used in the Emery study.447 As the several 

cases repeatedly cited above make clear, such criticism goes to weight, not 

admissibility. 

Defendants lodge identical challenges to the bathroom simulation.448 As with 

the car simulation, Defendants acknowledge the validation of the “non-peer 

443 Id.

444 Id. at 43 (quoting In re Zantac, 644 F.Supp.3d at 1147). 

445 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 264.

446 DEFAs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 42; Ex. 

10, at 230:16–17.

447 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 264.

448 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 44

(“Emery’s ‘bathroom simulation’ studies did not test Zantac product in a real-world bathroom, but 

instead attempted to recreate the conditions of a bathroom based on a series of unsupported 

assumptions . . . [it] has nothing to do with drug stability or the effect that a bathroom environment 

could have on a drug product.”).
88

reviewed” Aizawa study, but they retrench by alleging that Plaintiffs departed from 

the Aizawa model by using more “extreme conditions” than contemplated.449

Defendants also advance lack of general acceptance, and quote a near verbatim 

repetition from the MDL Order to that end, just as they did with the car simulation.450 

Yet, Defendants, again, missed a study relied upon by Plaintiffs that favors their 

position.

451

 

Plaintiffs’ last simulation created “climactic zones” to “simulate. . . common 

consumer experiences with Zantac.”452 Defendants again stress that the climatic 

zones on which they were based “were not designed to mimic real-world 

conditions,” and, citing the MDL order in Zantac, argue that they were “designed to 

increase the rate of chemical degradation or physical damage of a drug substance or 

drug product by using exaggerated storage conditions[.]”453 Defendants also attack 

the climactic zone testing’s reliability because, they say, “it departed from the actual 

Zantac container closure system” and for its lack of support for the assumption that 

a typical plaintiff or distributor stores ranitidine at 65 % relative humidity in an 

outside, non-air conditioned environment.454

449 Id.

450 Id. at 46.

451 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 264–65.

452 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 45. 

453 Id. (quoting In re Zantac, 644 F.Supp.3d at 1152) (emphasis in original).

454 Id. at 46. 
89

That criticism appears to validate the testing, as Plaintiffs explained, “because

[as noted below] a laboratory cannot actually recreate months’ worth of exposure to 

varied temperature and humidity conditions in the time frames involved with 

testing.”455

“General causation considers the possibility that a certain exposure caused a 

certain harm, not the likelihood that it did.”456 Plaintiffs designed the three 

simulations to address a corollary point; that is, “that under the conditions tested, 

which simulate real-world conditions, ranitidine breaks down to form NDMA, not 

that the exact NDMA levels reported by Emery would be the levels reported by 

Emery in any particular pill.”

457

 

Throughout their briefing on the three simulations, Defendants rely 

predominantly on the conclusions of the MDL Order. Plaintiffs challenge as 

“missing the point” Defendants’ (and the MDL Order’s) overarching criticism of the 

design of their simulations: “the entire purpose of stability testing is to see what 

happens in exaggerated conditions because a laboratory cannot actually recreate 

months’ worth of exposure to varied temperature and humidity conditions in the time 

frames involved with testing.”458 

455 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 265. 

456 Barrera, 2019 WL 2331090, at *4 (quoting Tumlinson II, 2013 WL 7084888, at *4).

457 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 266.

458 Id. at 265.
90

These tests, like opinions—especially those evolving in response to an issue 

that, it appears, science has not yet caught up with—depend on the “expert’s 

judgment in selecting and weighing her sources.”459 Defendants reject Emery’s 

science, including the decisions made in the design and execution of the simulations, 

as exemplified by the container system debate: Plaintiffs say the system used in 

their testing was proper. Defendants argue it was not. So it goes. But Emery’s 

opinion, and testing, are “rooted in science” and therefore “scientifically reliable.”460 

That is not to say they are unassailable. But, under these circumstances, the Court 

cannot and will not declare one side’s science as reliable and cast off the other’s.

461

This dispute is appropriate grist for the jury’s mill.462

h. Emery’s Simulated Gastric Fluid Test

Defendants’ attack on Emery’s Gastric Fluid tests regurgitates the criticism of 

Emery’s other tests, discussed above. They are: lack of general acceptance, lack of 

publication and peer review, improper and flawed assumptions, conclusions 

contradicted by other literature, improper premises, testing did not track 

hypothetical, and that the testing was results-oriented.463 For the same reasons 

459 Barrera, 2019 WL 2331090, at *4; see Long, 2004 WL 1543226, at *1.

460 Barrera, 2019 WL 2331090, at *14, 17. 

461 In re Asbestos Litig., 911 A.2d at 1207. 

462 Id.

463 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 47.
91

previously stated, there is no need to indulge in an extended discussion of them. The 

challenges go to weight, not admissibility. 

i. Emery’s Miscellaneous Tests

On this challenge, Defendants concede at the outset that “these studies suffer 

the same methodological issues as the testing” above.464 These challenges are 

rejected, for the same reasons.

Defendants also assert that “these tests have no purpose or connection to the 

facts of the case; i.e., they lack the requisite fit.”465 Not so. 

1. WHO NAP Test. The Nitrosation Assay Procedure (“NAP” test), 

developed by the World Health Organization (WHO) and the International 

Association for Research on Cancer (IARC), “combin[ed] an agent with sodium 

nitrite in simulated or real gastric fluid. . . to allow systematic comparisons between 

compounds is assessing their ability to nitrosate.”466 The creation of NDMA via 

nitrosation of ranitidine is very much a part of the analyses at issue here. The NAP 

test fits the case. That the test may not “represent physiological conditions” goes to 

weight, not admissibility.467

2. Simulated Gastric Fluid Testing. The Court has already addressed the 

464 Id. at 51. 

465 Id.

466 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 94.

467 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 52.
92

challenges to Emery’s primary Gastric Fluid Simulation. Defendants here challenge 

“additional SGF studies” based on the conclusions Defendants draw from “some of 

the experiments.”468 This challenge does not undermine the “fit” of the tests.

3. KSCN Testing. This test was performed to study the hypothesis that 

potassium thiocyanate, an endogenous compound present in human gastric juice, can 

promote nitrosation of NDMA moieties to form NDMA in the stomach.469 This is 

connected to the facts of this case, as nitrosation of NDMA is one of the processes 

at issue in exposure.

4. Refrigeration Testing. This test was performed to confirm GSK’s claim 

in its root cause analysis that storage at certain temperatures stops the formation of 

NDMA in ranitidine.470 It is relevant to whether Emery’s storage of ranitidine 

samples was a factor in the amount of NDMA found in baseline testing.471 This 

issue “fits” as it is connected to the facts of the case. 

5. Morphology Study. This challenge is more about challenges to the 

construct of and assumptions behind the test than “fit.”472 That said, Plaintiffs 

defend the test as intended to determine the accuracy of Defendant GSK’s hypothesis 

468 Id.

469 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 267.

470 Id.

471 Id.

472 See id. at 266.
93

regarding rate of degradation of higher bulk density active pharmaceutical 

ingredients (API,) compared to other API. This test is relevant to degradation and 

to any attempt by GSK to “portray its API” as “superior or more resistant than other 

sourced API.”473

6. Content Uniformity Test. Defendants again target Emery’s handling of 

the tests, and their conclusions, more than “fit.”474 Plaintiffs defend the test as 

“showing that the testing of single pills from a container would be generally 

representative of the levels of NDMA to be found in the ranitidine container.”475

This test “fits,” given the issue joined on the proper container to be used preparing 

opinions on degradation. 

7. Manufactured Table Study. Plaintiffs point out that this study was 

necessary because at the time of baseline testing, Defendants had not produced any 

tablets from one of the manufacturing sites (Jurong).476 Plaintiffs manufactured its 

own tablets from the API from both Jurong and a different manufacturer (BI), to 

tests for differences in degradation. It found none, countering any argument that the 

pill testing was not representative. Any criticisms of the test relating to Emery’s 

473 Id.

474 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 53. 

475 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 268.

476 Id.
94

failure to use “proprietary protective coating or actual packaging”

477 can be 

advanced in cross examination.

8. Stress Testing. This challenge, like many of the foregoing, distills to the 

design of the test (i.e., Emery exposed ranitidine to: “high levels of heat and 

humidity,” employing “implausible conditions.”).

478

 Emery explained its use of 

extreme conditions in defense of its simulations.479 That aside, again these criticisms 

go to weight, not admissibility. They also “fit.”

Defendants’ final two challenges go to Reproducibility and the integrity of 

Emery’s Delaware report.

j. Reproducibility

On reproducibility, Plaintiffs frame the formative issue this way: “The 

question to be answered by this Court is not whether the data reported in Emery’s 

MDL Report is reproducible, but whether the data reported in [Emery’s] Delaware 

Report, the only proffered opinion here, is reliable, reproducible, and admissible.”480 

Plaintiffs counter that this “entire argument hinges on the claim that the results 

reported in the Delaware Report do not match the results reported in the MDL 

477 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 55. 

478 Id. at 53.

479 Id.

480 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 269.
95

Report.”481 Plaintiffs concede that the results from the two studies do not match due 

to tabulation and sorting errors.482 But they argue that those errors do not impact the 

reproducibility of the testing done by Emery in this case.

483

Defendants emphasize that “[n]othing Plaintiffs did [in between the MDL 

Report and the Delaware Report] adequately cured the methodological shortcomings 

recognized by the MDL Court.”484 But as Plaintiffs emphasize, the only opinion 

being proffered here is the Delaware Report. As a practical matter, Defendants are 

inviting this Court, again, to defer to the MDL decision on reproducibility. This 

Court declines to do so.

The ability to reproduce a test turns on the availability and integrity of the data 

from the test to be reproduced. The Court has already plowed this ground. But we 

re-visit for ease of reference.

Plaintiffs maintain that “all of the underlying data has been produced to 

Defendants,” including “the corresponding test names, lot numbers, etc., in Excel 

format.”485 Plaintiffs go further, adding that “all of the written validated protocol, 

underlying raw and processed data from the conduct of the testing was provided to 

481 Id.

482 Id.

483 Id.

484 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 55.

485 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 270 (emphasis in 

original).
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Defendants in [the proper] format, with printed versions in the form of PDFs, and 

also stored electronically in the [proper] system.”486 Plaintiffs add that, for each 

experiment that was run, each of which was validated, the results of that validation 

were produced,487 and that beyond the “standalone validations,” they produced each 

analytical run including calibrations and quality control injections used to further 

validate the process run, as well as lab notebooks, in which each test was 

documented, maintained contemporaneously by the analyst conducting the 

experiment and counter signed by “another researcher who validated the 

experiment.”488

All this production, Plaintiffs argue, allows Defendants to “conduct their own 

data analysis to come up with whatever statistical calculations they wish;” 

something, Plaintiffs note more than once, Defendants did not do.489 Defendants 

“have never run any of their own tests on the pill samples tested by Emery, despite 

their ability to do so. . . to see if they could or could not reproduce Emery’s results. 

They have never done any re-processing or re-integration of the raw data provided 

by Emery to determine whether they could or could not reproduce Emery’s 

486 Id. at 257, 259; see id. at 272–73.

487 Id. at 256.

488 Id. at 256–57.

489 Id. at 258.
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results.”490 “With this information, Defendants are able to do their own analysis,

their own processing and integration, report their results, and do their own 

calculations of means, minimum and maximum values, or any other statistical 

measure they wish. They did no such thing.”

491

 Defendants resort to ipse dixit: the 

production, characterized as they deem appropriate, makes reproduction impossible. 

They never say they tried to reproduce Emery’s results. Instead, they cite to the 

MDL’s Order.

492

Defendants devote considerable space to the numerous failings and 

inconsistencies they find in Emery’s MDL and Delaware Reports.493 They also 

chastise Emery for its inability to reproduce its own results. This criticism might 

carry more weight if Emery were somehow prohibited from updating the report, or 

even more so if Emery had not explained to Defendants why the data was updated 

in the first instance.

494

 Further, none of the changes cited by Defendants concerns 

the baseline testing results.495 Also, some of the results of the changes made by Dr. 

Cheu following his review and re-processing are “actually lower than those reported 

490 Id. at 269.

491 Id. at 273.

492 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 56–58

(citing In re Zantac, 644 F.Supp.3d at 1130).

493 See id. at 57–63.

494 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 271–74.

495 Id. at 276.
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in the MDL Report,” belying any suggestion of bias to increase NDMA levels.496

None of these challenges is flattering. But many of them involve clerical 

errors;

497 its resolution fitted for twelve people in the jury box. For that reason, the 

Court will not exclude Emery’s opinion. The Court has already considered the 

incomplete/inadequate production issue. It stands on that decision. 

k. Reverse-engineering of the Emery Report

This challenge is hampered by the fact that some of the re-testing favored 

Defendants. Similarly, as noted above, the results from one of the changes made by 

Dr. Cheu, following his review and re-processing, are lower than those reported in 

the MDL Report.

498

 That statistic also contradicts an effort to increase NDMA 

levels. Some of Plaintiffs’ corrections skewed the testing against Plaintiffs.499 The 

extended discussion of what Dr. Cheu did and why also militates against 

Defendants’ notion of reverse-engineering.500

l. Transparency and Suggestion of “Lawyer-Driven” Changes

Plaintiffs detail the bases for their defense of transparency:

1. By reporting data and calculating the averages across each individual test, 

496 Id. at 274–75.

497 Id. at 271; see Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma

at 63 n.119 (stating chromatogram “mistakenly processed twice”).

498 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 274–76.

499 Id. at 276.

500 Id. at 271–73; see id. at 276.
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rather than reporting data as averages of multiple tests of the same lot and then 

calculating overall average, Emery was able to report results in a format that was 

fully transparent and allowed the inclusion of all the information Defendants 

complained about not having in the MDL.501 

2. Plaintiffs included all baseline testing in the Delaware Report.502

3. Emery re-processed and re-integrated “all of the testing it had done so that 

the results contained in the Delaware Report matched 100% with the underlying 

MassHunter data, and chromatograms therefrom.”503

These changes were made for three reasons:

First, Defendants complained that they were not able to match up the 

individual test data reported with individual chromatograms and underlying raw and 

processed data.504 Defendants complain now that this change is evidence of an intent 

to bias the results.

505

Second, Defendants accused Plaintiffs of cherry-picking data they reported 

because there were “many more tests in the native MassHunter data produced to 

501 Id. at 277.

502 Id.

503 Id. at 278.

504 See id. at 277.

505 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 63 (citing 

Dr. Cheu’s testimony) (arguing that lawyers made the decision to change methods). Contra Pls.’ 

Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 278–79.
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Defendants than contained in the MDL Report.”506

Third, Defendants complained in the MDL of problems matching test results 

on the printed PDF chromatograms generated by their experts from MassHunter data 

produced by Plaintiffs there.507

The re-processing and re-integration resulted in some “changes to reported 

values but none made a “material difference to the overall values reported.”508 

“None of the above are changes in methodology[;] they are changes in the detail and 

manner in which the results were reported.”509 These changes, along with the 

production made by Plaintiffs described above, overcome any suggestion that 

Plaintiffs’ methodology was not transparent.

Defendants’ final challenge to the Emery study sounds in the unfortunate 

allegation that changes in Emery’s method of presentation of chromatograms and 

underlying data, raw and processed, were “lawyer driven.”510 In support of that 

accusation, Defendants cite one question and its response:

Q: Okay. Well, then why did your methodology of 

averaging change?

A: This was a decision that was made I believe with the -

506 See Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 277.

507 Id. at 277–78.

508 Id. at 276–78.

509 Id. at 278.

510 Defs.’ Br. in Supp. of Brand Defs.’ & Patheon’s Mot. to Exclude Emery Pharma at 65.
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what is - the MDL lawyers.511

Defendants celebrate this answer as “definitive proof that Emery lacked a preset protocol.”512

 But contrary testimony followed only pages away.513 Dr. Cheu’s 

testimony makes clear that “the method of presentation of the averaging and selected 

results in the MDL Report was a decision made ‘with. . . the MDL lawyers.’”

514

 But 

the immediately following testimony “makes clear that the method of presentation 

of the results in the Delaware Report was made by Emery.”515 

The Court finds insufficient evidence that a lawyer-driven methodology 

manipulated the Emery study and rejects that assertion. Those allegations comprise 

only questions to be resolved by those in the jury box.

The Motion to exclude the Emery Pharma opinions is DENIED.

V. CONCLUSION

Although Daubert may have been intended to streamline expert practice under 

Rule 702, this case, like many around the country, suggests that goal has proven 

elusive. Differences in jurisprudence, interpretation of the law, and analyses may 

confound simpler approaches to such motions.

511 Id. at 68.

512 Id.

513 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 279; Pls.’ Opp’n to 

Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. Ex. 173, at 160:7–161:11.

514 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 278–79.

515 Pls.’ Opp’n to Defs.’ Mot. to Exclude Gen. Causation Experts’ Op. at 279 (emphasis added).
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In Delaware, our jurisprudence counsels that, subject to earnest deliberation, 

trial courts entrust questions of science to the scientists. Here, opposing teams of 

highly educated, skilled expert medical witnesses offer competing opinions. 

Through well-trained counsel, their efforts only clarify the distinct opposition that 

defines their respective positions. It would be improper to simply dismiss these 

experts as “poseurs or witnesses for hire. They are serious scientists.”516 As 

gatekeeper, the Court has found that each side has carried its required burden of 

demonstrating the reliability of its proffered Rule 702 evidence. Any remaining 

challenges will be made at trial via cross-examination and introduction of counter 

evidence. Having considered the full record herein, the parties’ Daubert challenges 

fail and their Motions to Exclude are DENIED. 

IT IS SO ORDERED.

/s/ Vivian L. Medinilla

Vivian L. Medinilla

Judge

cc: All Counsel of Record

516 In re Asbestos Litig., 911 A.2d at 1207.