In RE Zantac (Ranitidine) Litigation

Opinion

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

) IN RE ZANTAC (RANITIDINE) ) LITIGATION ) ) ) C.A. NO. N22C-09-101 ZAN ) )

Submitted: June 20, 2024 Decided: July 1, 2024

ORDER REFUSING TO CERTIFY DEFENDANTS’ APPLICATION FOR CERTIFICATION OF INTERLOCUTORY APPEAL OF OMNIBUS ORDER ON MOTIONS TO EXCLUDE EXPERT OPINIONS

This 1st day of July 2024, upon consideration of Defendants’ Application for

Certification of an Interlocutory Appeal (the “Application”); a Motion for Leave to

File Amici Curiae Brief (the “Motion”); Plaintiffs’ Opposition to Defendants’

Application for Certification of an Interlocutory Review (the “Response”); this

Court’s Omnibus Order on Motions to Exclude Expert Opinions Order dated May 31,

2024 (and corrected without substantive change on June 3, 2024) (the “Order”);

Supreme Court Rule 42 (“Rule 42”); and this civil action’s entire record, the Court

finds its Order denying exclusion of expert opinion under D.R.E. 702 and Daubert

does not determine a substantial issue of material importance that merits appellate

review before final judgment, and the Application is refused for the following reasons: BACKGROUND

1. The mass tort claims in these actions involve a molecule known as

ranitidine. Ranitidine is marketed under the label name of Zantac. N-

Nitrosodimethylamine (“NDMA”) is found in ranitidine. NDMA causes cancer.

2. In September of 2022, nearly 75,000 plaintiffs chose this forum to be

heard on allegations that Defendants collectively bear responsibility for their cancer

diagnoses, and the related injuries or deaths caused from their exposure to NDMA

from the ingestion of Zantac.

3. The claims are against Defendants, the five manufacturers of

prescription and over-the-counter ranitidine products—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”). All five

manufacturers are incorporated in Delaware.

4. Plaintiffs allege the development of one of ten cancers—bladder,

esophageal, gastric, liver, pancreatic, breast, colorectal, kidney, lung and prostate.

Consistent with the norm in such cases, the first phase of these proceedings has

addressed “general causation”—which involves the question of whether the

2 ingestion of this product is capable of causing cancer as alleged, not whether the

specific plaintiff has established that the product in question caused his or her

cancer. 1

5. To carry their burden at this stage, Plaintiffs retained ten experts to

offer opinions on general causation for the ten mentioned cancers. Defendants

moved to exclude them all. 2 Plaintiffs also moved to exclude certain opinions

proffered by Defendants’ sole general causation expert.

6. This Court considered, 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. 3 These motions were the subject of discovery,

a three-day “Daubert” hearing, multiple layers of briefing, and post-hearing

submissions all supported by more than forty volumes of exhibits, including

thousands of pages of scientific and legal materials.

7. On June 3, 2024 (correcting May 31st filing), the Court issued its 102-

1 The agreement between the parties was that both sides would be allowed to raise general causation challenges under D.R.E 702 and Daubert. If the Daubert challenges were denied, the experts would be permitted to testify and the litigation would proceed with the scheduling of ten bellwether trials representing the ten different cancers alleged. 2 Defendants moved 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”). 3 509 U.S. 579 (1993).

3 page Order finding that each side carried its required burden of demonstrating the

reliability of its proffered Rule 702 evidence.4 It further determined that any

remaining challenges would be made at trial via cross-examination and introduction

of counter evidence. 5 The parties’ Daubert challenges failed, and their motions were

denied.

8. Defendants did not move for reargument under Civil Rule 59.6 Nor

are there are any pending dispositive motions before this Court. Instead, Defendants

filed this application to certify its Daubert rulings for interlocutory appellate review.

The Plaintiffs timely filed their Response in opposition.

9. By letter dated June 18, 2024 (the “Letter”), a group of manufacturing

and business associations (“Movants”)7 informed the Court of technical issues

through File&Serve in their efforts to file a Motion for Leave to File an Amici Curiae

Brief in Support of the Defendants’ Application. Exhibits to the Letter include, inter

alia, the Motion, a Proposed Order, and the Amici Curiae Brief. Movants ground

4 Order at 102. 5 Id. 6 That might have allowed this Court to reconsider its findings of fact, conclusions of law, or judgment, if needed. See Ramon v. Ramon, 963 A.2d 128, 136 (Del. 2008) (“A motion for reargument is the proper device for seeking reconsideration by the Trial Court of its findings of fact, conclusion of law, or judgment.”) (internal citations omitted). 7 Those Movants are the Chamber of Commerce of the United States, the National Association of Manufacturers, the Biotechnology Innovation Organization, the Delaware Bioscience Organization, and the Pharmaceutical Research and Manufacturers Association.

4 the Motion on their “interest in the important legal issues at stake[.]” 8 Unable to file

through File&Serve, this Court permitted the docketing of the Motion with the

Prothonotary via traditional means and that has since been accomplished.

APPLICABLE STANDARD

10. Pursuant to Supreme Court Rule 42, “[n]o interlocutory appeal will be

certified by the trial court or accepted by this Court unless the order of the trial court

decides a substantial issue of material importance that merits appellate review before

a final judgment.”9

Interlocutory appeals should be exceptional, not routine, because they disrupt the normal procession of litigation, cause delay, and can threaten to exhaust scarce party and judicial resources. Therefore, parties should only ask for the right to seek interlocutory review if they believe in good faith that there are substantial benefits that will outweigh the certain costs that accompany an interlocutory appeal.10

11. In deciding whether to certify an interlocutory appeal, the trial court

must consider: (1) the eight factors listed in Rule 42(b)(iii); 11 (2) the most efficient

8 Motion, at 2. 9 Del. Supr. Ct. R. 42(b)(i). 10 Del. Supr. Ct. R. 42(b)(ii). 11 Delaware Supreme Court Rule 42(b)(iii) provides that the trial court should consider whether: (A) The interlocutory order involves a question of law resolved for the first time in this State; (B) The decisions of the trial courts are conflicting upon the question of law; (C) The question of law relates to the constitutionality, construction, or application of a statute of this State, which has not been, but should be, settled by this Court in advance of an appeal from a final order;

5 and just schedule to resolve the case; and (3) whether and why the likely benefits of

interlocutory review outweigh the probable costs, such that interlocutory review is

in the interests of justice. 12 “If the balance [of these considerations] is uncertain, the

trial court should refuse to certify the interlocutory appeal.”13

DISCUSSION

12. Before going any further, the Court first must determine if the Order

Defendants seek certification of “decides a substantial issue of material importance

that merits appellate review before a final judgment.” 14

13. Here, this Court was asked to consider only whether the parties carried

their respective evidentiary burdens to establish that their first-phase general

causation opinions were sufficiently reliable to allow them to be presented to the

jury. The experts’ qualifications were not disputed. The Court considered lengthy

(D) The interlocutory order has sustained the controverted jurisdiction of the trial court; (E) The interlocutory order has reversed or set aside a prior decision of the trial court, a jury, or an administrative agency from which an appeal was taken to the trial court which had decided a significant issue and a review of the interlocutory order may terminate the litigation, substantially reduce further litigation, or otherwise serve considerations of justice; (F) The interlocutory order has vacated or opened a judgment of the trial court; (G) Review of the interlocutory order may terminate the litigation; or (H) Review of the interlocutory order may serve considerations of justice. See Del. Supr. Ct. R. 42(b)(iii). 12 Id. 13 Id. 14 Del. Supr. Ct. R. 42(b)(i); Traditions, L.P. v. Harmon, 2020 WL 1646784, at *1 (Del. Apr. 2, 2020).

6 evidentiary presentations in support of the parties’ respective positions, which

covered all aspects of D.R.E. 702 and Daubert. The Daubert hearing lasted three

days, and the Daubert proceedings, in whole, included extensive briefing, oral

arguments, and post-hearing submissions.

14. The Court here considers the holding of In re Asbestos, where then-

Judge Slights rejected a similar request and refused interlocutory relief. 15 Similar to

this case, the Court denied motions to exclude expert testimony under Daubert and

held that a “Daubert analysis, at its core, leads the Court to a routine evidentiary

determination performed by trial courts every day—whether expert testimony

should be presented to a jury.”16 Such a determination “committed to the discretion

of the trial court . . . does not satisfy the criteria set forth in Delaware Supreme Court

Rule 42” because it was simply “a pre-trial evidentiary ruling[.]” 17 The Court in In

re Asbestos concluded its analysis there. 18

15. On a similar record, the Court made a similar evidentiary ruling and

issued its Order based upon settled principles of Delaware law; it found as

gatekeeper that both sides carried the necessary reliability burden to present their

15 See In re Asbestos Litig., 2006 WL 1579782 (Del. Super. Ct. June 7, 2006), app. refused, 906 A.2d 806 (Del. 2006). 16 Id. at *1. 17 Id. 18 Id. (“In light of this conclusion, the Court need not address the criteria set forth in Supreme Court Rule 42[.]”).

7 expert evidence under D.R.E. 702 and Daubert. The ten bellwether cases can now

be scheduled, and any resolution of the remaining scientific debates and challenges

to the experts’ opinions and conclusions should be addressed either through future

dispositive motion practice or by a jury at trial.

16. The questions presented here asked this Court to apply settled law to

these claims in the first phase of this litigation. Daubert analyses are not uncommon.

Whether an expert will be permitted to present an opinion to a jury is a routine

evidentiary determination made by the Court. And such a determination is always

committed to a trial court’s discretion and subject later to an abuse of discretion

standard of review. 19

17. Defendants’ damning refrain returns to the MDL’s ruling and portends

that were the Order permitted to stand, it will result in a high volume of cases that

“could require dozen of trials, empanelment of dozens of juries and extensive pre-

and post-trial litigation all before the Supreme Court has a chance to consider

whether the [Order]’s standard is truly more lenient than the consensus federal

standard.”20

18. To suggest that this Court’s lengthy opinion created a different or more

19 M.G. Bancorporation, Inc. v. Le Beau, 737 A.2d 513, 522 (Del. 1999) (“[T]he law grants the trial judge broad latitude to determine whether Daubert’s specific factors are, or are not, reasonable measures of reliability in a particular case,” and the determination of whether to admit or exclude expert testimony is subject to an abuse of discretion standard of review). 20 Defendants’ Application at 18.

8 lenient Daubert standard is incorrect and inaccurate as a matter of law. Where the

Court spoke about leniency, it was quoting Daubert, not expanding it.21

19. Furthermore, that this Court opted not follow the MDL should not be

misconstrued to suggest that this Court made some declaration of independence

from its federal sister. It did not. As discussed in the Order, this Court merely found

it could not follow the same course “from what was presented here.” 22 This is far

from extraordinary. That judges disagree is not remarkable. As observed in the

Order, other state courts too have disagreed with the MDL, elected not to follow it,

and instead allowed the jury to weigh the strength of the experts’ opinions.23

20. Notably, this Court considered that the Florida MDL relied heavily on

McClain v. Metabolife International, Inc. 24 The McClain plaintiff alleged that a

21 See Order at 12-13: 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.” . . . Restated, “[t]he reliability requirement is not a tool for the Court to use to exclude questionably reliable evidence.” This Court’s refusal to establish a bright line rule for proving causality has previously been considered. And no doubt, “the requisite proof necessary to establish causation will vary greatly case by case.” The Supreme Court in Daubert was more direct: ‘Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Thus guided, courts confronted by “shaky but admissible evidence” conduct their Daubert analyses “with a ‘liberal thrust’ favoring admission.” (internal citations omitted). 22 Order at 17. 23 Order at 5-6. 24 401 F.3d 1233, 1240 (11th Cir. 2005).

9 dietary supplement containing caffeine caused cardiac injury. The trial court did not

conduct a Daubert analysis and held “it lacked the knowledge” to make the call and

denied the challenges. Rather than remand, the Eleventh Circuit reversed and

conducted its own Daubert analysis, questioned the credibility of the experts, and

determined the scientific evidence was unreliable25 after having engaged internet

searches of online toxicological databases to support its interpretations. 26 Of note,

in Long v. Weider Nutrition Grp. Inc., this Court had earlier been faced with the

same Daubert challenge of the same scientific issues—but with a different experts;

this Court allowed the presentation of the cardiac injury opinions to a jury.27

21. To accept Defendants’ position that interlocutory review is warranted

merely because the issue decided might “determine Plaintiffs’ ability to prove the

essential element of causation” and thus, must be important, 28 would mean every

dispositive motion ruling would clear the first hurdle to interlocutory review. This

is contrary to Rule 42’s provisions that call for review only in exceptional

circumstances.

22. This evidentiary ruling applying Daubert does not present a

25 Id. at 1238. 26 Id. at 1242. 27 See Long v. Weider Nutrition Grp., Inc., 2004 WL 1543226, at *4-6 (Del. Super. Ct. June 25, 2004). 28 Application at 17–18.

10 substantial issue of material importance meriting appellate review before a final

judgment. In turn, as posited here, Defendants’ request for certification does not

satisfy Rule 42’s “substantial issue of material importance” prong.29 Thus, the

Application does not satisfy the criteria set forth in Delaware Supreme Court Rule

42(a).

23. No further consideration of the remaining factors is warranted. But an

examination of the delineated Rule 42 factors further suggests that certifying

Defendants’ application would be inappropriate.

24. Defendants seek certification by incanting three of the eight Rule

42(b)(iii) criteria, namely: (B) the decisions of the trial courts are conflicting upon

the question of law; (G) review of the interlocutory order may terminate the

litigation; or (H) review of the interlocutory order may serve considerations of

justice. For completeness, the Court considers these three factors.

25. Under Rule 42(b)(iii)(B), Defendants argue that the Daubert ruling

stands in conflict with Judge Slights’ In re Asbestos decisions because, to them, “the

focus of any general-causation inquiry must be on the product at issue, not the

29 See Pfizer, Inc. v. Advanced Monobloc, Corp., 1999 Del. Super. LEXIS 509, at ** 17, 19 (Judge Quillen refused to certify an interlocutory appeal in a case where the trial court’s potentially dispositive interlocutory orders, inter alia, struck a plaintiff’s damages expert under the well-settled criteria set forth in Daubert); Wilmington Medical Center, Inc. v. Coleman, 298 A.2d 320, 322 (Del. 1972)(finding that because the trial court’s interlocutory order did not “decide the underlying issue in the case at bar,” it likewise did not address a “substantial legal right” as required for certification under Rule 42(a)).

11 allegedly harmful component.” 30 There is no conflict. The Court considered, cited,

and was guided by: the holdings of In re Asbestos, other similar cases, Delaware

law interpreting D.R.E. 702, as well as, Daubert and its progeny. 31

26. Under Rule 42(b)(iii)(G), the Court agrees with Plaintiffs that

interlocutory review of the Order would not terminate the litigation. Defendants

argue that if review is granted, it may terminate the litigation because without

general causation experts, they will undoubtedly attain summary judgment.

27. The Court agrees with Plaintiffs that forcing the issue now, without

the benefit of a trial record—as no expert has actually provided testimony—is not

prudent. This pre-trial issue, as mentioned earlier, is in infant stages. Defendants

will undoubtedly appeal any adverse jury verdict on general causation. Interlocutory

review would allow for two bites of the appellate apple. Again, this is not the

intended purpose of Rule 42.

28. Under Rule 42(b)(iii)(H), review of the Order would not serve

considerations of justice. Defendants argue that it would be unfair to force them to

go to trial because of the implications it has on Delaware’s corporate image. This is

30 Application at 19. 31 Order at 47. Defendants also suggest there is conflict among the Delaware trial courts about whether a threshold dose is required to prove general causation. There is no conflict in the Delaware law, and this was also considered by this Court in its ruling as one factor for consideration under Daubert.

12 not an appropriate basis for relief. This also assumes no dispositive motions will be

filed at all and that Delaware, because of its status in the corporate world, should

allow interlocutory review where no other court—federal or state—has been asked

for such certification.

29. This request to protect corporations is blithely presented in the

Application and supplemented by Movants—a group of manufacturing and business

associations who sought leave to file an Amici brief. Aside from the timing of

Movants’ request, filed only days prior to this Court’s deadline, the proposed

arguments by Movants simply re-style Defendants’ arguments that this Court’s

failure to follow the MDL may result in dire consequences to Delaware’s reputation

in the corporate community. This factor has no bearing of this Court’s evidentiary

ruling under Rule 42. Any consideration of the Motion would not change this

Court’s ruling under Rule 42. 32

30. Interlocutory review here will not facilitate resolution. Nor do the

benefits outweigh certain costs. Cases resolve, one way or the other, when they

proceed to trial. These cases are no different. Efficiency is best achieved by

32 Movants emphasize that the Amici Brief discusses “from a policy perspective, the congruence of Delaware and federal law with respect to the admission of expert testimony.”32 That is, more specifically in this context, the Daubert standard: a topic developed and addressed in formal discovery, a three-day long Daubert hearing, hundreds of pages of post-hearing briefing that concluded on March 7, 2024, and the now challenged 102- page Order resolving the parties’ various Daubert challenges.

13 allowing the traditional judicial process here to move forward toward trial.

Interlocutory appellate review of the Order will not terminate this litigation and are

more likely instead to further prolong these proceedings.

31. Counsel for both sides are professional, well-versed in this area of law,

and have established the required agreements to address the logistics normally

involved in mass tort litigation. In fact, on June 21, 2024, after Defendants filed this

request for interlocutory review, they filed a Motion to Enforce Severance

Agreement, seeking that this Court enter an order requiring the regular filing of

Plaintiffs’ individual complaints to comply with the severance agreement and

deadline established in the parties’ Case Management Order (CMO 1). Thus, the

Defendant applicants themselves have asked the Court to keep the cases moving

here. This Court, too, is no stranger, to the process and trusts it. Interlocutory review

is not a necessary or usual part of the process. The case will move forward.

CONCLUSION

IT IS HEREBY ORDERED that certification to the Supreme Court of the

State of Delaware for disposition in accordance with Rule 42 is REFUSED.

/s/ Vivian L. Medinilla J. Vivian L. Medinilla