In RE Zantac (Ranitidine) Litigation

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
14