Dopson-Troutt et al v. Novartis Pharmaceuticals Corporation

Filing 187

ORDER granting in part and denying in part 143 Defendant's Omnibus Motion in Limine. Signed by Judge Susan C Bucklew on 9/23/2013. (GMS)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
RUTH DOPSON-TROUTT and
FRANK TROUTT,
Plaintiffs,
v.

Case No.: 8:06-CV-1708-T-24-EAJ

NOVARTIS PHARMACEUTICALS
CORPORATION,
Defendant.
__________________________________________/
ORDER
This cause comes before the Court on Defendant Novartis Pharmaceuticals Corporation’s
Omnibus Motion in Limine. [Doc. 143]. Plaintiffs Ruth Dopson-Troutt and Frank Troutt filed a
response in opposition. [Doc. 151].

A hearing on the motion was held after the pretrial

conference on September 12, 2013.
I.

BACKGROUND FACTS
Plaintiff Ruth Dopson-Troutt was diagnosed with breast cancer, which later metastasized

to her hip and pelvic bones. Dr. Arthur Feldman, her oncologist, prescribed Aredia and Zometa,
which are bisphosphonate drugs that are produced, sold, and marketed by Defendant Novartis
Pharmaceuticals Corporation (“NPC”). From 1999 to 2005, Dopson-Troutt was infused with
Aredia and then Zometa, with her last Zometa infusion occurring on May 12, 2005. DopsonTroutt had her tooth extracted, after which she began experiencing jaw pain caused by
osteonecrosis of the jaw (“ONJ”).
In 2006, Dopson-Troutt and her husband brought this action against NPC, alleging that
its manufacturing, labeling, marketing, selling, advertising, and distributing of Aredia and

Zometa caused their injuries and that NPC failed to, inter alia, adequately warn of the risk of
ONJ. This action was transferred to a Multidistrict Litigation Court in the Middle District of
Tennessee for consolidated pretrial proceedings with other actions brought against NPC.
In 2012, the case was remanded back to this Court. Jury trial is set to begin on October
21, 2013. Plaintiffs’ remaining claims are: negligent failure to warn (count III), breach of
express warranty (count IV), and loss of consortium (count VI). [Docs. 1, 138].
II.

NPC’S OMNIBUS MOTION IN LIMINE
A.

EVIDENCE OF PROXIMATE CAUSE

NPC seeks to exclude evidence regarding the possible impact of a proper and adequate
warning on a non-prescribing doctor—i.e., another doctor or a “reasonable doctor”—to show
proximate cause, arguing that such evidence is irrelevant and inadmissible. Plaintiffs respond
that proximate cause can be proven by evidence other than the prescribing doctor’s testimony.
Further, NPC raises a corollary issue—whether Pennsylvania applies a “heeding presumption” to
pharmaceutical failure-to-warn liability cases. NPC argues that a heeding presumption does not
apply; Plaintiffs argue that it does. The Court first briefly reviews Pennsylvania’s proximate
cause requirement in pharmaceutical drug failure-to-warn liability cases, before addressing the
parties’ heeding presumption and relevancy arguments.
1.

Pennsylvania failure-to-warn and proximate cause

In Pennsylvania, a failure-to-warn claim in a pharmaceutical products liability case is
governed by the negligence standard set forth in the Restatement (Second) of Torts § 388. See
Hahn v. Richter, 673 A.2d 888, 890-91 (Pa. 1996) (citing Incollingo v. Ewing, 282 A.2d 206,
220 n.8 (Pa. 1971)); Lance v. Wyeth, 4 A.3d 160, 165 (Pa. Super. 2010). A drug manufacturer is
liable only if it failed to exercise reasonable care to inform those, for whose use the

2

pharmaceutical is supplied, of the facts which make the product dangerous. See Lineberger v.
Wyeth, 894 A.2d 141, 150 (Pa. Super. 2006). The intended user is the prescribing physician—
not the patient. Id.
A prescription drug manufacturer’s duty to warn therefore runs to the prescribing
physician. Id. at 149. The rationale for this rule, known as the learned intermediary doctrine, is
that it is the prescribing physician’s responsibility to use his or her “own medical judgment,
taking into account the data supplied from the drug manufacturer, other medical literature, and
any other source available, and weighing that knowledge against the personal medical history of
the patient” when deciding whether to prescribe a drug. Id. at 150 (citation and quotation marks
omitted).

Thus, if a drug manufacturer adequately warned the prescribing physician, the

manufacturer is not liable for failure to warn.
However, if the warning is inadequate, a plaintiff must then establish that the inadequate
warning was a proximate cause of the plaintiff’s injury—i.e., that a proper and adequate warning
would have changed the prescribing behavior of the plaintiff’s prescribing physician:
In the duty to warn context, assuming that plaintiffs have established both duty
and a failure to warn, plaintiffs must further establish proximate causation by
showing that had defendant issued a proper warning to the learned intermediary,
he would have altered his behavior and the injury would have been avoided.
Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (citations and
quotations omitted) (“Absent proof that a more thorough or more explicit warning would have
prevented Mrs. Demmler’s use of Parnate, appellants cannot establish that SmithKline’s alleged
failure to warn was the proximate cause of Mrs. Demmler’s injuries.”).
2.

Heeding presumption

NPC argues that Pennsylvania does not apply a “heeding presumption”—a presumption
that if an adequate warning had been provided, the user would have read and heeded the
3

warning—to pharmaceutical failure-to-warn cases. If a heeding presumption were to apply, NPC
would have the burden to rebut the presumption of proximate cause. Plaintiffs respond that the
heeding presumption does apply.
NPC cites to a line of state trial court cases refusing to apply the heeding presumption to
pharmaceutical failure-to-warn cases. See Gronniger v. American Home Products Corp., 2005
WL 3766685, at *5-6 (Pa. Com. Pl. Oct. 21, 2005); Leffler v. American Home Products Corp.,
2005 WL 2999712, at *5 (Pa. Com. Pl. Oct. 20, 2005); Adams v. Wyeth, 2005 WL 1528656, at
*5-6 (Pa. Com. Pl. June 13, 2005). In these cases, the trial court found that Pennsylvania courts
only applied the heeding presumption to certain strict liability asbestos claims.

See e.g.,

Gronniger, 2005 WL 3766685, at *5-6; Leffler, 2005 WL 2999712, at *5. The court also
reasoned that applying the heeding presumption would conflict with Pennsylvania’s framework
for pharmaceutical failure-to-warn claims, where the manufacturer’s liability is premised on a
negligence theory and its duty to warn the learned intermediary.
Those state trial court cases were considered in Fecho v. Eli Lilly and Company, where a
federal court sitting in diversity likewise held that Pennsylvania applies no heeding presumption
to prescription drug failure-to-warn claims. 914 F. Supp. 2d 130, 147 (D. Mass. 2012). The
Fecho court acknowledged that Pennsylvania asbestos cases have applied the heeding
presumption. However, unlike prescription drug cases, asbestos cases are governed by a strict
liability standard and involve no learned intermediary exercising independent judgment; thus, the
court found that the reasoning of asbestos cases does not apply to prescription drug cases. Id. at
145-47 (reasoning that Coward v. Owens-Corning Fiberglas Corporation, 729 A.2d 614 (Pa.
Super. Ct. 1999), and Pavlik v. Lane Ltd./Tobacco Exporters Int’l, 135 F.3d 876 (3rd Cir. 1998),
do not require applying the heeding presumption in prescription drug cases).

4

In response, Plaintiffs assert that state trial court cases lack precedential value.
However, one of the state trial court cases, Lineberger v. Wyeth, was affirmed on appeal of the
trial court’s entry of summary judgment in Wyeth’s favor on the issue of proximate cause. 2005
WL 1274458, at *4-5 (Pa. Com. Pl. May 23, 2005), aff'd 894 A.2d 141 (Pa. Super. 2006).
Although the appellate court did not expressly hold that Pennsylvania does not apply the heeding
presumption to prescription drug cases, it affirmed based on its finding that the record evidence
did not create a genuine issue of material fact regarding whether a different warning would have
changed the doctor’s prescribing methods. Lineberger, 894 A.2d at 149-51.
Further, in arguing that a rebuttable heeding presumption applies in this case, Plaintiffs
cite without argument to asbestos strict liability cases, including the very ones considered and
rejected by Fecho and the state court trial cases cited by NPC. The Court rejects Plaintiffs’
argument and agrees with the analysis set forth in Fecho and the state trial court cases.
Plaintiffs also cite to Wolfe v. McNeil-PPC, Inc., 773 F. Supp. 2d 561 (E.D. Pa. 2011), a
failure-to-warn drug case.

However, not only is Wolfe distinguishable from this case—it

involved an over-the-counter, not a prescription, drug1—the court merely acknowledged that the
“Pennsylvania Supreme Court has not ruled on whether a heeding presumption applies in a case
such as this” and expressly declined to resolve the issue. Id. at 569.
Finally, Plaintiffs argue that Hahn v. Richter shows that the Pennsylvania Supreme Court
has clearly applied the heeding presumption to prescription drug failure-to-warn cases.
Plaintiffs’ argument rests on select language quoted from the opinion—“where warning is given,
the seller may reasonably assume that it will be read and heeded.” Hahn, 673 A.2d at 891.
1

Although the Wolfe defendants did not argue that “the learned intermediary doctrine should foreclose liability in”
their case, the Wolfe court noted that “the rationale underlying the doctrine—that the prescribing physician is always
the party making the ‘final judgment’ as to whether a patient should take a certain drug—is inapplicable to over-thecounter medicines, such as the Children’s Motrin involved in this case, which [is] available to the public without
prescriptions.” 773 F. Supp. 2d at 570 n.4.

5

However, this sound bite does not show that the Pennsylvania Supreme Court applied the
heeding presumption, or otherwise held that it applies to, pharmaceutical drug failure-to-warn
cases. The issue in Hahn was not whether the heeding presumption applied; it was whether the
trial court erred in determining that a pharmaceutical drug manufacturer’s liability for failing to
adequately warn is based on negligence, not strict liability. Id. at 889. In affirming, the
Pennsylvania Supreme Court relied on prior pharmaceutical drug liability cases, Incollingo v.
Ewing, 282 A.2d 206 (Pa. 1971), and Baldino v. Castagna, 478 A.2d 807 (Pa. 1984), and their
application of comments j and k to the Restatement (Second) of Torts § 402A. Id. at 889-91. In
this context, Hahn summarized comment j:
As to what constitutes proper warnings, comment j, titled “Directions or
warning,” provides that a seller must warn of risks, not generally known and
recognized, of which he has or reasonably should have knowledge, and, further,
that it can be assumed that where warnings are given they will be read and
heeded.
Id. at 890 (emphasis in original). Hahn concluded that:
Incollingo and Baldino, as well as comments j and k, make it clear that where the
adequacy of warnings associated with prescription drugs is at issue, the failure of
the manufacturer to exercise reasonable care to warn of dangers, i.e., the
manufacturer's negligence, is the only recognized basis of liability.
Id. at 891. Thus, Hahn’s reference to “read and heeded” was not for the purpose of applying, or
affirming the application of, the heeding presumption. Rather, the reference was made in the
context of summarizing comment j of § 402A to explain Hahn’s holding that negligence, not
strict liability, governed liability in failure-to-warn claims involving prescription drugs.
Therefore, Plaintiffs’ arguments regarding Hahn, or any other of Plaintiffs’ cited cases,
do not establish that Pennsylvania applies the heeding presumption.

Upon review of

Pennsylvania state court cases, the Court finds that heeding presumption does not apply here.

6

3.

Testimony from witnesses other than the prescribing doctor

NPC contends Plaintiffs must prove that an inadequate warning was the proximate cause
of Plaintiffs’ injury with testimony from Dr. Feldman, the Pennsylvania oncologist who
prescribed Aredia and Zometa to Dopson-Troutt. NPC argues that testimony from any other
doctor regarding whether an adequate warning would have changed their, or a reasonable
doctor’s, prescribing practices is inadmissible, irrelevant, and speculative.
As support for its argument, NPC relies on Adams v. Wyeth, 2005 WL 1528656 (Pa.
Com. Pl. June 13, 2005), where the state trial court granted Wyeth’s motion for summary
judgment because the plaintiff failed to establish proximate causation.

In Adams, the plaintiff

provided no testimony or record evidence from her prescribing doctor; she provided only a
pharmaceutical consultant’s affidavit opining that no reasonable doctor would have prescribed
the drug had an adequate warning been provided. In finding that the record did not have
sufficient evidence of proximate cause to proceed to trial, Adams stated that the pharmaceutical
consultant’s affidavit “[wa]s not admissible, [wa]s irrelevant and [wa]s contrary to the legal
standard long established under Pennsylvania law.” Id. at *5. Despite this language, the Court is
not persuaded that Adams stands for the proposition that any testimony from a nonprescribing
doctor regarding what a reasonable doctor would have done is inadmissible and irrelevant as a
matter of Pennsylvania law.

A fairer reading of Adams is that the court considered the

pharmaceutical consultant’s affidavit and, in light of the lack of any testimony from the
prescribing doctor, determined that evidence of proximate cause was insufficient to go to a jury.
Although NPC couches its arguments in terms of relevance, NPC’s motion boils down to
its belief that Plaintiffs cannot meet their burden of showing proximate causation. However, that
issue is not for the Court to decide on a motion in limine. The issue is whether the testimony of

7

other nonprescribing doctors regarding how an adequate warning would have affected them or a
“reasonable doctor” is relevant and admissible. The Court finds that such testimony could be
relevant. However, the Court does not know whose testimony NPC seeks to exclude, or what
that testimony will be; at this time, the Court is unable to determine whether it would be
admissible.

NPC’s motion to limine out the testimony of any doctors other than Dr. Feldman

regarding whether an adequate warning would have changed their or any reasonable doctor’s
prescribing practices is DENIED.
B.

PREEMPTION

Anticipating Plaintiffs’ potential arguments that NPC should have made certain label
changes, NPC argues that these arguments are preempted.
1.

Label changes regarding dosing and duration of use

NPC seeks to exclude evidence or argument that NPC should have: (1) recommended a
different dosage than the one approved by the FDA, or (2) suggested stopping Zometa after a
certain number of doses or months of treatment. [Doc. 143 at 7, 9]. NPC argues that any
changes to the FDA-approved dosing recommendations on the labels require prior FDA approval
and are therefore preempted.
Plaintiffs respond that the FDA does not prohibit including safety information about
dosing. [Doc. 151 at 11]. Plaintiffs cite to the changes-being-effected (“CBE”) regulation, 21
C.F.R. 314.70(c)(2)(iii), which allows a manufacturer to change the label “[t]o add or strengthen
an instruction about dosage and administration that is intended to increase the safe use of the
drug product” without prior FDA approval.2 Plaintiffs also cite to Wyeth v. Levine, 555 U.S. 555

2

In 1999, the CBE regulation governing labeling changes was 21 C.F.R. § 314.70(c)(2). In June 22, 2004, Section
314.70 was amended, and the CBE regulation governing labeling changes was renumbered to 21 C.F.R. §
314.70(c)(6). See 69 Fed. Reg. 18728-01. However, the prior version, § 314.70(c)(2), is essentially the same as
current version, § 314.70(c)(6)(iii).

8

(2009), where the United States Supreme Court held that federal law did not preempt the
plaintiff’s claim that the drug label inadequately warned about the risks of using the drug’s
administration method.
Levine involved Phenergan, a drug that could be administered intravenously by the “IVpush” method and the “IV-drip” method. The IV-push method presented a higher risk of the
drug entering an artery and causing gangrene. After the Levine plaintiff was administered the
drug by the IV-push method, Phenergan entered the plaintiff’s arteries and caused gangrene in
the plaintiff’s arm.

The plaintiff brought a failure-to-warn claim against Wyeth (the drug

manufacturer) under state law, arguing that the label failed to adequately warn about the risks of
the IV-push method. Wyeth argued that the plaintiff’s claim was preempted by federal law.
In addressing whether federal law preempted the plaintiff’s “claim that Phenergan’s label
did not contain an adequate warning about using the IV-push method of administration,” id. at
565, Levine rejected Wyeth’s argument—that Wyeth could not have unilaterally changed the
label to add a stronger warning because such a change would have rendered Phenergan a new
drug lacking an effective new drug application and therefore would have subjected Wyeth to
liability for violating FDA regulations governing unauthorized distribution. Levine held that
strengthening the label’s warning about the administration method would not have made
Phenergan a new drug; the CBE regulation permitted Wyeth to strengthen its warning about drug
administration without prior FDA approval. 3 Id. at 570-71.
Describing Wyeth’s argument as a “cramped reading of the CBE regulation,” Levine
stated that the CBE regulation “reflects the manufacturer’s ultimate responsibility for its label

3

Specifically, the CBE regulation allows a manufacturer to change a label to “add or strengthen a contraindication,
warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration
that is intended to increase the safe use of the drug product.” Levine, 555 U.S. at 568 (quoting 21 C.F.R. §§
314.70(c)(6)(iii)(A),(C) (2008)).

9

and provides a mechanism for adding safety information to the label prior to FDA approval.” Id.
at 571. Thus, “[w]hen the risk of gangrene from IV-push injection of Phenergan became
apparent, Wyeth had a duty to provide a warning that adequately described that risk, and the
CBE regulation permitted it to provide such a warning before receiving the FDA’s approval.”
Id. Although the FDA could reject any changes made pursuant to the CBE regulation, Levine
noted that Wyeth never argued that it gave the FDA an analysis concerning the risks of the
administration method or that it attempted to give, but the FDA prohibited, a stronger warning.
Id. at 572. Levine held that, absent clear evidence that the FDA would not have approved a label
change, it was not impossible for Wyeth to abide by both federal and state law. Id. at 571.
As support for its contention that Plaintiffs’ arguments are preempted, NPC cites to
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Company, Inc. v.
Bartlett, 133 S. Ct. 2466 (2013). NPC contends Mensing “rejected the plaintiffs’ argument that
the manufacturer could have strengthened its labeling (e.g., by proposing stronger warnings to
FDA) because [of] the preemptive effect of the federal regulations.” [Doc. 143 at 5].
In Mensing, the plaintiffs developed a disease after taking a generic drug and brought a
failure-to-warn claim against the generic drug manufacturer. Id. at 2573. The Supreme Court
held that the FDA’s prohibition on changes to generic drug labels preempted state failure-towarn claims against generic manufacturers, finding that “f]ederal law . . . demanded that generic
drug labels be the same at all times as the corresponding brand-name drug labels.” Id. at 2578.
The Supreme Court also found that the CBE process available to the brand-name manufacturer in
Levine was not available to the generic drug manufacturer in Mensing. Id. at 2581. Here, Aredia
and Zometa are not generic drugs. Mensing is therefore inapposite to whether Plaintiffs are

10

prohibited from arguing that NPC should have made certain label changes regarding dosing
recommendations under the CBE regulation.
NPC counters that Mensing is not limited to generic drug manufacturers but extends to
brand-name drug manufacturers. [Doc. 143 at 8]. Citing to Bartlett, NPC asserts that “the
Supreme Court made clear that federal law also prohibits labeling changes by brand name drug
manufacturers.” [Id.] In its argument, NPC inexplicably selects language from the Bartlett
opinion where the Supreme Court, in summarizing the generic drug approval process, quoted 21
C.F.R. § 314.70(b)(2)(i)—a provision governing supplemental “major changes” and expressly
requiring prior FDA approval—which prohibits a manufacturer from making any changes to the
“qualitative or quantitative formulation of the drug product.” This provision is separate from the
CBE regulation at issue here.4 Therefore, neither Mensing nor Bartlett assists NPC’s argument
that label changes regarding dosing recommendations are preempted in this case.
Notably, at the September 12, 2013 hearing before the Court, NPC asserted that its only
reason for citing Mensing and Bartlett was to state the general proposition that a label change
requiring prior FDA approval is preempted. The implication is that NPC did not cite Mensing
and Bartlett to suggest that the label changes at issue here in fact require prior FDA approval
(and are therefore preempted).
A review of NPC’s motion in limine suggests otherwise. Nonetheless, taking NPC’s
representation at face value—e.g., that Mensing and Bartlett explain that, if the FDA regulations
prohibit manufacturers from making a label change without prior FDA approval, then Plaintiffs
are preempted from arguing that NPC should have unilaterally made that label change—the issue
4

To the extent NPC argues Plaintiffs’ arguments relate to label changes that would constitute “major changes”
requiring prior FDA approval under § 314.70(b)—rather than changes requiring no FDA approval under the CBE
regulation § 314.70(c)—the Court disagrees. When describing what would be “major changes,” § 314.70(b)(2)(i)
expressly excludes changes described in the CBE regulation. Further, NPC has provided the Court with no authority
showing that § 314.70(b) applies here—as discussed, NPC’s reliance on Bartlett is not persuasive.

11

is still whether the label changes regarding the dosing recommendations at issue in this case are
changes permitted under the CBE regulation (and would therefore require no prior FDA
approval) or are changes falling outside the scope of the CBE regulation.
During its oral argument, NPC argued that the label changes regarding dosing are not
considered CBE changes; rather, they are considered changes that would render Aredia or
Zometa a new drug, requiring a new drug application and new clinical studies, under 21 C.F.R. §
310.3(h)(5), which states:
The newness of a drug may arise by reason (among other reasons) of . . . newness
of a dosage, or method or duration of administration or application, or other
condition of use prescribed, recommended, or suggested in the labeling of such
drug, even though such drug when used in other dosage, or other method or
duration of administration or application, or different condition, is not a new drug.
However, this argument was addressed and rejected in Levine. See 555 U.S. at 570 (changing
the label to warn about IV-push administration would not have made Phenergan a new drug).
NPC counters that the Levine label change regarding drug administration is different than the
label change regarding dosage at issue. Specifically, NPC asserts that the label change in Levine
would have simply clarified instructions regarding the existing administration method, whereas
label changes in this case would not clarify the dosing instructions.
The Court rejects NPC’s argument that any label change regarding dosage
recommendations in this case would render Aredia or Zomedia a new drug. NPC has provided
no evidence or authority showing what changes are considered a “newness of dosage” under §
310.3(h)(5), as opposed to changes that “add or strengthen an instruction about dosage” under §
317.70(c)(2)(iii). Further, given that Levine does not describe any particular warning that Wyeth
should have included5 and the term “clarification” appears nowhere in the opinion, NPC lacks a

5

In fact, Levine stated that the jury verdict did not mandate a particular warning; rather, the jury found that there
may have been several ways for Wyeth to strengthen the warning. See 129 S. Ct. at 1194.

12

basis for describing the Levine label change as a mere clarification of an instruction. NPC’s
unsupported characterization of the Levine label change notwithstanding, NPC has still failed to
explain why label changes regarding dosing at issue here would be unlike the label changes
regarding administration in Levine. Nor has NPC addressed the Supreme Court’s finding that
manufacturers are presumptively able to make label changes about dosage without FDA approval
under the CBE process “[a]bsent clear evidence that the FDA would not have approved a
change.” Levine, 555 U.S. at 571. NPC has provided no evidence, let alone clear evidence, to
suggest that the FDA would have rejected warnings reflecting a different dosing regimen.
Therefore, the Court will not preclude Plaintiffs from offering argument or evidence that
NPC should have changed the FDA-approved label by recommending a different dosing
regimen. Accordingly, NPC’s motion in limine as to dosing is DENIED.
2.

Label changes regarding comparisons between Aredia and Zometa

NPC seeks to prohibit Plaintiffs from arguing that the Zometa label should have stated
that Aredia was safer than Zometa.
Citing 21 C.F.R. 201.57(c)(2)(iii), NPC argues that comparisons of other drugs on drug
labels requires prior FDA approval, because they must be supported by “substantial evidence
derived from adequate and well-controlled studies as defined in § 314.126(b),” and that no data
from well-controlled studies shows that Aredia is superior to Zometa. [Doc. 143 at 7].
Plaintiffs respond that comparative studies of Zometa and Aredia in fact exist, because
Aredia was used as a control during the Zometa trials and the Zometa label already describes
Zometa as not inferior to Aredia. Plaintiffs argue that “[w]hen Novartis had indications that
Aredia’s safety profile on BRONJ was better than Zometa’s . . . it had carte blanche through the
CBE to say so on the label.” [Doc. 151 at 13].

13

Plaintiffs fail to explain how having “indications” is equivalent to having substantial
evidence from adequate and well-controlled studies—which Plaintiffs’ response does not dispute
is the applicable standard—showing that Aredia is safer than Zometa. However, NPC has not
established that, if evidence meeting the § 314.126(b) standard existed and showed that Aredia
was safer than Zometa, NPC could not have changed the label’s drug comparisons under the
CBE regulation (without prior FDA approval).
Without knowing what comparisons and supporting studies are at issue, the Court lacks
sufficient information to make a determination. NPC’s motion to prohibit argument that the
Zometa label should have stated that Aredia was safer than Zometa is therefore DENIED
WITHOUT PREJUDICE.
3.

Black box warning

NPC seeks to prohibit Plaintiffs from arguing that NPC failed to adequately warn because
it did not add a black box warning to the Aredia or Zometa label.6
NPC argues that this argument is preempted because FDA regulations prohibit NPC from
unilaterally adding a black box warning without FDA’s prior approval or request, and the FDA
has never approved or required a black box warning for Aredia or Zometa. NPC points to
several FDA statements in the Federal Register that, “to ensure the significance of boxed
warnings in drug labeling, they are permitted only when specifically required by FDA.” 44 Fed.
Reg. 37434, 37448 (June 26, 1979).7 Further, 21 C.F.R. § 201.57(e) provides:

6

A “black box” warning is the strongest warning that the FDA requires. Aaron v. Wyeth, 2010 WL 653984, at *8
(W.D. Pa. 2010).
7
See also 51 Fed. Reg. 43900-01, 43902 (Dec. 5, 1986) (“Under § 201.57(e) (21 CFR 201.57(e)), which lists
specific requirements on content and format of labeling for human prescription drugs, the agency has the authority
to require a ‘boxed’ warning on prescription drug packages for special problems, particularly those that may lead to
death or serious injury. The intent of the box is to draw special attention to the warning to assure that it will be
noted by the physician. The agency’s policy is to use restraint in requiring warnings to be boxed because overuse of
the box will ultimately lead to reducing its effect.”).

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Special problems, particularity those that may lead to death or serious injury, may
be required by the Food and Drug Administration to be placed in a prominently
displayed box. . . . If a boxed warning is required, its location will be specified by
the Food and Drug Administration.
Plaintiffs respond that “there is no case of the FDA striking a black box warning used by
a pharmaceutical company” and therefore they are not preempted from arguing that NPC should
have unilaterally added a black box warning. This does not rebut NPC’s contention that the
FDA regulations prohibit NPC from adding a black box warning unless the FDA specifically
requests that one be added. Nor do Plaintiffs address the FDA’s statements in the Federal
Register cited by NPC. Plaintiffs are therefore prohibited from arguing that NPC should have
unilaterally added a black box warning without prior FDA approval.
Accordingly, NPC’s motion is GRANTED. However, the Court notes that Plaintiffs’
response references NPC emails discussing the effect of a black box warning. [Doc. 151 at 6,
10]. The Court clarifies that evidence bearing on the issue of potential black box warnings may
be relevant to, inter alia, the sorts of warnings that NPC could have added without prior FDA
approval, and are therefore not necessarily inadmissible.
4.

Different label formatting

NPC seeks to preclude Plaintiffs from potentially arguing that it should have formatted
the Zometa labeling differently by, inter alia, placing the ONJ warning in different sections of
the label or using a different font size or bolded text.
NPC contends such arguments are barred by 21 U.S.C. § 337(a) and threatens FDA's
primary jurisdiction. Citing to Pom Wonderful LLC v. Coca-Cola Company, 679 F.3d 1170 (9th
Cir. 2012), and 21 C.F.R. § 201.57(d), NPC contends the FDA “comprehensively regulates the
formatting of prescription drug labeling” and Plaintiffs’ “challenges to the FDA-approved

15

formatting would . . . undermine FDA’s considered judgments and should be precluded.” [Doc.
143 at 9-10, 11].
However, Pom Wonderful is not a drug label case; rather, it is a food case about a
pomegranate blueberry drink label, where the Ninth Circuit discussed 21 C.F.R. § 102.33, which
provides requirements for the labeling of beverages that contain fruit or vegetable juice. NPC
has failed to explain how Pom Wonderful is applicable here. Further, NPC appears to cite to a
version of the FDA regulation that was not effective at the time Dopson-Troutt used Aredia and
Zometa. Compare 21 C.F.R. § 201.57(d) (2006) (titled “Format requirements” and providing
requirements for font size and bolded text of labels) with 21 C.F.R. § 201.57(d) (2005) (titled
“contraindications” and providing content requirements for the label’s contraindications section).
The Court therefore denies NPC’s motion to exclude any argument that NPC should have
formatted the label differently. However, Plaintiffs state that they will not argue about FDAdisapproved font; as to this issue, NPC’s motion is granted.
Accordingly, NPC’s motion is GRANTED to the extent that Plaintiffs seek to argue that
NPC should have used an FDA-disapproved font; NPC’s motion is otherwise DENIED.
C.

CORPORATE CONDUCT AFTER TOOTH EXTRACTION

NPC seeks to exclude evidence surrounding its corporate activities after Dopson-Troutt’s
tooth was extracted “in late 2003 or early 2004” under Rules 401-403 of the Federal Rules of
Evidence. NPC argues that its subsequent knowledge or notice of ONJ after Dopson-Troutt’s
tooth extraction is irrelevant to the determination of liability because “there is no proximate
causal connection between [its] later conduct and her injury.” [Doc. 143 at 11].
Plaintiffs respond that the Court should reserve ruling on this issue, pointing to another
Novartis case where the court declined to draw a strict time boundary for the admission of

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evidence. The Court agrees that imposing a strict cut-off date for admissibility of evidence is
impractical, because documents or actions by NPC after that date could bear on relevant issues,
such as NPC’s earlier knowledge about ONJ and Zometa.
The Court notes that the parties have stipulated that “documents, testimony, or other
evidence concerning alleged actions or omissions by Novartis that postdate Mrs. Trouttt’s last
use of Zometa (May 12, 2005) are irrelevant to prove Novartis’ liability and will not be offered
for that purpose.” [Doc. 181]. Although NPC included a footnote saying that it believed an
earlier cutoff date should be imposed, NPC has failed to show why it should be the date of
Dopson-Troutt’s first tooth extraction, rather than the date of Dopson-Troutt’s last infusion of
Zometa. Accordingly, NPC’s motion is DENIED.
III.

CONCLUSION
Accordingly, it is hereby ORDERED that Novartis Pharmaceuticals Corporation’s

Omnibus Motion in Limine [Doc. 143] is GRANTED IN PART AND DENIED IN PART as
provided above.
DONE AND ORDERED at Tampa, Florida, this 23rd day of September, 2013.

Copies To: Counsel of Record and Parties

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