                    United States Court of Appeals
                          FOR THE EIGHTH CIRCUIT
                                   ___________

                                   No. 11-2082
                                   ___________

Paul Schilf; Cynthia Schilf, as         *
Special Administrators for the          *
Estate of Peter Raymond Schilf,         *
Deceased; Paul Schilf; Cynthia          *
Schilf, Individually,                   *
                                        * Appeal from the United States
            Appellants,                 * District Court for the
                                        * District of South Dakota.
      v.                                *
                                        *
Eli Lilly & Company;                    *
Quintiles Transnational                 *
Corporation,                            *
                                        *
            Appellees.                  *
                                   ___________

                             Submitted: February 14, 2012
                                Filed: August 3, 2012
                                 ___________

Before GRUENDER, BENTON, and SHEPHERD, Circuit Judges.
                          ___________

BENTON, Circuit Judge.

      Paul R. and Cynthia J. Schilf sued Eli Lilly & Company and Quintiles
Transnational Corporation (“Lilly”). They alleged Lilly’s failure to warn and deceit
caused the death of their son, Peter Raymond Schilf. Lilly moved for summary
judgment, which the district court granted. Jurisdiction being proper under 28 U.S.C.
§ 1291, this court reverses and remands.

                                           I.

      This court states the facts most favorably to the Schilfs.

       On November 26, 2004, Cynthia Schilf accompanied her sixteen-year-old son
Peter to an appointment to discuss his depression with their family practitioner Dr.
Richard G. Briggs. Peter complained of having various symptoms of depression since
at least the prior summer. Dr. Briggs diagnosed Peter with depression and gave him
samples of the antidepressant medication Cymbalta. These samples had been
removed from the packaging and thus had no warning information. Dr. Briggs spoke
with Cynthia and Peter Schilf about the risks of antidepressant treatment. Dr. Briggs
recalls telling them that while there “may be an increased association with anti-
depressants and suicidal ideations and gestures,” “[n]o completed suicides occurred
during the clinical trials,” and “Cymbalta was not specifically studied.” Dr. Briggs
was referencing an FDA study and chose to prescribe Cymbalta in part because he
believed it was less linked to suicide than another antidepressant evaluated in that
study, Prozac.

       In fact, there were five completed suicides in Lilly-sponsored clinical trials of
Cymbalta, which was studied separately from the drugs Dr. Briggs referenced. Just
over a month before Peter’s appointment, the FDA issued a Public Health Advisory
telling the public that it directed manufacturers of antidepressants to include in their
packaging a “black box” warning: “Antidepressants increase the risk of suicidal
thinking and behavior (suicidality) in children and adolescents with major depressive
disorder (MDD) and other psychiatric disorders.” A black box warning describes
special problems, particularly those that may lead to death or serious injury, in a
prominently-displayed box so that it is readily apparent. On the same day, the FDA


                                          -2-
issued a press release entitled, “FDA Launches a Multi-Pronged Strategy to
Strengthen Safeguards for Children Treated with Antidepressant Medications.” In
a separate letter to manufacturers, the FDA said, “A causal role for antidepressants
in inducing suicidality has been established in pediatric patients.”

       Within a day of receiving the medication samples, Peter, with the oversight of
his father, searched the internet for Cymbalta and found Lilly’s website for it. Peter’s
father testified that if he had noticed a warning about suicidality, he would not have
allowed Peter to take the medication.

      On December 24, 2004, Peter committed suicide. One month later, Lilly
revised the Cymbalta literature to include the FDA-approved black box warning.

                                          II.

        This court reviews de novo a grant of summary judgment. Mason v. Corr.
Med. Servs., Inc., 559 F.3d 880, 884 (8th Cir. 2009). Summary judgment should be
granted when—viewing the facts most favorably to the nonmoving party and giving
that party the benefit of all reasonable inferences—the record shows that there is no
genuine issue of material fact. See Fed. R. Civ. P. 56(c); Torgerson v. City of
Rochester, 643 F.3d 1031, 1042 (8th Cir. 2011) (en banc). An issue is “genuine” if
the evidence is sufficient to persuade a reasonable jury to return a verdict for the
nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). “As
to materiality, the substantive law will identify which facts are material.” Id. At
summary judgment, the court’s function is not to weigh the evidence and determine
the truth of the matter itself, but to determine whether there is a genuine issue for
trial. Id. at 249.

      To survive summary judgment, the Schilfs must establish a genuine issue of
material fact whether an adequate warning would have altered Dr. Briggs’ decision

                                          -3-
to prescribe Cymbalta. See In re Prempro Prods. Liab. Litig., 586 F.3d 547, 569 (8th
Cir. 2009); see also Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir.
2004) (“The learned intermediary doctrine states that adequate warnings to
prescribing physicians obviate the need for manufacturers of prescription products
to warn ultimate consumers directly.”). The Schilfs rely on the heeding
presumption—the presumption that a reasonable person (here, Dr. Briggs) would act
according to an adequate warning. See Restatement (Second) of Torts § 402a cmt.
j. It is likely that South Dakota would adopt this presumption. See McElhaney v. Eli
Lilly, 739 F.2d 340, 340 (8th Cir. 1984). The district court, relying on Thom v.
Bristol-Myers Squib Co., 353 F.3d 848, 856 (10th Cir. 2003), ruled that Dr. Briggs’
behavior rebutted the presumption because he prescribed Cymbalta with knowledge
of its risks.

                                          A.

      The district court first found that “a warning from [Lilly] would not have
informed Dr. Briggs of anything he did not already know” about the risks of
Cymbalta. The court wrote: “Dr. Briggs was aware of the same warnings that [the
Schilfs] now say [Lilly] should have given to prescribing physicians such as Dr.
Briggs.” See Ehlis, 367 F.3d at 1016 (8th Cir. 2004) (noting that a plaintiff cannot
prevail on a failure-to-warn claim if the prescribing physician knew the information
that would have been in an adequate warning).

       The Schilfs’ desired warnings were that (1) five suicides occurred during
Cymbalta clinical trials (including one during a trial for a condition other than
depression), (2) there is a causal role for Cymbalta in suicidality, and (3) the suicide
risk in taking antidepressants is increased in children and adolescents.1 Dr. Briggs


      1
      The dissent states that the Schilfs did not state a desire for a causal role
warning “[u]ntil this appeal.” This is incomplete. In addition to twice referencing

                                          -4-
did not recall any suicides occurring in the clinical trials of Cymbalta, and he believed
that no causal connection had been established between Cymbalta and suicidality.



       Dr. Briggs was not aware of the five suicides that occurred during clinical trials
of Cymbalta. He testified he reviewed the Cymbalta package insert, which cautions
that “completed suicide” and “suicide attempt” were “infrequent adverse events.” At
his deposition, he did not recall this warning and was interested in “see[ing] the
information.” The insert did not state the number of suicides that occurred during the
clinical trials. It also did not indicate in any way that the “completed suicide” and
“suicide attempt” adverse events were more significant than the other events detailed
in fine-print surrounding them. Dr. Briggs testified that before prescribing Cymbalta,
he would have wanted to know the details about any suicide that occurred during its
clinical trials.

    Dr. Briggs testified that while he was not aware of a causal link between
Cymbalta and suicide, he was aware of an association. The package insert clearly


causality in the amended complaint, the Schilfs presented the argument several other
times. In their opposition to Lilly’s motion for summary judgment, the Schilfs stated
that summary judgment was inappropriate because “Dr. Briggs had no idea that
causality had been established for antidepressant induced pediatric suicidality.” In
the district court’s hearing on the matter, counsel for the Schilfs stated no less than
three times that “causality has been established.” The Schilfs’ counsel stated once
even more plainly: “This pill can cause you to take your own life.” The Schilfs’
expert on this point was also the subject of several motions by Lilly. In the opinion
on general causation, the expert wrote that Cymbalta “can cause younger patients to
become suicidal.” The district court also understood causality to be one thrust of the
Schilfs’ arguments. In its order granting summary judgment, the district court wrote
that it would presume the warnings inadequate for the purposes of the summary
judgment determination because “[a]lthough suicidality is mentioned, the warnings
provided by Lilly prior to the black box warnings do not convey a causal connection
between taking Cymbalta and suicidality.”

                                          -5-
said that “a causal role for antidepressants in inducing suicidality has not been
established,” but did caution that patients should “[n]evertheless” be observed for
suicidality. Dr. Briggs’ understanding of the FDA’s determination was that there was
an association between antidepressants and suicide but that “[t]hey weren’t saying the
risk was there.”2 Asked what he understood in 2004 about the increased risk in taking
antidepressants and suicide, he answered: “I think it was unknown at that time based
on the information available.” Asked whether “there’s an increase in suicide risk
when taking antidepressants,” Dr. Briggs answered, “I think it remains to be seen,
yeah.” A warning that an adverse effect is “associated” with a medication—like the
one Dr. Briggs gave—is not a warning that a causal connection exists. See Thom,
353 F.3d at 853-54 (collecting cases to that effect).

       Dr. Briggs’ testimony is unclear about what he knew about the increased risk
of suicide among children and adolescents who take Cymbalta. He testified that he
had not seen any reports on the effects of Cymbalta on people under the age of 18 but
could “remember seeing Cymbalta mentioned with pediatrics use.” No one asked Dr.
Briggs the source or the contents of the “mention.”

      The district court incorrectly stated that Dr. Briggs testified that he “read” the
2004 FDA press release and that the Schilfs admit he did so. To the contrary, Dr.
Briggs testified that he was “aware” of the press release because it was “in the
media”—“on the news, radio, televisions, all those.” He also did not answer a
question whether he had read the FDA study that was the basis of the press release.
He answered yes to a question whether he had “seen and become aware of” the press


      2
       The dissent’s argument that Dr. Briggs understood the contents of the FDA
study misses the mark. Even if Dr. Briggs was familiar with this information, he did
not understand that the study also represented the risks of taking antidepressants other
than those specifically studied, including Cymbalta, and based his prescription
decision on that belief. There is a genuine issue of material fact whether he knew the
suicide-related risks of Cymbalta.

                                          -6-
release. No one elicited testimony about what Dr. Briggs thought the press release
said.

       There are genuine issues of material fact whether Dr. Briggs knew the suicide-
related information that an adequate warning would have contained.3 See Ehlis, 367
F.3d at 1016 (8th Cir. 2004).
                                         B.

       The district court found that Dr. Briggs would have prescribed Cymbalta to
Peter even if he knew of its actual risks. See In re Prempro Prods. Liab. Litig., 586
F.3d at 569 (noting that a plaintiff cannot prevail on a failure-to-warn claim if an
adequate warning would not have changed the prescribing physician’s decision).

       Dr. Briggs’ deposition is unclear whether he would have still prescribed
Cymbalta if given information about the clinical trial suicides or any causal role for
Cymbalta in inducing suicidality. No one asked Dr. Briggs whether he would have
prescribed Cymbalta to Peter if Lilly—through a black box warning, a letter, or its
sales representatives—had informed him of the suicide-related information. Dr.
Briggs stated that he has not made a decision not to prescribe Cymbalta given the
information about suicides, but he could not remember whether he had prescribed it


      3
       Lilly asserts that federal pre-emption justifies summary judgment. Lilly argues
that because the FDA did not approve its language asserting a causal role for
Cymbalta in suicidality, the Schilfs’ failure-to-warn claim on that basis is pre-empted.
(Without mentioning pre-emption, the dissent also intimates that the FDA’s
determination not to allow the “causal role” language in antidepressant labeling
resolves the warning issue.) Lilly’s argument—restricted to the one sentence the
FDA rejected—would not resolve this case. Additionally, Lilly does not argue it was
barred from disseminating information through its sales representatives. Last, the
Schilfs’ claim is not limited to the time after the FDA issued its Public Health
Advisory, press release, and new warnings; they point to those events as evidence of
Cymbalta’s alleged misbranding.

                                          -7-
to an adolescent since Peter’s suicide. The district court relied heavily on Dr. Briggs’
statement that he still believed his prescription decision was appropriate, finding that
he testified that “he would prescribe Cymbalta for Peter Schilf given adequate
warnings.” The question Dr. Briggs was asked could be asking if Dr. Briggs’
decision was appropriate at the time it was made, given the information he had then.
Read this way, the question would be consistent with those asked earlier in the
deposition. When asked if there were anything he would have done differently, Dr.
Briggs answered: “Not at the time. I did – I did exactly what I would have done.”
The district court’s conclusion that Dr. Briggs would prescribe Cymbalta to Peter
again with an adequate warning also fails because, even at the time of his deposition,
Dr. Briggs was not aware of the suicide-related information.

      The district court’s conclusion is also inconsistent with Dr. Briggs’ behavior.
Dr. Briggs testified that he does not tell a patient every warning and precaution for
a drug he prescribes, but he does discuss the ones that are “most likely to apply.” He
discussed suicide with the Schilfs before prescribing Cymbalta—noting his belief that
no completed suicides occurred in the trial. He also specifically chose Cymbalta
because it was not included in the pooled study on which the FDA based its suicide
warning.

       Alternatively, Lilly argues that the 2004 Cymbalta warnings were adequate
because Peter’s father would not have allowed him to take the medication if he had
read the suicide-related statements in the warnings. There is no testimony, however,
about how Peter’s father would have evaluated those statements in the original
context. Considering the suicide-related statements contextually is critical because
the 2004 Cymbalta warning also stated that “a causal role for antidepressants in
inducing suicidality has not been established.”

      Dr. Briggs’ testimony and behavior indicate that knowledge of the five suicides
during the Cymbalta trials or of any causal role for Cymbalta in inducing suicidality

                                          -8-
may have changed his prescribing behavior. There are genuine issues of material
fact whether an adequate warning would have changed Dr. Briggs’ decision to
prescribe Cymbalta to Peter. See In re Prempro Prods. Liab. Litig., 586 F.3d at 569.

                                       *******

      The judgment of the district court is reversed, and the case remanded for
further proceedings consistent with this opinion.

GRUENDER, Circuit Judge, concurring in part and dissenting in part.

        I agree with the Court that the grant of summary judgment with respect to the
Schilfs’ desired warning that five suicides occurred during the Cymbalta clinical trials
must be reversed because South Dakota likely would adopt the learned intermediary
doctrine and the heeding presumption, see ante at 4, and because Lilly failed to rebut
the heeding presumption. Although Dr. Briggs testified that he had reviewed the
Cymbalta package insert, he did not recall that the insert cautioned that “completed
suicide” was an observed adverse reaction to Cymbalta use. In fact, the Cymbalta
package insert in use at the time Dr. Briggs prescribed Cymbalta for Peter disclosed
a rate of completed suicide of between one-in-one-hundred and one-in-one-thousand
trial participants. Because Dr. Briggs was unaware of this suicide rate and conceded
that he would want to know about incidents of completed suicide when deciding
whether to prescribe Cymbalta, I agree that the Schilfs raised a jury question as to
whether the size, font, and location of the suicide rate disclosures in the package
insert were adequate to warn Dr. Briggs of those risks.

      I respectfully dissent, however, from the Court’s holding that the Schilfs’
“desired warnings” included a warning of “a causal role for Cymbalta in suicidality”
separate from the actual warnings contained in the FDA’s October 2004 Public
Health Advisory (“PHA”), see id., and that there are genuine issues of material fact

                                          -9-
as to whether Dr. Briggs knew about the risks disclosed in the PHA. Until this
appeal, the Schilfs’ “desired warnings” were limited to (1) a disclosure of the five
suicides that occurred during the Cymbalta clinical trials, and (2) the FDA’s
recommended class-wide “black box” warning regarding the increased risk of
pediatric suicide from all antidepressants, including Cymbalta, as detailed in the
PHA. With regard to the second desired warning, the Schilfs relied on the PHA to
establish that Lilly was aware of the increased risk of suicidality among pediatric
antidepressant users, so the scope of their desired warning is limited to the warning
conveyed by the PHA. See Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 854
(10th Cir. 2003) (“In determining the adequacy of a warning, a court must also look
to evidence concerning the manufacturer’s knowledge of the danger of the product.”).
The Court correctly points out that “causality” was mentioned in the complaint and
before the district court.4 Ante at 4 n.1. However, on the few occasions where the
Schilfs addressed causation in relation to the FDA studies, it was not to argue that
Lilly should have given a separate warning that causality has been established, but
rather to argue that the PHA and the studies underlying it would have conveyed such
a warning specifically to Dr. Briggs. Establishing that the content of the PHA
included a disclosure of a causal link was relevant because it allowed the Schilfs to
argue that Dr. Briggs was not familiar with the “full import” of the warning contained
in the PHA, contradicting his claim that he had “seen and become aware” of the
PHA.5


      4
        In collecting examples of how “causality” was at issue before the district
court, the Court confuses the “causation” element of the Schilfs’ tort claims (i.e.,
whether the alleged failure to warn proximately caused the harm to Peter Schilf) with
the completely separate issue of whether Lilly should have known that a causation
warning was necessary based on the FDA studies underlying the PHA. Contrary to
the Court’s conflation of these issues, only the latter type of “causality” is at issue in
this appeal.
      5
      The Schilfs also argued before the district court that Dr. Briggs’s testimony
was not credible because he provided no contemporaneous proof of his familiarity

                                          -10-
       Even if there is a genuine controversy as to whether the FDA studies concluded
that a causal connection exists between suicidality and pediatric antidepressant use,
this issue is not material to this case, see Fed. R. Civ. P. 56(c), because the Schilfs’
desired warning from Lilly was not a causal warning in the abstract, but rather a
replication of the specific warning contained in the PHA.6 Thus, Lilly was entitled
to summary judgment if Dr. Briggs already had “seen and become aware” of the
“black box” warning in the PHA when he prescribed Cymbalta for Peter.

      I agree with the district court that there is no genuine issue of fact as to whether
Dr. Briggs was aware of the PHA and familiar with the warning disclosed therein.
As a threshold matter, the Schilfs concede that Dr. Briggs was “aware of the recent
FDA recommendation for a class wide suicide warning.” Dr. Briggs testified in his
deposition that he became aware of that recommendation shortly after the FDA issued
the PHA on October 15, 2004. Furthermore, he testified that, before he prescribed
Cymbalta for Peter, he had “seen and become aware of the [PHA] regarding
antidepressants in pediatric populations and the issue of suicidality.” When asked
whether he told Cynthia Schilf that the FDA had recommended a “black box”
warning for antidepressants, including Cymbalta, Dr. Briggs answered, “I can’t recall


with the PHA at the time he prescribed Cymbalta to Peter and because his description
of the warnings he gave to the Schilfs differed from how Cynthia Schilf described the
warnings related to them by Dr. Briggs. These arguments before the district court
confirm that the Schilfs were contending not that Lilly should have given a warning
of a causal link, but rather that Lilly should have given the specific warning contained
in the PHA.
      6
       The district court’s assumption, for purposes of its decision, that Lilly’s
package insert was inadequate because it did not “convey a causal connection
between taking Cymbalta and suicidality” merely reflects its understanding that the
Schilfs interpreted the PHA, the warning they desired, as conveying such a causal
connection. This interpretation is evidenced by the district court’s conclusion that
“Dr. Briggs was aware of the same warnings that [the Schilfs] now say [Lilly] should
have given to prescribing physicians such as Dr. Briggs.” Ante at 4.

                                          -11-
using those terms . . . [b]ut I know we breached that subject specifically.” Dr. Briggs
explained, “I told her about the FDA studies that were done . . . . I told her exactly
what those studies were indicating.” When asked whether he told Peter and Cynthia
“how much the increased risk was [in the PHA] with respect to antidepressants and
suicide,” Dr. Briggs responded that the PHA relied on several studies but that the
“average is 2 percent to 4 percent.” When asked whether he had understood “what
the FDA had indicated, that [the risk] had gone from 2 percent to 4 percent, back in
October 2004,” Dr. Briggs confirmed that he had, “[i]n the context of how the studies
were interpreted.” Furthermore, Dr. Briggs testified that he warned Peter and Cynthia
about the risk of pediatric suicide, repeatedly asked Peter whether he was having
suicidal thoughts, and asked Cynthia to watch for suicidal tendencies. He testified,
“We specifically discussed that issue, though, the FDA and their recommendations
or warnings.” Dr. Briggs’s undisputed testimony establishes that he was familiar with
the PHA warning of an increased risk of suicidality in pediatric users of
antidepressants and the need to warn pediatric Cymbalta users and their families to
watch for signs of suicidal tendencies. Thus, there is no genuine issue of material fact
as to whether Dr. Briggs was familiar with the PHA and the risks disclosed therein,
including its recommended “black box” warning of the increased risk of suicidality,
regardless of Lilly’s failure to include it in the packaging for Cymbalta.

       The Court’s finding of some ambiguity as to whether Dr. Briggs understood the
warning in the PHA is based on a misinterpretation of Dr. Briggs’s testimony. While
the Schilfs seek to interpret the studies underlying the PHA as sufficient to establish
a causal role for antidepressant use in suicidality, Dr. Briggs testified that, at the time
he prescribed Cymbalta to Peter Schilf, he interpreted the studies as merely
supporting the existence of a correlation between the two. Thus, Dr. Briggs’s
assertion during his deposition that neither the FDA studies underlying the PHA nor
subsequent studies established that antidepressant use causes pediatric suicidality
evidences a nuanced understanding of the FDA studies, not a lack of familiarity.
Most importantly, there is no evidence that Dr. Briggs’s interpretation of the studies

                                           -12-
would have been different if Lilly had directly provided the “black box” warning to
him.7 Dr. Briggs’s interpretation of the PHA is supported by the fact that, although
the FDA initially sent Lilly and other antidepressant manufacturers a letter suggesting
that they amend their package inserts to state that “[a] causal role for antidepressants
in inducing suicidality has been established in pediatric patients,” the FDA
subsequently required Lilly to “excise” the causation language and replace it with an
“increased risk” warning to better reflect the information contained in the “black box”
warning originally published in the PHA. The revised FDA-approved Cymbalta
package insert states that “[p]atients with major depressive disorder . . . may
experience worsening of their depression and/or emergence of suicidal ideation and
behavior (suicidality) or unusual changes in behavior, whether or not they are taking
antidepressant medications” (emphasis added). This statement is consistent with the
current FDA-approved “black box” warning for Cymbalta, which discloses that
antidepressants “increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children,” but also notes that “depression and certain other
psychiatric disorders are themselves associated with increases in the risk of suicide.”8


      7
        Contrary to the Court’s statement, ante at 6 n.2, Dr. Briggs’s familiarity with
the PHA is the dispositive issue, not whether he believed the information it contained
or interpreted it in the same way the Schilfs currently do. Dr. Briggs offered
uncontradicted testimony that he understood in 2004 that the FDA had determined
“that there was an association between antidepressants and suicide.” Id. at 6. Even
if the Court is correct that Dr. Briggs did not believe that the FDA study “represented
the risks of . . . Cymbalta,” id. at 6 n.2, this merely demonstrates that Lilly has
rebutted the heeding presumption in this case because Dr. Briggs was familiar with
the warning in the PHA, exactly what the Schilfs desired that Lilly should have
provided to him, and chose to disregard it. See In re Prempro Prods. Liab. Litig., 586
F.3d 547, 569 (8th Cir. 2009).
      8
        Contrary to the Court’s suggestion, ante at 7 n.3, I do not rely on the FDA’s
clarification that the PHA warning is one of association and not one of causation to
show that the Schilfs’ state-law claims are preempted by the FDA’s decision. Rather,
I rely on this information merely to show that Dr. Briggs’s interpretation of the PHA

                                         -13-
In summary, Dr. Briggs’s denial that a causal role for pediatric antidepressant use in
suicidality had been established in 2004 does not create a genuine issue of fact as to
whether he was familiar with the PHA and the suicidality warning it contained.

       Because the Schilfs relied on the PHA to establish what information regarding
suicidality Lilly should have provided to Dr. Briggs, see Thom, 353 F.3d at 854, Dr.
Briggs’s familiarity with the relevant information in the PHA at the time he
prescribed Cymbalta to Peter rebuts the heeding presumption and breaks the chain of
causation between Lilly’s failure to warn the Schilfs about the suicide risk disclosed
in the PHA and Peter’s tragic death. See Ehlis v. Shire Richwood, Inc., 367 F.3d
1013, 1016 (8th Cir. 2004) (“[T]he causal link between a patient’s injury and the
alleged failure to warn is broken when the prescribing physician had ‘substantially
the same’ knowledge as an adequate warning from the manufacturer should have
communicated to him.” (quoting Christopher v. Cutter Labs., 53 F.3d 1184, 1192
(11th Cir. 1995))).

       For the foregoing reasons, the grant of summary judgment should be affirmed
as to the Schilfs’ failure-to-warn claim based on Lilly’s failure to inform Dr. Briggs
of the FDA’s proposed “black box” warning as detailed in the PHA.
                             ______________________________




and the underlying FDA studies is not unreasonable. Having established that Dr.
Briggs’s interpretive disagreement with the Schilfs does not contradict his testimony
that he was familiar with the risks disclosed in the PHA, this disagreement becomes
immaterial to the resolution of this appeal because Dr. Briggs was familiar with the
Schilfs’ desired warning, as set forth in the PHA, and disagreed with the Schilfs’
interpretation of it.

                                        -14-
