Court Opinion

ID: 164099
Source: CourtListenerOpinion
Date Created: 2010-08-14 08:11:40+00
Date Added: 2024-06-11T14:21:51.176530
License: Public Domain

F I L E D
                                                                      United States Court of Appeals
                                                                              Tenth Circuit
                     UNITED STATES COURT OF APPEALS
                                                                              DEC 3 2003
                                  TENTH CIRCUIT
                                                                         PATRICK FISHER
                                                                                  Clerk

 CARLA GRAY,

          Plaintiff-Appellant,

 v.                                                        No. 02-7079
                                                            (E.D. Okla.)
 HOFFMAN-LA ROCHE, INC.;                             (D.Ct. No. 01-CV-493-S)
 ROCHE LABORATORIES, INC.;
 ROCHE PHARMACEUTICALS,

          Defendants-Appellees.

                             ORDER AND JUDGMENT *

Bill V. Wilkinson of Wilkinson Law Firm, Tulsa, Oklahoma, for Plaintiff-
Appellant.

Michael X. Imbroscio (Mark H. Lynch and Lanny A. Breuer of Covington &
Burling, Washington, D.C.; Harry A. Woods, Jr., of Crowe & Dunlevy, P.C.,
Oklahoma City, Oklahoma; Mary Morrissey Sullivan of Sullivan, Sullivan &
Nahigian, L.L.P., Boston, Massachusetts, with him on the brief) of Covington &
Burling, Washington, D.C., for Defendants-Appellees.

Before BRISCOE and McWILLIAMS, Circuit Judges, and BRORBY, Senior
Circuit Judge.

      *
          This order and judgment is not binding precedent except under the doctrines of
law of the case, res judicata and collateral estoppel. The court generally disfavors the
citation of orders and judgments; nevertheless, an order and judgment may be cited under
the terms and conditions of 10th Cir. R. 36.3.
      Appellant Carla Gray claims the prescription drug Accutane caused her to

experience severe depression. She sued Hoffman-La Roche, Inc., the drug’s

manufacturer, and Roche Laboratories, Inc., the drug’s distributor (collectively

“Roche”), 1 in federal court. The suit resulted in a jury verdict in favor of Roche.

This appeal followed. Exercising jurisdiction under 28 U.S.C. § 1291, we affirm.

      Roche manufactures and distributes Accutane, a prescription drug

commonly used to treat acne. Ms. Gray took Accutane to treat acne for a number

of years and claims to have suffered from severe depression during that time.

Believing Accutane caused her depression, Ms. Gray filed a complaint against

Roche based on diversity jurisdiction in the United States District Court for the

Eastern District of Oklahoma. She alleged Roche was liable because it failed to

adequately warn either her or her doctor about Accutane’s possible psychiatric

side effects. Ms. Gray proceeded under three Oklahoma state law causes of

action: (1) manufacturer’s products liability; (2) negligence; and (3) breach of

express and implied warranties. A jury returned a verdict in favor of Roche.

      1
       Ms. Gray also named Roche Pharmaceuticals as a defendant in her complaint.
However, according to Roche’s answer, “no corporate entity named Roche
Pharmaceuticals exists.”

                                         -2-
      On appeal, Ms. Gray raises five arguments. She believes the trial court:

(1) erred in a number of evidentiary rulings during her examination of Dr.

McCauley, her treating physician; (2) erred in a number of evidentiary rulings

during her cross-examination of one of Roche’s expert witnesses, Dr. Gudas; (3)

erred in excluding evidence of Ms. Gray’s daughter’s experience with Accutane

and depression; (4) erred in excluding evidence relating to Roche’s alleged profit

motive for not issuing a stronger Accutane warning; and (5) erred in rejecting a

jury instruction she proposed.

      We review a trial court’s evidentiary rulings and jury instructions for an

abuse of discretion. Hinds v. Gen. Motors Corp., 988 F.2d 1039, 1046-47 (10th

Cir. 1993). We will only find an abuse of discretion if the trial court’s decision

“was based on a clearly erroneous finding of fact or an erroneous conclusion of

law or manifests a clear error of judgment.” Cartier v. Jackson, 59 F.3d 1046,

1048 (10th Cir. 1995). Even if we find an abuse of discretion, we will disturb the

jury’s verdict only if the error affected “a substantial right of the party.” Fed. R.

Evid. 103(a). See also Fed. R. Civ. P. 61. Under these standards, we consider

Ms. Gray’s arguments in turn.

                                          -3-
      I. EXAMINATION OF DR. MCCAULEY

      Ms. Gray claims the trial court committed a number of evidentiary errors

during her examination of her treating physician, Dr. McCauley. Ms. Gray hoped

to prove Roche should have warned Dr. McCauley of Accutane’s alleged

psychological side effects “[a]nd, in turn, these warnings should have been given

by Dr. McCauley to [Ms. Gray].” To establish Roche proximately caused her

alleged injuries, Ms. Gray needed to demonstrate that “had [Roche] issued a

proper warning to [Dr. McCauley], he would have altered his behavior and the

injury would have been avoided.” Eck v. Parke, Davis & Co., 256 F.3d 1013,

1018 (10th Cir. 2001). Ms. Gray believes the trial court prevented her from

making this showing by: (a) sustaining objections during her examination of Dr.

McCauley, and (b) granting (in part) Roche’s motion in limine to exclude

“evidence regarding changes made to Accutane product warnings and

communications after the conclusion of Ms. Gray’s treatment with Accutane.”

            a. Sustained Objections

      First, Ms. Gray claims the trial court erred in sustaining Roche’s “asked

and answered” objections. Ms. Gray described two specific warnings she believes

Roche should have issued, and asked Dr. McCauley whether he would have

followed them. Dr. McCauley responded, “it depends.” He went on to explain:

                                        -4-
       “[W]e don’t rotely just follow instructions from drug companies.
       There are a lot of other things that go into evaluation of drugs with
       known and unknown side effects. So we would have taken this into
       account, but we also temper it with the experience that the patient is
       relating to us; also in regards to what other, what our own experience
       is with other patients....

               And also in regard to other literature that we may be reading,
       and the experiences that we have, our shared experiences that we had
       with colleagues. So we don’t just rote do what the drug companies
       tell us. We do it, we take this certainly into consideration, and we put
       it into the rest of the equation in regards to the information that we
       visit with our patients about and also counsel them in regards to the
       medications.

       Apparently dissatisfied with his response, Ms. Gray immediately repeated

her question. Roche objected on grounds the question had been asked and

answered, and the trial court sustained. Throughout the remainder of her

examination of Dr. McCauley, Ms. Gray repeatedly asked slight variations of this

same question. The trial court sustained a number of Roche’s objections on

grounds the question had been asked and answered. 2

       Trial courts may prohibit litigants from asking witnesses repetitive

       2
          In the instances the trial court allowed Dr. McCauley to respond to Ms. Gray’s
question, he indicated he “may or may not have done anything differently,” he was “not
sure that at this particular point it would have made any difference in the way that [he]
would have advised [Ms. Gray],” and he “may or may not have acted upon this any
differently.”

                                            -5-
questions. Fed. R. Evid. 611(a) (instructing courts to “exercise reasonable control

... so as to ... avoid needless consumption of time”); Fed. R. Evid. 403

(recognizing courts’ discretion to exclude evidence “if its probative value is

substantially outweighed ... by considerations of undue delay, waste of time, or

needless presentation of cumulative evidence”). See, e.g., Bragg v. Foretravel,

Inc., 652 F.2d 39, 40 (10th Cir. 1981) (holding a “trial court properly exercised its

discretion in order to prevent repetitive questioning and needless consumption of

judicial time”). Here, Dr. McCauley obviously did not provide the answer Ms.

Gray hoped to elicit. However, he did reply to the question with an appropriate

answer. The trial court did not abuse its discretion by prohibiting the repetitive

questions.

      Ms. Gray next complains the trial judge should have permitted her to ask

Dr. McCauley, in regard to part of a warning she asserts Roche should have

issued, “what those two sentences mean to him.” The sentences state: “Follow-

up visits during Accutane treatment should include specific questioning regarding

psychiatric signs and symptoms. Patients should be specifically warned to

immediately discontinue Accutane use and seek medical evaluation if depression

                                         -6-
or mood change occurs.” 3 The district court excluded the question on the ground

it called for Dr. McCauley to interpret the sentences.

      We have held, “where ... expert testimony is offered on an issue that a jury

is capable of assessing for itself, it is plainly within the trial court’s discretion to

rule that testimony inadmissible.” Thompson v. State Farm Fire & Cas. Co., 34

F.3d 932, 941 (10th Cir. 1994). Although Dr. McCauley testified as a lay

witness, the same reasoning applies here. Lay opinions, like expert opinions, are

only admissible if they are helpful to the jury. Fed. R. Evid. 701, 702. The

sentences Ms. Gray asked Dr. McCauley to interpret were not technical or

confusing; the jury was capable of understanding them without Dr. McCauley’s

assistance. The trial court did not abuse its discretion in sustaining Roche’s

objection.

      3
         Ms. Gray also asked Dr. McCauley whether he disagreed with these two
sentences. Dr. McCauley responded he would like to see the rest of the document to view
the sentences in their context. Ms. Gray immediately repeated the question, and the trial
court sustained Roche’s objection on the ground it had been asked and answered. Ms.
Gray believes the court erred in sustaining the objection because Dr. McCauley did not
answer her question. Again, we see no abuse of discretion. Although Dr. McCauley may
not have provided the answer Ms. Gray hoped for, his response was within the realm of
appropriate answers. Thus, the trial court did not abuse its discretion in sustaining
Roche’s objection.

                                           -7-
      Ms. Gray next argues the trial court improperly interrupted her when she

asked Dr. McCauley if he would have altered her treatment had he “received a

warning from Roche that he considered to constitute a significant change in the

warnings involving side effects for Accutane.” Troubled by the word

“significant,” the trial court ruled it would only allow Dr. McCauley to answer if

Ms. Gray clarified “what changes.” Ms. Gray argues “[i]t is up to the witness to

inform the Court if he cannot answer the question.” We disagree.

      Trial courts bear the responsibility of “mak[ing] the interrogation ...

effective for the ascertainment of the truth.” Fed. R. Evid. 611(a)(1). Here, the

court found Ms. Gray’s question vague, thus not helpful to the jury. We see no

abuse of discretion in its sua sponte interruption. See, e.g., United States v.

Head, 697 F.2d 1200, 1210 (4th Cir. 1982) (noting trial court’s prerogative to

interrupt witness examinations sua sponte). Moreover, the court gave Ms. Gray

the opportunity to clarify her question.

      Finally, Ms. Gray complains the trial court erroneously limited her redirect

examination of Dr. McCauley, finding her questions unrelated to Roche’s cross-

examination. She points out Roche had asked whether Dr. McCauley’s other

patients taking Accutane reported depression. Accordingly, Ms. Gray argues the

                                           -8-
court should not have prevented her from asking if “whether [his] patients report

psychiatric side effects ... [has] anything to do ... with whether the patient

understands that Accutane might cause the psychiatric side effects,” because this

question was related to Roche’s questioning on reported depression of other

patients.

      “The scope of redirect examination is committed to the sound discretion of

the trial court” and is normally limited to the scope of cross-examination. United

States v. Hodges, 480 F.2d 229, 233 (10th Cir. 1973). Here, the trial court

reasonably determined Ms. Gray’s question went beyond the scope of cross-

examination. Roche’s inquiry was limited to whether any of Dr. McCauley’s

other Accutane patients reported depression. Ms. Gray’s question, on the other

hand, delves into what factors might motivate his patients to report side effects.

The trial court acted within its discretion by curtailing this line of questioning.

             b. Subsequent Remedial Measures

      Ms. Gray also asserts the trial court erred by excluding evidence Roche

changed Accutane’s warnings after she stopped taking the drug. Ms. Gray sought

to introduce Roche’s revised “informed consent/patient agreement” form through

Dr. McCauley. This form, modified after Ms. Gray discontinued treatment,

                                          -9-
addresses possible psychological side effects associated with Accutane, and

requires patients to initial the form acknowledging their understanding of the

possible side effects. The trial court granted (in part) Roche’s motion in limine to

exclude the form as evidence of a subsequent remedial measure.

      In diversity actions involving a products liability claim, the admissibility of

subsequent remedial measures is a matter of state law. Wheeler v. John Deere

Co., 862 F.2d 1404, 1410 (10th Cir. 1988). Under Oklahoma law, “evidence of

subsequent measures” taken after an “event” is inadmissible “to prove negligence

or culpable conduct.” Okla. Stat. Ann. tit. 12, § 2407 (1993). However, we

found no Oklahoma law indicating whether this exclusion applies to products

liability suits. We must therefore turn to Rule 407 of the Federal Rules of

Evidence. Herndon v. Seven Bar Flying Serv., Inc., 716 F.2d 1322, 1326 (10th

Cir. 1983) (holding where no state rule of evidence is available, the federal rule

should be applied).

      Federal Rule of Evidence 407’s subsequent remedial measures exclusion

applies to products liability cases. See Fed. R. Evid. 407 advisory committee’s

note. In relevant part, it excludes evidence of measures taken after “an injury or

harm” occurred “that, if taken previously, would have made the injury or harm

                                        -10-
less likely to occur ... to prove ... a need for a warning and instruction.” Fed. R.

Evid. 407. However, such evidence may be admitted for other purposes, notably

for impeachment and for proving the “feasibility of precautionary measures, if

controverted.” Id. Roche’s revised patient informed consent form fits squarely

within the category of evidence Rule 407 bars. Therefore, the trial court properly

excluded the form as evidence Roche should have issued a stronger warning.

      Because Rule 407 does not exclude subsequent remedial measures taken by

non-parties, Mehojah v. Drummond, 56 F.3d 1213, 1215 (10th Cir. 1995), Ms.

Gray asserts the trial court should have admitted the evidence because she offered

it to show Dr. McCauley, a non-party, took the remedial measure of using

Roche’s revised form. We disagree.

      Evidence admissible under Rule 407 still faces Rule 403 scrutiny. Courts

must exclude evidence if “the dangers of prejudice or confusion substantially

outweigh the probative value of the evidence.” Fed. R. Evid. 407 advisory

committee’s note (1997 Amendments). Here, the form’s danger of prejudice to

Roche ran high. Because the form not only established Dr. McCauley’s

subsequent remedial measure, but Roche’s, as well, the jury might have used the

form against Roche for the very purpose Rule 407 prohibits – as evidence there

                                         -11-
was “a need for a warning.” Additionally, the form’s probative value was

minimal. As to Dr. McCauley’s remedial action, the form merely bolstered his

testimony that he now specifically questions his Accutane patients about

psychiatric side effects. The form’s potential for prejudice thus substantially

outweighed its probative value. The trial court acted within its discretion by

ordering it excluded. 4

                    1. Impeachment Exception

      Ms. Gray next argues the trial court should have allowed her to introduce

the form to impeach Dr. McCauley’s testimony. As discussed above, Dr.

McCauley testified he “may or may not have” followed instructions had Roche

issued them during Ms. Gray’s treatment. Ms. Gray contends she could have

impeached this testimony with the form because she claims Dr. McCauley’s

deposition testimony indicates, “as soon as he received the revised informed

patient consent form from [Roche], he immediately began using it.” (Emphasis

      4
         Ms. Gray also believes the court should have allowed her to introduce Roche’s
revised consent form because Roche failed to cite Oklahoma law mandating its exclusion.
She claims Meller v. Heil Co., 745 F.2d 1297 (10th Cir. 1984) places the burden of
demonstrating the evidence’s inadmissibility under state law upon the party seeking its
exclusion. However, the principle in Meller Ms. Gray refers to is our interpretation of a
Colorado statute excluding post-injury scientific advancements. Id. at 1302. The statute
in Meller does not apply to this case.

                                          -12-
added.) According to Ms. Gray, the deposition testimony shows Dr. McCauley

“responds directly and immediately to such warnings and instructions from the

drug manufacturer.” She believes she could have proved Dr. McCauley would

have altered her treatment had the trial court permitted her to introduce the form.

      Both Oklahoma law and Rule 407 permit litigants to introduce subsequent

remedial measures evidence for impeachment purposes. Fed. R. Evid. 407; Okla.

Stat. Ann. tit 12, § 2407 (1993). Here, the informed consent form itself did not

contradict Dr. McCauley’s testimony that he does not “rotely” follow instructions

from drug companies, or that he would have altered Ms. Gray’s treatment had

Roche issued warnings while she was taking Accutane. Furthermore, we are

unconvinced the form would have allowed Ms. Gray to elicit further testimony to

impeach Dr. McCauley.

      First, and contrary to Ms. Gray’s assertions, we found no indication in Dr.

McCauley’s deposition testimony that he began using the consent form

immediately after receiving it. On the contrary, Dr. McCauley testified he could

not remember when he received the informed consent form or when he began

using it. Second, the informed consent form differs in both form and content

from the warning Ms. Gray claims Roche should have issued years earlier. The

                                        -13-
fact he currently uses the form does not prove he would have followed a different

warning several years earlier. Indeed, Dr. McCauley’s deposition testimony

indicates he attained new information about Accutane’s possible side effect

around the time Ms. Gray stopped taking Accutane and before he adopted the

form. In light of these facts, we doubt Ms. Gray could have used the form to

demonstrate that, contrary to his testimony, Dr. McCauley would have proceeded

differently had Roche issued the two warning sentences. The trial court properly

excluded the form for impeachment purposes.

                    2. Feasibility Exception

        Next, Ms. Gray argues the trial court should have admitted the form under

the feasibility exception to the rules barring subsequent remedial measures. She

believes feasibility was controverted at trial. Ms. Gray first explains she

controverted feasibility when she attempted to show Roche’s former method of

informing doctors about Accutane’s possible side effects was infeasible, whereas

the revised patient informed consent form would have been feasible. Ms. Gray

also claims Roche controverted feasibility when its representative testified the

company “didn’t think to put” warnings on patient brochures and blister packs,

and testified it would not have been easy for Roche to revise the informed consent

form.

                                        -14-
      Neither the Oklahoma statute nor Rule 407 bars subsequent remedial

measures to prove the “feasibility of precautionary measures, if controverted.”

Fed. R. Evid. 407; Okla. Stat. tit. 12, § 2407 (emphasis added). The “if

controverted” requirement “allows the opposing party to lay the groundwork for

exclusion by making an admission.” Fed. R. Evid. 407 advisory committee’s

note. Here, in a pretrial brief, Roche stated it did not contest feasibility.

Although the trial court indicated its order excluding the form was “subject to

reconsideration at trial,” during the trial Ms. Gray never argued Roche’s

representative’s testimony controverted feasibility. Because she raises this

argument for the first time on appeal, we decline to review it. See Tele-

Communications, Inc. v. Commissioner, 12 F.3d 1005, 1007 (10th Cir. 1993). In

addition to waiving appellate review, Ms. Gray’s omission also deprived Roche of

the opportunity to make an admission regarding feasibility.

      Ms. Gray further suggests her efforts to controvert feasibility satisfy the “if

controverted” requirement irrespective of Roche’s response. We believe the

advisory committee’s note to Rule 407 forecloses this argument by reiterating the

parties must present a “genuine issue,” and by recognizing the opposing party’s

opportunity to “lay the groundwork for exclusion by making an admission.” Fed.

R. Evid. 407 advisory committee’s note. We affirm the trial court’s exclusion of

                                          -15-
the form to prove feasibility.

                    3. “Other purposes” exception

       Finally, Ms. Gray argues the form was admissible to demonstrate she was

not guilty of contributory negligence. We have upheld the admission of

subsequent remedial measures to demonstrate a plaintiff was not contributorily

negligent. See, e.g., Rimkus v. Northwest Colo. Ski Corp., 706 F.2d 1060, 1065-

66 (10th Cir. 1983). However, because Roche did not raise contributory

negligence as a defense at trial, the trial court properly excluded the evidence.

       In sum, the trial court did not abuse its discretion in excluding evidence

pertaining to Roche’s subsequent remedial measure under Oklahoma law and Rule

407.

       II. CROSS-EXAMINATION OF DR. GUDAS

       Roche called as an expert witness Dr. Lorraine Gudas, chairman of the

Pharmacology Department at Cornell Medical College. Based on her research and

background, Dr. Gudas opined there is no evidence Accutane causes depression.

Ms. Gray believes the trial court committed a number of errors that “substantially

interfered” with her cross-examination of Dr. Gudas.

                                        -16-
      First, Ms. Gray believes the trial court abused its discretion by preventing

Dr. Gudas from answering a hypothetical question she posed. Ms. Gray attempted

to discount Dr. Gudas’s opinion by suggesting the studies she relied upon (which

were designed to determine whether Accutane prevents cancer) could not

accurately determine whether the drug causes depression. Ms. Gray presented a

hypothetical scenario involving a study designed to “determine whether left-

handed people are smarter than right-handed people.” Attempting to analogize

the hypothetical study to Dr. Gudas’ cancer study, she asked Dr. Gudas, “that

study would not automatically tell you whether left-handed people grow bald

quicker than right-handed people; would it?” The trial court sustained Roche’s

objection on grounds the question was too speculative.

      Expert opinions are admissible only if they help the jury understand the

evidence or resolve a factual issue. Fed. R. Evid. 702. The opinion must be

“based upon sufficient facts or data.” Id. Ms. Gray’s hypothetical scenario

lacked sufficient facts and data necessary for Dr. Gudas to form a valid opinion.

In fact, in response to a similar question based on this hypothetical study, Dr.

Gudas stated the scenario was “too vague” and not “posed in a way that a scientist

[could] answer.” For these reasons, it also was not helpful to the jury. The trial

court acted within its discretion in sustaining Roche’s objection.

                                         -17-
      Second, Ms. Gray believes the trial court committed reversible error in

preventing her from asking “whether, as part of the cancer study, the participants

were ever specifically interviewed regarding psychiatric side effects.” She claims

the judge likewise erred in preventing her from exploring this topic through a

hypothetical question. Our review of the record revealed these alleged errors

were later cured when Ms. Gray elicited the answer to her questions. Dr. Gudas

testified the cancer study participants had, in fact, been interviewed about

depression specifically. Accordingly, the alleged errors do not warrant reversal. 5

      Third, Ms. Gray claims the trial court committed reversible error by

preventing her from having Dr. Gudas confirm the $30,000 she had already

received from Roche, combined with $30,000 she could earn during the trial,

would total $60,000. In response to Roche’s objection, the trial court commented:

“Well no need to ask the question because we can add.” We agree with the trial

court that the jury was capable of confirming counsel’s arithmetic. To the degree

the trial court’s comment may have been misplaced, we find such error harmless.

      5
         Ms. Gray also complains during this portion of her examination the trial court
made a “caustic remark” – a comment that both the witness and Ms. Gray’s counsel “like
to talk”– that devastated her cross-examination of Dr. Gudas. Because Ms. Gray did not
make a contemporaneous objection, we review the comment for plain error. See Glenn v.
Cessna Aircraft Co., 32 F.3d 1462, 1464 (10th Cir. 1994). Under this standard, we
conclude the district court did not err.

                                         -18-
      Fourth, Ms. Gray claims the trial court abused its discretion by sustaining

Roche’s objection when she asked whether Dr. Gudas realized “two completely

conflicting opinions” had been offered as to the importance of MedWatch reports.

This question misstated Dr. Gudas’s testimony and was potentially misleading to

the jury. Although Dr. Gudas had testified the reports are not “valid

scientifically,” she had not commented on whether they are “important.” The trial

court acted within its discretion in sustaining the objection.

      Ms. Gray’s remaining complaints arise from the trial court’s refusal to

allow her to ask questions that appear harassing and argumentative in tone.

Specifically, Ms. Gray asked Dr. Gudas if she expected the jury to “take this leap”

with her, and if Dr. Gudas was curious about whether Accutane “caused pain and

death” in the thousands of Accutane users in the MedWatch reports. “The trial

court sits in a far better position to resolve disputes over the tone of examination

than we do looking at the lifeless pages of a transcript.” United States v. Carter,

973 F.2d 1509, 1516-17 (10th Cir. 1992). We believe the trial court acted within

the bounds of its discretion in prohibiting these questions.

      In sum, we see no reversible errors in the trial court’s rulings pertaining to

Ms. Gray’s examination of Dr. Gudas.

                                         -19-
      III. DAUGHTER’S ACCUTANE USE

      Ms. Gray believes the trial court committed reversible error by excluding

her daughter’s testimony. Ms. Gray’s pretrial brief indicates her daughter would

have testified she took her mother’s Accutane for a few weeks to “clear up” her

skin before a formal dance, and experienced feelings of depression during this

time which subsided when she quit taking the medication.

      As previously discussed, trial courts may exclude otherwise admissible

evidence if it finds the “danger of ... confusion of the issues” or considerations of

“undue delay, waste of time, [and] needless presentation of cumulative evidence”

substantially outweigh its probative value. Fed. R. Evid. 403.

      Here, to prove Accutane causes depression, Ms. Gray introduced reports

from at least 2,000 patients who experienced psychiatric side effects while taking

Accutane. Testimony indicated one third of those patients “got better once the

drug was stopped.” While Ms. Gray’s daughter’s experience with Accutane may

have buttressed the reports, the proposed testimony offered substantively little to

the evidence already before the jury. Moreover, we believe it likely the testimony

would have resulted in a “trial within a trial,” thereby confusing the issues and

needlessly wasting time. Roche undoubtedly would have contested whether Ms.

                                        -20-
Gray’s daughter actually experienced depression and whether the alleged

depression could have been attributed to another source. These questions may

have required a substantial digression into her medical and psychiatric history, as

well as additional expert witness testimony. Therefore, the trial court did not

abuse its discretion in excluding the evidence under Rule 403.

      IV. LOST SALES EVIDENCE

      Ms. Gray also contends the trial court erred in excluding evidence relating

to whether profit concerns motivated Roche’s failure to issue a stronger warning

about Accutane’s possible psychiatric side effects. Specifically, she sought to

have her expert witness (a former Roche employee) testify “[Roche’s] failure to

warn was attributable to [Roche’s] concern for loss of sales.” Ms. Gray also

attempted to introduce documents she claims demonstrated Accutane sales in fact

decreased when Roche issued stronger warnings. The trial court excluded the

evidence, concluding profit motive was “not an issue,” and evidence relating to

profit motive would be “more prejudicial than probative.”

      Trial courts may only admit “evidence having any tendency to make the

existence of any fact that is of consequence to the determination of the action

more probable or less probable than it would be without the evidence.” Fed. R.

                                        -21-
Evid. 401, 402. Roche’s alleged motive for failing to issue a stronger warning is

immaterial to any element of Ms. Gray’s three causes of action, 6 and is therefore

inconsequential to the determination of the case. Our review of the trial indicates

Roche’s liability turned on whether the jury found: (1) Accutane caused Ms. Gray

to suffer from depression; (2) Roche’s warning was inadequate; and (3) Dr.

McCauley would have altered Ms. Gray’s treatment had Roche issued a stronger

warning. The trial court acted within its discretion under Rule 402 in determining

profit motive evidence bore no relevance to the issues posed to the jury.

       Arguing a Roche representative gave “incorrect” testimony, Ms. Gray

       6
          Under Oklahoma law, to recover under a manufacturer’s products liability claim,
“[a] plaintiff must prove the product was the cause of the injury, that the product was
defective when it left the control of the manufacturer, and that the defect made the
product unreasonably dangerous to an extent beyond which would be contemplated by the
ordinary consumer who purchases it.” Johnson v. Ford Motor Co., 45 P.3d 86, 91 n.12
(Okla. 2002). To recover under a negligence claim, “a plaintiff must establish the
concurrent existence of: a duty on the part of the defendant to protect the plaintiff from
injury; a failure of the defendant to perform that duty; and an injury to the plaintiff
resulting from the failure of the defendant.” Johnson v. Hillcrest Health Ctr., Inc., 70
P.3d 811, 816 (Okla. 2003). To recover for breach of warranty, a plaintiff must prove
“the existence of the warranty[,] ... the warranty was broken[,] and that the breach of the
warranty was the proximate cause of the loss sustained.” Am. Fertilizer Specialists, Inc.
v. Wood, 635 P.2d 592, 595 n.10 (Okla. 1981). Further, when a cause of action is based
on a failure to warn claim, a plaintiff “must prove that the drug caused the injury and that
the manufacturer breached a duty to warn of possible detrimental reactions.” McKee v.
Moore, 648 P.2d 21, 23-24 (Okla. 1982). None of these elements require an inquiry into
the defendant’s subjective knowledge, intent, or motive.

                                            -22-
apparently believes evidence of Accutane sales was also admissible for

impeachment purposes. Without record support, Ms. Gray claims the

representative testified she was “unaware of any harm [to Roche] which would

result from compliance with the [warning the Food and Drug Administration

recommended].” Even under Ms. Gray’s description of the testimony, the

evidence she sought to offer impeaches the testimony only remotely, if at all.

Neither the proposed expert testimony nor Accutane’s sales history reflect on the

witness’ knowledge of whether any harm to Roche might have occurred. Due to

its minimal probative value, the trial court acted within its discretion in excluding

the evidence under Rule 403.

      V. JURY INSTRUCTION

      Ms. Gray argues the trial court erred by not submitting to the jury one of

her requested instructions. The instruction states, in significant part:

            If you believe that the [Food and Drug Administration]
      required Defendants to provide direct warnings to the users of
      Accutane, then you are instructed that these circumstances constitute
      an exception to the Learned Intermediary Doctrine. If the
      Defendants failed to warn the consumer, you may consider this
      evidence that the drug is unreasonably dangerous.

      As a preliminary matter, Ms. Gray did not provide record proof that she

preserved this issue for appellate review by objecting at trial, as required by

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Federal Rule of Civil Procedure 51. See also 10th Cir. R. 28.2(C)(3)(b)

(requiring appellants to “cite the precise reference in the record where a required

objection was made and ruled on, if the appeal is based on ... [the] refusal to give

a particular jury instruction.”). We therefore review her claim for plain error.

Telecor Communications, Inc. v. Southwestern Bell, 305 F.3d 1124, 1142 (10th

Cir. 2002), cert. denied, 123 S. Ct. 2073 (2003). Under the plain error standard,

we will reverse “only in exceptional circumstances where the error was patently

plainly erroneous and prejudicial.” Reed v. Landstar Ligon, Inc., 314 F.3d 447,

453 (10th Cir. 2002) (quotation marks and citations omitted).

      Litigants are entitled to jury instructions “only if they are supported by ...

the evidence presented at trial.” FDIC v. Clark, 978 F.2d 1541, 1550 (10th Cir.

1992). Here, Ms. Gray’s requested instruction applies only “when the [Food and

Drug Administration] requires warnings be given directly to the patient.”

Edwards v. Basel Pharm., 933 P.2d 298, 303 (Okla. 1997) (emphasis added). Ms.

Gray made no attempt to demonstrate the Food and Drug Administration required

such a warning. We will not “sift through” the record to find support for her

argument. See SEC v. Thomas, 965 F.2d 825, 827 (10th Cir. 1992). Accordingly,

the alleged error is not “patently plainly erroneous and prejudicial.” Reed, 314

F.3d at 453 (quotation marks and citations omitted). Ms. Gray has not established

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the trial court committed plain error by refusing to submit her instruction to the

jury.

Conclusion

        For the foregoing reasons, we AFFIRM the trial court’s rulings.

                                       Entered by the Court:

                                       WADE BRORBY
                                       United States Circuit Judge

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