*This order and judgment is not binding precedent except under the doctrines of

law of the case, res judicataand 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. 

## F I L E D United States Court of Appeals Tenth Circuit 

### DEC 3 2003 

### PATRICK FISHER Clerk UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

CARLA GRAY, Plaintiff-Appellant,

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

ORDER AND JUDGMENT *

Bill V. Wilkinson of Wilkinson Law Firm, Tulsa, Okl ahoma, for PlaintiffAppellant. Michael X. Imbroscio (Mark H. Lynch and Lanny A. Br euer 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 o n the brief) of Covington & Burling, Washington, D.C., for Defendants-Appellees

.

Before BRISCOE and McWILLIAMS , Circuit Judges, and BRORBY , Senior Circuit Judge.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- Appellant Carla Gray claims the prescription drug A ccutane caused her to experience severe depression. She sued Hoffman-La Roche, Inc., the drug’s manufacturer, and Roche Laboratories, Inc., the dru g’s distributor (collectively “Roche”), 1 in federal court. The suit resulted in a jury ver dict in favor of Roche. This appeal followed. Exercising jurisdiction unde r 28 U.S.C. § 1291, we affirm.

Roche manufactures and distributes Accutane, a pres cription drug commonly used to treat acne. Ms. Gray took Accutan e to treat acne for a number of years and claims to have suffered from severe de pression during that time. Believing Accutane caused her depression, Ms. Gray filed a complaint against Roche based on diversity jurisdiction in the UnitedStates District Court for the Eastern District of Oklahoma. She alleged Roche wa s liable because it failed to adequately warn either her or her doctor about Accu tane’s possible psychiatric side effects. Ms. Gray proceeded under three Oklah oma 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.-3-

On appeal, Ms. Gray raises five arguments. She bel ieves the trial court: (1) erred in a number of evidentiary rulings during her examination of Dr. McCauley, her treating physician; (2) erred in a nu mber of evidentiary rulings during her cross-examination of one of Roche’s expe rt witnesses, Dr. Gudas; (3) erred in excluding evidence of Ms. Gray’s daughter’ s experience with Accutane and depression; (4) erred in excluding evidence rel ating 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 j ury 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 discreti on if the trial court’s decision “was based on a clearly erroneous finding of fact o r 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 substa ntial right of the party.” Fed. R. Evid. 103(a). See also Fed. R. Civ. P. 61. Under these standards, we con sider Ms. Gray’s arguments in turn.-4-

I. EXAMINATION OF DR. MCCAULEY Ms. Gray claims the trial court committed a number of evidentiary errors during her examination of her treating physician, D r. McCauley. Ms. Gray hoped to prove Roche should have warned Dr. McCauley of A ccutane’s alleged psychological side effects “[a]nd, in turn, these w arnings should have been given by Dr. McCauley to [Ms. Gray].” To establish Roche proximately caused her alleged injuries, Ms. Gray needed to demonstrate th at “had [Roche] issued a proper warning to [Dr. McCauley], he would have alt ered 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 motionin limine to exclude “evidence regarding changes made to Accutane produc t 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 sus taining Roche’s “asked and answered” objections. Ms. Gray described two s pecific warnings she believes Roche should have issued, and asked Dr. McCauley wh ether he would have followed them. Dr. McCauley responded, “it depends .” He went on to explain:2In 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- “[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 t aken this into account, but we also temper it with the experience that the patient is relating to us; also in regards to what other, whatour 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 experi ences 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 cons ideration, 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 themin regards to the medications.
Apparently dissatisfied with his response, Ms. Grayimmediately repeated her question. Roche objected on grounds the questi on had been asked and answered, and the trial court sustained. Throughout the remainder of her examination of Dr. McCauley, Ms. Gray repeatedly as ked 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 wit nesses repetitive-6-

questions. Fed. R. Evid. 611(a) (instructing court s 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 u ndue 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 “tria l court properly exercised its discretion in order to prevent repetitive questioni ng 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 discreti on 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 as serts Roche should have issued, “what those two sentences mean to him.” Th e sentences state: “Followup 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 medic al evaluation if depression3 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- or mood change occurs.” 3 The district court excluded the question on the g round it called for Dr. McCauley to interpret the sentenc es.

We have held, “where ... expert testimony is offere d on an issue that a jury is capable of assessing for itself, it is plainly w ithin 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. McCau ley testified as a lay witness, the same reasoning applies here. Lay opin ions, like expert opinions, are only admissible if they are helpful to the jury. F ed. R. Evid. 701, 702. The sentences Ms. Gray asked Dr. McCauley to interpret were not technical or confusing; the jury was capable of understanding th em without Dr. McCauley’s assistance. The trial court did not abuse its disc retion in sustaining Roche’s objection.-8-

Ms. Gray next argues the trial court improperly int errupted her when she asked Dr. McCauley if he would have altered her tre atment had he “received a warning from Roche that he considered to constitute a significant change in the warnings involving side effects for Accutane.” Tro ubled 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] t he 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 hel pful 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 erroneo usly limited her redirect examination of Dr. McCauley, finding her questions unrelated to Roche’s crossexamination. She points out Roche had asked whethe r Dr. McCauley’s other patients taking Accutane reported depression. Acco rdingly, Ms. Gray argues the-9-

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 psychiatr ic side effects,” because this question was related to Roche’s questioning on repo rted 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 sco pe 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 beyo nd the scope of crossexamination. Roche’s inquiry was limited to whethe r any of Dr. McCauley’s other Accutane patients reported depression. Ms. G ray’s question, on the other hand, delves into what factors might motivate his p atients to report side effects. The trial court acted within its discretion by curt ailing this line of questioning.

b. Subsequent Remedial Measures Ms. Gray also asserts the trial court erred by excl uding evidence Roche changed Accutane’s warnings after she stopped takin g the drug. Ms. Gray sought to introduce Roche’s revised “informed consent/pati ent agreement” form through Dr. McCauley. This form, modified after Ms. Gray d iscontinued treatment,-10-

addresses possible psychological side effects assoc iated 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 remedi al measure.

In diversity actions involving a products liabilityclaim, the admissibility of subsequent remedial measures is a matter of state l aw. 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 inad missible “to prove negligence or culpable conduct.” Okla. Stat. Ann. tit. 12, § 2407 (1993). However, we found no Oklahoma law indicating whether this exclu sion applies to products liability suits. We must therefore turn to Rule 40 7 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 me asures taken after “an injury or harm” occurred “that, if taken previously, would have made the injury or harm-11-

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 fit s squarely within the category of evidence Rule 407 bars. The refore, the trial court properly excluded the form as evidence Roche should have iss ued a stronger warning.

Because Rule 407 does not exclude subsequent remedi al 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 t he evidence because she offered it to show Dr. McCauley, a non-party, took the reme dial 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 establis hed 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 pr ohibits – as evidence there4Ms. 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- 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 Ac cutane patients about psychiatric side effects. The form’s potential forprejudice thus substantially outweighed its probative value. The trial court ac ted within its discretion by ordering it excluded. 4

1. Impeachment Exception Ms. Gray next argues the trial court should have al lowed her to introduce the form to impeach Dr. McCauley’s testimony. As d iscussed above, Dr. McCauley testified he “may or may not have” followe d 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-13-

added.) According to Ms. Gray, the deposition test imony shows Dr. McCauley “responds directly and immediately to such warnings and instructions from the drug manufacturer.” She believes she could have pr oved Dr. McCauley would have altered her treatment had the trial court perm itted 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 inform ed consent form itself did not contradict Dr. McCauley’s testimony that he does no t “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 fo und no indication in Dr. McCauley’s deposition testimony that he began using the consent form immediately after receiving it. On the contrary, D r. McCauley testified he could not remember when he received the informed consent form or when he began using it. Second, the informed consent form differ s in both form and content from the warning Ms. Gray claims Roche should have issued years earlier. The-14-

fact he currently uses the form does not prove he w ould have followed a different warning several years earlier. Indeed, Dr. McCaule y’s deposition testimony indicates he attained new information about Accutan e’s possible side effect around the time Ms. Gray stopped taking Accutane an d before he adopted the form. In light of these facts, we doubt Ms. Gray c ould have used the form to demonstrate that, contrary to his testimony, Dr. Mc Cauley would have proceeded differently had Roche issued the two warning senten ces. The trial court properly excluded the form for impeachment purposes.

2. Feasibility Exception Next, Ms. Gray argues the trial court should have a dmitted the form under the feasibility exception to the rules barring subs equent remedial measures. She believes feasibility was controverted at trial. Ms . Gray first explains she controverted feasibility when she attempted to showRoche’s former method of informing doctors about Accutane’s possible side ef fects was infeasible, whereas the revised patient informed consent form would hav e been feasible. Ms. Gray also claims Roche controverted feasibility when its representative testified the company “didn’t think to put” warnings on patient b rochures and blister packs, and testified it would not have been easy for Roche to revise the informed consent form.-15-

Neither the Oklahoma statute nor Rule 407 bars subs equent remedial measures to prove the “feasibility of precautionarymeasures, if controverted. ” Fed. R. Evid. 407; Okla. Stat. tit. 12, § 2407 (emp hasis added). The “if controverted” requirement “allows the opposing party to lay the groundwork for exclusion by making an admission.” Fed. R. Evid. 4 07 advisory committee’s note. Here, in a pretrial brief, Roche stated it d id not contest feasibility. Although the trial court indicated its order exclud ing 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 t o review it. See TeleCommunications, Inc. v. Commissioner , 12 F.3d 1005, 1007 (10th Cir. 1993). In addition to waiving appellate review, Ms. Gray’s om ission also deprived Roche of the opportunity to make an admission regarding feas ibility.

Ms. Gray further suggests her efforts to controvertfeasibility satisfy the “if controverted” requirement irrespective of Roche’s r esponse. We believe the advisory committee’s note to Rule 407 forecloses th is argument by reiterating the parties must present a “genuine issue,” and by reco gnizing the opposing party’s opportunity to “lay the groundwork for exclusion bymaking an admission.” Fed. R. Evid. 407 advisory committee’s note. We affirm the trial court’s exclusion of-16-

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 uph eld 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 no t raise contributory negligence as a defense at trial, the trial court p roperly excluded the evidence.

In sum, the trial court did not abuse its discretio n in excluding evidence pertaining to Roche’s subsequent remedial measure u nder Oklahoma law and Rule
407.

II. CROSS-EXAMINATION OF DR. GUDAS Roche called as an expert witness Dr. Lorraine Guda s, chairman of the Pharmacology Department at Cornell Medical College. Based on her research and background, Dr. Gudas opined there is no evidence A ccutane causes depression. Ms. Gray believes the trial court committed a numbe r of errors that “substantially interfered” with her cross-examination of Dr. Gudas

.-17-

First, Ms. Gray believes the trial court abused its discretion by preventing Dr. Gudas from answering a hypothetical question sh e posed. Ms. Gray attempted to discount Dr. Gudas’s opinion by suggesting the s tudies she relied upon (which were designed to determine whether Accutane prevent s cancer) could not accurately determine whether the drug causes depres sion. Ms. Gray presented a hypothetical scenario involving a study designed to “determine whether lefthanded 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 t rial court sustained Roche’s objection on grounds the question was too speculati ve.

Expert opinions are admissible only if they help th e 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 onthis 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 no t helpful to the jury. The trial court acted within its discretion in sustaining Roc he’s objection.5Ms. 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- 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 psychi atric side effects.” She claims the judge likewise erred in preventing her from exp loring this topic through a hypothetical question. Our review of the record re vealed these alleged errors were later cured when Ms. Gray elicited the answer to her questions. Dr. Gudas testified the cancer study participants had, in fac t, been interviewed about depression specifically. Accordingly, the alleged errors do not warrant reversal. 5

Third, Ms. Gray claims the trial court committed re versible error by preventing her from having Dr. Gudas confirm the $3 0,000 she had already received from Roche, combined with $30,000 she coul d earn during the trial, would total $60,000. In response to Roche’s object ion, the trial court commented: “Well no need to ask the question because we can ad d.” We agree with the trial court that the jury was capable of confirming couns el’s arithmetic. To the degree the trial court’s comment may have been misplaced, we find such error harmless.-19-

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 w as potentially misleading to the jury. Although Dr. Gudas had testified the rep orts are not “valid scientifically,” she had not commented on whether t hey are “important.” The trial court acted within its discretion in sustaining the objection.

Ms. Gray’s remaining complaints arise from the tria l court’s refusal to allow her to ask questions that appear harassing an d argumentative in tone. Specifically, Ms. Gray asked Dr. Gudas if she expec ted the jury to “take this leap” with her, and if Dr. Gudas was curious about whethe r Accutane “caused pain and death” in the thousands of Accutane users in the Me dWatch reports. “The trial court sits in a far better position to resolve disp utes over the tone of examination than we do looking at the lifeless pages of a trans cript.” United States v. Carter , 973 F.2d 1509, 1516-17 (10th Cir. 1992). We believ e the trial court acted within the bounds of its discretion in prohibiting these q uestions.

In sum, we see no reversible errors in the trial co urt’s rulings pertaining to Ms. Gray’s examination of Dr. Gudas.-20-

III. DAUGHTER’S ACCUTANE USE Ms. Gray believes the trial court committed reversi ble error by excluding her daughter’s testimony. Ms. Gray’s pretrial brie f indicates her daughter would have testified she took her mother’s Accutane for afew weeks to “clear up” her skin before a formal dance, and experienced feeling s of depression during this time which subsided when she quit taking the medication.

As previously discussed, trial courts may exclude o therwise admissible evidence if it finds the “danger of ... confusion o f the issues” or considerations of “undue delay, waste of time, [and] needless present ation of cumulative evidence” substantially outweigh its probative value. Fed. R . Evid. 403.

Here, to prove Accutane causes depression, Ms. Grayintroduced reports from at least 2,000 patients who experienced psychi atric side effects while taking Accutane. Testimony indicated one third of those p atients “got better once the drug was stopped.” While Ms. Gray’s daughter’s exp erience with Accutane may have buttressed the reports, the proposed testimonyoffered 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,” th ereby confusing the issues and needlessly wasting time. Roche undoubtedly would h ave contested whether Ms.-21-

Gray’s daughter actually experienced depression andwhether the alleged depression could have been attributed to another so urce. These questions may have required a substantial digression into her med ical and psychiatric history, as well as additional expert witness testimony. There fore, the trial court did not abuse its discretion in excluding the evidence unde r Rule 403.

IV. LOST SALES EVIDENCE Ms. Gray also contends the trial court erred in exc luding evidence relating to whether profit concerns motivated Roche’s failur e to issue a stronger warning about Accutane’s possible psychiatric side effects. Specifically, she sought to have her expert witness (a former Roche employee) t estify “[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 issu e,” and evidence relating to profit motive would be “more prejudicial than probative.”

Trial courts may only admit “evidence having any te ndency 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.6Under 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- Evid. 401, 402. Roche’s alleged motive for failing to issue a stronger warning is immaterial to any element of Ms. Gray’s three cause s 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 ha d Roche issued a stronger warning. The trial court acted within its discreti on under Rule 402 in determining profit motive evidence bore no relevance to the iss ues posed to the jury.

Arguing a Roche representative gave “incorrect” tes timony, Ms. Gray-23-

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 ha rm [to Roche] which would result from compliance with the [warning the Food and Drug Administration recommended].” Even under Ms. Gray’s description o f 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 mig ht 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 Administrati on] required Defendants to provide direct warnings to the users of Accutane, then you are instructed that these circum stances constitute an exception to the Learned Intermediary Doctrine. If the Defendants failed to warn the consumer, you may con sider this evidence that the drug is unreasonably dangerous.
As a preliminary matter, Ms. Gray did not provide r ecord proof that she preserved this issue for appellate review by object ing at trial, as required by-24-

Federal Rule of Civil Procedure 51. See also 10th Cir. R. 28.2(C)(3)(b) (requiring appellants to “cite the precise referenc e in the record where a required objection was made and ruled on, if the appeal is b ased on ... [the] refusal to give a particular jury instruction.”). We therefore rev iew 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 st andard, 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 i f 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 appl ies only “when the [Food and Drug Administration] requires warnings be given dir ectly 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 rec ord 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 erroneou s and prejudicial.” Reed, 314 F.3d at 453 (quotation marks and citations omitted) . Ms. Gray has not established-25-

the trial court committed plain error by refusing t o 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