E-Filed Document Jan :20: CA SCT Pages: 29 COMBINED RESPONSIVE BRIEF OF APPELLANTS / CROSS-APPELLEES

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1 E-Filed Document Jan :20: CA SCT Pages: 29 COMBINED RESPONSIVE BRIEF OF APPELLANTS / CROSS-APPELLEES

2 IN THE SUPREME COURT OF MISSISSIPPI No CA JOHNSON & JOHNSON, INC. AND ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC. Appellants / Cross-Appellees vs. BRENDA FORTENBERRY, AS THE CONSERVATOR OF THE ESTATE AND PERSON OF LOUISE TAYLOR Appellee / Cross-Appellant Appeal from the Circuit Court of Copiah County, Mississippi, Civil Action No Honorable Lamar Pickard, Circuit Judge COMBINED RESPONSIVE BRIEF OF APPELLANTS / CROSS-APPELLEES DONNA BROWN JACOBS (MB # 8371) PAUL V. CASSISA, JR. (MB # 5921) ADAM J. SPICER (MB # ) KATHLEEN INGRAM CARRINGTON (MB # ) BUTLER SNOW LLP Post Office Box 6010 Ridgeland, Mississippi Tel: Fax: ATTORNEYS FOR APPELLANTS / CROSS- APPELLEES JOHNSON & JOHNSON, INC. AND ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC.

3 TABLE OF CONTENTS TABLE OF CONTENTS... i TABLE OF AUTHORITIES... ii STATEMENT REGARDING ORAL ARGUMENT... 1 APPELLANTS REPLY BRIEF... 1 I. Introduction and summary II. III. IV. Promotional materials unseen by Dr. Rhoden are irrelevant to Plaintiff s negligent misrepresentation claim Dr. Rhoden understood and appreciated the risk of Ms. Taylor developing Tardive Dyskinesia from Risperdal, he chose to prescribe it despite the risk, and he stands by that decision today The substantive jury instructions were improper and included additional, irrelevant instructions that were confusing and misleading to the jury, and that were prejudicial to Defendants V. Plaintiff failed to connect Ms. Taylor s Tardive Dyskinesia to any economic injury VI. VII. Because economic damages should never have gone to the jury, Defendants are alternatively entitled to a remittitur Plaintiff s counsel s improper argument during closing was abusive and outside the confines of the record and warrants a new trial STATEMENT OF THE ISSUE ON CROSS-APPEAL I. Did the Circuit Court properly refuse to submit the issue of punitive damages to the jury? ARGUMENT ON CROSS-APPEAL I. The Circuit Court properly refused to submit the issue of punitive damages to the jury CONCLUSION CERTIFICATE OF SERVICE i

4 TABLE OF AUTHORITIES Cases Bradfield v. Schwartz, 936 So. 2d 931 (Miss 2006)... 18, 19 Causey v. Sanders, 998 So. 2d 393 (Miss. 2008) Choctaw Maid Farms, Inc. v. Hailey, 822 So. 2d 911 (Miss. 2002) Clemons v. State, 320 So. 2d 368 (Miss. 1975) Dedeaux Util. Co. v. City of Gulfport, 63 So. 3d 514 (Miss. 2001) Doe ex rel. Doe v. Salvation Army, 835 So. 2d 76 (Miss. 2003)... 19, 20 Eckman v. Moore, 876 So. 2d 975 (Miss. 2004) Elliott v. El Paso Corp., 181 So. 3d 263 (Miss. 2015) Goff v. State, 14 So. 3d 625 (Miss. 2009) In re C.B., 574 So. 2d 1369 (Miss. 1990) Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 2d 31 (Miss. 2004)... 5, 7, 11 Kerr v. Phillip Morris USA, Inc., No. 1:09cv482, 2010 WL (S.D. Miss. Mar. 25, 2010) Lashley v. Pfizer, Inc., 877 F. Supp. 2d 466 (S.D. Miss. 2012)... 5 Levens v. Campbell, 733 So. 2d 753 (Miss. 1999)... 5 Life & Cas. Ins. Co. of Tenn. v. Bristow, 529 So. 2d 620 (Miss. 1998) McGowen v. State, 859 So. 2d 320 (Miss. 2003)... 16, 17 McLendon v. Ravesies, 173 So. 303 (Miss. 1937)... 7 Moran v. Fairly, 919 So. 2d 969 (Miss. 2005) Phillips v. Illinois Cent. R. Co., 797 So. 2d 231 (Miss. Ct. App. 2000) R.J. Reynolds Tobacco Co. v. King, 921 So. 2d 268 (Miss. 2005) Skrmetta v. Bayview Yacht Club, Inc., 806 So. 2d 1120 (Miss. 2002)... 5 Smith v. Johnson & Johnson, Civ. A. No. 3:08CV245, 2011 U.S. Dist. LEXIS (S.D. Miss. Aug. 31, 2011)... 7 Summers ex rel. Dawson v. St. Andrew s Episcopal School, Inc., 759 So. 2d 1203 (Miss. 2000) Terex Corp. v. Ingalls Shipbuilding, Inc., 671 So. 2d 1316 (Miss. 1996) Thompson v. Dung Thi Hoang Nguyen, 86 So. 3d 251 (Miss. Ct. App. 2011) Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688 (Miss. 1988)... 7 ii

5 Rules and Statutes Miss. Code Ann Miss. Code Ann Miss. Code Ann iii

6 STATEMENT REGARDING ORAL ARGUMENT Appellants respectfully submit that permitting oral argument and providing counsel for the parties with the opportunity to address the questions of the Court will be of assistance in deciding this appeal. APPELLANTS REPLY BRIEF I. Introduction and summary. Plaintiff makes every effort in her Response brief to divert the Court s attention from the controlling liability issues in this case: (1) Whether an adequate warning about the risk of Tardive Dyskinesia would have caused Dr. Rhoden not to prescribe Risperdal to Ms. Taylor; and (2) whether Dr. Rhoden relied on any alleged misrepresentations from Defendants that caused him to prescribe Risperdal to Ms. Taylor. Plaintiff s tactics are understandable, as the actual evidence plainly defeats Plaintiff s failure-to-warn and negligent misrepresentation claims as a matter of law. Plaintiff pulls out all of the stops in her Response brief smoke screens, red herrings, mischaracterizations, and even testimony not presented to the jury to hold on to a verdict unsupported by the evidence. Her strategy on appeal mirrors her strategy at trial: broad assertions of bad conduct that have no connection to Dr. Rhoden and his decision to prescribe Risperdal to Ms. Taylor. Defendants will not attempt here to correct every mischaracterization and overreach in Plaintiff s brief, but instead will focus on those that relate most directly to the elements of Plaintiff s claims. Seeing through the innuendo and hyperbole, the Court will find Plaintiff failed to meet her burden of proving her claims at trial, and this verdict cannot stand. II. Promotional materials unseen by Dr. Rhoden are irrelevant to Plaintiff s negligent misrepresentation claim. The majority of Plaintiff s Response brief paints the picture that Defendants spent years developing and implementing a devious plan to trick doctors into believing Risperdal is safer than proven in studies, all for the sake of Defendants bottom line. While Defendants 1

7 vehemently dispute any truth to this allegation, its veracity is wholly irrelevant to this case because nothing presented at trial connects this supposed plan to Dr. Rhoden. Plaintiff s insistence that Dr. Rhoden received misrepresentations from Defendants suffers from a glaring evidentiary gap: Plaintiff cannot identify any specific information Dr. Rhoden received that was not contained in the package insert and reproduced in the Physician s Desk Reference ( PDR ), i.e. FDA-mandated and approved prescribing information. Rather, Plaintiff s Response brief speaks in generalities. See Pl. s Resp. Br. at For example, Plaintiff contends Dr. Rhoden s beliefs about Risperdal are such that he must have relied on something he got from marketing and advertising. Those beliefs, which Plaintiff characterizes as (1) Risperdal is safer than older anti-psychotics, (2) low doses do not carry the risk of side effects, and (3) Risperdal is generally a better and safer option for Ms. Taylor, stem from Dr. Rhoden s at-the-time nine years of experience prescribing Risperdal. R Q. I think you said early 90s You couldn t remember exactly when it came on the market, but you pretty much used [Risperdal ] since it came onto the market; didn t you? A. Correct. Q. Did you find that it was effective? A. I did. Q. In your experience at that time, did you find that the in your own experience, the occurrences of tardive dyskinesia... were lower with the drug Risperdal?.... A. Yes. Plaintiff further contends Dr. Rhoden admitted to attending dinner meetings where Risperdal was promoted, yet Plaintiff says nothing about when these dinner meetings occurred, 2

8 who attended, what was discussed, or what materials Dr. Rhoden was provided. Another example is that Dr. Rhoden testified Risperdal was marketed to him as atypical, yet Plaintiff s own experts agree that Risperdal was considered atypical in the medical community because it is a second-generation anti-psychotic. See, e.g., Tr. 200 (Dr. Fann testified that when all of these drugs, not just risperidone, came out, they were all marketed as clozapine-like. These are atypical. Clozapine is an atypical. ); Tr. 216 ( Anything before clozapine was the typical. Anything after clozapine was atypical. ). And Dr. Rhoden s decision to stay below 6 milligrams when prescribing Risperdal to Ms. Taylor simply reflects his familiarity with the FDA-mandated and approved label specifying that [d]oses above 6 mg/day... were associated with more extrapyramidal symptoms and other adverse effects, and are not generally recommended. R Notably missing from Plaintiff s Response brief is a direct assertion that Dr. Rhoden saw any particular promotional piece alleged to contain misrepresentations; or that any Janssen sales representative made particular misrepresentations. Plaintiff made no effort to establish with Dr. Rhoden that he received any particular alleged misrepresentation, much less that he relied on it in prescribing for Ms. Taylor. Plaintiff did not show Dr. Rhoden a single piece of promotional material or alleged misrepresentation during his deposition. Yet Plaintiff acknowledges in her own jury instructions that she was required to prove Dr. Rhoden s reliance on alleged misrepresentations by Defendants. See R Plaintiff s Relevant Facts are not relevant; they background noise encouraging assumed connections to Dr. Rhoden that simply do not exist. For example, Plaintiff touts a marketing document that compares Risperdal to placebo, see Pl. s Resp. Br. at 4, yet Plaintiff never showed Dr. Rhoden this document, and Dr. Rhoden s testimony proves that he had never seen a 3

9 document to that effect. R ( Q. Do you recall any promotionals or advertisements marketing Risperdal s EPS side effect profile as being comparable to placebo? A. No. ). Plaintiff also relies on Dr. Trosch s belief that Dr. Rhoden completely swallowed Janssen s marketing concepts because, according to Dr. Trosch, other psychiatrists did not understand that Risperdal could cause Tardive Dyskinesia, see Pl. s Resp. Br. at 11. Dr. Trosch never spoke to Dr. Rhoden, Tr. 157, and Dr. Rhoden explicitly testified to his understanding that Risperdal could cause Tardive Dyskinesia. R. 4475, See also R (medical record from March 18, 1999 noting that Dr. Rhoden explained to Plaintiff and Ms. Taylor the possible side effects, and specifically Tardive Dyskinesia). While Dr. Trosch might believe most psychiatrists did not know Risperdal could cause Tardive Dyskinesia, it is undisputed that Dr. Rhoden is not in that category. As a final example, Plaintiff claims Defendants had sales representatives who pushed Risperdal and took doctors to dinner to woo them to prescribe Risperdal, see Pl. s Resp. Br. at 5, but there is no evidence that Dr. Rhoden was one of these doctors, and his testimony regarding sales representatives was not specific to representatives selling Risperdal. R (testifying to [t]he way I handle representatives generally and noting he generally had one to two minutes for them). Negligence claims carry with them the burden of proving causation, and, in this case, proving Defendants alleged misrepresentations caused Ms. Taylor s Tardive Dyskinesia requires proof that Dr. Rhoden relied on specific alleged misrepresentations when he prescribed Risperdal to Ms. Taylor. The complete lack of evidence on this issue requires reversal. 1 See 1 As set forth in Defendants Principal Brief, Plaintiff s purported evidence of misrepresentation at trial was letters written by the FDA s division of Drug Marketing, Advertising and Communications ( DDMAC ) to Defendants about certain statements in promotional materials. R , , Plaintiff relied heavily on a letter discussing only proposed promotional materials prepared for the initial marketing of Risperdal, which were submitted to the 4

10 Skrmetta v. Bayview Yacht Club, Inc., 806 So. 2d 1120, 1124 (Miss. 2002) (affirming trial court s finding that there was no present misrepresentation of fact and, thus, negligent misrepresentation claim failed as a matter of law); Levens v. Campbell, 733 So. 2d 753, (Miss. 1999) (no fraud or negligent misrepresentation where plaintiffs failed to produce any evidence on the essential elements of the claims). III. Dr. Rhoden understood and appreciated the risk of Ms. Taylor developing Tardive Dyskinesia from Risperdal, he chose to prescribe it despite the risk, and he stands by that decision today. While Plaintiff admits the learned intermediary doctrine applies to her failure-to-warn claim, see Pl. s Resp. Br. at 16, she wholly ignores its mandate, i.e. that the warning must be adequate as to the prescribing physician. See Miss. Code Ann (c)(ii); see, e.g., Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 2d 31, 58 (Miss. 2004); see also Lashley v. Pfizer, Inc., 877 F. Supp. 2d 466, 473 (S.D. Miss. 2012). Plaintiff attempts to muddy the waters with irrelevant argument regarding what other doctors were allegedly told about Risperdal and whether Plaintiff s experts believed the Risperdal warning as to Tardive Dyskinesia was adequate. 2 See Pl. s Resp. Br. at The only doctor whose understanding of the risks FDA for approval but were not used because they were not approved. R , See R A second letter concerned Janssen s Hostile Elderly materials, which were developed for and used exclusively by Janssen s ElderCare sales force. R , See R The sales representatives who called on Dr. Rhoden, however, were from the CNS ( central nervous system ) sales force; they had their own promotional materials developed specifically for the CNS group, and they did not use the ElderCare sales force promotional materials. R As Dr. Arrowsmith testified, in terms of the 1999 sales aid[e]s, those were specific to the ElderCare promotional group as opposed to the CNS group who called on Dr. Rhoden. So if we re talking about Ms. Taylor, Ms. Taylor and Dr. Rhoden, none of those materials that were the subject of the 99 letter were used with Dr. Rhoden.... Tr Dr. Fann s opinion that Defendants warning was meaningless and consisted of cookie-cutter information, see Pl. s Resp. Br. at 16, ignores that Risperdal is part of a class of antipsychotic medications that is subject to an FDA class label, i.e. a label the FDA requires drug manufacturers to use with medicines the FDA identifies as members of the same class of medicines. Tr Between January 1994 (when Risperdal first came on the market) and January 2001 (when Dr. Rhoden stopped prescribing Risperdal to Ms. Taylor), all anti-psychotic medications on the market were required to 5

11 legally matters, however, is Dr. Rhoden, and he testified unequivocally that he found the label adequate to warn him of the risk of Tardive Dyskinesia in Risperdal users. R , APP 2. As is his practice with all patients, Dr. Rhoden made a specific, independent judgment about prescribing medications, and specifically Risperdal, to Ms. Taylor. R. 4474, 4478, APP 2. Dr. Rhoden commonly prescribed Risperdal in his practice, beginning in the early 1990s. R. 4477, APP 2. To keep informed about Risperdal, Dr. Rhoden consulted package inserts, updates in product labeling, and the Physicians Desk Reference ( PDR ). R. 4478, APP 2. Dr. Rhoden also read professional journals and medical literature to educate himself. R. 4474, APP 2. Dr. Rhoden had familiarized himself with Risperdal s labeling, including the WARNING (in bold, capital letters) that warned consistent with Dr. Rhoden s understanding of the risk of Tardive Dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements [which] may develop in patients treated with antipsychotic drugs. R , APP 2, R.E. 3. And he was aware of and understood the label warning that the prevalence of the syndrome appears to be highest among the elderly, especially elderly women.... R , APP 2, R.E. 3. Further, in his own experience with Risperdal at the time, Dr. Rhoden found the occurrence of Tardive Dyskinesia and other side effects associated with first generation antipsychotics was lower with Risperdal. R. 4477, APP 2. When asked whether even today you stand by your decision to prescribe Risperdal to Ms. Taylor, Dr. Rhoden unequivocally stated I do. Id. He testified further: Q. Doctor, despite this language [the Risperdal warning label] and despite your knowledge about tardive dyskinesia and Risperdal, you made the medical judgment that Risperdal was an appropriate medication for Ms. Taylor? carry the FDA-approved class label for Tardive Dyskinesia. Tr For the relevant provisions of the class label, see Defs. Principal Br. at

12 A. Correct.... A. Because the benefit was much greater and the loss of that benefit would be much worse than the risk of the side effects. Q..... What was your understanding of the benefits of Risperdal for a patient like Ms. Taylor? A. The benefits would be to decrease or put into remission the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects. R. 4480, APP 2. Dr. Rhoden s testimony nullifies any contention by Plaintiff that an alleged inadequacy in the warning caused Ms. Taylor s Tardive Dyskinesia. See Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688, 691 (Miss. 1988); Bailey, 878 So. 2d at 58; Smith v. Johnson & Johnson, Civ. A. No. 3:08CV245, 2011 U.S. Dist. LEXIS 98719, at *30 (S.D. Miss. Aug. 31, 2011). Plaintiff improperly invokes parts of Dr. Rhoden s deposition testimony that were not read at trial. See Pl. s Resp. Br. at 9, 18. Nearly every assertion in the final paragraph of page 18 purports to come from testimony at R. 4461, which, as the color copy of Dr. Rhoden s deposition transcript reflects, was not read to the jury. 3 Because it was never before the jury, it is improper for consideration on appeal and should be stricken. See, e.g., McLendon v. Ravesies, 173 So. 303, 304 (Miss. 1937) (in noting the rule that only facts before the trial court may be considered on appeal, the Supreme Court stated [t]he reason for this rule is, fundamentally, that this court is a court of appeals only, having no other jurisdiction, so that upon the merits of causes we have no authority to act upon any evidence whatever which was not introduced and submitted to the judgment of the trial court ). 3 See R (setting forth the color coding system used for designating Dr. Rhoden s testimony to be read to the jury); R (no color coding on this page, i.e. it was not read to the jury). 7

13 Even if that deposition testimony could be considered, Plaintiff again mischaracterizes Dr. Rhoden s testimony to create the false impression that Dr. Rhoden now second-guesses his decision to treat Ms. Taylor s manifestations of psychosis with Risperdal. Dr. Rhoden s testimony makes clear he does not. Dr. Rhoden knew all antipsychotic medications even the atypicals or second generation drugs, including Risperdal can cause Tardive Dyskinesia. R. 4458, He knew this from the prescribing information for Risperdal and other antipsychotics, and found the Risperdal label in particular adequate to inform him of that risk. R He knew that the prevalence of Tardive Dyskinesia is highest among elderly women. R He recognized that in 1999, whether different antipsychotic drugs had different potential to cause Tardive Dyskinesia really was unknown. R He could and did rely on his own years of experience prescribing both older and second generation antipsychotic drugs, and prescribing Risperdal a fair amount, to weigh the benefits against all the risk for Ms. Taylor. R. 4475, And he made a medical judgment to prescribe Risperdal for Ms. Taylor even with the knowledge of the risk of Tardive Dyskinesia associated with Risperdal. R Plaintiff argues that a single sentence in Dr. Rhoden s testimony indicates that he might not have prescribed Risperdal to Ms. Taylor if a different warning had been given. See Pl. s Resp. Br. at 18. Dr. Rhoden, a fact witness in this case, was asked a series of improper hypothetical questions. He was asked to assume, hypothetically, that someone had told him Risperdol is probably more like the older neuroleptics and carries an EPS/tardive profile similar to the older neuroleptics and it was suggested to him that under those circumstances, he would have prescribed another medication. R Dr. Rhoden s response was clear he did not make his prescribing decision based upon what someone told him. He made that decision based on what he believed about the drug. See id. Dr. Rhoden testified his own experience at 8

14 the time was that Risperdal resulted in a lower incidence of side effects than the older generation of antipsychotic drugs. R So Plaintiff s counsel tried again. This time the assumption was that Dr. Rhoden would not have prescribed Risperdal if the manufacturer had promoted it as a typical neuroleptic, basically, with the same risk profile as the older neuroleptics as a whole. R Dr. Rhoden disagreed again: Well, no, because it was identified professionally in all the literature as being part of atypical. It wouldn t be just from what the manufacturer said. Id. So Plaintiff s counsel tried a third time. This time, the assumption was hypothetically, if that were to have been disclosed otherwise, that the literature had indicated that it may not be truly atypical it being Risperdal is it true that you would have likely used one of the other atypical neuroleptics? Id. Dr. Rhoden still did not agree with the proposition: If hypothetically, the scientific information was that it was not atypical it was the same as Haldol in side effects yes, I would have chosen something else. Id. This response gains Plaintiff nothing, because she did not establish that the scientific information available when Dr. Rhoden prescribed Risperdal to Ms. Taylor showed Risperdal was the same as Haldol in side effects. Dr. Trosch testified that while today a neurologist or pharmacologist might conclude from the chemical make-up of a drug whether a drug could cause extrapyramidal symptoms (which is a different question than whether two drugs are the same in side effects ), he said I don t know back then. Tr.129. It was only later that some studies suggested a higher risk for EPS than demonstrated in those initial studies. Tr Dr. Trosch also conceded there were later studies that compared Risperdal specifically to Haldol and found less risk with Risperdal -- again, he just disagrees with those studies. Tr When asked directly if Risperdal is safer than Haldol in terms of EPS and Tardive Dyskinesia, Dr. Trosch responded I don t know. Not that I know of. Id. (emphasis added). In short, Plaintiff did not establish the factual premise that the scientific information in March 9

15 1999 established that Risperdal is the same as Haldol in side effects. And Dr. Rhoden s more-than-a-decade experience with the drugs, even today, is that they [second generation antipsychotic drugs] at least function as well, if not better, and they do have lower side effects than first generation mediations like Haldol. R Plaintiff also suggests that after Ms. Taylor developed Tardive Dyskinesia, Dr. Rhoden was enlightened about the risks associated with Risperdal, Pl. s Resp. Br. at 9, and would not now prescribe Risperdal to an elderly patient with Alzheimer s like Ms. Taylor. Id. at 18. Again, this is not what he testified to: Q. Currently, given what you know, would you prescribe Risperdal to a geriatric Alzheimer s patient? A. Not just as you described, no. Q. Okay. And why is that? Because of the risk we discussed? A. No. Because Alzheimer s patients are not necessarily psychotic. R (objections omitted) (emphasis added). 4 Simply stated, Plaintiff did not establish that Dr. Rhoden did not understand and appreciate the risk that Ms. Taylor might develop Tardive Dyskinesia from taking any of the anti-psychotic medications available at the time including Risperdal or that some unspecified adequate warning would have caused Dr. Rhoden not to administer Risperdal to Ms. Taylor. Because Plaintiff has not proven these essential elements of her failure-to-warn claim, the jury s verdict on this issue cannot stand. 4 Plaintiff s reliance on testimony not before the jury requires Defendants to counter that testimony with testimony also not before the jury. 10

16 IV. The substantive jury instructions were improper and included additional, irrelevant instructions that were confusing and misleading to the jury, and that were prejudicial to Defendants. A proper basis for granting a new trial is when the jury has been confused by faulty jury instructions. Thompson v. Dung Thi Hoang Nguyen, 86 So. 3d 251, 261 (Miss. Ct. App. 2011) (granting new trial for refusing certain jury instructions). Plaintiff s efforts to suggest these jury instructions were anything but confusing, misleading, and prejudicial fall flat. a. Instruction P-8 on Plaintiff s failure-to-warn claim improperly ignores the learned intermediary doctrine. Plaintiff s briefing on her failure-to-warn claim reveals the substantial error in Instruction P-8: it does not take into account the well-established elements of a failure-to-warn claim where the product is available only on a doctor s prescription. The manufacturer s duty to warn extends only to the prescribing physician, and liability attaches only if an adequate warning would have caused the prescribing physician not to prescribe the drug for that patient. See Bailey, 878 So. 2d at 58. Simply tracking the language of the MPLA does not instruct the jury on these critical elements unique to the prescription drug and device context. First, Plaintiff does not deny the confusing and misleading nature of using the phrase user or consumer in both paragraphs 4 and 5 of Instruction P-8; rather, Plaintiff only addresses its use in paragraph 5. See Pl. s Resp. Br. at 23. P-8 instructs the jury that their verdict shall be for Plaintiff if they find, inter alia, [t]hat at the time Risperdal left the control of Defendants, an ordinary user or consumer would not recognize the danger, if any posed by Risperdal, R (emphasis added), R.E. 4., when it should have required finding that Dr. Rhoden would not recognize the danger, if any, posed by Risperdal. A juror could easily confuse ordinary user or consumer with the person taking the medication, i.e. Ms. Taylor, and nothing in the instruction provided clarification. 11

17 Second, paragraph 2 of P-8 does not instruct the jury on its obligation to find that an adequate warning would have caused Dr. Rhoden not to prescribe Risperdal to Ms. Taylor. See Pl. s Resp. Br. at 24. Plaintiff does not dispute that this Court has found this to be an essential element of a failure-to-warn claim in the prescription drug context. See Bailey, 878 So. 2d at 58. The bald statement that the warning s adequacy is considered in the context of Dr. Rhoden s knowledge is not a causation instruction. R Third, Plaintiff s Response does not address P-8 s failure to specify the risk experienced by Ms. Taylor, i.e. Tardive Dyskinesia. See Pl. s Resp. at 22-24; Defs. Principal Br. at 29. If the jury found the warning inadequate in some respect other than its warning as to Tardive Dyskinesia, Instruction P-8 does not prevent them from reaching a verdict on such finding. b. Instruction P-12 on Plaintiff s negligent marketing/misrepresentation claim omits critical elements of the only legally cognizable claim proffered to the jury. The cases cited by Plaintiff in support of her negligent marketing claim do not assist the Court because they do not address negligent marketing. See Kerr v. Phillip Morris USA, Inc., No. 1:09cv482, 2010 WL , at *1 (S.D. Miss. Mar. 25, 2010) (noting the complaint in that case charges negligence, gross negligence, and deceptive marketing (emphasis added)); R.J. Reynolds Tobacco Co. v. King, 921 So. 2d 268, 270 (Miss. 2005) (noting the causes of action in plaintiff s complaint include deceptive advertising (emphasis added)). Even if deceptive and negligent were interchangeable (they are not), neither case sets forth the elements of either a deceptive or a negligent marketing claim. Accordingly, Plaintiff s assertion that P-12 fully and accurately instructed the jury on the elements of negligence found in a marketing/advertising claim remains unsupported under Mississippi law. Pl. s Resp. Br. at 24. The only legally cognizable claim within the improper Negligent Marketing/Misrepresentation combination is a claim of negligent misrepresentation, and, as Defendants state in their Principal Brief and Plaintiff fails to address in her Response 12

18 Instruction P-12 omits critical elements of that claim. See Defs. Principal Br. at 30. See also Pl. s Resp. Br. at c. Because there was no general negligence claim before the jury, there should not have been a general negligence instruction to the jury. Plaintiff s briefing on this issue misses the mark, see Pl. s Resp. Br. at 25-26, as Defendants do not dispute that Plaintiff could bring a negligent misrepresentation claim. Rather, P-3 is a stand-alone negligence claim which instructed the jury it could find for Plaintiff if Defendants failed to act as reasonably prudent manufacturers. R The stand-alone negligence instruction combined with the improper negligent marketing instruction is inherently confusing and misleading, as neither instruction actually instructs the jury on the elements of a negligent misrepresentation claim, i.e. the only negligence claim before the jury. Neither should have been given to the jury. d. Plaintiff s verdict form, Instruction P-18, did not fairly present the applicable law. As to the verdict form, Plaintiff contends [t]he only requirement is that the granted instructions taken as a whole do fairly present the applicable law. Pl. s Resp. Br. at 26. A review of the verdict form shows the opposite, as this case had nothing to do with adequate instructions, and there is no cognizable negligent marketing claim under Mississippi law. In conjunction with the above errors in the underlying instructions, this verdict form was confusing, misleading, and prejudicial to Defendants. The Court should have used Defendants proposed verdict form, which properly sets forth the elements of a failure-to-warn claim and negligent misrepresentation claim in the prescription drug context. APP 3. Because the Circuit Court did not require the jury to find these essential elements of Plaintiff s claims in reaching their verdict, Defendants are entitled to a new trial. 13

19 V. Plaintiff failed to connect Ms. Taylor s Tardive Dyskinesia to any economic injury. Plaintiff continues to play fast and loose with the record. First, Plaintiff s suggestion that Defendants waived their objection to Dr. Thomas s opinions and life care plan is incorrect. Defendants made their objections when they moved in limine to have Dr. Thomas s testimony excluded. See R As this Court has stated, a defendant s motion in limine regarding the introduction of evidence properly preserve[s] the issue for appeal, and an objection [is] not necessary. Goff v. State, 14 So. 3d 625, 640 (Miss. 2009). When the trial court denied their motion, Defendants used cross examination to challenge Dr. Thomas s opinions and his life care plan. That testimony reflects the falsity of Plaintiff s second misrepresentation i.e. that three different doctors testified that Ms. Taylor would need constant care for her Tardive Dyskinesia. Dr. Thomas, presumably one of the three experts, could not say that the need for 24- hour attendant care, either past or future, was necessitated by Ms. Taylor s Tardive Dyskinesia: Q. Sir, the care that you have talked to the jury about today, the past care and the future care as it relates to the need for Ms. Taylor to have someone with her for 24 hours a day, that care is not limited to dyskinesia, is it? A. I can t say yes or no. I mean, I know she has significant problems, but I don t know I don t think it is just limited to that. I don t know how to divide that out. Tr Dr. Thomas s damages assessment is likewise not specific to Ms. Taylor s Tardive Dyskinesia: Q. These numbers Mr. Porter wrote here on the chart, you didn t limit the numbers to treatment that Ms. Taylor needs for dyskinesia, did you? 5 See also R ( Plaintiff s proposed life care plan and assessment of past damages for home health care assumes that Plaintiff required and will continue to require attendant care 24 hours per day. No expert or treating physician has testified that Plaintiff s alleged injury requires any type of continuing care, let alon[e] 24-hour per day attendant care. In the absence of such evidence connecting Plaintiff s need for attendant care to the subject product, the life care plan and damages assessment is irrelevant and should be excluded. ). 14

20 A. It is not limited to any specific medical condition, that s right. Q. You were not considering what specific treatment she might need for Alzheimer s or dementia or psychosis, were you? A. The difference in treatment, like medical treatment versus care, like home care, there is nothing in my report that dealt with medical treatment or medications or anything like that. Tr Significantly, too, Dr. Thomas did not know that Ms. Fortenberry quit her job prior to Ms. Taylor taking Risperdal to care for Ms. Taylor full time because of her severe depression and severe psychosis. Tr To that end, Plaintiff s characterization of the life care planner s testimony as unimpeached is simply wrong. As for Plaintiff s expert Dr. Fann, he testified that she would need some care in the future for Tardive Dyskinesia, but he did not testify as Plaintiff implies, see Resp. Br. at 27 that she would require 24-hour care. Tr Significantly, Plaintiff s own expert Dr. Trosch testified that it was Ms. Taylor s Alzheimer s disease that necessitates 24-hour care. Tr He attributed her loss of mobility, seizures, and cognitive decline to Alzheimer s disease not Tardive Dyskinesia. Tr Tardive Dyskinesia is a movement disorder that affects only the mouth and face. The involuntary movement of her tongue has nothing to do with Plaintiff s ability to move, think, and otherwise engage in the general day-to-day activities of taking care of herself. That Ms. Taylor could not eat by herself, drink water that was not thickened, or wear dentures are not conditions that require 24-hour care. See Pl. s Resp. Br. at 27. It is Ms. Taylor s other ailments notably, her mental challenges that have required the need for attendant care. It is undisputed that Ms. Taylor s mental condition required her to have around-the-clock attention since her first suicide attempt in November 1998 the year before she first took Risperdal, and more than two years before Plaintiff says she 15

21 developed Tardive Dyskinesia. Tr. 283, 310. These facts do not support an economic damages award for 24-hour attendant care because of Ms. Taylor s Tardive Dyskinesia. With no evidence establishing a causal connection between Ms. Taylor s Tardive Dyskinesia and the need for 24-hour attendant care and in fact all evidence clearly to the contrary Dr. Thomas s testimony should never have been admitted. The prejudice to Defendants of his testimony outlining millions of dollars in purported economic damages, followed by instructions to the jury allowing them to assess the same, compels a new trial. VI. Because economic damages should never have gone to the jury, Defendants are alternatively entitled to a remittitur. This Court and any court of record in a case in which money damages were awarded may impose a remittitur of the award if the damages awarded were contrary to the overwhelming weight of credible evidence. Miss. Code Ann The overwhelming weight of the credible evidence standard is an objective standard. Terex Corp. v. Ingalls Shipbuilding, Inc., 671 So. 2d 1316, 1322 (Miss. 1996) (citation omitted) (granting remittitur because evidence revealed plaintiff not entitled to entire amount awarded by jury). Objectively reviewing the evidence as it pertains to economic damages or lack thereof in this case reveals that Plaintiff has not connected Ms. Taylor s need for 24-hour care to her Tardive Dyskinesia. See Defs. Principal Br. at See, e.g., Phillips v. Illinois Cent. R. Co., 797 So. 2d 231, 237 (Miss. Ct. App. 2000) (affirming trial court s grant of remittitur because plaintiff failed to show a causal nexus between his retirement and the accident and the lack of causal connection between Plaintiff s knee injuries and the subject accident ). The case law cited in Plaintiff s Response does not change this critical fact. 16

22 VII. Plaintiff s counsel s improper argument during closing was abusive and outside the confines of the record and warrants a new trial. Plaintiff goes on at length regarding the well-established rule that counsel can speak on matters far and wide in closing. Pl. s Resp. Br. at 31. See generally id. at But the Court need not go further than the first case Plaintiff cites in this section to find counsel s argument at trial surpassed the reach of this well-established rule and warrants a new trial. See id. at (citing McGowen v. State, 859 So. 2d 320 (Miss. 2003)). As McGowen states, while attorneys are afforded broad latitude... in making their closing arguments, such latitude has its limits: counsel may draw conclusions and inferences from evidence on behalf of his client in whatever he deems proper, so long as he does not become abusive and go outside the confines of the record. McGowen, 859 So. 2d at 346 (citation omitted) (emphasis added). Indeed, arguing that a Janssen sales representative selling Risperdal to Dr. Rhoden was dressed provocatively is clearly intended to suggest that Defendants encouraged a variety of negligent marketing strategies and were only concerned with profits. As phrased, it suggests that Dr. Rhoden chose Risperdal because of such strategies, and not because he reached a medically sound decision that Risperdal would benefit many of his patients, including Ms. Taylor. Not only was counsel s statement highly inappropriate, but it was also highly prejudicial to Defendants. This improper argument coupled with the Circuit Court s refusal to intervene warrants a new trial. See Eckman v. Moore, 876 So. 2d 975, 986 (Miss. 2004); Dedeaux Util. Co. v. City of Gulfport, 63 So. 3d 514, 543 (Miss. 2001); Clemons v. State, 320 So. 2d 368, 371 (Miss. 1975). 17

23 STATEMENT OF THE ISSUE ON CROSS-APPEAL I. Did the Circuit Court properly refuse to submit the issue of punitive damages to the jury? ARGUMENT ON CROSS-APPEAL I. The Circuit Court properly refused to submit the issue of punitive damages to the jury. This Court need not address Plaintiff s cross-appeal if it finds the jury s verdict cannot stand because [a]bsent a valid claim for compensatory damages, there can be no claim for punitive damages. Elliott v. El Paso Corp., 181 So. 3d 263, 275 (Miss. 2015) (internal quotation marks and citation omitted). See also id. ( Because we find that Plaintiffs underlying claims fail as a matter of law, we also find that Plaintiffs punitive-damages claims fail. ). Even if this Court confirms the compensatory damage award (it should not), the Circuit Court properly concluded this is not a punitive damages case. Mississippi law does not favor punitive damages; they are considered an extraordinary remedy and are allowed [only] with caution and within narrow limits. Life & Cas. Ins. Co. of Tenn. v. Bristow, 529 So. 2d 620, 622 (Miss. 1998). The kind of wrongs to which punitive damages are applicable are those which, besides the violation of a right or the actual damages sustained, import insult, fraud, or oppression and not merely injuries, but injuries inflicted in the spirit of wanton disregard for the rights of others. Summers ex rel. Dawson v. St. Andrew s Episcopal School, Inc., 759 So. 2d 1203, 1215 (Miss. 2000). To warrant punitive damages, there must enter into the injury some element of aggression or some coloring of insult, malice or gross negligence, evincing ruthless disregard for the rights of others, so as to take the case out of the ordinary rule. Id. And they must be established, if at all, by clear and convincing 18

24 evidence, Miss. Code Ann (1)(a) 6 (emphasis added), which is such a high standard that even the overwhelming weight of the evidence does not rise to the same level. Moran v. Fairly, 919 So. 2d 969, 975 (Miss. 2005) (citing In re C.B., 574 So. 2d 1369, 1375 (Miss. 1990)). The Circuit Court did not abuse its discretion when it concluded that the evidence did not warrant the jury deliberating on punitive damages. See Tr See also Choctaw Maid Farms, Inc. v. Hailey, 822 So. 2d 911, 923 (Miss. 2002) (decision not to send punitive damages to jury reviewed for abuse of discretion). Plaintiff contends the Circuit Court was obligated and failed to automatically proceed to the punitive damages phase following the compensatory damages award citing Bradfield v. Schwartz, 936 So. 2d 931 (Miss 2006). See Pl. s Resp. Br. at Not only is this not the law, but it also does not reflect the Circuit Court s actions. As this Court stated in an opinion discussing Bradfield, Plaintiff has misconstrued the use of the word automatically in Bradfield.... The word automatic refers to the facts in the Bradfield case itself. Causey v. Sanders, 998 So. 2d 393, 407 (Miss. 2008). In fact, Causey expressly states that punitive damages should not automatically be submitted to a jury by a trial court. Causey, 998 So. 2d at (emphasis added). What Bradfield requires is for the judge to hear the evidence and decide whether the jury should deliberate on punitive damages, and that is what happened here. As the gatekeeper on the issue of punitive damages, the Circuit Court had the specific authority to determine whether the facts of this case warranted sending the issue to the jury. See Doe ex rel. Doe v. Salvation Army, 835 So. 2d 76, 79 (Miss. 2003). See also Causey, 998 So. 2d at 407. The Circuit Court s decision in this case came after hearing/seeing over the course of the 6 This case, which was filed on or about August 6, 2002, is controlled by the 1993 version of the Mississippi punitive damages statute. Compare 1993 Miss. Laws Ch. 302 (act shall be in force from and after July 1, 1993), with 2004 Miss. Laws Ch. 1 (portions of act in effect from and after September 1, 2004 and applicable to all causes of action field on or after September 1, 2004). 19

25 trial the evidence Plaintiff argues is relevant on the issue of punitive damages and was, therefore, the equivalent of directing a verdict on punitive damages at the end of an evidentiary hearing. The Circuit Court reached a determination on this issue and stated its decision on the record: I just don t believe this is a punitive damages case. I don t see this being a case that would require jury consideration of punitive damages. I may be right or I may be wrong. That s my opinion, though. Tr The only different or additional evidence Plaintiff suggests might have been admitted during a punitives evidentiary hearing concerned a 2013 indictment that the Court concluded was not relevant to the time frame at issue, i.e. when Dr. Rhoden prescribed Risperdal to Ms. Taylor. See Pl. s Resp. Br. at 34. See Tr. 437 ( [I]f all of the acts that were covered by the guilty plea were acts that occurred after the time period which this lady, the plaintiff, didn t take this drug anymore and things of that nature, then that s irrelevant. That s my ruling. ). See also Tr. 72 (noting Defendants pled guilty to only a portion of the indictment, and that portion concerned a different warning label and at a time after Ms. Taylor took Risperdal ); R (guilty plea agreement applies to conduct between March 3, 2002 and December 31, 2003 ). Having seen all the evidence Plaintiff argues justified the jury considering punitive damages, the Circuit Court determined that the evidence did not warrant having a jury deliberate the issue. See Doe ex rel. Doe v. Salvation Army, 835 So. 2d 76, 79 (Miss. 2003) (noting [t]here is no right to punitive damages. Rather, the statute clearly states that if certain criteria are met then the court determines whether the issue of punitive damages may be submitted to the trier of fact. (citations omitted) (emphasis in original)). The facts of this case set forth above and in Defendants Principal Brief demonstrate the correctness of the Circuit Court s decision. Risperdal was the third antipsychotic medication prescribed to treat Ms. Taylor s severe and debilitating psychosis, which she first 20

26 began suffering 18 years ago in March Between January 1994 (when Risperdal first came on the market) and January 2001 (when Dr. Rhoden stopped prescribing Risperdal to Ms. Taylor), Risperdal carried the FDA-approved class label for Tardive Dyskinesia, which more than sufficiently warned prescribing physicians about the syndrome. Tr See Defs. Principal Br. at 4-5. Dr. Rhoden testified unequivocally that the label was adequate to warn him of the risk of Tardive Dyskinesia in Risperdal users, R , APP 2, and further that he still stands by his decision to prescribe Risperdal to Ms. Taylor [b]ecause the benefit was much greater and the loss of that benefit would be much worse than the risk of the side effects. R Additionally, there is no proof that Dr. Rhoden relied on much less saw any materials Plaintiff alleged at trial were misrepresentations by Defendants. Based on the record before the Circuit Court, there was nothing to support sending the issue of punitive damages to the jury. It was within the sound discretion of the Circuit Court to reach this conclusion, and it should not be reversed. CONCLUSION Looking past the smoke and mirrors of Plaintiff s Response brief, it becomes clear that the evidence presented to the jury does not support the verdict. First, Plaintiff s failure-to-warn claim required proof that Dr. Rhoden found Risperdal s warning of Tardive Dyskinesia inadequate, and that an adequate warning would have prevented Dr. Rhoden from prescribing the drug to Ms. Taylor. Plaintiff proved neither. Second, Plaintiff s negligent misrepresentation claim required proof that Dr. Rhoden was both exposed to and relied upon misrepresentations by Defendants, and that these misrepresentations caused Dr. Rhoden to prescribe Risperdal to Ms. Taylor. Again, Plaintiff proved none of these. Nothing in Plaintiff s Response brief saves her claims, and the jury s verdict should be reversed. 21

27 For these reasons and for the reasons set forth in Defendants Principal Brief, Defendants respectfully request that the Court reverse the jury s verdict and render judgment in Defendants favor. If the Court does not reverse and render, Defendants alternatively request a new trial because (1) the jury instructions were substantively improper and inadequate, (2) the jury was prevented from reaching an impartial verdict when the Circuit Court allowed Plaintiff s highly offensive closing argument, and (3) the jury should never have had the opportunity to award economic damages when no evidence connected Ms. Taylor s Tardive Dyskinesia to the need for 24-hour attendant care, i.e. the only item of economic damages Plaintiff sought in this case. Also in the alternative, Defendants request a remittitur of the entire $650, economic damages award because it was unsupported by the evidence. Without compensatory damages, there can be no punitive damages. Even if there were, however, the Circuit Court did not abuse its discretion when it determined this was not a punitive damages case. Defendants, therefore, additionally request that this Court find in favor of Defendants on Plaintiff s cross-appeal and conclude the Circuit Court appropriately found the issue of punitive damages should not be submitted to the jury. Respectfully submitted, this the 17th day of January,

28 By: s/ Kathleen Ingram Carrington DONNA BROWN JACOBS (MB # 8371) PAUL V. CASSISA, JR. (MB # 5921) ADAM J. SPICER (MB # ) KATHLEEN INGRAM CARRINGTON (MB # ) BUTLER SNOW LLP Post Office Box 6010 Ridgeland, Mississippi Tel: Fax: ATTORNEYS FOR APPELLANTS / CROSS- APPELLEES JOHNSON & JOHNSON, INC. AND ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC. 23

29 CERTIFICATE OF SERVICE I, Kathleen Ingram Carrington, one of the attorneys for Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Johnson & Johnson, Inc., hereby certify that I electronically filed the foregoing Brief of Appellants with the Clerk of the Court using the MEC system. Further, I hereby certify that I will mail on January 18, 2017 by U.S. Mail, postage prepaid, the document to the following: Honorable Lamar Pickard Post Office Box 310 Hazlehurst, MS COPIAH COUNTY CIRCUIT COURT JUDGE John T. Givens Tim Porter Patrick Malouf Porter & Malouf, P.A. Post Office Box Jackson, MS Danny McGlynn McGlynn Glisson & Mouton Law Firm 340 Florida Street Baton Rouge, LA ATTORNEYS FOR PLAINTIFFS SO CERTIFIED this 17th day of January, s/ Kathleen Ingram Carrington KATHLEEN INGRAM CARRINGTON ButlerSnow v v1 24