IN THE SUPREME COURT OF MISSISSIPPI. No CA SCT RESPONSE IN OPPOSITION TO MOTION FOR REHEARING

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1 E-Filed Document Dec :48: CA SCT Pages: 11 IN THE SUPREME COURT OF MISSISSIPPI No CA SCT JOHNSON & JOHNSON, INC., et al. APPELLANTS / CROSS-APPELLEES vs. BRENDA FORTENBERRY, as the Conservator of the Estate and Person of Louise Taylor APPELLEE / CROSS-APPELLANT RESPONSE IN OPPOSITION TO MOTION FOR REHEARING Appellants/Cross-Appellees Johnson & Johnson, Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (collectively Defendants ), by and through counsel and pursuant to Mississippi Rule of Appellate Procedure 40(a), respond in opposition to Appellee/Cross- Appellant Brenda Fortenberry s ( Plaintiff ) Motion for Rehearing. INTRODUCTION AND SUMMARY Plaintiff s Motion for Rehearing is an insolent attack on this Court s charge as a body of appellate jurists. Plaintiff repeatedly claims the Court failed to consider argument and evidence, but her entire first argument is based on something she failed to do: assert the argument anywhere else. Indeed, despite Defendants clear statement in their principal brief that this case has nothing to do with Risperdal s instructions, Plaintiff was completely silent in response. Rightfully so, as the relevant question is whether the Risperdal label adequately warned Dr. Rhoden of the risk of Tardive Dyskinesia. This Court, reviewing the facts and applying the correct legal doctrine, found the Risperdal label in no uncertain terms warned Dr. Rhoden of the danger of Tardive Dyskinesia. The language of the label coupled with treating physician Dr. Rhoden s testimony (the only physician s opinion that legally matters on this issue) results in the 1

2 undeniable conclusion that the jury got it wrong. As there is no credence to Plaintiff s Motion for Rehearing, it should be denied. LAW AND ARGUMENT I. Whether the Risperdal label provided adequate instructions is not and has never been an issue in this case for the Court s (or the jury s) consideration. A motion for rehearing is not an opportunity to make a new argument not presented to the Court in the party s appeal brief. But that is what Plaintiff has done. Plaintiff asserts the Court disregarded expert testimony, ignored the instruction aspect given with Risperdal, and fail[ed] to address it, see Pl. s Mot. at 4, 6, 7, but it is impossible to overlook or ignore or address something never presented for consideration. Plaintiff tacitly admits this argument was not made in her Brief, stating that this key point... must now be examined. Id. at 3 (emphasis added). This argument was not raised by Plaintiff in her Brief, and she is wrong to argue the Court overlooked or misapprehended an argument articulated only after the Court found the Tardive Dyskinesia warning adequate as a matter of law. See McFarland v. Entergy Miss., Inc., 919 So. 2d 894, 904 (Miss. 2005) (citing Brewer v. State, 819 So. 2d 1169, 1175 (Miss. 2002); Irving v. State, 441 So. 2d 846, 854 (Miss. 1983) ( The issue may not now be raised for the first time on a petition for rehearing and it is procedurally barred. ). Plaintiff tries to excuse this omission by suggesting Defendants arguments kept the Court from understanding what is now described as a key part of Plaintiff s case. Pl. s Mot. at 7. If Plaintiff believed an inadequate instruction about Tardive Dyskinesia was an alternative basis for affirming the product liability claim that Defendants had not appealed, the claim would have been argued loudly and repeatedly in Plaintiff s principal brief. The Court will search Appellee s Brief in vain for any mention of an alleged inadequate instruction related to Tardive 2

3 Dyskinesia (or anything else) in the Risperdal label, or a citation to the expert testimony Plaintiff now claims the Court disregarded. Id. at 4. Quite the opposite: Defendants stated in the Appellants Brief, as they had when objecting to the inclusion of Instruction in the Jury Verdict Form, [t]his case does not concern the adequacy of any instructions regarding Risperdal, and Plaintiff did not dispute that assertion. Br. of Appellants at 38; see also Tr. 455:11-22, R.E. 5 (Defendants objections to P-18). Plaintiff quotes extensively from the MPLA where the word instruction is used, but then ignores a key phrase describing an adequate warning or instruction: one that communicates sufficient information on the dangers and safe use of the product.... Compare Pl. s Mot. at 5, 6, 9 with Miss. Code Ann (c)(ii) (emphasis added). Thus, for some products a warning might alert a user to the particular danger and instruct how to avoid that danger while using the product. Such warnings typically are found in non-pharmaceutical products cases, and address the manner and method of using the product safely, such as an instruction to disconnect the power source before attempting to clean the saw blade. Defendants research did not reveal a decision from this Court specifically addressing a product liability claim for alleged inadequate instructions as distinct from warnings, and Plaintiff does not cite any. Austin v. Wil-Burt Company, 232 F. Supp. 2d 682 (N.D. Miss. 2002), provides a good example of a warning that both alerts the user to the danger and instructs how to avoid that danger. Austin was killed when the aluminum telescoping mast on a TV station s van came in contact with an 8,000-volt power line. 232 F. Supp. 2d at 685. His survivors claimed that the warning on the mast was inadequate. Id. at 686. The manufacturer had affixed two labels to the mast that warned the operator of the danger of electrocution and instructed the operator how to avoid the danger: 3

4 DANGER! PLEASE READ INSTRUCTIONS BEFORE RAISING! DANGER. WATCH FOR WIRES. YOU CAN BE KILLED IF THIS PRODUCT COMES NEAR ELECTRICAL POWER LINES. Id. at 687. The District Court found that this information was adequate as a matter of law, and thus plaintiffs had not proven the mast failed to contain adequate warnings or instructions. Id. The instruction watch for wires allowed for safe use of the mast, and had it been heeded, the danger could have been avoided. Id. This Court found the Risperdal label unequivocally and in no uncertain terms communicated the danger experienced by Ms. Taylor the risk she would develop Tardive Dyskinesia. Op. 26, 33. Thus, Janssen discharged its duty to communicate sufficient information on the dangers of the product. That leaves the safe use component of the statute. There is no information that allows safe use of Risperdal, and Plaintiff does not suggest otherwise. There is no precaution -- for example, do not consume caffeine while taking this drug -- that eliminates the risk of Tardive Dyskinesia. All anti-psychotics in use when Ms. Taylor was treated had the potential to cause Tardive Dyskinesia; the FDA-mandated label functioned to inform prescribing physicians of that risk. That same FDA-mandated label made clear there was no way to predict whether a particular patient would develop the condition: Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. R. 4602, R.E. 3. The label also warned the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose... increase but the syndrome could develop after relatively brief treatment periods at 4

5 low doses. Id. In other words, there was no way to know who would be affected, and no way to protect against it. Plaintiff has not identified any instruction from the Risperdal label, much less one that addresses the safe use of Risperdal viz. the risk of Tardive Dyskinesia. Plaintiff s new argument revolves around the first statement in the INDICATION section of the FDAapproved label -- the section that identifies the conditions the drug is approved to treat. In its entirety, that section reads: INDICATIONS AND USAGE RISPERDAL (risperidone) is indicated for the management of the manifestations of psychotic disorders. The antipsychotic efficacy of RISPERDAL was established in short-term (6- to 8 weeks) controlled trials of schizophrenic inpatients (See CLINICAL PHARMACOLOGY). The effectiveness of RISPERDALI in long-term use, that is, for more than 6 to 8 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use RISPERDAL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (See DOSAGE AND ADMINISTRATION). R. 4601, R.E. 3. This was the indication approved by the FDA in No one disputes that Ms. Taylor was experiencing manifestations of psychotic disorders when she was first prescribed anti-psychotic medication in 1998 or when Dr. Rhoden first prescribed Risperdal in Plaintiff argues this accurate factual statement of the approved indication is an inadequate instruction to physicians because it states psychotic disorders generally rather than schizophrenia specifically. The evidence cited by Plaintiff now (but not in her Appellee s Brief) is Dr. Parisian s opinion that Risperdal was approved only for the psychotic part of schizophrenia an opinion debunked by the plain language of the FDA-approved label. 5

6 To advance her characterization, Plaintiff cleverly substitutes instruction for indication when referencing the Risperdal label even referring to the label s INSTRUCTION component. Pl. s Mot. at 4. Plaintiff s capitalization and punctuation choices clearly were intended to create the false impression there is a section in the Risperdal label called INSTRUCTION. Id. at 8. Plaintiff s artifice aside, not even she argues that limiting prescriptions only to patients diagnosed with schizophrenia communicates information about safe use of Risperdal. That is, Plaintiff does not argue that Ms. Taylor s risk of developing Tardive Dyskinesia depended upon whether she was experiencing manifestations of a psychotic disorder or the psychotic part of schizophrenia. This statement of the approved indication is not the type of instruction addressed in the MPLA, as it provides no information relevant to the safe use of Risperdal. II. The Court correctly found the Risperdal warning was adequate as a matter of law. Plaintiff accuses this Court of improperly acting as a thirteenth juror by allegedly weighing evidence and construing conflicting testimony against the verdict. See Pl. s Mot. at This could not be further from the truth. Instead, the Court in its well-reasoned opinion reviewed the facts applicable to the appropriate legal doctrine at issue on Plaintiff s failure-towarn claim and concluded the jury got it wrong as a matter of law. Although Plaintiff admitted in her response brief that the learned intermediary doctrine applies to her failure-to-warn claim, see Pl. s Resp. Br. at 16, her challenge here makes clear that she would like for this Court to ignore the reaches of that doctrine. That doctrine codified by the Mississippi Product Liability Act provides that a warning must be adequate as to the prescribing physician. See Miss. Code 6

7 Ann (c)(ii). 1 Correctly applying this doctrine, the Court found the Risperdal warning adequate under the Act. Indeed, Plaintiff challenges the Court s opinion because expert after expert opined that the Janssen instruction was inadequate, and [] Dr. Parisian specifically explained how Janssen resisted the FDA s push to rewrite the instruction. Pl. s Mot. at 9. Telling, Plaintiff does not cite this Court to any testimony in her motion or principal brief on appeal, for that matter on this particular point. More importantly, what other experts have to say about the adequacy of the Risperdal warning, however, has no bearing on whether Dr. Rhoden found the warning adequate. See Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 3d 31, 58 (Miss. 2004) ( The Plaintiffs bear the burden of establishing that... an adequate warning would have convinced the treating physician not to prescribe the product for the Plaintiffs. (internal quotation marks and citations omitted)). Under the learned intermediary doctrine, the only doctor whose understanding of the risks of Tardive Dyskinesia that legally matters in this case is Dr. Rhoden, and he plainly testified that he found the label adequate to warn him of the risk of Tardive Dyskinesia in Risperdal users. R , APP 2. In keeping with this correct application of the learned intermediary doctrine, the Court appropriately relied on its precedent in Wyeth Laboratories, Inc. v. Fortenberry, 530 So. 2d 688 (Miss. 1988), to reverse the jury verdict on Plaintiff s failure-to-warn claim. In reversing and 1 As that section of the MPLA provides: An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates sufficient information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to an ordinary consumer who purchases the product; or in the case of a prescription drug, medical device or other product that is intended to be used only under the supervision of a physician or other licensed professional person, taking into account the characteristics of, and the ordinary knowledge common to, a physician or other licensed professional who prescribes the drug, device or other product. 7

8 rendering the jury verdict in Fortenberry and finding the vaccine warning in that case adequate as a matter of law, the Court relied on (1) the language of the warning itself and (2) the testimony of the treating physician. See id. at As stated in that opinion, although Fortenberry was in that group of healthy adults for whom the vaccine was not recommended and the warning recommended making persons considering the vaccine aware of the possible risk of GBS (Guillain-Barre syndrome), Dr Moore testified that he kept abreast of the medical literature and did not believe there was a sufficient connection between the vaccine and GBS to warrant a warning. Id. at Similarly here, the Court relied on (1) the language of the Risperdal warning itself regarding the risk of Tardive Dyskinesia and (2) the testimony of Dr. Rhoden, the treating physician, in finding the warning adequate as a matter of law. See Op. at The Court first correctly found that the Risperdal label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal. Id. at 26 (emphasis added). The Court went so far as to find the Risperdal label warned Dr. Rhoden in no uncertain terms of the danger of Tardive Dyskinesia. Id. at 33. The Court quoted multiple paragraphs from the Risperdal label that demonstrate how clearly the Risperdal label communicated the danger of Tardive Dyskinesia: WARNINGS Tardive Dyskinesia A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.... 8

9 The risk of developing Tardive Dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for establishes cases of Tardive Dyskinesia.... Given these considerations, RISPERDAL (risperidone) should be prescribed in a manner that is most likely to minimize the occurrence of Tardive Dyskinesia.... In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. Id. at 11. Second, looking to Dr. Rhoden s testimony, the Court noted that (1) Dr. Rhoden specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor, (2) Dr. Rhoden s records and testimony confirm that he understood and appreciated the risk of tardive dyskinesia associated with Risperdal, and (3) Dr. Rhoden only prescribed Risperdal to Plaintiff after concluding the benefits outweighed the risks. Id. at 27. In light of the foregoing, the Court here, like in Fortenberry, ha[d] no alternative but to reverse and render. Fortenberry, 530 So. 2d at 689. CONCLUSION For the foregoing reasons, Appellants/Cross-Appellees Johnson & Johnson, Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc. pray that this Court will deny Plaintiff s Motion for Rehearing. Defendants request all other and further relief to which they may be entitled. THIS, the 18th day of December,

10 Respectfully Submitted, s/ Donna Brown Jacobs s/ Kathleen Ingram Carrington Donna Brown Jacobs (MB #8371) Kathleen Ingram Carrington (MB #104220) BUTLER SNOW LLP 1020 Highland Colony Parkway Suite 1400 (39157) Post Office Box 6010 Ridgeland, Mississippi Phone: Fax: Counsel for Appellants/Cross-Appellees Johnson & Johnson, Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc. OF COUNSEL: Donna Brown Jacobs (MB #8371) Paul V. Cassisa, Jr. (MB #5921) Adam J. Spicer (MB #102880) Kathleen Ingram Carrington (MB #104220) Butler Snow LLP Post Office Box 6010 Ridgeland, MS Tel: Fax:

11 CERTIFICATE OF SERVICE I, Donna Brown Jacobs, one of the attorneys for Appellants/Cross-Appellees Johnson & Johnson, Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc., do hereby certify that I have this day served a true and correct copy of the above and foregoing document by electronically filing same using this Court s ECF system, which sent notification of the filing of this document to the following counsel of record: Timothy W. Porter John T. Givens Porter & Malouf, P.A. Post Office Box Jackson, MS David Neil McCarty David Neil McCarty Law Firm, PLLC 416 East Amite Street Jackson, MS Danny McGlynn McGlynn Glisson & Mouton Law Firm 340 Florida Street Baton Rouge, LA COUNSEL FOR APPELLEE/CROSS-APPELLANT So certified, this the 18th day of December s/ Donna Brown Jacobs DONNA BROWN JACOBS 11