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Johnson & Johnson, Inc. v. Fortenberry

Supreme Court of Mississippi

October 19, 2017


          DATE OF JUDGMENT: 01/27/2015







         ¶1. The subject of the present products liability lawsuit is Risperdal, an antipsychotic medication approved by the Federal Food and Drug Administration on December 29, 1993, as a safe and effective prescription drug for the management of the manifestation of psychotic disorders. We hold that, as a matter of law, the Risperdal in question contained an adequate warning; we reverse and render the statutory inadequate warning judgment. We further hold that, as more fully set forth below, various errors in the jury instructions require reversal of the plaintiff's verdict that sounded in negligent misrepresentation, and we reverse and remand the negligent misrepresentation claim. We also address other, nondispositive issues that might arise again upon retrial.

         ¶2. Louise Taylor began suffering psychotic episodes when she was seventy-one years old, in early 1998. From March 1998 to January 2001, Psychiatrist Richard Rhoden prescribed Risperdal to Taylor for the treatment of her recurrent psychotic manifestations. In February 2001, Taylor developed tardive dyskinesia, a movement disorder caused by antipsychotic medications. Tardive dyskinesia is a syndrome of potentially irreversible, involuntary, dyskinetic movements in patients treated with antipsychotic drugs. Tardive dyskinesia is a type or subcategory of extrapyramidal symptoms, which is a general category of movement disorders that may result from neuroleptic exposure to antipsychotics.

         ¶3. On August 6, 2002, Taylor[1] filed a complaint against Ortho-McNeil Janssen Pharmaceuticals, the manufacturer, seller, and distributer of Risperdal, and its parent company Johnson & Johnson (collectively "Janssen"), claiming that Risperdal caused her to develop tardive dyskinesia. Taylor also named her treating physician, Dr. Richard Rhoden, as a defendant in her complaint. Taylor settled her claims against Dr. Rhoden prior to trial. The case went to trial on November 7, 2014. On November 14, 2014, the jury, in a nine to three decision, found that Taylor was harmed by Risperdal due to: (1) Janssen's "failure to provide adequate warnings/instructions" and (2) Janssen's "negligent marketing/misrepresentation." The jury awarded Taylor $650, 000 in actual economic damages and $1.3 million in noneconomic damages, for a total damages award of $1, 950, 000.

         ¶4. Janssen appeals, raising the following issues:

I. Is Janssen entitled to judgment as a matter of law on Taylor's failure-to-warn claim because there was no evidence of any alleged inadequacy in the Risperdal warning because Janssen warned of the risk of Tardive Dyskinesia; and there was no evidence that any alleged inadequacy in the Risperdal warning proximately caused Taylor's Tardive Dyskinesia?
II. Is Janssen entitled to judgment as a matter of law on Taylor's negligent misrepresentation claim because Taylor failed to offer proof that Taylor's prescribing physician, Dr. Rhoden, received any specific misrepresentation from Janssen, much less that Dr. Rhoden relied on any alleged misrepresentation in prescribing Risperdal to Taylor?
III. Is Janssen alternatively entitled to a new trial because the trial court's substantive jury instructions were improper?
IV. Is Janssen alternatively entitled to a new trial because economic damages should not have gone to the jury, as there was no proof connecting Taylor's Tardive Dyskinesia, the only condition allegedly caused by Risperdal, to the need for twenty-four-hour attendant care - the only economic damages Taylor sought?
V. Is Janssen alternatively entitled to a remittitur of the economic damage award because it is not supported by evidence?
VI. Is Janssen alternatively entitled to a new trial because Taylor's counsel used inflammatory, highly offensive, and improper argument during closing?

         ¶5. Taylor cross appeals, raising the following issue:

VII. Did the evidence warrant a punitive damages proceeding?


         ¶6. In early 1998, Taylor began suffering psychotic episodes featured by paranoia, delusions, and hallucinations. One morning, Taylor prevented her daughter Fortenberry from leaving their house to go to work by physically blocking the door because she believed there were people outside her house trying to do Fortenberry harm. Taylor believed what she saw and heard really was there despite Fortenberry's assurances otherwise. Due to the episode, Fortenberry took Taylor to a local physician, who referred Taylor to Charter Hospital, an inpatient behavioral health facility. Taylor was admitted to Charter Hospital and diagnosed with "severe depression with a single psychotic episode." While a patient at Charter Hospital, caregivers prescribed Taylor Haldol (generic: Haloperidol), a "first generation" or "typical" antipsychotic medication. Taylor received treatment for a number of weeks at Charter Hospital, and on March 3, 1998, she was discharged and was referred to Dr. Rhoden for further treatment.

         ¶7. On March 23, 1998, Taylor first saw Dr. Rhoden. Dr. Rhoden continued Taylor's Haldol prescription for her previously existing psychosis. Dr. Rhoden did not observe Taylor exhibiting extrapyramidal symptoms during the visit. At the next visit, on June 4, 1998, Dr. Rhoden discontinued Haldol and prescribed Seroquel (generic: quetiapine), a "second generation" or "atypical" antipsychotic medication. Dr. Rhoden explained that he changed medications because he believed Seroquel would help Taylor's insomnia. Dr. Rhoden also explained that Seroquel was "one of the newer types of [antipsychotics, ]" and he "was trying to change people from the older type antipsychotics to the newer atypical type." Dr. Rhoden provided Taylor and Fortenberry with the material side effects of Seroquel. Dr. Rhoden testified that the material side effects he believed he would have discussed included "the different types of EPS which could be either temporary, or in some cases long term movement or pulling or different kinds of muscle abnormalities that could occur."

         ¶8. At the next visit on July 20, 1998, Dr. Rhoden continued the prescription for Seroquel and noted that Taylor "has a mouth twitch some since stopping Haldol[.]" On September 17, 1998, Dr. Rhoden noted that Taylor's "mouth twitching is better[.]" Dr. Rhoden also noted that Taylor was doing well with the current treatment and continued the prescription for Seroquel.

         ¶9. On November 19, 1998, Taylor was hospitalized at Hardy Wilson Memorial Hospital following an suicide attempt by taking sixty Seroquel pills and some Prozac pills, which also had been prescribed for her. Taylor was diagnosed with "major depression, recurrent with psychosis[.]" On December 10, 1998, Taylor was discharged with the need for constant supervision until her next appointment scheduled for December 15, 1998, with Region 8 Mental Health. Following the discharge, Fortenberry left her job to care for Taylor twenty-four hours a day because of Taylor's severe depression and psychosis.

         ¶10. On March 18, 1999, Taylor returned to Dr. Rhoden for her next visit. Dr. Rhoden recognized that Taylor "was on Seroquel and at some point, she was worse and had to be hospitalized[, ]" so he discontinued the Seroquel. In an effort to "try something different[, ]" Dr. Rhoden prescribed Risperdal (generic: risperidone), a "second generation" or "atypical" antipsychotic, to Taylor. Dr. Rhoden first started Taylor on Risperdal at one to two milligrams at nine p.m. as directed. Dr. Rhoden's record confirmed that "side effects [were] given inc[luding] T.D. [and] EPS." Dr. Rhoden testified that he informed both Taylor and Fortenberry of the risk of tardive dyskinesia and extrapyramidal symptoms during the visit. Dr. Rhoden explained that he would have told Taylor and Fortenberry: "[R]emember that this medicine, as in all medicines in this class, can produce certain movement problems or pulling or muscle problems that can develop that can be short term. It can be treated, but sometimes they can't be; they can be long term."

         ¶11. Risperdal, along with all other antipsychotic medications on the market, were required to carry the Food and Drug Administration approved class label warning for tardive dyskinesia. The Food and Drug Administration utilizes a class label for the purpose of informing the physician that the medication carries the potential risk for the same particular adverse events as all the other medications in the same class. The pertinent portions of the Food and Drug Administration approved class label included in the Risperdal label during the time period that Dr. Rhoden prescribed Risperdal to Taylor provided:

         RISPERDAL ™

         (Risperidone tablets)

RISPERDAL ™ (risperidone) is an antipsychotic agent belonging to a new chemical class, the benzisoxazole derivatives. . . . .
RISPERDAL ™ (risperidone) is indicated for the management of the manifestations of psychotic disorders.
. . . .
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. Whether antipsychotic drug products differ in their potential to cause Tardive Dyskinesia is unknown.
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 established cases of Tardive Dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
Given these considerations, RISPERDAL ™ (risperidone) should be prescribed in a manner that is most likely to minimize the occurrence of Tardive Dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. 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.
If signs and symptoms of Tardive Dyskinesia appear in a patient on RISPERDAL ™, drug discontinuation should be considered. However, some patients may require treatment with RISPERDAL ™ despite the presence of the syndrome.

         ¶12. Dr. Rhoden was aware that all antipsychotics, including Risperdal, had been associated with tardive dyskinesia. Dr. Rhoden, who had prescribed Risperdal since the early 1990s, had familiarized himself with the Risperdal label before prescribing it. Dr. Rhoden verified that the label's language regarding tardive dyskinesia was consistent with his understanding of tardive dyskinesia and its association with Risperdal.

         ¶13. Dr. Rhoden continued to treat Taylor with Risperdal and on May 6, 1999, Dr. Rhoden increased Taylor's dosage to three milligrams per day. On November 10, 1999, Dr. Rhoden noted that, "psychiatrically [Taylor] is more bright and stable than ever." On January 10, 2000, Dr. Rhoden noted: "reviewed again side effects of Rx esp. Risperdal" including, "T.D." and "EPS[.]" Dr. Rhoden also noted "no significant problems" of the side effects, tardive dyskinesia and extrapyramidal symptoms. On May 1, 2000, Dr. Rhoden noted "no EPS[, ]" and increased Risperdal to four milligrams. On November 6, 2000, Dr. Rhoden noted "no EPS[.]" On January 24, 2001, Dr. Rhoden noted that Taylor had "developed an oral dyskinesia which I had previously warned her and her daughter about." In response, Dr. Rhoden decreased the dosage of Risperdal and restarted Taylor on Seroquel.

         ¶14. On February 21, 2001, Taylor visited with Dr. Rhoden for the last time. Dr. Rhoden noted that since the previous month's visit, Taylor "has been having trouble w[ith her] tongue moving around inside and darting outside of her mouth since changing from the Risperdal to the new medication - Seroquel- to the point of being unable to wear dentures." Dr. Rhoden noted that Taylor's chief concern was the cause of the involuntary movement of her tongue. Dr. Rhoden noted that Taylor was "clearer psychiatrically, not dizzy - is pleased [with] this even though her oral dyskinesia has increased as above - most likely rebound effect after Risperdal [decreased] - I again reminded her and her daughter of T.D. and [associated] risk factors (age, gender . . .) - [t]hey want to continue [prescription] and try to [treat] side effects[.]" It was apparent to Dr. Rhoden that Taylor had developed tardive dyskinesia as of the February 21, 2001, visit.

         ¶15. Taylor has since been treated by dozens of other physicians and has continuously needed an antipsychotic medication for the treatment of her severe psychosis. At the time of trial, Taylor was on Seroquel.

         ¶16. Dr. Richard Trosch, a neurologist specializing in movement disorders, testified for Taylor. Dr. Trosch explained that all tardive dyskinesia is caused by antipsychotic medications or neuroleptics by definition. Dr. Trosch opined that Taylor's exposure to Risperdal over a period of nearly three years had caused her tardive dyskinesia. Dr. Trosch opined that, with regard to extrapyramidal symptoms and tardive dyskinesia, the safest antipsychotics are Seroquel and Clozaril (generic: Clozapine). Dr. Trosch opined that had Taylor been prescribed Seroquel or Clozaril, rather than Risperdal, it would be "very unlikely" that she would have developed tardive dyskinesia.


         I. Whether Janssen is entitled to judgment as matter of law on Taylor's failure to warn claim.

         ¶17. Janssen argues that the trial court erred by denying its motion for a judgment notwithstanding the verdict. Specifically, Janssen argues that Taylor's failure to warn claim fails as a matter of law because she failed to present evidence of any inadequacy in the Risperdal warning. Alternatively, Janssen argues that there was no evidence that any inadequacy in the Risperdal warning caused Taylor's tardive dyskinesia.

         ¶18. "The standard of review for the denial of a motion for a judgment notwithstanding the verdict (JNOV) is de novo." United Servs. Auto. Ass'n (USSA) v. Lisanby, 47 So.3d 1172, 1176 (¶ 8) (Miss. 2010). "A motion for JNOV is a challenge to the legal sufficiency of the evidence, and this Court will affirm the denial of a JNOV if there is substantial evidence to support the verdict." Id. The Court considers the evidence in the light most favorable to the appellee, giving that party the benefit of all favorable inferences that may be reasonably drawn from the evidence. Id. "In essence, judgments as a matter of law present both the trial court and the appellate court with the same question - whether the evidence, as applied to the elements of a party's case, is either so indisputable, or so deficient, that the necessity of a trier of fact has been obviated." Id.

         ¶19. Under the Mississippi Products Liability Act, "[a] manufacturer is liable under a failure-to-warn theory if the product 'failed to contain adequate warnings, ' the inadequate warnings 'rendered the product unreasonably dangerous to the user or consumer, ' and the inadequate warning 'proximately caused the damages for which recovery is sought.'" Union Carbide Corp. v. Nix, Jr., 142 So.3d 374, 385 (¶ 18) (Miss. 2014) (quoting Miss. Code Ann § 11-1-63(a)(i)-(iii)).

         ¶20. A drug manufacturer has a duty adequately to warn the prescribing physician of any known adverse effects which might result from the use of its prescription drugs. Wyeth Labs., Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss. 1988) (citing Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987). The Court has explained:

The general rule is that where prescription drugs are concerned, a manufacturer's duty to warn only extends to physicians and not to laymen. If the language of the warning is adequate then the drug manufacturer ordinarily is freed from liability. The learned intermediary doctrine is the basis for this rule.

Janssen Pharmaceutica, Inc. v. Bailey, 878 So.2d 31, 57 (¶ 122) (Miss. 2004) (quoting Fortenberry, 530 So.2d at 691 (internal quotations and citations omitted)).

         ¶21. Under the learned intermediary doctrine, "the manufacturer's failure to warn the patient of the product's risks does not render the product defective or unreasonably dangerous so long as the manufacturer adequately warns the learned intermediary." Bailey, 878 So.2d at 58 (¶ 124). "If there is no physician in the role of 'learned intermediary' then the drug manufacturer has a duty to adequately warn the consumer." Fortenberry, 530 So.2d 688 at 692.

         ¶22. "By law, the labeling of every prescription drug must include a package insert listing known side effects." Bailey, 878 So.2d at 36 (¶ 7) (citing 21 C.F.R. §§ 201.56-201.57). "The [Food and Drug Administration] must approve the content of such inserts, which communicate to prescribing physicians the essential information about the medication's benefits and risks." Id. "An adequate warning is one reasonable under the circumstances." Id. at 55 (¶ 109). "To be reasonable, the warning should neither understate nor overstate the known risks associated with the use of a particular product." Id. In some cases, a package insert may be sufficient for the warning to be adequate as a matter of law. Id. at 55 (¶ 110).

         ¶23. The Court also has held that "[t]he issue of a warning's adequacy is factual and usually will be resolved by the trier of fact." Fortenberry, 530 So.2d at 692. The adequacy of a warning addressed to the medical community may fall into the category of issues requiring expert testimony because prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. Id. "Where the adequacy of the warning is not obvious to the ordinary layperson it is necessary to have expert testimony[.]" Id.

         ¶24. In Fortenberry, Billy Joe Fortenberry suffered paralysis after receiving a flu vaccine manufactured by Wyeth Laboratories and administered by his local physician, Dr. T.L. Moore. Id. at 689. Fortenberry eventually was diagnosed with transverse myelitis, which is closely related, in etiology and pathology, to Guillain-Barre syndrome. Id. Fortenberry filed a complaint against Wyeth and Dr. Moore for failure to warn. Id. The vaccine package contained an insert for the prescribing physician warning of possible adverse reactions, including Guillain-Barre syndrome. Id. Dr. Moore testified that he had received and read the package insert and kept abreast of recent medical literature. Id. Dr. Moore also testified that he believed the risk to be minimal and remote. Id. Therefore, Dr. Moore believed a warning to his patients would scare them and was not required. Id.

         ¶25. The Court determined it was clear from the record that Fortenberry was in the group of "healthy adults" for whom the vaccine was not recommended. Id. at 692. The vaccine was recommended for those "who are at increased risk of adverse consequences from infections of the lower respiratory tract." Id. at 692-93. The package insert went on to warn physicians that, although the connection between the vaccine and Guillain-Barre syndrome was not clear, persons considering the vaccine "should be made aware of the benefits and possible risks, including [Guillain-Barre syndrome], of administration." Id. at 693. Dr. Moore testified that he kept abreast of the medical literature and did not believe there was a sufficient connection between the vaccine and Guillain-Barre syndrome to warrant a warning. Id. Therefore, Dr. Moore decided to give no warning to Fortenberry. Id. The Court held that the warning on the package insert was adequate as a matter of law and reversed and rendered judgment in favor of Wyeth. Id. at 691, 693.

         ¶26. Here, the Risperdal label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal. The label provided that tardive dyskinesia "may develop in patients treated with antipsychotic drugs." The label also provided: "[w]hether antipsychotic drug products differ in their potential to cause Tardive Dyskinesia is unknown." Dr. Rhoden, who was not designated as an expert, specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Rispderal users at the time he prescribed it to Taylor.

         ¶27. Dr. Rhoden testified that he became familiar with Risperdal's package insert before prescribing the medication to his patients. Dr. Rhoden's records and testimony confirm that he understood and appreciated the risk of tardive dyskinesia associated with Risperdal. Dr. Rhoden's awareness also was evident from the medical records in which he repeatedly noted that he specifically had warned Taylor and Fortenberry about the risk of extrapyramidal symptoms and tardive dyskinesia associated with Risperdal. Dr. Rhoden prescribed Risperdal after performing a risk/benefit analysis. Dr. Rhoden testified:

Q. Doctor, despite th[e label's] language and despite your knowledge about tardive dyskinesia and Risperdal, you made the medical judgment that Risperdal was an appropriate medication for Ms. Taylor?
A. Correct.
Q. And that is even with the knowledge of the risk associated?
A. Correct. Because the benefit was much greater than 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.
Q. And despite that, you did, nonetheless, warn Ms. Taylor and her daughter, Brenda Fortenberry, of the risk of tardive dyskinesia with Risperdal?
A. Correct.

         ¶28. Taylor sought to prove that the warning was inadequate by way of Janssen's promotional materials, internal documents, and expert testimony. Dr. William Edwin Fann, an academic psychiatrist and academic physician, testified for Taylor. Dr. Fann testified that the Food and Drug Administration Risperdal class warning label was cookie cutter information and meaningless because it was marketed as "atypical." Dr. Fann testified:

[Y]ou could go through the PDR, Physicians' Desk Reference, or go through the U.S. Pharmaceutical and Drug Information, and that same information is there on every anti-psychotic. It was required. That doesn't mean as much as it sounds like it means. Because all of this has been gained, that is, not erased but balanced, counter-balanced by saying it's an atypical. To say this drug is as likely to cause tardive dyskinesia as any of the others, but it's a -- you know, those that's what some people would call cookie-cutter information. That's something you're saying about every drug.

         ¶29. Taylor's attempt to prove her failure to warn claim through Janssen's marketing materials and internal documents expanded the claim beyond the statutory scope of the Products Liability Act. Based on the terms of the Act, enacted in 1993, the only pertinent question is whether the prescription drug label contained adequate warnings or instructions. See Miss. Code Ann. § 11-1-63(c)(i)-(ii) (Rev. 2014).

         ¶30. Although the statutory scope of a failure to warn claim is limited to actual warnings or instructions for a product, the Court has mentioned marketing materials in the prescription drug context. In a pre Products Liability Act case, the Court stated: "Notwithstanding the government regulations in this field, the package insert is a marketing or merchandising procedure to promote sales." Thompson v. Carter, 518 So.2d 609, 612 (Miss. 1987) (holding that a package insert was admissible in a medical malpractice case). Moreover, the Court stated, "[d]rug manufacturers have had to answer for alleged dilution of warnings by over-promotion in sales programs." Id.

         ¶31. In Bailey, a post-Act case, the Court alluded to the association of prescription drug marketing materials in the context of a failure to warn claim. There, the Court reversed and remanded for severance and new trial of the claims of ten plaintiffs based on improper joinder, and the Court discussed pertinent principles of an inadequate warning case against a prescription drug manufacturer. Bailey, 878 So.2d at 49 (¶ 88). The plaintiffs contended that they had offered sufficient proof to show that, through aggressive marketing and over promotion, the drug manufacturer had nullified the effectiveness of the warnings that it did issue. Id. at 55 (ΒΆ 109). The Court concluded that the issue of whether the Food and Drug Administration approved labeling was adequate, was a question of fact which should be determined by ...

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