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Trejo v. Johnson & Johnson

California Court of Appeals, Second District, Fourth Division

June 30, 2017

CHRISTOPHER TREJO, Plaintiff and Respondent,
JOHNSON & JOHNSON et al., Defendants and Appellants.

         APPEAL from a judgment of the Superior Court of Los Angeles County No. YC058023 Robert H. O'Brien, Judge. Reversed and remanded.

          Law Offices of Brian D. Witzer, Inc., Brian D. Witzer, Jeffrey E. Zinder and Michael P. Manapol for Plaintiff and Respondent.

          Butler, Snow, O'Mara, Stevens & Cannada, Kari L. Sutherland; Drinker Biddle & Reath, Thomas W. Pulliam, Jr., Vernon I. Zvoleff, Alan J. Lazarus, Kenneth P. Conour, Benjamin J. Holl; O'Melveny & Myers, Catalina J. Vergara and Charles C. Lifland for Defendants and Appellants.

          WILLHITE, J.

         After taking Motrin, an over-the-counter ibuprofen medication manufactured and sold by McNeil Consumer Healthcare (McNeil), plaintiff Christopher Trejo suffered a reaction in the form of a rare skin disease, Stevens-Johnson Syndrome, and the more severe variant, Toxic Epidermal Necrolysis (collectively SJS/TEN).[1] He sued McNeil and its corporate parent, Johnson & Johnson, on various theories of products liability, four of which went to trial: strict liability failure to warn and negligent failure to warn, based on defendants' failure to include the symptoms of SJS/TEN (skin reddening, rash, and blisters) on Motrin's warning label, and strict liability design defect and negligent design defect, based on McNeil's failure to sell an allegedly safer product, dexibuprofen (an isomer or component of ibuprofen) rather than ibuoprofen.

         Returning a special verdict, the jury found McNeil liable for negligent failure to warn (but not for strict liability failure to warn), negligent design defect, and strict liability design defect under the consumer expectation test (but not under the risk-benefit test). The jury found Johnson & Johnson liable for strict liability design defect on a consumer expectation theory (but not on a risk-benefit theory), and not liable on plaintiff's other claims.

         In this appeal by defendants, we hold that the jury's verdict finding McNeil liable for negligent failure to warn must be reversed because it is fatally inconsistent with the verdict finding McNeil not liable for strict liability failure to warn. Accordingly, we reverse the negligent failure to warn verdict, and remand for a new trial on the claims against McNeil for negligent and strict liability failure to warn. We also conclude that the negligent failure to warn special verdict was defective on a second ground: the failure to include the necessary question whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger (an issue we consider because there might be a retrial).

         Further, we hold that the verdicts against McNeil for negligent and strict liability design defect, as well as against Johnson & Johnson for strict liability design defect, must be reversed, because the design defect claims were based on a theory-failure to sell dexibuprofen-that is impliedly preempted by the United States Supreme Court's decision in Mutual Pharmaceutical Co., Inc. v. Bartlett (2013) __ U.S. __, 133 S.Ct. 2466, 2473 (Bartlett). We also conclude that the strict liability design defect verdicts must be reversed on a second ground: the jury found McNeil and Johnson and Johnson liable solely under the consumer expectation test, but that test does not apply when, as here, the question of design defect involves complex questions of feasibility, practicality, risk, and benefit beyond the common knowledge of jurors. Accordingly, we reverse the verdicts finding McNeil liable for negligent and strict liability design defect, and finding Johnson and Johnson liable for strict liability design defect. Because plaintiff's negligent and strict liability design defect claims are preempted, and because the only theory of strict liability design defect found by the jury (the consumer expectation test) does not apply, none of plaintiff's design defect claims can be retried.

         Therefore, the ultimate disposition is that the judgment as to McNeil and Johnson and Johnson is reversed, and the case is remanded for retrial on the sole remaining claims in the case: those against McNeil for negligent and strict liability failure to warn.


         I. Factual Background

         A. Ibuprofen

         Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It was approved by the Food and Drug Administration (FDA or agency) for prescription use in the United States to treat arthritis and pain in 1974, and for over-the-counter (OTC) use in 1984. Both prescription and OTC ibuprofen are composed of the same ingredient, differing only in the dosage amounts. In 2006, the FDA estimated that approximately 29 million prescriptions for ibuprofen were dispensed per year, and that OTC ibuprofen had approximately 100 million users per year.

         There are many different OTC ibuprofen products, both generic and brand name, sold by various companies. They all have the same labeling, regardless of the manufacturer. Motrin is a brand name ibuprofen product. McNeil acquired the right to produce Motrin from the Upjohn Manufacturing Company before the events giving rise to this action. In 1994, the FDA approved McNeil's application for OTC ibuprofen gelcaps, concluding “the drug is safe and effective for use as recommended in the submitted labeling.”

         Regarding the risk of SJS and TEN from taking ibuprofen, in 1989, the FDA provided McNeil with a medical officer review informing the company that, in 1982, 10 billion doses of ibuprofen were used worldwide, and that SJS was an adverse reaction reported with ibuprofen products at a rate of less than one percent. The labeling approved by the FDA in the 1980's for prescription ibuprofen contained a reference to SJS and TEN as possible adverse events. However, the FDA-approved label for OTC ibuprofen did not refer to SJS, TEN, skin reddening, rash or blisters. The labels differed because prescription labeling is intended for use by physicians, while OTC labeling is aimed at consumers.

         The warning label on the bottle of OTC Motrin plaintiff took in October 2005 included the following FDA-approved warnings and instructions:


         “Allergy alert: Ibuprofen may cause a severe allergic reaction which may include:

         “• hives • facial swelling • asthma (wheezing) • shock...

         “Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer....

         “Stop use and ask a doctor if

         “• an allergic reaction occurs. Seek medical help right away.

         “• pain gets worse or lasts more than 10 days

         “• fever gets worse or lasts more than 3 days

         “• stomach pain or upset gets worse or lasts

         “• redness or swelling is present in the painful area

         “• any new symptoms appear”

         The label did not include specific warnings about skin reddening, rash, and blisters as possible allergic reactions. According to McNeil, the FDA did not require such a specific warning for OTC products prior to 2005 because the warning to seek medical help if any new symptoms appeared was a broader warning that included these symptoms. McNeil did not seek permission from the FDA to add SJS or TEN to its OTC labels. On one occasion before 2005, it had asked the FDA for permission to change the allergy alert language, but the agency advised it not to do so.

         In July 2005, the FDA made a “class label change, ” directing McNeil and other manufacturers of OTC ibuprofen products to change their labels within six months to add three additional symptoms-skin reddening, rash, and blisters. McNeil made the requested changes to its labels.

         B. Plaintiff's Use of Motrin

         Plaintiff was born in November 1988 and lived in Honduras with his grandmother, great-grandmother, and sister. His mother, Naara Silver, lived in the United States with her husband and other children and occasionally sent plaintiff care packages that included OTC medication. In 2005, Silver purchased OTC Motrin and sent it to plaintiff. She had never purchased Motrin before, but she wanted her grandmother to try it for her arthritis pain. Silver testified that she would not have bought Motrin had she known of the possibility of blisters because her grandmother was elderly and had delicate skin.

         In October 2005, plaintiff experienced aches and soreness in his legs after a strenuous soccer practice. Plaintiff took half a tablet of aspirin and took a nap. Plaintiff took aspirin for two days because he continued to feel sore and very warm, but he stopped taking it after reading the label's warning about Reye's Syndrome.

         Plaintiff continued to experience fever and muscle pain. He found Motrin in the medicine cabinet and read the label because he had never taken it before. After seeing that Motrin would treat pain and fever, plaintiff took one pill and felt better. However, his symptoms returned after a four-hour nap, so he took another Motrin and slept through the night. The following morning, he was warm and his legs hurt, so he took a third Motrin and continued to take it for two more days. When he awakened on the second day, he noticed blisters in his mouth. One of the blisters broke and started bleeding, so he asked his grandmother to take him to the doctor. He did not take any more Motrin.

         Plaintiff testified that if there had been a warning about blisters on Motrin's label, he would not have taken it because he knew that blisters were painful and could lead to an infection. He also testified that a warning about skin reddening and rash would have convinced him not to take Motrin because he was a teenager and would not have wanted blisters or rash on his face. He acknowledged that he read the label, which included warnings about hives and facial swelling, and he took the Motrin even though he understood that facial swelling would affect his appearance.

         Plaintiff was hospitalized in Honduras for about 10 days until November 4, 2005, when he was transferred to Shriners Hospital for Children in Galveston, Texas. When plaintiff arrived in Texas, he had blisters or open wounds over most of his body. He was treated for TEN and discharged on November 27, 2005.

         C. SJS/TEN

         The disease from which plaintiff suffered, SJS/TEN, is a rare disease, thought to be an allergic reaction to a drug. SJS and TEN are part of the same disease spectrum, differing only in severity.[2] The initial signs of SJS/TEN include fever, malaise, redness of the skin, rash, and blisters, known as non-specific symptoms. The early symptoms last several days before the disease fully develops. Because various drugs may be taken to treat the early, non-specific symptoms, it is difficult to determine the cause of SJS and TEN.

         At trial, one of plaintiff's experts, Roger Salisbury, opined that plaintiff's TEN was caused by the Motrin he consumed and not by any environmental factors. Another plaintiff's expert, Randall Tackett, testified that he did not believe the aspirin and Tylenol that plaintiff consumed contributed to his disease. He stated that TEN is referred to as an idiosyncratic side effect that can occur at a dosage even lower than the minimum recommended dosage. Tackett described the mechanism by which he believed ibuprofen caused plaintiff's TEN, explaining that NSAIDs affect a chemical in the body related to inflammation, leading to an immune system process and a reaction affecting a chemical compound known as tumor necrosis factor.

         D. FDA Safety Review and Citizen's Petition

         In early 2005, the FDA undertook a comprehensive safety review of NSAIDs, including ibuprofen. In February 2005, Salisbury, Tackett and several experts involved in other Motrin litigation, submitted a Citizen's Petition to the FDA and McNeil, asserting that the label on OTC Motrin should contain a warning about SJS and TEN. Salisbury asked the FDA to conduct a risk assessment of SJS/TEN, to investigate whether manufacturers had withheld “critical safety information regarding the risks of SJS and TEN associated with ibuprofen products, ” and to require manufacturers to add warnings of SJS/TEN to their labeling.

         The FDA responded to the petition in a detailed letter dated June 22, 2006. The agency explained that in April 2005, it issued a press release, a public health advisory, and a decision memo explaining the risks of NSAID products but emphasizing the need for a wide variety of NSAID options. The agency decided to ask prescription NSAID manufacturers to change their labels to include additional warnings about SJS/TEN. As to OTC NSAIDs, the FDA decided to warn consumers about the risks of severe skin reactions but did not believe it was useful to use the terms “SJS” and “TEN” because most consumers are not familiar with those terms. The agency thus decided to add warnings about skin reddening, rash, and blisters to OTC NSAID labels.

         The FDA disputed Salisbury's estimate that there are 49-60 per million cases of SJS per year, stating instead that there are 1.2 to 6 per million cases of SJS per year and 0.4 to 1.2 per million of TEN per year. The agency's estimate was based on its review of the Adverse Event Report System database, which revealed 88 cases from 1975 through March 2005, of which 49 were possibly related to the use of ibuprofen. Given that “there are approximately 29 million prescriptions dispensed per year in the U.S. retail setting for prescription single-ingredient ibuprofen... and probably more than 100 million users of OTC ibuprofen per year, ” the FDA concluded that the risk of SJS/TEN was much lower than Salisbury had asserted.

         The FDA further disputed Salisbury's assertion that the mortality rate for SJS was 5 to 30 percent and 80 percent for TEN. Instead, the agency asserted that SJS was fatal in 5 percent of cases and TEN in 30 percent of cases. Salisbury acknowledged at trial that the mortality rate for TEN patients at his burn center was actually 30 percent or lower, not 80 percent.

         In response to the petition's assertion that manufacturers withheld safety information about SJS/TEN, the FDA stated that Salisbury provided no evidence, and the FDA had no evidence of undisclosed safety information. Salisbury acknowledged at trial that he was not aware of any adverse event report received by McNeil that it failed to report to the FDA.

         The FDA disagreed with Salisbury's statement that the agency should “reconsider the OTC status of the pediatric formulation of ibuprofen” because “the incidence of SJS or TEN is not as great as cited.” The agency further explained that “the overall benefit versus risk profile for ibuprofen products remains very favorable when they are used according to the labeled instructions. It is in the interest of the public health to maintain in the pediatric OTC market a range of therapeutic options for the short-term relief of pain.”

         E. Dexibuprofen as an Alternative to Ibuprofen

         Tackett testified that dexibuprofen, an isomer or component of ibuprofen, “appears to be a safer product” with fewer side effects than ibuprofen. He believed that defendants should have withdrawn ibuprofen and marketed dexibuprofen instead, even though the FDA has not approved dexibuprofen for sale in the United States. Tackett testified that when the FDA denied an application to market dexibuprofen, it was not due to a safety issue but because it “had not been put forward as a prescription drug first, which is the usual way things... go from prescription to over the counter.”

         Tackett opined that, unlike dexibuprofen, Motrin contained a component called racemic ibuprofen that contributed to SJS/TEN, and that dexibuprofen was not associated with SJS/TEN. However, a prescription label for dexibuprofen, which was sold outside the United States, contained a warning for SJS/TEN. Tackett acknowledged that dexibuprofen use was much lower than ibuprofen, which had been used several billion times.

         II. Procedural History

         A jury trial commenced in August 2011 on plaintiff's claim that he developed SJS/TEN as a result of taking Motrin. He alleged claims for strict liability failure to warn, negligent failure to warn, negligent design defect, and strict liability design defect based on the consumer expectation test and the risk-benefit test.[3]

         The jury found McNeil liable for negligent failure to warn, strict liability design defect under the consumer expectation test, and negligent design defect. As to Johnson & Johnson, the jury found in favor of plaintiff only on his strict liability design defect claim under the consumer expectation test. The jury awarded plaintiff $11, 401, 220 in economic damages, $21, 166, 660 in non-economic damages, $6, 833, 330 in punitive damages against McNeil, and $8, 791, 670 in punitive damages against Johnson & Johnson.

         After polling the jurors on their verdicts, the trial court asked if there was any reason why the jury should not be discharged. Defense counsel stated, “Other than about the verdict being fatally inconsistent.” The court replied, “Anything else. Other than that.” Defense counsel said no, and the court discharged the jury. The court subsequently asked counsel to put their objections on the record, which they did, arguing that the verdicts on negligent and strict liability failure to warn were fatally inconsistent. As later explained in the trial court's order denying defendants' motion for new trial, defendants raised the issue of inconsistent verdicts in an unreported chambers discussion before the jury was discharged, but the court did not find the verdicts to be inconsistent. Defendants timely appealed from the judgment.


         I. Inconsistent Verdicts on Negligent and Strict Liability Failure to Warn

         By special verdict, the jury found McNeil liable on plaintiff's claim for negligent failure to warn, but not liable on plaintiff's claim for strict liability failure to warn. McNeil contends that the verdicts are inconsistent, and that therefore the verdict of liability on the negligence theory must be set aside. For the reasons explained below, we agree.[4]

         A. Inconsistency in Special Verdicts

         “‘“The inconsistent verdict rule is based upon the fundamental proposition that a factfinder may not make inconsistent determinations of fact based on the same evidence....” [Citations.] An inconsistent verdict may arise from an inconsistency between or among answers within a special verdict [citation] or irreconcilable findings. [Citation.] Where there is an inconsistency between or among answers within a special verdict, both or all the questions are equally against the law. [Citation.] The appellate court is not permitted to choose between inconsistent answers.' [Citation.]” (Oxford v. Foster Wheeler LLC (2009) 177 Cal.App.4th 700, 716 (Oxford).)

         “The proper remedy for an inconsistent special verdict is a new trial. [Citation.]” (Singh v. Southland Stone, U.S.A., Inc. (2010) 186 Cal.App.4th 338, 358 (Singh).) “A court reviewing a special verdict does not infer findings in favor of the prevailing party [citation], and there is no presumption in favor of upholding a special verdict when the inconsistency is between two questions in a special verdict. [Citation.]” (Zagami, Inc. v. James A. Crone, Inc. (2008) 160 Cal.App.4th 1083, 1092 (Zagami).) The standard of review for inconsistency in a special verdict is de novo.[5] (Cumbre, Inc. v. State Comp. Ins. Fund (2010) 189 Cal.App.4th 1381, 1388.)

         B. Products Liability Failure to Warn

         Products liability may be premised upon a theory of design defect, manufacturing defect, or failure to warn. (Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 995 (Anderson).) “[A] plaintiff may seek recovery in a ‘products liability case' either ‘on the theory of strict liability in tort or on the theory of negligence.' [Citations.] The rules of products liability ‘focus responsibility for defects, whether negligently or nonnegligently caused, on the manufacturer of the completed product.' [Citation.] Thus, under either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury. [Citations.] Under a negligence theory, a plaintiff must also prove ‘an additional element, namely, that the defect in the product was due to negligence of the defendant.' [Citations.]” (Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 478-479 (Merrill); Brown v. Superior Court (1988) 44 Cal.3d 1049, 1056 (Brown) [“Strict liability differs from negligence in that it eliminates the necessity for the injured party to prove that the manufacturer of the product which caused injury was negligent.”].) “‘Ordinarily, strict liability, which was developed to ease a claimant's burden of proof, requires proof of fewer elements than negligence, making a positive verdict on the latter difficult to explain if strict liability cannot be found.'” (1 Owen & Davis on Prod. Liab. (4th ed. 2016) § 5:29, fn. 25.)

         The failure to warn theory of products liability is based on the premise that “‘a product, although faultlessly made, may nevertheless be deemed “defective” under the rule and subject the supplier thereof to strict liability if it is unreasonably dangerous to place the product in the hands of a user without a suitable warning and the product is supplied and no warning is given.' [Citation.]” (Anderson, supra, 53 Cal.3d at pp. 995-996.) “Whether the absence of a warning makes a product defective involves several factors, including a consumer's normal expectations of how a product will perform; degrees of simplicity or complication in its operation or use; the nature and magnitude of the danger to which the user is exposed; the likelihood of injury; and the feasibility and beneficial effect of including such a warning. [Citation.]” (Oxford, supra, 177 Cal.App.4th at p. 717.)

         C. The Jury's Verdicts

         In the present case, the evidentiary basis of plaintiff's failure to warn theory for both strict liability and negligence was that OTC Motrin was defective because its warning label did not include the potential side effects of skin reddening, rash and blisters. In returning a special verdict finding McNeil not liable on a theory of strict liability failure to warn, the jury found that OTC Motrin had “potential risks, side effects and/or allergic reactions that were known or knowable through the use of scientific knowledge available at the time of manufacture, distribution or use by Christopher Trejo, ” that “ordinary consumers [would not] have recognized the potential risks, side effects and/or allergic reactions, ” and that “McNeil fail[ed] to adequately warn or instruct of [sic] the potential risks, side effects and/or allergic reactions.” But in response to question 6 on verdict form, the jury answered “no” to the query: “Did the potential risks, side effects, and/or allergic reactions present a substantial danger when the OTC Motrin is used or misused in an intended or reasonably foreseeable way?”[6] This “no” response-i.e., that OTC had no potential risks that caused a substantial danger when used in a foreseeable way-compelled a verdict in McNeil's favor, because under the jury instructions for strict liability, OTC Motrin lacked adequate warnings only if it “had potential risks/side effects/allergic reactions that were known or knowable by the use of scientific knowledge available at the time of manufacture/distribution/sale, ” and if those reactions “presented a substantial danger when the Motrin is used or misused in an intended or reasonably foreseeable way.”[7] (Italics added.)

         By contrast, the jury found McNeil liable on plaintiff's cause of action for negligent failure to warn. In returning that special verdict, the jury found (in response to question 8) that McNeil knew or “should... reasonably have known that OTC Motrin was dangerous or was likely to be dangerous when used in a reasonably foreseeable manner.” The jury also concluded that McNeil knew or “should... reasonably have known that users would not realize the danger, ” and McNeil's “failure to warn [was] a substantial factor in causing harm to [plaintiff].” These findings compelled a verdict for plaintiff on the negligent failure to warn claim, because under the jury instructions for that claim, McNeil was liable if it “knew or reasonably should have known that the Motrin was dangerous or was likely to be dangerous when used or misused in a reasonably foreseeable manner, ” but failed to warn of the danger under circumstances in which a reasonable manufacturer would have warned.

         Considering that both the strict liability and negligence theories were premised on a single alleged defect-failure to warn of potential skin reddening, rash and blisters-the jury's findings meant, in substance, that McNeil was not strictly liable for failure to warn of those possible reactions because they created no substantial danger, but was liable for negligent failure to warn because those possible reactions were, or were likely to be, dangerous. As we next explain, we conclude that these verdicts are fatally inconsistent. (See Oxford, supra, 177 Cal.App.4th at p. 720 [“a finding of negligent failure to warn is logically and legally inconsistent with the jury's finding [in favor of defendants] on plaintiffs' strict products liability failure to warn”]; Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1483 (Valentine) [“the manufacturer's strict liability duty to warn is greater than its duty under negligence, and thus negligence requires a greater showing by plaintiffs”]; Lambert, supra, 67 Cal.App.4th at pp. 1185-1186 [jury's finding of negligent design inconsistent with its finding of no strict liability design defect].)

         D. The Verdicts are Inconsistent

         The decision in Valentine, supra, 68 Cal.App.4th 1467 is particularly instructive, and virtually indistinguishable in all pertinent aspects from the present case. As here relevant, the plaintiff in Valentine sued a manufacturer of silicone gel breast implants for strict liability and negligent failure to warn, based on the manufacturer's failure to warn her physician (and through him, her) that the migration or bleeding of silicone from implants might cause disease. The case was tried twice. The first jury returned a special verdict for the defense on the plaintiff's strict liability failure to warn claim, but deadlocked on negligent failure to warn. After the declaration of a mistrial, the negligent failure to warn claim was tried to a second jury. That jury deadlocked as well, and the trial court directed a defense verdict on that claim.

         On appeal, the appellate court considered whether “the defense verdict in the first trial on strict liability failure to warn subsume[d] the cause of action for negligent failure to warn so that the court presiding over the second trial was within its authority to direct a defense judgment on that negligence count.”[8] (Valentine, supra, 68 Cal.App.4th at p. 1471.) The court concluded that the defense verdict on strict liability failure to warn mandated a defense verdict on negligent failure to warn as well.

         For strict liability failure to warn, the jury in Valentine was instructed in part that “‘[a] product is defective if the use of the product in a manner that is reasonably foreseeable by the defendant involves a substantial danger that would not be readily recognized by the ordinary user of the product and the manufacturer knows or should have known of the danger but fails to give adequate warning of such danger.... A manufacturer has a duty to provide an adequate warning to the user on how to use the product if a reasonably foreseeable use of the product involves a substantial danger of which the manufacturer is either aware or should be aware, and that would not be recognized by the ordinary user.” (Valentine, supra, 68 Cal.App.4th at p. 1481.)

         For negligent failure to warn, the jury was instructed that a supplier who “‘knows or has reason to know [the product] is dangerous or is likely to be dangerous for the use for which it is supplied, has a duty to use reasonable care to give warning of the dangerous condition of the product or of facts which make it likely to be dangerous to those who the supplier would expect to use the product or to be endangered by its probable use, if the supplier has reason ...

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