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
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. ----,
FACTUAL AND PROCEDURAL BACKGROUND
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
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:
"Warnings"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
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 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.
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
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
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
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.
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.
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.
DISCUSSION
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.
" ' "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)
"The proper remedy for an inconsistent special verdict is a new trial. [Citation.]" ( Singh v. Southland Stone, U.S.A., Inc. (2010)
Products liability may be premised upon a theory of design defect, manufacturing defect, or failure to warn. ( Anderson v. Owens-Corning Fiberglas Corp. (1991)
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,
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
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
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,
D. The Verdicts are Inconsistent
The decision in Valentine , supra ,
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."
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
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 to believe that they will not realize its dangerous condition.' " ( Valentine , supra , 68 Cal.App.4th at pp. 1481-1482,
Under these instructions (as pertinent here),
The court explained: "The [trial] court defined a product as defective if its use involved a substantial danger that would not be readily recognized by the ordinary user and the manufacturer knows/should have known of the danger but fails to warn. Under the negligence warning instructions, the manufacturer was charged with knowing/having reason to know that the product is dangerous or likely to be dangerous for its intended use." ( Valentine , supra ,
Similarly, the court reasoned that "the finding of the [first] jury [for strict liability purposes] that the implants were not defective due to Baxter's [the manufacturer's] failure to warn included the finding that Baxter discharged its duty to warn of
The court also concluded "the 'known or knowable in light of' language in the strict liability instruction at a minimum encompasses the 'knows or has reason to know' language in the negligence instruction. Under a negligence standard, a reasonable manufacturer would not be charged with knowing more than what would come to light from the prevailing scientific and medical knowledge.... 'Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Thus, in strict liability, as opposed to negligence, the reasonableness of the defendant's failure to warn is immaterial.' " ( Valentine , supra , 68 Cal.App.4th at pp. 1483-1484,
On the other hand, for strict liability in Valentine, the jury instructions permitted a finding of liability if "use [of the product] involved a substantial danger that would not be readily recognized by the ordinary user and the
Given that the jury here was instructed on the same principles as in Valentine, the same conclusions necessarily flow from the jury's finding in its strict liability verdict that "the potential risks, side effects, and/or allergic reactions" of OTC Motrin-skin reddening, rash and blisters-did not "present a substantial danger when the OTC Motrin is used or misused in an intended or reasonably foreseeable way." As in Valentine : (1) the strict liability instructions "more than subsumed the elements of duty to warn set forth in the negligence instructions" ( Valentine , supra ,
If there were any doubt that the verdicts are inconsistent, that doubt is put to rest by the decision in Oxford, supra,
In the present case, unlike Oxford , plaintiff did not pursue a general negligence claim based on different factual bases, but rather a specific claim of negligent failure to warn based on a single factual basis-the failure to include warnings of skin reddening, rash, and blisters. Further, the jury returned a special verdict, not a general verdict. Thus, we need not ask whether the jury's finding of negligence can be supported on some factual basis other than failure to warn; we know it cannot. Under these circumstances, as in Oxford, the jury's finding of negligent failure to warn was "logically and legally inconsistent" with the finding of no strict products liability failure to warn. ( Oxford , supra ,
Plaintiff also argues that the verdicts are not inconsistent because the term "danger" in the negligence instructions and in question 8 of the negligence special verdict referred to a different type of danger than "substantial danger" as referred to in the strict liability instructions and in question 6 of the strict liability verdict. According to plaintiff, "substantial danger" for strict liability is a quantitative danger and refers to how rare the disease is, while "danger" for negligence purposes is a qualitative danger and refers to how severe the disease is. Thus, in plaintiff's view, the jury could have concluded for strict liability that the risk of skin reddening, rash and blisters from SJS/TEN was not a substantial danger because it was such a rare reaction, but at the same time concluded for negligence that such a reaction was a danger because of its severity. To support this supposed dichotomy, plaintiff relies on Cavers v. Cushman Motor Sales, Inc. (1979)
In Cavers, the court rejected the plaintiff's challenge to a jury instruction on strict liability failure to warn, which gave guidance on the concept of substantial danger: " 'Whether a danger is substantial or insubstantial must be determined from the evidence and measured in the light of several criteria none of which is totally controlling including the potential injurious consequences of such danger, the likelihood that injury might result, the quality and extent of danger to which the user is exposed, and whether a danger is latent or patent (patent means apparent and latent is its antonym).' " ( Cavers , supra ,
For several reasons, plaintiff's attempt to draw a quantitative-qualitative distinction between "substantial danger" and "danger" fails. First, the jury instruction on negligence itself defeats the claim that "danger" for negligence purposes referred to a qualitative danger, that is, the severity of the potential reaction. Under the instructions, liability was premised on
Third, plaintiff relies on Cavers for the proposition that "the term 'substantial danger' embraces several criteria, 'none of which is totally controlling.' " But even if this concept had been explained to the jury, it directly contradicts plaintiff's argument on appeal that "substantial danger" in the strict liability failure to warn instructions and verdict refers only to a singular type of danger-a quantitative danger, meaning how rare SJS/TEN is. Fourth, as we have noted, under the reasoning of Valentine, there is no "real difference between a warning to ordinary users about a product use that involves a substantial danger, and a warning about a product that is dangerous or likely to be dangerous for its intended use." ( Valentine , supra ,
II. Failure to Include Question on Duty to Warn
Although we reverse the verdict on negligent failure to warn as inconsistent with the verdict on strict liability failure to warn, in the event of a retrial, we also consider defendants' contention that the special verdict for negligent failure to warn was defective for failing to include an essential element: whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger. We agree that the verdict form was defective.
" '[A] special verdict is that by which the jury find the facts only, leaving the judgment to the Court. The special verdict must present the conclusions of fact as established by the evidence, and not the evidence to prove them; and those conclusions of fact must be so presented as that nothing shall remain to the Court but to draw from them conclusions of law.' ( Code Civ. Proc., § 624.) [¶] ... 'A special verdict is "fatally defective" if it does not allow the jury to resolve every controverted issue. [Citations.]'
Defendants' proposed verdict form for negligent failure to warn included the following question: "Would a reasonable manufacturer, distributor or seller under the same or similar circumstances have warned of the danger of or instructed on
On appeal, plaintiff contends that the special verdict form did require the jury to consider appellants' duty to warn, despite the omission of the question. He cites question 5(a), under the Strict Liability-Failure to Warn portion of the special verdict form: "Did McNeil fail to adequately warn or instruct of the potential risks, side effects and/or allergic reactions ?" He also cites question 10, under the Negligence-Failure to Warn portion of the form: "Was [McNeil's] failure to warn a substantial factor in causing harm to [plaintiff]?" He contends that the jury's findings on these questions sufficiently answer whether a reasonable manufacturer would have provided the warning. Plaintiff further argues that the jury instruction on a reasonable manufacturer's duty to warn rendered it unnecessary to include the question on the verdict form. None of these contentions is meritorious.
First, question 5(a), regarding strict liability failure to warn, is irrelevant to whether the special verdict form omitted an element as to negligent failure to warn. " 'Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct.' " ( Carlin , supra ,
Second, question 10, asking whether McNeil's failure to warn was a substantial factor in causing plaintiff harm, deals with causation and does not
Third, that the jury instruction on negligent failure to warn defined a reasonable manufacturer's duty to warn did not obviate the necessity of including that required element in the special verdict. "A jury instruction alone does not constitute a finding. Nor does the fact that the evidence might support such a finding constitute a finding." ( Myers Building Industries, Ltd. v. Interface Technology, Inc. (1993)
Plaintiff relies on Amerigraphics, Inc. v. Mercury Casualty Co. (2010)
Amerigraphics is distinguishable. Unlike Amerigraphics , the jury's findings here regarding strict liability to warn and causation do not "necessarily include[ ]" a finding regarding whether a reasonable manufacturer would have added a warning about skin reddening, rash, and blisters to an ibuprofen
Instead, the situation here is similar to Fuller-Austin and Saxena v. Goffney (2008)
Similarly, in Saxena , the court reversed a special verdict that did not require the jury to make a finding on the plaintiff's battery claim. ( Saxena , supra ,
Similar to Fuller-Austin and Saxena , whether a reasonable ibuprofen manufacturer would have added a warning about skin reddening, rash, and blisters was a controverted issue not addressed by the special verdict form. As in Fuller-Austin , the defective verdict "affords an additional basis for reversal" of the jury's negligent failure to warn findings. ( Fuller-Austin, supra ,
At oral argument, plaintiff argued that under Babcock v. Omansky (1973)
According to the appellate opinion, the jury was presented with "special verdicts (in response to pertinent interrogatories)." ( Babcock, supra ,
On appeal, Leon contended that the judgment was void because in these two findings, the jury made conclusions of law, not fact. As to the first finding, Leon argued that the verdict should have asked the jury to make findings on each element of fraud. The court disagreed: "Although, as pointed out by Leon, the court in its own motion instructed the jury on all such elements ..., we do not believe that a cumbersome interrogatory embracing each of the several elements was necessarily required. Said the court in McCloud v. Roy Riegels Chemicals ,
For several reasons, Babcock is of no aid to plaintiff. First, despite the appellate court's description of the verdict as a special verdict, the jury's findings at issue were in the nature of a general verdict (one in which findings
Third, to the extent Babcock 's reasoning may apply to a special verdict, it does not apply here. In Babcock, the jury was asked to find in general terms the "ultimate fact" whether fraud occurred. Because the question was so phrased, the appellate court could conclude that the verdict form permitted the jury to resolve every controverted issue regarding fraud under the jury instructions. But in the present case, the jury was not asked generally to find whether McNeil was negligent. The jury was asked to make findings on specific elements of the negligence cause of action-all elements except the fundamental question, which was contested at trial, whether a reasonable manufacturer in the same or similar circumstances would have warned of the danger. In that circumstance, the verdict was clearly defective, because it cannot be inferred from the findings made by the jury that it resolved that controverted issue. " ' " 'The requirement that the jury must resolve every controverted issue is one of the recognized pitfalls of special verdicts. "[T]he possibility of a defective or incomplete special verdict, or possibly no verdict at all, is much greater than with a general verdict that is tested by special findings...." [Citation.]' [Citation.]" ' 'A special verdict is "fatally defective" if it does not allow the jury to resolve every controverted issue.' " ( J.P. v. Carlsbad Unified School Dist. (2014)
On remand, therefore, any special verdict form for negligent failure to warn must include a question regarding whether a reasonable manufacturer under the same or similar circumstances would have given a warning.
III. Design Defect Claims
In addition to his strict liability and negligent failure to warn theories at trial, plaintiff also sought recovery for design defect on strict liability and negligence theories. The alleged design defect for both claims was that
On appeal, defendants contend that under Ramirez v. Plough, Inc. (1993)
A. Design Defect Defined
"A design defect exists when the product is built in accordance with its intended specifications, but the design itself is inherently defective. [Citation.]" ( Chavez v. Glock, Inc. (2012)
" '[T]he Supreme Court [has] recognized two tests for proving design defect. The "consumer expectation test" permits a plaintiff to prove design defect by demonstrating that "the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner." [Citation.] ... [¶] 'The second test for design defect is known as the "risk-benefit test." Under this test, products that meet ordinary consumer expectations nevertheless may be defective if the design embodies an " 'excessive preventable danger.' " [Citations.]' " ( Chavez , supra ,
In Ramirez, supra, the plaintiff alleged that he suffered Reye's syndrome as a reaction to OTC children's aspirin, and sued the manufacturer for products liability based (as here relevant) on the manufacturer's failure to withdraw the aspirin from the market.
Defendants argue that Ramirez bars plaintiff's design defect claim because ibuprofen is approved by the FDA. However, Ramirez did not hold that the FDA's approval preempts all state law claims, but only that the FDA's judgment "deserves serious consideration." ( Ramirez , supra ,
Here, defendant's appeal is not from a grant of summary judgment, but rather from a jury verdict. Unlike the standard of review in Ramirez, therefore, which was de novo, our review is circumscribed by the rules governing an appeal from a judgment following a jury verdict, including the substantial evidence rule. In the present case, plaintiff did present to the jury evidence tending to contradict the FDA's conclusion concerning the safety of OTC Motrin. Much of plaintiff's case was directed to proving that OTC Motrin was unsafe without a label warning of skin reddening, rash and blisters. Moreover, Tackett testified that dexibuprofen is an isomer or component of ibuprofen, and "appears to be a safer product" with fewer side effects than ibuprofen. Although the FDA denied an application to market dexibuprofen, that denial was not due to a safety issue, but rather to the failure to "put [the drug] forward as a prescription drug first, which is the usual way things ... go from prescription to over the counter." Tackett further testified that, unlike dexibuprofen, Motrin contained a component called racemic ibuprofen that contributed to SJS/TEN, and that dexibuprofen was not associated with SJS/TEN.
On this record, it is not for this court to declare, as a matter of law, that a jury could not disagree with the FDA's conclusions. The reasoning of Ramirez simply does not govern this case.
C. Brown
We likewise disagree that
The court's decision was based on the determination that neither of the two tests for strict liability design defect-consumer expectation and risk-benefit-should be applied to a prescription drug manufacturer. As for the consumer expectation test, the court reasoned that, assuming the manufacturer
As for the risk benefit analysis, the court conceded that the rationale of strict liability (to deter manufacturers from marketing unsafe products and to pass the cost of injury to all consumers, who will pay a higher price for the product because of a manufacturer's increased insurance burden) "could justify application of the doctrine to the manufacturers of prescription drugs. It is indisputable, as plaintiff contends, that the risk of injury from such drugs is unavoidable, that a consumer may be helpless to protect himself from serious harm caused by them, and that, like other products, the cost of insuring against strict liability can be passed on by the producer to the consumer who buys the item. Moreover, ... in some cases additional testing of drugs before they are marketed might reveal dangerous side effects, resulting in a safer product." ( Brown, supra,
Nonetheless, the court concluded that public policy weighed in favor of precluding imposition of strict liability on manufacturers of prescription drugs. The court observed that unlike non-medical products for which manufacturers had been held strictly liable in the past, which were "product[s] used to make work easier or to provide pleasure," prescription drugs "may be necessary to alleviate pain and suffering or to sustain life. Moreover, unlike other important medical products (wheelchairs, for example), harm to some users from prescription drugs is unavoidable. Because of these distinctions, the broader public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability for injuries resulting from their use. [¶] Perhaps a drug might be made
Relying on the public policy concerns expressed by Brown , courts have applied its exemption from strict liability design defect claims to manufacturers of a limited range of other products, including implanted prescription medical products ( Hufft v. Horowitz (1992)
We disagree that the rationale of Brown extends that far. A necessary predicate of Brown's public policy analysis, and that of Artiglio and Garrett , is intervention of a physician between the manufacturer and the patient. As recognized in Artiglio , "all of the drugs considered in Brown and following cases were stipulated, or assumed to be, available only by 'prescription.' The conclusion is that the imposition of the condition of 'prescription' provides insulation between the manufacturer and the user such as to warrant elimination of the consumer protections afforded by strict liability. We find the same to be true of medical prostheses, at least as to those in the category of devices available only through the services of a physician." ( Artiglio , supra ,
D. Federal Preemption
Although neither Ramirez nor Brown preempts plaintiff's claim, we conclude that plaintiff's design defect claim that defendants should have withdrawn Motrin from the market is preempted by the impossibility preemption analysis of the United States Supreme Court in Bartlett,
In his supplemental brief, plaintiff concedes that his "risk/benefit design-defect claim premised on the defendants' failure to use an alternative active ingredient in Motrin is preempted" under Bartlett .
For reasons we explain below, we conclude that the record does not support plaintiff's contention that the jury based its design defect finding on a failure to warn theory. We agree with plaintiff that his claim that defendants should have sold dexibuprofen instead of ibuprofen is preempted under Bartlett . We further conclude that the consumer expectation test was not properly applied in these circumstances.
Plaintiff's contention that his design defect claim was based in part on the theory of failure to warn is not supported by the record. He did not argue his design defect claim to the jury under a failure to warn theory, but under the theory that dexibuprofen was a safer product that defendants should have sold. Nor was the jury instructed to find design defect by the failure to warn. Rather, the jury was instructed separately on the design defect and failure to warn claims, and the design defect instructions did not refer to the warning label as a consideration.
Plaintiff relies on the negligence instruction on design defect, which instructed the jury to "balance what Johnson & Johnson and/or McNeil knew or should have known
Plaintiff also relies on the jury's finding of negligent failure to warn to support his contention that the negligent design defect verdict was based on the failure to warn. However, the jury's special verdict on negligent design defect did not refer to the warning label at all, and we cannot infer such a finding. (See Zagami , supra ,
2. General Principles of Federal Preemption
Having concluded that plaintiff's design defect claim was based on the theory that defendants should have sold dexibuprofen instead of ibuprofen,
"Under the supremacy clause of the United States Constitution, '[w]hen a state statute, administrative rule, or common-law cause of action conflicts with a federal statute, it is axiomatic that the state law is without effect. [Citations.]' [Citation.] 'In determining whether federal law preempts state law, a court's task is to discern congressional intent. [Citation.] Congress's express intent in this regard will be found when Congress explicitly states that it is preempting state authority. [Citation.] Congress's implied intent to preempt is found (i) when it is clear that Congress intended, by comprehensive legislation, to occupy the entire field of regulation, leaving no room for the states to supplement federal law [citation]; (ii) when compliance with both federal and state regulations is an impossibility [citation]; or (iii) when state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." [Citations.]' [Citations.] In addition, federal agency regulation with the force of law can preempt conflicting state requirements. [Citations.]" ( Eckler v. Neutrogena Corp. (2015)
Preemption of state product liability suits regarding OTC drugs is addressed by 21 United States Code section (U.S.C. §) 379r, which is entitled, "National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packing of Cosmetics." The statute "authorizes the FDA to regulate, among other things, the ingredients and labeling of nonprescription, over-the-counter (OTC) drugs.... Section 751 of the FDCA [Federal Food, Drug, and Cosmetic Act], codified at 21 United States Code section 379r(a), specifically prohibits state requirements that are not identical with federal requirements: 'no State ... may establish or continue in effect any requirement-[¶] (1) that relates to the regulation of a drug ... and [¶] (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter....' " ( Eckler , supra ,
The Supreme Judicial Court of Massachusetts came to the opposite conclusion in Reckis , supra ,
The federal district court in Batoh , supra ,
Our colleagues in Division Seven similarly stated regarding the FDCA that, " 'even where the express preemption provision in [ 21 U.S.C. § 379r ] is not applicable, implied preemption may arise [citation].' [Citation.]" ( Eckler , supra ,
3. Bartlett's Holding
The plaintiff in Bartlett asserted a New Hampshire design defect claim against the manufacturer of a generic prescription NSAID (sulindac ) after she contracted SJS/TEN. New Hampshire design defect law relied on the risk-utility test, under which " 'a product is defective as designed if the magnitude of the danger outweighs the utility of the product.' [Citation.]" ( Bartlett ,
Pertinent to the case before us, Bartlett rejected the appellate court's reasoning that the manufacturer "could escape the impossibility of complying with both its federal- and state-law duties by 'choos[ing] not to make [the drug] at all.' [Citation.]" ( Bartlett , supra ,
"Given the impossibility of redesigning sulindac, the only way for [the manufacturer] to ameliorate the drug's 'risk-utility' profile-and thus to escape liability-was to strengthen 'the presence and efficacy of [sulindac's]
4. Bartlett's Application to OTC Drugs
Bartlett concerned generic prescription drugs, not OTC drugs, and the Court noted the difference, stating that "the FDCA's treatment of prescription drugs includes neither an express pre-emption clause (as in the vaccine context, 42 U.S.C. § 300aa-22(b)(1) ), nor an express non-pre-emption clause (as in the over-the-counter drug context, 21 U.S.C. §§ 379r(e), 379s(d) ). In the absence of that sort of 'explicit' expression of congressional intent, we are left to divine Congress' will from the duties the statute imposes." ( Bartlett , supra ,
In Brown v. Johnson & Johnson , supra , the federal district court concluded that Bartlett 's holding did not extend to manufacturers of nonprescription drugs and therefore rejected the defendants' argument that federal law preempted the plaintiffs' claim that Children's Motrin was defectively designed. ( Brown v. Johnson & Johnson , supra ,
Consistent with our conclusion that the savings clause in 21 U.S.C. § 379r(e) does not prevent the applicability of ordinary
5. Impossibility Preemption Analysis
In determining whether impossibility preemption applies, we begin with the manufacturer's duties under state law. (See Bartlett , supra ,
Under plaintiff's theory, the design of Motrin was inherently defective because defendants used ibuprofen instead of dexibuprofen. However, federal law prohibited defendants from changing the design of Motrin by selling dexibuprofen without prior FDA approval.
According to Tackett's testimony in the present case, dexibuprofen is an isomer or component of ibuprofen. 21 C.F.R. section 310.3(h)(1) provides that "The newness of a drug may arise by reason (among other reasons) of: [¶] (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component." Dexibuprofen therefore would be a new drug, requiring a new drug application. (See Kanter v. Warner-Lambert Co. (2002)
In light of the statutes and regulations regarding new drug applications and preventing changes to drugs already approved by the FDA, defendants could not have "unilaterally changed the active ingredient of Motrin from ibuprofen to dexibuprofen to satisfy their state law duty" without violating federal law. ( Batoh , supra ,
Thus, under federal law-including
In his supplemental brief, plaintiff argues that Bartlett does not preempt his design defect claims because defendants could have strengthened the warning label without FDA approval. He cites the following language in Bartlett : "In cases where it is impossible-in fact or by law-to alter a product's design (and thus to increase the product's 'usefulness' or decrease its 'risk of danger'), the duty to render a product 'reasonably safe' boils down to a duty to ensure 'the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.' [Citation.]" ( Bartlett , supra ,
For the foregoing reasons, we conclude that plaintiff's design defect claim is preempted under Bartlett .
E. Consumer Expectation Test
Defendants argue that the trial court erred in instructing the jury on the consumer expectation test for design defect. We agree. "We review de novo claims of instructional error. [Citation.]" ( Romine v. Johnson Controls, Inc. (2014)
"[T]he consumer expectations test is reserved for cases in which the everyday experience of the product's users permits a conclusion that the product's design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design ." ( Soule , supra ,
In order to establish a design defect under the consumer expectation test when a " ' "product is one within the common experience of ordinary consumers," ' " the plaintiff must " ' "provide[ ] evidence concerning (1) his or her use of the product; (2) the circumstances surrounding the injury; and (3) the objective features of the product which are relevant to an evaluation of its safety." [Citation.] The test is that of a hypothetical reasonable consumer, not the expectation of the particular plaintiff in the case.' " ( Mansur v. Ford Motor Co. (2011)
In Mansur , the court affirmed the trial court's decision not to instruct the jury on the consumer expectation test in the plaintiffs' design defect action following the rollover of their vehicle. ( Mansur , supra ,
In Soule , the plaintiff sued the manufacturer of her car after she was injured in an accident, alleging that the defective design of the car caused her injuries. The California Supreme Court held that the jury should not have been instructed on the consumer expectation test because the plaintiff's "theory of design defect was one of technical and mechanical detail. It sought to examine the precise behavior of several obscure components of her car under the complex circumstances of a particular accident." ( Soule , supra ,
Similarly, in Morson , supra , the court held that the consumer expectation test did not apply to the plaintiffs' design defect claim against manufacturers of latex gloves. ( Morson , supra ,
Morson explained that "[t]he clear trend of authority allows for the application of scientific understanding and analysis in the products liability context, and this is particularly so where there are allegations of allergic and/or idiosyncratic reactions to the product that is allegedly defective in design. The complex nature of the design defects alleged here requires such scientific resources to achieve a just resolution of the controversy by the finder of fact." ( Morson , supra ,
The court in Pruitt v. General Motors Corp. (1999)
Plaintiff here contends that the consumer expectation test applies because the ordinary consumer does not expect to contract SJS/TEN from taking OTC Motrin. However, it could be said that any injury from the intended or
As the court in Morson explained, "Plaintiffs view the product as a simple one that can give rise to simple consumer expectations of safety that have nothing to do with the chemical composition of the material from which the product is manufactured, or any other design characteristics for which specialized knowledge is required for understanding or taking appropriate precautions. [¶] However, the protective or barrier function of the latex gloves, on which the Plaintiffs' safety argument is mainly premised, is not their only characteristic. These gloves are made of a particular material through a particular manufacturing process. The effect of this material and these processes may well be to create in their users many degrees of allergic reactions. Understanding and assessing responsibility for such allergic reactions is a matter that is driven by the science of the manufacturing and preparation procedures, as well as the medical aspects of an individual's allergic reactions to various substances."
Soule , Morson , Mansur and Pruitt indicate that the consumer expectation test does not apply merely because the consumer states that he or she did not expect to be injured by the product. As in those cases, the design defect claim here involves "technical and mechanical detail" ( Soule , supra ,
The need in this case for expert testimony about the risks and benefits of Motrin's design is highlighted by the fact that the trial court repeatedly sustained objections and admonished plaintiff's counsel not to allow expert testimony related to the consumer expectation test. " '[E]xpert witnesses may not be used to demonstrate what an ordinary consumer would or should expect,' because the idea behind the consumer expectations test is that the lay jurors have common knowledge about the product's basic safety. [Citation.] Using expert testimony to demonstrate common knowledge would be inappropriate ( Evid. Code, § 801, subd. (a) ), 'and would invite circumvention of the rule that the risks and benefits of a challenged design must be
It cannot reasonably be disputed that contracting SJS/TEN after taking OTC Motrin is an "idiosyncratic reaction[ ]" to the drug, which the FDA estimated is used approximately 100 million times per year in the United States. ( Morson , supra ,
"That causation for a plaintiff's injuries was proved through expert testimony does not mean that an ordinary consumer would be unable to form assumptions about the product's safety. [Citations.]" ( Romine , supra ,
We summarize our holdings as follows:
(1) The jury's finding that McNeil was not liable for strict liability failure to warn is fatally inconsistent with its finding that McNeil was liable for negligent failure to warn.
(2) The special verdict form for negligent failure to warn was defective for failing to include the element of whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger.
(3) Plaintiff's negligent and strict liability design defect claims, which were based on defendants' failure to sell dexibuprofen instead of ibuprofen, are preempted under federal law.
(4) The consumer expectation test of design defect 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.
As to both McNeil and Johnson and Johnson, the judgment is reversed. As to McNeil alone, the case is remanded for retrial on plaintiff's claims for negligent and strict liability failure to warn. The parties shall bear their own costs on appeal.
We concur:
EPSTEIN, P.J.
COLLINS, J.
Notes
This is one of a number of SJS/TEN cases being brought against defendants, with varying results. (See, e.g., Robinson v. McNeil Consumer Healthcare (7th Cir. 2010)
Generally, the diagnosis is SJS when less than 10 percent of the body surface area is affected, SJS/TEN when 10 to 30 percent is affected, and TEN when more than 30 percent of the body is affected.
In January 2011, we denied defendants' petition for writ of mandate challenging the trial court's order denying their motion for summary adjudication of issues regarding punitive damages. (See Johnson & Johnson v. Superior Court (2011)
Plaintiff contends that McNeil forfeited this contention by failing to object before the jury was discharged and ask the court to have the jury reconvene under Code of Civil Procedure section 619 to correct the inconsistency. We disagree. First, no objection was required to preserve the claim. (Lambert v. General Motors (1998)
Plaintiff asserts that "A jury's 'verdict will stand unless the facts found by the jury in answer to special interrogatories are so clearly antagonistic to it as to be absolutely irreconcilable, the conflict being such as to be beyond the possibility of being removed by any evidence admissible under the issues,' " quoting Lowen v. Finnila (1940)
The jury's full findings on strict liability and negligent failure to warn were as follows:
"(Strict Liability-Failure to Warn)
"1. Did Defendant McNeil manufacture, distribute and/or sell over-the-counter ('OTC') Motrin ? [¶] Yes 12 No 0 ...
"2a. Did Defendant Johnson & Johnson receive a direct financial benefit from the sale of OTC Motrin ? [¶] Yes 12 No 0 ...
"2b. Was Defendant Johnson & Johnson an integral part of the marketing enterprise such that its conduct was a necessary factor in bringing OTC Motrin to the consumer market? [¶] Yes 12 No 0 ...
"2c. Did Defendant Johnson & Johnson have control over, or a substantial ability to influence, the marketing of OTC Motrin ? [¶] Yes 12 No 0 ...
"3. Did OTC Motrin have 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? [¶] Yes 12 No 0 ...
"4. Would ordinary consumers have recognized the potential risks, side effects and/or allergic reactions ? [¶] Yes 1 No 11...
"5(a) Did McNeil fail to adequately warn or instruct of the potential risks, side effects and/or allergic reactions ? [¶] Yes 10 No 2 ...
"5(b) Did Johnson & Johnson fail to adequately warn or instruct of the potential risks, side effects and/or allergic reactions associated with OTC Motrin ? [¶] Yes 2 No 10 ...
"6. 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? [¶] Yes 2 No 10
"If you answered 'Yes' to Question 6, please answer Question 7. If you answered 'No,' please skip to Question 8.
"7. Was the lack of sufficient warnings or instructions a substantial factor in causing harm to Plaintiff? [¶] Yes __ No __ ...
"(Negligence-Failure to Warn)
"8. Did Defendant know or should it reasonably have known that OTC Motrin was dangerous or was likely to be dangerous when used in a reasonably foreseeable manner?
Defendant McNeil Yes 10 No 2 ...
Defendant Johnson & Johnson Yes 10 No 2
"If you answered 'Yes' to either part of Question 8, please answer Question 9 as to that Defendant or Defendants. Otherwise, please proceed to Question 11.
"9. Did Defendant know or should it reasonably have known that users would not realize the danger?
Defendant McNeil Yes 10 No 2 ...
Defendant Johnson & Johnson Yes 10 No 2
"If you answered 'Yes' to either part of Question 9, please answer Question 10 as to that Defendant or Defendants. Otherwise, please skip to Question 11.
"10. Was Defendant's failure to warn a substantial factor in causing harm to Christopher Trejo?
Defendant McNeil Yes 9 No 3 ...
Defendant Johnson & Johnson Yes 1 No 11."
We note that the verdict form for strict liability failure to warn presented the elements of the claim in a different order than the strict liability jury instruction, CACI No. 1205, and the sample verdict form for CACI No. 1205 provided by the Judicial Council. CACI No. 1205 and VF-1205, as well as the verdict form proposed by defendants, ask whether the potential risks present a substantial danger before asking whether the defendant failed to adequately warn of the potential risks. Placing the special verdict questions in that order is more logical than the verdict form here, because if the potential risks do not present a substantial danger, there is no need to warn under strict liability principles.
Plaintiff contends that Valentine is inapplicable because the court there was not deciding whether two special verdicts were inconsistent. However, the different procedural posture is immaterial. The issue decided by Valentine was the same as that raised here: whether a jury's finding of no strict liability failure to warn foreclosed a finding of negligent failure to warn. (Valentine, supra, 68 Cal.App.4th at pp. 1480-1481,
The court also considered claims that the strict liability instructions did not adequately convey that the duty to warn was a continuing duty (Valentine, supra,
Plaintiff contends that Valentine does not apply because the jury instructions in Valentine differ from the jury findings here. However, plaintiff compares the jury instructions in Valentine with the jury's findings here, rather than the instructions given here, which is not an apt comparison. We compare the jury instructions to the instructions here. The jury instructions are similar and are, in fact, identical as to the salient requisite elements.
The instruction on negligent failure to warn was CACI No. 1222, modified to address plaintiff's claim, as follows: "[P]laintiff claims that Johnson & Johnson and/or McNeil was negligent by not using reasonable care to warn or instruct about the Motrin's dangerous condition or about facts that make Motrin likely to be dangerous. To establish this claim, [plaintiff] must prove all of the following: [¶] 1. That Johnson & Johnson and/or McNeil manufactured, distributed, or sold Motrin ; [¶] 2. That Johnson & Johnson and/or McNeil 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; [¶] 3. That Johnson & Johnson and/or McNeil knew or reasonably should have known that users would not realize the danger; [¶] 4. That Johnson & Johnson and/or McNeil failed to adequately warn of the danger or instruct on the safe use of Motrin ; [¶] 5. That a reasonable manufacturer, distributor, or seller under the same or similar circumstances would have warned of the danger or instructed on the safe use of Motrin ; [¶] 6. That plaintiff was harmed by Motrin ; and [¶] 7. That Johnson & Johnson and/or McNeil's failure to warn or instruct was a substantial factor in causing [plaintiff]'s harm."
The instruction on strict liability failure to warn was CACI No. 1205, modified to address plaintiff's claim, as follows: "Plaintiff claims that the Motrin [product] lacked sufficient [instructions] [or] [warning of potential [risks/side effects/allergic reactions ]]. To establish this claim, [plaintiff] must prove all of the following: [¶] That [Johnson & Johnson] and/or McNeil [manufactured/distributed/sold] the [product]; [¶] That the [product] 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]; [¶] 3. That the potential [risks/side effects/allergic reactions ] presented a substantial danger when the Motrin is used or misused in an intended or reasonably foreseeable way; [¶] 4. That ordinary consumers would not have recognized the potential [risks/side effects/allergic reactions ]; [¶] 5. That [Johnson & Johnson] and/or McNeil failed to adequately warn [or instruct] of the potential [risks/side effects/allergic reactions ]; [¶] 6. That [plaintiff] was harmed; and [¶] 7. That the lack of sufficient [instructions] [or] [warnings] was a substantial factor in causing [plaintiff]'s harm."
Because the inconsistency was between a general and special verdict, the court did not apply the standard applicable to inconsistency between special verdicts (the situation in the present case), but the more lenient rule applicable to inconsistencies between the special and general verdicts. "General and special verdicts are deemed inconsistent when they are 'beyond possibility of reconciliation under any possible application of the evidence and instructions.' [Citations.] 'If any conclusions could be drawn thereunder which would explain the apparent conflict, the jury will be deemed to have drawn them.' [Citation.] Where the jury's findings are so inconsistent that they are incapable of being reconciled and it is impossible to tell how a material issue is determined, the decision is ' "against law" ' within the meaning of Code of Civil Procedure section 657. [Citation.]" (Oxford, supra,
Though it did not involve failure to warn, the decision in Lambert, supra,
Because we reverse the negligent failure to warn verdict, we do not address defendants' argument that the failure to warn of skin reddening, rash, and blisters did not cause plaintiff's injuries.
This question is taken from the standard CACI verdict form of negligent failure to warn, VF-1205.
Plaintiff contends that this design defect claim also relied on the theory that Motrin's design was defective for its failure to warn of skin reddening, rash, and blisters. However, as we explain, infra, the jury was not instructed on that theory of design defect, plaintiff did not argue it, and the verdict form did not refer to it.
Ramirez is better known for its rejection of the plaintiff's claim that the manufacturer should have used an additional Spanish-language warning, instead of "adopt[ing] the legislative/regulatory standard of care that mandates nonprescription drug package warnings in English only." (Ramirez, supra,
(See Michael M. Walsh, Testing Liability: While Brown v. Superior Court Remains A Foundational Case in Medical Products Litigation, Attempts to Expand Its Reach Have Not Always Been Successful, L.A. Law., September 2014, at p. 26 [explaining that "there remain efforts to expand Brown 's protection against design defect claims to a widening scope of medical products. The most likely candidates for this include nonprescription drugs and medical products that, while not implanted, interact with the human body."].)
Plaintiff concedes, on the one hand, that his design defect claim is barred to the extent that it relied on defendants' failure to use dexibuprofen instead of ibuprofen in Motrin. On the other hand, he asserts that he did not argue that defendants "should have withdrawn Motrin from the marketplace, or should have never sold it in the first place." This argument is merely a matter of semantics. No matter how plaintiff words his argument, the claim that defendants failed to sell dexibuprofen instead of ibuprofen requires the claim that defendants should have withdrawn Motrin from the market because defendants could not have changed the active ingredient of Motrin without undergoing an entirely new FDA drug application process. (
After oral argument, plaintiff filed a letter brief reiterating his argument that he did rely on the failure to warn theory to support his design defect claim. As discussed above, we disagree. Even if the record supported plaintiff's contention, the negligent failure to warn verdict is fatally inconsistent with the strict liability failure to warn verdict. The failure to warn accordingly cannot be relied upon to support the design defect claim. Moreover, plaintiff's contention is that the warning label is relevant to the consumer expectation test. As explained below, we conclude that the consumer expectation test does not apply in these circumstances.
Generic drug manufacturers are not free to strengthen drug label warnings under
It is undisputed that dexibuprofen has not been approved by the FDA.
The risk-utility inquiry under New Hampshire law was based on three factors: " 'the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.' [Citations.]" (Bartlett, supra,
Plaintiff relies on language in Fraser v. Wyeth, Inc. (D. Conn. 2014)
The court subsequently held that the instructional error was harmless because it was "not reasonably probable defendant would have obtained a more favorable result in its absence. [Citations.]" (Soule, supra,
Because we conclude the case must be retried, we do not address defendants' argument that the negligent design defect finding against McNeil is inconsistent with the finding in favor of defendants on the risk-benefit test. We note, however, that our Supreme Court has stated that, "in a products liability action based on negligence in the design of a product 'placed on the market,' the test of negligent design 'involves a balancing of the likelihood of harm to be expected from a machine with a given design and the gravity of harm if it happens against the burden of the precaution which would be effective to avoid the harm.' [Citation.] ... Thus, 'most of the evidentiary matters' relevant to applying the risk/benefit test in strict liability cases 'are similar to the issues typically presented in a negligent design case.' " (Merrill, supra, 26 Cal.4th at pp. 479-480,