West v. Johnson & Johnson Products, Inc.

Citations: 174 Cal. App. 3d 831; 220 Cal. Rptr. 437; 59 A.L.R. 4th 1; 1985 Cal. App. LEXIS 2788Docket: A021842

Court: California Court of Appeal; November 21, 1985; California; State Appellate Court

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Lynette West contracted toxic shock syndrome while using a vaginal tampon manufactured by Johnson Products, Inc. (JJP). In a strict product liability case, a jury awarded West $500,000 in compensatory damages and $10 million in punitive damages. The trial court denied JJP's motion for judgment notwithstanding the verdict but conditionally granted a new trial due to excessive damages, unless West accepted reductions to $100,000 in compensatory damages and $1 million in punitive damages, which she did. JJP appealed the judgment and the denial of its motion, arguing that West's counsel mischaracterized the case, that there was insufficient evidence to show a lack of adequate warnings caused her injury, that the trial court erred by allowing consumer complaint evidence, and that West's counsel engaged in misconduct. JJP also contested the jury instructions on the consumer expectation test and punitive damages. In her cross-appeal, West argued that the trial court abused its discretion in conditioning the denial of a new trial on her acceptance of reduced damages. The court found all of JJP's contentions without merit and affirmed the judgment and order. West, a 20-year-old student, had used JJP's tampons for five years and experienced symptoms of toxic shock after inserting one before a concert.

West experienced severe health issues after feeling faint and hot during an event, leading her to lie down in an aisle. After returning home, she felt exhausted and hot, eventually deciding to stay in bed the next day due to worsening symptoms, which she initially attributed to the flu. By the evening, she began vomiting and lost bowel control. The following morning, she collapsed in the bathroom and was taken to a hospital emergency room.

Upon examination, West exhibited critical symptoms, including low blood pressure approaching shock, a high fever of 104.4 degrees, vomiting, skin reddening, an accelerated heartbeat, and swollen tonsils. Lab tests revealed liver and kidney dysfunctions. After removing a tampon, cultures indicated the presence of beta-hemolytic streptococcus in her throat, while vaginal and rectal cultures were negative. Due to her deteriorating condition, she was admitted to the intensive care unit and treated with intravenous fluids and antibiotics, including penicillin.

West remained in severe shock for approximately 18 hours but began to stabilize by February 29, with her blood pressure and organ functions returning to normal by March 4. She experienced skin peeling upon returning home but resumed classes after a week. Initially perplexed by her symptoms, physicians diagnosed her with shock due to unclear etiology and secondary streptococcal pharyngitis. On follow-up visits, she reported feeling well and showed no residual effects by June 30. However, after reviewing her case against CDC reports, the physicians later concluded that she had suffered from menstrually related toxic shock syndrome, a diagnosis contested during her trial.

Toxic Shock Syndrome (TSS) was first identified in 1978 by Dr. James K. Todd and initially observed only in children. Retrospective studies later revealed that TSS also affects adult men and women, with its existence likely predating its recognition. By early 1980, the CDC began receiving reports of a ‘new disease,’ primarily affecting menstruating women, with symptoms including high fevers (up to 107 degrees), shock, low blood pressure, rashes, and organ abnormalities. In response to an increase in reported cases, the CDC formed a task force, which defined TSS with specific diagnostic criteria including high temperature, a rash, skin peeling, low blood pressure, gastrointestinal symptoms, muscle pain, and organ dysfunction. Reports established a strong correlation between TSS and tampon usage. In June 1980, the CDC sought information from tampon manufacturers, including JJP, which had limited data to provide. Through its own studies, the CDC identified the cause of TSS as a toxin from the bacteria Staphylococcus aureus, commonly found in some women’s vaginas. Recommendations from the CDC included discontinuing tampon use to mitigate TSS risk and placing warnings on tampon packaging.

JJP, a New Jersey corporation and subsidiary of Johnson, Inc., manufactured various products, including the o.b. tampon, designed in Germany by Dr. Judith Esser and marketed since the late 1940s. The o.b. tampon consists of 70% rayon and 30% cotton, with Tween 20 added during manufacturing to prevent static buildup.

Tampon fibers in the o.b. design are intricately intertwined, rolled, and compressed to enhance absorbency, allowing the tampon to expand radially against the vaginal walls upon absorption of menstrual fluid. Unlike other brands, o.b. tampons do not come with an applicator; users insert them manually. Initially imported to the U.S. in 1974, JJP began domestic manufacturing and distribution in 1977. 

Between 1971 and 1973, Personal Products Company (PPC), a subsidiary of JJP's parent corporation Johnson, conducted microbiological studies to analyze bacterial presence in the vagina during different menstrual phases. Findings indicated that the vagina's environment shifts from slightly acidic to neutral or alkaline during menstruation, allowing pathogenic bacteria, including staphylococcus, to proliferate. Approximately 6% of women tested had Staphylococcus aureus present. Research notes documented these findings, with key information communicated to JJP scientists.

In 1975 and 1976, PPC conducted further studies on experimental o.b. tampons containing 'acidic residue' to assess their impact on vaginal acidity and bacterial growth. However, these studies showed no significant advantage, revealing instead that the use of o.b. tampons reduced overall bacterial counts during menstruation and that small fibers sometimes remained in the vagina after tampon removal. 

As part of preparing for U.S. production, JJP aimed to replicate the German version of the o.b. tampon, selecting cotton and rayon of equivalent quality and performing unspecified tests for clinical effects. A microbiologist referred to these as 'patch tests,' which indicated no skin irritation among twenty-five female panelists over seventy-two hours. Up to the trial date, JJP had not conducted studies to evaluate any correlation between tampon usage and vaginal infections.

Consumer complaints regarding o.b. tampons began in 1975, with issues predominantly related to adverse reactions from users, including irritation, infections, vaginitis, discharge, pain, burning, and rash. Specific complaints included the presence of fibers left in the vagina upon tampon removal, difficulty in removal leading to surgical intervention, and severe vaginitis reported by a physician concerning his daughter. Other complaints involved bladder infections, recurrent vaginal infections, and pelvic inflammatory disease, with medical confirmation from physicians in some cases. Between 1975 and February 1980, approximately 150 serious complaints were received by JJP, although the total number of complaints was not documented. JJP's responses varied; some consumers and physicians were uncooperative, while others returned unused tampons for testing against manufacturing specifications. Despite the complaints, JJP did not conduct further testing on o.b. tampons, believing the issues were coincidental with pre-existing conditions such as vaginitis.

In a subsequent trial, expert testimonies from physicians and microbiologists presented conflicting diagnoses for the illness of a consumer named West. West's experts attributed her symptoms to menstrually related Toxic Shock Syndrome (TSS), while JJP's experts diagnosed her with streptococcal scarlet fever. West’s symptoms included fever, low blood pressure, a sunburn-like rash, diarrhea, vomiting, muscle pain, and abnormalities in liver and kidney functions, along with skin peeling post-hospitalization.

Symptoms such as a smooth rash, diarrhea, and liver and kidney abnormalities in West were inconsistent with streptococcal scarlet fever. However, the presence of streptococcus bacteria in her throat could align with a diagnosis of menstrually related Toxic Shock Syndrome (TSS). The absence of staphylococcus bacteria in cultures was irrelevant, as the lab was not tasked with testing for it. JJP's experts noted that exudate on swollen tonsils is rare in TSS cases. The combination of streptococcus presence, exudate, and lack of staphylococcus indicated streptococcal scarlet fever. Staphylococcus aureus, which causes TSS, is resistant to penicillin, unlike streptococcus, which West was treated with, leading to her recovery. 

During the trial, the causal link between tampons and menstrually related TSS had not been established, with JJP's experts arguing that tampons alone do not cause TSS and that o.b. tampons were not defective. In contrast, West's experts claimed o.b. tampons had several defects contributing to TSS incidence, including: 

1. Tampons act as foreign bodies, impairing white blood cell function against pathogens.
2. The high absorbency of o.b. tampons, enhanced by Tween 20, creates an ideal environment for bacteria to thrive.
3. Radial expansion of the tampon occludes the vaginal canal, potentially leading to abscess-like conditions and leaving fibers that can harbor bacteria.
4. The fiber network within the tampon inhibits white blood cell action against pathogens.
5. Insertion with fingers can introduce pathogenic bacteria from hands into the vagina.
6. Manufacturer instructions encourage prolonged tampon use, which may be unhealthy.

West's experts presented varying opinions on the role of tampons in causing toxic shock syndrome (TSS), with one stating that tampons are a critical factor for developing TSS, and another asserting that Miss West's condition was directly linked to tampon use. Disagreement existed among experts regarding the timeline of TSS discovery and the adequacy of testing on o.b. tampons. JJP's experts claimed that a newly emergent strain of staphylococcus aureus was responsible for menstrually associated TSS, which wasn't isolated until late 1980, asserting that prior to February 1980, no association could have been predicted. They maintained that o.b. tampons were adequately tested before marketing and that consumer complaints did not warrant further testing.

In contrast, West's experts argued that the strain and its associated toxin had existed longer, with cases of TSS dating back to 1947. They contended that appropriate testing could have identified the risks much earlier than 1980. They noted a lack of significant preliminary studies by JJP on vaginal microbiology, attributing this oversight to irresponsible practices. One expert criticized JJP's failure to test for pathogenic bacteria introduced by tampon use, deeming their consumer instructions negligent. West's experts emphasized that JJP should have conducted a thorough testing program in response to consumer complaints regarding infection risks. They also criticized earlier studies conducted by Dr. Kraskin for being inadequate, highlighting issues such as insufficient sample sizes and a lack of investigation into the effects of prolonged tampon use.

An expert witness criticized the testing conducted in the case, indicating significant oversight. West's first amended complaint included four claims: negligence, breach of express warranty, breach of implied warranty of fitness, and strict product liability due to design and manufacturing defects. The latter claim sought punitive damages, alleging that JJP was aware of the defects in o.b. tampons but disregarded consumer safety by placing the products on the market without disclosure. After resting her case, West's counsel decided to pursue only the strict product liability claim. Disputes arose regarding jury instructions, specifically whether the case should be categorized as a design defect or failure to warn. JJP's counsel argued that West's focus on product instructions indicated a failure to warn, while West's counsel asserted that the product's design itself posed risks, including unsafe instructions. The trial court opted for jury instructions on design defects and dismissed JJP's proposed warnings about testing. JJP contended that West's counsel manipulated the case theory from failure to warn to design defect, claiming this deprived them of a defense. The court found this argument unconvincing, stating that a plaintiff is not obligated to choose a theory that would lead to an automatic dismissal. This position echoed a precedent where similar claims were rejected, affirming the jury's findings based on the evidence supporting design defect liability.

In Kehm v. Procter & Gamble Mfg. Co. (8th Cir. 1983), the wrongful death action arose after a wife died from toxic shock syndrome (TSS) linked to a vaginal tampon produced by the defendant. The husband claimed liability based on defective design and failure to warn, leading to a jury verdict in favor of the plaintiff, which was upheld on appeal. The appellate court did not address the defective design theory, as the defendant did not challenge the evidence supporting the jury’s liability and causation findings. The case illustrates the application of defective design to tampons.

During trial, the plaintiff's counsel emphasized the lack of warnings about TSS, noting that the FDA had requested such warnings post-TSS identification, which the defendant later included in their product packaging. Counsel argued that the inclusion of warnings post-incident supported the claim of a defect in the product. It was established that in strict product liability cases, post-accident warnings can indicate defects at the time of injury.

Counsel clarified that the case was not about a failure to warn but rather about inherent defects in the product design and its usage instructions. He asserted that the product’s defects were the focus, not the reasonableness of the manufacturer's actions. Counsel explicitly dismissed the notion that the defect was related to a failure to warn about TSS, highlighting that TSS was not well-defined until after the plaintiff’s hospitalization and that the argument for failing to warn was untenable.

Counsel argued that the warning included in o.b. tampon boxes, mandated by the FDA, contradicted JJP's claim that their tampons were not linked to toxic shock syndrome (TSS). Counsel suggested that including the warning indicated JJP's acknowledgment of a potential association with TSS, thereby implying liability. Three critical points were made: (1) the warning served as evidence of a defect in o.b. tampons at the time of West's illness; (2) the product's usage instructions, which highlighted its "super-absorbent" features, constituted a defect; and (3) an ordinary consumer would not expect to become seriously ill from using the tampons. JJP's assertion that these remarks were about failure to warn rather than design defect was rejected. The determination of design defect is a factual matter for the jury. Substantial evidence indicated o.b. tampons were defective in design, supporting West's claims. Even if additional instructions on failure to warn had been provided, it was unlikely the jury would have reached a different outcome regarding design defect liability. Thus, there was no error in allowing West to proceed on this theory or in rejecting JJP's failure to warn instructions, and any potential error was not prejudicial. Regarding proximate cause, JJP claimed West failed to prove she read or followed the instructions, arguing this undermined her case. However, West's testimony indicated familiarity and preference for o.b. tampons, having used them for nearly five years, suggesting an implicit understanding of their use despite the lack of direct evidence on reading the instructions.

An insert from a package of o.b. tampons was introduced as evidence in the case, specifically as part of the plaintiff's exhibit 1. This insert included usage instructions and a description highlighting that the o.b. tampon features special outer absorbing and inner holding layers, allowing it to absorb moisture twice as fast and hold over 50% more than leading brands. It claimed that o.b. tampons provide enhanced safety even during heavy menstrual flow. Evidence suggested that West, the plaintiff, likely read these instructions at some point. 

The case included substantial testimony indicating that tampon use is a significant factor in the development of menstrually associated Toxic Shock Syndrome (TSS), with one expert attributing West's illness directly to the use of o.b. tampons. The testimony of a single credible witness is sufficient to establish a fact under Evidence Code section 411.

During the trial, an expert testified about consumer complaints received by JJP regarding o.b. tampons and their reactions to these complaints. The court allowed this testimony solely to determine whether JJP had been notified of defects in their product. Although the expert initially described and read some complaints, the court later ruled that the actual written complaints could not be admitted as evidence, nor could the witness read them verbatim. JJP argued that the expert's testimony was prejudicial, asserting that the consumer complaints did not indicate any risk of TSS, which was not known at the time. They also contended that verbatim readings were inflammatory. 

JJP referenced the case Wolf by Wolf v. Procter & Gamble Co., where consumer complaints related to injuries from another brand of tampon were deemed inadmissible to show product defects. Conversely, in Kehm v. Procter & Gamble Mfg. Co., evidence of consumer complaints about tampons that did not mention TSS was admitted, but the defendant later argued this was a reversible error on appeal.

The court of appeals asserted that consumer complaints do not need to precisely match the scientific definition of Toxic Shock Syndrome (TSS) to demonstrate substantial similarity between the illnesses experienced by other consumers and Mrs. Kehm's illness. Procter & Gamble had the opportunity to challenge these complaints by highlighting differences in symptoms, leaving the jury to determine their relevance. Although there is no direct California ruling on this matter, the Kehm case is considered persuasive, aligning with prior California case law that allows evidence of other accidents to establish defective conditions if the circumstances are sufficiently similar. In particular, the court noted that the requirement for similarity is relaxed when demonstrating the defendant's awareness of a dangerous condition. The Kehm court permitted the inclusion of consumer complaint documents as evidence, while the trial judge in this case admitted testimony about these complaints but excluded the documents, reasoning they likely contained hearsay. The judge allowed witness descriptions of the complaints to provide context for the jury. An expert relied on these complaints to assert that JJP should have conducted adequate testing, suggesting that earlier testing could have revealed TSS sooner. JJP was able to present expert testimony asserting no connection between TSS and other conditions, and no request for limiting instructions was made to clarify the admissibility of the expert's basis for opinion.

The trial court did not err in admitting consumer complaint testimony. JJP argues that West's counsel engaged in improper advocacy by repeatedly referring to JJP as "Johnson. Johnson," describing them as "old and big and very successful," and suggesting they were reluctant to come to court. JJP also claims West's counsel asserted unsupported facts and attempted to testify. However, the trial spanned 13 court days with isolated comments, and the "Johnson. Johnson" reference was part of JJP's corporate name, which mitigated potential prejudice. Furthermore, JJP's counsel often failed to object to these comments, and when objections were made, they were usually sustained. The absence of timely objections or requests for jury admonition generally waives claims of misconduct unless the conduct is egregious. West's counsel occasionally acknowledged their overstepping and apologized. The trial court found no misconduct or prejudice, a determination that is typically upheld unless clearly erroneous. Overall, the appellate review found no evidence of bad faith or disregard for professional standards by West's counsel.

The trial judge maintained control over the proceedings and informed jurors that counsel's statements were not evidence, leading to no prejudice or miscarriage of justice for JJP. JJP challenged the jury instructions, specifically regarding the "Consumer Expectation" test as outlined in Barker v. Lull Engineering Co. The trial court's instruction, which was based on BAJI No. 9.00.5, required West to prove the o.b. tampon was defective by not performing safely as expected by an ordinary consumer. Barker established two tests for product design defect: the "consumer expectation" test and the "risk-benefit" test. JJP argued that the trial court should have used the "risk-benefit" test instead, but there was no record of JJP requesting such an instruction. In civil cases, parties must propose comprehensive jury instructions; failure to do so means the court is not obliged to provide them. Additionally, under the "risk-benefit" test, the manufacturer bears the burden to show that the benefits of the design outweigh the inherent risks, with the jury considering factors like safer alternative designs and associated costs.

JJP failed to provide evidence demonstrating that a safer alternative design for the o.b. tampon was unfeasible, excessively costly, or more dangerous to consumers. Thus, even if a "risk-benefit" instruction had been requested, it would have lacked evidentiary support. JJP argues that the "consumer expectation" test is inappropriate for cases requiring expert testimony, referencing Lunghi v. Clark Equipment Co., where the trial court denied a "consumer expectation" instruction in a wrongful death case involving a front-end loader. The appellate court affirmed this denial, reasoning that the expectations regarding heavy machinery could not be assessed by ordinary consumers without specialized knowledge. The court distinguished this scenario from typical consumer products, emphasizing that laypeople could not adequately evaluate the safety expectations of complex equipment. Additionally, the court's interpretation in Campbell v. General Motors Corp. is cited, where the plaintiff presented sufficient evidence to proceed under either the "risk-benefit" or "consumer expectation" tests, showing that expert testimony was not necessary for the latter. The court highlighted that the plaintiff's own account and photographic evidence were adequate for jury consideration regarding the product's design safety.

Public transportation is a common experience, negating the need for expert testimony for the jury to make a decision regarding safety expectations. The court expressed skepticism about what an expert could contribute on the safety expectations of ordinary consumers. Establishing a prima facie case of design defect under the "consumer expectation" test does not follow a simple formula but generally involves the plaintiff providing evidence of their product use, the circumstances of the injury, and relevant product features. In this case, evidence was presented that supported the application of the "consumer expectation" test.

Specifically, o.b. tampons were not new at the time of the incident, having been sold nationally for three years, and the plaintiff, West, had used them for five years. Users could reasonably expect that the tampons would not cause serious illness. West became seriously ill after using an o.b. tampon, with expert testimony indicating a design defect and that the tampon contributed significantly to her illness. The jury could thus find that the product failed to meet safety expectations.

Regarding punitive damages, the trial court provided instructions based on established guidelines, which the defendant JJP accepted in wording but contested on the grounds of lack of supporting evidence. JJP argued that there was no proof of knowledge about the association between tampons and toxic shock syndrome (TSS) before West's injury, asserting that it could not be deemed to have acted with conscious disregard for safety. Conversely, West maintained that the issue of punitive damages was valid.

JJP was aware that the vagina can harbor pathogenic bacteria during menstruation, yet failed to conduct sufficient testing of the o.b. tampon prior to its marketing in the U.S. Despite receiving ongoing consumer complaints regarding infections linked to o.b. tampons, JJP did not undertake further studies to investigate these issues. The determination of punitive damages typically lies within the jury's discretion, as established in cases like Davis v. Hearst and Egan v. Mutual of Omaha Ins. Co. In strict product liability cases, malice, defined as a conscious disregard for safety, is a factual question for the jury, as illustrated in Hilliard v. A.H. Robins Co., where a plaintiff developed pelvic inflammatory disease due to a defective intrauterine device. In that case, the court found that substantial evidence supported the existence of punitive damages, noting the manufacturer’s awareness of infection reports but continued marketing of the device without modifications. Similarly, JJP's inadequate premarket testing of the o.b. tampon, including insufficient clinical and animal studies, has been criticized, indicating a potential basis for punitive damages.

JJP's records revealed minimal investigation into the vaginal bacterial count related to their o.b. tampons. An expert testified that neglecting this aspect was an act of severe irresponsibility and that JJP's lack of inquiry into the risks of digital tampon insertion demonstrated a disregard for public safety. The expert criticized JJP's usage instructions as "unbelievable" and noted ongoing consumer complaints from 1975 to 1979, suggesting that JJP should have conducted appropriate testing in response. Another expert labeled JJP's failure to explore the link between tampon use and vaginal infections as conscious negligence, asserting a scientific obligation to investigate potential adverse reactions. He further indicated that JJP's existing studies were inadequate, missing critical areas of concern.

Additionally, the CDC quickly identified a statistical link between tampon use and toxic shock syndrome (TSS) related to staphylococcus aureus. The jury could reasonably infer from this evidence that adequate testing could have established a connection between tampon use and infections, and that JJP's testing was insufficient. JJP's decision to forgo further testing despite consumer complaints was deemed conscious disregard for safety. The trial court acknowledged that while the jury's punitive damages award was excessive, it found the damages were nonetheless warranted based on substantial evidence of JJP's malicious conduct. The trial judge's familiarity with trial evidence was highlighted as significant, although not binding on appellate review. JJP also referenced prior case law to argue against the punitive damage instructions given at trial.

In Gamble Mfg. Co., 724 F.2d 613, the court distinguishes its position from the Kehm case regarding punitive damages. It notes that jurors in Kehm were instructed on punitive damages but opted not to award them, and the appellate court found insufficient evidence of the defendant's disregard for the plaintiff's rights. The Kehm case lacked expert testimony indicating conscious disregard for safety. In contrast, the current case presented substantial evidence justifying instructions on punitive damages.

JJP argues the trial court erred in allowing evidence of the financial status of its parent corporation, Johnson. Johnson, Inc. During the trial, West's counsel subpoenaed Johnson. Johnson, Inc. to produce net worth documents, but JJP's objections were not addressed before trial. A witness from Johnson. Johnson, Inc. provided testimony regarding net worth, and the trial court ruled that West had established a prima facie case for punitive damages, allowing the net worth evidence to be admitted. JJP's counsel later stipulated to the net worth value of $2.249 billion in front of the jury, but now contends this was unnecessary and prejudicial. The court asserts that the ruling permitting this evidence was justified, emphasizing that JJP should have presented its own financial condition to contest the punitive damages claim, aligning with the principle that wrongdoers must demonstrate the potential impact of punitive damages based on their financial status.

The defendant is best positioned to provide accurate financial data and is not required to present this information until the plaintiff establishes a sufficient case for punitive damages. If the defendant wishes to contest exemplary damages on appeal, the provision of financial data will support the appellate review. The plaintiff is not obligated to present evidence of the defendant's financial condition in seeking punitive damages. In this case, JJP did not present evidence of its financial status at trial, resulting in the trial court reducing the original punitive damage award without JJP demonstrating any prejudice.

Regarding the willful suppression of evidence, the trial court instructed the jury based on BAJI No. 2.03, as it determined that JJP intentionally withheld specific research notebooks. Before trial, West's counsel requested documents relating to o.b. tampons and their testing. JJP initially provided access to approximately 9,500 documents but revealed the existence of the research notebooks only shortly before trial. Despite requests for these notebooks, JJP did not produce them, although they delivered some related studies just before trial commenced. During the trial, expert witness Dr. Kraskin testified about earlier research that he relied on, which was not disclosed to West's counsel in time for proper review.

A witness testified that he brought some laboratory notebooks regarding the "acidified" tampon from PPC but left others at PPC's laboratories. JJP contended that it and PPC were distinct entities and thus had no control or obligation to produce PPC's records, arguing that it did not willfully suppress evidence. The court disagreed, referencing Code of Civil Procedure section 2031, which mandates a party to produce documents in their "possession, custody, or control." JJP was aware prior to trial that Kraskin might testify as an expert and likely discussed the notebooks with him. JJP's facilitation of Kraskin's travel and testimony indicated some level of control over the notebooks. Additionally, JJP was required to conduct a reasonable investigation to answer interrogatories accurately, as established in Jones v. Superior Court. Testimony revealed prior interactions between JJP and Kraskin, supporting the need for JJP to investigate despite any lapses in memory. The jury was left to determine whether JJP intentionally suppressed evidence.

On West's cross-appeal, the trial court conditionally granted a new trial solely on the grounds of excessive compensatory and punitive damages. The court highlighted that West failed to provide evidence of special damages or wage loss, had recovered from her illness, and any future damages were speculative. It deemed $100,000 as the highest reasonable compensatory damage award. Regarding punitive damages, the court found substantial evidence of JJP's malice through expert testimony, but noted JJP's significant sales of 70 million units of o.b. tampons over seven years.

The court noted a relatively small number of complaints against the defendant and determined that punitive damages must be proportionate to actual damages. It concluded that $1,000,000 was a sufficient deterrent and that the defendant's conduct, although reprehensible, did not justify a higher punitive award. The court attributed the excessive jury awards to "passion and prejudice." On cross-appeal, West argued that the court's reasoning lacked substantial evidential support. She contended that she had not fully recovered from her illness and still had residual fears of contracting Toxic Shock Syndrome (TSS). West also highlighted the defendant's significant wealth and argued that the reduced punitive amount represented only 0.7% of the gross sales for the product involved. Medical testimony indicated that West had no lasting damage from her illness, and although she experienced emotional distress related to changes in her menstrual cycle, she did not assert a fear of TSS recurrence. Expert testimony acknowledged potential long-term effects of TSS, but the medical community lacks definitive knowledge about these long-term consequences. The principles governing motions for a new trial due to excessive damages were outlined, emphasizing the trial court's role as an independent fact-finder. The court referenced the California Code of Civil Procedure, which allows a new trial for excessive damages under specific conditions. The appellate court may only reverse such orders for a manifest abuse of discretion, which the court found was not present in this case, as it had carefully considered relevant factors.

The court weighed various factors and exercised independent judgment in determining what constituted "fair and reasonable" compensatory and punitive damages. It found substantial evidence supporting the trial court's decision, thus declining to modify the judgment. The court rejected JJP's claim that jury bias, referred to as "passion and prejudice," affected their liability determination, asserting that even if excessive damages were influenced by such bias, it did not extend to the liability verdict. The trial court's order for a conditional new trial focused solely on excessive damages, and its description of JJP's conduct as "reprehensible" indicated strong evidence supported the liability verdict. The judgment is presumed correct under the circumstances, with a new trial being reviewed based on a potentially reduced verdict. The jury had ample evidence to conclude JJP was strictly liable due to defective design, spending approximately four days deliberating and requesting evidence during the process. The court believes the jury's liability verdict was likely made thoughtfully despite potential excess in damages. Both the judgment and the order were affirmed, with costs awarded to the plaintiff. Rehearing and Supreme Court review petitions were denied, with a note that the parties are designated as plaintiff and defendant for clarity.

The record lacks a definition for "o.b." tampons, but West identified four types: minis, regular, supers, and super plus. West experienced a significant drop in blood pressure, leading to severe shock. Prior to trial, o.b. tampons were marketed as offering "gap-free protection" against menstrual fluid leakage. In 1974, Procter & Gamble began testing its Rely tampon, a competitor product. Dr. Kraskin, a microbiologist and director of applied research at PPC, consulted on the microbiological aspects of tampon manufacturing with Johnson & Johnson Products (JJP) in the mid-1970s. Witnesses referred to a related phenomenon as "sloughing." Consumer complaints about the product spanned from 1975 to 1979, with the provided examples being illustrative rather than exhaustive. JJP's experts acknowledged that West's symptoms aligned with menstrually related Toxic Shock Syndrome (TSS), and some conceded that tampons disrupt natural processes and absorb both menstrual fluid and staphylococci. One expert suggested that the idea of "gap-free protection" was possibly flawed, while another noted that tampons create an environment conducive to bacterial growth. A microbiologist reflected that caution should have been exercised regarding super absorbency advancements, indicating that earlier recognition of TSS could have occurred with vigilant monitoring. Notably, notes from 1971-1973 studies at PPC were not disclosed during discovery. The trial court rejected JJP's proposed instruction regarding the manufacturer's duty to warn, which was based on known or reasonably knowable risks associated with its product.

The determination of whether the manufacturer provided adequate warning is limited to the medical and scientific knowledge available at the time of the plaintiff's illness, excluding any data that emerged afterward. The rejected instruction G proposed by JJP emphasized the manufacturer's duty to adequately test for known or foreseeable side effects based on existing scientific knowledge. The jury's consideration of whether the manufacturer adequately tested must also adhere to the same temporal limitation. The plaintiff's withdrawn instruction suggested a product is defective if it poses a substantial danger not easily recognized by ordinary users, and the manufacturer fails to provide adequate warning. The notion that West's counsel misled the trial judge into giving improper instructions lacks support. On appeal, JJP argues that the duty to test is encompassed within the broader duty to warn, asserting that inadequate testing is only relevant if it could have revealed a risk necessitating a warning. Previous case law indicates that whether reasonable testing would have uncovered a defect is a jury question, applicable in strict product liability cases as well. JJP’s focus on the trial court's failure to instruct on the duty to warn, rather than the duty to test, suggests a negligence standard should be considered. Notably, after the plaintiff's incident, Johnson & Johnson revised their warnings, which were previously included externally on the product, to include a significant warning about toxic shock syndrome in an insert, suggesting that such a warning would have been beneficial for the plaintiff.

Tampon manufacturers failed to adequately consider women's health when marketing their products, resulting in a lack of necessary warnings about the risks of toxic shock syndrome (TSS). The FDA's intervention led to the inclusion of warnings on tampon packaging, affirming that Lynette West experienced TSS caused by tampons, which created a bacterial infection. 

The argument presented asserts that while tampons may appear benign—being primarily made of cotton and rayon—their use instructions made them dangerous. Specifically, the guidance encouraged prolonged use, allowing bacteria to proliferate, which contributed to the risk of infection. Evidence suggests that from 1977 onwards, the absorbency of tampons increased, incentivizing women to leave them in longer, thus heightening the risk of TSS. 

Counsel contends that no reasonable consumer would expect to contract TSS from tampons, especially prior to the late 1980s, when warnings were not present on the packaging. The case emphasizes that the product's defectiveness lies not just in the tampon itself but also in the accompanying instructions and packaging that misled consumers about safety.

Lynette West possessed a box of o.b. products when diagnosed with Toxic Shock Syndrome (T.S.S.), yet the box contained no information regarding T.S.S. The back of the box promoted the o.b. method, claiming enhanced absorbency and a snug fit, with instructions indicating that proper use should not cause injury. The manufacturer's liability hinges on defects in design and whether the product performed safely as expected by ordinary consumers. The excerpt references legal precedents, notably Bates v. John Deere Co. and Barker v. Lull Engineering Co., which address product liability and the application of "consumer expectation" and "risk-benefit" tests in determining design defects. It highlights evidence against Robins regarding the Dalkon Shield's known issues, contrasting it with the current case's lack of similar elements. Additionally, it notes that punitive damages are not recoverable in wrongful death actions in California, referencing the case of Kehm. The spelling of a party's name, Christensen, is also clarified, along with the fact that he did not testify.

An attorney from the general counsel's office is identified in the trial record, and JJP does not contest West's description of Mr. Christensen's role. The court ruled that Johnson's wealth, net worth, or assets could be admitted as evidence, clarifying that any judgment would solely be against Johnson Products, Inc., the named defendant. JJP's counsel sought clarification on whether the court would allow the net figure of Johnson, Inc. to be introduced, to which the court affirmed, stating a prima facie case for punitive damages had been established. Subsequently, JJP's counsel agreed to stipulate to the net worth statement of the parent corporation instead of presenting the annual report to the jury. 

Both parties waived the standard discovery cut-off date. West's counsel requested research notebooks related to the testing of o.b. tampons by Johnson Products, but JJP's counsel expressed uncertainty regarding the existence and availability of these notebooks, indicating it may not be feasible to compile them before the trial date. He further noted that Personal Products Company (PPC) is not a defendant and he could not agree to produce any materials from PPC. Additionally, West's counsel argued that JJP's failure to call a specific witness was a basis for a jury instruction, but it was noted that West's counsel could have deposed the witness prior to trial.