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Weiss v. Astrazeneca Pharmaceuticals

California Court of Appeals, Second District, Second Division
Aug 30, 2010
No. B215901 (Cal. Ct. App. Aug. 30, 2010)

Opinion

NOT TO BE PUBLISHED

APPEAL from a judgment and order of the Superior Court of Los Angeles County. Super. Ct. No. BC323107 Victoria G. Chaney, Judge.

Hagens Berman Sobol Shapiro, Elaine T. Byszewski, Steve W. Berman, and Craig R. Spiegel for Plaintiffs and Appellants.

Sidley Austin, John W. Treece, Mark E. Haddad, Alycia A. Degen, Joshua E. Anderson, and David R. Carpenter for Defendants and Respondents.


CHAVEZ, J.

Plaintiffs and appellants James Weiss (Weiss), Patricia Vogt (Vogt), Rodney Saum (Saum), and Lucille Joaquim-Blackie (Joaquim-Blackie) (collectively, plaintiffs) appeal from the trial court’s denial of their motion for class certification and from the summary judgment entered in favor of defendants and respondents AstraZeneca Pharmaceuticals LP (AstraZeneca) and Zeneca Inc. (collectively, defendants), in plaintiffs’ action for deceptive marketing of the prescription drug Nexium. We affirm the judgment and the order denying class certification.

BACKGROUND

This action was originally brought in October 2004 by three organizational plaintiffs who were subsequently dismissed, and by Weiss, who was later added as a plaintiff. Plaintiffs’ counsel obtained leave to notify 2, 500 Nexium consumers and ask their consent to be contacted. One hundred forty-five people agreed to be contacted, and three became plaintiffs.

In the operative fourth amended complaint, plaintiffs alleged that defendants implemented a deceptive marketing campaign to convince the public that the prescription drug Nexium is superior to both the prescription and over-the-counter versions of Prilosec, another drug marketed and sold by defendants. Plaintiffs did not allege that they suffered any adverse effects from taking Nexium, but they claimed that defendants’ deceptive marketing caused them to purchase Nexium at a higher price than Prilosec, an equally effective and less expensive alternative. Plaintiffs asserted causes of action for violations of the Unfair Competition Law (Bus. & Prof. Code, §17200 et seq.) (UCL), the False Advertising Law (Bus. & Prof. Code, § 17500 et seq.) (FAL), and the Consumer Legal Remedies Act (Civ. Code, § 1750 et seq.) (CLRA) and for unjust enrichment. They sought actual damages and restitution of all unlawful profits received by defendants as a result of the allegedly deceptive conduct.

Plaintiffs sought to certify a class of all persons or entities in California who purchased Nexium since December 2002, including third-party payors (TPPs), cash payors, and those making a co-payment, as well as a subclass of individuals who were at least 65 years old when they paid some or all of the purchase price. Defendants opposed class certification. Defendants also moved for a no-merit determination as to plaintiffs’ CLRA cause of action and for summary judgment as to plaintiffs’ other causes of action on the ground that plaintiffs could not establish causation as an element of their deceptive marketing claims. The evidence presented in connection with both motions is summarized below.

1. Motion for Class Certification

A. Nexium and Prilosec

Nexium and Prilosec are proton-pump-inhibitors (PPIs) formulated and sold by defendants. PPIs inhibit the production of stomach acid and are used to treat gastroesophageal reflux disease (GERD). The most common symptom of GERD is frequent and persistent heartburn, but the disease can also cause damage to the lining of the esophagus and a more serious condition known as erosive esophagitis, or EE.

The active molecule in Prilosec is omeprazole. Omeprazole exists in two mirror image forms, or isomers, called the S-form (Senantiomer or esomeprazole) and the R form (Renantiomer). Both forms can inhibit acid production. Prilosec contains both forms, whereas Nexium contains only the S-form of omeprazole.

Nexium and Prilosec are approved by the Food and Drug Administration (FDA) for healing EE, maintenance and healing of EE, and treatment of GERD. The approved dosage for Prilosec is 20 milligrams, and the approved dosages for Nexium are 20 and 40 milligrams.

Defendants introduced Prilosec in 1989. Other drug companies thereafter introduced three other prescription PPIs: Prevacid, Aciphex, and Protonix. The patent for Prilosec was set to expire in 2001, at which time its value would decrease as generic drug manufacturers entered the market. To preserve revenues, defendants developed Nexium, which they launched in March 2001. Generic Prilosec became available in December 2002, and non-prescription (over-the-counter) Prilosec was introduced in September 2003.

B. FDA Approval of Nexium

Before marketing Nexium, defendants were required to submit to the FDA a new drug application demonstrating Nexium’s safety and efficacy, and to obtain FDA approval of the Nexium labeling. (21 U.S.C. §355; 21 C.F.R. §§ 314.125-314.126.) As part of that approval process, defendants submitted four clinical studies comparing 40 mg and 20 mg of Nexium to 20 mg of Prilosec for healing and maintenance of EE. In two of these studies, 40 mg of Nexium provided statistically higher rates of healing EE than 20 mg of Prilosec. The same four studies assessed resolution of heartburn in EE patients. In two studies, 40 mg of Nexium provided statistically significant more rapid and complete heartburn control in EE patients than 20 mg of Prilosec.

In a report dated September 21, 2000, an FDA medical officer who reviewed the clinical studies submitted by defendants noted that the data demonstrated that Nexium “affords rates of healing which are comparable to omeprazole in the treatment of [EE]” and “is highly effective in the maintenance of healing of [EE].” The FDA reviewer commented, however, that none of the studies would support a claim that Nexium is superior to Prilosec in the first-line treatment of healing of EE, maintenance of healing EE, or treatment of symptomatic GERD. The reviewer stated: “[I]t is recommended not to allow the sponsor to claim that [Nexium] has any significant clinical advantage over omeprazole in the first-line treatment of these acid-related disorders because no data in support of such a claim have been submitted.”

On February 6, 2001, representatives from AstraZeneca and the FDA met to discuss proposed labeling for Nexium. The minutes from that meeting indicate that upon reviewing the data from the Nexium clinical studies, Dr. Florence Houn from the FDA’s Office of Drug Evaluation expressed concern that “physicians understand that Nexium is not superior to omeprazole.”

The Nexium labeling approved by the FDA summarizes the results of the Nexium clinical studies, including the four clinical studies comparing Nexium to Prilosec. It contains no statement that Nexium is superior to omeprazole or Prilosec, nor does it state that Nexium is not superior to Prilosec.

C. Nexium Advertising and Promotion

As part of its regulation of prescription drug advertising, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) reviews promotional materials before a new drug is marketed. (See 21 U.S.C. § 352(n); 21 C.F.R. § 314.81(b)(3)(i) (2010).) Thereafter, DDMAC monitors a drug’s marketing and issues notice of violation letters for advertising it finds to be misleading. Before launching Nexium, AstraZeneca submitted its consumer advertising materials and physician-directed promotional materials to DDMAC for advance review and addressed comments raised by DDMAC. AstraZeneca received no notice of violation letters from the DDMAC with respect to Nexium advertising and promotion.

Plaintiffs alleged that defendants engaged in a campaign of uniform misrepresentations and omissions in order to deceive consumers and physicians into believing that Nexium is superior to Prilosec. As evidence of defendants’ deceptive marketing, plaintiffs offered AstraZeneca’s internal marketing documents describing the company’s marketing strategy and goals for Nexium as intending to convey a “clear superiority message” to consumers, and direct-to-consumer advertisements for Nexium that used the phrases the “new purple pill, ” “today’s purple pill, ” and “from the makers of Prilosec.” Plaintiffs also presented training materials for AstraZeneca’s sales representatives in which Nexium is described as “better” or “more effective than” Prilosec, and surveys and call notes of sales representatives’ visits with physicians during which these messages were purportedly delivered.

Defendants presented declarations from AstraZeneca employees describing the various consumer advertising campaigns and physician-directed promotional materials used for Nexium and how they changed over time. Defendants also presented evidence that the phrases the “new purple pill” “today’s purple pill, ” and “from the makers of Prilosec” were included in draft ads reviewed by the DDMAC, that the agency never objected to those phrases, and that none of those phrases were used in direct-to-consumer advertisements after December 2002. Defendants presented evidence that AstraZeneca used many different physician-directed promotional materials, called “Core Visual Aids” (CVAs) or “Core Sell Sheets” (CSSs) that contained detailed information about Nexium’s bioavailability, pH control, efficacy in healing EE and sustained heartburn resolution in patients with EE, pharmacology, safety, indications, and dosing. The CVAs and CSSs were also reviewed and approved by the DDMAC.

D. Physician Prescribing Decisions

Defendants presented the declaration and testimony of an expert witness, Dr. Nimish Vakil (Dr. Vakil), who stated that physicians’ prescribing decisions are patient-based and vary depending on each patient’s medical history, symptoms, prescription drug coverage, and prior experience with other medications. Dr. Vakil further stated that physicians consider a drug’s treatment efficacy and may prescribe Nexium based on clinical studies that demonstrate Nexium’s efficacy in suppressing stomach acid and in maintenance and healing of EE. Dr. Vakil opined that because there are many different reasons physicians prescribe Nexium for their patients that exist independent of any allegedly misleading promotion of Nexium, it is not reasonable to assume that the alleged promotion caused all or most Nexium prescriptions to be written.

E. TPP Formulary Decisions

Defendants also presented the declaration of Dr. Robert Navarro (Dr. Navarro), a clinical pharmacologist and expert on managed care companies. Dr. Navarro described how managed care companies create a formulary, or listing of preferred drugs, through a Pharmacy & Therapeutics (P&T) Committee. Dr. Navarro stated that P&T Committees consider a broad array of clinical, economic, and other data when developing formularies, including the contents of FDA files and comments from FDA reviews, published and unpublished data comparison and clinical study data, and internal clinical and economic analyses conducted by health plans. He further stated that information received from drug manufacturers is subject to critical review and is used principally as a resource to supplement the P&T Committees’ own independent investigations, and that drug efficacy, safety, and cost are important considerations in a P&T Committee’s assessment of a drug.

2. Motion for Summary Judgment

Both parties presented the deposition testimony of plaintiffs and their doctors about the reasons Nexium was prescribed for the plaintiffs and why they discontinued using that drug.

3. Trial Court Rulings

On March 4, 2009, the trial court denied plaintiffs’ motion for class certification. The trial court concluded that regardless of whether plaintiffs’ false advertising claim was premised on the theory that defendants affirmatively misrepresented Nexium as superior to Prilosec, or on the theory that defendants failed to disclose Nexium’s nonsuperiority over Prilosec, common issues of proof did not predominate. The trial court found that plaintiffs failed to identify any specific misrepresentation, and that even if they had, the evidence demonstrated that they and the class members purchased Nexium for different reasons.

With regard to the nondisclosure theory, the court found that plaintiffs failed to demonstrate they could establish a duty to disclose based on classwide evidence. The trial court rejected the comments of FDA reviewers during Nexium preapproval meetings as evidence of an affirmative duty to disclose that Nexium is not superior to Prilosec.

On March 5, 2009, the trial court granted defendants’ motion for summary judgment as to all plaintiffs. Judgment was entered in defendants’ favor on April 24, 2009. This appeal followed.

DISCUSSION

I. Class Certification

A. Standard of Review

“‘Because trial courts are ideally situated to evaluate the efficiencies and practicalities of permitting group action, they are afforded great discretion in granting or denying certification.... [I]n the absence of other error, a trial court ruling supported by substantial evidence generally will not be disturbed “unless (1) improper criteria were used [citation]; or (2) erroneous legal assumptions were made [citation].”’ [Citations.]” (In re Tobacco II Cases (2009) 46 Cal.4th 298, 311 (Tobacco II).) An appellate court reviewing a class certification ruling considers the trial court’s rationale, not only its result. “Erroneous legal assumptions or improper criteria may require reversal ‘even though there may be substantial evidence to support the court’s order.’ [Citation.] Thus, we must determine whether the trial court engaged in a correct legal analysis. [Citation.] Accordingly, we will analyze the reasons given by the superior court in denying class certification. Any valid pertinent reason stated will be sufficient to uphold the order. [Citation.]” (Caro v. Procter & Gamble Co. (1993) 18 Cal.App.4th 644, 655-656.) “‘Where a certification order turns on inferences to be drawn from the facts, “‘the reviewing court has no authority to substitute its decision for that of the trial court.”’ [Citation.]” (In re Vioxx Class Cases (2009) 180 Cal.App.4th 116, 127-128 (Vioxx).)

B. Class Action Requirements

Code of Civil Procedure section 382 governs UCL and FAL claims brought as class actions. (Quacchia v. DaimlerChrysler Corp. (2004) 122 Cal.App.4th 1442, 1449 (Quacchia).) That statute authorizes class action lawsuits “when the question is one of a common or general interest, of many persons, or when the parties are numerous, and it is impracticable to bring them all before the court....” (Code Civ. Proc., § 382.) “‘“In order to maintain a class action, certain prerequisites must be met, specifically, ‘the existence of an ascertainable class and a well-defined community of interest among the class members. [Citation.] The community of interest requirement embodies three factors: (1) predominant common questions of law or fact; (2) class representatives with claims or defenses typical of the class; and (3) class representatives who can adequately represent the class.’”’ [Citation.]” (Vioxx, supra, 180 Cal.App.4th at p. 128.) “The predominance factor requires a showing ‘that questions of law or fact common to the class predominate over the questions affecting the individual members.’ [Citation.]” (In re Cipro Cases I & II (2004) 121 Cal.App.4th 402, 410.) The burden is on the party seeking certification to establish the existence of both an ascertainable class and a well-defined community of interest among the class members. (Washington Mutual Bank v. Superior Court (2001) 24 Cal.4th 906, 913.)

“A CLRA claim brought as a class action is governed exclusively by Civil Code section 1781, which sets out the four conditions that, if met, mandate certification of a class: ‘(1) It is impracticable to bring all members of the class before the court. [¶] (2) The questions of law or fact common to the class are substantially similar and predominate over the questions affecting the individual members. [¶] (3) The claims or defenses of the representative plaintiffs are typical of the claims or defenses of the class. [¶] (4) The representative plaintiffs will fairly and adequately protect the interests of the class.’ [Citations.] The trial court, however, has ‘considerable latitude’ under those four conditions in deciding whether a class action is proper. [Citation.]” (Steroid Hormone Product Cases (2010) 181Cal.App.4th 145, 153 (Hormone Cases).)

Under either statutory scheme, a plaintiff seeking class certification must demonstrate that common questions of law or fact predominate. (Quacchia, supra, 122 Cal.App.4th at p. 1449.) “To determine whether the questions of fact and law at issue in the litigation are common or individual, it is necessary to consider the individual causes of action pleaded, and the issues raised thereby.” (Vioxx, supra, 180 Cal.App.4th at p. 128.)

C. The UCL and FAL

The UCL defines unfair competition as “any unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising and any act prohibited by [the FAL].” (Bus. & Prof. Code, § 17200.) The FAL prohibits the dissemination of any advertising “which is untrue or misleading, and which is known, or which by the exercise of reasonable care should be known, to be untrue or misleading.” (§ 17500.) The instant case concerns an allegation of a fraudulent business act or practice – specifically, deceptive advertising and misrepresentations about Nexium.

A fraudulent business practice in violation of the UCL is also a violation of the FAL. (Bus. & Prof. Code, § 17500 et seq.; Tobacco II, supra, 46 Cal.4th at p. 312, fn. 8.)

Under Business and Professions Code section 17204, a private person seeking to assert a claim under the UCL must meet a two-pronged test. Such a person has standing to sue only if he or she (1) “has suffered injury in fact, ” and (2) “has lost money or property as a result of such unfair competition.” (§ 17204; Californians for Disability Rights v. Mervyn’s, LLC (2006) 39 Cal.4th 223, 227.) The statutory language “as a result of” unfair competition “requires a showing of a causal connection or reliance on the alleged misrepresentation.” (Hall v. Time Inc. (2008) 158 Cal.App.4th 847, 855.)

“Historically, in order to state a cause of action under either the UCL or the FAL, case law only required a showing that “‘“members of the public [were] likely to be deceived.” [Citations.]’ [Citation.] Allegations of actual deception, reasonable reliance and damage were unnecessary. [Citation.]” (Pfizer Inc. v. Superior Court (2010) 182 Cal.App.4th 622, 630 (Pfizer).)

In the November 2004 general election, voters in California adopted Proposition 64, which changed the standing requirement for class representatives seeking to certify a UCL class action. Before Proposition 64, the UCL authorized any person acting for the general public to sue for relief from unfair competition. (Tobacco II, supra, 46 Cal.4th at p. 314; Pfizer, supra, 182 Cal.App.4th at p. 630.) Standing to sue did not depend on a showing of injury or damage. (Tobacco II, at p. 314.) Proposition 64 amended the UCL to provide that “a private action for relief may be maintained only if the person bringing the action ‘has suffered injury in fact and has lost money or property as a result of the unfair competition.’ (Bus. & Prof. Code, § 17204.)” (Hormone Cases, supra, 181 Cal.App.4th at p. 154.)

In Tobacco II, the California Supreme Court analyzed the impact of Proposition 64 on UCL class actions. The court in Tobacco II addressed two questions: (1) “who in a UCL class action must comply with Proposition 64’s standing requirements, the class representatives or all unnamed class members, in order for the class action to proceed?” and (2) “what is the causation requirement for purposes of establishing standing under the UCL, and in particular what is the meaning of the phrase ‘as a result of’ in section 17204?” (Tobacco II, supra, 46 Cal.4th at p. 306.)

The Supreme Court held that the “standing requirements are applicable only to the class representatives, and not all absent class members.” (Tobacco II, supra, 46 Cal.4th at p. 306.) The court reasoned that Proposition 64 was not intended “to undermine the efficacy of the UCL as a means of protecting consumer rights” and that “requiring all unnamed members of a class action to individually establish standing would effectively eliminate the class action lawsuit as a vehicle for the vindication of such rights.” (Id. at p. 321.)

As to causation, the Supreme Court concluded: “[A] class representative proceeding on a claim of misrepresentation as the basis of his or her UCL action must demonstrate actual reliance on the allegedly deceptive or misleading statements, in accordance with well-settled principles regarding the element of reliance in ordinary fraud actions. Those same principles, however, do not require the class representative to plead or prove with an unrealistic degree of specificity that the plaintiff relied on particular advertisements or statements when the unfair practice is a fraudulent advertising campaign.” (Tobacco II, supra, 46 Cal.4th at p. 306.)

In the instant case, the trial court issued its ruling denying class certification without the guidance of the Supreme Court’s decision in Tobacco II, which was issued approximately two months later.

D. The CLRA

The CLRA proscribes numerous unlawful practices in the sale of goods or services to consumers. (Civ. Code, § 1770, subd. (a).) These unlawful practices include: “[r]epresenting that goods... have... characteristics, ... uses, [or] benefits... which they do not have” (§ 1770, subd. (a)(5)); “[r]epresenting that goods... are of a particular standard, quality, or grade... if they are of another” (§ 1770, subd. (a)(7)); and “[a]dvertising goods... with intent not to sell them as advertised” (§ 1770, subd. (a)(9)). The statute provides that “[a]ny consumer who suffers any damage as a result of the use or employment by any person of a method, act, or practice declared to be unlawful by Section 1770 may bring an action against that person to recover or obtain” actual damages, an injunction, restitution, and punitive damages. (§§ 1780, subd. (a); 1781, subd. (a).)

A class action claim under the CLRA thus requires a different analysis than a UCL claim because the CLRA requires a showing of actual injury as to each class member. (Hormone Cases, supra, 181 Cal.App.4th at p. 155.) The statutory language “makes clear that, to obtain relief under the CLRA, both the named plaintiff and the unnamed class members must have suffered some damage caused by a practice deemed unlawful under Civil Code section 1770. [Citation.]” (Hormone Cases, at p. 156.)

“The language of the CLRA allows recovery when a consumer ‘suffers any damage as a result of’ the unlawful practice. [Citation.] This provision ‘requires that plaintiffs in a CLRA action show not only that a defendant’s conduct was deceptive but that the deception caused them harm.’ [Citation.] Causation, on a classwide basis, may be established by materiality. If the trial court finds that material misrepresentations have been made to the entire class, an inference of reliance arises as to the class. [Citation.] This is so because a representation is considered material if it induced the consumer to alter his position to his detriment. [Citation.] That the defendant can establish a lack of causation as to a handful of class members does not necessarily render the issue of causation an individual, rather than a common, one. ‘“[P]laintiffs [may] satisfy their burden of showing causation as to each by showing materiality as to all.”’ [Citation.] In contrast, however, if the issue of materiality or reliance is a matter that would vary from consumer to consumer, the issue is not subject to common proof, and the action is properly not certified as a class action. [Citation.]” (Vioxx, supra, 180 Cal.App.4th at p. 129.)

E. Typicality

The trial court found that the individual plaintiffs’ claims were not typical of the claims of the TPPs, based on “persuasive evidence that the decisionmaking that goes into purchasing Nexium on an individual basis is entirely distinct from the process of putting it into a group formulary.” Plaintiffs argue that the decisionmaking process of the TPPs is irrelevant because the TPP class members are entitled to restitution whenever they paid all or part of a Nexium prescription during the class period, regardless of why they placed Nexium on their formularies. They maintain that if an individual patient paid for Nexium as the result of defendant’s misrepresentations, the TPP that paid a portion of the purchase price should also be entitled to recover.

In Vioxx, Division Three of this court considered this precise issue in a case involving strikingly similar circumstances. The plaintiffs in Vioxx asserted causes of action under the UCL and CLRA based on allegations that the manufacturer of the prescription drug Vioxx knew about cardiovascular risks associated with the drug but engaged in a campaign to hide or explain away those risks. (Vioxx, supra, 180 Cal.App.4th at pp. 122-123.) The plaintiffs claimed that Vioxx was no more effective, and less safe, than a generic drug that was also less expensive than Vioxx. (Ibid.) The court in Vioxx rejected the argument that TPPs should be treated the same as individual class members: “The flaw in plaintiffs’ analysis is that it treats the TPP as a passive entity which simply pays its share of the cost of any prescription written for any of its members, with no independent say in the matter. While some TPPs may have, in fact, preapproved Vioxx for use in all patients, the evidence also indicates that other TPP’s were not so passive.” (Id. at p. 132.) The same is true here. Defendants presented evidence that TPPs have specialized committees that make their own decisions regarding the relative efficacy and cost-effectiveness of competing drugs and that formulary decisions are influenced by factors such as patient co-payments and rebates from the pharmaceutical manufacturer. The record contains substantial evidence that the process for including Nexium in a group formulary differs substantially from the decisionmaking process for purchasing Nexium on an individual basis.

The court in Vioxx also concluded that the evidence supported a finding that the individual plaintiffs’ claims were not typical of those of the TPPs because assessing the materiality of the misrepresentations to individual patients was “a completely different inquiry” from that involved with respect to TPPs:

“With respect to plaintiffs’ CLRA claim, we would consider whether the misrepresentations were material to the TPP’s. Clearly, the evidence supports the trial court’s conclusion that whether... misrepresentations were material to individual patients is a completely different inquiry from whether the misrepresentations were material to P&T committees, whose sole purpose was to investigate which drugs were appropriate for their respective TPP’s formularies. Similarly, with respect to the UCL claim, in considering whether the representation was likely to mislead, we consider the audience to whom the misrepresentation was directed. Whether an individual patient or physician was likely to be misled by Merck’s representations is a completely different inquiry from whether a sophisticated P&T committee, with substantial resources and the ability to conduct its own research, was likely to be misled. Thus, the trial court did not err in concluding the individual plaintiffs’ claims were not typical of the claims of the TPP’s.”

(Vioxx, supra, 180 Cal.App.4th at p. 132.)

Here, as in Vioxx, the evidence showed that the factors considered by an individual patient or physician deciding whether to take or prescribe Nexium differ substantially from those considered by a TPP deciding whether, and in what circumstances, to include Nexium on a group formulary. There was evidence that individual patients consider relief from symptoms as the primary factor in deciding between Nexium and other PPIs. Defendants presented evidence that doctors consider numerous criteria in deciding whether to prescribe Nexium, including patient history, managed care and cost considerations, treatment efficacy, disease severity and predictability of treatment response, and physician experience with the medication. There was evidence that P&T Committees making formulary decisions consider different factors, including drug safety, patient co-payments, and manufacturer rebates and their impact on pharmacy budgets. Substantial evidence supports the trial court’s determination that plaintiffs’ claims were not typical of the claims of the TPPs.

F. Commonality

1. Individual Issues Predominate--Evidence of Deception--CLRA and UCL/FAL

The trial court also denied class certification on the ground that plaintiffs’ claims of deceptive advertising, whether by misrepresentation or omission, were not subject to classwide proof and that individual issues would predominate. Substantial evidence supports that finding.

a. No Uniformity in Marketing

The record shows no uniformity in defendants’ marketing of Nexium. The methods defendants used to market Nexium to patients differed significantly from the promotional methods used for physicians. Defendants marketed Nexium to patients via television, radio, internet, magazine, and newspaper advertisements, and by using a consumer rebate program for Nexium in California. Defendants used a variety of different channels to communicate with physicians, including in-person visits by pharmaceutical sales representatives and printed information such as CVAs and CSSs. Plaintiffs’ claims of deception would thus require individualized inquiries into the many different channels used to promote Nexium among patients and physicians.

b. Plaintiffs’ Misrepresentation Theory

There was no evidence of uniform misrepresentations to class members. Rather, the evidence showed that Nexium advertising for patients differed significantly in content from the promotional materials used for physicians. Patient advertising focused on relieving heartburn and other symptoms, whereas physician-directed promotional materials contained data and other detailed information about the drug, including the FDA approved labeling.

There was no evidence of uniform misrepresentations to patients. The evidence showed that between 2001 and December 2004, defendants used six different consumer advertising campaigns, each with different key messages. Plaintiffs claim that defendants implemented a uniform campaign of deceptive consumer advertising promoting Nexium as superior to Prilosec by using the phrases “today’s purple pill, ” “the new purple pill, ” and “from the makers of Prilosec, ” however, none of these slogans contain any claim that Nexium is superior to Prilosec. Moreover, the record shows that defendants did not use any of these phrases in direct-to-consumer advertising during the class period. Defendant discontinued using the phrase “new purple pill” in Nexium ads after September 2001, and stopped using the phrase “today’s purple pill” after December 2002. None of defendant’s direct-to-consumer ads referred to Prilosec after 2002, and in early 2003, defendant’s promotional efforts for Nexium focused on comparisons with Prevacid, which had become the PPI market leader. Many class members would therefore have not been exposed to any advertising containing the allegedly misleading slogans. Plaintiffs identified no alleged misrepresentation that was uniformly presented to consumers during the class period.

There was no evidence of uniform misrepresentations to physicians. The evidence concerning physician-directed promotional materials for Nexium shows that defendants used different promotional materials covering different subjects that changed over time, including Nexium’s labeling, formulary status, dosing, samples, and studies concerning Nexium’s attributes on various metrics. Although plaintiffs contend defendants’ sales representatives uniformly misrepresented to physicians that Nexium was superior to Prilosec, the evidence showed that sales representatives’ visits with health care providers vary significantly as to the amount of time spent with the provider and the content of the visit, and that some physicians do not talk to sales representatives at all.

Plaintiffs contend the trial court erroneously “excluded” statements made by FDA representatives during preapproval meetings for the Nexium labeling as evidence that “AstraZeneca failed to convince the FDA that Nexium is superior to Prilosec... but nonetheless implemented a nationwide campaign to convince the public otherwise.” There is nothing in the record to indicate that the trial court excluded this evidence or ruled it inadmissible. That evidence would not be relevant, in any event, to the issue of whether plaintiffs presented classwide evidence of uniform misrepresentations to patients and physicians.

Plaintiffs further contend the trial court erred when it made the following observation about plaintiffs’ failure to identify any specific, actionable misrepresentation by defendants:

“Though plaintiffs frequently complain Nexium is not ‘superior, ’ i.e., is no better or ‘more effective’ than Prilosec, those allegations cannot form the basis of their claims because they do not assert an actionable misrepresentation. That a product is ‘superior’ to another is a nonspecific, legally meaningless conclusion. Plaintiffs may recover only insofar as defendants failed to disclose that specific characteristics of Nexium were nonsuperior to those of Prilosec in light of a material metric.”

Plaintiffs maintain that the foregoing statements reflect the trial court’s rejection of their theory of recovery and was an improper ruling on the merits that mandates reversal of the order denying class certification. The trial court’s observations were not an improper ruling on the merits. In its written order, the trial court went on to state: “Plaintiffs decline to identify any specific misrepresentation. Even if they did, their own evidence demonstrates they and class members purchased Nexium for different reasons.... [¶] Even if plaintiffs’ claims of nonspecific misrepresentations were cognizable, their own evidence also demonstrates that those misrepresentations cannot be established by classwide proof. The declarations and deposition testimony of plaintiffs and their physicians indicates they and the physicians saw different ads (or no ads) containing different representations at different times.” The trial court’s order makes clear that it denied class certification because plaintiffs failed to establish that questions of law or fact common to the class would predominate over individualized issues affecting the class members with regard to their claims of misrepresentation.

Substantial evidence supports the trial court’s determination that there were no uniform misrepresentations likely to deceive the class and that plaintiffs’ claims require individualized inquiries into what was communicated to the class members. Class certification was properly denied on that basis. (Quacchia, supra, 122 Cal.App.4th at pp. 1449-1450.)

c. Plaintiffs’ Nondisclosure Theory

Substantial evidence also supports the trial court’s finding that individualized issues of fact and law would predominate with regard to plaintiffs’ claim that defendants failed to disclose that Nexium is not superior to Prilosec. To prove defendants’ liability for failure to disclose this fact, plaintiffs would have had to establish a duty to disclose that fact. (Buller v. Sutter Health (2008) 160 Cal.App.4th 981, 987.) The trial court properly found that establishing such a duty would require individualized evaluations of the various promotional materials used for Nexium. As discussed, the record shows that defendant used six different direct-to-consumer advertising campaigns with varying content over different time periods and multiple promotional methods and materials for physicians emphasizing different Nexium attributes and metrics. Plaintiffs failed to show that the evidence they would use to establish a duty to disclose would apply on a classwide basis.

Plaintiffs claim they presented classwide evidence that would support a duty to disclose that Nexium is not superior to Prilosec, in the form of statements made by FDA representatives during negotiations over the contents of the Nexium label. They contend the trial court erred by rejecting this evidence, which includes a statement attributed to an FDA scientist concerning data comparing 40 mg and 20 mg of Nexium to 20 mg of omeprazole (Prilosec):

“Dr. Houn stated that 40 mg is very good and 20 mg also works. She stated that they do want to show this data. The concern they had was to make physicians understand that Nexium is not superior to omeprazole. She asked if there was some suggestion for that. Mr. Mallon responded that AstraZeneca agreed with the full presentation of the data and AstraZeneca would work on wording that balances the superiority issue.”

The trial court discounted this evidence, on the ground that FDA regulations state that comments in preapproval meetings are not formal FDA findings and do not have the force of law. (See 21 C.F.R. § 10.85(k) (2010) [“A statement or advice given by an FDA employee orally... is an informal communication that represents the best judgment of that employee at that time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed”]; 21 C.F.R. §10.65(a) (2010) [action on meetings between an FDA representative and an outside person “does not constitute final administrative action subject to judicial review”]; DePriest v. AstraZeneca Pharmaceuticals (2009) Ark. 547 [__ S.W.3d __, 2009 Ark. Lexis 722] fn. 11 at p. *18].)

Plaintiffs cite Zeneca, Inc. v. Eli Lilly & Co. (N.Y. Jul. 19, 1999, No. 99 CIV. 1452(JGK)) 1999 U.S. Dist. Lexis 10852, as support for their argument that comments by FDA representatives during pre-approval review proceedings is evidence of an affirmative duty to disclose that Nexium is not superior to Prilosec. In Zeneca, the FDA required Eli Lilly to state on its label for Evista, an osteoporosis drug, that its effectiveness “‘in reducing the risk of breast cancer has not yet been established.’” (Id. at p. *3.) Eli Lilly maintained, however, that its sales representatives were authorized to state that Evista reduces the risk of breast cancer (id. at pp. *47, *56), because the labeling requirement was simply FDA’s way of communicating that Evista had been proven efficacious, but was not yet indicated for breast cancer reduction. (Id. at p. *74.) In assessing Eli Lilly’s interpretation of the Evista label, the Zeneca court considered FDA documents, including minutes of meetings that occurred both before and after the approval of Evista’s labeling. The court in Zeneca concluded that Eli Lilly’s interpretation of the label was “contrary to the plain meaning of the FDA documents.” (Id. at p. *76.) The court in Zeneca did not hold that comments made at an FDA preapproval meeting established a legal duty to make affirmative disclosures that the FDA did not also require in the label itself.

In this case, the FDA did not require defendant to disclose, in Nexium labeling or advertising, that Nexium is not superior to Prilosec or omeprazole. Plaintiffs’ expert conceded that the product labeling, not notes from an FDA preapproval meeting, reflects the FDA’s conclusions on information doctors should have about a prescription drug. The trial court did not err by rejecting statements made by FDA representatives at a preapproval meeting for Nexium labeling as classwide evidence of an affirmative duty to disclose that Nexium is not superior to Prilosec.

2. Individual Issues Predominate--Reliance and Materiality--CLRA

The trial court found that plaintiffs’ entitlement to relief under the CLRA was not subject to common proof because issues of reliance or materiality could not be resolved on a classwide basis but depended on an individual determination with respect to each class member. The trial court found that defendants presented overwhelming evidence establishing that a decision to purchase or prescribe Nexium is influenced by several case-specific factors and that “[p]laintiffs’ own histories indicate Nexium was prescribed to them for several different, non-interchangeable reasons.” The trial court expressly rejected plaintiffs’ argument that classwide reliance could be inferred based on the evidence presented and concluded that there was “little if any common evidence as to what consumers perceived or what they would find material” and “[n]o evidence [that] suggests prescription decisions are made uniformly on the basis of advertising.” Substantial evidence supports these findings.

Plaintiffs themselves testified that they either did not recall seeing any allegedly misleading Nexium ads, or that the ads did not cause them to believe that Nexium was superior to Prilosec or to ask their doctors to prescribe Nexium for them. Joaquim-Blackie did not recall having seen any Nexium advertisements before she began taking Nexium. After she began taking Nexium, Joaquim-Blackie saw television advertisements for “the little purple pill called Nexium” but she “did not get the impression from those advertisements that Nexium was superior to Prilosec.” Saum also admitted that he did not get the impression from any Nexium ads that Nexium was superior to Prilosec. Weiss saw magazine and television advertisements describing Nexium as the “purple pill” but he testified that none of these advertisements caused him to communicate with his doctor about Nexium or to prescribe Nexium for him. Vogt also saw television, magazine and newspaper ads describing Nexium as “the new purple pill” but admitted that none of the Nexium ads caused her to talk to her doctor about Nexium.

Because Nexium is available to consumers only by prescription, determining whether defendants’ promotional campaign for Nexium was “likely to deceive” class members necessarily involves an examination of the factors that influence physician prescribing decisions. Defendants’ expert, Dr. Vakil, testified that a physician prescribing Nexium takes into account a variety of factors, including patient-specific factors such as individual medical history and disease severity, the predictability of treatment response, ongoing treatment efficacy, and other factors such as the physician’s personal experience with the drug and any TPP formulary position. Dr. Vakil further testified that a physician’s reasons for prescribing Nexium are independent of any product promotion, and that physicians typically place greater weight on their own clinical experiences when testing a manufacturer’s claims of efficacy or comparative effectiveness for any given drug.

Plaintiffs argue that “the record in this case compels an inference of reliance on the undisclosed information that the FDA found (and wanted physicians to know) that Nexium is not superior to Prilosec.” As discussed, the FDA made no formal “finding” that Nexium is not superior to Prilosec, nor did it require defendants to disclose that information to physicians or patients. The evidence on which plaintiffs rely -- oral statements by an FDA employee during negotiations on the Nexium label at a preapproval meeting -- does not support an inference of classwide reliance. Plaintiffs also cite defendants’ internal marketing materials which describe Nexium ads as communicating “a clear superiority message to consumers” by using phrases such as “From the ‘Makers of Prilosec’” and “the Next Purple Pill” and stating that the “[p]rimary consumer takeaway (although not stated in the ad) is that Nexium is superior to Prilosec.” None of the Nexium ads state that Nexium is superior to Prilosec. Although the internal marketing materials may be evidence of defendants’ marketing ambitions, they are not persuasive evidence of the materiality of the alleged misrepresentation or of what consumers would find to be persuasive.

Substantial evidence supports the trial court’s determination that the materiality of defendants’ alleged misrepresentations or nondisclosures was a matter on which individual issues prevailed over common issues, and the trial court properly denied class certification of plaintiffs’ CLRA claim on that basis. (Vioxx, supra, 180 Cal.App.4th at p. 134 [class certification of CLRA false advertising claim properly denied when evidence showed that patient-specific factors such as patient’s history, drug allergies, condition being treated, and whether patient’s TPP required preapproval of drug, were part of prescribing decision].)

The trial court denied class certification of plaintiffs’ UCL and FAL claims on the same ground -- that issues of materiality and reliance required individualized inquiry into each class member’s medical needs and history. Plaintiffs contend this constituted legal error because, as our Supreme Court stated in Tobacco II: “[R]elief under the UCL is available without individualized proof of deception, reliance and injury.” (Tobacco II, supra, 46 Cal.4th at p. 320.) Several appellate courts, including Divisions Three, Four, and Eight of this District, have considered the effect of the Tobacco II decision on motions for class certification under the UCL and FAL; however, no clear consensus has emerged. (See, e.g., Pfizer, supra, 182 Cal.App.4th 622; Hormone Cases, supra, 181 Cal.App.4th 145; Cohen v. DIRECTV, Inc. (2009) 178 Cal.App.4th 966; Vioxx, supra, 180 Cal.App.4th 116.) We need not consider the trial court’s findings with respect to materiality and reliance in plaintiffs’ UCL and FAL causes of action, however, because its findings with respect to typicality and deception are sufficient to support the denial of class certification of plaintiffs’ UCL and FAL claims. (See Vioxx, supra, at p. 134, fn. 19.)

II. Summary Judgment and No-Merit Determination

A. Standard of Review

Summary judgment is granted when a moving party establishes the right to entry of judgment as a matter of law. (Code Civ. Proc., § 437c, subd. (c).) “The purpose of the law of summary judgment is to provide courts with a mechanism to cut through the parties’ pleadings in order to determine whether, despite their allegations, trial is in fact necessary to resolve their dispute. [Citation.]” (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 843 (Aguilar).)

A defendant moving for summary judgment bears the initial burden of proving that there is no merit to a cause of action by showing that one or more elements of the cause of action cannot be established or that there is a complete defense to that cause of action. (Code Civ. Proc., § 437c, subd. (p)(2); Cucuzza v. City of Santa Clara (2002) 104 Cal.App.4th 1031, 1037.) Once the defendant has made such a showing, the burden shifts to the plaintiff to show that a triable issue of one or more material facts exists as to that cause of action or as to a defense to the cause of action. (Aguilar, supra, 25 Cal.4th at p. 849.) If the plaintiff does not make such a showing, summary judgment in favor of the defendant is appropriate. In order to obtain a summary judgment, “all that the defendant need do is to show that the plaintiff cannot establish at least one element of the cause of action.... [T]he defendant need not himself conclusively negate any such element....” (Id. at p. 853.)

On appeal from a summary judgment, an appellate court makes “an independent assessment of the correctness of the trial court’s ruling, applying the same legal standard as the trial court in determining whether there are any genuine issues of material fact or whether the moving party is entitled to judgment as a matter of law. [Citations.]” (Iverson v. Muroc Unified School Dist. (1995) 32 Cal.App.4th 218, 222.)

A CLRA cause of action cannot be summarily disposed of by means of a motion for summary adjudication or summary judgment (Civ. Code, § 1781, subd. (c)); however, it can be dismissed before trial on a motion for a determination that it is without merit (i.e., a no-merit determination). (§ 1781, subd. (c)(3); Olsen v. Breeze, Inc. (1996) 48 Cal.App.4th 608, 624.) In practice, courts apply the standards applicable to motions for summary judgment and summary adjudication in deciding motions for no-merit determinations. (See, e.g., Kagan v. Gibraltar Sav. & Loan Assn. (1984) 35 Cal.3d 582, 589, 597, disapproved on another ground by Meyer v. Sprint Spectrum L.P. (2009) 45 Cal.4th 634, 643, fn. 3; Consumer Advocates v. Echostar Satellite Corp. (2003) 113 Cal.App.4th 1351, 1359-1362 [“no meaningful distinction in the choice” between dismissal of a cause of action after a motion for summary judgment and a motion for a no-merit determination].)

In the instant case, defendants met their burden of proving that each of the plaintiffs could not establish causation, a necessary element in their causes of action under the CLRA, UCL, and FAL, and plaintiffs failed to raise any triable issue of material fact necessary to preclude summary judgment or a no-merit determination.

B. Plaintiff Joachim-Blackie

Defendant presented evidence, which was undisputed, that Joachim-Blackie did not ask her doctor to prescribe Nexium, nor did she even discuss Nexium with him, as a result of any Nexium advertisement. Joaquim-Blackie admitted that she saw no Nexium ads before taking Nexium. Joachim-Blackie’s primary care physician, Dr. Allen Priest (Dr. Priest), testified in deposition that he prescribed Nexium for her because she had failed on Prilosec and Aciphex, and not for any other reason. Dr. Priest further testified that the only reason he continued to prescribe Nexium for Joachim-Blackie was that, in his professional judgment, it was the best medication for her at the time. Dr. Sidney Yassinger (Dr. Yassinger), a gastroenterologist who prescribed Nexium for Joaquim-Blackie once in June 2002, testified that the only reason he did so was because Nexium was relieving her symptoms and she had not done as well with either 20 mg of Prilosec or 20 mg of Aciphex.

Although Joaquim-Blackie contends her doctors prescribed Nexium for her because they relied on, and were misled by, Nexium promotion, the evidence she presented does not support that contention. The evidence includes deposition testimony by Dr. Priest, who recalled defendant’s sales representatives comparing Nexium and Prilosec, and call notes documenting sales representatives’ conversations with Dr. Priest about Nexium’s bioavailability and efficacy compared to Pilosec and other PPIs. This evidence creates no triable issue of material fact about the reasons why Dr. Priest prescribed Nexium for Joaquim-Blackie. The undisputed evidence shows that the only reason he did so was because Joaquim-Blackie had failed on Prilosec and Aciphex and because, in his professional judgment, it was the best medication for her at the time.

Joaquim-Blackie also presented deposition testimony by Dr. Yassinger, who recalled sales representatives promoting Nexium as having greater potency and efficacy as compared to Prilosec. This evidence, too, creates no triable issue of fact as to why Dr. Yassinger prescribed Nexium for Joaquim-Blackie. Dr. Yassinger testified that he prescribed Nexium for Joaquim-Blackie “[b]ecause it was relieving her symptoms” and for no other reason. Dr. Yassinger also expressly stated that his decision to prescribe Nexium for Joaquim-Blackie was not influenced by advertising or by communications with an AstraZeneca sales representative.

The evidence does not support Joaquim-Blackie’s contention that her doctors would not have prescribed Nexium had defendant disclosed “the truth.” Joaquim-Blackie cites the following testimony by Dr. Priest and Dr. Yassinger in response to questions about whether they would have prescribed Prilosec for their patients generally if defendant had disclosed that Nexium is not superior to Prilosec:

Dr. Priest

“Q: So if you were informed by AstraZeneca that Prilosec is just as effective as Nexium, would you prescribe Prilosec to your patients if you knew that it was indeed cheaper?...

“[Dr. Priest]: Yeah. I mean, if you are having two drugs for that particular patient, let’s say, and one was less expensive, that would be the most reasonable one to choose.”

Dr. Yassinger

“Q: Had AstraZeneca sales reps disclosed to you that the FDA had concluded that Nexium was not superior to Prilosec, would you have earlier prescribed Prilosec for patients instead if it were cheaper for them?...

“[Dr. Yassinger]: Yes.

Dr. Priest also testified, however, that his prescribing decision for Joachim-Blackie would not have changed because she had already “failed on Prilosec”:

“Q: [Plaintiff’s counsel] gave you a hypothetical about a situation where you were told that Nexium and Prilosec were equally effective, but Prilosec is cheaper and asking you which drug you prescribe. Do you recall that?

“[Dr. Priest]: Yes.

“Q: But in deciding whether to prescribe a particular PPI to any particular patient, you consider all of the things that we’ve discussed previously, right; the formulary status, the package insert, the patient’s prior history including, you know, the patient’s failure on other PPIs?

“A: Right.

“Q: So for any particular -- so if a particular patient had failed on Prilosec, for example, you might not prescribe Prilosec to that patient even if it was cheaper. Is that right?

“A: I think the answer is yeah. As I mentioned, I don’t recall any of this stuff. But looking back at the record, looked to me like [Joachim-Blackie] failed on Prilosec, so that’s why I probably, probably the reason why I didn’t prescribe it again.”

Joaquim-Blackie fails to raise any triable issue of material fact as to why her doctors prescribed Nexium for her instead of Prilosec. The doctors’ responses to general hypothetical questions about what they might have done for other patients had they been told that both drugs were equally effective has no bearing on the decision to prescribe Nexium for Joaquim-Blackie specifically. (See Mirzada v. Department of Transportation (2003) 111 Cal.App.4th 802, 809 [“In the face of specificity, generalities do not overcome a motion for summary judgment”].) Both Dr. Priest and Dr. Yassinger testified unequivocally that they prescribed Nexium for Joaquim-Blackie because she had “failed on Prilosec” and “[b]ecause [Nexium] was relieving her symptoms” and “she had not done as well with” other PPIs.

Joaquim-Blackie argues that she can establish causation because, after taking Nexium, she saw ads which made her think Nexium was better, and that she reported this to her doctors, contributing to a “feedback loop” that shaped her doctors’ decision to continue prescribing Nexium for her. That argument is foreclosed by Joaquim-Blackie’s admission in a declaration submitted in support of class certification in which she stated that after viewing television advertisements for Nexium, “I did not get the impression from those advertisements that Nexium was superior to Prilosec.” (Thompson v. Williams (1989) 211 Cal.App.3d 566, 573 [“After-the-fact attempts to reverse prior admissions are impermissible because a party cannot rely on contradictions in his own testimony to create a triable issue of fact”].)

Summary judgment and a no-merit determination were properly granted as to the claims asserted by plaintiff Joaquim-Blackie.

C. Plaintiff Vogt

It is undisputed that Nexium ads did not cause Vogt to ask her doctor about Nexium or to ask her doctor to prescribe Nexium. It is also undisputed that before taking Nexium in November 2001, Vogt had tried all of the PPIs available at the time, including Prilosec. Vogt’s doctor, Adriena Kajdos (Dr. Kajdos), testified that she started Vogt on Nexium “as a last resort” because Vogt had tried the other available PPIs, which were not working adequately for her.

Vogt contends she would have switched from Nexium to Prilosec OTC sooner had defendants told Dr. Kajdos that Nexium was no more effective than Prilosec. She claims that because defendants did not make this disclosure, Dr. Kajdos in turn did not inform Vogt, who continued to purchase Nexium for many years before switching to Prilosec.

There is no evidence that such a disclosure would have altered Dr. Kajdos’s decision to prescribe Nexium for Vogt. When asked whether her decision to prescribe Nexium or Prilosec for patients would have been affected by disclosures that both drugs were equally effective, Dr. Kajdos responded that her decisions were based on patient-specific information:

“Q:... If the AstraZeneca sales reps had instead told you that Prilosec was as effective as Nexium, would you have prescribed Prilosec for your patients if it was cheaper for them to obtain?...

“[Dr. Kajdos]: It depends on the patient. If patient benefitted better from Prilosec than Nexium, I’ll prescribe Prilosec. If patient benefitted better from Nexium, I would prescribe Nexium. If both drugs work for the patient, then I will go for one which patient can get and actually use, as long as the safety is the same.

“[¶]... [¶]

“Q: If the AstraZeneca sales reps told you that the Federal Food and Drug and Administration had concluded that Nexium was not superior to Prilosec, would you have prescribed Prilosec to your patients instead of Nexium where they could get Prilosec for less?...

“[Dr. Kajdos]: I would choose what drug to prescribe by patient response and benefit from the drug, not by what FDA says, as long as it’s the same safety and the same indication.”

Dr. Kadjos further testified that she did not believe Nexium was better than Prilosec because PPIs “work differently in different patients” and “[p]atients are individual people.”

Vogt’s claim that had defendant told Dr. Kadjos that Nexium was not superior to Prilosec, Dr. Kadjos would in turn have disclosed this information to Vogt is contradicted by Dr. Kadjos’s own testimony:

“Q: Would you have told Mrs. Vogt that Nexium was no more effective than Prilosec over the counter?

“[Dr. Kadjos]: I would not.

“Q: Would you have told her that the FDA determined that Nexium was no more effective than Prilosec?

“A: I’m not aware of that statement....

“Q: So you wouldn’t have told Mrs. Vogt that?

“A: No.”

Moreover, Vogt’s own actions contradict her claim that she would have discontinued using Nexium and switched to Prilosec had Dr. Kadjos told her the two drugs were equally effective. In her notes regarding a March 2004 office visit, Dr. Kadjos wrote that Vogt “tried a variety of PPIs and other agents and the only medication which worked for her is Nexium 40 mg q am ac, but that is quite expensive and she has difficulty paying for it.” The notes indicate that Dr. Kadjos “suggested she try generic omeprazole at 40 mg daily. It might still control her symptoms adequately and perhaps cost much less.” Vogt nevertheless continued using Nexium until August 2007.

Vogt failed to raise any triable issue of material fact as to whether defendant’s nondisclosure would have prompted her to switch from Nexium to Prilosec sooner than she did. Summary judgment and a no-merit determination were properly granted as to Vogt’s claims.

D. Plaintiff Saum

There was undisputed evidence that Nexium advertising and marketing did not cause plaintiff Saum to talk to his doctor about Nexium or to ask his doctor to prescribe it for him. Saum did not recall seeing any Nexium advertising before trying Nexium. Saum admitted that he did not get the impression from any Nexium ads that Nexium was superior to Prilosec. Saum further admitted that Nexium advertisements did not cause him to communicate with his doctor about Nexium or to ask his doctor to prescribe Nexium for him. Saum and his doctor, Deborah Higer (Dr. Higer), both testified that Saum asked Dr. Higer to prescribe Nexium for him in May 2004 because he had tried it and it had worked for him. It is thus undisputed that Saum did not rely on any Nexium advertising or marketing when he asked his doctor to prescribe Nexium for him.

There was evidence that Saum resisted efforts by his insurance company to get him to switch from Nexium to Prilosec. The record shows that in May 2005, Saum’s insurance company wanted him to switch from Nexium to generic Prilosec, but Saum told Dr. Higer that he had tried generic Prilosec and that it did not work for him. Although Saum’s statement was untrue, because he had not tried generic Prilosec at the time, he told Dr. Higer generic Prilosec did not work for him because he did not want to stop taking Nexium.

There was also evidence that Saum’s doctor would not have altered her decision to prescribe Nexium for him even if she had known that Nexium was no more effective than Prilosec. Dr. Higer testified that had she known in 2004 that the FDA had determined that Nexium was no more effective than Prilosec, she would not have altered her prescribing decision for Saum because he insisted on taking Nexium:

“Q: If you had known back in 2004 that the FDA had determined that Nexium was no more effective than Prilosec, if you had known that Prilosec would cost Mr. Saum less, would you have originally prescribed it for him?...

“A: Basically I would have done exactly what I did. My clinical experience is, this is probably going to be less expensive for you, and he insisted on the Nexium so I wrote the Nexium.”

Saum maintains that he continued using Nexium until December 2006, and that he switched to Prilosec OTC when Dr. Higer told him that “Prilosec was the same as Nexium... the same chemical as Nexium only in a reduced strength.” He contends a triable issue of fact exists as to whether he would have switched to Prilosec OTC sooner had defendants’ advertisements informed him that Nexium was “essentially the same” as Prilosec. Saum’s contention raises no triable issue as to causation, as it is undisputed that no misleading advertising caused him to take Nexium in the first place. His contention, premised on the theory that defendant had an affirmative duty to disclose that Nexium and Prilosec are “the same” or “essentially the same, ” is also untenable as a matter of law.

Although Nexium and Prilosec are in the same class of drugs, they are not the same drug. Plaintiffs acknowledge in their complaint that Nexium and Prilosec have different chemical makeups and were subject to different patents and separate FDA approval proceedings. Nexium and Prilosec were approved by the FDA for their own respective set of label indications. Nexium and Prilosec labeling differ significantly with respect to drug interactions, approved indications, and dosages. Nexium received FDA approval for the treatment of a condition known as Zollinger-Ellison Syndrome, whereas Prilosec did not.

Saum offers no authority to support his contention that defendants had an affirmative duty to disclose that Nexium is “the same” or “essentially the same” drug as Prilosec, and there is no basis for finding the existence of such a duty in this case. A failure to disclose a fact one has no affirmative duty to disclose is not likely to deceive anyone. (Daugherty v. American Honda Motor Co., Inc. (2006) 144 Cal.App.4th 824, 838 [“We cannot agree that a failure to disclose a fact one has no affirmative duty to disclose is ‘likely to deceive’ anyone within the meaning of the UCL”].) The absence of such a disclosure in defendant’s advertising of Nexium was not deceptive, misleading, or fraudulent as a matter of law. Summary judgment and a no-merit determination were properly granted as to Saum’s claims.

E. Plaintiff Weiss

Weiss does not claim to have been personally misled by Nexium advertising. He admitted that Nexium ads did not cause him to talk to his doctor about Nexium or to ask his doctor to prescribe Nexium. Weiss’s sole claim is that his doctor, Phil Lugo (Dr. Lugo), was misled by Nexium marketing into prescribing Nexium for him.

Weiss took both Prevacid and Protonix before he switched to Nexium in September 2003 on the recommendation of Dr. Lugo. Dr. Lugo testified that the decision to switch Weiss from Prevacid to Nexium “likely” “was driven by insurance requirements.” Although Dr. Lugo initially could not recall the reason for switching Weiss from Prevacid to Nexium, after reviewing Weiss’s medical records, Dr. Lugo confirmed that those “records do not reflect any other reasoning other than insurance” as the reason for the change. Dr. Lugo further testified that in his clinical experience, Nexium was the most effective of the PPIs. While Dr. Lugo recalled sales representatives of different drug companies, including Nexium sales representatives, touting the superiority of their respective products, he said he did not take those claims at face value.

Weiss contends Dr. Lugo’s decision to prescribe Nexium for Weiss was driven by Nexium marketing and that he would have prescribed Prilosec OTC for Weiss “if he had known the truth.” As support for this contention, Weiss cites deposition testimony by Dr. Lugo in which he states that information from drug sales representatives is one of several factors he considers when prescribing a drug:

“Q:... Is a sales rep telling you that their drug is the best alone a reason for you to prescribe the drug?

“A: That is often the case that they tell us that, yes.

“Q: Okay. Do you give that claim any weight?

“A: It’s a consideration -- it’s information, it’s considered. It’s put into -- it’s grouped along with clinical experience, patients reporting back what’s effective, what’s not effective, taking into consideration side effects that the patient reports. Oftentimes these particular drug reps do show data that is suggestive of more effectiveness in their own -- in referencing a particular study. And some of that has some -- it is considered, and I do give that some credit, because it is backed by a study or some objective scrutiny.”

The record shows, however, that immediately before and after the preceding testimony, Dr. Lugo testified that he does not take sales representatives’ claims at face value, but that he verifies the accuracy of those claims by reviewing the data:

“Q: Okay. Have you heard sales reps claiming that their drug is the best?

“A: All the time.

“Q: Do you take those claims at face value?

“A: No.”

“[¶]... [¶]

“Q: Is it fair to say that you would not assume that a drug is better than others based on a sales rep’s oral claim to you alone that their drug is best, that you would look to the data?

“A: Yes.”

Weiss also relies on Dr. Lugo’s response to the following hypothetical question about whether he would have prescribed Nexium or generic omeprazole for “a patient” had he been told that Prilosec was just as effective as Nexium:

“Q: If AstraZeneca sales reps on any of these calls that we have been discussing this morning had told you that Prilosec was just as effective as Nexium, would you still have prescribed Nexium to a patient if that patient could have got generic omeprazole for less on their formulary?

“[Objections].

“[Dr. Lugo]: I would prescribe omeprazole.

Dr. Lugo immediately qualified his response to this hypothetical question, however, with the following caveat: “But let me add, as given everything else being equal, and my own personal experience did not bias me in one direction or another, if I felt for a particular case for a particular patient, all things being equal, and no previous history of experiences with particular PPIs, knowing that cost is a factor in medicine, I would have prescribed omeprazole.” Dr. Lugo’s qualified response to a question about what he might have done for a hypothetical patient raises no triable issue of material fact regarding his treatment of Weiss. Plaintiffs did not ask Dr. Lugo what he would have done for Weiss, who had a history of experiences with other PPIs, if the alleged nondisclosures had been made.

Weiss cites Conte v. Wyeth, Inc. (2008) 168 Cal.App.4th 89 as support for the argument that his evidentiary showing was sufficient to raise a triable issue as to causation. Conte involved claims for failing to warn of certain risks associated with the prescription drug Reglan and its generic equivalent. In support of its motion for summary judgment, the defendant in Conte offered the declaration of the plaintiff’s prescribing physician stating that “‘[a]t no time’” did he “‘rely in any way on representations’” made in the product labeling. (Id. at p. 99.) The plaintiff produced conflicting evidence, in the form of the physician’s deposition testimony, stating that he had “‘probably’” read the Reglan label information in a physician’s desk reference, that he believed the information to be accurate, and that he generally would rely on that information when prescribing Reglan to his patients. (Ibid.) The court in Conte found that this evidence supported a reasonable inference that the Reglan product information was a substantial factor in the physician’s decision to treat the plaintiff and raised a sufficient factual question to preclude summary judgment. (Id. at p. 100.)

The record here shows no comparable conflict in the evidence. Dr. Lugo testified that he does not take sales representatives claims at face value, but that he considers the underlying data and other factors such as his own clinical experience and the patient’s experience. Dr. Lugo further testified that his decision to prescribe Nexium for Weiss was likely driven by insurance requirements, and he confirmed that Weiss’s medical records indicate no reason for switching him from Prevacid to Nexium other than insurance.

Weiss failed to raise any triable issue of fact regarding Dr. Lugo’s prescribing decision. Summary judgment and a no-merit determination were properly granted as to Weiss’s claims.

DISPOSITION

The judgment and the order denying class certification are affirmed. Defendants are awarded their costs on appeal.

We concur: P. J., J. BOREN DOI TODD


Summaries of

Weiss v. Astrazeneca Pharmaceuticals

California Court of Appeals, Second District, Second Division
Aug 30, 2010
No. B215901 (Cal. Ct. App. Aug. 30, 2010)
Case details for

Weiss v. Astrazeneca Pharmaceuticals

Case Details

Full title:JAMES WEISS et al., Plaintiffs and Appellants, v. ASTRAZENECA…

Court:California Court of Appeals, Second District, Second Division

Date published: Aug 30, 2010

Citations

No. B215901 (Cal. Ct. App. Aug. 30, 2010)

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