KATHLEEN HARDIN et al., Plaintiffs and Respondents, v. PDX, INC., et al., Defendants and Appellants.
No. A137035
First Dist., Div. Three.
June 19, 2014.
227 Cal. App. 4th 159
Davis, Wright, Tremaine, Thomas R. Burke, Jeff Glasser and Jeanne Sheahan for Defendants and Appellants.
Newdorf Legal, David B. Newdorf, Vicki F. Van Fleet; Hersh & Hersh, Nancy Hersh and Kate Hersh-Boyle for Plaintiffs and Respondents.
OPINION
SIGGINS, J.—PDX, Inc., claims the trial court erred when it denied a motion to strike brought under
BACKGROUND
Kathleen Hardin suffered complete blindness and permanent, severe and painful scarring after she began taking lamotrigine, the generic form of the medication Lamictal. According to her complaint, Hardin later learned that
Hardin and her husband1 filed suit for negligence and products liability against multiple defendants, including the physician who prescribed her lamotrigine, GlaxoSmithKline, which manufactured it, Safeway, Inc., where she purchased it, and Wolters Kluwer Health, Inc. (WKH), which produced the drug information pamphlet, or monograph, Safeway provided when it filled Hardin‘s prescription. WKH monographs offer summaries of information from official FDA physician package inserts and patient medication guides written in lay language for consumers and are intended to provide a written supplement to the oral counseling patients receive from their pharmacists when they have a prescription filled. (See generally Rivera v. First DataBank, Inc. (2010) 187 Cal.App.4th 709, 713 (Rivera).) Unlike physician package inserts and patient medication guides, which are FDA mandated, WKH monographs are not regulated or reviewed by the FDA. Rather, the monographs are produced as part of a self-regulating action plan required under public law as approved by the Secretary of the United States Department of Health and Human Services. (Pub.L. No. 104-180 (Aug. 6, 1996) 110 Stat. 1593.)
The action plan summarizes its goal by stating: “The purpose of this Action Plan is to improve the quality and availability of useful information that is voluntarily provided to consumers with their prescription medicines. The rationale for the Plan is that providing consumers with useful information about their prescription medicines can reduce the risk of preventable, medication-induced injury and improve health outcomes.” The action plan goes on to describe useful information as “that which is sufficiently comprehensive and communicated such that consumers can make informed decisions about how to receive the most benefit from medicines and protect themselves from harm. Both the substance and presentation of the information are important.” Nevertheless, each monograph states that it is not intended to be a comprehensive statement of all risks and benefits of the medication and cautions consumers against relying solely on the monograph for information about the medication.
There does not seem to be any material factual dispute about the nature of PDX‘s activities. As explained in the declaration of Benjamin Loy, PDX‘s vice-president of industry relations, in support of the motion to strike, PDX is “an independent provider of software that distributes drug information to pharmacy customers.” One component of its business involves disseminating
Decisions about the content of these monographs were made by Safeway, not by PDX. According to Mr. Loy, “WKH, as the [data] owner and licensor, writes, formats, develops and updates the drug product information that PDX accesses through its license with WKH. Neither PDX nor NHIN modify the drug product information in any manner whatsoever.” Prior to 2005, PDX‘s software enabled its licensees to print out either the long (eight-section) or short (five-section) version of the monograph for any given drug. The short version excluded sections under the headings “Before Using This Medication,” “Overdose,” and “Additional Information.” The “Before Using This Medication” section contains warnings about taking the drug that may include warnings about drug interactions or complications due to coexisting medical conditions. In 2005, in response to regulatory guidelines, PDX revised its software so that it would no longer print the abbreviated monographs. For reasons not clear from the record, Safeway did not want to utilize the full eight-section monographs and asked PDX to revise its software so that Safeway could continue to print only the five-section versions. PDX complied with that request after it obtained a release of liability and indemnity agreement from Safeway.
The WKH monograph was the only information received by Hardin when she first filled her prescription for lamotrigine, and the only patient information she considered in deciding whether to take the medication. The abbreviated warning utilized by Safeway and provided to Hardin omitted what is referred to as the “Black Box” warning under the heading “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. . . . Contact your doctor immediately if you develop rash symptoms, including red, swollen, blistered or peeling skin. Treatment with this medication should be stopped unless it is clearly determined that the medicine did not cause the rash. Even if the medicine is stopped, a rash caused by this medicine may still become life-threatening or cause serious side effects (such as permanent scarring).” Hardin says that had she been provided this warning, she would not have taken the medication.
Hardin amended her complaint to allege causes of action for negligence and products liability against PDX, Inc., and NHIN.3 PDX also moved under the anti-SLAPP statute to strike Hardin‘s claims, which it argued were identical to the dismissed claims against WKH and barred for the same reasons.
This time, the trial court disagreed. It determined that the activity underlying PDX‘s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings about SJS instead of the full eight-section version that included those warnings. “Plaintiffs have asserted acts by PDX that go beyond mere distribution of the WKH[‘s] monographs. Plaintiffs assert that in 2005 PDX revised its software program to prevent its customers, including Safeway, ‘from printing the five section abbreviated monograph and allowed only the printing of the complete eight section monograph.’ [Citation.] According to Mr. Loy, Senior Vice President of Industry Relations for PDX, Inc. and National Health Information Network Inc., [citation], ‘[t]his software revision was made in response to both regulatory guidelines for the provision of patient education information and an internal recommendation by Jim Boyd, R.Ph., then Sr. Vice President [of] Network Services NHIN.’ [Citation.] Then, in 2006, a Safeway representative contacted PDX because it wanted to use the five section monograph, rather than the eight section monograph with the warnings at issue here. [Citation.] In response, ‘[p]rogramming to allow the system to provide the five section monograph was made available by PDX . . . to Safeway. . . .’ [Citation.] Given these facts, this is not a case in which a defendant merely distributed information from a third party author or publisher.”
The court concluded that PDX‘s reprogramming activities were not acts in furtherance of defendant‘s right of petition or free speech within the meaning
DISCUSSION
I. The Anti-SLAPP Statute
Unmeritorious claims that are brought to thwart constitutionally protected speech or petitioning activity may be stricken pursuant to a motion filed under
We consider an anti-SLAPP motion in a two-step process. “First, the court decides whether the defendant has made a threshold showing that the challenged cause of action is one arising from protected activity. The moving defendant‘s burden is to demonstrate that the act or acts of which the plaintiff complains were taken ‘in furtherance of the [defendant]‘s right of petition or free speech under the United States or California Constitution in connection with a public issue,’ as defined in the statute. (
We review the trial court‘s determinations as to whether the plaintiff has shown a probability of prevailing independently. (ComputerXpress, Inc. v. Jackson (2001) 93 Cal.App.4th 993, 999.) An anti-SLAPP motion does not survive this prong ” ‘if the plaintiff presents evidence establishing a prima facie case which, if believed by the trier of fact, will result in a judgment for the plaintiff. [Citation.]’ ” (Fleishman v. Superior Court (2002) 102 Cal.App.4th 350, 356.) We neither ” ‘weigh credibility [nor] compare the weight of the evidence. Rather, [we] accept as true the evidence favorable to the plaintiff [citation] and evaluate the defendant‘s evidence only to determine if it has defeated that submitted by the plaintiff as a matter of law.’ [Citation.]” (Nygård, Inc. v. Uusi-Kerttula (2008) 159 Cal.App.4th 1027, 1036 (Nygård).) “In order to satisfy due process, the burden placed on the plaintiff must be compatible with the early stage at which the motion is brought and heard [citation] and the limited opportunity to conduct discovery. . . .” (Wilcox v. Superior Court (1994) 27 Cal.App.4th 809, 823, disapproved on other grounds in Equilon, supra, 29 Cal.4th at p. 68, fn. 5.) Only a minimal showing of merit is required. (Yu v. Signet Bank/Virginia (2002) 103 Cal.App.4th 298, 318.)
We affirm if the trial court‘s decision is correct for any reason, regardless of the correctness of the grounds upon which it reached its conclusion. (Estate of Beard (1999) 71 Cal.App.4th 753, 776.)
II. Analysis
The trial court based its ruling on its conclusion that PDX‘s role in the production and dissemination of the short-form monograph Hardin received was not “conduct in furtherance of the exercise of the constitutional right of petition or the constitutional right of free speech in connection with a public issue or an issue of public interest,” and, thus, was beyond the scope of
PDX argues that Hardin‘s negligence claim fails under Rivera, supra, 187 Cal.App.4th 709. It maintains Rivera holds that, as a matter of law, PDX has no duty to consumers who receive drug monographs through its software. We are not persuaded that Rivera controls here.
The plaintiffs’ decedent in Rivera committed suicide shortly after he began taking the antidepressant drug Paxil. First DataBank, Inc. (First DataBank), published the drug monograph Rivera received from his pharmacist. The plaintiffs alleged the monograph omitted the FDA‘s Black Box suicide warnings for Paxil, and that the warnings it included were vague, confusing, and buried in fine print. (Rivera, supra, 187 Cal.App.4th at pp. 713-714.) The trial court denied the motion (id. at p. 714), but the Court of Appeal reversed. After concluding that the lawsuit targeted protected speech (
This case is different. Unlike in Rivera, here there was evidence that the Black Box warning had been deleted from the monograph Hardin received with her prescription. Hardin attested that “[t]he Wolters Kluwer Health medicine information monograph I received, read and relied upon in deciding to take Lamictal/Lamotrigine did not include the section which is in capital letters and starts with WARNING: SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE, that the rashes warned about appear as red, swollen, blistered, peeling skin and that the rashes warned about could be life-threatening even if you stop taking the medication and that the rashes warned about could cause serious side effects such as permanent scarring.” The evidence Hardin submitted also contains the abbreviated monograph described in her declaration alongside the full eight-section monograph complete with the omitted warnings. In further contrast to Rivera, the omitted sections, if included, would have applied to all potential consumers of lamotrigine. The evidentiary shortcomings presented in Rivera are not present here.
Rivera is also of limited precedential value for another reason: it does not address Hardin‘s theory that, in undertaking to provide patient drug monographs, PDX assumed a duty of care under the negligent undertaking doctrine. (See Ginns v. Savage (1964) 61 Cal.2d 520, 524, fn. 2 [“Language used in any opinion is of course to be understood in the light of the facts and the issue then before the court . . . .“].)
This common law theory, restated in section 324A of the Restatement Second of Torts (hereinafter Restatement section 324A), “is one of liability to third persons for physical harm caused when, under certain listed circumstances, one negligently performs an undertaking to another. In its entirety, section 324A reads: ‘One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of a third person or his things, is subject to liability to the third person for physical harm resulting from his failure to exercise reasonable care to [perform] his undertaking, if [¶] (a) his failure to exercise reasonable care increases the risk of such harm, or [¶] (b) he has undertaken to perform a duty owed by the other to the third person, or [¶] (c) the harm is suffered because of reliance of the other or the third person upon the undertaking.’ [¶] . . . Indeed, ‘[i]t is ancient learning that one who assumes to act . . . may thereby become subject to a duty of acting carefully, if he acts at all.’ [Citation.] As ‘Dean Prosser says . . . , “[i]f the defendant enters upon an affirmative course of conduct affecting the interests of another, he is regarded as assuming a duty to act, and will thereafter be liable for negligent acts or omissions[.]” ’ ” (Artiglio v. Corning Inc. (1998) 18 Cal.4th 604, 612-613, fn. omitted (Artiglio).)
FNS Mortgage Service Corp. v. Pacific General Group, Inc. (1994) 24 Cal.App.4th 1564 is illustrative. The defendant, IAPMO (International Association of Plumbing and Mechanical Officials), promulgated a uniform plumbing code, certified plumbing products that met its standards, and published a directory listing certified products. The owners and developers of an apartment complex sued IAPMO for property damage allegedly caused by defective, IAPMO-certified drain, waste and vent pipes. (Id. at pp. 1566-1570.) Citing Restatement section 324A, the Court of Appeal held that IAPMO assumed the duty to exercise reasonable care in carrying out its enterprise when it voluntarily undertook to identify pipe manufacturers that adhered to its standards for the consuming public. (FNS Mortgage, at p. 1572; see Hanberry v. Hearst Corp. (1969) 276 Cal.App.2d 680, 684 [publisher that conducted product endorsement program assumed a duty of ordinary care to consumers who relied on its endorsement].) Other jurisdictions, although apparently no California courts, have considered that parties who engage in providing medication warnings to consumers may be found to have assumed a duty to use due care in carrying out their
Here, Hardin presented evidence that PDX knew that enabling Safeway to print the abbreviated monograph could place patients at risk, including, notably, the acknowledgement in its 2006 agreement with Safeway that providing the full eight-section version would better enable patients to “use the medication properly and appropriately, receive the maximum benefit, and avoid harm.” This record sufficiently makes out a claim that PDX assumed a duty of care by undertaking to render services to Safeway “of a kind [it] should have recognized as necessary for the protection of third persons. . . .” (Artiglio, supra, 18 Cal.4th at p. 614).
Citing Rivera, PDX also argues it had no duty to Hardin because the abbreviated lamotrigine monograph included a warning that it did not cover all possible adverse effects and advised patients to read the medication guide and consult their physicians before taking the medication. We disagree with PDX‘s view that, as a matter of law, this language has any bearing upon the scope of its duty. The cited provisos and their foreseeable effect on consumers are relevant to whether PDX acted with due care when it enabled Safeway to omit warnings from WKH monographs, but it is the nature of PDX‘s undertaking, not the care with which it was carried out, that determines whether it assumed a duty under Restatement section 324A in the first place.
PDX‘s remaining arguments merit only brief attention. PDX claims Hardin failed to show causation, but her declaration says the WKH monograph was the only medication information she received, that she read and relied on it, and that she would not have taken lamotrigine had it included a warning about serious or fatal rashes. PDX also asserts
Hardin‘s claim against PDX does not arise from its role as the software or service provider that enabled Safeway to access the WKH lamotrigine monograph. Hardin sued PDX because it intentionally modified its software to allow Safeway to distribute abbreviated drug monographs that automatically omitted warnings of serious risks. As the trial court found, “this is not a case in which a defendant merely distributed information from a third party author or publisher.” PDX cites, and we are aware of, no case holding the CDA to have immunized a defendant from allegations that it participated in creating or altering content. (See Anthony, supra, 421 F.Supp.2d at pp. 1262-1263.) “One need look no further than the face of the statute to see why. The CDA only immunizes ‘information provided by another information content provider.’ (
DISPOSITION
The order denying PDX‘s anti-SLAPP motion is affirmed.
McGuiness, P. J., and Pollak, J., concurred.
A petition for a rehearing was denied July 21, 2014, and the opinion was modified to read as printed above. Appellants’ petition for review by the Supreme Court was denied September 24, 2014, S220250.