Judge: H. Jay Ford, III, Case: 21STCV35340, Date: 2022-08-04 Tentative Ruling

Case Number: 21STCV35340    Hearing Date: August 4, 2022    Dept: O

Case Name:  Shain v. Merck & Co., Inc., et al.

SUBJECT:                DEMURRER TO COMPLAINT

MOVING PARTY:   Defendant Alisa A. Bromberg, MD

RESP. PARTY:         Plaintiff Hayden Shain

TENTATIVE RULING

            Defendant Alisa A. Bromberg, MD’s Demurrer to the 7^th, 8^th and 9^th causes of action is OVERRULED as to the 7^th cause of action for medical malpractice and 9^th cause of action for breach of fiduciary duty and SUSTAINED WITHOUT LEAVE TO AMEND as to the 8^th cause of action for battery.  Defendant to answer in 10 days. 

I.  Demurrer based on statute of limitations under CCP §340.5—OVERRULE

            Defendant Bromberg demurs to the 7^th through 9^th causes of action for medical malpractice, battery and breach of fiduciary duty based on the one-year provision of CCP §340.5:  “In an action for injury or death against a health care provider based upon such person's alleged professional negligence, the time for the commencement of action shall be three years after the date of injury or one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first.”  Code Civ. Proc., § 340.5. 

Defendant Bromberg argues that, based on Plaintiff’s complaint allegations, Plaintiff discovered or should have discovered his injury by February 2018, when he allegedly began to experience symptoms after receiving his first and only Gardasil shot.  See Complaint, ¶353.  Bromberg argues Plaintiff was therefore required to bring his claims by February 2019.

Bromberg’s argument fails to take into account Plaintiff’s status as a 15-year old minor when he received the Gardasil injection.  See Complaint, ¶349.  Under CCP §340.5, “[a]ctions by a minor shall be commenced within three years from the date of the alleged wrongful act…”  Code Civ. Proc., § 340.5.  A person who is a minor at the time of the wrongful act remains entitled to the 3-year limitations period for minors, regardless of when he or she reached the age of majority.  See Steketee v. Lintz, Williams & Rothberg (1985) 38 CA.3d 46, 54-56; 3 Witkin, Cal. Proc. (6^th ed. 2022), Actions, §640. 

Based on this provision, Plaintiff argues in opposition that the applicable SOL is three years from January 2018, subject to tolling while his petition before the Vaccine Compensation Board was pending from October 2020 through July 2021.  Bromberg does not address this argument on reply.

In addition, Plaintiff’s allegations are not limited to Defendant Bromberg’s recommendation of Gardasil and her failure to fully inform Plaintiff of its side effects prior to its administration in January 2018.  Plaintiff also alleges that Defendant Bromberg was negligent, because she failed to “timely and properly diagnose that Plaintiff had sustained a Gardasil adverse reaction following his January 8, 2018 Gardasil injection.”  See Complaint, ¶484.  The exact time frame of this post-injection negligence is unclear. 

Bromberg fails to establish on demurrer that the 7^th through 9^th causes of action are clearly, affirmatively and necessarily barred by the SOL under CCP §340.5.  See Roman v. County of Los Angeles (2000) 85 Cal.App.4th 316, 324-325 (“If the dates establishing the running of the statute of limitations do not clearly appear in the complaint, there is no ground for general demurrer”); CrossTalk Productions, Inc. v. Jacobson (1998) 65 Cal.App.4th 631, 635 (“demurrer based on an affirmative defense cannot properly be sustained where the action might be barred by the defense, but is not necessarily barred.”)  Bromberg’s demurrer based on CCP §340.5 is OVERRULED. 

II.  7^th cause of action for medical malpractice—OVERRULED

            The elements of a medical malpractice cause of action are (1) the duty of the professional to use such skill, prudence, and diligence as other members of his profession commonly possess and exercise; (2) a breach of that duty; (3) a proximate causal connection between the negligent conduct and the resulting injury; and (4) actual loss or damage resulting from the professional's negligence.  See Avivi v. Centro Medico Urgente Medical Center (2008) 159 Cal.App.4^th 463, 468 fn 2. 

            A lack of informed consent is a separate theory of liability from professional negligence or malpractice, and can generally be established by the patient–plaintiff's testimony.  See Cobbs v. Grant (1972) 8 Cal.3d 229, 240–244; Arato v. Avedon (1993) 5 Cal.4th 1172, 1190–1191. As an “alternative negligence theor[y],” lack of informed consent can establish liability even when expert testimony has eliminated allegations of negligent performance.  See Willard v. Hagemeister (1981) 121 Cal.App.3d 406, 417–418.  The relevant question of fact is whether the treating professional gave the plaintiff sufficient information as to the nature of the procedure “so that she could intelligently decide whether to undergo the ... procedure. If [the treating professionals] did not make this minimal disclosure of material facts, they are liable for all injuries sustained by [the plaintiff] during the course of this ... treatment, whether the treatment was negligent or not.”  Id. at p. 418; Jambazian v. Borden (1994) 25 Cal.App.4th 836, 845.

            Plaintiff’s 7^th cause of action for medical malpractice is based on multiple acts of negligence.  Bromberg was allegedly negligent when she (1) negligently failed to timely and properly diagnose Plaintiff’s adverse reaction to Gardasil; (2) negligently relied on “facts and information provided to them by Merck with respect to the effectiveness, safety, and the need for the administration of the Gardasil vaccine and in advising Plaintiff he be administered the Gardasil vaccine”; (3) informing Plaintiff that Gardasil was “safe” and only disclosing “nonspecific possible reactions listed on the Vaccine Information Statement”; and (4) failing to provide Plaintiff with “material facts and information as to the effectiveness, safety and need for the administration of the Gardasil vaccinations and in particular of the specific risk/benefit and quantitative risks, including but not limited to the serious autoimmune risks and lack of efficacy associated with the Gardasil vaccine.”  See Complaint, ¶¶482-491. 

            Plaintiff alleges that he was deprived of his right to informed consent, because Defendant’s negligent failure to provide him with this information and providing incomplete information regarding the safety and effectiveness of Gardasil.  See Complaint, ¶488.  Plaintiff alleges neither he nor his mother would have consented to Gardasil if they had known of the true risks associated with it and its lack of effectiveness.  Id. at ¶489. 

            Defendant Bromberg argues Plaintiff failed to allege breach of any applicable standard of care.  However, to the extent Plaintiff’s 7^th cause of action for medical malpractice is based on lack of informed consent, Plaintiff need not allege that Bromberg’s disclosure breached a community standard of care.  “[T]he patient’s right of self-decision is the measure of the physician’s duty to reveal…The scope of a physician’s communications to the patient…must be measured by the patient’s need, and the need is whatever information is material to the decision.  Thus the test for determining whether a potential peril must be divulged is its materiality to the patient’s decision.”  Cobbs v. Grant (1972) 8 Cal.3d 229, 243, 245. 

            More recently, the Supreme Court “underlin[ed] the limited and essentially subsidiary role of expert testimony in informed consent litigation.”  See Arato, supra, 5 Cal.4^th at 1191.  The Supreme Court reiterated its rejection of “an absolute rule” that “filters the scope of patient disclosure entirely through the standards of the medical community.”  Id.  “Nevertheless…there may be a limited number of occasions in the trial of informed consent claims where the adequacy of disclosure in a given case may turn on the standard of practice within the relevant medical community.”  Id. 

 Thus, breach of an applicable community standard of care is not necessarily an element of Plaintiff’s 7^th cause of action for medical malpractice based on lack of informed consent.  Defendant Bromberg fails to demonstrate that Plaintiff’s case is one of the “limited number of occasions…where the adequacy of disclosure in a given case may turn on the standard of practice within the relevant medical community.”  Arato, supra, 5 Cal.4^th at 1191. 

In addition, Plaintiff’s allegations of medical negligence (“negligently” relying on Merck’s marketing information and “negligently” failing to timely and properly diagnose Plaintiff’s adverse vaccine reaction) are sufficient to allege breach of the applicable standard of care.  By describing those acts as negligent, Plaintiff is alleging that that those acts fell below the standard of care and it is reasonable to infer the fact of breach.  “[A]ll material facts pleaded in the complaint and those that arise by reasonable implication, but not conclusions of fact or law, are deemed admitted by the demurring party.  The complaint must be construed liberally by drawing reasonable inferences from the facts pleaded.”  Rodas v. Spiegel (2001) 87 Cal.App.4^th 513, 517.    

Defendant argues Plaintiff will be unable to establish negligence based on the alleged facts.  However, on demurrer, all allegations must be accepted as true. The Court does not consider the plausibility of those allegations or Plaintiff’s ability to prove them, i.e. whether Plaintiff will be able to locate an expert willing to testify that Defendant Bromberg’s conduct fell below an applicable standard of care.  “Because a demurrer tests only the legal sufficiency of the pleading, we accept as true even the most improbable alleged facts, and we do not concern ourselves with the plaintiff's ability to prove its factual allegations.”  Nolte v. Cedars-Sinai Medical Center (2015) 236 Cal.App.4th 1401, 1406. 

Finally, Defendant Bromberg argues Plaintiff’s allegations of lack of informed consent are inconsistent with Plaintiff’s allegations that Merck fraudulently concealed information regarding Gardasil’s effectiveness, safety and the need for administration of the Gardasil vaccine.”  Bromberg argues Plaintiff does not allege that Bromberg knew the truth about Gardasil’s effectiveness, and such knowledge would be inconsistent with Plaintiff’s claim that Merck fraudulently concealed the truth about Gardasil from the general public, including physicians like Bromberg.  Bromberg argues Plaintiff can allege inconsistent theories but not inconsistent facts. 

Even if Plaintiff’s lack of informed consent claim were based on inconsistent facts, Plaintiff’s claims are not based solely on lack of informed consent.  Plaintiff’s claims against Bromberg also include allegations that Bromberg negligently failed to diagnose Plaintiff’s condition as an adverse reaction to Gardasil.  Bromberg’s negligent failure to diagnose Plaintiff’s condition does not rely upon the allegedly inconsistent facts. 

In addition, the allegation that Bromberg negligently relied on Merck’s general information regarding Gardasil’s effectiveness, safety and need is not necessarily irreconcilable with or “antagonistic” to Plaintiff’s allegation that Bromberg failed to fully disclose all material facts that she knew, or should have known as a physician, about Gardasil, about HPV generally, about cervical cancer generally and whether Gardasil should have been recommended to Plaintiff specifically.  “[A]t most, they are alternative factual allegations relying on alternative legal theories, which does not run afoul of truthful pleading.” Williams v. Southern California Gas Co. (2009) 176 Cal.App.4^th 591, 598 (no inconsistency between claim asserted against manufacturer of wall furnace based on malfunction of wall heater and claim asserted against property owners based on their failure to notice visible discoloration of the grate cover of wall furnace); Wells v. Brown (1950) 97 Cal.App.2d 361, 364 (“there is no prohibition against pleading inconsistent causes of action stated in as many way saspalintiff believes his evidence will show”; plaintiff properly alleged two inconsistent counts based on alternative facts that defendant either negligently killed plaintiff’s dog by running his car into it or intentionally killed his dog by shooting it after the dog was hit by the car).  Thus, when “a pleader is in doubt about what actually occurred or what can be established by the evidence, the modern practice allows that party to plead in the alternative and make inconsistent allegations.”  Fleet v. Bank of America, N.A. (2014) 229 Cal.App.4th 1403, 1413 (reversing order sustaining demurrer without leave as to promissory estoppel claim against bank defendant; allegations were sufficient to state a claim for both breach of contract and promissory estoppel as alternative theories of recovery). 

Defendant Bromberg’s Demurrer to the 7^th cause of action for medical malpractice is OVERRULED.

III.  8^th cause of action for medical battery—SUSTAIN WITHOUT LEAVE TO AMEND

To establish a medical battery claim, plaintiff must prove the following: 1. defendant performed a medical procedure without plaintiff's consent; or plaintiff consented to one medical procedure, but defendant performed a substantially different medical procedure; 2. That plaintiff was harmed; and 3. That defendant's conduct was a substantial factor in causing plaintiff's harm.  See CACI 530A.  A patient can consent to a medical procedure by words or conduct.  Id. 

“The battery theory should be reserved for those circumstances when a doctor performs an operation to which the patient has not consented. When the patient gives permission to perform one type of treatment and the doctor performs another, the requisite element of deliberate intent to deviate from the consent given is present.  However, when the patient consents to certain treatment and the doctor performs that treatment but an undisclosed inherent complication with a low probability occurs, no intentional deviation from the consent given appears; rather, the doctor in obtaining consent may have failed to meet his due care duty to disclose pertinent information. In that situation the action should be pleaded in negligence.”  Cobbs v. Grant (1971) 8 Cal.3d 229, 240; see Kaplan v. Mamelak (2008) 162 Cal.App.4th 637, 646-647)(consent form signed by plaintiff only agreed to surgery on disk T8-9 of spine and defendant performed surgery on T6-7 and T7-8; finder of fact had to determine whether surgery on an incorrect disk is a reasonable risk of surgery performed on plaintiff or if it qualified as entirely different procedure); Ashcraft v. King (1991) 228 Cal.App.3d 604, 611 (medical battery claim stated where patient only agreed to blood transfusions from family members and physician transfused nonfamily member blood, in violation of patient’s consent and unwittingly infecting him with HIV). 

Plaintiff’s battery claim is based on lack of informed consent.  Defendant Bromberg allegedly failed to fully disclose the risks of Gardasil before recommending and administering it to Plaintiff.  See Complaint, ¶¶495-496.  Plaintiff is not alleging that he consented to receive one drug, vaccination or treatment but received an entirely different drug or vaccine.  Plaintiff is not alleging that his consent was conditional, that Defendant Bromberg knew of this condition and despite this knowledge, Gardasil was administered in violation of that condition.  Based on Plaintiff’s allegations, Plaintiff is alleging negligence based on lack of informed consent, not medical battery under Cobbs. 

Defendant Bromberg’s demurrer is SUSTAINED WITHOUT LEAVE TO AMEND. 

IV.  9^th cause of action for breach of fiduciary duty—OVERRULE 

            “The doctor-patient relationship is a fiduciary one and as a consequence of the physician's ‘fiducial” obligations,’ the physician is prohibited from misrepresenting the nature of the patient's medical condition.”  Hahn v. Mirada (2007) 147 Cal.App.4^th 740, 748.  A “fiduciary relationship exists between the patient and the physician. As a result, the physician has a duty to disclose fully and completely the nature and extent of injuries and any material concealment or misrepresentation will amount to fraud sufficient to entitle the party injured thereby to a cause of action. The duty of disclosure is fiduciary in nature because of the confidential patient-physician relationship, the duty of disclosure is measured by fiduciary standards (not limited by medical standards), and the physician subjects himself to liability should he withhold facts necessary to a total disclosure.”  Nelson v. Gaunt (1981) 125 Cal.App.3d 623, 634. 

            “[I]n soliciting the patient’s consent, a physician has a fiduciary duty to disclose all information material to the patient’s decision.”  Moore v. Regents of University of California (1990) 51 Cal.3d 120, 129 (physician’s fiduciary duty of disclosure of all information material to patient’s decision includes physician’s personal interests unrelated to patient’s health that may affect the physician’s professional judgment and failure to disclose such interests may give rise to either cause of action for lack of informed consent or breach of fiduciary duty).

            Plaintiff alleges Defendant Bromberg failed to disclose all material information to his and his mother’s decision to receive an injection of Gardasil, specifically the lack of efficacy and the existence of serious and disabling adverse events associated with the Gardasil vaccine.  See Complaint, ¶503.  Plaintiff alleges Defendant Bromberg provided false and misleading information regarding the efficacy and safety profile of Gardasil, claiming that Gardasil would prevent cancer and was perfectly safe with no major side effects other than temporary pain at the injection site.  Id. at ¶504.  Plaintiff therefore alleges a breach of Bromberg’s fiduciary duty to disclose all information material to his decision to receive Gardasil.  Such allegations can give rise to either lack of informed consent or breach of fiduciary duty.  Moore, supra.  Plaintiff is entitled to allege both theories at the pleading stage.  See Fleet, supra, 229 Cal.App.4th at 1413. 

            Defendant’s Demurrer to the 9^th cause of action for breach of fiduciary duty is OVERRULED. 

  Case Name:  Shain v. Merck & Co., Inc., et al.

SUBJECT:                (1) DEMURRER TO COMPLAINT

                                    (2) MOTION TO STRIKE

MOVING PARTY:   Defendants Merck & Co., Inc. and Merck Sharp & Dohme Corp.

RESP. PARTY:         Plaintiff Hayden Shain

TENTATIVE RULING

             Defendants Merck & Co., Inc. and Merck Sharp & Dohme Corp.’s Demurrer to Complaint is SUSTAINED WITH 20 DAYS LEAVE TO AMEND as to the 3^rd cause of action for manufacturing defect and OVERRULED as to the 1^st cause of action for negligence, 2^nd cause of action for strict liability based on failure to warn, 4^th cause of action for breach of express warranty, 5^th cause of action for fraud and 6^th cause of action for unfair competition

I.  Defense of preemption based on design defect under Vaccine Act, 42 USC §300aa-22(b)(1)—OVERRULE

            Under the Vaccine Act, design defect claims against vaccine manufacturers are preempted:  “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”  42 USC §300aa-22(b)(1). 

            “Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore pre-empted.”  Bruesewitz v. Wyeth LLC (2011) 562 U.S. 223, 231–232.  “The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. Which plainly implies that the design itself is not open to question.”  Id.

            Defendants argue Plaintiff’s causes of action are thinly-veiled design defect claims and therefore preempted by the 42 USC §300aa-22(b)(1).  “[W]hile preemption can be decided on demurrer in a proper case, the implication that it should be decided on demurrer is erroneous. There are numerous circumstances in which the facts must be determined in order to decide whether a claim is preempted by federal law, and it is not uncommon to have preemption claims decided based on an evidentiary showing. Indeed, preemption is an affirmative defense as to which defendants have the burden of proof.”  Apollo Capital Fund, LLC v. Roth Capital Partners, LLC (2007) 158 Cal.App.4th 226, 250–251. 

            Moreover, in order to sustain demurrer based on an affirmative defense like preemption, Defendants must establish that the action is “necessarily” barred by preemption.  A “demurrer based on an affirmative defense cannot properly be sustained where the action might be barred by the defense, but is not necessarily barred.”  CrossTalk Productions, Inc. v. Jacobson (1998) 65 Cal.App.4th 631, 635. 

            Defendants fail to establish that Plaintiff’s causes of action are necessarily barred by preemption under the Vaccine Act.  Plaintiff’s complaint does not allege any cause of action for design defect.  Plaintiff alleges negligence, strict liability (failure to warn), strict liability (manufacturing defect), breach of warranty, common law fraud and violation of unfair competition law.  On its face, the complaint does not allege any design defect cause of action and is not preempted by 42 USC §300aa-22(b)(1). 

            In addition, Plaintiff’s allegations that Defendants are designers of Gardasil are merely descriptive and do not form the basis of any wrongful conduct.  These descriptive allegations do not establish preemption of all causes of action.

            Finally, disregarding the labels attached to these causes of action and examining Plaintiff’s substantive allegations, the causes of action are not clearly or solely based on design defect.  Plaintiff’s 1^st cause of action for negligence is based on several categories of conduct, some of which clearly have nothing to do with the design of the production.  See Complaint, ¶374 (“testing, marketing, supply, promotion, advertisement, packaging, labeling, sale and distrubtion of Gardasil”).  Some of the alleged conduct may ultimately qualify as design defects, such as “research, development…testing…of Gardasil,” but they are ambiguous and do not clearly implicate the design of Gardasil  See Complaint, ¶374; ¶375 (failure to appropriately and adequately test safety and efficacy).  Plaintiff does not expressly allege “design defect.” 

Because the negligence cause of action is based on conduct that is clearly not barred by the Vaccine Act and conduct that might be barred depending on the meaning of “research, development…testing,” demurrer to the 1^st cause of action based on the Vaccine Act is overruled.  A “demurrer based on an affirmative defense cannot properly be sustained where the action might be barred by the defense, but is not necessarily barred.”  CrossTalk Productions, Inc. v. Jacobson (1998) 65 Cal.App.4th 631, 635. 

Moreover, a demurrer cannot be sustained to part of a cause of action.  “Ordinarily, a general demurrer does not lie as to a portion of a cause of action and if any part of a cause of action is properly pleaded, the demurrer will be overruled.”  Elder v. Pacific Bell Telephone Co. (2012) 205 Cal.App.4th 841, 856.  Thus, even if the negligence claim contained some elements of a design defect claim, it would not justify sustaining demurrer to the entire cause of action. 

Plaintiff’s 2^nd cause of action for “failure to warn” is by definition not based on a design defect.  In the 2^nd cause of action, Plaintiff alleges that Merck should have known of the dangers of its product, and Merck “failed to adequately warn patients, parents, medical providers and reasonably foreseeable users of the risks.”  See Complaint, ¶394.  The basis of this claim is therefore failure to warn, not negligent design.  Design defect immunity under 42 USC §300aa-22(b)(1) only applies “given safe manufacture and warning.”  Bruesewitz, supra, 562 U.S. 223, 231–232.  In the 2^nd cause of action for failure to warn, Plaintiff is attacking the sufficiency of Defendants’ warnings, not Gardasil’s design. Demurrer to the 2^nd cause of action for failure to warn based on the Vaccine Act is overruled.

Plaintiff’s 3^rd cause of action for “manufacturing defect” is likewise not based on a design defect by definition.  Plaintiff alleges that “the Gardasil injected into Plaintiff was defectively and unreasonably dangerous because it failed to comply with the approved manufacturing specifications…”  See Complaint, ¶¶413-414.  Plaintiff alleges his specific dose of Gardasil was not manufactured to FDA-approved design specifications, because it contained dangerous and undisclosed components that were not included in those specifications.  Id. at ¶412.  These allegations do not allege a design defect and only allege a manufacturing defect. 

Unlike Stratton v. Merck & Co., Inc., the Court has not been presented with judicially noticeable evidence establishing that the components were in fact part of the FDA-approved design specifications.  See Stratton v. Merck & Co., Inc. (D.S.C., Nov. 17, 2021, No. CV 2:21-02211-RMG) 2021 WL 5416705, at *2 (granting 12(b)(6) motion to dismiss in part on grounds that judicially noticeable evidence established that manufacturing defect allegations were in fact design defect allegations based on components in Gardasil that were part of FDA-approved design).  Demurrer to the 3^rd cause of action based on the Vaccine Act is overruled.

Plaintiff’s 4^th cause of action for breach of express warranty is based on Defendants’ express statements in Gardasil’s label, publications, television advertisements, billboards, print advertisements, online advertisements and website, and other written materials intended for consumers, patients, parents of minor-aged patients, medical providers, and the general public, that Gardasil.  See Complaint, ¶¶426-428.  Plaintiff’s 4^th cause of action seeks to impose liability for breach of the warranties made in these statements.  Id. at ¶429.  Defendants fail to establish that the 4^th cause of action for breach of express warranty is based on the design of Gardasil.  Demurrer to the 4^th cause of action based on the Vaccine Act is overruled.

Plaintiff’s 5^th cause of action for common law fraud is by definition based on Defendants’ statements regarding Gardasil, either for affirmative misrepresentations or intentional concealment.  Plaintiff claims Defendants breached its duty of care to patients and medical providers by failing to provide true information regarding Gardasil’s efficacy and risks.  See Complaint, ¶441.  A claim based on Defendants’ statements about Gardasil is not an action based on Defendants’ design of Gardasil.  Demurrer to the 5^th cause of action for common law fraud based on the Vaccine Act is overruled. 

Plaintiff’s 6^th cause of action for unfair competition law is based on Merck’s allegedly false and misleading advertising materials for Gardasil.  See Complaint, ¶¶466-480.  Plaintiff is not alleging that Merck’s design of Gardasil was an unlawful, fraudulent and unfair business practice.  Plaintiff’s unlawful competition claim is based on the same conduct as the breach of warranty and fraud claims.  For the same reasons, no design defect claim is contained in the 6^th cause of action for unfair competition.  Demurrer to the 6^th cause of action for unfair competition based on the Vaccine Act is overruled. 

II.  Learned Intermediary Doctrine and Defense of preemption based on Vaccine Act, 42 USC §300aa-22(c) and to 2^nd cause of action for failure to warn, 4^th cause of action for breach of express warranty, 5^th cause of action for fraud and 6^th cause of action for Unfair Competition--OVERRULE

            A. Vaccine Act, 42 USC §300aa-22(c)

            “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.”  42 USC §300aa-22(c).

            “Manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements (including but not limited to warning requirements) and have given the warning either to the claimant or the claimant's physician.”  Bruesewitz, supra, 562 U.S. at 229 (citing 42 USC §300aa-22(c)); Stratton v. Merck & Co., Inc. (D.S.C., Nov. 17, 2021, No. CV 2:21-02211-RMG) 2021 WL 5416705, at *2.  “The immunity does not apply if the plaintiff establishes by clear and convincing evidence that the manufacturer was negligent, or was guilty of fraud, intentional and wrongful withholding of information, or other unlawful activity.”  Id. at 230, fn 25. 

B.  Learned Intermediary Doctrine

            “[I]n the case of prescription drugs, the duty to warn runs to the physician, not to the patient.”  Carlin v. Supr. Ct. (1996) 13 Cal.4th 1104, 1116 (recognition of cause of action for strict liability based on failure to warn in connection with prescription drugs would not inevitably result in manufacturers inundating consumers with warnings of even speculative risks because duty to warn runs to physician, not patient).  “[I]f adequate warning of potential dangers of a drug has been given to doctors, there is no duty by the drug manufacturer to insure that the warning reaches the doctor's patient for whom the drug is prescribed.”  Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65. 

            Under the learned intermediary doctrine, as this rule is known, “the physician stands in the shoes of the 'ordinary user' because it is through the physician that a patient learns of the properties and proper use of the drug or implant. Thus, the duty to warn in these cases runs to the physician, not the patient.”  Bigler-Engler v. Breg, Inc. (2017) 7 Cal.App.5th 276, 319.

            C.  Plaintiff’s allegations sufficiently allege failure to provide adequate warnings to Plaintiff’s medical providers

            Plaintiff’s failure to warn, breach of warranty, fraud and unfair competition causes of action are based on Defendants’ representations regarding Gardasil.  Plaintiff alleges that Defendants negligently and fraudulently provided inadequate warnings regarding Gardasil to medical providers, patients and the public, including his medical providers.  See Complaint, ¶¶367, 377(m)-(p), 381, 393, 394, 404, 422, 429(a)-(b), 439, 448, 458, 463.  Plaintiff alleges his medical providers would not have offered or recommended Gardasil to Plaintiff had they received adequate and truthful warnings.  Id.  Plaintiff alleges the information Merck negligently or fraudulently failed to include in warnings to medical providers, patients and the general public.  Id. at ¶¶399-400. 

            Based on these allegations, Plaintiff’s failure to warn, breach of warranty, fraud and unfair competition causes of action are not necessarily barred by 42 USC §300aa-22(c).  Plaintiff does not allege that his vaccine injury was “solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative).”  Plaintiff alleges that his injuries were due to Defendants’ failure to provide adequate warnings and information about Gardasil to Plaintiff’s medical providers, as well as himself and his mother.   

            These same allegations refute Defendants’ assertion that the learned intermediary doctrine necessarily bars Plaintiff’s claims.  Plaintiff is alleging failure to warn, breach of warranty, fraud and UCL based on the adequacy of statements and warnings to Plaintiff’s medical providers.  These same allegations also allege reliance, i.e. Plaintiff’s medical providers would not have recommended or prescribed Gardasil to him had they known the true facts.  See Complaint, ¶¶381, 404.

            In addition, the learned intermediary doctrine is inapplicable to Plaintiff’s claim for fraud based on misrepresentations directed by Defendants to him and his mother. Plaintiff’s fraud claim alleges both fraud by concealment and intentional misrepresentation.  As Plaintiff argues, the basis of a fraud claim is a defendant’s breach of the duty not to engage in “deceit,” as defined in Civil Code §1710.  “One who willfully deceives another with intent to induce him to alter his position to his injury or risk, is liable or any damage which he thereby suffers.”  Civil Code §1709.  The learned intermediary doctrine, however, governs the parameters of the affirmative duty to warn in connection with prescription drugs.  See Carlin v. Supr. Ct. (1996) 13 Cal.4th 1104, 1116. 

            Defendants also fail to cite any provision of the Vaccine Act that would immunize a vaccine manufacturer from affirmative misrepresentations.  Neither 42 USC §300aa-22(b)(1) nor 42 USC §300aa-22(c) indicate immunity from a state law claim for intentional fraud.

            Defendants fail to establish that these causes of action are necessarily barred by either the Vaccine Act or that Plaintiff has failed to state a claim based on the Learned Intermediary Doctrine.  Defendants’ demurrer to the failure to warn, breach of warranty, fraud and unfair competition causes of action based on 42 USC §300aa-22(c) and Learned Intermediary Doctrine is overruled. 

III.  1^st cause of action for negligence based on failure to warn—OVERRULED

            “To prevail in a negligence action, a plaintiff must show that the defendant owed a legal duty, the defendant breached that duty and the breach proximately caused injury to the plaintiff.”  Garcia v. W&W Community Development, Inc. (2010) 186 Cal.App.4th 1038, 1044.  “Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about.”  Carlin, supra, 13 Cal.4^th at 1112. 

“Ordinarily, negligence may be alleged in general terms, without specific facts showing how the injury occurred, but there are limits to the generality with which a plaintiff is permitted to state his cause of action, and the plaintiff must indicate the acts or omissions which are said to have been negligently performed. He may not recover upon the bare statement that the defendant's negligence has caused him injury.”  Berkley v. Dowds (2007) 152 Cal.App.4^th 518, 527.

The elements of a negligence claim based on failure to warn are: (1) that defendant manufactured, distributed and/or sold the product; (2) that defendant knew or reasonably should have known that the product was dangerous or was likely to be dangerous when used or misused in a reasonably foreseeable manner; (3) that defendant knew or reasonably should have known that users would not realize the danger; (4) that defendant failed to adequately warn of the danger or instruct on the safe use of the product; (5) that a reasonable manufacturer, distributor and/or seller under the same or similar circumstances would have warned of the danger or instructed on the safe use of the product; (6) that the defendant was a substantial factor in causing plaintiff’s harm.  CACI 1222.  “The warning must be given to the prescribing physician and must include the potential risks or side effects that may follow the foreseeable use of the product.”  Id.

Plaintiff alleges that Defendants were the manufacturers and distributors of Gardasil.  See Complaint, ¶390.  Plaintiff alleges that Defendants knew or should have known that Gardasil posed an unreasonable risk of harm to patients, including increased risk of autoimmune disease.  Id. at ¶¶370, 393-398.  Plaintiff alleges Defendants knew or should have known that users would not realize the danger.  See Complaint, ¶373.  Plaintiff alleges Defendants failed to adequately warn plaintiff, his mother, plaintiff’s medical providers, patients and medical providers in general of the dangers of autoimmune disease and other grave illnesses.  Id. at ¶377(k)-(p).  Plaintiff alleges that Defendants breached the duty of care when they failed to provide adequate warnings of these dangers.  Id. at ¶¶374, 375, 377.  Plaintiff alleges that “had Merck nont engaged in the negligent and fraudulent conduct alleged…then upon information and belief, Plaintiff’s medical providers would not have recommended or offered Gardasil to Plaintiff.”  Id. at ¶381.  Plaintiff alleges that Defendants’ conduct was the proximate cause of Plaintiff’s injury.  Id. at ¶382. 

Plaintiff sufficiently alleges negligence based on failure to warn.  Defendants’ demurrer to the 1^st cause of action for negligence is OVERRULED.

IV.  2^nd cause of action for strict liability based on failure to warn—OVERRULED

            “Failure to warn in strict liability differs markedly from failure to warn in the negligence context…Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Thus, in strict liability, as opposed to negligence, the reasonableness of the defendant's failure to warn is immaterial.  Stated another way, a reasonably prudent manufacturer might reasonably decide that the risk of harm was such as not to require a warning as, for example, if the manufacturer's own testing showed a result contrary to that of others in the scientific community. Such a manufacturer might escape liability under negligence principles. In contrast, under strict liability principles the manufacturer has no such leeway; the manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product.  Similarly, a manufacturer could not escape liability under strict liability principles merely because its failure to warn of a known or reasonably scientifically knowable risk conformed to an industry-wide practice of failing to provide warnings that constituted the standard of reasonable care.”  Carlin, supra, 13 Cal.4th 1104, 1112–1113. 

            The elements of a strict liability for failure to warn cause of action are:  (1) that defendant manufactured, distributed and/or sold the product; (2) that the product had potential risks, side effects or allergic reactions that were known or knowable in light of the scientific and/or medical knowledge that was generally accepted in the scientific community at the time of manufacture, distribution or sale; (3) that the potential risks, side effects, allergic reactions presented a substantial danger when the product is used or misused in an intended or reasonably foreseeable way; (4) that ordinary consumers would not have recognized the potential risks, side effects or allergic reactions; (5) that defendant failed to adequately warn or instruct of the potential risks, side effects, allergic reactions; (6) that plaintiff was harmed; and (7) that the lack of sufficient instructions or warnings was a substantial factor in causing plaintiff’s harm.  CACI 1205.  “The warning must be given to the prescribing physician and must include the potential risks, side effects, or allergic reactions that may follow the foreseeable use of the product.”  CACI 1205. 

            Plaintiff alleges that Defendants manufactured, sold and distributed Gardasil.  See Complaint, ¶388.  Plaintiff alleges that Gardasil’s risk of cancer and autoimmune disease were known to Defendants or scientifically knowable to Defendants through appropriate research and testing by known methods.  Id. at ¶393.  Plaintiff alleges Gardasil was not safe and effective for its intended use due to these known risks.  Id. at ¶¶377(q), 393.  Plaintiff alleges that targeted consumers and patients, the parents of these patients and the children’s medical providers were unaware of these risks.  Id. at ¶¶373, 393.  Plaintiff alleges Defendants failed to adequately warn or instruct of these risks and potential side effects, completely failing to warn of them.  Id. at 393, 398.  Plaintiff alleges Defendant’s failure to provide adequate warnings to Plaintiff, his mother and his medical providers was a substantial factor in causing his injury.  Id. at ¶403.  Plaintiff alleges that, if adequate warnings had been provided, his medical providers would not have offered or recommended Gardasil, nor would he or his mother have consented to Plaintiff’s injection with Gardasil.  Id. at ¶404.

            Plaintiff states a claim for strict liability failure to warn. Defendants’ demurrer to the 2^nd cause of action is OVERRULED.

III.  3^rd cause of action for strict liability manufacturing defect—SUSTAINED WITH 20 DAYS LEAVE TO AMEND

            Under a strict liability manufacturing defect theory, “a defective product is one that differs from the manufacturer's intended result or from other ostensibly identical units of the same product line.”  Barker v. Lull Eng'g Co. (1978) 20 Cal. 3d 413, 429.  Strict liability based on manufacturing defect assumes that “a suitable design is in place, but that the manufacturing process has in some way deviated from that design.”  In re Coordinated Latex Glove Litig. (2002) 99 Cal. App. 4th 594, 613.

            “A manufacturing defect is one which results from an error in the production process. The product comes off the assembly line in a substandard condition: in some way it differs from the manufacturer's intended result or from other ostensibly identical units of the same product line.  Such defective products are relatively easy to identify.  [¶]  The design defect is more difficult to identify. When the injury-producing agent is common to all the products of a certain line, the defect, if it exists, lies in the original design or model. To paraphrase Justice Traynor, there is something ‘wrong…not in the manufacturer's manner of production, but in his product.’”

Finn v. G. D. Searle & Co. (1984) 35 Cal.3d 691, 715–716. 

            A manufacturing defect claim is sufficiently pled where the plaintiff alleges that the product “failed to meet FDA-imposed manufacturing quality standards” and “failed to comply with FDA-mandated design and materials specifications.”  Mize v. Mentor Worldwide LLC (2020) 51 Cal.App.4^th 850, 861-862.  A plaintiff need not plead how the defendant manufacturer failed to comply with FDA requirements or how that failure affected the manufacture of the product.  Id. at 861 (plaintiff sufficiently alleged manufacturing defect cause of action by pleading that “in years leading up to her implant surgery [defendant] failed to meet FDA imposed manufacturing quality standards, destroyed evidence of its implants’ high rupture rates, sold contaminated implants, and failed to comply with FDA mandated design and materials specifications”); Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4^th 413, 435 (allegation that defendant failed to “comply with the manufacturing specifications required” by FDC Act was sufficient to plead state law claim for manufacturing defect and issue of preemption should not have been determined on demurrer). 

            Plaintiff alleges that the “Gardasil vaccines injected into Plaintiff were defective and unreasonably dangerous because they failed to comply with manufacturing specifications required by the governing manufacturing protocols and also required by the regulatory agencies, including but not limited to the FDA, by among other things, containing ingredients and toxins that were not disclosed in the FAD-approved specifications and/or otherwise not disclosed in the package insert.”  Complaint, ¶412.  Plaintiff alleges “by way of example” that his doses of Gardasil contained dangerous and undisclosed HPV L1-DNA fragments and PMSF, a toxic nerve agent this is not intended for human consumption or injection.  Id. at ¶414. 

These allegations are sufficient to allege a manufacturing defect.  Plaintiff alleges that the particular doses of Gardasil injected into him suffered from a manufacturing defect, because it deviated from the FDA approved design. 

            However, as Defendants point out, these allegations of a manufacturing defect are followed by an allegation that directly contradicts the existence of a manufacturing defect:  “At all times relevant to this litigation, Merck’s Gardasil products reached the intended consumers…including Plaintiff, without substantial change in their condition as designed…by Merck.”  Id.  If the Gardasil doses received by Plaintiff were “as designed” and intended by Merck, there was no manufacturing defect by definition. See Finn, supra, 35 Cal.3d at 715–716 (product that suffers from manufacturing defect “in some way it differs from the manufacturer's intended result or from other ostensibly identical units of the same product line”); Barker, supra, 20 Cal. 3d at 429 (same); Colbath v. Merck & Co., Inc. (S.D.Ca. Mar. 29, 2022) 2022 WL 935195 (granting 12(b)(6) motion to state law claim for manufacturing defect with leave to amend based on allegation that plaintiff’s dose of Gardasil reached plaintiff “without substantial change in their condition as designed” by Merck).

            Due to these directly contradictory allegations, Plaintiff’s 3^rd cause of action for manufacturing defect is SUSTAINED WITH 20 DAYS LEAVE TO AMEND. 

IV.  4^th cause of action for breach of express warranty—OVERRULED

            An express warranty “is a contractual promise from the seller that the goods conform to the promise.”  Daugherty v. American Honda Motor Co., Inc. (2006) 144 Cal. App. 4th 824, 830. Breach of express warranty requires the exact terms of the warranty, plaintiff's reasonable reliance, and a breach, which proximately causes injury to plaintiff.  See Williams v. Beechnut Nutrition Corp. (1986) 185 Cal. App. 3d 135, 142. 

            “We emphasize, however, that the ‘consumer expectation’ aspect of a breach of warranty action is subject, in the prescription drug context, to the general rule, discussed above, that warnings concerning the drug's properties are properly directed to the physician rather than the patient…Thus, for purposes of liability for breach of warranty, ordinarily it is the prescribing doctor who in reality stands in the shoes of ‘the ordinary consumer.’”  Carlin, supra, 13 Cal.4th at 1118. 

Defendants demur to the 4^th cause of action for express warranty on grounds that (1) the Vaccine Act preempts any claim for express warranty based on representations to Plaintiff and his mother; (2) the learned intermediary doctrine also precludes any claim for breach of express warranty based on warranties to Plaintiff and his mother; and (3) there are no allegations that Plaintiff and/or his mother relied on any specific representations by Merck.

            Plaintiff’s breach of warranty claim is not based solely on representations or warranties made to him and his mother. Plaintiff alleges that the representations and warranties were made to “Plaintiff, his mother and/or his medical providers.”  See Complaint, ¶429. Plaintiff therefore alleges breach of warranty in conformity with the learned intermediary doctrine and Carlin.

            Plaintiff also alleges that he and his mother relied on Defendants’ warranties in consenting to Gardasil.  See Complaint, ¶432.  Plaintiff also alleges that his medical providers would not have offered or recommended Gardasil to Plaintiff were it not for Merck’s representations in its labeling, advertisements and promotions.  Id. at 381.

            Finally, the sections of the Vaccine Act relied upon by Defendants do not bar a cause of action based on express warranty to a prescribing medical provider.  Plaintiff does not allege that his vaccine injury was “solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative).”  42 USC §300aa-22(c).  Plaintiff is alleging breach of express warranty based on representations made to his medical providers as well.

V.  5^th cause of action for common law fraud--OVERRULED

            The elements of fraud are: (1) misrepresentation (false representation, concealment, or nondisclosure); (2) knowledge of falsity (scienter); (3) intent to defraud or induce reliance; (4) justifiable reliance; and (5) damages.  See Civil Code §1709.  Fraud actions are subject to strict requirements of particularity in pleading.  See Committee on Children's Television, Inc. v. General Foods Corp. (1983) 35 Cal. 3d 197, 216.  A plaintiff must allege what was said, by whom, in what manner (i.e. oral or in writing), when, and, in the case of a corporate defendant, under what authority to bind the corporation.  See Goldrich v. Natural Y Surgical Specialties, Inc. (1994) 25 Cal.App.4th 772, 782. 

Plaintiff’s 5^th cause of action for fraud is based on numerous express representations made directly to him and his mother, as well as his prescribing physicians, regarding the safety and efficacy of Gardasil, the prevalence of cervical cancer, that Gardasil prevented cervical and anal cancer and that Gardasil’s only risks were injection site pain and fever, when Defendants knew that there were numerous other serious potential side effects.  See Complaint, ¶453.  Plaintiff alleges that his mother was exposed to these misrepresentations through Defendants’ marketing campaign entitled “One Less,” which included television and print advertisements and posters at doctors’ offices, and other advertising.  See Complaint, ¶¶83, 85, 449.  Plaintiff was exposed to Defendants’ representations regarding Gardasil based on statements to him by his physician.  Id. at ¶448.  Plaintiff alleges these representations were made to the general public and to physicians specifically.  Id. at ¶¶426, 429(a).  Plaintiff alleges that one of the marketing campaigns directed to the general public, including Plaintiff, his mother and his medical providers, was conducted in 2016. 

            These allegations sufficiently allege fraud against Defendants.  The nature of the misrepresentations, including whether they were written or verbal, is alleged.  The alleged misrepresentations were made in advertisements and marketing materials approved by and from Merck.  The advertisements are specifically identified.  Plaintiff alleges that he received his shot in 2018 and at least one of the campaigns was conducted in 2016.  This is sufficient for Defendants to discern when the alleged representations were made.  Moreover, Defendants would have better knowledge regarding when Defendants held the specific conferences to medical professionals and when they ran the specific campaigns identified by Plaintiff.  “Each element of a fraud count must be pleaded with particularity so as to apprise the defendant of the specific grounds for the charge and enable the court to determine whether there is any basis for the cause of action, although less specificity is required if the defendant would likely have greater knowledge of the facts than the plaintiff.”  Chapman v. Skype Inc. (2013) 220 Cal.App.4th 217, 231. 

            On reply, Defendants argue the fraud claim fails, because Plaintiff cannot allege a duty of disclosure to support fraudulent concealment. However, Plaintiff’s fraud claim alleges intentional misrepresentation in addition to fraudulent concealment.  So long as the intentional misrepresentation claim is sufficiently pleaded, the demurrer must be overruled.  A “general demurrer does not lie as to a portion of a cause of action and if any part of a cause of action is properly pleaded, the demurrer will be overruled.”  Elder v. Pacific Bell Telephone Co. (2012) 205 Cal.App.4th 841, 856. 

            Defendants also argue that the Vaccine Act and the Learned Intermediary Doctrine bar Plaintiff’s intentional misrepresentation claim. As discussed above, Defendants fail to cite to any section of the Vaccine Act that would apply to an intentional misrepresentation claim based on intentional misrepresentations made directly to the patient.

            Defendants argue that the learned intermediary doctrine applies to intentional misrepresentation claims involving prescription drugs.  Defendants rely on Colbath for this proposition.  Defendants’ argument fails for several reasons.  Colbath dismissed the plaintiff’s intentional misrepresentation claim with leave to amend on grounds that the “plaintiff failed to allege that his medical providers saw, let alone relied on Defendants’ affirmative misrepresentations.”  Colbath, supra, 2022 WL 935195, at *8.  Here, Plaintiff alleges that his medical providers saw and relied on the Defendants’ misrepresentations.

            Defendants are correct that Colbath required plaintiff to allege his medical providers’ exposure and reliance on the alleged misrepresentations based on the learned intermediary doctrine.  “Under the Vaccine Act and the Learned Intermediary Doctrine, the duty to warn runts to the physician, not to the patient.”  Id.  Colbath relies on Conte v. Wyeth (2008) 168 Cal.App.4^th 89 and Saavedra v. Eli Lilly and Co. 2013 WL 6345442. 

However, Saavedra expressly refrained from applying the learned intermediary doctrine to consumer protection claims and stated:  “Defendant has failed to identify any California case holding that the learned intermediary doctrine bars a tort cause of action, despite the plethora of claims-strict liability, negligence, breach of implied and express warranties, fraudulent misrepresentation-that a failure to warn claim can give rise to.”  Saavedra, supra, 2013 WL 6345442, at *5.

Conte involved alleged misrepresentations by a drug manufacturer in the labeling of Reglan, a prescription drug, and in a monograph on Reglan provided by the manufacturer for the Physician’s Desk Reference.  See Conte, supra, 168 Cal.App.4^th 89, 98.  Conte held the undisputed evidence established lack of causation and reliance where the prescribing physician testified that he did not rely on either representation in prescribing Reglan to the plaintiff.  Id. at 99.  On that basis, the Court granted the drug manufacturer’s motion for summary judgment of the fraud, fraudulent concealment and negligent misrepresentation causes of action.  Id. at 95.  The alleged misrepresentations were therefore contained in materials directed at prescribing physicians. Unlike Plaintiff Shain’s complaint, the Conte complaint did not allege fraudulent misrepresentations made in advertising directed to patients. 

Defendants fail to cite to any case law applying the learned intermediary doctrine to cases of fraud based on drug manufacturer’s misrepresentations in advertisements intentionally directed at patients and the general public.  As Plaintiff argues in opposition, the learned intermediary doctrine applies to the duty to warn as to prescription drugs, while Plaintiff’s fraud claim is based in part on the duty not to make affirmative misrepresentations. 

Defendants’ demurrer to the 5^th cause of action for common law fraud is OVERRULED.

VI.  6^th cause of action for Unfair Competition—OVERRULED

            Defendants demur to the 6^th cause of action for unfair competition on the exact same grounds as the 1^st through 5^th causes of action—Vaccine Injury Act, Learned Intermediary, failure to allege misrepresentations with specificity.  For the same reasons stated in connection with the demurrer to these other causes of action, plaintiff states a cause of action for unfair competition.  Defendants’ demurrer is OVERRULED.

VII.  Motion to Strike—DENY

            Defendants’ motion to strike the punitive damages claim is DENIED.  Plaintiff sufficiently alleges claims for fraud and allegations that would support a finding of malice based on despicable conduct in conscious disregard of the rights and safety of other under CC §3294. 

“An employer shall not be liable for damages pursuant to subdivision (a), based upon acts of an employee of the employer, unless the employer had advance knowledge of the unfitness of the employee and employed him or her with a conscious disregard of the rights or safety of others or authorized or ratified the wrongful conduct for which the damages are awarded or was personally guilty of oppression, fraud, or malice. With respect to a corporate employer, the advance knowledge and conscious disregard, authorization, ratification or act of oppression, fraud, or malice must be on the part of an officer, director, or managing agent of the corporation.”  CC §3294(c). 

Plaintiff alleges liability based on Merck’s actions toward the general public, e.g. Merck’s corporate advertising, Merck’s marketing, Merck’s methodology of operating clinical trials and obtaining FDA approval and Merck’s intentional failure to provide adequate warnings regarding Gardasil in medical literature.  Plaintiff therefore need not satisfy the requirements of CC §3294(c).  A reasonable inference is that such mass marketing campaigns and actions in Merck’s name were done with the approval an officer, director or managing agent of Merck. 

Defendants’ Motion to Strike Plaintiff’s Vioxx and Other Product Allegations as irrelevant is GRANTED per CCP §435.  “An immaterial allegation in a pleading is any of the following: (1) An allegation that is not essential to the statement of a claim or defense. (2) An allegation that is neither pertinent to nor supported by an otherwise sufficient claim or defense. (3) A demand for judgment requesting relief not supported by the allegations of the complaint or cross-complaint.”  CCP §431.10.  For purposes of pleading, the Vioxx allegations are irrelevant and immaterial as defined under CCP §430.10.  The Vioxx allegations are not necessary to satisfy an essential element of Plaintiff’s causes of action. At best, they are evidentiary facts which are immaterial to the complaint.  To survive a demurrer, “each evidentiary fact that might eventually form part of the plaintiff's proof need not be alleged.”  C.A. v. William S. Hart Union High School Dist. (2012) 53 Cal.4th 861, 872. 

Defendants’ Motion to Strike Plaintiff’s “design defect” allegations is DENIED.  As discussed in connection with the demurrer, Plaintiff’s express allegations regarding “design” are descriptive of Defendants’ role and duties as to Gardasil.  Plaintiff’s allegations regarding “research,” “development” and “testing” are ambiguous and are not clearly “design defect” allegations from the face of the complaint. 

Defendants’ Motion to Strike the 3^rd cause of action for manufacturing defect is MOOT in light of the Court’s order sustaining demurrer with leave to amend.