Judge: Teresa A. Beaudet, Case: 22STCV24209, Date: 2023-04-14 Tentative Ruling

Case Number: 22STCV24209    Hearing Date: April 14, 2023    Dept: 50

Superior Court of California

County of Los Angeles

Department 50

Background

Plaintiff Victoria Trevisan (“Plaintiff”) filed this action on July 27, 2022 against

Defendants Merck & Co., Inc., Merck Sharp & Dohme Corp., Providence Health System – Southern California, Providence Medical Institute, Providence Medical Associates, Inc., and Tristy Shaw, M.D. The Complaint asserts causes of action for (1) negligence, (2) strict liability (failure to warn), (3) strict liability (manufacturing defect), (4) breach of warranty, (5) fraudulent concealment, (6) fraudulent misrepresentation, (7) violation of California’s Unfair Competition Law, (8) medical malpractice, (9) battery, and (10) breach of fiduciary duty.[1]

            In the Complaint, Plaintiff alleges that the instant action “arises out of serious and debilitating injuries, including autoimmune injuries and resulting sequalae that plaintiff, Victoria Trevisan, sustained as a result of receiving multiple injections of the Gardasil vaccine, which was manufactured, labeled, and promoted by defendants Merck & Co., Inc., and Merck, Sharp and Dohme Corporation…and prescribed and administered by medical provider defendant, Tristy Shaw, M.D. at a Providence Medical Institute medical office.” (Compl., ¶ 1.)

Providence Medical Associates, Inc. and Tristy Shaw, M.D. (jointly, the “PMA Defendants”) demur to the eighth, ninth, and tenth causes of action of the Complaint. Plaintiff opposes.

Merck & Co., Inc. and Merck Sharp & Dohme LLC (formerly Merck Sharp & Dohme

Corp.) (jointly, the “Merck Defendants”) demur to the third, fifth, and sixth causes of action of the Complaint. The Merck Defendants also move to strike portions of the Complaint. Plaintiff opposes both.

Request for Judicial Notice

The Court denies Plaintiff’s request for judicial notice.   

The PMA Defendants’ Demurrer

A.    Legal Standard

A demurrer can be used only to challenge defects that appear on the face of the pleading under attack or from matters outside the pleading that are judicially noticeable. (Blank v. Kirwan (1985) 39 Cal.3d 311, 318.) “To survive a demurrer, the complaint need only allege facts sufficient to state a cause of action; 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.) For the purpose of testing the sufficiency of the cause of action, the demurrer admits the truth of all material facts properly pleaded. (Aubry v. Tri-City Hospital Dist. (1992) 2 Cal.4th 962, 966-967.) A demurrer “does not admit contentions, deductions or conclusions of fact or law.” (Daar v. Yellow Cab Co. (1967) 67 Cal.2d 695, 713.)

B.    Statute of Limitations

The PMA Defendants first assert that Plaintiff’s eighth, ninth, and tenth causes of action fail to state a claim because they are barred by the statute of limitations set forth in Code of Civil Procedure section 340.5.

Code of Civil Procedure section 340.5 provides, inter alia, as follows:

“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. In no event shall the time for commencement of legal action exceed three years unless tolled for any of the following: (1) upon proof of fraud, (2) intentional concealment, or (3) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person. Actions by a minor shall be commenced within three years from the date of the alleged wrongful act except that actions by a minor under the full age of six years shall be commenced within three years or prior to his eighth birthday whichever provides a longer period. Such time limitation shall be tolled for minors for any period during which parent or guardian and defendant’s insurer or health care provider have committed fraud or collusion in the failure to bring an action on behalf of the injured minor for professional negligence.”

The PMA Defendants cite to Bispo v. Burton (1978) 82 Cal.App.3d 824, 828, footnote 11, where the Court of Appeal noted that “the word injury, as used in section 340.5 to denote the start of the four-year limitation period, seems clearly to refer to the damaging effect of the alleged wrongful act and not to the act itself…Until the patient suffers appreciable harm as a consequence of the alleged act of malpractice, he cannot establish a cause of action. It follows that the statute of limitations does not begin to run against a negligence action until some damage has occurred.” (Internal quotations omitted.)  The PMA Defendants assert that “Plaintiff’s allegations leave no doubt that she suffered appreciable harm and was aware of that harm shortly after the Gardasil injections in December 2015, February 2016 and July 2016.” (Demurrer at     p. 8:15-16.)

In the Complaint, Plaintiff alleges she was “13 years old when she received her first shot of Gardasil on December 29, 2015, at the recommendation of Tristy Shaw, M.D. at a Providence Medical Institute facility in Redondo Beach, California.” (Compl., ¶ 345.) “Plaintiff returned to Dr. Shaw’s office on February 29, 2016, at her pediatrician’s recommendation, to receive the second dosage of Gardasil. She received the third dosage of Gardasil on July 12, 2016.” (Compl., ¶ 348.) Plaintiff alleges that “[i]mmediately following her third Gardasil shot, Plaintiff fainted and hit her head on the window or windowsill in the examination room at Dr. Shaw’s office.” (Compl., ¶ 349.)

Plaintiff alleges that “[t]wo days later on July 14, 2016, Plaintiff was seen by her allergist, Dr. Joyce Shoettler, and reported that she became severely short of breath after five minutes of a soccer game and had to stop playing…” (Compl., ¶ 350.) “In August 2016, Plaintiff went to a cardiologist, Dr. Dominic Blurton, for evaluation of her symptoms, which included dizziness, dyspnea with exertions, chest pains, blurry vision, nasal congestion, headaches, memory loss, and insomnia. She was also experiencing GI symptoms, including nausea, abdominal distention, and decreased appetite.” (Compl., ¶ 351.) Plaintiff alleges that “[b]ased on her chronic and severe post-Gardasil symptoms and adverse events…and the tests performed by a number of medical providers, Plaintiff has been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome (“POTS”), fibromyalgia, mast cell activation syndrome (“MCAS”), Hashimoto’s thyroiditis, ulcerative colitis, chronic fatigue, generalized anxiety, and major depressive disorder.” (Compl., ¶ 355.)

The PMA Defendants contend that the foregoing allegations “demonstrate an awareness

of an appreciable harm no later than July 14, 2016.” (Demurrer at p. 8:22-23.) The instant action was filed on July 27, 2022, approximately six years later.

The parties also note that the Complaint references 42 U.S.C. section 300aa-11, subdivision (a)(2)(A), which provides that “[n]o person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine-related injury or death, unless a petition has been filed, in accordance with section 2116 [42 USCS § 300aa-16], for compensation under the Program for such injury or death and—(i) (I) the United States Claims Court [United States Court of Federal Claims] has issued a judgment under section 2112 [42 USCS § 300aa-12] on such petition, and (II) such person elects under section 2121(a) [42 USCS § 300aa-21(a)] to file such an action, or (ii) such person elects to withdraw such petition under section 2121(b) [42 USCS § 300aa-21(b)] or such petition is considered withdrawn under such section.”

            In the Complaint, Plaintiff alleges that she “filed her petition with the U.S. Court of Federal Claims on June 5, 2019, seeking compensation for her Gardasil vaccine-related injuries under the National Vaccine Injury Compensation Program. A judgement thereon was rendered on or about November 30, 2020, and Plaintiff duly filed her election to file a civil action on November 30, 2020.” (Compl., ¶ 360.) Plaintiff notes that pursuant to 42 U.S.C. section 300aa-16, “[i]f a petition is filed under section 2111 [42 USCS § 300aa-11] for a vaccine-related injury or death, limitations of actions under State law shall be stayed with respect to a civil action brought for such injury or death for the period beginning on the date the petition is filed and ending on the date (1) an election is made under section 2121(a) [42 USCS § 300aa-21(a)] to file the civil action or (2) an election is made under section 2121(b) [42 USCS § 300aa-21(b)] to withdraw the petition.” The Court notes that there are 544 days between June 5, 2019 and November 30, 2020. (Compl., ¶ 360.)

The PMA Defendants assert that “[a]ssuming plaintiff’s allegation is true that accrual of her claims were tolled while her petition with the U.S. Court of Federal Claims was pending, this complaint is still untimely.” (Demurrer at p. 8:26-27.) More specifically, they assert that “[t]aking the latest possible date of harm of July 14, 2016, under normal calculations of the         § 340.5 period, her claims must have been filed no later than July 14, 2019. Plaintiff filed her petition with the U.S. Court of Federal Claims on Jun [sic] 5, 2019, barely within that three-year period…Assuming her civil claims were tolled from the date of her petition to the date of her election to file a civil action (November 30, 2020), plaintiff was still required to file this case no

later than January 8, 2021.” (Demurrer at p. 8:28-9:5.) The Court notes that 544 days after July 14, 2019 is January 8, 2021. As set forth above, the instant action was filed on July 27, 2022.

            In the opposition, Plaintiff asserts the eighth, ninth, and tenth causes of action were timely filed.

As to the eighth cause of action, Plaintiff agrees that the applicable statute of limitations is Code of Civil Procedure section 340.5, but contends that the PMA Defendants have not met their burden of showing that Plaintiff’s claims accrued on July 14, 2016. Specifically, Plaintiff asserts that “[b]ecause the Complaint does not provide the specific dates of all of her injuries, because the [PMA Defendants] concealed the cause of the injuries, because the statute of limitations were further stayed during the approximately one year and five-month period Plaintiff’s claim was in vaccine court, and because Defendants’ statute of limitations defense presents issues of fact to be adjudicated by the trier of fact, the [PMA Defendants] have failed to carry their heavy to burden to show that [Plaintiff’s] negligence action is untimely as a matter of law.” (Opp’n at p. 8:15-21.)

More specifically, Plaintiff asserts that “under Section 340.5, in light of the fiduciary relationship between a doctor and patient, the statute of limitations of the negligence cause of action against the [PMA Defendants] is…tolled during the period [Plaintiff’s] medical providers concealed the cause of her various injuries.” (Opp’n at p. 6:9-12.) In support of this assertion, Plaintiff points to allegations in the eighth cause of action that “Providence Defendants’ negligent and wrongful acts include and incorporate their negligent failure to timely and properly diagnose that Plaintiff had sustained a Gardasil adverse reaction following her July 12, 2016 Gardasil injection,” and that “the Providence Defendants’ negligent and wrongful acts incorporate their negligent failure to medically diagnose the nature and cause of Plaintiff’s underlying immunological disease processes.” (Compl., ¶¶ 497-498.) But as the PMA Defendants note, Plaintiff does not allege that the PMA Defendants “concealed the cause” of Plaintiff’s injuries.  

Plaintiff also asserts that “as outlined in the Complaint, [Plaintiff] has sustained a myriad of differing injuries as a result of her Gardasil vaccinations, which manifested on different dates. While dates are provided for some of her symptoms (like fainting that occurred on the date of her third vaccination and shortness of breath which she reported two days later), specific dates have not been provided for all of the various and distinct injuries that occurred after her final Gardasil injection on July 12, 2016, nor was [Plaintiff] required to provide the dates of the onset and diagnosis of the various specific injuries, which include POTS, fibromyalgia, MCAS, Hashimoto’s thyroiditis, and ulcerative colitis.” (Opp’n at p. 6:19-25, emphasis omitted.)[2]

Plaintiff contends that because the Complaint alleges the dates of Plaintiff’s Gardasil vaccinations and not the dates of all of Plaintiff’s Gardasil-induced injuries, the Complaint “does not reveal on its face” that Plaintiff’s claims are barred by the statute of limitations. Plaintiff cites to JPMorgan Chase Bank, N.A. v. Ward (2019) 33 Cal.App.5th 678, 689, where the Court of Appeal noted that “[w]here a complaint does not reveal on its face that it is barred by the statute of limitations, a plaintiff has no obligation to plead around the defense.” The PMA Defendants do not address this point in their reply, which the Court construes as a concession of the merits of Plaintiff’s argument.

Plaintiff also asserts that “given that [Plaintiff] sustained a myriad of different and distinct injuries at different points in time, each of which may have different statute of limitations under California law, and the Complaint does not identify the dates of every single injury, it cannot be concluded at this procedural posture that all of the alleged injuries are time-barred.” (Opp’n at p. 7:13-16, emphasis omitted.) Plaintiff cites to Pooshs v. Philip Morris USA, Inc. (2011) 51 Cal.4th 788, 800, footnote 6, where the California Supreme Court found that “in Grisham, supra, 40 Cal.4th 623, we concluded the plaintiff’s later-manifesting claim for physical injury was timely without also determining whether that claim involved the same primary right as the plaintiff’s earlier-manifesting claim for economic damage. In so doing, we necessarily, albeit implicitly, assumed that, even if the plaintiff’s various claims involved only a single primary right (as the defendants there asserted), we could still apply the statute of limitations separately to the plaintiff’s physical injury claim. In other words, we necessarily accepted the possibility that a plaintiff can have a single cause of action that accrues (for statute of limitations purposes) at different times with respect to different types of harm, thus permitting some damage claims to proceed although others are time-barred.” (Internal citation omitted.) The PMA Defendants also do not address this point in the reply.

As to the ninth cause of action for battery, Plaintiff asserts that Code of Civil Procedure section 340.5 is not the applicable statute of limitations. Plaintiff asserts that her battery cause of action is governed by Code of Civil Procedure section 335.1 and is subject to a two-year statute of limitations. Pursuant to Code of Civil Procedure section 335.1, the statute of limitations for “[a]n action for assault, battery, or injury to, or for the death of, an individual caused by the wrongful act or neglect of another” is two years.

Plaintiff contends that any running of the statute of limitations as to the battery cause of action would be tolled during the period in which Plaintiff was a minor. Pursuant to Code of Civil Procedure section 352, subdivision (a), “[i]f a person entitled to bring an action, mentioned in Chapter 3 (commencing with Section 335) is, at the time the cause of action accrued either under the age of majority or lacking the legal capacity to make decisions, the time of the disability is not part of the time limited for the commencement of the action.” As set forth above, Plaintiff alleges that she “was 13 years old when she received her first shot of Gardasil on December 29, 2015,” that she “returned to Dr. Shaw’s office on February 29, 2016…to receive the second dosage of Gardasil,” and that she “received the third dosage of Gardasil on July 12, 2016.” (Compl., ¶¶ 345, 348.) Plaintiff asserts that “because she was still a minor when she filed her vaccine court petition, the two-year statute of limitations on her battery cause of action… had not even accrued and was stayed throughout the time Plaintiff’s claim was pending in vaccine court. Plaintiff’s claim did not accrue until November 30, 2020, when the vaccine court proceedings terminated, and she filed her election to file a civil case…Thus, [Plaintiff] still had at least two years from November 30, 2020 (i.e., until at least November 30, 2022) to file her battery claim…which she timely did on July 27, 2022.” (Opp’n at p. 11:5-11, emphasis omitted.)

 In their reply, the PMA Defendants do not address Plaintiff’s arguments pertaining to the statute of limitations applicable to the battery cause of action. 

            As to the tenth cause of action for breach of fiduciary duty, Plaintiff asserts that Code of Civil Procedure section 340.5 is not the applicable statute of limitations. Plaintiff notes that “[t]he statute of limitations for breach of fiduciary duty is four years.” (Stalberg v. Western Title Ins. Co. (1991) 230 Cal.App.3d 1223, 1230, citing Code Civ. Proc., § 343.) Plaintiff asserts that “[h]ere, as with Plaintiff’s battery claim, because Plaintiff was a minor throughout the time her claim was pending in vaccine court, Plaintiff’s claim did not accrue until November 30, 2020, when the vaccine court proceedings terminated, and she filed her election to file a civil case…Thus, [Plaintiff] still had at least four years from November 30, 2020 (i.e., until at least November 30, 2024) to file her breach of fiduciary duty claim, which she timely filed on July 27, 2022.” (Opp’n at p. 13:18-20, emphasis omitted.)

In their reply, the PMA Defendants do not address Plaintiff’s arguments in the opposition pertaining to the statute of limitations applicable to the breach of fiduciary duty cause of action. 

Based on the foregoing, the Court does not find that the PMA Defendants have shown that the eighth, ninth, or tenth causes of action are barred by the applicable statute of limitations.

C.    Battery

Next, the PMA Defendants assert that Plaintiff’s “battery and breach of fiduciary claims are just disguised claims for medical negligence and do not constitute independent causes of action.” (Demurrer at p. 9:19-21.) In the ninth cause of action for battery, Plaintiff alleges that “[t]he administration and injection of each of the three Gardasil injections by the Providence Defendants was without the informed consent of Plaintiff and constitutes a battery against Plaintiff.” (Compl., ¶ 508.) Plaintiff further alleges that she “did not consent to an ineffective vaccine that contains all of the undisclosed serious and debilitating side effects, including but not limited to the autoimmune causing side effects outlined in this Complaint, being injected into her body.” (Compl., ¶ 509.)

The PMA Defendants cite to Saxena v. Goffney (2008) 159 Cal.App.4th 316, 324, where the Court of Appeal noted that “[o]ur high court has made it clear that battery and lack of informed consent are separate causes of action. A claim based on lack of informed consent—which sounds in negligence—arises when the doctor performs a procedure without first adequately disclosing the risks and alternatives. In contrast, a battery is an intentional tort that occurs when a doctor performs a procedure without obtaining any consent.” The PMA Defendants assert that here, Plaintiff “is not alleging that [the PMA Defendants] injected plaintiff with a different vaccine than Gardasil, the one consented to, or that [the PMA Defendants] performed a different procedure entirely. Instead, plaintiff alleges that she did not give ‘informed consent’ because she was not made aware of the risks and potential harms of the vaccine. These allegations sound in negligence rather than the intentional tort of battery.” (Demurrer at p. 10:8-12.) The Court agrees.

In the opposition, Plaintiff asserts that her battery cause of action is adequately pled. Plaintiff cites to Cobbs v. Grant (1972) 8 Cal.3d 229, 239, where the California Supreme Court noted that “[w]here a doctor obtains consent of the patient to perform one type of treatment and subsequently performs a substantially different treatment for which consent was not obtained, there is a clear case of battery.” In the Complaint, Plaintiff alleges that “[w]hile Plaintiff may have agreed to receive a fully safe vaccine that was effective against preventing cervical cancer, the product that was ultimately injected in her by the Providence Defendants was substantially different than the promised vaccine, as it was not, and is not, effective for the advertised and promised indications and contained serious, fatal and disabling undisclosed side effects. Had Plaintiff received accurate information concerning the true lack of efficacy and risk profile of the Gardasil vaccine, she would not have permitted the injection.” (Compl., ¶ 510.)

But as the PMA Defendants note, there are no allegations that Dr. Shaw performed a different treatment or procedure than the one consented to. “An action should be pleaded in negligence when the doctor performs an operation to which plaintiff consents, but without disclosing sufficient information about the risks inherent in the surgery. The battery theory should be reserved for those circumstances when a doctor performs an operation to which the patient has not consented.” (Saxena v. Goffney, supra, 159 Cal.App.4th at p. 324 [internal quotations and citations omitted].)

Plaintiff also asserts that the PMA Defendants deceptively represented the therapeutic effects of the Gardasil injection, such that a battery cause of action is appropriate. Plaintiff cites to Rains v. Superior Court (1984) 150 Cal.App.3d 933, 935, which involved a “petition seek[ing] review of an order sustaining a demurrer to a cause of action for battery without leave to amend. The alleged batteries occurred as an aspect of an in-patient psychiatric treatment program in which plaintiffs participated and consented to defendants using physical violence upon them as a therapeutic measure.” In Rains, “[t]he fifth count of the second amended complaint allege[d] that defendants committed numerous batteries upon plaintiffs in the administration of the psychiatric program.” (Id. at p. 936.) “The count allege[d] that any consent to such touchings occurred as a result of the fraudulent representations described in Paragraphs 8 and 14 of the First Cause of Action.” (Id. at p. 937 [internal quotations omitted].)

The Court of Appeal noted that “[w]hether a viable cause for battery has been or might be pleaded turns upon whether plaintiffs’ consent to use of physical violence by defendants as a therapeutic treatment may be vitiated by allegations that defendant psychiatrists actually did not administer such violence for any therapeutic purposes but for the improper ulterior purpose of subjugating plaintiffs and controlling their behavior to defendants’ personal advantage.” (Rains v. Superior Court, supra, 150 Cal.App.3d at 936.) The Court of Appeal concluded that “plaintiffs can state a cognizable cause of action for battery.” (Id. at p. 938.) The Court noted that “the authorities cited in Fleming on Torts (op. cit. supra, at p. 78, fns. 28 and 31) support the correctness of the determination that a physician’s intentional misrepresentation that an otherwise offensive touching is medically necessary vitiates the consent given in ignorance of the true nontherapeutic character of the touching.” (Id. at p. 940.) 

The Court agrees with the PMA Defendants that Rains is distinguishable. As the PMA Defendants note, Plaintiff’s ninth cause of action for battery does not allege that the PMA Defendants made an intentional misrepresentation to Plaintiff. Instead, Plaintiff alleges, as set forth above, that “[w]hile Plaintiff may have agreed to receive a fully safe vaccine that was effective against preventing cervical cancer, the product that was ultimately injected in her by the Providence Defendants was substantially different than the promised vaccine, as it was not, and is not, effective for the advertised and promised indications and contained serious, fatal and disabling undisclosed side effects.” (Compl., ¶ 510.)

Based on the foregoing, the Court sustains the PMA Defendants’ demurrer to Plaintiff’s ninth cause of action for battery.

D.    Breach of Fiduciary Duty

The PMA Defendants also assert that the breach of fiduciary duty cause of action is duplicative of the medical malpractice cause of action. In support of the tenth cause of action for breach of fiduciary duty, Plaintiff alleges, inter alia, that “Providence Defendants breached their fiduciary duty to Plaintiff by failing to act as a reasonably careful medical provider and fiduciary would have acted under the same circumstances.” (Compl., ¶ 516.)

The PMA Defendants cite to Moore v. Regents of University of California (1990) 51 Cal.3d 120, 129, where the California Supreme Court concluded that “a physician must disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect the physician’s professional judgment; and (2) a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of fiduciary duty.” The Moore Court held that “a physician who is seeking a patient’s consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient’s informed consent, disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect his medical judgment.” (Id. at pp. 131-132.) The PMA Defendants appear to assert that Moore stands for the proposition that a breach of fiduciary duty cause of action may only pertain to a physician’s failure to disclose personal, nonmedical interests to a patient. However, the Court does not find that Moore stands for such a proposition.

In addition, Plaintiff notes that “a breach of fiduciary duty is a species of tort distinct from a cause of action for professional negligence.” (Stanley v. Richmond (1995) 35 Cal.App.4th 1070, 1086.) “The elements of a cause of action for breach of fiduciary duty are: (1) [the] existence of a fiduciary duty; (2) breach of the fiduciary duty; and (3) damage proximately caused by the breach. [A] physician has a fiduciary duty to disclose all information material to the patient’s decision, when soliciting a patient’s consent to a medical procedure. A cause of action premised on a physician’s breach of this fiduciary duty may alternatively be referred to as a claim for lack of informed consent.” (Jameson v. Desta (2013) 215 Cal.App.4th 1144, 1164 [internal quotations and citations omitted].)  

Here, Plaintiff alleges in support of the tenth cause of action that “Providence Defendants and DOES 26 through 50 were medical facilities, medical providers or doctors who provided medical care to Plaintiff, and in that capacity, they owed a fiduciary duty to Plaintiff under California law.” (Compl., ¶ 515.) Plaintiff alleges that the Providence Defendants breached their fiduciary duty to Plaintiff in a number of ways, and that as a result, Plaintiff has been damaged. (Compl., ¶¶ 516-522.)

Based on the foregoing, the Court overrules the PMA Defendants’ demurrer to the tenth cause of action for breach of fiduciary duty.  

E.     Medical Malpractice

            Lastly, as to the eighth cause of action for medical malpractice, the PMA Defendants assert that “Plaintiff’s [sic] cannot plausibly allege that [the PMA Defendants] fell below the standard of care given inconsistent allegations regarding Merck’s fraudulent concealment.” (Demurrer at p. 11:1-3.) More specifically, the PMA Defendants assert that “Plaintiff fails to allege that [PMA Defendants] were actually aware of the alleged significant risks of the Gardasil vaccine, and in fact alleges the opposite, that [the PMA Defendants] were too misled by Merck’s representations that the vaccine was safe and effective.” (Demurrer at p. 11:13-16.) The PMA Defendants point to allegations in the Complaint that “Merck’s advertisements assert that the HPV vaccine prevents cervical cancer. For example, in a presentation to medical doctors, Merck proclaimed: ‘Every year that increases in coverage [of the vaccine] are delayed, another 4,400 women will go on to develop cervical cancer.’ The presentation goes on to tell doctors that women who do not get the vaccine will go on to develop cancer.” (Compl., ¶ 117.) Plaintiff further alleges that Merck’s negligence includes “[f]ailing to disclose to Plaintiff, her mother, her medical providers and to the general public that, contrary to Merck’s promotion of the vaccine, Gardasil has not been shown to be effective at preventing cervical cancer…” (Compl., ¶ 375(p), emphasis added.)

The PMA Defendants cite to Larson v. UHS of Rancho Springs, Inc. (2014) 230 Cal.App.4th 336, 343, where the Court of Appeal noted that “a court is not bound to accept as true allegations contrary to factual allegations in former pleading in the same case.” (Internal quotations omitted.) The Larson Court also noted that “[a] plaintiff may not avoid a demurrer by pleading facts or positions in an amended complaint that contradict the facts pleaded in the original complaint or by suppressing facts which prove the pleaded facts false.” (Id. at p. 344.)

The PMA Defendants also assert that Plaintiff fails to allege that a reasonably prudent physician in the relevant community should have been aware of the risks of Gardasil or disclosed them to the patient, as Merck allegedly concealed the risks of Gardasil. The PMA Defendants cite to Sanchez v. Rodriguez (1964) 226 Cal.App.2d 439, 449, where the Court of Appeal noted that “[a] doctor is not a warrantor of cures nor is he required to guarantee results and in the absence of a want of reasonable care and skill will not be held responsible for untoward results.”

Plaintiff contends that the PMA Defendants ignore law that even if Plaintiff’s allegations against Merck are inconsistent with those asserted against the PMA Defendants, alternative pleading is permitted. Plaintiff notes that “[w]here the exact nature of the facts is in doubt, or where the exact legal nature of plaintiff’s right and defendant’s liability depend on facts not well known to the plaintiff, the pleading may properly set forth alternative theories in varied and inconsistent counts.” (Rader Co. v. Stone (1986) 178 Cal.App.3d 10, 29.)

            The PMA Defendants counter that “Plaintiff is correct that causes of action can be pled in the alternative, but those alternative allegations must relate to how the facts apply to the law, rather than alleging directly contradictory facts themselves.” (Reply at p. 4:17-19.) The PMA Defendants cite to Manti v. Gunari (1970) 5 Cal.App.3d 442, 449, where the Court of Appeal found, “[i]t is to be noted that in the first three counts plaintiff alleged the existence of a joint tenancy account, with right of survivorship, which was duly admitted by the answer, and pro tanto, removed from further factual contest. In the fourth, plaintiff averred no such account was created. While inconsistent theories of recovery are permitted, a pleader cannot blow hot and cold as to the facts positively stated.” (Internal citations omitted, emphasis in original.) The PMA Defendants also cite to Duffey v. Tender Heart Home Care Agency, LLC (2019) 31 Cal.App.5th 232, 242, footnote 7, where the Court of Appeal noted that “[f]or the bar on inconsistent fact pleading to apply, the facts must be antagonistic, and the bar applies to facts, not legal conclusions to be drawn from the facts...” (Internal quotations omitted.)

            The Court agrees with the PMA Defendants that Plaintiff has pled inconsistent facts with regard to the PMA Defendants’ alleged medical malpractice and the alleged concealment on the part of the Merck Defendants.

            Based on the foregoing, the Court sustains the PMA Defendants’ demurrer to the eighth cause of action for medical malpractice.

The Merck Defendants’ Demurrer

A.    Legal Standard

A demurrer can be used only to challenge defects that appear on the face of the pleading under attack or from matters outside the pleading that are judicially noticeable. (Blank v. Kirwan, supra, 39 Cal.3d at p. 318.) “To survive a demurrer, the complaint need only allege facts sufficient to state a cause of action; 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., supra, 53 Cal.4th at p. 872.) For the purpose of testing the sufficiency of the cause of action, the demurrer admits the truth of all material facts properly pleaded. (Aubry v. Tri-City Hospital Dist., supra, 2 Cal.4th at p. 966-967.) A demurrer “does not admit contentions, deductions or conclusions of fact or law.” (Daar v. Yellow Cab Co., supra, 67 Cal.2d at p. 713.)

A pleading is uncertain if it is ambiguous or unintelligible. (Code Civ. Proc., § 430.10(f).) A demurrer for uncertainty may lie if the failure to label the parties and claims renders the complaint so confusing defendant cannot tell what he or she is supposed to respond to.¿ (Williams v. Beechnut Nutrition Corp. (1986) 185 Cal.App.3d 135, 139, fn. 2.) However, “[a] demurrer for uncertainty is strictly construed, even where a complaint is in some respects uncertain, because ambiguities can be clarified under modern discovery procedures.” (Khoury v. Maly’s of California, Inc. (1993) 14 Cal.App.4th 612, 616.)¿ 

B.    Strict Liability (Manufacturing Defect)

The Merck Defendants assert that Plaintiff’s third cause of action for strict liability (manufacturing defect) fails because Plaintiff does not allege that her particular Gardasil doses were defective or differed from their intended design in any way. The Merck Defendants note that “[b]oth the traditional definitions of manufacturing defect presuppose that a suitable design is in place, but that the manufacturing process has in some way deviated from that design…focus is on whether the particular product involved in the incident was manufactured in conformity with the manufacturer’s design.” (In re Coordinated Latex Glove Litigation (2002) 99 Cal.App.4th 594, 613.)

In support of the third cause of action, 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 FDA-approved specifications and/or otherwise not disclosed in the package insert.” (Compl., ¶ 410.) Plaintiff also alleges that

“the Gardasil injected into Plaintiff was defective and unreasonably dangerous because it failed to comply with the approved manufacturing specifications, by containing dangerous and undisclosed HPV L1-DNA fragments, and these DNA fragments could act as a Toll-Like Receptor 9 (TLR9) agonist, further adjuvanting the vaccine and making it more potent and dangerous than intended.” (Compl., ¶ 411.) In addition, Plaintiff alleges that “the Gardasil injected into Plaintiff was defective and unreasonably dangerous because it failed to comply with the approved manufacturing specifications, by containing dangerous and undisclosed ingredients and neurotoxins, including but not limited to, phenylmethylsulfonyl fluoride (PMSF), a toxic nerve agent that is not intended for human consumption or injection.” (Compl., ¶ 412.)

The Merck Defendants assert that the foregoing allegations “are made against all Gardasil doses writ large and therefore attack Gardasil’s design, not the manufacturing of her particular doses.” (Demurrer at p. 5:2-3.) The Merk Defendants also note that in Bruesewitz v. Wyeth LLC (2011) 562 U.S. 223, 243, the United States Supreme Court held that “the National Childhood Vaccine Injury Act pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”

In the opposition, Plaintiff asserts that the manufacturing defect cause of action is sufficiently alleged. Plaintiff cites to Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 435, where the Court of Appeal noted that “Coleman’s second amended complaint alleged that the Infuse device implanted in him was defective because it failed to comply with the manufacturing specifications required by Infuse’s Premarket Approval and Current Good Manufacturing Practices under the FDCA as they related to the leakage of rhBMP-2 into the surgical site. In ruling on Medtronic’s demurrer to the second amended complaint, the trial court directed this claim dismissed without leave to amend because the complaint did not identify a specific requirement of the premarket approval process which Coleman alleges Medtronic violated.” (Internal quotations omitted.) The Court of Appeal concluded that “the complaint alleges sufficient facts to state a cause of action for manufacturing defect…” (Id. at p. 436.) 

But as the Merck Defendants note, Plaintiff does not allege how her Gardasil doses differed from Gardasil’s intended design or from other doses of Gardasil. Plaintiff does not identify any characteristic that distinguishes her doses of Gardasil from all others. As set forth above, “the traditional definitions of manufacturing defect presuppose 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 Litigation, supra, 99 Cal.App.4th at p. 613.)

Based on the foregoing, the Court sustains the Merck Defendants’ demurrer to the third cause of action for strict liability (manufacturing defect).

C.    Fraudulent Concealment

“[T]he elements of a cause of action for fraud based on concealment are: (1) the defendant must have concealed or suppressed a material fact, (2) the defendant must have been under a duty to disclose the fact to the plaintiff, (3) the defendant must have intentionally concealed or suppressed the fact with the intent to defraud the plaintiff, (4) the plaintiff must have been unaware of the fact and would not have acted as he did if he had known of the concealed or suppressed fact,  and (5) as a result of the concealment or suppression of the fact, the plaintiff must have sustained damage.” (Bigler-Engler v. Breg, Inc. (2017) 7 Cal.App.5th 276, 310-311 [internal quotations omitted].)

The Merck Defendants assert that “Plaintiff’s Complaint contains no allegations that, if true, would establish element number (2): that Merck was under a duty to disclose any information about Gardasil to Plaintiff.” (Demurrer at p. 6:15-16.)

The Merck Defendants note that “[t]here are four circumstances in which nondisclosure or concealment may constitute actionable fraud: (1) when the defendant is in a fiduciary relationship with the plaintiff; (2) when the defendant had exclusive knowledge of material facts not known to the plaintiff; (3) when the defendant actively conceals a material fact from the plaintiff; and (4) when the defendant makes partial representations but also suppresses some material facts. Where…a fiduciary relationship does not exist between the parties, only the latter three circumstances may apply. These three circumstances, however, presuppose[] the existence of some other relationship between the plaintiff and defendant in which a duty to disclose can arise. A duty to disclose facts arises only when the parties are in a relationship that gives rise to the duty, such as seller and buyer, employer and prospective employee, doctor and patient, or parties entering into any kind of contractual arrangement.” (Bigler-Engler v. Breg, Inc., supra, 7 Cal.App.5th at p. 311 [internal quotations and citations omitted].)

The Bigler-Engler Court further noted that “[o]ur Supreme Court has described the necessary relationship giving rise to a duty to disclose as a transaction between the plaintiff and the defendant: In transactions which do not involve fiduciary or confidential relations, a cause of action for non-disclosure of material facts may arise in at least three instances: (1) the defendant makes representations but does not disclose facts which materially qualify the facts disclosed, or which render his disclosure likely to mislead; (2) the facts are known or accessible only to defendant, and defendant knows they are not known to or reasonably discoverable by the plaintiff; (3) the defendant actively conceals discovery from the plaintiff…Such a transaction must necessarily arise from direct dealings between the plaintiff and the defendant; it cannot arise between the defendant and the public at large.” (Bigler-Engler v. Breg, Inc., supra, 7 Cal.App.5th at pp. 311-312 [internal quotations, citations, and emphasis omitted].)

The Merck Defendants assert that Plaintiff does not allege that she bought any Gardasil dose from Merck, that Merck is her employer, or that she has any kind of contractual agreement with Merck. The Merck Defendants assert that there is thus no “transaction” or “relationship” of any kind alleged in Plaintiff’s Complaint, and no “direct dealings” between the parties.

Plaintiff asserts that Bigler-Engler is distinguishable from the facts here because Plaintiff has alleged that the Merck Defendants failed to provide adequate warnings to Plaintiff’s doctor. In support of the fraudulent concealment cause of action, Plaintiff alleges that “Merck fraudulently concealed material information concerning Gardasil’s severe adverse event risks from Plaintiff’s medical providers.” (Compl., ¶ 442.) Plaintiff alleges that “[h]ad Merck not fraudulently concealed this material safety information from Plaintiff’s medical providers, then, upon information and belief, Plaintiff’s medical providers would not have recommended Gardasil or would have passed on this safety information concerning Gardasil’s risks to Plaintiff and her mother.” (Compl., ¶ 443.)

Plaintiff notes that the Bigler-Engler Court discussed the application of the “learned intermediary doctrine.” The Bigler-Engler Court noted that “[i]n the case of prescription drugs, the duty to warn runs to the physician, not to the 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.” (Bigler-Engler v. Breg, Inc., supra, 7 Cal.App.5th at p. 318 [internal quotations, citations, and emphasis omitted]; see also Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65 [“[i]n the case of medical prescriptions, ‘if 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.’”].) Plaintiff contends that “Merck’s duty argument completely overlooks the direct dealings between Merck and Plaintiff’s medical providers.” (Opp’n at         p. 8:15-16.)

The Bigler-Engler matter arose “from Whitney Engler’s use of a medical device, the Polar Care 500, that was manufactured by Breg, Inc. (Breg), and prescribed by David Chao, a medical doctor. Engler suffered injuries as a result of her use of the Polar Care 500, and she brought various tort claims against Chao, his medical group, Oasis MSO, Inc. (Oasis), and Breg, among others.” (Bigler-Engler v. Breg, Inc., supra, 7 Cal.App.5th at p. 284.) The Bigler-Engler Court concluded that the learned intermediary doctrine “does not apply to medical devices such as the Polar Care 500, which require the patient to use and apply the medical device themselves. Unlike prescription drugs (which may have only rudimentary patient instructions, e.g., take by mouth twice daily) or implantable medical devices (which may have no patient instructions at all), medical devices such as the Polar Care 500 are intended to be operated by the patient outside the medical environment.” (Id. at p. 319.) Plaintiff contends that these facts are in contrast to the situation here, where Plaintiff allegedly obtained injections directly from her medical providers.

The Merck Defendants assert that Bigler-Engler’s discussion of the learned intermediary doctrine occurs in the context of a cause of action for failure to warn, not fraudulent concealment. In Bigler-Engler, “Breg contend[ed] the court erred by refusing to instruct the jury that Breg’s strict liability duty to warn could be discharged by adequate warnings to prescribing medical providers—rather than their patients—under the learned intermediary doctrine.” (Bigler-Engler v. Breg, Inc., supra, 7 Cal.App.5th at p. 318.) But the Merck Defendants do not cite to legal authority indicating that the learned intermediary doctrine may not be applicable in determining what qualifies as a “duty” for purposes of a cause of action for fraudulent concealment.[3]

The Merck Defendants also assert that Plaintiff does not plead the fraudulent concealment cause of action with the requisite particularity. However, the arguments set forth in pages 9:6-14:3 of the Merck Defendants’ demurrer appear to only concern the sixth cause of action for fraudulent misrepresentation.

Based on the foregoing, the Court overrules the demurrer to the fifth cause of action for fraudulent concealment.

D.    Fraudulent Misrepresentation

The Merck Defendants assert that Plaintiff does not plead her fraudulent misrepresentation cause of action with the requisite particularity. “In California, fraud must be pled specifically; general and conclusory allegations do not suffice. Thus the policy of liberal construction of the pleadings . . . will not ordinarily be invoked to sustain a pleading defective in any material respect…This particularity requirement necessitates pleading facts which show how, when, where, to whom, and by what means the representations were tendered.” (Lazar v. Superior Court (1996) 12 Cal.4th 631, 645 [internal quotations, citations, and emphasis omitted].)

In support of the sixth cause of action for fraudulent misrepresentation, Plaintiff alleges, inter alia, that that “[t]he false representations Merck made to the children, the parents of children, the medical community, including to Plaintiff and her mother, included: a) that Gardasil is effective in preventing cervical cancer, when Merck knew that, contrary to these representations (i) no clinical studies were performed to test whether Gardasil prevents cancer; and (ii) the clinical studies confirmed that Gardasil is indeed ineffective when used in patients who have previously been exposed to HPV, and that Gardasil actually increases the risk of cervical cancer in any child or patient who has been previously exposed to HPV; b)  that Gardasil is safe, when in reality, Gardasil causes and presents severe risks of cancer (including cervical cancer, the very cancer it is promoted as preventing), fertility problems, autoimmune disease, including POTS, and other grave illnesses; c) false advertising and disease mongering by scaring parents into believing that cervical cancer was far more prevalent than it really was; that Gardasil prevented cervical cancer; and that Gardasil only had risks of injection site pain and fever, when in reality none of these representations were true…” (Compl., ¶ 466.)

The Merck Defendants assert that Plaintiff cannot state a claim for fraud based on the alleged advertisements.

The Merck Defendants cite to 42 U.S.C. section 300aa-22, subdivision (c), which provides that “[n]o 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 the effective date of this part [effective Oct. 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.” (Underline added.) The Merck Defendants assert that “[t]hus, under the Vaccine Act, Plaintiff cannot state a fraud claim premised on any allegation that Merck’s advertising was misleading because it failed to warn her or her parents of Gardasil’s alleged risks—which is exactly what Plaintiff brings in Count VI.” (Demurrer at p. 10:8-11.)

Plaintiff counters that she “is not ‘solely’ relying upon the misrepresentations and omissions Merck made to her and her parents through its direct-to-consumer television advertising.” (Opp’n at p. 12:19-20.) Plaintiff notes that she also alleges that “Merck expressly represented through statements it made in its publications, ubiquitous 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 was safe and effective at preventing cancer.” (Compl., ¶ 457, underline added.) In addition, Plaintiff alleges that “Merck also engaged in a number of additional fraudulent activities that led to regulators, medical providers…and the general…to be duped into believing that Gardasil is safe and effective.” (Compl., ¶ 471.)

Plaintiff also cites to Bruesewitz v. Wyeth LLC, supra, 562 U.S. at page 229, which provides that “[t]he [National Childhood Vaccine Injury Act of 1986] requires claimants to seek relief through the compensation program before filing suit for more than $1,000. 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…See § 300aa-22(b)(2), (c). 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. See §§ 300aa-22(b)(2), 300aa-23(d)(2).” (Bruesewitz v. Wyeth LLC, supra, 562 U.S. at p. 229, fn. 25.)

The Merck Defendants also assert that “under California’s learned intermediary doctrine, in the case of prescription drugs and medical devices, the duty to warn runs to the physician, not to the patient…Accordingly, any allegations that a plaintiff saw and relied on a vaccine manufacturer’s advertisements are irrelevant.” (Demurrer at p. 10:13-18 [internal quotations and citations omitted].) Plaintiff counters that “[e]ven where there is no duty to make a disclosure, when one does undertake to inform, he must speak the whole truth.” (Low v. Wheeler (1962) 207 Cal.App.2d 477, 484.) Plaintiff thus asserts that the learned intermediary doctrine “provide[s] that the general duty to warn can be met by warning a physician (in lieu of the patient). But once a manufacturer decides to speak directly to consumers, it brings upon itself a duty to speak truthfully and, if it fails to do so, it can be liable for damages under state common law governing deceit, misrepresentation, and fraud.” (Opp’n at p. 14:3-6.)

The Merck Defendants also assert that as to her allegations that Merck made representations to the medical community, Plaintiff fails to meet the heightened particularity standard for fraud claims against corporations. “A plaintiff’s burden in asserting a fraud claim against a corporate employer is even greater. In such a case, the plaintiff must allege the names of the persons who made the allegedly fraudulent representations, their authority to speak, to whom they spoke, what they said or wrote, and when it was said or written.” (Lazar v. Superior Court, supra, 12 Cal.4th at p. 645 [internal quotations omitted].)

The Merck Defendants note that Plaintiff alleges that “Merck’s advertisements assert that the HPV vaccine prevents cervical cancer. For example, in a presentation to medical doctors, Merck proclaimed: ‘Every year that increases in coverage [of the vaccine] are delayed, another 4,400 women will go on to develop cervical cancer.’ The presentation goes on to tell doctors that women who do not get the vaccine will go on to develop cancer.” (Compl., ¶ 117.) The Merck Defendants note that Plaintiff does not allege when or where this presentation occurred, who gave the presentation, whether Plaintiff’s prescribing physician attended, or whether Plaintiff’s physician relied upon any information provided. Plaintiff does not respond to this point in the opposition. However, the Court notes that “¿a demurrer cannot rightfully be sustained to part of a cause of action or to a particular type of damage or remedy.¿” (¿Kong v. City of Hawaiian Gardens Redevelopment Agency (2002) 108 Cal.App.4th 1028, 1047¿; ¿see also PH II, Inc. v. Superior Court (1995) 33 Cal.App.4th 1680, 1682 [“A demurrer does not lie to a portion of a cause of action.”]¿.) Plaintiff’s sixth cause of action for fraudulent misrepresentation does not solely concern the alleged representation described in paragraph 117 of the Complaint. 

The Merck Defendants also assert that Plaintiff does not allege that the subject ads stated anything that the Merck Defendants knew to be false. “The elements of fraud are a false representation of a material fact, knowledge of the falsity, intent to induce another to rely on the representation, reliance, and resulting damages.” (Kalnoki v. First American Trustee Servicing Solutions, LLC (2017) 8 Cal.App.5th 23, 35.) But Plaintiff alleges that “Merck knew or should have known that the risks expressly included in Gardasil’s promotional material and labels did not and do not accurately or adequately set forth the true and complete risks of developing the serious injuries that are associated with Gardasil, as previously alleged herein, and which include but are not limited to, POTS, systemic adverse events, autoimmune disease, increased risk of cancer, and death.” (Compl., ¶ 460.)

The Merck Defendants also assert that “Plaintiff is improperly attempting to repurpose garden-variety failure-to-warn product liability claims as fraud claims.” (Demurrer at p. 11:23-24.) The Merck Defendants cite to Goldrich v. Natural Y Surgical Specialties, Inc. (1994) 25 Cal.App.4th 772, 782, where “[i]n the fraud cause of action of her second amended complaint, Mrs. Goldrich alleged that the defendants falsely and fraudulently represented to her, her physicians and other members of the general public that their product was safe for use in breast surgery, that it posed no dangerous risks of injury to [Mrs. Goldrich], and that it would not require frequent removal from [her] body. [Mrs. Goldrich] is unable to provide further specificity with respect to representations made to [her] physician [but] defendants . . . possess full information and knowledge concerning the content of all such representations made to [her] physician. The representations by [the] defendants were, in fact, false. The true facts were that the . . . product was not safe for said purpose and was, in fact, dangerous to [Mrs. Goldrich's] health and body . . . and required frequent removal. In equally conclusory terms, the pleading alleges that, at the time the representations were made, the defendants knew they were false and nevertheless made them in order to defraud and deceive Mrs. Goldrich and with the intent to induce her to use the product in breast surgery.” (Internal quotations omitted.) The Court of Appeal found that “[t]his is not the stuff of which a fraud claim is made,” and noted that “Mrs. Goldrich has done nothing more than recast her negligence and products liability claims--that the implants were negligently and defectively made and distributed--in the traditional words of fraud, without any supporting facts. That simply is not enough.” (Id. at pp. 782-783.) The Court finds that the allegations in the Complaint here are more specific than those described in Goldrich.

            The Merck Defendants also note that Plaintiff alleges that “Merck also engaged in a number of additional fraudulent activities that led to regulators, medical providers (upon information and belief, including but not limited Plaintiff’s medical providers), and the general public (including directly and/or indirectly Plaintiff and her mother) to be duped into believing that Gardasil is safe and effective.” (Compl., ¶ 471.) The Merck Defendants assert that these fraudulent acts include, inter alia, “[f]ailing to test Gardasil against a true inert placebo,” and “[f]ailing to conduct a sufficient number of studies for the targeted patient population…” (Compl., ¶ 471(d), (e).)  

            The Merck Defendants assert that “Plaintiff’s failure-to-test allegations cannot rescue her fraud claims.” (Demurrer at p. 13:3.) The Merck Defendants cite to Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1486, where the Court of Appeal noted that “[a]ppellant forgets that Baxter was charged with an ongoing duty to warn of side effects known or knowable in the scientific community. In this light, imposition of liability for breach of an independent duty to conduct long-term testing, where the causal link to the known harm to plaintiff is the unknown outcome of testing that was not done, would be beyond the pale of any California tort doctrine we can identify.” (Internal quotations and emphasis omitted.)

            The Merck Defendants also assert that the remainder of Plaintiff’s “fraudulent conduct” allegations are not sufficiently specific, as they do not “provide the defendants with the fullest possible details of the charge so they are able to prepare a defense to this serious attack.” (Goldrich v. Natural Y Surgical Specialties, Inc., supra, 25 Cal.App.4th at p. 782.) In addition, the Merck Defendants assert that a fraud claim must be based on a specific “misrepresentation” or “omission,” not “activities” like those Plaintiff has alleged, such as “failing to adequately capture and properly code adverse events.” (Compl., ¶ 471(f).) However, as discussed above, “¿a demurrer cannot rightfully be sustained to part of a cause of action or to a particular type of damage or remedy.¿” (¿Kong v. City of Hawaiian Gardens Redevelopment Agency, supra, 108 Cal.App.4th at p. 1047.)

            Lastly, the Merck Defendants assert that Plaintiff fails to plead the elements of reliance. The Merck Defendants contend that “[n]owhere does Plaintiff allege that her prescribing doctor (or, though irrelevant, she or her parents) ever reviewed any information at all about adverse event reporting or in any way could have relied on Merck’s supposed failure ‘to adequately capture and properly code adverse events and symptoms’ during clinical trials. Compl. ¶ 471(f).” (Demurrer at p. 13:27-14:2.) But this argument does not address the remaining allegations of Plaintiff’s sixth cause of action for fraudulent misrepresentation. Plaintiff also alleges in this cause of action that “Plaintiff’s mother reasonably and justifiably relied upon the truth of the assurance made by Merck in its direct-to-consumer marketing concerning the efficacy and safety of Gardasil (which were also echoed by Plaintiff’s medical providers), when she and Plaintiff provided their consent to Plaintiff being injected with the Gardasil vaccine.” (Compl., ¶ 496.)

            Based on the foregoing, the Court overrules the Merck Defendants’ demurrer to the sixth cause of action or fraudulent misrepresentation.

The Merck Defendants’ Motion to Strike

A court may strike any “irrelevant, false, or improper matter inserted in any pleading” or all or any part of a pleading “not drawn or filed in conformity with the laws of this state, a court rule, or an order of the court.” (Code Civ. Proc., § 436.) “The grounds for a motion to strike shall appear on the face of the challenged pleading or from any matter of which the court is required to take judicial notice.” (Code Civ. Proc., § 437.)

Punitive Damages

The Merck Defendants move to strike a number of allegations from the Complaint.

First, the Merck Defendants assert that Plaintiff’s requests for punitive damages should be stricken because they lack any allegations that a Merck officer perpetrated or ratified any allegedly wrongful conduct. As noted by the Merck Defendants, Plaintiff seeks punitive damages in connection with the first cause of action for negligence, the second cause of action for strict liability (failure to warn), the third cause of action for strict liability (manufacturing defect), the fourth cause of action for breach of express warranty, the fifth cause of action for fraudulent concealment, and the sixth cause of action for fraudulent misrepresentation. (Compl., ¶¶ 382, 383, 405, 406, 420, 421, 433, 434, 448, 449, 476, 477.) These causes of action are all alleged against the Merck Defendants.

As set forth above, the Court sustains the Merck Defendants’ demurrer to the third cause of action for strict liability (manufacturing defect). Thus, the Merck Defendants’ motion to strike paragraphs 420 and 421 of the Complaint is denied as moot.

As to the remaining causes of action, Civil Code section 3294, subdivision (a) provides that “[i]n an action for the breach of an obligation not arising from contract, where it is proven by clear and convincing evidence that the defendant has been guilty of oppression, fraud, or malice, the plaintiff, in addition to the actual damages, may recover damages for the sake of example and by way of punishing the defendant.”  Civil Code section 3294, subdivision (b) provides as follows:

“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.”

The Merck Defendants assert that Plaintiff fails to allege that any Merck officer, director, or managing agent committed any purportedly oppressive, fraudulent, or malicious act, and that Plaintiff does not plead that any manager had “advance knowledge” and ratified the alleged conduct at issue.

Plaintiff asserts that she has adequately alleged ratification. Plaintiff points to paragraph 14 of the Complaint, which alleges that “[a]t all times herein mentioned, defendants were fully informed of the actions of their agents and employees, and thereafter no officer, director or managing agent of defendants repudiated those actions, which failure to repudiate constituted adoption and approval of said actions, and all defendants and each of them thereby ratified those actions.” (Compl., ¶ 14.) The Merck Defendants assert that “not repudiating” conduct does not mean a manager authorized it and does not mean that any manager was aware of it. The Merck Defendants note that “[a] company ratifies a managing agent’s decision when it knows about and accepts the decision.” (Tilkey v. Allstate Ins. Co. (2020) 56 Cal.App.5th 521, 554.) The Merck Defendants also note that this allegation does not identify any officer, director or managing agent who supposedly “fail[ed] to repudiate” the conduct.  

Plaintiff also asserts that paragraph 14 of the Complaint is alleged “in conjunction with pages of allegations concerning high-level corporate conduct, conduct that would not be possible without officer, director, or managing agent performance or ratification.” (Opp’n at p. 9:1-3.) But the Court agrees with the Merck Defendants that Plaintiff does not specifically allege that “the advance knowledge and conscious disregard, authorization, ratification or act of oppression, fraud, or malice” was “on the part of an officer, director, or managing agent of the corporation.” (Civ. Code, § 3294, subd. (b).)

Thus, the Court grants the Merck Defendants’ motion to strike Plaintiff’s punitive damages allegations. Specifically, the Court grants the Merck Defendants’ motion to strike paragraphs 362, 382, 383, 405, 406, 433, 434, 448, 449, 476, and 477 of the Complaint, and paragraph F of the Prayer for Relief. As set forth above, the Merck Defendants’ motion to strike paragraphs 420 and 421 of the Complaint is denied as moot.

Allegations Regarding Vioxx

The Merck Defendants also assert that Plaintiff’s allegations concerning Vioxx are irrelevant and should be stricken. They note that “[i]rrelevant and redundant matter inserted in a pleading may be stricken by the court.” (Hill v. Wrather (1958) 158 Cal.App.2d 818, 823.)

More specifically, the Merck Defendants assert that Plaintiff’s Vioxx allegations are immaterial to her claims alleging personal injuries from exposure(s) to a wholly different product –

Gardasil.

Plaintiff counters that the Vioxx allegations are relevant to the instant case. Specifically, Plaintiff contends that “one of the allegations in this litigation is that Merck failed to undertake sufficient studies to test the long-term safety and efficacy of Gardasil and it rushed Gardasil onto the market via fast-track approval…The Vioxx allegations outlined in the prologue provide an explanation and a motive as to why Merck rushed Gardasil onto the market, namely, that Merck had withdrawn its blockbuster drug Vioxx from the market and needed a new product to replace the lost Vioxx revenue, and to help pay for the billions of dollars in tort and criminal liability it was facing from the Vioxx litigation.” (Opp’n at p. 10:16-22, emphasis omitted.)

Plaintiff points to allegations in the Complaint that “Merck paid nearly $5 billion to settle the tens of thousands of personal injury actions that had been brought against it as a result of its concealment of Vioxx’s cardiovascular risks. Merck paid an additional $1 billion to settle a securities class action brought by investors who had lost money when Merck’s stock tanked following revelations of the drug’s risks and subsequent lost sales. Merck was also forced to pay $950 million in civil and criminal fines to the Department of Justice and other governmental entities as a result of various criminal activities Merck had engaged in with respect to Vioxx.” (Compl., ¶ 26.) Plaintiff further alleges that “[i]n 2005, Merck pulled Vioxx from the market and was desperate to find a replacement for its previous multi-billion-dollar blockbuster,” and that “Merck viewed Gardasil as the answer to the financial woes it had suffered from Vioxx.” (Compl., ¶¶ 27-28.)

Plaintiff also asserts that “the Vioxx allegations help provide context and background for the same transgressions that occurred with respect to Gardasil.” (Opp’n at p. 11:20-21.) Plaintiff points to the allegation in the Complaint that “[c]ertain Merck employees, scientists, and executives involved in the Vioxx scandal were also involved with Gardasil, and it appears they employed the very same methods of manipulating science and obscuring risks as they did with Vioxx.” (Compl., ¶ 31.)

The Merck Defendants also assert that Plaintiff’s Vioxx allegations serve only to prejudice the Merck Defendants and should accordingly be stricken. However, the Merck Defendants do not cite to any binding authority in support of this assertion. (See Mot. at p. 5:25-6:22.)

Based on the foregoing, the Court finds that Plaintiff has demonstrated that the allegations relating to Vioxx are relevant to this action, and thus declines to strike them.

Design Defect Allegations

Lastly, the Merck Defendants assert that certain allegations in Plaintiff’s complaint concern Gardasil’s design, and thus must be stricken because design-defect claims against FDA-approved vaccines like Gardasil are preempted by the Vaccine Act. As set forth above, in Bruesewitz v. Wyeth LLC, supra, 562 U.S. at page 243, the United States Supreme Court held that “the National Childhood Vaccine Injury Act pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”

Plaintiff asserts that the paragraphs Merck seeks to strike do not contain “hidden design defect allegations.” (Opp’n at p. 13:14-15.) Plaintiff asserts that the “Complaint paragraphs discussing the risks associated with Gardasil’s various ingredients are not allegations of a design defect, rather, they are relevant to establishing what warnings Merck should have provided concerning Gardasil considering Gardasil’s ingredients.” (Opp’n at p. 14:16-18.) Plaintiff asserts that such allegations are relevant to her failure to warn claim. Indeed, in support of the second cause of action for strict liability (failure to warn), Plaintiff alleges that “Merck engaged in the business of researching, testing, manufacturing, marketing, selling, distributing, and promoting Gardasil, which is defective and unreasonably dangerous to consumers, including Plaintiff, because it does not contain adequate warnings or instructions concerning the dangerous characteristics of Gardasil and its ingredients and adjuvants.” (Compl., ¶ 386.) The Merck Defendants do not assert that the second cause of action for strict liability (failure to warn) is preempted by the Vaccine Act.

Plaintiff also asserts that “Merck’s challenge against paragraphs (discussing Merck’s failure to research and properly test) contained in Plaintiff’s negligence cause of action is also misplaced. These paragraphs simply alleged Merck did not adequately test the safety of Gardasil (and its respective ingredients)— allegations that are relevant to the negligence and failure to warn claims since a manufacturer cannot provide adequate warnings if it did not properly test the product.” (Opp’n at p. 13:28-14:4.)

The Court does not find that the Merck Defendants have demonstrated that the portions of the Complaint identified in pages vii:20-viii:7 of the Merck Defendants’ motion are preempted, and thus declines to strike them. As set forth above, the Court sustains the Merck Defendants’ demurrer to the third cause of action for strict liability (manufacturing defect). Thus, the Merck Defendants’ motion to strike “Count Three Strict Liability Manufacturing Defect in its entirety, including Paragraph 407 through Paragraph 421,” is denied as moot. 

Conclusion

Based on the foregoing, the PMA Defendants’ demurrer to the eighth and ninth causes of action of the Complaint is sustained, with leave to amend. The PMA Defendants’ demurrer to the tenth cause of action is overruled.

The Merck Defendants’ demurrer to the third cause of action is sustained, with leave to amend. The Merck Defendants’ demurrer to the fifth and sixth causes of action is overruled.

The Merck Defendants’ motion to strike is granted as to paragraphs 362, 382, 383, 405, 406, 433, 434, 448, 449, 476, and 477 of the Complaint, and paragraph F of the Prayer for Relief, with leave to amend. The Merck Defendants’ motion to strike is otherwise denied.

The Court orders Plaintiff to file and serve an amended complaint, if any, within 20 days of the date of this Order. If no amended complaint is filed within 20 days of this Order, the PMA Defendants and the Merck Defendants are ordered to file and serve their answer within 30 days of the date of this Order.¿ 

The Merck Defendants are ordered to give notice of this Order. 

DATED:  April 14, 2023                                ________________________________

Hon. Teresa A. Beaudet

Judge, Los Angeles Superior Court