Colbath v. Merck & Co.

Decision Date29 March 2022
Docket Number3:21-cv-120-W (DEB)
CourtU.S. District Court — Southern District of California
PartiesMICHAEL COLBATH, Plaintiff, v. MERCK & CO., INC., AND MERCK SHARP & DOHME CORP., Defendants.



No. 3:21-cv-120-W (DEB)

United States District Court, S.D. California

March 29, 2022


Pending before the Court is Defendants Merck & Co., Inc., and Merck Sharp & Dohme Corp.'s (collectively “Defendants”) Motion to Dismiss Plaintiff Michael Colbath's Complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). (Mot. to Dismiss (“MTD”) [Doc. 6].) Plaintiff opposes the Motion. (Opp'n [Doc. 12].) The Court decides the matter on the papers submitted and without oral argument. See Civ. L.R. 7.1(d)(1). For the reasons stated below, the Court GRANTS IN PART AND DENIES IN PART Defendants' Motion to Dismiss. [Doc. 6].

I. Background

On May 6, 2014, Plaintiff Michael Colbath, who was 14 years old at the time,


received his first dose of Gardasil-a vaccine for Human Papillomavirus (“HPV”). (Compl. [Doc. 1] ¶ 346.) He received his second dose two months later on July 9, 2014. (Id.) Prior to receiving the vaccine, Plaintiff was physically active, athletic, and did well in school. (Id. ¶ 348.) He allegedly had no autoimmune diseases, no autonomic issues, and no orthostasis. (Id.) After receiving his first Gardasil dose, however, Plaintiff experienced a burning sensation over his arm and developed extreme fatigue. (Id. ¶¶ 350-51.) After his second dose, Plaintiff experienced that same burning pain in his arm, developed severe foot pain, forcing him to use crutches, started to have memory problems, and developed “terrible” headaches. (Id. ¶ 352.)

When the time for his third dose came, Plaintiff's pediatrician, Dr. Krak, decided not to administer the third injection, fearing that the Gardasil may have caused Plaintiff's foot pain. (Id. ¶ 353.) Plaintiff's injuries allegedly got worse over time, and he was eventually diagnosed with Postural Orthostatic Tachycardia (“POTS”), Idiopathic Hypersomnia (“IH”), Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (“ME/ CFS”), Chronic Fatigue and Immune Dysfunction Syndrome (“CFIDS”), Immune-mediated Encephalitis (“IE”), Complex Regional Pain Syndrome (“CRPS”), and Gastroparesis. (Id. ¶ 358.)

As a result, Plaintiff brings this action against Defendants Merck & Co., Inc., and Merck Sharp & Dohme Corp. He alleges that Defendants' Gardasil vaccine-which they designed, manufactured, and marketed-caused him to suffer severe autonomic, neurological, and heterogeneous autoimmune injuries. (Id. ¶ 1.) He asserts claims for: (1) negligence; (2) strict liability failure to warn; (3) strict liability manufacturing defect; (4) breach of express warranty; (5) common law fraud; and (6) violation of California's unfair competition law. (Id. ¶¶ 365-481.)

II. Legal Standard

The Court must dismiss a cause of action for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). A motion to dismiss under Rule 12(b)(6)


tests the legal sufficiency of the complaint. Parks Sch. of Bus., Inc. v. Symington, 51 F.3d 1480, 1484 (9th Cir. 1995). A complaint may be dismissed as a matter of law either for lack of a cognizable legal theory or for insufficient facts under a cognizable theory. Balistreri v. Pacifica Police Dep't., 901 F.2d 696, 699 (9th Cir. 1988). In ruling on the motion, a court must “accept all material allegations of fact as true and construe the complaint in a light most favorable to the non-moving party.” Vasquez v. L.A. Cnty., 487 F.3d 1246, 1249 (9th Cir. 2007).

Complaints must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). The Supreme Court has interpreted this rule to mean that “[f]actual allegations must be enough to rise above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 554, 555 (2007). The allegations in the complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.'” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 570).

Well-pleaded allegations in the complaint are assumed true, but a court is not required to accept legal conclusions couched as facts, unwarranted deductions, or unreasonable inferences. Papasan v. Allain, 478 U.S. 265, 286 (1986); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). Leave to amend should be freely granted when justice so requires. See Fed.R.Civ.P. 15(a). However, denial of leave to amend is appropriate when such leave would be futile. See Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 339 (9th Cir. 1996); Plumeau v. Sch. Dist. No. 40 Cnty. of Yamhill, 130 F.3d 432, 439 (9th Cir. 1997).

III. Discussion

Plaintiff asserts the following six claims against Defendants: (1) negligence; (2) strict liability failure to warn; (3) strict liability manufacturing defect; (4) breach of express warranty; (5) fraud; and (6) unfair competition. Defendants move to dismiss all of Plaintiff's claims under Rule 12(b)(6) for failure to state claim. Defendants also


request judicial notice of 31 exhibits, which include publications and releases from the FDA, CDC, WHO, and European Medicine Agency, Gardasil patient information and prescribing information, and medical definitions of Plaintiff's alleged injuries. [Doc. 7]. Plaintiff opposes Defendants' request for judicial notice because the exhibits allegedly contain disputed facts. [Doc. 12]. The Court elects to take notice of the exhibits for their existence, not for the truth of the disputed facts. See, e.g., Sciortino v. Pepsico, Inc., 108 F.Supp.3d 780, 791 n.2 (N.D. Cal. 2015).

A. Failure to Warn Under Theories of Negligence and Strict Liability (Counts I-II)

Plaintiff alleges that Defendants failed to adequately warn him, his parents, his medical providers, and the “general public” of serious side effects of Gardasil. (Compl. ¶¶ 370, 377). He asserts claims for “failure to warn” under theories of negligence (Count I) and strict liability (Count II). (Id. ¶¶ 381, 393; Opp'n at 5-6.) Defendants argue that Plaintiff's failure to warn claims are barred by the Vaccine Act and the Learned Intermediary Doctrine and are deficient for inadequate causation. (MTD at 12-14.)

To maintain a negligence action under California law, a plaintiff must allege that a defendant owed him a legal duty, breached that duty, and that the breach proximately caused injury to him. Garcia v. W & W Cmty. Dev., Inc., 186 Cal.App.4th 1038, 1044 (2010). In the negligence failure to warn context, plaintiffs must 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 v. Super. Ct., 13 Cal.4th 1104, 1112 (1996) (citation omitted).

To maintain a strict liability failure to warn claim, a plaintiff must prove that:

(1) the defendant manufactured, distributed, or sold the product; (2) the product had potential risks that were known or knowable at the time of manufacture or distribution, or sale; (3) that the potential risks presented a substantial danger to users of the product; (4) that ordinary consumers would
not have recognized the potential risks; (5) that the defendant failed to adequately warn of the potential risks; (6) that the plaintiff was harmed while using the product in a reasonably foreseeable way; (7) and that the lack of sufficient warnings was a substantial factor in causing the plaintiff's harm.

Rosa v. City of Seaside, 675 F.Supp.2d 1006, 1011 (N.D. Cal. 2009) (citing Jud. Council of Cal. Civ. Jury Instruction No. 1205). Regarding the second factor-whether the risks were known or knowable at the time of manufacture-plaintiff must 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.” Rosa, 675 F.Supp.2d at 1012 (quoting Anderson v. Owens-Corning Fiberglas Corp., 53 Cal.3d 987, 1002 (1991)).

In 1986, Congress passed the National Childhood Vaccine Injury Act (the “Vaccine Act”) “in an attempt to balance the need for widespread childhood vaccinations with the need for ‘optimal prevention against adverse reactions to vaccines.'” Holmes v. Merck & Co., Inc., 697 F.3d 1080, 1082 (9th Cir. 2012) (quoting 42 U.S.C. § 300aa-1). “Congress passed the law after hearing testimony that, although vaccines inevitably harmed only a very small number of people, litigation arising from these injuries was threatening the stability of the nation's vaccine program.” Holmes, 697 F.3d at 1082.

Section 22 of the Vaccine Act states: “No vaccine manufacturer shall be liable … 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 U.S.C. § 300aa-22(c). In other words, the Vaccine Act “eliminat[es] liability for not providing direct warnings to a claimant.” Holmes, 697 F.3d at 1083. Similarly, California's Learned Intermediary Doctrine provides that “in the case of prescription drugs, the duty to warn runs to the physician, not to the patient.” Carlin, 13 Cal.4th at 1116.[1]


The first issue to decide is whether Plaintiff's failure to warn claims are barred by the Vaccine Act and the Learned Intermediary Doctrine. Plaintiff alleges that Defendants failed to warn him, his parents, his medical providers, and the general public. (Compl. ¶¶ 370, 377.) While Defendants do not have a duty to warn Plaintiff, his mother, or the public in general, they do have a duty to warn Plaintiff's...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT