Stratton v. Merck & Co.

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Abigail Stratton, Plaintiff, v. Merck & Co., Inc., a New Jersey Corporation; and Merck Sharp & Dohme Corp., a new Jersey Corporation, Defendants.

C. A. No. 2:21-02211-RMG

United States District Court, D. South Carolina, Charleston Division

November 17, 2021

ORDER AND OPINION

RICHARD MARK GERGEL, UNITED STATES DISTRICT JUDGE

Before the Court is Defendants' motion to dismiss Plaintiffs complaint. (Dkt. No. 6). For the reasons set forth below, the Court grants in part and denies in part Defendants' motion to dismiss.

I. Background

On November 6, 2017, Dr. Vanessa A. Hajzus administered the first dose of Defendants' Gardasil vaccine to Plaintiff. (Dkt. No. 1. ¶ 347). As a result, Plaintiff allegedly developed various health problems including but not limited to postural orthostatic tachycardia syndrome (“POTS”). Plaintiff declined to receive a second dose of Gardasil. (Id. ¶¶ 351-56).

In accordance with the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq. Plaintiff brought a petition in the United States Court of Federal Claims seeking compensation for her alleged vaccine-related injuries. The Order Concluding Proceedings was filed on July 8, 2021. Defendants do not dispute that Plaintiffs claims are properly exhausted.

Plaintiff now brings this complaint asserting claims for (1) negligence; (2) strict liability (failure to warn); (3) strict liability (manufacturing defect); (4) breach of warranty; and (5) common law fraud. (Dkt. No. 1).

On October 10, 2021, Defendants moved to dismiss Plaintiff's complaint in its entirety. Plaintiff opposes Defendants' motion. (Dkt. No. 9). Defendants have filed a reply. (Dkt. No. 10). Defendants' motion is fully briefed and ripe for disposition.^[1]

II. Legal Standard

Rule 12(b)(6) of the Federal Rules of Civil Procedure permits the dismissal of an action if the complaint fails “to state a claim upon which relief can be granted.” A claim survives the motion if the complaint provides enough facts to “‘state a claim to relief that is plausible on its face.'” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). This is a test of the legal sufficiency of the complaint and, therefore, Rule 12(b)(6) “does not resolve contests surrounding the facts, the merits of the claim, or the applicability of defenses.” Republican Party of N.C. v. Martin, 980 F.2d 943, 952 (4th Cir. 1992). Instead, the district court's “inquiry then is limited to whether the allegations constitute a short and plain statement of the claim showing that the pleader is entitled to relief.” Id. (internal quotation marks and citation omitted). For that analysis, the district court “need not accept as true unwarranted inferences, unreasonable conclusions, or arguments”; however, it must “assume the truth of all facts alleged in the complaint and the existence of any fact that can be proved, consistent with the complaint's allegations.” E. Shore Mkts., Inc. v. J.D. Assocs. Ltd. P'ship, 213 F.3d 175, 180 (4th Cir. 2000).

III. Discussion

As noted above, Plaintiff brings six causes of action against Defendants: (1) negligence; (2) strict liability (failure to warn); (3) strict liability (manufacturing defect); (4) breach of warranty; and (5) common law fraud. Defendants argue the entirety of Plaintiff's claims are subject to dismissal. The Court addresses each of Defendants' arguments in turn.

A. Plaintiff's Negligence Claim Is Preempted in Part by the Vaccine Act.

Defendants argue that Plaintiff's negligence claim is, at least partially, a veiled design defect claim that the National Childhood Vaccine Injury Act (the “Vaccine Act”) preempts. See 42 U.S.C. § 300aa-1 et seq. Plaintiff agrees that the Vaccine Act preempts design defect claims but denies that her negligence claim challenges Gardasil's design.

In Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) the Supreme Court held that § 300aa-22(b)(1) of the Vaccine Act bars state-law design defect claims against vaccine manufacturers. Section 300aa-22(b)(1) reads, “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.” The Bruesewitz court reasoned:

The “even though” clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side effect to be considered “unavoidable” under the statute. 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.

If a manufacturer could be held liable for failure to use a different design, the word “unavoidable” would do no work. A side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element. 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.

562 U.S. at 231-32 (footnotes omitted). The Vaccine Act also affords immunity from liability for, inter alia, failure to warn if a manufacturer has complied with regulatory requirements and has given the warning to the healthcare professional, the vaccine recipient or the vaccine recipient's legal representative. § 300aa-22(c); Bruesewitz, 562 U.S. at 229 & n.25 (“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.”) (citing §§ 300aa-22(b)(2), 30aa-23(d)(2)); Holmes v. Merck & Co, Inc., 697 F.3d 1080, 1085 (9th Cir. 2012).

The Court finds that portions of Plaintiff's negligence claim are barred by the Vaccine Act. Plaintiff alleges that Defendants “lied” to the FDA about Gardasil containing HPV L1-DNA fragments. (Dkt. No. 1 ¶ 137). Plaintiff also takes issue with Gardasil containing amorphous aluminum hydroxyphosphate sulfate, borax, polysorbate, and yeast. (Id. ¶¶ 129, 148, 154, 159). Publicly available documents show, however, that the FDA is aware of the presence of such substances. “FDA Information on Gardasil - Presence of DNA Fragments Expected, No Safety Risk, ” (Dkt. No. 6-33); Gardasil 9 Label (Dkt. No 6-34 at 11) (listing other ingredients).^[2] Given the FDA is aware of the components Plaintiff attacks in its complaint, the Court finds that, to the extent Plaintiff's negligence claim challenges these components, the claim is a veiled design defect claim preempted by the Vaccine Act.

In sum, the Court grants Defendants' motion to the extent that Plaintiff's negligence claim challenges the presence of HPV L1-DNA fragments, amorphous aluminum hydroxyphosphate sulfate, borax, polysorbate, or yeast in Gardasil.

B. Plaintiff's Manufacturing Defect Claim Is Inadequately Pled and Otherwise Barred by the Vaccine Act.

Defendants argue that Plaintiff's manufacturing defect claim must be dismissed because it is a veiled design-defect claim. Plaintiff disputes the contention and argues her claim is properly pled.

A manufacturing defect claim is an allegation “that a particular product was defectively manufactured.” Watson v. Ford Motor Co., 699 S.E.2d 169, 174 (S.C. 2010). “There is not an abundance of case law in South Carolina about how a manufacturing defect differs from other defects.” Fisher v. Pelstring, 817 F.Supp.2d 791, 818 (D.S.C. 2011), on reconsideration in part (Jan. 11, 2012). Other courts have defined a manufacturing defect as existing “when a product does not conform to the design standards and blueprints of the manufacturer and the flaw makes the product more dangerous and therefore unfit for its intended or foreseeable uses.” See Gerber v. Hoffmann-La Roche, Inc., 392 F.Supp.2d 907, 922 (S.D. Tex. 2005) (internal quotation marks and citation omitted) (applying Texas law) (granting summary judgment to a manufacturer on a plaintiff's manufacturing defect claim in a products liability action involving prescription drug Accutane); see also Wheeler v. HO Sports, Inc., 232 F.3d 754, 757 (10th Cir. 2000) (applying Oklahoma law) (“A product is defective in manufacture if it deviates in some material way from its design or performance standards. The issue is whether the product was rendered unsafe by an error in the manufacturing process, ” which is “often established by showing that a product, as produced, failed to conform with the manufacturer's specifications.” (internal quotation marks and citations omitted)); Wankier v. Crown Equip. Corp., 353 F.3d 862, 867 (10th Cir.2003) (applying Utah law) (holding that “a manufacturing defect claim, by its nature, involves a deviation from the product's design specifications, to the injury or potential injury of a user” and that “[t]he gravamen of the tort is not defective design but defective execution of the design”).

Plaintiff alleges that Gardasil is defectively manufactured because it includes HPV L1-DNA fragments. (Dkt. No. 1 ¶¶ 137 412) (“Merck lied both to the FDA and the public about including a secret and potentially hazardous ingredient, HPV L1-DNA fragments in Gardasil.”). Plaintiff alleges that Gardasil is also defectively manufactured because it contains “dangerous...