Herlth v. Merck & Co.
| Decision Date | 15 March 2022 |
| Docket Number | 3:21-cv-438 (JAM) |
| Court | U.S. District Court — District of Connecticut |
| Parties | KORRINE HERLTH, Plaintiff, v. MERCK & CO., INC. et al., Defendants. |
KORRINE HERLTH, Plaintiff,
v.
MERCK & CO., INC. et al., Defendants.
No. 3:21-cv-438 (JAM)
United States District Court, D. Connecticut
March 15, 2022
ORDER GRANTING MOTION TO DISMISS
Jeffrey Alker Meyer United States District Judge
Plaintiff Korrine Herlth alleges that she was injured after receiving two doses of the Gardasil vaccine. Herlth now brings a variety of product liability claims against the vaccine's manufacturers, Merck & Co., Inc., and Merck Sharp & Dohme Corp. (collectively, “Merck”). Merck has moved to dismiss her amended complaint. For the reasons set forth below, I will grant the motion to dismiss without prejudice.
Background
I accept the following facts as true for purposes of considering Merck's motion to dismiss. After first receiving approval by the Food and Drug Administration (“FDA”) in 2006, Merck has marketed versions of its Gardasil vaccine as a safe and effective means of preventing infection by the Human Papillomavirus (“HPV”).[1] HPV is a viral infection and sexually transmitted disease that is believed to be associated with cervical and other cancers.[2] Since around that same time, the Centers for Disease Control and Prevention (“CDC”) has recommended that nearly all children and young adults receive the Gardasil vaccine.[3] Gardasil is
currently approved for men and women between the ages of 9 and 45 years old, although Merck markets the vaccine primarily to pre-teen children and their parents.[4]
Herlth was 15 years old when her pediatrician, Dr. Allison Whitaker, recommended that she receive the Gardasil vaccine.[5] With the consent of Herlth's mother, Dr. Whitaker administered Herlth's first dose of Gardasil on October 2, 2013, during a routine visit to the pediatrician's office.[6]
Before the doctor's visit, Herlth's mother had seen television ads and other marketing regarding the safety and efficacy of the Gardasil vaccine.[7] Herlth alleges that her mother relied upon those marketing materials in choosing to have her vaccinated with Gardasil.[8]
Before receiving the vaccine, Herlth was in overall good health.[9] She was a vocational agriculture student and excelled in her studies.[10] She traveled with the school choir for performances, and she enjoyed being outdoors and taking care of farm animals.[11]
But after receiving her second dose of Gardasil in December 2013, Herlth began experiencing dizziness, shakiness, headaches, and nausea. She also experienced faintness, an elevated heartrate, and unsteadiness upon standing.[12] Based on her daughter's developing symptoms, Herlth's mother withdrew her consent, and Herlth did not receive her third dose of Gardasil.[13]
Over the following months, Herlth's health worsened. She was seen by multiple physicians for a variety of severe symptoms, including: daily seizures; vision, hearing, and balance problems; fatigue; anxiety and panic attacks; convulsions; sleep problems; depression; cognitive difficulties; numbness and tingling in her lower extremities; involuntary movements and tics; weakened connective tissue and chronic joint pain; and vaginismus and endometriosis.[14] Due to her health, Herlth opted out of normal teenage activities. She pulled back from participation in school and choir, and eventually, she was forced to finish high school from home and put off attending college altogether.[15]
Based upon her post-Gardasil symptoms and the results of several tests, Herlth has been diagnosed with a variety of severe medical conditions, including Postural Orthostatic Tachycardia Syndrome (“POTS”) and chronic fatigue syndrome (“CFS”).[16] POTS is a condition that affects the autonomic nervous system, which is responsible for automatically regulating vital bodily functions. POTS affects the body's ability to adjust the heartrate and compensate for blood flow, especially when the individual moves from a lying to standing position.[17] Individuals with POTS frequently experience dizziness, lightheadedness, vertigo, chronic headaches, vision issues due to the loss of blood flow to the brain, light and sound sensitivity, loss of consciousness, shortness of breath, chest pain, gastrointestinal issues, body pains, insomnia, and confusion and/or difficulty sleeping.[18] Researchers have allegedly linked POTS, CFS, and a variety of other autoimmune diseases to the Gardasil vaccine.[19]
On January 13, 2016, Herlth filed a petition for compensation in the Office of the Special Masters of the U.S. Court of Federal Claims (sometimes called “Vaccine Court”).[20] Under the National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. § 300aa-10 et seq., an individual seeking compensation for an alleged vaccine-related injury must begin by filing a petition in Vaccine Court. Id. at § 300aa-11. If the injured party receives an unfavorable outcome, only then may she file a civil action against the vaccine manufacturer. Id. at § 300aa-21. On July 2, 2020, the Vaccine Court dismissed Herlth's claim for “insufficient proof.” Herlth v. Sec'y of Health & Hum. Servs., 2020 WL 4280698, at *2 (Fed. Cl. 2020).
On March 30, 2021, Herlth filed this federal lawsuit. Count One of her amended complaint alleges violations of the Connecticut Product Liability Act (“CPLA”), Conn. Gen. Stat. § 52-572m et seq. Gathered under her CPLA claim are a variety subclaims, including for failure to warn, manufacturing defect, and negligence.[21] Count Two is a claim for common law fraud. Merck now moves to dismiss the amended complaint for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure.[22]
Discussion
The standard that governs a motion to dismiss under Rule 12(b)(6) is well established. A complaint may not survive unless it alleges facts that, taken as true, give rise to plausible grounds to sustain a plaintiff's claims for relief. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Kim v. Kimm, 884 F.3d 98, 103 (2d Cir. 2018). As the Supreme Court has explained, this “plausibility” requirement is “not akin to a probability requirement, ” but it “asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678. In other words, a valid
claim for relief must cross “the line between possibility and plausibility.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 557 (2007). A court must “accept as true all factual allegations and draw from them all reasonable inferences; but [it is] not required to credit conclusory allegations or legal conclusions couched as factual allegations.” Hernandez v. United States, 939 F.3d 191, 198 (2d Cir. 2019).[23]
Count One - Connecticut Product Liability Act (CPLA)
Count One of the amended complaint alleges three subclaims for liability under the CPLA: (1) failure to warn, (2) manufacturing defect, and (3) negligence. I will address each subclaim in turn.
Failure to warn
Merck argues that Herlth's failure-to-warn claim as presently pleaded in the amended complaint is preempted by the Food, Drug, and Cosmetics Act (“FDCA”), 21 U.S.C. § 301 et seq. I agree.
Under Connecticut law, manufacturers of products have a duty to ensure that their products are accompanied by adequate warnings or instructions. See Conn. Gen. Stat. § 52-572q(a); LaMontagne v. E.I. DuPont De Nemours & Co., Inc., 41 F.3d 846, 859 (2d Cir. 1994). At the same time, the FDCA strictly regulates the labeling of all pharmaceuticals. See 21 U.S.C. § 301 et seq.; Wyeth v. Levine, 555 U.S. 555, 566-68 (2009). Before the FDA will approve the marketing of a new vaccine or other drug, the manufacturer must submit and the FDA must approve the exact text of the proposed label. See 21 U.S.C. § 355(b)(1)(A)(vi); Wyeth, 555 U.S. at 568; Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 707 (2d Cir. 2019).
Generally speaking, a manufacturer may only change a vaccine label after the FDA approves a supplemental application. See 21 C.F.R. § 601.12(f)(1); Wyeth, 555 U.S. at 568. The exception to this rule is when a manufacturer may unilaterally modify its label through compliance with the “changes being effected” (“CBE”) regulation. See Gibbons, 919 F.3d at 707. The CBE regulation allows a manufacturer to change its label without the FDA's preapproval if the changes “reflect newly acquired information” concerning contraindications, warnings, precautions, possible adverse reactions, or proper dosage and administration. See 21 C.F.R. § 601.12(f)(2)(i).[24]
A state law failure-to-warn claim against a drug manufacturer is preempted unless the drug manufacturer can simultaneously comply with its state law duty to warn and with federal labeling requirements under the FDCA. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 618-19 (2011). Because Merck secured FDA approval of its label in the first instance, Herlth's failure-to-warn claim is therefore preempted by federal law unless she has pleaded a labeling deficiency that Merck could have unilaterally corrected in accordance with the requirements of the CBE regulation. See Gibbons, 919 F.3d at 708; Ignacuinos v. Boehringer Ingelheim Pharms. Inc., 490 F.Supp.3d 533, 541 (D. Conn. 2020), aff'd, 8 F.4th 98 (2d Cir. 2021).
Under the terms of the CBE regulation, a manufacturer may unilaterally change its label only if it has “newly acquired information.” 21 C.F.R. § 601.12(f)(2)(i). Any “information will be considered newly acquired if it consists of data, analyses, or other information not previously submitted to the agency.” Id. at § 601.12(f)(6). Such information “may include (but [is] not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of
previously submitted data . . . if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” Ibid.
Moreover, the regulations include a causation requirement between the newly acquired information and an adverse...
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