Opinion
3:21-cv-00878-AR
05-17-2022
MICHAEL JAMES HARNED, individually and as Personal Representative of the Estate of Hannah Camelia Yarbour-Harned; and as legal guardian of Shay Angeline Yarbour, a minor child, Plaintiff, v. UNITED STATES OF AMERICA; and MERCK & CO., a foreign corporation, Defendants.
FINDINGS AND RECOMMENDATION
JEFFREY ARMISTEAD UNITED STATES MAGISTRATE JUDGE
Introduction
Plaintiff Michael James Harned brings a medical malpractice and product liability action on behalf of his widow, Hannah Camelia Yarbour-Harned, and their minor child, alleging that Yarbour-Harned died after ingesting medication prescribed by Dr. Gregory Guffanti and manufactured by defendant Merck & Co., Inc. (“Merck”). The United States was substituted as defendant for Dr. Guffanti. F & R, ECF No. 22. Currently before the court are two motions to dismiss: (1) the United States moves to dismiss for lack of subject-matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1), arguing that Harned failed to exhaust his administrative remedies under the Federal Tort Claim Act (“FTCA”); and (2) Merck moves to dismiss for failure to state a claim under Rule 12(b)(6), arguing that Harned failed to plead facts with enough specificity to establish it manufactured the medication that is claimed to have killed Yarbour-Harned. The court recommends that both motions be granted, and that the claims be dismissed without prejudice.
Factual and Procedural Background
On March 15, 2018, Yarbour-Harned was treated by Dr. Guffanti for a migraine headache. Notice of Removal Ex. 3 ¶ 3, ECF No. 1 (attaching First Amended Complaint (“FAC”)). At the time, Yarbour-Harned was 18 to 22 weeks pregnant. FAC ¶ 3. Dr. Guffanti prescribed “Rizatriptan (MAXALT),” which Yarbour-Harned ingested as directed. FAC ¶ 4. She died later that night. FAC ¶4. At the time of Yarbour-Harned's death, Dr. Guffanti was employed by the Neighborhood Health Center (“NHC”), a federally funded health center. Decl. Sarah E. Feldman (“Feldman Decl.”), ECF No. 4.
Harned filed a wrongful-death action in Clackamas County Circuit Court, claiming that Dr. Guffanti knew or should have known Yarbour-Harned was pregnant, prescribed a medication that was unreasonably dangerous, failed to provide adequate warnings, and negligently caused her death. FAC ¶¶ 3, 5. Harned also claims that (1) the medication prescribed to Yarbour-Harned was manufactured by Merck and was “unreasonably dangerous”; (2) Merck “knew or should have known” of the “unreasonably dangerous side effects to consumers” like Yarbour-Harned; (3) Merck failed to warn Yarbour-Harned and Dr. Guffanti of the risks of rizatriptan; and (4) its failures were “intentionally misleading.” FAC ¶¶ 9-10.
On June 10, 2021, the United States, together with Dr. Guffanti and Merck, removed this case, arguing that the Federally Supported Health Centers Assistance Act, 42 U.S.C. § 233, and the FTCA, 28 U.S.C. §§ 2671-2680, provide the exclusive remedy for Harned, and that the United States must be substituted as defendant for Dr. Guffanti. Defendants also filed the motions to dismiss at issue here. Harned moved to remand. Mot. to Remand, ECF No. 12. U.S. Magistrate Judge John V. Acosta stayed briefing on defendants' motions to dismiss, pending resolution of Harned's motion to remand.
In October 2021, Judge Acosta recommended that Harned's motion to remand be denied. F. & R., ECF No. 22(“October F&R”). Judge Acosta disagreed with Harned's first argument that the NHC should not be deemed a Public Health Service (“PHS”), based on his finding that sufficient evidence existed to show that NHC was “a PHS-deemed entity.” Additionally, Harned's assertion that he lacked information regarding Dr. Guffanti's employment status at NHC was not well-taken by Judge Acosta, who concluded that Dr. Guffanti was an employee of NHC. Lastly, Harned's argument that Dr. Guffanti's alleged medical negligence was not within the scope of his employment was likewise rejected by Judge Acosta.
Without objections from Harned, U.S. District Judge Marco A. Hernandez adopted the October F&R. Order, ECF No. 25. After Harned's motion to remand was denied, the court resumed briefing on the pending motions to dismiss. Scheduling Order, ECF No. 26. Harned did not file responses to the pending motions. On March 24, this action was reassigned from Judge Acosta to this court. Notice of Case Reassignment, ECF No. 27.
Discussion
I. United States' Rule (12)(b)(1) Motion to Dismiss
“Federal district courts have jurisdiction to hear a plaintiff's tort claim under the FTCA only after the plaintiff has exhausted the claim by submitting it to the appropriate federal agency first.” Vacek v. U.S. Postal Serv., 447 F.3d 1248, 1250 (9th Cir. 2006) (citing 28 U.S.C. § 2675(a)). Accordingly, a party may move to dismiss a complaint for lack of subject-matter jurisdiction under Rule 12(b)(1) by asserting that the plaintiff has failed to exhaust administrative remedies as required by the FTCA. D.L. by & through Junio v. Vassilev, 858 F.3d 1242, 1245-46 (9th Cir. 2017).
Further, when a Rule 12(b)(6) motion is supported by a declaration asserting that plaintiff did not file an administrative tort claim, it is a factual attack on the complaint's allegations. Savage v. Glendale Union High Sch., Dist. No. 205, Maricopa Cnty., 343 F.3d 1036, 1040 n.2 (9th Cir. 2003) (“In evaluating the Rule 12(b)(1) motion to dismiss, the district court considered affidavits furnished by both parties. This is proper because Rule 12(b)(1) attacks on jurisdiction can be either facial, confining the inquiry to allegations in the complaint, or factual, permitting the court to look beyond the complaint.”). Under a factual attack, the court is permitted to look beyond the complaint. Courthouse News Serv. v. Planet, 750 F.3d 776, 780 (9th Cir. 2014) (providing in a factual challenge, the challenger “relies on affidavits or any other evidence properly before the court” to dispute allegations). The party who asserts jurisdiction and opposes the motion is required to present affidavits or other evidence to establish that the court possesses subject-matter jurisdiction. St. Clair v. City of Chico, 880 F.2d 199, 201 (9th Cir. 1989); Holdner v. Oregon Dep't of Agric., 676 F.Supp.2d 1141, 1144 (D. Or. 2009) (stating party asserting jurisdiction has burden to demonstrate it exists). Because the United States waives sovereign immunity under the FTCA and the exhaustion requirement is jurisdictional in nature, the exhaustion requirement “must be interpreted strictly.” Vacek, 447 F.3d at 1250.
The United States argues that Harned failed to file an administrative claim with the Department of Health and Human Services (“HHS”). That is, the FTCA requires that a plaintiff “shall have first presented the claim to the appropriate Federal agency.” 28 U.S.C. § 2675(a). A claim is deemed presented for purposes of § 2675(a) when a party files “(1) a written statement sufficiently describing the injury to enable the agency to begin its own investigation, and (2) a sum certain damages claim.” Warren v. U.S. Dep't of Interior Bureau of Land Mgmt., 724 F.2d 776, 780 (9th Cir. 1984) (en banc). Because Harned failed to present the required written statement to HHS, the United States asserts that he failed to exhaust his administrative remedies, which therefore deprives the court of subject-matter jurisdiction.
As noted, Dr. Guffanti provided medical services to Yarbour-Harned while employed by the Neighborhood Health Center, which is a healthcare provider for the purposes of the FTCA. According to a declaration from Sarah Feldman, an attorney for the United States, the Neighborhood Health Center's website stated at the time of Yarbour-Harned's death that it is a “Federal Tort Claims Act (FTCA) Deemed Facility as of 2015” and it “receives HHS funding and has Federal Public Health Services (PHS) deemed status with respect to certain health or health-related claims, including medical malpractice claims, for itself and its covered individuals.” Feldman Decl. ¶¶ 2 and 3, ECF No. 4. Further, in a declaration from Meredith Torres-Senior Attorney for HHS who is familiar with the official records of tort claims- Torres states that a search of the Claims Office database found “no record of an administrative tort claim filed by” Harned or an authorized representative relating to Dr. Guffanti and NHC. Notice of Removal Ex. 1 ¶ 4, ECF No. 1.
Harned, failing to respond to the United States' motion to dismiss, has not provided affidavits or any other evidence that would satisfy his burden of establishing that the court has subject-matter jurisdiction. See Safe Air for Everyone v. Meyer, 373 F.3d 1035, 1039 (9th Cir. 2004) (providing court “need not presume the truthfulness of the plaintiff's allegations” and plaintiff “must furnish affidavits or other evidence necessary to satisfy its burden of establishing subject matter jurisdiction”). Based on the United States' declarations and Harned's failure to respond, the court agrees with the United States that Harned has not met his burden of establishing subject-matter jurisdiction. The court therefore recommends that the United States' motion to dismiss be granted.
The court, however, disagrees with the United States' contention that Harned's claim against it should be dismissed with prejudice. The United States argues that the statute of limitations has expired and, therefore, Harned is “forever barred” from bringing his claim. See 28 U.S.C. § 2401(b) (“A tort claim against the United States shall be forever barred unless it is presented in writing to the appropriate Federal agency within two years after such claim accrues.”). A claim accrues when the plaintiff knew, or after exercising reasonable diligence, should have known of the injury and its cause. United States v. Kubrick, 444 U.S. 111, 119-22 (1979).
Here, the United States contends that a litigant exercising reasonable diligence should have been able to discover on March 15, 2018-the day Yarbour-Harned died-that the medication prescribed by Dr. Guffanti caused her death. Harned's allegation that Yarbour-Harned died from taking medication that Dr. Guffanti negligently prescribed does not necessarily lead to the conclusion that Harned would have arrived at that belief-after exercising reasonable diligence-on the date of her death on March 15, 2018. The court rejects the United States' contention that, based on the pleadings, it can be conclusively established when Harned's claim accrued for limitation purposes under the FTCA.
The United States also contends that equitable tolling is unavailable to Harned. Tolling is warranted upon a showing that a plaintiff has been pursuing his rights diligently and that some extraordinary circumstance stood in the plaintiff's way and prevented timely filing. U.S. v. Wong, 575 U.S. 402, 412 (2015) (holding statute of limitations in § 2401(b) is subject to equitable tolling). The United States asserts that the FAC is without any facts that support equitable tolling and that the NHC's information on its website that it was a PHS establishes that equitable tolling is unavailable to Harned. The court disagrees that the NHC's information on its website about its PHS status is dispositive-at this stage in the proceedings-as to whether Harned's claim could be equitably tolled. It is possible that Harned could amend his complaint to allege facts supporting an argument that his claim is subject to equitable tolling.
This case is unlike the case cited by the United States, Frigard v. U.S., 862 F.2d 201 (9th Cir. 1988), in which the court held that the plaintiffs would not be able to redraft their claims to avoid the discretionary function and misrepresentation exceptions to the FTCA. Here, Harned's defect is not that it is a claim subject to the FTCA's exceptions; it is possible that Harned could rebut the United States' argument with evidence about when the accrual of his claim began and that he exhausted his administrative remedies. See Wright v. U.S., No. 3:14-CV-01861-PK, 2015 WL 1931962, at *4 (D. Or. Apr. 27, 2015) (“Since it is possible that [the plaintiff] can amend her complaint to allege sufficient facts supporting subject matter jurisdiction by properly exhausting her administrative remedies under the FTCA and thereby rebutting the factual dispute raised by the United States, Wright's action against the United States is dismissed without prejudice.”). The court therefore recommends that Harned's claim against the United States be dismissed without prejudice.
II. Merck's Rule 12(b)(6) Motion to Dismiss
The court may grant a Rule 12(b)(6) motion to dismiss for failure to state a claim when there is no cognizable legal theory to support the claim or when the complaint lacks sufficient factual allegations to state a facially plausible claim for relief. Shroyer v. New Cingular Wireless Servs., Inc., 622 F.3d 1035, 1041 (9th Cir. 2010). On a motion to dismiss under Rule 12(b)(6), the court accepts all material facts as true and construes them in the light most favorable to the plaintiff. Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1140 (9th Cir. 2012). To be entitled to a presumption of truth, a complaint's allegations “may not simply recite the elements of a cause of action, but must contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively.” Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011). All reasonable inferences from the factual allegations are drawn in the plaintiff's favor. Newcal Indus. v. Ikon Office Sol., 513 F.3d 1038, 1043 n.2 (9th Cir. 2008). The court need not, however, credit the plaintiff's legal conclusions that are couched as factual allegations. Ashcroft v. Iqbal, 556 U.S. 662, 678-79 (2009).
A complaint must contain sufficient factual allegations to “plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation.” Starr, 652 F.3d at 1216. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). “The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Mashiri v. Epsten Grinnell & Howell, 845 F.3d 984, 988 (9th Cir. 2017) (quoting Iqbal, 556 U.S. at 678). Determining whether a complaint states a plausible claim for relief is a context-specific task requiring the court to draw on its judicial experience and common sense. Iqbal, 556 U.S. at 679.
Merck contends that the claim against it is properly construed as a products liability claim that is governed by Oregon law, ORS § 30.900 to ORS § 30.920. And, under ORS § 30.920, a product's manufacturer is liable for injuries caused to the product's user or to a third party if the plaintiff shows that the product is both defective and unreasonably dangerous. McCathern v. Toyota Motor Corp., 332 Or. 59, 77 (2001); Cornell v. Merck & Co., 87 Or.App. 373, 376 (1987) (providing that to state a products liability claim, the plaintiff must allege that the product was sold “in a defective condition unreasonably dangerous to the user or consumer”). The defective condition can be a “design, inspection, testing, manufacturing or other defect,” ORS § 30.900(1); a “failure to warn regarding a product,” ORS § 30.900(2); or a “failure to properly instruct in the use of a product,” ORS 30.900(3). Additionally, Merck cites Mason v. Mt. St. Joseph, Inc., 226 Or.App. 392, 401 (2009), for the proposition that a complaint alleging products liability must specifically allege that the defendant manufactured the specific product that allegedly harmed the plaintiff.
Merck argues that the FAC is deficient in three ways. First, Merck argues the FAC fails to identify the specific medication that caused Yarbour-Harned's death. Id. Second, Merck contends the FAC fails to allege any facts about the allegedly defective condition of the medication rendering it unreasonably dangerous. McCathern, 332 Or. at 77. Third, Merck asserts the FAC fails to allege any facts about Merck's alleged failure to warn. ORS § 30.900(2).
As to Merck's first basis for dismissal, Merck asserts that the FAC failed to name Merck as the manufacturer of the medication that caused Yarbour-Harned's death. See Mason, 226 Or.App. at 401 (stating that, under ORS § 30.900, “‘a manufacturer' does not include any manufacturer of the product at issue; it means a manufacturer of the product who is otherwise liable for its condition”). Merck argues that Harned “inconsistently alleges that Ms. Yarbour-Harned took ‘Rizatriptan,' the generic medication, and ‘Maxalt,' the specific brand medication manufactured by Merck. Both allegations cannot be true[.]” In fact, the FAC alleges that the “pharmaceutical medication prescribed to [Yarbour-Harned] was unreasonably dangerous and unsafe. It was manufactured by MERCK[.]” On a motion to dismiss, the court must accept Harned's allegation as true and construe it in his favor. Teixeira v. Cty. of Alameda, 873 F.3d 670, 678 (9th Cir. 2017). The court thus presumes the medication given to Yarbour-Harned was made by Merck.
Further, the court understands that rizatriptan is the name of the prescription medication given to Yarbour-Harned and that Maxalt is the trade name for rizatriptan. Consequently, a person can take rizatriptan that is manufactured by Merck and sold under the brand name Maxalt. Thus, contrary to Merck's contention, the court does not find Harned's allegations inconsistent.
Although the court disagrees with Merck's argument that the FAC failed to identify the specific medication prescribed to Yarbour-Harned, the court agrees with Merck that the FAC fails to allege a strict products liability claim under any theory. The FAC fails to specify the alleged defective condition of the prescribed medication. It is insufficient to simply allege that the prescribed medication was “unreasonably dangerous and unsafe.” See Cornell, 87 Or.App. at 376 (affirming dismissal of complaint where plaintiff alleged drug was “unreasonably dangerous for use by reason of having dangerous and adverse side effects” because it contained no allegation of a manufacturing or design defect). The FAC also fails to specifically allege a failure to warn claim. The FAC contains no allegations about what the alleged side effects were, what warnings were given, and how the given warnings were inadequate to explain the dangerousness of the side effects. Absent those specific factual allegations, the claim against Merck lacks the factual content necessary for the court to draw a reasonable inference that Merck is plausibly liable for its failure to warn of allegedly dangerous side effects. See Iqbal, 556 U.S. at 678.
The court turns to whether Harned should be granted leave to amend his products liability claim against Merck. Merck argues that he should not be allowed to do so. In Merck's view, because plaintiff's counsel admitted during conferral conducted after Harned filed his complaint that the medication given to Yarbour-Harned was the generic version of rizatriptan, not the Maxalt-branded version manufactured by Merck, Harned's claim against it is futile. See Gardner v. Martino, 563 F.3d 981, 990 (9th Cir. 2009) (holding district court does not err in denying leave to amend where amendment would be futile). Plaintiff's counsel's “admission” during the conferral process, however, is not the kind of matter outside the pleadings that the court may consider. See Hicks v. PGA Tour, Inc., 897 F.3d 1109, 1117 (9th Cir. 2018) (stating that, on a Rule 12(b)(6) motion, the court can consider “exhibits attached to the Complaint or matters properly subject to judicial notice” and “documents whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiff's] pleading”). Merck argues that it raises the “admission” only as to the futility of amendment and not as part of its motion to dismiss but cites no legal authority for its contention that extrinsic evidence should prevent leave to amend on a motion to dismiss. The court believes that this stage of the parties' litigation is not the appropriate time to do so. Cf. Roth v. BASF Corp., No. C0-07-00176-MJP, 2008 WL 4163127, at *3 (W.D. Wash. Sept. 4, 2008) (“While recognizing that futility can be a[] valid grounds for denial of [a motion to amend], the Court will not consider that factor in this motion precisely because the proposed claims might be subject to dismissal on summary judgment. Defendants' very argument implies a level of factual inquiry and extrinsic evidence that is simply not appropriate at this juncture of the parties' litigation and in this type of motion.”).
Accordingly, the court is not persuaded by Merk's argument regarding the futility of amendment and recommends that the claim against Merck be dismissed without prejudice.
Conclusion
For all the reasons stated, the court recommends that the United States' Motion to Dismiss for Lack of Jurisdiction (ECF No. 3) and Merck's Motion to Dismiss for Failure to State a Claim (ECF No. 8) be GRANTED, and that the claims be DISMISSED, without prejudice.
Scheduling Order
The Findings and Recommendation will be referred to a district judge. Objections, if any, are due within fourteen (14) days. If no objections are filed, the Findings and Recommendation will go under advisement on that date. If objections are filed, a response is due within fourteen (14) days. When the response is due or filed, whichever date is earlier, the Findings and Recommendation will go under advisement.