Opinion
CV 23-9082-JFW(JPRx)
02-06-2024
Mary BAGHIKIAN, et al. v. PROVIDENCE HEALTH & SERVICES, et al.
Garabed Kamarian, Kamarian Law Inc., Burbank, CA, for Mary Baghikian, et al. David R. Tredway, Terrence J. Schafer, Doyle Schafer McMahon LLP, Irvine, CA, for Dr. Taback, Dr. Sitker.
Garabed Kamarian, Kamarian Law Inc., Burbank, CA, for Mary Baghikian, et al.
David R. Tredway, Terrence J. Schafer, Doyle Schafer McMahon LLP, Irvine, CA, for Dr. Taback, Dr. Sitker.
PROCEEDINGS (IN CHAMBERS): ORDER GRANTING DEFENDANTS GILEAD SCIENCES, INC. AND GENENTECH, INC.'S MOTION TO DISMISS PLAINTIFFS' FIRST AMENDED COMPLAINT [filed 1/2/2024; Docket No. 53]
JOHN F. WALTER, UNITED STATES DISTRICT JUDGE.
On January 2, 2024, Defendants Gilead Sciences, Inc. ("Gilead") and Genentech, Inc. ("Genentech") (collectively, the "Manufacturer Defendants") filed a Motion to Dismiss Plaintiffs' First Amended Complaint ("Motion to Dismiss"). On January 12, 2024, Plaintiffs Mary Baghikian and Estate of Sarkis Baghikian ("Plaintiffs") filed their Opposition. On January 22, 2024, the Manufacturer Defendants filed a Reply. Pursuant to Rule 78 of the Federal Rules of Civil Procedure and Local Rule 7-15, the Court finds that this matter is appropriate for decision without oral argument. The hearing calendared for February 12, 2024 is hereby vacated and the matter taken off calendar. After considering the moving, opposing, and reply papers, and the arguments therein, the Court rules as follows:
I. FACTUAL AND PROCEDURAL BACKGROUND
Plaintiffs do not oppose Gilead and Genentech's Request for Judicial Notice (Docket No. 54), and that Request for Judicial Notice is GRANTED.
Gilead developed and manufactures the antiviral medicine Veklury® (remdesivir). The FDA issued an emergency use authorization for Veklury to treat COVID-19 in May 2020 and then fully approved it in October 2020. Veklury became the first FDA-approved antiviral treatment for patients hospitalized for COVID-19.
Genentech manufactures the medicine Actemra® (tocilizumab). In March 2020, the U.S. Government entered into an agreement with Genentech, which provided that the company would conduct clinical trials to evaluate whether Actemra could be used to safely and effectively treat COVID-19. Actemra (tocilizumab) had previously been approved by the FDA for the treatment of rheumatoid arthritis, but scientists theorized that medicines like Actemra might also prove to be effective in treating COVID-19. In June 2021, the FDA issued an Emergency Use Authorization for Actemra to treat COVID-19, and, in December 2022, Actemra received full FDA approval as a safe and effective treatment for COVID-19.
Plaintiffs allege that, on December 24, 2021, the decedent presented himself to Providence Hospital in Los Angeles, California, where he was diagnosed with pneumonia and subsequently admitted for COVID-19. First Amended Complaint ("FAC") ¶¶ 23, 24. Plaintiffs further allege that sometime during the decedent's three-week stay at the hospital, decedent was administered Veklury and Actemra, without any explanation of the potential side effects of these medications and without the consent of the decedent or any of his family members. Id. at ¶ 31. Plaintiffs allege that, "after the administration of
these drugs, decedent took a vertical medical dive and experienced organ shut off until he died on January 15, 2022." Id. at ¶ 91.
In Plaintiffs' First Amended Complaint filed on December 18, 2023, Plaintiffs allege the following claims for relief against Defendants Gilead and Genentech: (1) Wrongful Death — Negligence (First Cause of Action); (2) Strict Products Liability (Seventh Cause of Action); (3) Products Liability — Failure to Warn (Eighth Cause of Action); (4) Constructive Fraud (Tenth Cause of Action); (5) violation of the Consumer Legal Remedies Act, Cal. Civ. Code § 1750, et seq. (Eleventh Cause of Action); (6) violation of the False Advertising Law, Cal. Bus. & Prof. Code § 17500, et seq. (Twelfth Cause of Action); and (7) Elder Abuse (Thirteenth Cause of Action).
Genentech removed this action based on the federal-officer removal statute, 28 U.S.C. § 1442(a)(1).
Gilead and Genentech move to dismiss Plaintiffs' First Amended Complaint, arguing in relevant part that Plaintiffs' claims alleged against them are barred by the Public Readiness and Emergency Preparedness Act ("PREP Act").
II. LEGAL STANDARD
A motion to dismiss brought pursuant to Federal Rule of Civil Procedure 12(b)(6) tests the legal sufficiency of the claims asserted in the complaint. "A Rule 12(b)(6) dismissal is proper only where there is either a 'lack of a cognizable legal theory' or 'the absence of sufficient facts alleged under a cognizable legal theory.'" Summit Technology, Inc. v. High-Line Medical Instruments Co., Inc., 922 F. Supp. 299, 304 (C.D. Cal. 1996) (quoting Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir. 1988)). However, "[w]hile a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the 'grounds' of his 'entitlement to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (internal citations and alterations omitted). "[F]actual allegations must be enough to raise a right to relief above the speculative level." Id.
"Ordinarily affirmative defenses may not be raised by motion to dismiss...." Scott v. Kuhlmann, 746 F.2d 1377, 1378 (9th Cir. 1984) (per curiam). However, "a complaint may be dismissed when the allegations of the complaint give rise to an affirmative defense that clearly appears on the face of the pleading." Boquist v. Courtney, 32 F.4th 764, 774 (9th Cir. 2022) (quotations and citations omitted). An affirmative defense is grounds for dismissal at the pleading stage only if "the plaintiff pleads itself out of court—that is, admits all the ingredients of an impenetrable defense...." Durnford v. MusclePharm Corp., 907 F.3d 595, 603 n.8 (9th Cir. 2018) (quoting Xechem, Inc. v. Bristol-Myers Squibb Co., 372 F.3d 899, 901 (7th Cir. 2004)).
In deciding a motion to dismiss, a court must accept as true the allegations of the complaint and must construe those allegations in the light most favorable to the nonmoving party. See, e.g., Wyler Summit Partnership v. Turner Broadcasting System, Inc., 135 F.3d 658, 661 (9th Cir. 1998). "However, a court need not accept as true unreasonable inferences, unwarranted deductions of fact, or conclusory legal allegations cast in the form of factual allegations." Summit Technology, 922 F. Supp. at 304 (citing Western Mining
Council v. Watt, 643 F.2d 618, 624 (9th Cir. 1981) cert. denied, 454 U.S. 1031, 102 S.Ct. 567, 70 L.Ed.2d 474 (1981)).
"Generally, a district court may not consider any material beyond the pleadings in ruling on a Rule 12(b)(6) motion." Hal Roach Studios, Inc. v. Richard Feiner & Co., 896 F.2d 1542, 1555 n. 19 (9th Cir. 1990) (citations omitted). However, a court may consider material which is properly submitted as part of the complaint and matters which may be judicially noticed pursuant to Federal Rule of Evidence 201 without converting the motion to dismiss into a motion for summary judgment. See, e.g., id.; Branch v. Tunnell, 14 F.3d 449, 454 (9th Cir. 1994).
Where a motion to dismiss is granted, a district court must decide whether to grant leave to amend. Generally, the Ninth Circuit has a liberal policy favoring amendments and, thus, leave to amend should be freely granted. See, e.g., DeSoto v. Yellow Freight System, Inc., 957 F.2d 655, 658 (9th Cir. 1992). However, a Court does not need to grant leave to amend in cases where the Court determines that permitting a plaintiff to amend would be an exercise in futility. See, e.g., Rutman Wine Co. v. E. & J. Gallo Winery, 829 F.2d 729, 738 (9th Cir. 1987) ("Denial of leave to amend is not an abuse of discretion where the pleadings before the court demonstrate that further amendment would be futile.").
III. DISCUSSION
The Court concludes' that Plaintiffs' claims against Gilead and Genentech are barred by the PREP Act.
As an initial matter, Plaintiffs argue that their California state law claims are not barred by the PREP Act based on the Ninth Circuit's holding in Saldana v. Glenhaven Healthcare, LLC, 27 F.4th 679 (9th Cir. 2022). Plaintiffs, however, appear to be confusing the jurisdictional doctrine of complete preemption with immunity under the PREP Act. Indeed, in Saldana, the Ninth Circuit held that the PREP Act does not "completely preempt"—and thereby render removable to federal court—all state-law causes of action that might fall within the grant of immunity. 27 F.4th at 688. In other words, the Ninth Circuit held that, although the PREP Act provides immunity from state-law claims, it does not necessarily transform such claims into federal causes of action. The complete-preemption holding of Saldana is not at issue here because federal subject-matter jurisdiction is based on the federal-officer removal statute, not on the PREP Act.
Passed in 2005, the PREP Act authorizes the Secretary of Health and Human Services ("HHS") to issue a declaration determining that "a disease or other health condition or other threat to health constitutes a public health emergency." 42 U.S.C. § 247d-6d(b). If applicable, the PREP Act provides that "a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure." 42 U.S.C. § 247d-6d(a)(1).
The "covered person[s]" who are entitled to immunity under the PREP Act include "manufacturer[s]" and "distributor[s]" of covered countermeasures. 42 U.S.C. § 247d-6d(i)(2)(B)(i)-(ii). The term "covered countermeasures" includes "qualified pandemic or epidemic product[s]," such as diagnostics, treatments, or protective gear, as designated by a declaration of the HHS Secretary. 42 U.S.C. § 247d-6d(i)(7). PREP Act immunity extends to "any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the covered countermeasure's design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure." Id. § 247d-6d(a)(2)(B).
If immunity applies, the injured person or their survivors may seek compensation from the Countermeasures Injury Compensation Program — a regulatory program that provides reimbursement for certain losses associated with the use of covered countermeasures. 42 U.S.C. § 247d-6e. The only exception to the Act's immunity is when the injury occurs through willful misconduct. In those instances, the PREP Act provides procedural rules that govern the injured person's claim. 42 U.S.C. § 247d-6d(d). For example, they must file in the U.S. District Court for the District of Columbia and the burden of proof is clear and convincing evidence. Id.; 42 U.S.C. § 247d-6d(c).
On March 17, 2020, the HHS Secretary issued a declaration designating COVID-19 a "public health emergency ... under the PREP Act." Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020). Consistent with the Act, the Declaration defines "covered persons" to include "manufacturers" of covered countermeasures. Id. at 15,201. The Declaration designates as "Covered Countermeasures" for COVID-19 "any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2... or any device used in the administration of any such product." Id. at 15,202.
The First Amended Complaint describes Gilead as the manufacturer of Veklury, and Genentech as the manufacturer of Actemra. See FAC ¶¶ 19, 20. As Veklury's and Actemra's "manufacturer[s]," Gilead and Genentech are plainly "covered person[s]" under the Act. 42 U.S.C. § 247d-6d(i)(2). As "antiviral" medicines or "other drug[s]" "used to treat" COVID-19, both Veklury and Actemra are also unquestionably covered countermeasures. Id.; see also Moody v. Lake Worth Invs. Inc., 2021 WL 4134414, at *4 (N.D. Tex. May 26, 2021) ("The most notable countermeasures appear to be vaccinations, devices, or medication designed to or at least thought to reduce the severity of COVID-19, such as [r]emdesivir...."). In fact, an HHS advisory opinion specifically lists Veklury as a countermeasure covered by the Act. Request for Judicial Notice, Ex. 2, Advisory Opinion on the PREP Act, at 1 & n.2 (HHS Apr. 17, 2020, as modified May 19, 2020) (linking to a list of covered countermeasures that includes Remdesivir). Similarly, the federal Biomedical Advanced Research and Development Authority ("BARDA") has categorized Actemra as a "medical countermeasure" intended to combat COVID-19. See Request for Judicial Notice, Ex. 11.
The Court also concludes that Plaintiffs' claims are "for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual" of Veklury and Actemra, 42 U.S.C. § 247d-6d(a)(1). Indeed, each of Plaintiffs' claims is predicated on the alleged "causal relationship" between the decedent's injuries and the "design, development,... labeling, ... marketing, promotion, sale, purchase, ... dispensing, prescribing, administration, ... or use" of Veklury and Actemra. 42 U.S.C. § 247d-6d(a)(2)(b). Plaintiffs allege, for example, that:
• "[A]fter the administration of [Veklury and Actemra] decedent took a vertical medical dive and experienced organ shut off until he died on January 15[,] 2022." FAC ¶ 91.
• The "administration [of Veklury and Actemra] ... caused decedent to suffer ... pre death injuries including lung and kidney failures, stop breathing and ultimately death." FAC ¶ 166.
• Gilead and Genentech did not "change[] or modif[y] [their] warnings" and "Defendants did not warn that these medications may cause sever[e] bodily injury and or death." FAC ¶ 110.
Plaintiffs do not dispute that Gilead and Genentech are covered persons under the PREP Act and do not dispute that Veklury and Actemra are covered countermeasures. Rather, Plaintiffs contend that because the decedent did not provide informed consent prior to the administration of Veklury and Actemra, the PREP Act does not apply. However, Plaintiffs do not cite a single case to support this position, and the Court is aware of none. Indeed, courts have held that consent is not a requirement for the application of PREP Act immunity. See, e.g., Bird v. State, 2023 WY 102, ¶¶ 15-17, 537 P.3d 332, 336 (Wyo. 2023) (holding PREP Act applied when prisoner claimed he did not give consent to receive covered countermeasure); Cowen v. Walgreen Co., 2022 WL 17640208, at *3 (N.D. Okla. Dec. 13, 2022) (same); M.T. as next friend of M.K. v. Walmart Stores, Inc., 63 Kan.App.2d 401, 528 P.3d 1067, 1084 (2023) (noting that courts have held that the PREP Act applies to "claims based on the failure to obtain consent," and holding that "a claim based on the administration of a covered countermeasure without parental consent is causally related to the administration of a covered countermeasure"). The Court agrees and concludes that the PREP Act applies to claims based on failure to obtain consent.
Plaintiffs also argue that Gilead and Genentech are not immune from suit under the PREP Act because decedent's death was proximately caused by willful misconduct. However, the Court concludes that Plaintiffs have not alleged any claims for willful misconduct under the PREP Act.
A claim for willful misconduct under the PREP Act has several elements. The plaintiff must show (1) "an act or omission," that is taken (2) "intentionally to achieve a wrongful purpose," (3) "knowingly without legal or factual justification," and (4) "in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit." 42 U.S.C. § 247d-6d(c)(1)(A). Moreover, the action must be (5) "against a covered person," (6) "for death or serious physical injury" that is (7) "proximately caused by [the covered person's] willful misconduct." Id. § 247d-6d(d)(1). The plaintiff must prove these elements by "clear and convincing evidence." Id. § 247d-6d(c)(3). The PREP Act also provides a rule of construction: the willful-misconduct requirement "shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness." Id. § 247d-6d(c)(1)(B).
Maglioli v. All. HC Holdings LLC, 16 F.4th 393, 410 (3d Cir. 2021). None of Plaintiffs' allegations satisfy the requirements for a willful misconduct claim under the PREP Act. Plaintiffs' claims sound in strict liability, negligence, or at most recklessness. See, e.g., FAC ¶¶ 42-48 (alleging claim for "Wrongful Death-Negligence"); ¶¶ 86-110 (alleging claims for strict products liability); ¶ 146 ("On information and belief, Defendant committed these acts with reckless indifference to Plaintiff"); ¶ 154 ("Defendant knew or should have known through the exercise of reasonable care that its advertising Remdesivir as a safe and effective drug for the treatment
of Covid-19 is false and misleading"). Although Plaintiffs also allege, for example, that "Plaintiffs believe[] that the willful misconduct exception will apply here because of all the facts pointing toward intentional wrongful purpose, and/or a disregard of a known or obvious risk," FAC ¶ 181, and "[on] information and belief, Defendant's violations ... were done with actual knowledge, intent, and awareness that the conduct alleged was wrongful," see, e.g., FAC ¶ 146, their conclusory allegations are insufficient to satisfy the stringent standard of "willful misconduct" under the PREP Act. See 42 U.S.C. § 247d-6d(e)(3)(A) (a willful misconduct claim must be plead with particularity).
In any event, Plaintiffs cannot pursue their willful misconduct claims in this Court. Indeed, such claims must be filed and maintained only in the United States District Court for the District of Columbia. See 42 U.S.C. § 247d-6d(e)(1); Perez v. Oxford Univ., 2022 WL 1446543, at *6 (S.D.N.Y. Apr. 11, 2022), report and recommendation adopted 2022 WL 1468438 (S.D.N.Y. May 10, 2022) (dismissing willful-misconduct claims concerning injuries allegedly caused by a COVID-19 vaccine because "[t]he language of the PREP Act is clear—if Perez wishes to bring claims against the Defendants under the PREP Act, he must do so by filing an action in the U.S. District Court for the District of Columbia").
Accordingly, the Court concludes that Plaintiffs' claims against Gilead and Genentech are barred by the PREP Act. To the extent Plaintiffs wish to pursue willful misconduct claims under the PREP Act, Plaintiffs must file an action in the U.S. District Court for the District of Columbia (in full compliance with the procedures and requirements set forth in the PREP Act). See 42 U.S.C. §§ 247d-6d(e)(1), (3)-(4), 247d-6e(d)(1).
IV. CONCLUSION
For the foregoing reasons, Gilead and Genentech's Motion to Dismiss is GRANTED without leave to amend. Plaintiffs' claims against Defendants Gilead and Genentech are DISMISSED with prejudice. However, to the extent Plaintiffs' claims against Gilead and Genentech could be construed as willful misconduct claims under the PREP Act, those claims are DISMISSED without prejudice so that Plaintiffs may pursue those claims in the U.S. District Court for the District of Columbia.
IT IS SO ORDERED.