Owen v. FDA Office of Generic Drugs
| Decision Date | 27 August 2021 |
| Docket Number | CIVIL 1:20-cv-00098-MR |
| Parties | TED JACKSON OWEN, Plaintiff, v. FDA OFFICE OF GENERIC DRUGS, et al., Defendants. |
| Court | U.S. District Court — Western District of North Carolina |
THIS MATTER is before the Court on the Plaintiff's “Notice of Substitution of the United States as the Sole Party Defendant and Motion to Amend Caption” [Doc 12] and the United States' Motion to Dismiss [Doc. 13].
On April 20, 2020, Ted Jackson Owen (the “Plaintiff”), proceeding pro se initiated this action against the Food and Drug Administration (the “FDA”) Office of Generic Drugs and several FDA employees, including Former FDA Acting Commissioner Dr. Norman Sharpless, Dr. Howard Chazin, and Debra M. Catterson (collectively, the “Individual Defendants”). [Doc. 1 at 2]. The Complaint asserts a claim under the Federal Tort Claims Act (“FTCA”) stemming from a heart attack the Plaintiff suffered in 2013. [Doc. 1 at 2].
On December 1, 2020, the United States filed the present “Notice of Substitution of the United States as the Sole Party Defendant and Motion to Amend the Caption” (the “Motion to Substitute and Amend”). [Doc. 12]. The United States also filed a Motion to Dismiss on behalf of all the Defendants. [Doc. 13]. The Plaintiff has filed a response to the Motion to Dismiss. [Doc. 16]. The United States has filed a reply. [Doc. 17].[1]
Having been fully briefed, this matter is ripe for disposition.
A motion to dismiss made pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure addresses whether the court has subject-matter jurisdiction to hear the dispute. See Fed.R.Civ.P. 12(b)(1). Where a defendant contends that a complaint fails to allege facts upon which the Court can base subject matter jurisdiction, the Court must assume as true the factual allegations in the complaint. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 1982). The burden of establishing subject matter jurisdiction on a motion to dismiss rests with the party asserting jurisdiction. Id.; Williams v. United States, 50 F.3d 299, 304 (4th Cir. 1995).
The central issue for resolving a Rule 12(b)(6) motion is whether the claims state a plausible claim for relief. See Francis v. Giacomelli, 588 F.3d 186, 189 (4th Cir. 2009). In considering such a motion, the Court accepts the plaintiff's allegations as true and construes them in the light most favorable to the plaintiff. Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250, 253 (4th Cir. 2009); Giacomelli, 588 F.3d at 190-92. When considering a motion to dismiss, the Court is obligated to construe a pro se complaint liberally, “however inartfully pleaded[.]” Booker v. S.C. Dep't of Corr., 855 F.3d 533, 540 (4th Cir. 2017), cert. denied, 138 S.Ct. 755, 199 L.Ed.2d 604 (2018) (quoting Erickson v. Pardus, 551 U.S. 89, 94 (2007)).
Although the Court accepts well-pled facts as true, the Court is not required to assume the truth of “bare legal conclusions.” Aziz v. Alcolac, Inc., 658 F.3d 388, 391 (4th Cir. 2011). “The mere recital of elements of a cause of action, supported only by conclusory statements, is not sufficient to survive a motion made pursuant to Rule 12(b)(6).” Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012).
The claims need not contain “detailed factual allegations, ” but must contain sufficient factual allegations to suggest the required elements of a cause of action. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007); see also Consumeraffairs.com, 591 F.3d at 256. Namely, the complaint is required to contain “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570; see also Consumeraffairs.com, 591 F.3d at 255. “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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); see also Consumeraffairs.com, 591 F.3d at 255. The mere possibility that a defendant acted unlawfully is not sufficient for a claim to survive a motion to dismiss. Consumeraffairs.com, 591 F.3d at 256; Giacomelli, 588 F.3d at 193. Ultimately, the well-pled factual allegations must move a plaintiff's claim from possible to plausible. Twombly, 550 U.S. at 570; Consumeraffairs.com, 591 F.3d at 256.
Viewing the well-pled factual allegations in the Complaint as true, the following is a recitation of the relevant facts.
For roughly six years, the Plaintiff took the prescription drug Imitrex. [Doc. 1 at 6]. In December 2013, the Plaintiff began taking Sumatriptan, a generic version of Imitrex manufactured by Dr. Reddy's Laboratories (“Dr. Reddy's”). [Id.]. On December 20, 2013, the Plaintiff experienced chest pains and had a heart attack. [Id.].
On December 29, 2016, the Plaintiff sued Dr. Reddy's in Transylvania County Superior Court, claiming that the Sumatriptan caused his heart attack. [Doc. 14-6 at 1]. On February 1, 2017, Dr. Reddy's removed the case to this Court. [Id.].[2]
In June 2017, the Plaintiff submitted one of his Sumatriptan tablets to an independent laboratory for testing. [Doc. 14-9 at 7]. In July 2017, the Plaintiff sent three tablets to the FDA “requesting an analysis of these pills because each time [he] took one of this lot of medication [he] suffered chest pains.” [Doc. 1 at 7]. The Plaintiff further stated that “[i]t is important to me to test this drug for any inconsistenc[ies] or release variations or any other differences.” [Id.]. The Plaintiff submitted the independent laboratory testing results to the FDA in September 2017. [Doc. 1-1 at 26, 28]. On December 15, 2017, the FDA emailed the Plaintiff that they had used “highly sophisticated, state-of the art technology” to compare the Plaintiff's tablets to other approved tablets available on the marketplace and that the “results from all samples showed no identifiable differences.” [Doc. 1-1 at 24].
On December 13, 2017, the Magistrate Judge issued a Memorandum and Recommendation recommending that the Court grant Dr. Reddy's Motion for Judgment on the Pleadings. [Doc. 14-6]. On February 2, 2018, this Court accepted the Magistrate Judge's Memorandum and Recommendation, granted Dr. Reddy's Motion for Judgment on the Pleadings, and dismissed the case with prejudice. [Doc. 14-7].
On April 20, 2020, the Plaintiff filed the present action. [Doc. 1].
“The Federal Employees Liability Reform and Tort Compensation Act of 1988, commonly known as the Westfall Act, accords federal employees absolute immunity from common-law tort claims arising out of acts they undertake in the course of their official duties.” Osborn v. Haley, 549 U.S. 225, 229 (2007) (citing 28 U.S.C. § 2679(b)(1)). Once the Attorney General of the United States, or a United States Attorney, certifies that the defendant employees were “acting within the scope of their employment at the time of the incident out of which the claim arose, ” the United States is substituted as the defendant and the individual employees are dismissed from the action. Doe v. Meron, 929 F.3d 153, 160 (4th Cir. 2019); 28 U.S.C. § 2679(d)(1). If a plaintiff fails to challenge the certification submitted by the Attorney General or a United States Attorney, “the certification is conclusive.” Meron, 929 F.3d at 160.
Here, the United States has provided a Certification of Scope of Employment from the United States Attorney, which states that “with respect to the events alleged in the Complaint, which allegations are denied for purposes of assessing liability, Defendants Dr. Howard Chazin, Debra M. Catterson and Norman Sharpless, MD, employees of the United States, were acting at all relevant times within the course and scope of their federal employment.” [Doc. 12 at 6; Doc. 14-11]. The Plaintiff has not opposed the Motion to Substitute or challenged the Certification. Accordingly, the United States will be substituted for the Individual Defendants, and the Individual Defendants will be dismissed as parties. See Meron, 929 F.3d at 160.
Sovereign immunity protects the United States and its agencies from suit absent a waiver of immunity. FDIC v. Meyer, 510 U.S. 471, 475 (1994); Welch v. United States, 409 F.3d 646, 650 (4th Cir. 2005). The FTCA “provides a limited waiver of sovereign immunity for civil actions against the United States.” Seaside Farm, Inc. v. United States, 842 F.3d 853, 857 (4th Cir. 2016) (citing 28 U.S.C. §§ 1346(b)(1), 2674). In FTCA suits, however, the United States is the only proper defendant-not any government agency or employee. See 28 U.S.C. § 2679(a); Smith v. United States, 561 F.3d 1090, 1099 (10th Cir. 2009) (). Because the Plaintiff cannot bring his FTCA claims against any party other than the United States, the FDA Office of Genetic Drugs will be dismissed as a defendant.[3]
The United States argues that the Plaintiff's claims relating to the FDA's approval of Sumatriptan are barred by sovereign immunity. [Doc. 14]. The United States further argues that the Plaintiff's other claims regarding any testing or misrepresentations by the FDA fail to state a claim upon which relief can be granted. [Id.].
The FTCA waives the United States' immunity with respect to civil actions for injuries “caused by the negligent or wrongful act or omission of any employee of the...
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