Pietrantoni v. Corcept Therapeutics Inc.

640 F.Supp.3d 197

Anna PIETRANTONI, Plaintiff, v. CORCEPT THERAPEUTICS INCORPORATED and Optime Care Inc., Defendants.

CIVIL ACTION NO. 22-10072-WGY

United States District Court, D. Massachusetts

Signed November 10, 2022

Seth D. Jacobs, Zisson & Jacobs, Boston, MA, Adam Almen, Pro Hac Vice, Gilbert Alden Barbosa PLLC, Burnsville, MN, Vincent J. Moccio, Pro Hac Vice, Bennerotte & Associates, Eagan, MN, for Plaintiff.

Kevin G. Kenneally, Warren D. Hutchison, Freeman Mathis & Gary, LLP, Boston, MA, William E. Gildea, Locke Lord LLP, Boston, MA, for Defendant Corcept Therapeutics.

Warren D. Hutchison, Freeman Mathis & Gary, LLP, Boston, MA, Erika J. Doherty, Katharine S. Perry, Manning Gross & Massenburg LLP, Boston, MA, William E. Gildea, Locke Lord LLP, Boston, MA, for Defendant Optime Care Inc.

MEMORANDUM & ORDER

YOUNG, JUDGE of the UNITED STATES¹

I. INTRODUCTION

Anna Pietrantoni ("Pietrantoni") brings this action against Corcept Therapeutics Incorporated ("Corcept") and Optime Care Inc. ("Optime") (collectively, the "Defendants") for the manufacture, marketing, and distribution of Korlym, a pharmaceutical prescribed to treat Cushing's Disease. See Am. Compl. & Jury Demand ("Compl."), ECF No. 10. Pietrantoni alleges that taking Korlym caused harm to her reproductive system resulting in an emergency dilation and curettage that rendered her unable to carry a pregnancy to term. See id. ¶ 1.

Pietrantoni brings nine counts alleging negligence, misrepresentation, and breach of warranty. Distributed among these nine counts are several categories of claims: (1) Korlym is defectively designed ("defective design"); (2) Corcept failed to warn consumers and physicians of the extent to which Korlym could harm the female reproductive system ("failure to warn") either through (A) product labeling or (B) reports to the Food and Drug Administration ("FDA"); and (3) Corcept and Optime failed to carry out their duty to monitor Pietrantoni's health while taking Korlym ("failure to monitor"). See generally Compl.

Corcept and Optime move to dismiss all counts on the grounds that the claims are preempted by federal law and also fail independently under state law. See Mot. Defs. Corcept & Optime Dismiss All Counts Am. Compl. ("Mot Dismiss"), ECF No. 24.

At a motion hearing on June 29, 2022, the Court ALLOWED the motion as to counts six and seven for failure to plead with particularity and took the remainder under advisement. See Electronic Clerk's Notes, ECF No. 46. This Memorandum addresses the outstanding claims.

With respect to the remaining counts, the motion is now ALLOWED in part and DENIED in part. The motion is ALLOWED as to counts one and three insofar as they allege defective design and failure to warn premised on product labeling; count four insofar as it alleges failure to warn premised on product labeling; count five in its entirety; count eight in its entirety; and count nine in its entirety.

The motion is DENIED as to count one insofar as it alleges negligent failure to warn premised on FDA reporting; count two in its entirety; count three insofar as it alleges grossly negligent failure to monitor; and count four, which is construed as a breach of warranty claim, insofar as it alleges failure to warn premised on FDA reporting.

II. PROCEDURAL HISTORY

Pietrantoni filed suit against Corcept and Optime on January 19, 2022. Compl. & Jury Demand ("Original Compl."), ECF No. 1. On February 17, 2022, Pietrantoni filed an amended complaint. See Compl.

She brings nine counts: negligent failure to warn and defective design against Corcept (count 1), id. ¶¶ 21-30; negligent failure to monitor against Corcept and Optime (count 2), id. ¶¶ 31-38; grossly negligent failure to warn, defective design, and failure to monitor against Corcept and Optime (count 3), id. ¶¶ 39-48; strict products liability for failure to warn (count 4), and defective design (count 5) against Corcept, id. ¶¶ 49-73; intentional and negligent misrepresentation as to the failure to warn against Corcept and Optime (count 6), id. ¶¶ 74-81; intentional and negligent misrepresentation as to the failure to monitor against Corcept and Optime (count 7), id. ¶¶ 82-87; breach of express warranty through failure to warn and defective design against Corcept (count 8), id. ¶¶ 88-93; and breach of implied warranty through failure to warn and defective design against Corcept (count 9), id. ¶¶ 94-99.

On May 9, 2022, Corcept and Optime filed a motion to dismiss all counts. See Mot. Dismiss. The parties have fully briefed the motion. Defs.' Mem. Law Supp. Mot. Dismiss ("Defs.' Mem."), ECF No. 25; Pl.'s Mem. Opp'n Defs.' Mot Dismiss ("Pl.'s Mem."), ECF No. 36; Reply Defs. Corcept Therapeutics & Optime Support Mot. Dismiss ("Defs.' Reply"), ECF No. 39.

In conjunction with their motion to dismiss, the Defendants requested that the Court take judicial notice of five exhibits. Defs.' Req. Judicial Notice, ECF No. 26. Pietrantoni filed her own request for judicial notice, Pl.'s Mem., Ex. 1, Pl.'s Req. Judicial Notice ("Pl.'s Req. Judicial Notice"), ECF No. 36-1, which the Defendants have opposed, Defs.' Opp'n Pl.'s Req. Judicial Notice ("Defs.' Opp'n Judicial Notice"), ECF No. 40.

This Court held a hearing on the motion to dismiss on June 29, 2022. After hearing counsels' arguments, the Court ALLOWED the motion as to counts six and seven in their entirety for not satisfying the particularity requirements of Federal Rule of Civil Procedure 9(b). It took the remainder under advisement. See Electronic Clerk's Notes, ECF No. 46.

III. STATUTORY AND REGULATORY FRAMEWORK

A. Approval of a New Drug

The Food, Drug, and Cosmetic Act ("FDCA"), implemented and enforced by the FDA, governs the approval and labeling of prescription drugs. See 21 U.S.C. §§ 301, et seq. The FDCA requires drug manufacturers to obtain approval from the FDA before marketing a new drug. 21 U.S.C. § 355(a). To do so, manufacturers must submit a New Drug Application ("NDA") containing "full reports of [clinical] investigations" showing that the drug is safe and effective for its use. Id. §§ 355(b), (d). For approval, the NDA must prove by "substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling." Id. § 355(d).

Manufacturers of a prescription drug are required to include in their NDAs "specimens of the labeling proposed to be used for such drug." Id. § 355(b). These package inserts must contain, inter alia, warnings, precautions, contraindications, and adverse reactions. 21 C.F.R. §§ 201.56, 201.57. Certain prescription drugs which "pose a serious and significant public health concern" are subject to an additional labeling requirement in that manufacturers must submit "Medication Guides" -- documents comprising additional statements of risk that must comport with package inserts. Id. §§ 208.1. The FDA conducts a detailed review of product labeling, 21 C.F.R. §§ 201.56, 201.57, and its approval of a new drug "includes the approval of the exact text in the proposed label,". Wyeth v. Levine, 555 U.S. 555, 568, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (citing 21 U.S.C. § 355; 21 C.F.R. § 314.105(b)).²

The FDA may approve an NDA only if clinical investigations indicate that the drug (1) is safe for its intended use, (2) will have the effect it purports to have, and (3) has labeling that is not "false or misleading in any particular." 21 U.S.C. § 355(c), (d); see also 21 C.F.R. § 314.105(c).

B. Changes to Drug Labeling

After obtaining FDA approval of a new drug, in order to alter the drug or drug label, the manufacturer must file a supplemental application. See 21 C.F.R. § 314.70(b). By default, manufacturers are required to receive prior FDA approval to make a proposed change. See id. There exists, however, a path by which brand-name drug manufacturers may change a drug label without waiting for FDA approval; this is done through the "changes being effected" ("CBE") regulation. Under the CBE regulation, upon the submission of a supplemental application to the FDA, brand-name manufacturers may unilaterally implement labeling changes. See 21 C.F.R. §§ 314.70(c)(6).

Any change made pursuant to the CBE regulation must meet two requirements. See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 37 (1st Cir. 2015). First, it must "reflect newly acquired information." 21 C.F.R. § 314.70(b) (emphasis added). The FDA defines "newly acquired information" as:

data, analyses, or other information not previously submitted to the Agency, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. § 314.3 (emphasis added). Second, it must seek to achieve one of the following objectives:

(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling . . . ;

(B) To add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage;

(C) To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product;

(D) To delete false, misleading, or unsupported indications for use or claims for effectiveness; or

(E) Any labeling change normally requiring a supplement submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision.

Id. § 314.70(c)(6) (emphasis added). After a manufacturer has made a change pursuant to the CBE regulation, the FDA retains authority retroactively to approve or reject the supplemental submission. Id. § 314.70(c)(7).

IV. REQUESTS FOR JUDICIAL NOTICE

With respect...