Judge: William D. Claster, Case: 19-01121146, Date: 2022-11-04 Tentative Ruling

1. Defendant Corcept Therapeutics Inc.'s Notice of Demurrer and Demurrer to Fourth Amended Complaint for Damages ROA 263

2. Defendant  Corcept Therapeutics Inc.'s Notice of Motion and Motion to Strike Portions of Plaintiff's Fourth Amended Complaint ROA 268

Defendant Corcept Therapeutics Incorporated’s demurrer to the Fourth Amended Complaint (4AC) of Plaintiff Maren S. Miller is OVERRULED.  Corcept’s motion to strike is DENIED as to the allegations pertaining to ovarian cysts (pp. 2-3 of the notice of motion to strike) and GRANTED as to the allegations pertaining to endometrial changes requiring hysterectomy (pp. 3-5 of the notice of motion to strike).  At the hearing, the parties should be prepared to discuss whether leave to amend would be proper.

Corcept’s two requests for judicial notice, which appear identical in all material respects, are GRANTED.

I.            Relevant History

This is a pharmaceutical products liability matter principally sounding in failure to warn.  Among other things, Corcept contends that Plaintiff’s failure to warn claims are preempted by federal law.  Broadly speaking, state law failure to warn claims for name-brand drugs like Corcept’s Korlym are preempted when the FDA has approved a warning label.  An exception to that general rule, relevant to this case, is the “changes being effected” regulation (“CBE regulation”).

Corcept previously demurred to Plaintiff’s 2AC on several grounds, including preemption.  The Court overruled the demurrer insofar as it was based on preemption.  The Court found Plaintiff’s claims relating to endometrial changes so severe as to require hysterectomy were preempted.  However, Plaintiff had adequately pled the applicability of the CBE regulation to her claims regarding ovarian cysts.  Because a demurrer does not lie to a portion of a cause of action (see PH II, Inc. v. Superior Court (1995) 33 Cal.App.4th 1680, 1682), the Court overruled the demurrer on preemption grounds.

Plaintiff then filed a 3AC that addressed other pleading deficiencies identified by the Court.  Corcept moved to strike the allegations regarding endometrial changes in the 3AC, arguing they were preempted.  Rather than oppose the motion, Plaintiff stipulated to strike those allegations, but reserved the right to move for leave to amend the complaint after discovery.

In discovery, Plaintiff uncovered information that she believes trigger the CBE regulation for her allegations about endometrial changes.  The Court granted her motion for leave to file a 4AC, holding that Corcept’s arguments in opposition were better suited to a pleadings challenge than a motion for leave to amend.  Corcept now challenges the 4AC.

II.          Uncertainty

Corcept advances uncertainty as a ground for demurrer.  Its argument on this ground is limited to two sentences of its opening memorandum, without citation to authority.  (See Demurrer Memo. at p. 23.)  The Court treats this ground for demurrer as waived.

III.       Ovarian Cysts

Corcept renews its argument that Plaintiff’s claims relating to ovarian cysts are preempted.  First, it points to page 129 of a Medical Review conducted by the FDA’s Center for Drug Evaluation and Research.  (RJN, Ex. D.)  It contends page 129 shows the FDA was aware of a risk of ovarian cysts caused by Korlym use at the time Korlym was approved, meaning the claims are preempted.

The Court rejected this argument in connection with Corcept’s demurrer to the 2AC.  As previously explained: “Plaintiff also alleges an increased risk of ovarian cysts that was unknown to the FDA at the time of approval.  The CDER’s medical review notes that ovarian cysts were screened for in the trials, but it does not discuss any risks associated with ovarian cysts.  (See RJN, Ex. D, at pp. 129-133.)  Accordingly, the Court cannot conclude from judicially noticeable material that the FDA was aware of such risks at the time of approval.”  (ROA 95, at pp. 6-7.)  The Court sees no reason to depart from this analysis now, and Corcept provides none.  Again, the Medical Review states that researchers screened for ovarian cysts, but there is no mention of any causal relationship between Korlym use and ovarian cysts.

Second, Corcept points to the Pharmacology Review conducted by the CDER.  According to the Pharmacology Review, a study of Korlym use in albino laboratory rats found an increase in follicular ovarian cysts at doses greater than 5 milligrams per kilogram of body weight.  (RJN, Ex. F, at p. 27.)  At the demurrer stage, this study is insufficient to meet Corcept’s burden, because it invites further questions.  For example, do rats have the same reaction to Korlym as humans?  The Court cannot discern the import of this study without improper resort to extrinsic material, so it is not a viable ground for demurrer.

For these reasons, Plaintiff has adequately pled the applicability of the CBE regulation to her ovarian cyst claims at this stage.  A demurrer does not lie to a portion of a cause of action, so Corcept’s demurrer is overruled.  Its motion to strike allegations pertaining to ovarian cysts is denied.

IV.         Endometrial Changes

Plaintiff previously agreed to strike allegations relating to endometrial changes.  These were re-added by the 4AC.  The Court already found them preempted in the 2AC, so the only way to get around this is if the CBE regulation applies.

Plaintiff’s alleged trigger for the CBE regulation is a collection of “adverse event reports” turned over in discovery, specifically FDA MedWatch reports and FDA Federal Adverse Event Reporting System (“FAERS”) reports.  (See 4AC, ¶¶ 22, 24; see also Opp. at p. 10, citing Moccio Decl. Exs. D-G [MedWatch and FAERS reports].) 

Corcept argues that “adverse event reports” don’t qualify as relevant “newly acquired information” in the first place, and thus don’t trigger the CBE regulation.  More background of the CBE regulation is needed to understand this argument. 

A.           CBE Regulation

Under the CBE regulation, the manufacturer may change a label without FDA approval to “add or strengthen a contraindication, warning, precaution, or adverse reaction” if there is sufficient “evidence of a causal association” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.”  (21 C.F.R. § 314.70(c)(6)(a)(iii)(A), (C).)  But such changes may only be made to “reflect newly acquired information.”  (21 C.F.R. § 314.70(c)(6)(a)(iii).)

The full definition of “newly acquired information” is “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.”  (21 C.F.R. § 314.3(b).)  It would appear, at first blush, that adverse event reports are literally covered by “newly acquired information,” which includes “reports of adverse events.”

But not all “newly acquired information” can trigger the CBE regulation.  As relevant here, it allows “[c]hanges in the labeling to reflect newly acquired information . . . [t]o 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 under § 201.57(c) of this chapter.”  (21 C.F.R. § 314.70(c)(6)(a)(iii)(A).)  That regulation, in turn, provides in relevant part: “In accordance with §§ 314.70 and 601.12 of this chapter, the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.”  (21 C.F.R. § 201.57(c)(6)(i).)

Reading these regulations together, “newly acquired information” only triggers the CBE regulation if it provides “reasonable evidence of a causal association” between a “clinically significant hazard” and “a drug.” 

B.           Application

Corcept’s argument is that adverse event reports, standing alone, are insufficient as a matter of law to provide reasonable evidence of a causal association between the adverse event and the drug.  This finds strong support in the authorities Corcept cites, particularly Gayle v. Pfizer Inc. (S.D.N.Y. 2020) 452 F. Supp.3d 78.  That case explains why adverse event reports about Lipitor users being diagnosed with diabetes were insufficient to trigger the CBE regulation:

These adverse event reports do not constitute “newly acquired information.” In order to qualify as “newly acquired information,” the information must demonstrate “reasonable evidence of a causal association with a drug ....” 21 C.F.R. § 201.57. But “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44, 131 S.Ct. 1309, 179 L.Ed.2d 398 (2011). The reports describe instances where patients taking Lipitor were diagnosed with type 2 diabetes but do not reach any conclusions regarding a causal association. Under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute “newly acquired information.”  (Gayle, supra, 452 F.Supp.3d at p. 88.)

The Court finds this argument persuasive.  All Plaintiff offers are reports that (1) a person took Korlym and (2) that person subsequently suffered endometrial changes that required a hysterectomy.  The reports themselves do not offer any analysis tending to indicate causation.  As a result, they are insufficient to trigger the CBE regulation.

Plaintiff offers two rejoinders.  The first is that Corcept’s case law is simply wrong: “Corcept argues that such reports are ineffective to trigger such a duty based on the recent reasoning of certain courts outside of this jurisdiction.  [Citations.]  First, Plaintiff asserts that these decisions are wrongly decided as they beg the question of how the needed information regarding causation is to be garnered by the plaintiff in the absence of discovery.”  (Demurrer Opp. at pp. 11-12.)  But Plaintiff points to no decision that comes out the other way.  This is simply a plea to reject the only authority before the Court.  In any event, the Court does not see why formal discovery is needed to establish a causal connection. 

Plaintiff’s second argument is that there’s already an admitted causal connection between the use of Korlym and endometrial changes. Plaintiff contends that the adverse event reports contain newly acquired information about the severity of the changes, specifically, that they could be severe enough to require a hysterectomy.   But as discussed in the order on Corcept’s demurrer to the 2AC, the CDER’s Medical Review said three of the four patients who developed endometrial thickening as a result of Korlym use got hysterectomies.  If the FDA was aware that 75% of Korlym patients who experienced endometrial changes were forced to get hysterectomies, the Court does not see what the adverse event reports would add to the FDA’s awareness of severity.

As a result, the Court concludes the CBE regulation doesn’t apply to Plaintiff’s claims about endometrial changes.  The motion to strike is granted as to these allegations, which are preempted by federal law.  (See PH II, Inc., supra, 33 Cal.App.4th at pp. 1682-1683 [“We conclude that when a substantive defect is clear from the face of a complaint . . . a defendant may attack that portion of the cause of action by filing a motion to strike.”].)