Judge: William D. Claster, Case: 19-01121146, Date: 2022-07-28 Tentative Ruling

Plaintiff’s Motion for Leave to File a Fourth Amended Complaint

Plaintiff Maren S. Miller’s motion for leave to file a Fourth Amended Complaint (4AC) is GRANTED.  Plaintiff is to file and serve the proposed 4AC (ROA 201, Ex. H) by August 5, 2022.

A court “may, in the furtherance of justice . . . allow a party to amend any pleading.”  (CCP § 473(a)(1).)  “[C]ourts are bound to apply a policy of great liberality in permitting amendments to the complaint at any stage of the proceedings, up to and including trial.”  (Magpali v. Farmers Group, Inc. (1996) 48 Cal.App.4th 471, 487.)  But the policy of liberality does not apply “[w]here inexcusable delay and probable prejudice to the opposing party is shown.”  (Estate of Murphy (1978) 82 Cal.App.3d 304, 311.)  Leave to amend may be denied where amendment would be futile (see Foxborough v. Van Atta (1994) 26 Cal.App.4th 217, 230), but “the preferable practice would be to permit the amendment and allow the parties to test its legal sufficiency by demurrer, motion for judgment on the pleadings or other appropriate proceedings.”  (Kittredge Sports Co. v. Superior Court (1989) 213 Cal.App.3d 1045, 1048.)

The principal purpose of Plaintiff’s proposed amendment is to return to the complaint allegations previously struck from the complaint by stipulation.  By way of background, this is a case largely sounding in failure to warn of dangers associated with a Korlym, a brand-name prescription drug.  As explained in the Court’s prior rulings, drug warning labels are closely regulated by the FDA, and state law failure to warn claims are largely preempted to the extent a plaintiff argues a warning label should be worded differently from the label approved by the FDA.  Plaintiff contends her failure to warn claims fall within a recognized exception to the general preemption rule called the “changes being effected” or “CBE” regulation.  As relevant here, under the CBE regulation, a manufacturer may update a warning label without prior FDA approval if it learns of new information indicating evidence of a causal association between the drug and adverse reactions.  Plaintiff contends that Defendants acquired new information about adverse reactions caused by Korlym use after the FDA approved the warning label, and that they should have updated the label under the CBE regulation.

Defendants moved to strike the allegations at issue from the 3AC, contending that the specific adverse reactions alleged were not “newly acquired information.”  (Other adverse reactions remained in the complaint; the case has focused on them.)  Rather than oppose the motion to strike, Plaintiff stipulated to strike the allegations, but she specifically reserved the right to seek leave to replead them if justified after discovery.  (See ROA 117.)

Defendants offer two arguments against amendment.  First, they argue the proposed amendment is futile because the repled allegations are preempted by federal law.  As Kittredge Sports Co. explains, however, the better practice is to test the amendment’s legal sufficiency by demurrer or motion for judgment on the pleadings.  The Court will follow that course here.

Second, Defendants argue Plaintiff has unduly delayed seeking amendment.  But as Estate of Murphy explains, denial is appropriate only with inexcusable delay and prejudice to the opposing party.  Defendants have not shown the prejudice necessary to justify denial, for the following reasons:

• Defendants argue they will be prejudiced if the Court allows Plaintiff to replead allegations it already found wanting.  But Defendants stipulated to allow Plaintiff to seek leave to replead these allegations.  Defendants can hardly claim prejudice from Plaintiffs seeking the very relief Defendants stipulated they could seek.  Furthermore, while Defendants moved to strike these allegations, they were ultimately struck by stipulation, not because the Court found them wanting.

• Defendants argue they will be prejudiced if Plaintiff is allowed to replead the allegations without sufficiently alleging “newly acquired information.”  This simply restates the futility argument, which is better suited for demurrer.

• Defendants express concern that they will not have sufficient time to mount a pleadings challenge before the current trial date of November 28, 2022.  If Defendants believe they will not have time to mount a pleadings challenge, this prejudice can easily be cured by a trial continuance.  As the deadline to bring this case to trial is no earlier than December 2024, there is more than enough time to continue the trial for pleadings challenges and whatever discovery has not yet been taken to prepare the case for trial.