Judge: Donald F. Gaffney, Case: Westland v. Providence, Date: 2022-10-19 Tentative Ruling
TENTATIVE RULINGS:
Demurrer
Defendants Merck & Co., Inc. and Merck Sharp & Dohme LLC’s (“Defendants” or the “Merck Defendants”) Demurrer to the First Amended Complaint is SUSTAINED in part and OVERRULED in part. To the extent the demurrer is sustained, Plaintiffs are granted 30 days leave to amend after service of notice of ruling.
The Merck Defendant’s request for judicial notice is granted.
General Principles
A demurrer presents an issue of law regarding the sufficiency of the allegations set forth in the complaint. (Lambert v. Carneghi (2008) 158 Cal.App.4th 1120, 1126.) The challenge is limited to the “four corners” of the pleading (which includes exhibits attached and incorporated therein) or from matters outside the pleading which are judicially noticeable under Evidence Code §§ 451 or 452. Although California courts take a liberal view of inartfully drawn complaints, it remains essential that a complaint set forth the actionable facts relied upon with sufficient precision to inform the defendant of what plaintiff is complaining, and what remedies are being sought. (Leek v. Cooper (2011) 194 Cal.App.4th 399, 413.)
On demurrer, a complaint must be liberally construed. (CCP § 452; Stevens v. Superior Court (1999) 75 Cal.App.4th 594, 601.) All material facts properly pleaded, and reasonable inferences, must be accepted as true. (Aubry v. Tri-City Hospital Dist. (1992) 2 Cal.4th 962, 966-67.)
A pleading is adequate if it contains a reasonably precise statement of the ultimate facts, in ordinary and concise language, and with sufficient detail to acquaint a defendant with the nature, source and extent of the claim. The degree of detail required depends on the extent to which the defendant in fairness needs such detail which can be conveniently provided by the plaintiff. Less particularity is required when the defendant ought to have co-extensive or superior knowledge of the facts. Under normal circumstances, there is no need for specificity in pleading evidentiary facts. However, bare conclusions of law are insufficient. (CCP §§ 425.10(a), 459; Doe v. City of Los Angeles (2007) 42 Cal.4th 531, 549-50; Zelig v. County of Los Angeles (2002) 27 Cal.4th 1112, 1126; Doheny Park Terrace HOA v. Truck Ins. Exchange (2005) 132 Cal.App.4th 1076, 1098-99; Berger v. California Insurance Guarantee Assn (2005) 128 Cal.App.4th 989, 1006.)
Special demurrers based on uncertainty are rarely sustained – only where the complaint is so bad that defendant cannot reasonably respond—i.e., he or she cannot reasonably determine what issues must be admitted or denied, or what counts or claims are directed against him or her. (See Khoury v. Maly's of Calif., Inc. (1993) 14 Cal.App.4th 612, 616.) However, a demurrer for uncertainty may lie if the failure to label the parties and claims renders the complaint so confusing defendant cannot tell what he or she is supposed to respond to. (See Williams v. Beechnut Nutrition Corp. (1986) 185 Cal.App.3d 135, 139.)
The Demurrer to all Causes of Action (“COA”)
Defendant Merck Sharp & Dohme LLC contends that other than identifying it as a defendant in the caption, the FAC is devoid of facts against it. Defendant is correct as it is not mentioned again in the FAC. Plaintiffs concede this point and admit this was in error and request leave to amend. Accordingly, the demurrer by Defendant Merck Sharp & Dohme LLC is SUSTAINED with leave to amend.
The remainder of this analysis addresses Merck & Co. Inc.’s arguments.
Uncertainty
The demurring defendants are correct in that this FAC contains few facts. Further, as evidenced by the Opposition, the plaintiffs clearly have additional fact that would shed light on the facts/circumstances surrounding this action. However, there is no authority to support the defendants’ position that the FAC must be pleaded with specificity, such as for claims of fraud. Thus, as noted above, complaints are liberally construed and the plaintiffs need only plead ultimate (as opposed to evidentiary) facts.
Further, although the FAC uses the general term of “defendants” throughout the FAC, each COA is clearly labeled and specifically identifies the defendants against whom each claim is brought. The FAC is not so uncertain that the Merck Defendants cannot reasonably respond. This is an unverified FAC, and the Merck Defendants know enough that they could file a general denial.
Based upon the foregoing, the demurrer on this ground is OVERRULED.
Second COA for Products Liability
Merck & Co. contends that this COA is generically labeled and products liability encompasses both strict liability and negligence causes of action that may be based on an alleged defect in the design, manufacture, or warnings of a product. Merc, & Co. argue this COA fails for two reasons.
First, it fails to plead facts sufficient to infer a causal link between any alleged defect related to Keytruda and Plaintiffs’ damages, which is required under all theories of products liability. Second, it fails to identify any actionable defect on which any of the three basic theories of products liability could rest – to the extent Plaintiffs’ allege design defect claims, those claims are preempted by federal law, and the FAC fails to provide any material facts to support claims of either a manufacturing defect or a deficiency in Keytruda’s warnings (which are also preempted by federal law).
In Opposition, Plaintiffs contend that this cause of action sufficiently pleads a claim for strict liability – failure to warn, and the claims are not preempted.
1. Causation
California applies the learned intermediary doctrine to prescription drug warning claims, so Merck & Co. duty to warn runs to Plaintiff’s doctor, not to her. (See Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 361, fn. 6.) “A plaintiff asserting causes of action based on a failure to warn must prove not only that no warning was provided or that the warning was inadequate, but also that the inadequacy or absence of the warning caused the plaintiff’s injury.” (Motus v. Pfizer, Inc. (C.D.Cal. 2001) 196 F.Supp.2d 984, 991 [applying California law].) That is, “a defendant is not liable to a plaintiff if the injury would have occurred even if the defendant had issued adequate warnings.” (Huitt v. Southern California Gas Co. (2010) 188 Cal.App.4th 1586, 1604.)
Plaintiffs FAC alleges that the pharmaceutical drug at issue is Keytruda and/or Pembrolizumab, an immunotherapy medication to treat cancer. (FAC ¶ 46.) Merck designed, researched, manufactured, tested, advertised, promoted, marketed, sold and distributed the Keytruda at issue. (Id. at ¶ 47). The medication was being used in a reasonably foreseeable manner, failed, and Plaintiffs sustained injuries as a direct result thereof. (Id. at ¶ 49.) Keytruda and/or Pembrolizumab was defective due to inadequate warnings or
instruction for use, both prior to marketing and post-marketing. (Id. at ¶ 52). The FAC also alleges that the drug had potential risks or side effects that were known or should have been known by Merck. (Ibid); that Keytruda and/or Pembrolizumab created significant risks of serious bodily harm and death to the consumers. (Ibid); and that resulting failures were the direct and proximate cause of Plaintiffs severe and serious injury. (FAC pg. 10, ¶ 54-57).
Here, while the FAC alleges the warnings were deficient, the FAC is devoid of allegations indicating that if her doctor had gotten a proper warning, he/she would not have prescribed the medication at issue. Plaintiff makes no allegation about what the doctor would have done with a proper warning or that there was any reliance on an alleged improper warning. Accordingly, the FAC fails to allege causation and the demurrer to this cause of action is SUSTAINED.
2. Preemption
A. FDA Approval Process
No new drug may be sold or marketed in the US unless it has been approved by the FDA. (21 U.S.C. § 355(a).) Approval is governed by the New Drug Approval (“NDA”)process. (21 U.S.C. § 355(b).) Approval may only be granted if the drug is both safe and effective for its intended use. (21 U.S.C. § 355(b)(1)(A).) With limited exceptions, once a new drug is approved, the manufacturer may not change “the qualitative or quantitative formulation of the drug product, including inactive ingredients” from “the specifications provided in the approved NDA” without prior FDA approval. (21 C.F.R. § 314.70(b)(2)(i).)
The NDA process also includes approval of warning labels. (21 U.S.C. § 355(b)(1)(F).) The principal warning label, referred to as a “package insert,” is principally directed at physicians, for a drug manufacturer’s duty to warn runs to the physician. (See 21 C.F.R. §§ 201.56, 201.57 [contents of package insert]; Rivera v. First DataBank, Inc. (2010) 187 Cal.App.4th 709, 713 [“package inserts [are] directed at physicians”]; Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 361, fn. 6 [manufacturer’s duty to warn runs to physician].) For some drugs that have serious side effects, the manufacturer must also create “medication guides” directed at pharmacies. (21 C.F.R. §§ 208.1, 208.24.) The FDA must approve medication guides to ensure they are consistent with the corresponding package inserts. (21 C.F.R. § 208.20(a)(2).)
As with changes to the drug itself, changes to the label generally may not be made without prior FDA approval. (21 C.F.R. § 314.70(b)(2)(v).) There is, however, an exception relevant to this case: the changes being effected, or CBE, regulation. Under this regulation, the manufacturer may change a label without prior 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)), defined as “information not previously submitted to the” FDA. (21 C.F.R. § 314.3(b).)
It is undisputed that Keytruda and/or Pembrolizumab’s NDA and label were approved prior to Plaintiff’s use.
B. Preemption Standards
Under the Supremacy Clause of the United States Constitution, federal law is the supreme law of the land. (U.S. Const., art. VI, cl. 2.) Thus, when it is impossible for a party to simultaneously comply with both federal and state law, the state law is preempted, and the federal law controls. (Mutual Pharmaceutical Co., Inc. v. Bartlett (2013) 570 U.S. 472, 480.) This is referred to as implied preemption or conflict preemption.
In three relatively recent opinions, the United States Supreme Court explored the boundaries of implied preemption in the drug context. Wyeth v. Levine (2009) 555 U.S. 555 considered preemption of failure to warn claims against brand-name drug manufacturers. PLIVA, Inc. v. Mensing (2011) 564 U.S. 604 considered preemption of failure to warn claims against generic drug manufacturers. Mutual Pharmaceutical Co., Inc. v. Bartlett (2013) 570 U.S. 472 considered preemption of design defect claims against generic drug manufacturers.
Relying on Mutual Pharmaceutica and cases that followed, Merck & Co. argues that the failure to warn claim is preempted. Plaintiffs, in opposition, correctly note that the rules applying to brand-name and generic manufacturers are different, and claims that are preempted against generic manufacturers may not necessarily be preempted against manufacturers of brand-name drugs such as Merck.
Accordingly, Plaintiff may be able to state a cause of action for failure to warn if she can identify “newly acquired information” that should have resulted in a new warning under the CBE regulation. Otherwise, her claims may be preempted. Defendant is correct in that the FAC woefully fails to include any such facts. Accordingly, the demurrer to this cause of action is also SUSTAINED on this ground.
Third COA for Loss of Consortium
“A cause of action for loss of consortium is, by its nature, dependent on the existence of a cause of action for tortious injury to a spouse…. [I]t stands or falls based on whether the spouse of the party alleging loss of consortium has suffered an actionable tortious injury.” (Hahn v. Mirda (2007) 147 Cal.App.4th 740, 746.) Accordingly, the demurrer to this cause of action is SUSTAINED.
Misjoinder
This ground for demurrer is typically based upon a claim that the plaintiffs lack sufficient unity of interest (CCP § 378); or there is no common question of law or fact as to the defendants (CCP § 379). While the Code seemingly authorizes demurrer on this ground without any such showing, case law is apparently to the contrary: i.e., a demurrer for misjoinder will be overruled if the defendant shows no prejudice suffered or interests impaired by the misjoinder. See Anaya v. Superior Court (1984) 160 Cal.App.3d 228, 231.
Defendant argues that there is no common question of law or fact as to the defendants. Defendant argues the professional healthcare defendants were joined to this matter in order to keep this matter in state court, and therefore the Merck Defendants are deprived of their right to have this matter heard in federal court.
Nothing in the FAC establishes that there is a misjoinder of parties. The FAC alleges common questions of fact and the same transactions or occurrence as Plaintiffs claims arise from Plaintiff Amy Westland’s medical care and treatment, which included the medication at issue, for which Plaintiffs allege caused them injury. Based upon the foregoing, the demurrer based on this ground is OVERRULED.
Should Plaintiffs wish to file a Second Amended Complaint to address this ruling, they must file it within 30 days of service of notice of ruling.
Moving Parties to give notice.
Motion to Strike
Defendants Merck & Co., Inc. and Merck Sharp & Dohme LLC’s (“Defendants” or the “Merck Defendants”) Motion to Strike Portions of the First Amended Complaint is GRANTED with 30 days leave to amend.
The Merck Defendant’s request for judicial notice is granted.
Here, Defendants move to strike the word “design” from the FAC on the grounds that allegations of design defects are preempted by federal law.
In Opposition, Plaintiffs argue that allegations regarding failure to warn is not preempted. As noted in Reply, Plaintiffs miss the point of the motion to strike.
The design defect theory could sound in failure to warn, insofar as the alleged defect is a warning label inadequate as designed. But it could also sound in a drug that is unacceptably unsafe as designed, i.e., the Merck Defendants should have formulated a different drug with fewer risks. Which, if either, of these is alleged, is unclear from the FAC. Nevertheless, the motion to strike is granted based upon the same authority noted in the demurrer, above, with regard to preemption.
Moving Parties to give notice.