Judge: John C. Gastelum, Case: 20-01138157, Date: 2023-11-01 Tentative Ruling
(1) Demurrer to Second Amended Complaint (SAC) (2) Motion to Strike (3) CMC
Tentative Ruling: Defendant Pfizer Inc. (“Pfizer”) demurs to the SAC of Plaintiff Maria Rodriguez (“Plaintiff”) and moves to strike certain allegations of the same.
As an initial matter, the Court notes Plaintiff filed the Opposition papers one day after the deadline. However, Pfizer was able to file substantive Replies on the merits in support of both the Demurrer and Motion to Strike. Thus, any objection by Pfizer has been effectively waived and Pfizer has not been prejudiced.
Request for Judicial Notice:
Pfizer requests judicial notice of the following:
(1) The Inflectra label and medication guide in place since April 2016; and
(2) The FDA’s website regarding Tumor Necrosis Factor blockers.
The Request for Judicial Notice as to Exhibit 2 (the FDA’s website regarding Tumor Necrosis Factor blockers) is DENIED. The document is not relevant to the determination of the issues. (State Compensation Ins. Fund v. ReadyLink Healthcare, Inc. (2020) 50 Cal.App.5th 422, 442-443.)
The Request for Judicial Notice as to Exhibit 1 is GRANTED. (Evid. Code, § 452(h); Sciortino v. PepsiCo, Inc. (N.D. Cal. 2015) 108 F.Supp.3d 780, 79, fn. 2 [granting judicial notice of product labels referred to in the pleading and placed in issue by the plaintiffs’ claims].)
Demurrer:
The claims alleged against Pfizer in the SAC are the Second COA (Products Liability) and Third COA (Negligence).
The SAC alleges Pfizer is a pharmaceutical company involved in researching, manufacturing, distributing, and selling Inflectra and/or Remicade. (SAC, ¶ 30.) On December 10, 2018, December 27, 2018, January 24, 2019, and March 11, 2019, Inflectra and/or Remicade were in use at Arthritis & Osteoporosis Medical Center and being used in a reasonably foreseeable manner. (SAC, ¶¶ 40-41.) The products failed due to a defect in design, manufacture, production, and installation, and Plaintiff’s son, David Rodriguez, died as a direct and proximate result thereof. (SAC, ¶¶ 41-42.) Further, the medication was defective due to being manufactured and designed to deliver dangerously high doses of medication that could lead to infection and sepsis. (SAC, ¶ 47.)
The SAC further alleges that Inflectra and/or Remicade were defective due to inadequate warnings or instruction for use both prior to marketing and post-marketing. (SAC, ¶ 45.) Pfizer knew or should have known that the products created significant risks of serious bodily harm and death to consumers and failed to warn consumers and their healthcare providers of such risks. (Ibid.) Pfizer failed to disclose that the medication should not be provided to a patient that is morbidly obese and/or immune compromised. (SAC, ¶ 47.) Decedent used the products as a result of Pfizer’s failure to provide adequate warnings. (SAC, ¶ 46.)
In support of the Negligence Cause of Action, the SAC alleges Pfizer had a duty to exercise reasonable care in the preparation, design, research, development, manufacture, inspection, labeling, marketing, promotion, and sale of the medication, including a duty to warn. (SAC, p. 12, ¶¶ 12-13.) It further alleges that Pfizer breached the standard of care in failing to disclose that the medication may cause serious and permanent injury/death, failing to provide adequate instructions for the safe use of the medication, failing to disclose that the medication should not be provided to a patient who is morbidly obese and/or immune compromised, and delivering dangerously high doses of medication that could lead to infection and sepsis. (SAC, pp. 12-13, ¶ 15.)
Failure to Warn:
Pfizer argues both causes of action against it fail to the extent they are based on a failure to warn theory of liability because the Inflectra label adequately warned of the risks of injuries Plaintiff attributes to the medication: risk of severe illness and death, serious infection, malignancies, heart failure, cardiovascular risks, the impact of diabetes on infection risk, and the need to monitor patients taking Inflectra.
However, Plaintiff has also alleged that Pfizer failed to provide adequate warnings that the medication should not be provided to a patient who is morbidly obese and/or immune compromised. Pfizer’s Demurrer is silent as to Inflectra’s adequacy of warning of these alleged risks. Further, the Demurrer makes no mention of the adequacy of any warning label for Remicade, which Pfizer is also alleged to have manufactured. Moreover, the Court notes the cases cited by Pfizer in support of its argument are procedurally distinguishable from this matter, which is still in the pleadings stage. (See Temple v. Velcro USA, Inc. (1983) 148 Cal.App.3d 1090, 1091 [summary judgment]; Kearl v. Lederle Laboratories (1985) 172 Cal.App.3d 812, 817 [appeal after jury trial].)
Because Pfizer has failed to address warnings related to Remicade and all the alleged failures to warn as to Inflectra, the Court rejects Pfizer’s argument that Plaintiff’s claims are barred due to adequate warning.
Pfizer also argues that the failure to warn theory fails because federal law preempts any allegation that it should have included different or additional warnings in the FDA-approved Inflectra label. Pfizer states it cannot change its FDA-approved label without the express approval of the FDA and, therefore, claims seeking to impose civil liability based on a purported inadequacy of the label are barred by the doctrine of impossibility preemption.
Pfizer cites to PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 620. There, the United States Supreme Court held that claims that a generic drug manufacturer should have included stronger warning labels imposed an impossible standard on the manufacturer, which was required to use a label equivalent to the brand-name drug’s label on its own generic drugs. Because the manufacturer could not comply with both its duty under federal law to match the brand-name label and the claimed duty under state law to provide stronger warning labels, such a state requirement would be preempted by federal law. (Ibid.)
The Court noted that whether a brand-name drug or a generic drug is at issue changes the outcome. Had the respondents there been prescribed the brand-name drug by their doctors, their lawsuits would not be pre-empted. (Id., at p. 625; accord T.H. v. Novartis Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 158 [“Because federal regulations preclude generic manufacturers from unilaterally altering the warning labels on their drugs [citation], federal law preempts state tort claims against generic manufacturers for failure to provide adequate warnings. [Citation.] State tort claims against a brand-name manufacturer based on a failure to warn, however, are not preempted.].)
Here, nothing on the face of the SAC nor the judicially noticed document demonstrates whether Inflectra and Ramicade are generic or brand-name drugs. Thus, the Court cannot conclude that Plaintiff’s failure to warn claims are preempted by federal law.
Given the above, the Court OVERRULES the Demurrer on this ground.
Design Defect:
Pfizer argues both causes of action against it fail to the extent they are based on a design defect theory of liability because: (1) Pfizer cannot be held strictly liable for an alleged design defect in Inflectra because California law prohibits such a claim against the manufacturer of a prescription medication; and (2) federal law preempts a negligent design defect theory to the extent Plaintiff’s allegations are based on the assertion that Pfizer had a duty to submit some other product for FDA approval.
The SAC does not allege Pfizer had any duty to submit some other product for FDA approval. Rather, it alleges Inflectra was defective due to being manufactured and designed to deliver dangerously high doses of medication that could lead to infection and sepsis and due to inadequate warnings or instruction for use both prior to marketing and post-marketing. Prescription drug manufacturers may be liable under general principles of negligence and for failure to warn of known or reasonably knowable side effects. (Brown v. Superior Court (1988) 44 Cal.2d 1049, 1069, fn. 12; Trejo v. Johnson & Johnson (2017) 13 Cal.App.5th 110, 144.)
Because Pfizer has not shown Plaintiff’s design defect theory based on negligent design defect should be dismissed, the Demurrer on this ground is OVERRULED. The Court need not address Pfizer’s arguments regarding strict liability against a manufacturer of prescription medication or manufacturing defect, as those arguments would not dispose of either of Plaintiff’s causes of action. (See Elder v. Pacific Bell Telephone Co. (2012) 205 Cal.App.4th 841, fn. 14 [“ ‘Ordinarily, a general demurrer does not lie as to a portion of a cause of action and if any part of a cause of action is properly pleaded, the demurrer will be overruled.’ ”].)
Causation:
Pfizer last argues that Plaintiff’s allegations fail for lack of causation because they refer to risks associated with pain pumps, anesthetics, and over-delivery of medication, and Inflectra is not a pain pump, anesthetic, or a mechanism used to deliver any medication.
The SAC alleges that, as a direct and proximate result of the conduct alleged against Defendants, the Decedent sustained severe and serious injury resulting in his death and Plaintiff incurred expenses for ambulances, hospital and medical services, and funeral and burial services. (SAC, ¶¶ 48, 50.) Construing the allegations in the SAC liberally and as a whole, the Court finds that causation has been adequately alleged.
Thus, the Court OVERRULES the Demurrer in its entirety.
Motion to Strike:
Entire SAC
Pfizer first argues the SAC should be struck in its entirety because Plaintiff filed it a day late. Pfizer argues Plaintiff was granted 20 days’ leave to amend and Pfizer served a notice of ruling on July 27, 2022 by electronic service, making Plaintiff’s SAC due on August 18, 2022.
Plaintiff argues the SAC was timely filed. Plaintiff calendared 20 days plus 2 days based on the July 28, 2022 hearing, which made the deadline August 19, 2022.
The Minute Order sustaining Pfizer’s Demurrer to the FAC is dated July 28, 2022. (ROA 207.) Pfizer’s July 27, 2022 notice gave Plaintiff notice of the Court’s tentative ruling, which did not become an order until July 28, 2022. (ROA 204.) Thus, the Court finds that Plaintiff’s SAC was timely filed based on the July 28, 2022 hearing date.
Irrelevant Allegations:
Pfizer alternatively moves to strike allegations wherein Plaintiff alleges Inflectra and/or Remicade is “a testosterone replacement therapy,” that Pfizer had a duty to warn all health care providers and consumers of the risks, dangers, and adverse side effects of pain pumps and the anesthetics used in the pumps, and that Pfizer should be liable for manufacturing a product designed to deliver dangerously high doses of medication that could lead to infection and sepsis.
Pfizer argues these allegations have no connection to Inflectra or Plaintiff’s claims and are therefore irrelevant and should be stricken.
Pfizer argues allegations that Inflectra was negligently designed to deliver dangerously high doses of the medication, which may lead to infection and sepsis, should be stricken. Pfizer assumes this allegation necessarily means Inflectra was a medical device designed to deliver medication to patients. However, another interpretation of the allegation is that the drug itself was designed in such a way so as to allow for delivery of dangerously high doses to patients. Thus, the Court DENIES the Motion as to allegations that Pfizer should be liable for manufacturing a product designed to deliver dangerously high doses of medication that could lead to infection and sepsis.
As to the remaining allegations, Plaintiff concedes that “testosterone replacement therapies” and “pain pumps and the anesthetics used in the pumps” should be stricken and Plaintiff requests leave to amend those portions of the complaint to correct typographical errors.
Thus, the Court GRANTS the Motion with 20 days’ leave to amend as to these allegations only.
Pfizer to give notice.