Judge: Richard Y. Lee, Case: 30-2020-01145357, Date: 2022-09-29 Tentative Ruling

Defendant Pfizer Inc. (“Pfizer”) seeks an order sustaining its demurrer to the 1-3rd causes of action of Plaintiff Michael Walsh’s First Amended Complaint based on failure to state sufficient facts to constitute a cause of action, without leave to amend. [Cal. Code Civ. Proc. § 431.10(e).]

1st Cause of Action – Medical Negligence

As to the 1st cause of action for Medical Negligence, “[C]ourts have broadly construed ‘professional negligence’ to mean negligence occurring during the rendering of services for which the health care provider is licensed.” [Arroyo v. Plosay (2014) 225 Cal.App.4th 279, 297.] However, in the First Amended Complaint ¶4, Plaintiff defines Defendant Pfizer as a manufacturer of products, and not as a health care provider. As such, Defendant argues that Plaintiff does not, and indeed cannot, allege that Pfizer had any role in providing medical care to him. [See First Amended Complaint¶¶18-21.]  Plaintiff fails to respond to Defendant’s argument. Indeed the opposition does not address Defendant’s demurrer to the 1st cause of action.

Plaintiff’s failure to oppose the Demurrer to the 1st cause of action for Medical Negligence can be treated as an implied concession to the merits of the same.  [Herzberg v. County of Plumas (2005) 133 Cal.App.4th 1, 20.]  Additionally, the Court may construe the absence of a memorandum as waiver of all grounds not supported.  [CRC 3.1113(a).] Furthermore, the demurrer to this cause of action has merit based on the facts pleaded in the First Amended Complaint.

Therefore, the demurrer to the 1st cause of action for Medical Negligence is SUSTAINED without leave to amend.

2nd Cause of Action – Products Liability – Failure to Warn

As to the 2nd cause of action for Products Liability—Failure to Warn, initially, both sides seemingly agree that in the case of prescription drugs, the duty to warn runs to the physician, not to the patient. [See Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1116.] Thus, as set forth in the case cited by Plaintiff, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.” [Motus v. Pfizer Inc. (C.D. Cal. 2001) 196 F.Supp.2d 984, 990–991, aff'd sub nom. Motus v. Pfizer Inc. (Roerig Div.) (9th Cir. 2004) 358 F.3d 659.] This concept is the “learned intermediary doctrine.” [Id.] To that end, Plaintiff pleads in the 2nd cause of action the following:

“12. In 2019, WALSH experienced a low back flare up and was recommended to undergo a lumbar epidural injection (the “Injection”) under the care of DEFENDANTS, and each of them.

“13. The specific medications given to WALSH on or about July 20, 2019 were Bupivacaine and Methylprednisolone. These medications were used to treat pain present on WALSH’s body.

“21. As a direct, legal and proximate cause of DEFENDANTS’, and each of them, breach of duty, WALSH has been rendered a wheelchair bound paraplegic and has suffered damages as a result thereof.

“23. Defendant PFIZER’s products were defective and unreasonably dangerous when they left the possession of the Defendants in that they contained warnings insufficient to alert consumers, including Plaintiff, of the dangerous risks associated with the subject product, including but not limited to the risk of paralysis, loss of feeling throughout the body, loss of use of the legs, and cognitive defect which are associated with and did cause serious injury.

“24. Information provided by PFIZER to the medical community and to consumers concerning the safety and efficacy of its medication did not accurately reflect the serious and potentially fatal adverse effect Plaintiff did and can suffer.”

However, Defendant Pfizer argues that as a matter of law, the warnings it provided on the label for the specific medications at issue, Bupivacaine and Methylprednisolone, used to treat Plaintiff’s pain (First Amended Complaint¶13) were sufficient. That is, Defendant does not argue Plaintiff fails to state sufficient facts to support a specific element of the cause of action; but rather, that “An adequate warning is a sufficient defense to a strict liability action.” [Temple v. Velcro USA, Inc. (1983) 148 Cal.App.3d 1090, 1094.]

Notably, “Although a general demurrer does not ordinarily reach affirmative defenses, it ‘will lie where the complaint ‘has included allegations that clearly disclose some defense or bar to recovery.’ ” [Ivanoff v. Bank of America, N.A. (2017) 9 Cal.App.5th 719, 726.]

To support its argument, Defendant requests judicial notice of the drugs’ labeling as located on the FDA’s website. “When a court is required to rule on a demurrer, the discretion provided by Evidence Code section 452 allows the court to take judicial notice of a fact or proposition within a recorded document “ ‘that cannot reasonably be controverted, even if it negates an express allegation of the pleading.” [Jenkins v. JPMorgan Chase Bank, N.A. (2013) 216 Cal.App.4th 497, 536, as modified (June 12, 2013) disapproved of by Yvanova v. New Century Mortgage Corp. (2016) 62 Cal.4th 919.]

In this instance, Plaintiff does not object to the request for judicial notice or otherwise challenge the authenticity of the documents.

As such, the Court grants judicial notice of Defendant’s Exs. 1 and 2, pursuant to Ca Evidence Code §452(h), “Facts and propositions that are not reasonably subject to dispute and are capable of immediate and accurate determination by resort to sources of reasonably indisputable accuracy.”

As to Methylprednisolone, the label appearing on the FDA website states:

“WARNINGS Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.” [RJN, Ex. 1, page 4.]

As such, it appears Defendant warned of paraplegia (suffered by Plaintiff, FAC¶21) in the event this drug was used in connection with an epidural injection, as allegedly occurring herein. [FAC¶12,13.]

As to Bupivacaine, Defendant requests judicial notice of Ex. 2 page 10 of the FDA website. However, page 10 contains language relating to Dosage and Administration, and not necessarily specific warnings of side effects.

However, Ex. 2, page 8 does appear to list Adverse Reactions:

“Neurologic effects following spinal anesthesia may include loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness and paralysis of the lower extremities, and loss of sphincter control all of which may have slow, incomplete, or no recovery; hypotension, high or total spinal block…” [RJN Ex. 2, page 8]

As such, it appears Defendant warned of paralysis of the lower extremities, which Plaintiff appears to have suffered.

However, there is no argument before the Court that the “labels” which apparently appear on the FDA website, were in fact provided to the doctor, or that the doctor had notice of them.

Additionally, there is no solid authority cited by Defendant suggesting that the mere existence of the labels provided to the FDA, alone, is sufficient to constitute an adequate warning to the doctor.

Defendant also argues the defense of federal pre-emption. That is, Defendant argues that Plaintiff effectively seeks to impose a requirement of Pfizer to provide a different warning for these two FDA-approved medications. However, the Court cannot determine from the four corners of the First Amended Complaint and the matters judicially noticed that the Failure to Warn cause of action effectively seeks to change the warnings, or that federal pre-emption applies. 

All in all, because the Court cannot determine as a matter of law that there is a complete defense to the 2nd cause of action for Products Liability, the demurrer is OVERRULED.  It may in fact be the case that Defendant’s arguments are prematurely litigated in this demurrer proceeding, and are more appropriate by way of summary judgment or trial.

3rd Cause of Action – Products Liability – Design Defect

As to the 3rd cause of action for Products Liability—Design Defect, Defendant again argues what appears to be a defense. That is, Defendant argues pursuant to Brown v. Superior Court (1988) 44 Cal.3d 1049, 1069, California law has prohibited a plaintiff from alleging a design defect claim against the manufacturer of a prescription medication. Indeed, subsequent cases seem to have confirmed that, “The Supreme Court held that a manufacturer of a prescription drug could not be held strictly liable under a design defect theory.” [Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 357; see also  Patterson v. Bayer Healthcare Pharmaceuticals, Inc. (E.D. Cal., Feb. 24, 2015, No. 1:14-CV-01087-LJO) 2015 WL 778997, at *9, wherein the Court ruled,  “Because the instant action for design defect relates to an intrauterine device's administration of levonorgestrel—a prescription drug—the claim is precluded as a matter of law. Accordingly, the Court will grant Defendant's motion to dismiss as to Patterson's cause of action for strict liability—design defect (Claim II), without leave to amend.”]

Plaintiff fails to address either the defense argued by Defendant or the Brown case. As such, demurrer is SUSTAINED without leave to amend as to the 3rd cause of action for Products Liability-Design Defect.

Defendant to file an answer within 20 days.

Defendant to give notice.