Marroquin v. Pfizer, Inc.

367 F.Supp.3d 1152

Gilbert MARROQUIN, as Successor in Interest to Agapita Marroquin, Plaintiff

v.PFIZER, INC., Mylan Institutional Inc., and Does 2-25, Defendants

Case No. 1:18-CV-0974 AWI SAB

United States District Court, E.D. California.

Signed February 14, 2019

Justin Dennis Harris, Harris Law Firm, PC, Fresno, CA, for Plaintiff.

George J. Gigounas, Jeanette Barzelay, DLA Piper LLP (US), San Francisco, CA, Brooke Leanne Kim, DLA Piper LLP (US), San Diego, CA, Benjamin Thomas Nicholson, McCormick Barstow Sheppard Wayte & Carruth, LLP, Fresno, CA, Clem C. Trischler, Pro Hac Vice, Jason Reefer, Pro Hac Vice, Pietragallo Gordon Alfano Bosick & Raspanti LLP, Pittsburgh, PA, for Defendants.

ORDER ON DEFENDANTS' MOTION TO DISMISS

Anthony W. Ishii, SENIOR DISTRICT JUDGE

The case stems from the death of Agapita Marroquin after she had taken the generic prescription drug amiodarone. Plaintiff Gilbert Marroquin, Mrs. Marroquin's husband, brings seven claims under California law against Defendants Pfizer, Inc. ("Pfizer") and Mylan Institutional, Inc. ("Mylan") for strict products liability, negligence based products liability, breach of warranty, intentional misrepresentation, negligent misrepresentation, and concealment. The active complaint is the First Amended Complaint ("FAC"). Both defendants have filed a Rule 12(b)(6) motion to dismiss. For the reasons that follow, Defendants' motions will be granted.

RULE 12(b)(6) FRAMEWORK

Under Federal Rule of Civil Procedure 12(b)(6), a claim may be dismissed because of the plaintiff's "failure to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6). A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. See Mollett v. Netflix, Inc., 795 F.3d 1062, 1065 (9th Cir. 2015). In reviewing a complaint under Rule 12(b)(6), all well-pleaded allegations of material fact are taken as true and construed in the light most favorable to the non-moving party. Kwan v. SanMedica, Int'l, 854 F.3d 1088, 1096 (9th Cir. 2017). However, complaints that offer no more than "labels and conclusions" or "a formulaic recitation of the elements of a cause of action will not do." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ; Johnson v. Federal Home Loan Mortg. Corp., 793 F.3d 1005, 1008 (9th Cir. 2015). The Court is "not required to accept as true allegations that contradict exhibits attached to the Complaint or matters properly subject to judicial notice, or allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences." Seven Arts Filmed Entm't, Ltd. v. Content Media Corp. PLC, 733 F.3d 1251, 1254 (9th Cir. 2013). To avoid a Rule 12(b)(6) dismissal, "a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Mollett, 795 F.3d at 1065. "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Somers v. Apple, Inc., 729 F.3d 953, 959 (9th Cir. 2013). "Plausibility" means "more than a sheer possibility," but less than a probability, and facts that are "merely consistent" with liability fall short of "plausibility." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 ; Somers, 729 F.3d at 960. The Ninth Circuit has distilled the following principles for Rule 12(b)(6) motions: (1) to be entitled to the presumption of truth, allegations in a complaint or counterclaim may not simply recite the elements of a cause of action, but must contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively; (2) the factual allegations that are taken as true must plausibly suggest entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation. Levitt v. Yelp! Inc., 765 F.3d 1123, 1135 (9th Cir. 2014). In assessing a motion to dismiss, courts may consider documents attached to the complaint, documents incorporated by reference in the complaint, or matters subject to judicial notice. In re NVIDIA Corp. Sec. Litig., 768 F.3d 1046, 1051 (9th Cir. 2014). If a motion to dismiss is granted, "[the] district court should grant leave to amend even if no request to amend the pleading was made ...." Ebner v. Fresh, Inc., 838 F.3d 958, 962 (9th Cir. 2016). However, leave to amend need not be granted if amendment would be futile or the plaintiff has failed to cure deficiencies despite repeated opportunities. Garmon v. County of L.A., 828 F.3d 837, 842 (9th Cir. 2016).

BACKGROUND

From the Complaint, on April 15, 2016, through April 28, 2016, amiodarone¹ was administered orally and intravenously to Mrs. Marroquin at Kaweah Delta Medical Center. However, the amiodarone caused pulmonary disease and her resulting death on May 6, 2016. Amiodarone is listed as a cause of death on Mrs. Marroquin's death certificate. The admiodarone administered to Mrs. Marroquin was manufactured and distributed by Pfizer and Mylan.

Marroquin alleges that: (1) the amiodarone was defective at the time it left Defendants' control; (2) Defendants breached their duty of care regarding preparation, design, research, development, manufacture, inspection, labeling, market, promotion, and sale of amiodarone ; (3) Defendants' breached the warranty of suitability/fitness with respect to amiodarone ; (4) Defendants failed to adequately warn of amiodarone's potential risks; (5) Defendants intentionally or negligently misrepresented that amiodarone was safe, fit, and effective for human use; and (6) Defendants concealed the fact that amiodarone was not safe, fit, or effective for human use.

I. PFIZER'S MOTION

Defendant's Arguments

Pfizer argues that the FDA approved label for amiodarone /Cordarone clearly warns of the risks and dangers of developing pulmonary toxicity and that pulmonary toxicity was fatal 10% of the time. In fact, pulmonary toxicity is identified 15 times in the drug label. Each of FAC's claims depend on a finding that the warning label was inadequate. Because the warning label is clear and adequate, no recovery is possible. By operation of California's learned intermediary doctrine, this is true even if Mrs. Marroquin did not read any part of the warning label.

Alternatively, Pfizer argues that the FAC fails to meet any of the applicable pleading requirements. First, the FAC's claims of concealment and negligent and intentional misrepresentation fail to comply with Rule 9(b). The FAC lumps defendants together and makes only conclusory allegations that do not identify the who, what, when, where, and how of any "fraudulent" conduct. Second, the first cause of action for "strict products liability" does not differentiate between a design defect and a manufacturing defect. However, California law does not recognize a design defect claim with respect to pharmaceutical products, and the manufacturing defect claim does not explain how the manufacturing process deviated from the intended outcome. Third, because the FAC's negligence claim is congruent with first claim for products liability except for an added element of causation, the negligence claim fails for the same reasons as the products liability claim. Fourth, the failure to warn products liability claim fails because the FAC fails to identify any danger about which no warning was given, nor does the FAC allege that any failure to warn was the cause of Mrs. Marroquin's death. Fifth, the FAC fails to allege the terms of any warranty, or that Mrs. Marroquin or her physician relied on any terms of a warranty. Further, any implied warranty theory fails because Mrs. Marroquin relied on the skill and judgment of her physician. Finally, the request for punitive damages fails because no factual allegations suggest oppressive, fraudulent, or malicious conduct.

Plaintiff's Opposition

Marroquin argues that not all of his claims are based on a failure to warn, and, under Rule 8, he need not prove anything, rather he need only plead plausible claims. Marroquin also argues that the FAC is adequately pled in general. First, the strict products liability contains allegations that track Judicial Council of California, Civil Jury Instruction ( CACI) 1201, manufacturing defect.

Second, Marroquin states that he agrees that he must prove the four elements of negligence, plus the element that the product defect was due to defendants' negligence. However, the FAC does allege that Pfizer breach its duty to Ms. Marroquin, which caused her health. If the Court finds the allegations incomplete, additional facts may be alleged.

Third, the "exact terms" of a warranty do not need to be alleged. Although the FAC adequately alleges breaches of both express and implied warranties, additional allegations regarding Pfizer's advertising to the public that its product was safe, fit, and effective could be made.

Fourth, a strict liability failure to warn claim has been properly pled. The adequacy of a warning is generally a fact question, it is unknown whether the label proffered by Pfizer is the same label provided on the relevant batch of amiodarone that was administered in this case. These are fact questions that prevent dismissal at this stage.

Fifth, Marroquin agrees that additional allegations are necessary to allege a plausible intentional misrepresentation claim.

Sixth, there is a growing trend among the district courts within the Ninth Circuit that negligent misrepresentation claims need not comply with Rule 9(b). Because the FAC allegations that Pfizer misrepresented that Amiodarone was safe, fit, and effective, a plausible claim has been stated.

Seventh, Pfizer's arguments are not clear. The FAC alleges that Pfizer concealed that...