1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 HARRY H. DAVALLOU, Case No.: 20-cv-00619-DMS-MDD

12 Plaintiff,

ORDER GRANTING MOTION TO

13 v. DISMISS 14 GLENMARK PHARMACEUTICALS US HEAD QUARTERS, a business of 15 unknown form, 16 Defendant. 17 18 19 Pending before the Court is Defendant Glenmark Pharmaceuticals Inc.’s motion to 20 dismiss Plaintiff Harry H. Davallou’s Complaint for failure to state a claim. Plaintiff, 21 proceeding pro se, filed two separate responses to Defendant’s motion, and Defendant filed 22 a reply. For the reasons given herein, the Court grants Defendant’s motion to dismiss 23 without prejudice. 24 I. 25 BACKGROUND 26 On March 3, 2020, Plaintiff filed a Complaint based on products liability in the 27 Superior Court of California, County of San Diego. (ECF No. 1 at 11). Plaintiff alleges 28 that in November of 2019, his previously mild Parkinson’s disease worsened and he 1 experienced “general weakness in [his] body.” (Id. at 14). Plaintiff alleges that at the same 2 time, he received a letter from CVS Pharmacy indicating that the prescription drug he had 3 been taking—ranitidine, the generic version of the brand-name Zantac heartburn and ulcer 4 medication—was recalled. (Id. at 14, 17). Plaintiff connected the progression of his 5 Parkinson’s disease1 to the recall of ranitidine. (Id. at 14). Based on these alleged facts, 6 Plaintiff brought suit against the manufacturer of ranitidine, Glenmark Pharmaceuticals 7 Inc., seeking punitive damages of $20,000,000. (Id. at 13). On March 31, 2020, Defendant 8 removed the case to this Court, asserting diversity jurisdiction under 28 U.S.C. § 1332(a). 9 (Id. at 1). 10 On February 6, 2020, the United States Judicial Panel on Multidistrict Litigation 11 (“JPML”) centralized all actions involving consumers alleging physical injuries in the form 12 of liver, bladder, and other types of cancer as a result of their purchase of ranitidine 13 products. The case is captioned In Re Zantac (Ranitidine) Products Liability Litigation, 14 MDL No. 2924 (“Zantac MDL”). On April 1, 2020, Defendant filed a notice of potential 15 tag-along action to the Zantac MDL pursuant to Rule 7.1(a) of the JPML and moved to 16 stay this action, pending the JPML’s decision. (ECF No. 12-1 at 9). On April 8, 2020, the 17 JPML determined without opinion that this action was not appropriate for inclusion in the 18 Zantac MDL. (Id.). 19 Defendant then withdrew its motion to stay the action and filed a motion to dismiss 20 Plaintiff’s complaint under Federal Rules of Civil Procedure 8 and 12(b)(6). Defendant 21 argues that Plaintiff fails to adequately allege his products liability claim. 22 / / / 23

24 25 1 In his responses to Defendant’s motion, Plaintiff discusses other medical conditions that he believes his consumption of ranitidine caused. These conditions include weight loss 26 and eczema. Because Plaintiff’s additional allegations were not included in his Complaint, 27 the Court cannot consider them in ruling on Defendant’s motion to dismiss. Twombly, 550 U.S. at 570 (noting that a motion to dismiss should be granted if a plaintiff’s complaint 28 1 II. 2 LEGAL STANDARD 3 A Rule 12(b)(6) motion to dismiss tests the sufficiency of the complaint. See 4 Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Rule 12 (b)(6) is read in conjunction with Rule 5 8(a), which requires only “a short and plain statement of the claim showing that pleader is 6 entitled to relief[.]” Fed. R. Civ. P. 8(a)(2). While Rule 8 does not require detailed factual 7 allegations, at a minimum, a complaint must allege enough facts to provide “fair notice” of 8 both the particular claims being asserted and “the grounds upon which [those claims] 9 rests.” Bell Atlantic Corp. v. Twombly, 556 U.S. 544, 555 & n.3 (2007). 10 In deciding a motion to dismiss, all material factual allegations of the complaint are 11 accepted as true, as well as all reasonable inferences to be drawn from them. Cahill v. 12 Liberty Mut. Ins. Co., 80 F.3d 336, 338 (9th Cir. 1996). A court, however, need not accept 13 all conclusory allegations as true. Rather it must “examine whether conclusory allegations 14 follow from the description of facts as alleged by the plaintiff.” Holden v. Hagopian, 978 15 F.2d 115, 1121 (9th Cir. 1992). A motion to dismiss should be granted if a plaintiff’s 16 complaint fails to contain “enough facts to state a claim to relief that is plausible on its 17 face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff pleads 18 factual content that allows the court to draw the reasonable inference that the defendant is 19 liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 20 556). 21 Pro se complaints are “held to a less stringent standard than formal pleadings drafted 22 by lawyers.” Hebbe v. Pliler, 627 F.3d 338, 342 (9th Cir. 2010). A pro se plaintiff’s 23 complaint must be construed liberally to determine whether a claim has been stated. See 24 Zichko v. Idaho, 247 F.3d 1015, 1020 (9th Cir. 2001). However, a pro se litigant’s 25 pleadings still must meet some minimum threshold in providing the defendants with notice 26 of what it is that they allegedly did wrong. See Brazil v. U.S. Dep’t of Navy, 66 F.3d 193, 27 199 (9th Cir. 1995). 28 / / / 1 III. 2 DISCUSSION 3 A. Plaintiff Does Not Adequately Allege A Products Liability Claim 4 A plaintiff may seek recovery in a products liability case either on the theory of strict 5 liability in tort or on the theory of negligence. See Merrill v. Navegar, Inc., 28 P.3d 116, 6 124 (Cal. 2001). Plaintiff checked the ‘products liability’ box in his state court Complaint. 7 As such, the Court will consider his allegations under both theories of liability. 8 Under California law, a manufacturer of prescription drugs may only be strictly 9 liable for injuries if its product is either: (1) defectively manufactured; or (2) distributed 10 without adequate instructions or warnings as to its potential for harm. Artiglio v. Superior 11 Court, 27 Cal. Rptr. 2d 589, 591 (Cal. Ct. App. 1994); see also Brown v. Superior Court, 12 751 P.2d 470, 482–83 (Cal. 1988) (holding that drug manufacturers cannot be held strictly 13 liable for design defects in prescription drugs, but may be held liable for defective 14 manufacturing or defective warnigns). To prevail on a defective manufacturing claim, a 15 plaintiff must demonstrate that the product caused a plaintiff’s injury because it deviated 16 from the manufacturer’s intended result or from other ostensibly identical units of the same 17 product line. See Morris v. Parke, Davis & Co., 667 F. Supp. 1332, 1335 (C.D. Cal. 1987). 18 This theory posits that “a suitable design is in place, but that the manufacturing process has 19 in some way deviated from that design.” In re Coordinated Latex Glove Litigation, 121 20 Cal. Rptr. 2d 301, 316 (Cal. Ct. App. 2002). 21 Here, Plaintiff does not allege that his tablets of ranitidine were any different from 22 other ranitidine tablets manufactured by Defendant. In fact, Plaintiff appears to allege the 23 opposite. His claim appears to rely on the recall of ranitidine. As such, Plaintiff alleges 24 that his ranitidine did not deviate from Defendant’s intended design, instead it contained 25 the same impurities as all other ranitidine tablets. Plaintiff, therefore, cannot successfully 26 plead a manufacturing defect. 27 Plaintiff also fails to allege causation. Specifically, Plaintiff does not allege that the 28 ranitidine caused his Parkinson’s disease to worsen. Instead, Plaintiff alleges that his 1 consumption of ranitidine and the worsening of his Parkinson’s were simultaneous. In 2 support of this allegation, Plaintiff provides the two letters he received—one from CVS 3 Pharmacy and one from Blue Shield of California—informing him of ranitidine’s recall 4 and the possibility of it containing carcinogens. Neither letter, however, indicates the 5 plausibility of ranitidine aggravating a nervous system disorder like Parkinson’s disease. 6 To prevail on a manufacturing defect theory of liability, Plaintiff would need to 7 demonstrate a plausible connection between the ranitidine he ingested and the worsening 8 of his specific medical condition. 9 To prevail on a defective warnings claim, a plaintiff must “identify which danger 10 was not warned against, explain that the danger was substantial, and that the danger was 11 known or reasonably knowable, or explain how any warning that was given was 12 inadequate.” Marroquin v. Pfizer, Inc., 367 F. Sup. 3d 1152, 1160–61 (E.D. Cal. 2019) 13 (citing Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1156 n.1 (E.D. Cal. 2010)). 14 Furthermore, “in the case of prescription drugs, the duty to warn runs to the physician, not 15 the patient.” Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996); see also Stevens 16 v. Parke, Davis & Co., 507 P.2d 653, 661 (Cal. 1973) (“In the case of medical prescriptions, 17 if adequate warnings of potential dangers of a drug has been given to doctors, there is no 18 duty by the drug manufacturer to insure that the warning reaches the doctor’s patient for 19 whom the drug is prescribed.”). A plaintiff, therefore, must allege that the defendant failed 20 to warn or inadequately warned his or her doctor about the specific danger and that “a 21 different warning would have changed the prescribing physician’s decision.” Thompson 22 v. Janssen Pharm., Inc., No. CV 16-2628, 2017 WL 5135548, at *8 (C.D. Cal. Oct. 23, 23 2017); see also Georges v. Novartis Pharm., Corp., 988 F. Supp. 2d 1152, 1157 (C.D. Cal. 24 2013) (“If the plaintiff would have taken the drugs and suffered the same injuries, even 25 with an adequate warning, the defendant’s failure to warn cannot have caused her injury.”). 26 Furthermore, state law claims involving generic drugs labels or warning are 27 preempted by federal law. PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011). “Federal 28 law . . . demand[s] that generic drug labels be the same at all times as the corresponding 1 brand-name drug labels.” Id. (citing 21 C.F.R. § 314.150(b)(10)). Because it would be 2 “impossible for the [m]anufacturers to comply with both their state-law duty to change the 3 label and their federal-law duty to keep the label the same[,]” state law claims concerning 4 generic drug warnings are preempted. Id.; see also Mut. Pharm. Co., Inc. v. Bartlett, 570 5 U.S. 472, 486 (2013) (“As PLIVA made clear, federal law prevents generic drug 6 manufacturers from changing their labels.”). 7 Here, Plaintiff does not allege that Defendant failed to warn or inadequately warned 8 his doctor about the risk of ranitidine aggravating his Parkinson’s disease. As explained 9 above, although Plaintiff includes the recall letters in his Complaint, those letters indicate 10 ranitidine may contain carcinogens—they do not contain any information connecting 11 ranitidine to the worsening of nervous system disorders. As such, if Plaintiff’s claim 12 concerns Defendant’s failure to warn of ranitidine’s possible carcinogenic effect, Plaintiff 13 fails to allege proximate cause. In other words, Plaintiff does not demonstrate how 14 Defendant’s failure to warn that ranitidine causes cancer caused his ultimate injury: the 15 progression of his Parkinson’s disease. 16 Plaintiff’s claim may also be preempted by federal law. Because ranitidine is a 17 generic drug, Defendant is bound by federal law to use the same label, warnings, and design 18 approved by the Federal Drug Administration (“FDA”) in connection with Zantac. 19 Therefore, if Plaintiff alleges that Defendant should have included additional warnings on 20 ranitidine’s label, Plaintiff’s claim is preempted. 21 Finally, the Court considers Plaintiff’s products liability claim under a negligence 22 theory. To prevail on a negligence claim, a plaintiff must show that the defendant “owed 23 her a legal duty, breached the duty, and that the breach was a proximate or legal cause of 24 her injury.” Gonzalez v. Autoliv ASP, Inc., 64 Cal. Rptr. 3d 908, 919 (Cal. Ct. App. 2007). 25 A plaintiff must also demonstrate that “the defect in the product was due to negligence of 26 the defendant.” Id. (quoting Merrill v. Navegar, Inc., 28 P.3d 116, 125 (Cal. 2001)). 27 Plaintiff does not allege duty, breach, or causation. Again, if Plaintiff’s claim is that 28 Defendant breached its duty by marketing ranitidine, despite the drug being impure or 1 || potentially carcinogenic, then Plaintiff fails to show how this breach caused his specific 2 ||injuries. Without factual allegations connecting his harm to Defendant’s actions or 3 ||inactions, Plaintiff fails to state a claim. 4 ||B. Leave To Amend 5 Generally, leave to amend is granted “even if no request to amend the pleading was 6 ||made, unless [the court] determines that the pleading could not possibly be cured by the 7 || allegation of other facts.” Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir. 2000) (en banc) 8 || (internal citation omitted). Here, Plaintiff should be afforded an opportunity to attempt to 9 the deficiencies in his Complaint. Accordingly, the Court grants Plaintiff leave to 10 amend his Complaint. 1] IV. 12 CONCLUSION AND ORDER 13 For the foregoing reasons, Defendant’s motion to dismiss is granted. Plaintiff may 14 || file a First Amended Complaint within 30 days of this order. 15 IT IS SO ORDERED. 16 || Dated: July 27, 2020 V7 ns my. L4\ Hon. Dana M. Sabraw 18 United States District Judge 19 20 21 22 23 24 25 26 27 28