Drescher v. Bracco Diagnostics Incorporated

1 WO [8] IN THE UNITED STATES DISTRICT COURT [9] FOR THE DISTRICT OF ARIZONA [11] Candice Drescher, No. CV-19-00096-TUC-RM (LCK) [12] Plaintiff, ORDER [13] v. [14] Bracco Diagnostics Incorporated, et al., [15] Defendants. [17] On January 31, 2020, Magistrate Judge Lynette C. Kimmins issued a Report and [18] Recommendation (Doc. 57) recommending that this Court grant Defendants’ Motions to [19] Dismiss (Docs. 46, 47, 48) and grant Plaintiff leave to amend the operative Complaint. [20] The Report and Recommendation (“R&R”) further recommended denying Defendants’ [21] first round of Motions to Dismiss (Docs. 15, 16, 20) as moot because they were based on [22] the original Complaint, which was superseded by the First Amended Complaint (Doc. [23] 35). Plaintiff filed an Objection (Doc. 58) and Defendants responded (Doc. 59). For the [24] following reasons, the Court will grant the Motions to Dismiss and adopt Judge [25] Kimmins’ Report and Recommendation. [26] I. Background [27] Plaintiff filed her original Complaint on February 25, 2019. (Doc. 1.) Each group [28] of Defendants filed a Motion to Dismiss the Complaint. (Docs. 15, 16, 20.) Defendants 1 also moved to transfer the case to a judge with related cases, but the request was denied. 2 (Docs. 33, 53.) Plaintiff filed her Amended Complaint (FAC) on July 29, 2019. (Doc. 3 35.) Defendants then filed the Motions to Dismiss which are the subject of Judge 4 Kimmins’ Report and Recommendation. (Docs. 46, 47, 48.) 5 The Amended Complaint alleges that Plaintiff was injected with the linear 6 gadolinium-based contrast agent (GBCA) “OptiMARK,” which is produced and sold by 7 Defendants Guerbet and Mallinckrodt, prior to a January 19, 2013 magnetic resonance 8 imaging (MRI) procedure.1 (Doc. 35 ¶ 2.) Plaintiff further alleges that she was injected 9 with linear GBCA MultiHance, which is produced and sold by Defendant Bracco, prior 10 to MRIs on August 11, 2015 and November 8, 2016. (Id.) At the time of the GBCA 11 injections, Plaintiff had normal kidney function. (Id. ¶ 43.) Plaintiff alleges that a urine 12 test in May 2017 revealed that her body had retained high levels of gadolinium, a toxic 13 heavy metal, in her organs, bone, and skin and that it had crossed the blood-brain barrier 14 and deposited in her brain. (Id. ¶ 4.) The retention of gadolinium caused numerous 15 symptoms, including joint pain, fatigue, cognitive problems, loss of mobility, muscle 16 weakness, chronic pain, fibrosis, and skin changes. (Id.) Plaintiff claims that her doctors 17 have diagnosed and treated her for “gadolinium toxicity.” (Id.) 18 Beginning in 2007, the Food and Drug Administration (FDA) required all GBCA 19 labels to add a “black box” warning that GBCAs increased the risk of Nephrogenic 20 Systemic Fibrosis (NSF), a disease that causes fibrosis of skin and organs, for patients 21 with reduced renal function. (Id. ¶¶ 74,77.) The Amended Complaint cites numerous 22 studies documenting gadolinium retention in patients with normal kidney function. (Id. ¶¶ 23 47, 70, 86, 88.) It also cites patient reports of adverse events (AERs) after gadolinium 24 exposure despite normal kidney function, between 2007 and 2016. (Id. ¶¶ 47, 70, 85.) In 25 December 2017, the FDA mandated a new warning for all GBCAs for MRIs that 26 gadolinium may be retained in patients’ bodies, including the brain, for months to years 27 1 Gadolinium is a heavy metal that functions as a contrast agent. Contrast agents are injected into the body before an MRI procedure to enhance the imaging. Sabol v. Bayer 28 Healthcare Pharm., Inc., No. 18 CIV. 11169 (VM), 2020 WL 705170 , at *1 (S.D.N.Y. Feb. 12, 2020). 1 after receiving the drug. (Id. ¶ 111.) The FDA required GBCA manufacturers to issue a 2 patient medication guide and to conduct further studies to assess the safety of GBCAs. 3 (Id.) 4 Plaintiff alleges that Defendants knew or should have known of the adverse 5 consequences of gadolinium retention in people, like her, with normal kidney function. 6 (Id. ¶ 50.) Plaintiff alleges that the Defendant manufacturers falsely promised the 7 gadolinium would leave her body without harming her. (Id. ¶¶ 2, 6, 9.) Plaintiff further 8 alleges that Defendants should have sold macrocyclic GBCAs, which are less likely to be 9 retained in the body, instead of linear GBCAs. (Id. ¶¶ 84, 89, 95.) Plaintiff alleges that 10 Defendants limited the warnings regarding gadolinium retention to the subset of patients 11 with abnormal kidney function. (Id. ¶ 114.) Plaintiff alleges that Defendants are liable 12 based on: (1) strict product liability: inadequate warning; (2) strict product liability: 13 defective design; and (3) negligence due to inadequate warning and defective design. 14 In response to Plaintiff’s FAC, Defendants filed Motions to Dismiss, arguing that 15 the FAC should be dismissed for the following reasons: untimely service; preemption; 16 failure to plead causation; failure to plead foreseeable risk; punitive damages are barred; 17 and the allegations fail to state a claim and violate Fed. R. Civ. P. 8. (Docs. 46, 47, 48.) 18 II. Standard of Review 19 A district judge must “make a de novo determination of those portions” of a 20 magistrate judge’s “report or specified proposed findings or recommendations to which 21 objection is made.” 28 U.S.C. § 636 (b)(1); see also Johnson v. Zema Sys. Corp., 170 22 F.3d 734, 739 (7th Cir. 1999) (“If no objection or only partial objection is made, the 23 district court judge reviews those unobjected portions for clear error.”); Prior v. Ryan, 24 CV 10-225-TUC-RCC, 2012 WL 1344286 , at *1 (D. Ariz. Apr. 18, 2012) (reviewing for 25 clear error unobjected-to portions of Report and Recommendation). 26 “To survive a motion to dismiss, a complaint must contain sufficient factual 27 matter, accepted as true, to state a claim to relief that is plausible on its face.” Ashcroft v. 28 Iqbal, 556 U.S. 662, 678 (2009). Dismissal is only appropriate if the complaint’s factual 1 allegations, together with all reasonable inferences drawn in the plaintiff’s favor, fail to 2 state a plausible claim for relief. Id. at 678 ; see also Erickson v. Pardus, 551 U.S. 89 , 94 3 (2007) (all factual allegations in the complaint must be accepted as true). However, 4 allegations that “contradict matters properly subject to judicial notice or by exhibit” need 5 not be accepted as true. Gonzalez v. Planned Parenthood of Los Angeles, 759 F.3d 1112 , 6 1115 (9th Cir. 2014); see also Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th 7 Cir. 2001) (courts need not accept as true allegations that “contradict matters properly 8 subject to judicial notice or by exhibit” or that are “merely conclusory, unwarranted 9 deductions of fact, or unreasonable inferences.”) “[A] court may disregard allegations of 10 the complaint that are contradicted by attached exhibits.” Castle v. Eurofresh, Inc., No. 11 CV09-8114-PCT-MHMDKD, 2010 WL 797138 , at *3 (D. Ariz. Mar. 8, 2010). “[W]here 12 scientific studies are cited and thus incorporated into the complaint, and where those 13 studies simply do not support the allegations, the Court may find that the deficiencies … 14 go to the very heart of the plausibility standard under Iqbal.” Sabol v. Bayer Healthcare 15 Pharm., Inc., No. 18 CIV. 11169 (VM), 2020 WL 705170 , at *12 (S.D.N.Y. Feb. 12, 16 2020). 17 While a complaint need not plead “detailed factual allegations,” the factual 18 allegations it does include “must be enough to raise a right to relief above the speculative 19 level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 545 (2007). A plaintiff must allege 20 “enough facts to state a claim to relief that is plausible on its face.” Matrixx Initiatives, 21 Inc. v. Siracusano, 563 U.S. 27 , 45 n.12 (2011) (quoting Twombly, 550 U.S. at 570 ). The 22 allegations must “raise a reasonable expectation that discovery will reveal [material] 23 evidence” and thus “allow the court to draw the reasonable inference that the defendant is 24 liable” for the alleged misconduct. Id. at 46. The plausibility standard demands “more 25 than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 . A 26 formulaic recitation of the elements of a cause of action is not enough to establish a 27 claim, and legal conclusions are not entitled to an assumption of truth. Id. at 679 . 28 In resolving a Rule 12(b)(6) Motion to Dismiss for failure to state a claim, “the 1 Court’s task is to assess the legal feasibility of the complaint, not to assay the weight of 2 the evidence which might be offered in support thereof.” Sabol, 2020 WL 705170 , at *6 3 (internal citations and quotations omitted). Within the context of the facts stated in the 4 complaint or documents attached to or incorporated into the complaint by reference, the 5 Court must “draw reasonable inferences and resolve any doubts in favor of the non6 moving party.” Id. 7 III. Report and Recommendation 8 The Report and Recommendation recommends dismissing Plaintiff’s FAC with 9 leave to amend. The R&R addresses each of Defendants’ arguments for dismissal as if 10 raised by all Defendants. See Silverton v. Dep't of Treasury of U. S. of Am., 644 F.2d 11 1341, 1345 (9th Cir. 1981) (“A District Court may properly on its own motion dismiss an 12 action as to defendants who have not moved to dismiss where such defendants are in a 13 position similar to that of moving defendants or where claims against such defendants are 14 integrally related.”); Bornstein v. Trans Union LLC, No. CV-18-04773-PHX-JJT, 2019 15 WL 2372020 , at *2 (D. Ariz. June 5, 2019) (applying dismissal argument of one 16 defendant to all defendants because claims were identical). 17 The R&R first addresses Defendants’ argument that the FAC should be dismissed 18 for failure to timely serve. The Magistrate Judge found that because Plaintiffs served 19 Defendants shortly after the deadline, because Plaintiff’s claim would be barred by the 20 statute of limitations if dismissed, and because Defendants did not show prejudice 21 resulting from the two-week delay in service, dismissal based on improper service is not 22 warranted. (Doc. 57 at 4.) 23 Next, the R&R addresses Defendants’ argument that Plaintiff’s inadequate 24 warning claim and design defect claim, sounding in strict liability and negligence, are 25 preempted by the FDA’s regulatory scheme. (Id. at 5.) The R&R finds that Plaintiff’s 26 inadequate warning claim is preempted because it did not state a plausible claim that the 27 Defendant manufacturers could have changed their labels under the Changes Being 28 Affected, or “CBE,” regulation, 21 C.F.R. § 314.70 (c)(6)(iii). (Id. at 10.) The R&R 1 further finds that Plaintiff’s design defect claim is preempted because Plaintiff’s proposed 2 change to Defendants’ linear GBCA product would constitute a major change under 3 applicable state regulations and would therefore require obtaining prior FDA approval, 4 and a label alteration to ameliorate the purported risk was also not possible without FDA 5 approval. (Id. at 14.) 6 The R&R goes on to address Defendants’ argument that Plaintiff failed to plead 7 that Defendants knew, or should have known, that their linear GBCA products posed an 8 unreasonable danger to patients with normal kidney function and finds that Plaintiff’s 9 attached exhibits demonstrate that “the FDA concluded, more than a year after Plaintiff 10 last was exposed to gadolinium, that no GBCAs were unreasonably dangerous and there 11 was no known adverse health effect from gadolinium retention.” (Id. at 17.) Therefore, 12 the R&R rejected as conclusory Plaintiff’s allegation that there was a known risk of harm 13 that Defendants could and should have foreseen prior to 2016. (Id.) 14 Finally, the R&R addresses Plaintiff’s request for punitive damages. (Id.) 15 Defendants contend that punitive damages are barred by Arizona state law. (Id.) The 16 R&R finds that Plaintiff is barred from seeking punitive damages because she did not 17 plead that Defendants’ products were non-compliant with their FDA-approved 18 manufacturing or labeling. (Id. at 18.) 19 Because the R&R found that Plaintiff’s claims should be dismissed in their 20 entirety based upon preemption and failure to plead foreseeability, the R&R does not 21 address Defendants’ other arguments for dismissal. (Id.) The R&R recommends granting 22 Plaintiff leave to amend the complaint only if she possesses additional factual allegations 23 that allow her to state at least one claim for relief. (Id.) The R&R finds that, at a 24 minimum, Plaintiff must include allegations of: (1) reasonable evidence of a causal 25 association of harm (relevant to preemption and causation necessary to state a claim for 26 failure to warn or design defect); (2) a foreseeable risk of harm to patients with normal 27 kidney function from Defendants’ linear GBCA products (necessary to state a claim for 28 failure to warn or design defect); and (3) Defendants’ ability under federal law to 1 redesign their GBCA products to comply with state law (necessary to state a claim for 2 design defect). (Id. at 19.) 3 IV. Objection 1: The Magistrate Judge failed to properly apply the Motion 4 to Dismiss Standard. 5 Plaintiff objects that the magistrate judge failed to properly apply the Motion to 6 Dismiss standard by failing to draw all reasonable inferences in Plaintiff’s favor. (Doc. 7 58 at 2-4, Doc. 57 at 7-9.) Plaintiff contends that the R&R failed to draw “important 8 inferences” in Plaintiff’s favor but does not specify what those inferences should have 9 been. (Id. at 4.) Defendants respond that the R&R applied the appropriate legal standard 10 by rejecting Plaintiff’s conclusory allegations that are contradicted by the FDA 11 statements and findings set forth in the exhibits attached to the complaint. (Doc. 59 at 3.) 12 On de novo review, the Court finds that the magistrate judge correctly applied the 13 legal standard for motions to dismiss. Citing Sprewell, 255 F.3d at 988, the R&R finds 14 that “Plaintiff’s conclusory allegations of causation … are contradicted by the supporting 15 facts and studies included in the Amended Complaint and its attachments” and that there 16 was no “reasonable evidence of a causal association of harm for patients with normal 17 renal function.” (Doc. 57 at 9, 17.) Drawing all reasonable inferences in Plaintiff’s favor, 18 the Court finds no basis in the record to reach a different conclusion. The information 19 provided by Plaintiff as attachments to the FAC does not provide a basis for a reasonable 20 inference that there exists a causal connection between GBCAs and risk of harm to 21 patients with normal kidney function. Rather, the information provided by Plaintiff shows 22 that the FDA found, after inquiry and studies, that it could not establish a causal 23 association between adverse health effects reported by patients with normal kidney 24 function and gadolinium retention. (See Doc. 35, Exs. C; D at 6, 22; E at 6; F at 5, 19; H 25 at 3.) Furthermore, Plaintiff’s factual allegations, supported by the information in the 26 attached exhibits, do not raise a right to relief beyond a speculative level or state a 27 facially plausible claim. Twombly, 550 U.S. at 545, 570 . The magistrate judge, in 28 recommending granting the Motions to Dismiss based upon the factual allegations in and 1 exhibits attached to the FAC, correctly applied the legal standard for motions to dismiss. 2 See Sprewell 266 F.3d at 988 (courts need not accept as true allegations that “contradict 3 matters properly subject to judicial notice or by exhibit” or that are “merely conclusory, 4 unwarranted deductions of fact, or unreasonable inferences.”) 5 V. Objection 2: The Magistrate Judge erred in finding that the FDA 6 found no causal association between GBCAs and adverse health effects. 7 Plaintiff objects to the magistrate judge’s finding that the FDA found no causal 8 association between GBCAs and adverse health effects in patients with normal kidney 9 function. (Id. at 4-6, Doc. 57 at 9-10, 17.) Plaintiff contends that the FDA requirement 10 that there be “reasonable evidence of a causal association between the drug and the 11 adverse event” in order to include an adverse event in a drug warning, in conjunction 12 with the fact that the FDA ordered “actions to alert health care professionals and patients 13 about gadolinium retention after an MRI using a GBCA,” provides evidence of a causal 14 relationship between the use of Defendants’ linear GBCA product and gadolinium 15 retention in patients with normal kidney function. (Id. at 5-6.) Defendants respond that 16 the FDA has expressly confirmed that there is no established causal association between 17 GBCAs and adverse health effects in patients with normal renal function. (Doc. 59 at 4.) 18 Defendants point to the FDA’s warnings in 2017 and 2018 in which the FDA concluded 19 that no causal association had been established. (Id. at 5.) 20 The Court finds that Plaintiff’s objection misconstrues the R&R’s findings and the 21 standard under which a warning of a causal relationship between GBCAs and adverse 22 health effects in patients with normal kidney function would be required. First, Plaintiff’s 23 objection ignores the R&R’s specific findings regarding the FDA’s explicit findings that 24 gadolinium retention has not been directly linked to adverse health effects in patients 25 with normal kidney function. (Doc. 57 at 9-10.) The R&R cites to the FDA’s label 26 change in 2018, which stated that “adverse events involving multiple organ systems have 27 been reported in patients with normal renal function without an established causal link to 28 gadolinium retention.” (Id. at 9.) Prior to that, the FDA issued a warning in 2017 stating 1 that a causal association between reports of adverse events involving multiple organ 2 systems in patients with normal kidney function and gadolinium retention “could not be 3 established.” (Id. at 16.) Plaintiff’s objection does not address these findings or explain 4 how her argument that reasonable evidence of a causal association between the drug and 5 the adverse event exists is valid considering the FDA’s explicit findings to the contrary. 6 In other words, Plaintiff’s argument that there is reasonable evidence of a causal 7 association between adverse health effects in people with normal kidney function and 8 gadolinium retention is plainly contradicted by the FDA warnings. 9 Plaintiff further argues that “it is incorrect to believe that the FDA ruled out linear 10 GBCAs as a cause for the adverse events reported by patients.” (Doc. 58 at 5.) However, 11 the R&R does not make this finding nor does the FDA mandate warnings for a causal 12 association that has not been ruled out. Rather, the FDA guidance requires “reasonable 13 evidence of a causal association between the drug and the adverse event.” (Id.) Plaintiff 14 argues that the language in the 2018 label change meets this standard but neglects to 15 address the FDA’s finding that no causal link was established, and instead asks the Court 16 to draw an inference that is both unsupported and explicitly contradicted by the record 17 before it. (See Doc. 57 at 9-10, 16-17.) Accordingly, the Court finds that the magistrate 18 judge did not err in finding that the FDA found no causal association between GBCAs 19 and adverse health effects in patients with normal renal function. 20 VI. Objection 3: The Magistrate Judge erred in finding that Plaintiff’s 21 Design Defect claim fails under Restatement (Third) of Torts § 6(c). 22 Plaintiff objects to the magistrate judge’s finding that her design defect claims fail 23 under Restatement (Third) of Torts § 6(c) because Defendants would have had to change 24 their design. (Id. at 6-7, Doc. 57 at 13-14.) Plaintiff objects that the design defect claims 25 were properly pled because Defendants should have sold the safer macrocyclic GBCA 26 product instead of the linear GBCA products, which have defective designs. (Id. at 6.) 27 Plaintiff further contends that she has alleged sufficient facts to support a claim consistent 28 with Restatement (Third) of Torts § 6(c). (Id.) 1 Plaintiff’s objection does not address the magistrate judge’s analysis regarding 2 preemption of the design defect claims. (Doc. 57 at 11-14.) Plaintiff does not argue and 3 cites to no authority supporting the contention that the magistrate judge incorrectly 4 applied the preemption framework to Plaintiff’s design defect claim pursuant to Mutual 5 Pharm Co., Inc. v. Bartlett, 570 U.S. 472 (2013). The R&R finds that Plaintiff’s design 6 defect claims are preempted by federal law because Defendants were unable to alter the 7 formulation of the linear GBCA drug after its approval by the FDA. (Doc. 57 at 13); see [8] 21 C.F.R. § 314.70 (b)(2)(i) (“Once a drug—whether generic or brand-name—is 9 approved, the manufacturer is prohibited from making any major changes to the 10 qualitative or quantitative formulation of the drug product, including active 11 ingredients[.]”). Plaintiff alleges that Defendants should have sold macrocyclic GBCAs, 12 which are less likely to be retained in the body, instead of linear GBCAs. However, the 13 active ingredients and chemical structures in each of these drugs are different and 14 therefore such a change would require FDA approval. (Doc. 17 at 13-14.) 15 Furthermore, the Supreme Court expressly rejected Plaintiff’s argument that 16 Defendants should have simply replaced the linear GBCA products with macrocyclic 17 GBCA products in Bartlett, 570 U.S. 488 (“We reject this ‘stop-selling’ rationale as 18 incompatible with our preemption jurisprudence. Our pre-emption cases presume that an 19 actor seeking to satisfy both his federal and state-law obligations is not required to cease 20 acting altogether in order to avoid liability”); see also Yates v. Ortho-McNeil-Janssen 21 Pharm., Inc., 808 F.3d 281, 295 (6th Cir. 2015) (explaining that the Bartlett court 22 “explicitly rejected the lower court’s conclusion that the defendant could have complied 23 with both state and federal law by simply exiting the market[.]”). 24 As for Plaintiff’s argument regarding the magistrate judge’s application of the 25 Restatement (Third) of Torts § 6(c), the R&R finds that § 6(c) applies to Plaintiff’s 26 design defect claims but that Defendants’ duties with respect to product design apply 27 only to foreseeable risks of harm under that section. (Doc. 57 at 13, 15.) 28 § 6(c) states: 1 A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or [2] medical device are sufficiently great in relation to its foreseeable 3 therapeutic benefits that reasonable health care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or [4] medical device for any class of patients. [5] The commentary to the Restatement provides that “[d]uties concerning the design [6] and marketing of prescription drugs and medical devices arise only with respect to risks [7] of harm that are reasonably foreseeable at the time of sale.” The R&R addresses [8] Plaintiff’s claims of foreseeability and finds that they are conclusory and are contradicted [9] by factual allegations in the Amended Complaint or its exhibits. (Doc. 57 at 15-16.) The [10] Court finds that the record before it provides no basis for a reasonable inference that the [11] alleged risks posed by the linear GBCA agents to patients with normal kidney function [12] were foreseeable. Because the linear GBCA products posed no reasonably foreseeable [13] risks of harm to patients with normal kidney function, § 6(c) does not provide a basis for [14] Plaintiff’s design defect claim. Even if Plaintiff could show that the risks of harm were [15] reasonably foreseeable and that § 6(c) did apply, the Court would find that Plaintiff’s [16] design defect claims fail due to preemption. (See Doc. 57 at 11-14.) [17] . . . . [18] . . . . [19] . . . . [20] . . . . [21] . . . . [22] . . . . [23] . . . . [24] . . . . [25] . . . . [26] . . . . [27] . . . . [28] . . . . 1 The Court has reviewed Judge Lynette C. Kimmins’s Report and || Recommendation, the parties’ briefs, and the record. The Court finds no error in Judge Lynette C. Kimmins’s Report and Recommendation. 4 Accordingly, 5 IT IS ORDERED that the Report and Recommendation (Doc. 57) is accepted 6|| and adopted in full. 7 IT IS FURTHER ORDERED that Plaintiff's Objections (Doc. 58) are 8 || overruled. 9 IT IS FURTHER ORDERED that Defendants’ Motions to Dismiss (Docs. 46, 10|| 47, 48) are granted. Plaintiff is granted leave to amend the Amended Complaint (Doc. 35) consistent with the parameters set forth in the Report and Recommendation. 12 Dated this 26th day of March, 2020. [13] 14 Ly bs □□ [15] Honorable Rosthary Mafquez 16 United States District □□□□□ [28] -12-