Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-4_19-cv-00096/USCOURTS-azd-4_19-cv-00096-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

Candice Drescher, 

Plaintiff, 

v. 

Bracco Diagnostics Inc., et al., 

Defendants. 

No. CV-19-00096-TUC-RM (LCK) 

REPORT AND RECOMMENDATION 

Pending before the Court are Defendants Guerbet LLC and Liebel-Flarsheim 

Company, LLC’s (Guerbet) Motion to Dismiss (Doc. 46); Defendant Bracco Diagnostics 

Inc.’s (Bracco) Motion to Dismiss (Doc. 47); and Defendants Mallinckrodt Inc. and 

Mallinckrodt LLC’s (Mallinckrodt) Motion to Dismiss (Doc. 48). The motions are fully 

briefed (Docs. 50-52, 54-56.) Pursuant to the Rules of Practice of the Court, this matter 

was referred to Magistrate Judge Kimmins for Report and Recommendation. The 

Magistrate Judge recommends the District Court, after its independent review of the record, 

grant the motions to dismiss and give Plaintiff leave to amend. 

FACTUAL AND PROCEDURAL BACKGROUND 

Plaintiff initiated this action on February 25, 2019. (Doc. 1.) After an order to show 

cause for failure to timely serve (Doc. 9), Plaintiff completed service on all Defendants. 

(Docs. 10, 34.) Each group of Defendants filed a motion to dismiss the Complaint. (Docs. 

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15, 16, 20.) Defendants also filed a motion to transfer the case to a judge with related cases, 

which was denied. (Docs. 33, 53.) Plaintiff filed an Amended Complaint on July 29, 2019. 

(Doc. 35.) Defendants then filed motions to dismiss the Amended Complaint, which are 

currently before the Court. 

The Amended Complaint alleges that Plaintiff was injected with the linear 

gadolinium-based contrast agent (GBCA) OptiMARK (produced and sold by Defendants 

Guerbet and Mallinckrodt) prior to a January 19, 2013 MRI, and linear GBCA MultiHance 

(produced and sold by Defendant Bracco) prior to MRIs on August 11, 2015, and 

November 8, 2016. (Doc. 35 ¶ 2.) At the time of the GBCA injections, Plaintiff had normal 

kidney function. (Id. ¶ 43.) Plaintiff alleges that, in May 2017, a urine test revealed that her 

body had retained high levels of gadolinium in her brain, heart, liver, kidney, bones, and 

skin. (Id. ¶¶ 3-4.) That retention caused fibrosis of her organs, bone, and skin and, as a 

result, she suffers from joint pain, fatigue, cognitive problems, loss of mobility, muscle 

weakness, chronic pain, burning and “crawling” sensation in her skin, and skin changes. 

(Id. ¶ 4.) Plaintiff alleges her doctors have diagnosed and treated her for “gadolinium 

toxicity.” (Id.) 

Beginning in 2007, the FDA required all GBCA labels to add a warning that GBCAs 

increased the risk of Nephrogenic Systemic Fibrosis (NSF) for patients with reduced renal 

function. (Doc. 35 ¶ 77.) The Amended Complaint cites numerous studies documenting 

gadolinium retention in patients with normal kidney function. (Id. ¶¶ 47, 70, 86, 88.) It also 

cites patient reports of adverse events after gadolinium exposure despite normal kidney 

function, occurring between 2007 and 2016. (Id. ¶¶ 47(g), 47(h), 47(u), 47(v), 47(w), 70, 

85.) In December 2017, the FDA mandated a warning on all GBCAs that gadolinium is 

retained in patients’ bodies, including the brain, for months to years after receiving the 

drug. (Id. ¶ 111.) 

Plaintiff alleges Defendants knew or should have known of the consequences of 

gadolinium retention in people, like her, with normal renal function. (Id. ¶ 50.) Plaintiff 

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alleges the manufacturers falsely promised the gadolinium would harmlessly leave her 

body, and Defendants failed to warn her about the risks of gadolinium retention. (Id. ¶¶ 2, 

6, 9.) Plaintiff alleges Defendants are liable based on (1) strict liability: inadequate 

warning; (2) strict liability: defective design; and (3) negligence due to inadequate warning 

and defective design. 

STANDARD OF REVIEW 

 “To survive a motion to dismiss, a complaint must contain sufficient factual matter, 

accepted as true, to state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 

556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557 (2007)) 

(internal quotation marks omitted). Dismissal is only appropriate if the complaint’s factual 

allegations, together with all reasonable inferences drawn in the plaintiff’s favor, fail to 

state a plausible claim for relief. Id. at 678; see also Erickson v. Pardus, 551 U.S. 89, 94 

(2007) (allegations in the complaint must be construed in the light most favorable to the 

plaintiff). While a complaint need not plead “detailed factual allegations,” the factual 

allegations it does include “must be enough to raise a right to relief above the speculative 

level.” Twombly, 550 U.S. at 545. The plausibility standard does not amount to a 

probability requirement, however, it demands “more than a sheer possibility that a 

defendant has acted unlawfully.” Iqbal, 556 U.S. at 678. A mere formulaic recitation of the 

elements of a cause of action is not sufficient to establish a claim, and legal conclusions 

are not entitled to an assumption of truth. Id. at 679. 

DISCUSSION 

 Defendants argue the Amended Complaint should be dismissed for the following 

reasons: untimely service; preemption; failure to plead causation; failure to plead 

foreseeable risk; punitive damages are barred; and the allegations fail to state a claim and 

violate Rule 8. Each group of Defendants moved to dismiss on a subset of the grounds 

stated above. Because Plaintiff’s claims against each group of Defendants are identical, the 

Court addresses each argument as if raised by all Defendants. See Silverton v. Dep’t of 

Treasury of U.S.A., 644 F.2d 1341, 1345 (9th Cir. 1981) (“A District Court may properly 

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on its own motion dismiss an action as to defendants who have not moved to dismiss where 

such defendants are in a position similar to that of moving defendants or where claims 

against such defendants are integrally related.”); Bornstein v. Trans Union LLC, No. CV18-04773-PHX-JJT, 2019 WL 2372020, at *2 (D. Ariz. June 5, 2019) (applying dismissal 

argument of one defendant to all defendants because claims identical). 

SERVICE 

Defendants argue that the Amended Complaint should be dismissed for failure to 

timely serve. Plaintiff filed her initial Complaint on February 25, 2019. (Doc. 1.) Plaintiff’s 

90 days to serve under Rule 4(m) of the Federal Rules of Civil Procedure expired on May 

28, 2019. On June 11, the Court directed Plaintiff that, on or before June 21, 2019, she was 

required to “file proof of service or show good cause why the time for service should be 

further extended and this action should not be dismissed.” (Doc. 9.) Plaintiff filed proof 

that she served all Defendants on June 13, 2019. (Docs. 10, 34.) The Court intended its 

language in the June 11 Order to require proof of timely service or a showing of good cause 

why the service time should be extended. However, the language was not without 

ambiguity. Because Plaintiff served all Defendants shortly after the 90-day deadline, her 

claim would be barred for re-filing by the statute of limitations if dismissed, and no 

prejudice has been shown,1

 the Court determines that an extension of the service deadline 

is warranted. See In re Sheehan, 253 F.3d 507, 512 (9th Cir. 2001) (finding the Court has 

discretion under Rule 4(m) to extend the service period without a plaintiff demonstrating 

good cause). Therefore, dismissal based on improper service is not warranted. 

1

 Defendants argue they were prejudiced because, if Plaintiff had served earlier, the 

case could have been transferred to Judge Campbell prior to his Daubert hearing in three related cases. (Doc. 42 at 3; Doc. 44 at 5.) Service in this matter was delayed only 16 days beyond the period prescribed by Rule 4. If Defendants wanted to request an expedited transfer or delay of the Daubert hearing in the related cases, the untimely service left them with almost three weeks to do so. Additionally, Defendants did not dispute that their counsel were contacted as early as June 6 (9 days after the initial service deadline) by Plaintiff’s counsel, who requested that counsel accept service. (Doc. 36-1 ¶ 5; Doc. 37-1 ¶ 5; Doc. 38-1 ¶ 5; Doc. 42 at 2-3.) If Defendants’ counsel had accepted informal service, that would have provided additional time to attempt a case transfer. (Doc. 36-1 ¶¶ 5, 6; Doc. 37-1 ¶¶ 5, 6; Doc. 38-1 ¶¶ 5, 6.) Therefore, the Court finds Defendants suffered no 

meaningful prejudice by the two-week delay in service. 

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PREEMPTION 

Defendants allege that Plaintiff’s inadequate warning claims and design defect 

claims, sounding in strict liability and negligence, are preempted by the FDA’s regulatory 

scheme. (Doc. 46 at 10, 11-12; Doc. 47 at 8-13; Doc. 48 at 3-15.) Plaintiff’s claims will be 

preempted only if it was impossible for Defendants to comply with both federal and state 

law. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019). If Defendants 

could not comply with Arizona law without first obtaining permission from the FDA, then 

the state law requirement is preempted. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 620-24 

(2011) (“The question for ‘impossibility’ is whether the private party could independently 

do under federal law what state law requires of it.”). 

The Court must examine: (1) the state law that requires drug manufacturers to warn 

consumers of the risks associated with their drug and to design drugs that are not 

unreasonably dangerous; and (2) federal regulations by which the FDA oversees 

prescription drug labels and design. Albrecht, 139 S. Ct. at 1672. For purposes of the 

preemption analysis, the Court assumes Plaintiff pled sufficient facts to establish that 

Defendants violated state law by providing an inadequate warning or designing an 

unreasonably dangerous drug. Id. at 1678. 

Failure to Warn 

 Plaintiff alleges that Defendants breached their duty to warn that use of their linear 

GBCAs carried a risk, despite normal renal function, that she would retain gadolinium in 

her organs and that could cause her injury. Prescription drug manufacturers have a duty 

under Arizona law to warn of “foreseeable risks of harm from using their products.” 

Conklin v. Medtronic, Inc., 431 P.3d 571, 577, 245 Ariz. 501, 507 (2018). This theory is 

alleged as both strict liability (Claim 1) and negligence (Claim 3). 

Typically, a drug manufacturer may not alter its approved label without permission 

from the FDA. See Wyeth v. Levine, 555 U.S. 555, 568 (2009). However, a manufacturer 

may change its label under federal law, without pre-approval, if it satisfies the procedures 

set forth in the “changes being effected” (CBE) regulation. Id. (citing 21 C.F.R. 

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§ 314.70(c)(6)(iii)). Plaintiff alleges Defendants should have changed their label under the 

CBE provisions.2

 (Doc. 35 ¶ 54.) The CBE regulation allows a label change to reflect 

“newly acquired information,” in order to: “‘add or strengthen a . . . warning’ where there 

is . . . ‘evidence of a causal association’ between the drug and a risk of harm.” Albrecht, 

139 S. Ct. at 1673 (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A)).3

 Newly acquired information 

is defined as newly acquired data or “new analyses of previously submitted data,” if they 

reveal “risks of a different type or greater severity or frequency than previously included 

in submissions to the FDA.” 21 C.F.R. § 314.3(b). 

Plaintiff argues the failure to warn claim is not preempted because Defendants could 

comply with state and federal law by altering their label using the CBE process. She relies 

on Wyeth and Albrecht, which set an extremely high bar for impossibility preemption, 

requiring “clear evidence that the FDA would not have approved a change” to the drug’s 

label. Wyeth, 555 U.S. at 571; see also Albrecht, 139 S. Ct. at 1672, 1678 (holding that 

clear evidence “is evidence that shows the court that the drug manufacturer fully informed 

the FDA of the justifications for the warning required by state law and that the FDA, in 

turn, informed the drug manufacturer that the FDA would not approve a change to the 

drug’s label to include that warning.”) The Supreme Court has noted that this standard will 

rarely be met because the manufacturer is entitled under the CBE regulations to 

preliminarily alter the label, “based on reasonable evidence, without prior FDA approval.” 

2

 Defendants allege Plaintiff’s failure to warn claim also is preempted to the extent it is based on a failure to communicate information to the FDA prior to the approval of its original label. (Doc. 48 at 5-7.) Plaintiff did not respond directly to this argument, but she argued that Defendants knew of the risks of GBCAs as early as 2007 (after MultiHance 

and OptiMARK’s original labels were approved and modified to warn about NSF). (Doc. 

52 at 4.) Further, review of the Amended Complaint indicates that Plaintiff did not bring a claim for inadequate warning based on the initial label. The complaint alleges Defendants should have sought a change to the label between 2007 and the time Plaintiff was exposed to the drugs (2013-2016), and that Defendants acquired new information after the initial label was approved. (Doc. 35 ¶¶ 46, 47, 54.) Because Plaintiff has not alleged Defendants are liable for the lack of warning on their original label, the Court need not examine 

preemption as to that claim. To the extent Plaintiff intended to bring such a claim, it is subject to dismissal for failure to respond to Defendant’s motion. LRCiv 7.2(i). 

3

 The regulations provide that “the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal 

association with a drug.” 21 C.F.R. § 201.57(c)(6)(i) (emphasis added). 

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Albrecht, 139 S. Ct. at 1679 (noting the FDA could subsequently reject the change, but it 

would be permitted in the interim). 

Defendants contend the stringent standard set forth in these cases applies only if a 

label change is permitted under the CBE regulations. They argue it is inapplicable here, 

because they could not meet the CBE criteria, as evidenced by Plaintiff’s failure to plead a 

causal association between gadolinium and a risk of harm to patients with normal kidney 

function. In Wyeth, the Court noted that when the risk of gangrene leading to amputation 

“became apparent . . . the CBE regulation permitted it to provide such a warning.” 555 U.S. 

at 571; see also Mensing, 564 U.S. at 624 (distinguishing Wyeth because, in that case, the 

brand-name manufacturer was permitted to unilaterally strengthen its label under the CBE 

regulation). And, in Albrecht, the manufacturer conceded that the CBE regulation “would 

have permitted” a label change. 139 S. Ct. at 1675. The Supreme Court has acknowledged 

that, under the CBE regulations, a drug manufacturer “cannot propose a change that is not 

based on reasonable evidence.” Id. at 1679; see Mason v. SmithKline Beecham Corp., 596 

F.3d 387, 392 (7th Cir. 2010) (“It is technically a violation of federal law to propose a CBE 

that is not based on reasonable evidence.”) (citing 18 U.S.C. § 1001); see also In re Celexa 

& Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 42 (1st Cir. 2015) (finding claim 

preempted because label change not allowed under CBE regulation absent “newly acquired 

information,” which Plaintiff had not pled). Therefore, the Court examines whether 

Plaintiff has pled reasonable evidence of a causal association sufficient to allow a CBE 

label change. 

In the Amended Complaint, Plaintiff alleged that studies demonstrated gadolinium 

is retained by some patients with normal renal function, NSF is caused by gadolinium (not 

renal impairment), and individuals have reported adverse effects after administration of 

gadolinium. (Doc. 35 ¶¶ 78-80, 82, 87-88, 90.) Plaintiff alleged that Defendants should 

have known all of this information, which put them on notice that gadolinium retention 

causes physical injury in patients with normal renal function. Therefore, Plaintiffs allege 

and argue that a CBE label change was permitted. The Court disagrees. 

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The Amended Complaint cites many studies and alleges extended facts about NSF 

and patients with compromised renal function. (Doc. 35 ¶¶ 47(t), 47(x), 47(y), 47(bb), 

47(cc), 68, 71-77, 83, 90-92.). However, none of those facts evidence a causal association 

between retained gadolinium and risk of harm to patients with no renal impairment. Many 

of the studies or facts Plaintiff included were dated before Defendants’ original labels were 

approved by the FDA (Doc. 35 ¶¶ 47(o), 63, 65, 66), see supra note 2, or after Plaintiff’s 

last exposure to gadolinium in November 2016 (Doc. 35 ¶¶ 47(l), 47(p), 47(s), 48, 102, 

107-09, 110). And, there are several studies without a direct corollary to IV administration 

of gadolinium in humans (Doc. 35 ¶ 47(n) (GBCA injected into rat brains, 1996); ¶ 47(q) 

(perinatal GBCA exposure to rats, 2007); and ¶ 47(r) (repeated injections of GBCA into 

epidural space, 2010)). Plaintiff also alleged, however, that new data revealed gadolinium 

is retained in patients with normal kidney function. (Doc. 35 ¶¶ 47(a), 47(k), 47(m), 47(v), 

47(w), 47(bb), 70, 86, 88.) And, Plaintiff cited the following patient reporting of adverse 

events: ¶ 47(g) (skin changes, undated); ¶ 47(h) (multiple organ systems, undated); ¶ 47(u) 

(skin plaques, 2015); ¶ 47(v) (skin changes, Oct. 2016); ¶ 47(w) (deposition in skin and 

joint contractures after repeated exposures, 2016); ¶ 79 (since 2007, “significant numbers” 

of adverse events reported); ¶ 85 (patient letters, as early as 2012, reporting gadolinium 

toxicity). 

Neither the retention of gadolinium nor the limited patient reports (without evidence 

of causation) signal a causal connection between GBCAs and risk of harm to patients with 

normal kidney function.4

 The Court does not accept as true Plaintiff’s conclusory 

allegations of causation (see Doc. 35 ¶¶ 50, 56, 59, 79, 93, 135, 157) that are contradicted 

by the supporting facts and studies included in the Amended Complaint and its 

4

 Separate from preemption, Defendants argued that Plaintiff failed to plead how any Defendant’s product caused her alleged injuries. (Doc. 46 at 5-8; Doc. 47 at 4-8.) For 

her strict liability and negligence claims, Plaintiff must prove that her injuries were caused by Defendants’ defective products. Brown v. Sears, Roebuck & Co., 667 P.2d 750, 754, 

136 Ariz. 556, 560 (Ct. App. 1983); Diaz v. Phoenix Lubrication Serv., Inc., 230 P.3d 718, 

721, 224 Ariz. 335, 338 (Ct. App. 2010). While the Court focuses its analysis on preemption, its conclusion that Plaintiff has failed to plead a causal connection between Defendants’ products and her injury is also fatal to her ability to state a necessary element for each of her claims. 

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attachments. See Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir.) (holding 

courts are not required to “accept as true allegations that are merely conclusory, 

unwarranted deductions of fact, or unreasonable inferences” or “that contradict matters 

properly subject to judicial notice or by exhibit.”), opinion amended on denial of reh’g, 

275 F.3d 1187 (9th Cir. 2001). Because there was an absence of reasonable evidence of a 

causal association of harm, for patients with normal renal function, Defendants could not 

propose a label change. See Albrecht, 139 S. Ct. at 1679. 

Although the FDA ultimately required a label change in 2018, which Plaintiff agrees 

met Defendants’ state law obligations, that label explicitly refutes a causal association. 

Plaintiff attached the critical FDA documents and product labels to the Amended 

Complaint (Doc. 35, Exs. A-H). See Sprewell, 266 F.3d at 988 (allowing a court to reject 

allegations that are contradicted by facts established by exhibit). In requiring a new 

warning, the FDA stated: “Gadolinium retention has not been directly linked to adverse 

health effects in patients with normal kidney function” and “[a] causal association between 

these [reported] adverse events and gadolinium retention could not be established.” (Doc. 

35-2, Ex. B at 2, 3.) Defendants subsequently included the following warning on their 

products: 

5.3 Gadolinium Retention 

Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the 

bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen. The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. 

Consequences of gadolinium retention in the brain have not been established. 

Pathologic and clinical consequences of GBCA administration and retention 

in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions (5.1)]. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse 

events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention [see Adverse Reactions (6.2)]. 

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While clinical consequences of gadolinium retention have not been 

established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible. 

(Doc. 35-4, Ex. D; Doc. 35-6, Ex. F.) The FDA’s conclusion that no known causal 

association existed in 2017 precludes finding that Defendants could have made a CBE label 

change years earlier. 

 Several recent district court cases reviewing similar allegations have concluded 

failure to warn claims were preempted because they did not state a plausible claim that the 

manufacturers could have changed their labels under the CBE regulations. See McGrath v. 

Bayer Healthcare Pharms., Inc., 393 F. Supp. 3d 161, 169, 171 (E.D.N.Y. 2019) (finding 

allegations insufficient because the failure to warn claims required a failure to warn of the 

risk of gadolinium retention but the complaint only alleged the fact of retention); Klein v. 

Bayer Healthcare Pharms., Inc., No. 2:18-cv-01414-APG-EJY, 2019 WL 3945652, at *5 

(D. Nev. Aug. 21, 2019) (finding failure to allege “facts showing that gadolinium retention 

is in itself a clinically significant adverse reaction”); Goodell v. Bayer Healthcare Pharms., 

Inc., No. 18-cv-10694-IT, 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019) (finding no 

factual allegations of newly acquired information that would have allowed amendment 

pursuant to the CBE regulation). The Court agrees with these rulings and finds Plaintiff’s 

failure to warn claims are preempted. However, because it is not clear that the deficiency 

could not be cured by amendment, the Court will allow Plaintiff to amend.5

5

 The Amended Complaint alleges that Defendants could have satisfied their 

obligation to Plaintiff under state law by adopting, prior to her GBCA exposure, the label ultimately required by the FDA in 2018. (Doc. 35 ¶¶ 114, 162.) However, in responding to Defendants’ preemption arguments, Plaintiff argued that Defendants could have added the 2018 warning “or an even stronger warning” prior to January 2013. (Doc. 52 at 12.) Plaintiff did not identify what stronger warning she believes was warranted; presumably such a warning would have linked gadolinium retention to resulting harm for patients with normal kidney function. Given the Court’s conclusion that the 2018 warning did not fit within the CBE parameters, a “stronger warning” would also fail for lack of reasonable 

evidence of a causal association of harm. 

Additionally, after review of all available evidence regarding the impact of gadolinium retention for patients without renal impairment, the FDA’s 2017 advisory committee found no causal relationship with the symptoms Plaintiff alleges and did not 

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Design Defect 

 Plaintiff alleges Defendants’ products were defective in design because they were 

more dangerous than a reasonable person would expect when used in the intended manner. 

The foreseeable risk in the design includes the retention of gadolinium in organs and tissues 

with resulting fibrosis. Plaintiff alleges the risks are so great that, if known, healthcare 

providers would refuse to prescribe Defendants’ products. Plaintiff also alleges that there 

are GBCAs on the market with a safer design. Plaintiff alleges design defect based on both 

strict liability (Claim 2) and negligence (Claim 3). 

 Defendants argue this claim is preempted by federal law because they were 

prohibited from altering the formulation of their drugs after approval by the FDA. (Doc. 

46 at 11-12; Doc. 48 at 15.) The Amended Complaint does not allege that Defendants 

should have designed their drugs differently prior to seeking FDA approval, only that the 

design at the time they were prescribed to Plaintiff was unreasonably dangerous.6

 (Doc. 35 

at 53-57.) Defendants’ preemption argument relies upon Mutual Pharm. Co., Inc. v. 

Bartlett, 570 U.S. 472 (2013). Bartlett involved a design defect claim based on a generic 

pharmaceutical drug, and the Supreme Court concluded the claim was preempted because 

it was impossible for the manufacturer to comply with its state law duty and federal law. 

recommend a warning of harm (Doc. 35, Exs. A, B). See Davis v. McKesson Corp., No. 

CV-18-1157-PHX-DGC, 2019 WL 3532179, at *5 (D. Ariz. Aug. 2, 2019) (quoting the committee’s chair who provided this summary of their conclusion, “I think there is fair 

uniformity that there is no evidence of a causal relationship between the symptoms and signs in patients with normal renal function and the retention of gadolinium.”). These findings provide clear evidence the FDA would have rejected a label change that warned of the harm Plaintiff alleges she suffered from gadolinium retention. See Cerveny v. 

Aventis, Inc., 855 F.3d 1091, 1105 (10th Cir. 2017) (finding clear evidence because, after analyzing claims and data, the FDA had rejected a citizen petition seeking the same warning requested by the plaintiff). 

6

 Courts have reached different conclusions about whether pre-approval design defect claims are preempted by federal law. Compare Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281, 300 (6th Cir. 2015); Brazil v. Janssen Research & Dev. LLC, 196 F. Supp. 3d 1351, 1364 (N.D. Ga. 2016) (finding pre-approval non-sensical because, 

“[t]he Supreme Court has repeatedly characterized the state tort law at issue in this case as 

a duty to make changes or as a remedial effort.”), with Holley v. Gilead Scis., Inc., 379 F. 

Supp. 3d 809, 824 (N.D. Cal. 2019). In responding to the motions to dismiss, Plaintiff framed the argument as preemption based on Defendants inability to alter the design once approved. (Doc. 51 at 11.) Because Plaintiff has not suggested Claim 2 is premised on pre- approval design, the Court does not address that claim. 

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Id. at 478, 480. Redesign of the generic drug to comply with state law was not possible 

because it was required under federal law to have the same composition as the brand-name 

drug on which it was based. Id. at 483-84 (finding that state law would require a change to 

the drug’s active ingredients to either increase the drug’s usefulness or decrease its 

associated risk). 

Because Plaintiff’s claims are brought against brand-name manufacturers and 

Bartlett involved a generic drug, Plaintiff contends it is without application to her case. 

Neither the Supreme Court nor the Ninth Circuit have evaluated Bartlett’s applicability to 

name-brand manufacturers. And, other courts are not in agreement on how far Bartlett

extends. See Paulsen v. Abbott Labs., 368 F. Supp. 3d 1152, 1173 (N.D. Ill. 2019) (noting 

that whether all design defect claims are preempted under Bartlett is a question that “has 

divided federal courts across the country.”) (citing Brazil v. Janssen Research & Dev. LLC, 

249 F. Supp. 3d 1321, 1341 (N.D. Ga. 2016)). The Court need not evaluate the full 

parameters of Bartlett, it need only apply the rules from Bartlett and prior preemption cases 

to Plaintiff’s claims. 

The Court must first identify Defendants’ duties under state law. See Bartlett, 570 

U.S. at 480. In Arizona, a design defect claim, premised on either strict liability or 

negligence, requires Plaintiff to show “the product left the defendants’ hands in a defective 

condition, the defect rendered the product unreasonably dangerous, and the defect was a 

proximate cause of plaintiff’s injuries.” Mills v. Bristol-Myers Squibb Co., No. CV 11-

00968-PHX-FJM, 2011 WL 4708850, at *1 (D. Ariz. Oct. 7, 2011) (citing Sw. Pet Prods., 

Inc. v. Koch Indus., Inc., 273 F. Supp. 2d. 1041, 1051 (D. Ariz. 2003)). 

No Arizona court has evaluated whether to apply the Restatement (Third) of Torts 

§ 6(c) to a design defect claim for pharmaceuticals. That section provides: 

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 medical device are sufficiently great in relation to its foreseeable therapeutic benefits that 

reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. 

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Restatement (Third) of Torts § 6(c) (1998). Several factors support relying on § 6(c): 

Arizona previously applied the Restatement (Second) to a tort claim based on a 

pharmaceutical, see Gaston v. Hunter, 588 P.2d 326, 338, 121 Ariz. 33, 45 (Ct. App. 1978); 

the Arizona Supreme Court has adopted the subsequent section of the Restatement (Third), 

see Watts v. Medicis Pharm. Corp., 365 P.3d 944, 949, 239 Ariz. 19, 24 (2016) (adopting 

§ 6(d) for a failure to warn claim and noting the absence of authority to the contrary); and, 

this Court has applied the Restatement (Third) to cases brought under Arizona law, Welch 

v. Wright Med. Tech., Inc., No. CV-11-2113-PHX-DGC, 2012 WL 4711899, at *2 (D. 

Ariz. Oct. 3, 2012) (applying Restatement § 6(c) because Arizona has indicated willingness 

to look to the Restatement and this Court has followed it in prior cases). For those reasons, 

this Court applies § 6(c) to its analysis. The commentary to the Restatement provides: 

“Duties concerning the design and marketing of prescription drugs and medical devices 

arise only with respect to risks of harm that are reasonably foreseeable at the time of sale.” 

Restatement (Third) of Torts § 6 cmt. g (1998). If Plaintiff fails to plead a strict liability 

claim, her negligence claims also will fail. Mills, 2011 WL 4708850, at *4. 

 To comply with Arizona law (applying the Restatement (Third) of Torts), 

Defendants would have had to change the design of their GBCAs to decrease the risk in 

comparison to the benefit so that reasonable doctors would not decline to prescribe their 

drugs. See Bartlett, 570 U.S. at 483 (“A drug’s usefulness and its risk of danger are both 

direct results of its chemical design and, most saliently, its active ingredients.”). However, 

Defendants were not allowed to redesign their drugs under federal regulations because 

“[o]nce a drug – whether generic or brand-name – is approved, the manufacturer is 

prohibited from making any major changes to the ‘qualitative or quantitative formulation 

of the drug product, including active ingredients, or in the specifications provided in the 

approved application.” Id. at 477 (quoting 21 C.F.R. § 314.70(b)(2)(i)). 

Plaintiff pled that there was a safer alternative design, macrocyclic GBCAs. (Doc. 

35 ¶ 188.) As reflected in the FDA documents attached to the Amended Complaint, the 

active ingredient in each GBCA, whether linear or macrocyclic, is different; also, a 

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macrocyclic chemical structure is distinct from a linear chemical structure. (Doc. 35, Ex. 

B at 3, Table 1.) Because it would constitute a major change under the regulations, 

Defendants were not able to alter their linear GBCAs to mirror a macrocyclic GBCA 

formulation without obtaining prior FDA approval. 21 C.F.R. § 314.70(b) (including as a 

major change “drug substance, drug product, production process”); see Gustavsen v. Alcon 

Labs., Inc., 903 F.3d 1, 9-10 (1st Cir. 2018) (“Controlling case law is clear . . . that if the 

change they contend state law requires qualifies as “major,” then federal law preempts 

plaintiffs’ cause of action because defendants cannot lawfully make such a change without 

prior FDA approval.”) 

In Bartlett, once the Court concluded that the defendant could not redesign its drug 

to alter its risk profile in compliance with state law, it looked at whether a stronger warning 

label could ameliorate the risk. 570 U.S. at 484. Because the answer was no, for a generic 

drug, the Supreme Court found that claim preempted as well. Id. at 486-87. A label 

alteration also is not possible in this case. First, Plaintiff contends that failure to warn is 

not part of her design defect claim (Doc. 52 at 14), and Arizona views them as distinct 

claims.7

 Second, and more importantly, this Court has determined that Defendants were 

unable to alter their label without FDA approval. When the Supreme Court in Bartlett

concluded that the defendant could neither redesign its drug nor alter its label without prior 

FDA approval, it concluded the design defect claim was wholly preempted. 570 U.S. at 

486-87, 489 (holding state law claims that “place a duty on manufacturers to render a drug 

safer by either altering its composition or altering its labeling are in conflict with federal 

laws that prohibit manufacturers from unilaterally altering drug composition or labeling.”) 

Here, too, Plaintiff’s design defect claims are preempted. Because it is not clear that the 

deficiency could not be cured by amendment, the Court will allow Plaintiff to amend. 

7

 In Bartlett, the Court was evaluating a design-defect claim under New Hampshire law, which provided that a manufacturer could satisfy its obligation not to design an unreasonably dangerous product by redesigning it or strengthening its warning. 570 U.S. at 482, 484. Arizona treats design defect claims and failure to warn claims as distinct causes 

of action although there is substantial overlap in the elements. See Brown v. Sears, Roebuck 

& Co., 667 P.2d 750, 756, 136 Ariz. 556, 562 (Ct. App. 1983) (recognizing three distinct product liability claims, design defects, warning defects, and manufacturing defects); Mather v. Caterpillar Tractor Corp., 533 P.2d 717, 719, 23 Ariz. App. 409, 411 (1975). 

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Request for Discovery 

 Plaintiff requests that, if the Court is inclined to dismiss any claims on the basis of 

preemption, the Court should treat the motion as one for summary judgment and allow 

discovery prior to ruling. Plaintiff would then seek discovery regarding whether 

Defendants attempted to place a stronger warning label on their products and/or requested 

FDA permission to place a stronger warning on their products, and whether the FDA 

inhibited Defendants ability to issue a stronger warning. The Court’s ruling regarding 

Plaintiff’s failure to warn claims is premised solely on the allegations in the Amended 

Complaint and attached exhibits, and it does not rely on whether Defendants took steps to 

strengthen the warning on their products. Therefore, Plaintiff’s requested discovery is not 

relevant. Plaintiff did not request any discovery regarding Defendants’ preemption defense 

as to the defective design claims. The Court finds no basis to convert the motions to ones 

for summary judgment. 

FORESEEABILITY 

 Defendants argue Plaintiff failed to plead that Defendants knew (or should have 

known) their products posed an unreasonable danger to patients with normal kidney 

function. (Doc. 48 at 16-17.) In Arizona, “[m]anufacturers generally have a duty to warn 

consumers of foreseeable risks of harm from using their products.” Watts, 365 P.3d at 949, 

239 Ariz. at 24; see also Restatement (Third) of Torts § 2 (1998). “This is so whether, as 

in Watts, the failure-to-warn claim is couched as one of strict liability in tort . . . or instead 

as a negligence claim,” Conklin, 431 P.3d at 577, 245 Ariz. at 507. Similarly, as discussed 

above, Defendants’ duties with respect to product design (strict liability or negligence) 

apply only to foreseeable risks of harm. Restatement (Third) of Torts § 6 cmt. g (1998); 

Mills, 2011 WL 4708850, at *4 (finding negligence allegations will fail if plaintiff fails to 

state a strict liability claim). 

Plaintiff cites the following allegations from the Amended Complaint (Doc. 35) as 

alleging foreseeability: it was reasonably foreseeable that Defendants’ drugs would cause 

gadolinium retention, fibrosis, and related injuries (¶ 52); Plaintiff used the product in a 

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manner reasonably foreseeable to Defendants (¶¶ 168, 175); the foreseeable risks 

associated with the design of Defendants’ products included that the design was more 

dangerous than a reasonable consumer would have expected and resulted in retention of 

gadolinium and fibrosis (¶¶ 178-79); and, the foreseeable risks outweigh the product’s 

therapeutic utility such that, if known, healthcare providers would not prescribe them for 

any class of patients (¶¶ 180-81, 183). These allegations are all conclusory and are 

contradicted by factual allegations in the Amended Complaint or its exhibits. Further, as 

discussed above, many of the studies that Plaintiff refers to are irrelevant because they were 

completed after Plaintiff’s last exposure to gadolinium in November 2016 (Doc. 35 

¶¶ 47(l), 47(p), 47(s), 48, 102, 107-09, 110) or involved patients with compromised renal 

function (id. ¶¶ 47(t), 47(x), 47(y), 47(bb), 47(cc), 68, 71-77, 83, 90-92). Additionally, she 

cites several studies without a direct corollary to IV administration of gadolinium in 

humans. (Id. ¶¶ 47(n), 47(o), 47(q), 47(r).) 

Critically, Plaintiff cites no studies confirming injury to a single patient with normal 

kidney function due to GBCA exposure. Neither the bodily retention of gadolinium without 

injury as documented in numerous studies (Doc. 35 ¶¶ 47(a), 47(k), 47(m), 47(v), 47(w), 

47(bb), 63, 65, 66, 70, 86, 88), nor the limited patient reports cited by Plaintiff (id. ¶¶ 47(g), 

47(h), 47(u), 47(v), 47(w), 79, 85), demonstrate that Defendants should have known their 

products posed an unreasonable danger or a foreseeable risk of harm. This conclusion is 

highlighted by an FDA document informing the public about gadolinium retention and 

what was known about its risk. Plaintiff attached to the Amended Complaint a December 

2017 FDA Warning, which provided: 

To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in 

a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these 

adverse events and gadolinium retention could not be established. 

(Doc. 35, Ex. B at 3.) The FDA also concluded that “the benefit of all approved GBCAs 

continues to outweigh any potential risks.” (Id. at 2.) These findings were issued after an 

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FDA committee reviewed all published literature and case reports as well as all patient 

reports submitted to the FDA. Davis v. McKesson Corp., No. CV-18-1157-PHX-DGC, 

2019 WL 3532179, at *5 (D. Ariz. Aug. 2, 2019). 

 Plaintiff’s extensive allegations amount only to the fact of gadolinium retention and 

that certain individuals correlated retention with their physical ailments. However, the FDA 

concluded, more than a year after Plaintiff last was exposed to gadolinium, that no GBCAs 

were unreasonably dangerous and there was no known adverse health effect from 

gadolinium retention. In light of these exhibits, the Court does not accept as true Plaintiff’s 

conclusory allegations to the contrary. Sprewell, 266 F.3d at 988. Plaintiff has failed to 

plead there was a known risk of harm that Defendants could have foreseen prior to 2016. 

See McGrath, 393 F. Supp. 3d at 172 (finding that, in 2015, it was not reasonably 

foreseeable that exposure to GBCAs would injure the plaintiff). Because it is not absolutely 

clear that Plaintiff could not cure this deficiency, she should be granted leave to amend. 

PUNITIVE DAMAGES 

 In Plaintiff’s original complaint, the Prayer for Relief included a request for punitive 

damages. (Doc. 1 at 41.) Subsequently, she filed a Notice of Voluntary Dismissal, in which 

she requested (among other things) that the court dismiss her request for punitive damages. 

(Doc. 14.) In her Amended Complaint, Plaintiff did not include punitive damages in the 

Prayer for Relief (Doc. 35 at 62), but she did request them within her negligence claim (id.

¶ 198). The Court assumes the request in the Amended Complaint was an oversight, in 

light of the removal from the prayer for relief. However, Plaintiff did not clarify her intent 

by responding to this argument. (Doc. 51.) 

Defendants contend punitive damages are barred by Arizona statute (Doc. 46 at 13-

14), which provides: 

A. The manufacturer or seller of a drug is not liable for exemplary or 

punitive damages if the drug alleged to cause the harm either: 

1. Was manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license issued by the federal food and drug administration under the food, drug and cosmetic act (21 United States Code § 301, et seq.). 

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Ariz. Rev. Stat. Ann. § 12-701. 

Plaintiff’s Amended Complaint is premised on Defendants’ drugs and their labels 

being FDA-approved. (Doc. 35 ¶¶ 24, 46, 47, 50, 77, 104, 111, 114.) Plaintiff did not plead 

that Defendants’ drugs were out of compliance with their FDA-approved manufacturing or 

labeling. For that reason, Plaintiff is barred from seeking punitive damages from 

Defendants. See Kobar ex rel Kobar v. Novartis Corp., 378 F. Supp. 2d 1166, 1177 (D. 

Ariz. 2005) (barring punitive damages for injuries arising from FDA-approved drugs based 

on § 12-701(A), while finding an exception set forth in subpart (B) to be unconstitutional 

but severable). In light of the statutory prohibition, amendment as to punitive damages is 

not warranted. 

OTHER ARGUMENTS & AMENDMENT 

 Because the Court finds Plaintiff’s claims should be dismissed in entirety based on 

preemption and failure to plead foreseeability, the Court does not reach Defendants’ 

numerous other arguments. However, if Plaintiff chooses to amend, she should consider 

these arguments when doing so. 

 Plaintiff amended once after consulting with Defendants’ counsel and reviewing a 

first set of motions to dismiss. Additionally, Plaintiff’s counsel has brought numerous cases 

nationwide on behalf of other plaintiffs alleging gadolinium retention and related injury. 

Their experience and knowledge in this field suggest their current pleading likely included 

all facts available to state a claim under Arizona law. Thus, the possibility that amendment 

will cure the deficiencies is slim. Plaintiff may amend only if she possesses additional 

factual allegations that allow her to state at least one claim for relief. See Klein, 2019 WL 

3945652, at *5 & n.3 (noting that, in McGrath, the plaintiff had been unable to cure the 

deficiencies by amendment and requiring any amended pleading to “offer additional factual 

allegations of a causal association between Magnevist and clinically significant adverse 

reactions.”). At a minimum, Plaintiff must include allegations of: reasonable evidence of a 

causal association of harm (relevant to preemption and causation necessary to state a claim 

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for failure to warn or design defect),8 a foreseeable risk of harm to patients with normal 

kidney function from Defendants’ GBCAs (necessary to state a claim for failure to warn 

or design defect), and Defendants ability under federal law to redesign their drugs to 

comply with state law (for a design defect claim). 

 If Plaintiff files a second amended complaint, she would be better served with a 

more concise pleading. The Amended Complaint is unnecessarily long and repetitive. 

Additionally, it failed to allege numerous relevant facts. For example, Plaintiff did not state 

with clarity: her alleged injury (retention alone or the symptoms she alleges resulted from 

retention), when the injury occurred and when she discovered it, when her symptoms 

began, the basis for her allegation that gadolinium was retained in her brain or other specific 

body locations, and what data or analyses were newly acquired in that they had not been 

previously submitted to the FDA. Additionally, Plaintiff’s allegations that Defendants’ 

GBCAs were so dangerous that no reasonable physician would prescribe them to any 

patient (Doc. 35 ¶¶ 181-83) are wholly conclusory and without supporting factual 

allegations. 

RECOMMENDATION

 Based on the foregoing, the Magistrate Judge recommends that the District Court 

enter an order granting Defendants’ Motions to Dismiss (Docs. 46-48) but granting 

Plaintiff leave to amend in accord with the Court’s directions. The Court also recommends 

dismissing Defendants’ first round of motions to dismiss as moot because they are based 

on the original complaint. (Docs. 15, 16, 20.) 

8

 As discussed above, the FDA committee findings in 2017 suggest Plaintiff may not be able to plead a factually based causal association or foreseeability. Or, if pled sufficiently, proving the claims might be an insurmountable hurdle. See Davis, 2019 WL 

3532179 (excluding all Plaintiff’s experts on general causation under Rule 702); Davis v. 

McKesson Corp., No. CV-18-1157-PHX-DGC, 2019 WL 5535376 (D. Ariz. Oct. 25, 

2019) (granting summary judgment and dismissing three related cases because Plaintiffs were unable to prove general causation without experts). 

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 Pursuant to Federal Rule of Civil Procedure 72(b)(2), any party may serve and file 

written objections within fourteen days of being served with a copy of the Report and 

Recommendation. A party may respond to the other party’s objections within fourteen 

days. No reply brief shall be filed on objections unless leave is granted by the District 

Court. If objections are not timely filed, they may be deemed waived. 

 Dated this 31st day of January, 2020. 

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