Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-4_19-cv-00529/USCOURTS-azd-4_19-cv-00529-0/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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WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Monica Granillo, et al.,

Plaintiffs,

v. 

Johnson & Johnson, et al.,

Defendants.

No. CV-19-00529-TUC-CKJ (MSA)

REPORT AND 

RECOMMENDATION

This matter is on referral pursuant to Rules 72.1 and 72.2 of the Local Rules of Civil 

Procedure. Pending before the Court is Defendants Johnson & Johnson and Ethicon 

Incorporated’s partial motion for summary judgment. (Doc. 26.) The motion has been 

fully briefed and is suitable for determination without oral argument. (Docs. 27, 28, 29, 

30, 56.) For the following reasons, the Court will recommend that the motion be granted 

in part and denied in part.

I. Background

At some point prior to February 2005, Plaintiff Monica Granillo was diagnosed with 

stress urinary incontinence. (Doc. 26-1 at 4.) Monica discussed treatment options with her 

physician, Dr. Mitzi J. Barmatz, including physical therapy and surgical implantation of 

pelvic mesh. (Doc. 26-1 at 4; Doc. 26-2 at 12.) Monica elected to do the surgery, which 

took place on February 17, 2005. (Doc. 26-1 at 4.) Following the surgery, Monica has 

experienced pain, urinary problems, dyspareunia (pain before, during, or after intercourse), 

urinary urgency, stress urinary incontinence, infections, vaginal scarring, and emotional 

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and psychological distress. (Id. at 5.)

In Count One, Plaintiffs allege a claim of negligence. (Doc. 1 at 4; Doc. 36, Attach. 

10, at 24–26.) They allege Defendants were negligent in the performance of several distinct 

activities relating to the pelvic mesh, including “design, manufacture, labeling, warning, 

instruction, training, selling, marketing, and distribution.” (Doc. 36, Attach. 10, at 24.) 

Distilled down, Count One is a claim for negligent design, negligent manufacture, and 

negligent failure to warn.

II. Legal Standard

Summary judgment is proper “if the movant shows that there is no genuine dispute 

as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. 

Civ. P. 56(a). A fact is material if it “might affect the outcome of the suit under the 

governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A factual 

dispute is genuine if the evidence is such that a reasonable trier of fact could resolve the 

dispute in favor of the nonmoving party. Id. In evaluating a motion for summary judgment, 

the court must “draw all reasonable inferences from the evidence” in favor of the 

nonmovant. O’Connor v. Boeing N. Am., Inc., 311 F.3d 1139, 1150 (9th Cir. 2002). A 

reasonable inference is one which is supported by “significant probative evidence” rather 

than “threadbare conclusory statements.” Barnes v. Arden Mayfair, Inc., 759 F.2d 676, 

680–81 (9th Cir. 1985). If “the evidence yields conflicting inferences [regarding material 

facts], summary judgment is improper, and the action must proceed to trial.” O’Connor, 

311 F.3d at 1150.

The party moving for summary judgment bears the initial burden of identifying 

those portions of the record, together with affidavits, if any, that it believes demonstrate 

the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 

(1986). If the movant meets this burden, the burden shifts to the nonmovant to “come 

forward with specific facts showing that there is a genuine issue for trial.” Matsushita 

Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (emphasis omitted); see 

also Fed. R. Civ. P. 56(c)(1).

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III. Discussion1

A. Negligent Design

Defendants contend that Plaintiffs’ claim for negligent design should be dismissed 

because it is duplicative of, and subsumed by, their claim for strict liability design. The 

Court disagrees.

Under Arizona law, there are two theories of recovery for injuries caused by a 

defectively designed product: strict liability design and negligent design. See Dart v. Wiebe 

Mfg., Inc., 709 P.2d 876, 880–82 (Ariz. 1985). In negligent design cases, the plaintiff 

“must prove that the designer . . . acted unreasonably at the time of . . . design of the 

product.” Id. at 881. This inquiry focuses on what the designer knew or reasonably should 

have known at the time of design. Id. “In a strict liability risk/benefit analysis, however, 

it is not the conduct of the . . . designer which is primarily in question, but rather the quality 

of the end result; the product is the focus of the inquiry.” Id. Thus, a factfinder may 

consider not only what was actually known to the designer at the time of design (as it would 

in a negligent design analysis) but also any other facts about the product’s harmful 

characteristics that are proven at trial—whether the designer knew about them at the time 

of design or not. Id.; see Golonka v. Gen. Motors Corp., 65 P.3d 956, 961–64 (Ariz. Ct. 

App. 2003).

These theories overlap. Clearly, the “universe of knowledge” attributed to a 

designer in a strict-liability analysis will include what the designer actually knew or should 

have known at the time of design, which is all that matters in a negligent design case. See 

Golonka, 65 P.3d at 964. As such, if a plaintiff “cannot prove his case in strict liability,” 

which takes into account all that negligent design cases do and more, “he cannot prove it 

in negligence either.” Gomulka v. Yavapai Mach. & Auto Parts, Inc., 745 P.2d 986, 990 

(Ariz. Ct. App. 1987). It is from this fact that Defendants argue that Plaintiffs’ negligence 

claim should be dismissed as subsumed by their strict liability claim.

1 Defendants moved for dismissal of thirteen of Plaintiffs’ eighteen claims. In 

response, Plaintiffs have abandoned twelve of the challenged claims. The abandoned 

claims are not discussed in this report.

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However, Defendants ignore that negligent design and strict liability design are 

separately viable theories. Indeed, the case on which Defendants rely for their argument, 

Gomulka, does not stand for the proposition that a negligent design theory can never 

accompany a strict liability design theory. See 745 P.2d at 243. If Defendants were correct 

that overlap between the theories is reason to dismiss the narrower theory, there would be 

no reason for Arizona to recognize both legal theories. Moreover, the Golonka case, 

decided more than 15 years after Gomulka, belies Defendants’ argument; that case involved 

a trial on both strict liability design and negligent design theories. 65 P.3d at 960. 

Defendants have not shown they are entitled to judgment as a matter of law. 

Consequently, the Court will recommend that summary judgment be denied.

B. Negligent Manufacture

“A defectively manufactured product is one that is flawed as a result of something 

that went wrong during the manufacturing process.” Gomulka, 745 P.2d at 988–89. Here, 

Defendants have shifted the summary-judgment burden to Plaintiffs by arguing there is no 

evidence that the pelvic mesh implanted into Monica deviated from Defendants’ intended 

design. See Fairbank v. Wunderman Cato Johnson, 212 F.3d 528, 532 (9th Cir. 2000) 

(stating that a defendant moving for summary judgment “may shift the burden of producing 

evidence to the nonmoving plaintiff merely by ‘showing’—that is, pointing out through 

argument—the absence of evidence to support plaintiff’s claim”). Plaintiffs have not 

responded with counterargument or evidence. Therefore, the Court will recommend that 

summary judgment be granted in favor of Defendants. See Nissan Fire & Marine Ins. Co. 

v. Fritz Cos., 210 F.3d 1099, 1103 (9th Cir. 2000) (stating that if “a moving party carries 

its burden of production, the nonmoving party must produce evidence to support its claim 

or defense” (emphasis added)).

C. Negligent Failure to Warn

Defendants argue that Plaintiffs cannot establish a claim for failure to warn because 

Monica’s physician knew all the risks associated with the mesh prior to doing Monica’s 

surgery, and any such claim fails under the learned intermediary doctrine (“LID”).

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The LID applies in the context of products liability. A plaintiff may sue a product 

manufacturer claiming that its product was defective or unreasonably dangerous due to the 

lack of adequate instructions or warnings. Watts v. Medicis Pharm. Corp., 365 P.3d 944, 

948 (Ariz. 2016). A failure-to-warn claim requires proof that the manufacturer had a duty 

to warn consumers about the product’s dangerousness. Id. “In certain contexts, however, 

the manufacturer’s or supplier’s duty to warn end users of the dangerous propensities of its 

product is limited to providing an adequate warning to an intermediary, who then assumes 

the duty to pass the necessary warnings on to the end users.” Id. (quoting Centocor, Inc. 

v. Hamilton, 372 S.W.3d 140, 154 (Tex. 2012)). Under the LID, “if the manufacturer

provides complete, accurate, and appropriate warnings about the product to the learned 

intermediary, it fulfills its duty to warn the consumer” and consequently may not be held 

liable for a failure to warn. Id. at 949. 

The Arizona Supreme Court has indicated that the LID applies “whether . . . the 

failure-to-warn claim is couched as one of strict liability in tort based on an alleged 

information defect . . . or instead as a negligence claim.” Conklin v. Medtronic, Inc., 431 

P.3d 571, 577 (Ariz. 2018) (internal citations omitted). As noted above, one of Plaintiffs’ 

negligence theories is that Defendants were negligent in warning of risks associated with 

the pelvic mesh. (Doc. 36, Attach. 10, at 25.) This part of the negligence claim is subject 

to the LID. See Conklin, 431 P.3d at 577.

The LID bars a claim only if “the manufacturer provides complete, accurate, and 

appropriate warnings about the product to the learned intermediary.” Watts, 365 P.3d at 

949. Thus, “a patient could sue and directly recover from a . . . manufacturer based on its 

failure to properly warn the prescribing physician.” Id. Here, Defendants point out that 

Monica’s physician, Dr. Barmatz, testified that she read Defendants’ product instructions 

and attended Defendants’ training program. (Doc. 26-2 at 6, 9, 10–11.) Defendants also 

point out that Dr. Barmatz testified she was aware of all relevant risks associated with the 

pelvic mesh, including dyspareunia, pain, vaginal scarring, infection, organ and nerve 

damage, bleeding, inflammation, and urinary problems including dysuria (pain while 

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urinating), urinary urgency, and stress urinary incontinence. (Id. at 8–9.)

By arguing that Plaintiffs cannot establish causation and by raising the LID as a 

defense, Defendants have met their initial burden on summary judgment. See Fairbank, 

212 F.3d at 532. Plaintiffs have not met their responsive burden to establish a triable issue, 

as they have withdrawn their opposition to application of the LID. (Doc. 56.) Furthermore, 

Plaintiffs have not disputed Defendants’ contention that they are unable to establish 

causation for a failure-to-warn claim. See Nissan Fire, 210 F.3d at 1103. Therefore, the 

Court will recommend that summary judgment be granted in favor of Defendants.

IT IS RECOMMENDED that Defendants’ motion for partial summary judgment

(Doc. 26) be granted in part and denied in part, as follows:

1. On Count One, the Court recommends that summary judgment be denied to 

the extent that Plaintiffs have alleged a claim of negligent design, and that 

summary judgment be granted to the extent that Plaintiffs have alleged 

claims of negligent manufacture and negligent failure to warn; and

2. On Counts Two, Three, Four, Seven, Eight, Nine, Ten, Eleven, Twelve, 

Thirteen, Fourteen, and Fifteen, the Court recommends that summary 

judgment be granted.2

This recommendation is not an order that is immediately appealable to the Ninth 

Circuit Court of Appeals. The parties shall have fourteen days from the date of service of 

a copy of this recommendation within which to file specific written objections with the 

district court. See 28 U.S.C. § 636(b)(1); Fed. R. Civ. P. 72(b). The parties shall have 

fourteen days within which to file responses to any objections. Failure to file timely 

objections to this recommendation may result in the acceptance of the recommendation by 

the district court without further review. See United States v. Reyna-Tapia, 328 F.3d 1114, 

1121 (9th Cir. 2003) (en banc). Failure to file timely objections to any factual 

determination made in this recommendation may be considered a waiver of a party’s right 

to appellate review of the same finding in an order or judgment by the district court which 

2

If the recommendation is adopted, Counts One (in part), Five, Six, Sixteen, 

Seventeen, and Eighteen would remain for trial.

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adopts the recommendation. See Fed. R. Civ. P. 72.

Dated this 12th day of February, 2020.

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