“[U]nder Stone, with 18 a properly prepared product, the element of ‘defect’ in a drug case under [Alabama law] turns on 19 the adequacy of the warning that accompanied the product.”
How later courts described this case
- “[U]nder Stone, with 18 a properly prepared product, the element of ‘defect’ in a drug case under [Alabama law] turns on 19 the adequacy of the warning that accompanied the product.”
- listing Alabama as a state that “provide[s] all prescription drugs categorical 16 immunity from strict liability for design defects”
Written by the judges who cited it.
The opinion
1
2
3
4 UNITED STATES DISTRICT COURT
5 NORTHERN DISTRICT OF CALIFORNIA
6
7 ADRIAN HOLLEY, et al., Case No. 18-cv-06972-JST
8 Plaintiffs,
ORDER GRANTING IN PART AND
9 v. DENYING IN PART DEFENDANT’S
MOTION FOR SUMMARY
10 GILEAD SCIENCES, INC., JUDGMENT ON COMMON ISSUES
11 Defendant. Re: ECF No. 1126
12
13 Before the Court is Defendant Gilead Sciences, Inc.’s motion for summary judgment on
14 common issues. ECF No. 1126. The Court will grant the motion in part and deny it in part.
15 I. BACKGROUND
16 Plaintiffs in these cases have taken one of more of Gilead’s drugs containing tenofovir
17 disoproxil fumarate (“TDF”): Viread, Truvada, Atripla, Complera, and Stribild. The Court has
18 consolidated approximately 75 cases for pretrial purposes only, with over 3,000 remaining
19 plaintiffs from the District of Columbia and every state except for California and Delaware.1
20 Plaintiffs contend that they have suffered unnecessary kidney and bone damage caused by
21 Gilead’s failure to provide adequate warnings and its profit-driven decision to develop drugs
22 containing TDF rather than the allegedly safer tenofovir alafenamide fumarate (“TAF”). Under
23 their respective states’ laws, Plaintiffs assert claims based on design defect, failure to warn,
24 negligence, fraud, breach of the implied warranty of merchantability, and violation of consumer
25 protection laws.
26 The Food and Drug Administration (“FDA”) first approved Viread in 2001, with approvals
27
1 for Truvada, Atripla, Complera, and Stribild coming in 2004, 2006, 2011, and 2012, respectively.
2 Gilead has also received FDA approval for three TAF drugs: Genvoya in 2015 and Odefsey and
3 Descovy in 2016. All of these drugs are used to treat and, in some cases, prevent HIV/AIDS.
4 Prior to the approval of Viread, Gilead had already started developing TAF. It completed
5 its first clinical trial of TAF, GS-120-1101 or Study 1101, in 2003, and it stopped development of
6 TAF in 2004. Gilead contends that it did so because there did not appear to be significant
7 differences between TDF and TAF, and a toxicology study in dogs showed potentially new side
8 effects for TAF as compared to TDF. Plaintiffs argue that Gilead knew that TAF was a safer
9 alternative to TDF, but that it was driven by profits and believed that developing TAF drugs would
10 harm sales of TDF drugs already in development or on the market. With FDA approval, Gilead
11 re-started TAF development in 2010. It argues that it did so at that time because the HIV patient
12 population was evolving, and Gilead viewed TAF as a potential lower-dose alternative for an
13 aging population that had higher risks of renal and bone-density issues.
14 The Court has resolved two rounds of motions to dismiss. When ruling on the first motion,
15 the Court dismissed with leave to amend “Plaintiffs’ failure-to-warn claims based on post-
16 approval, post-2008 labeling changes, and . . . Plaintiffs’ fraud and consumer protection claims to
17 the extent those claims are based on misrepresentations and not omissions.” ECF No. 75 at 30.
18 The Court subsequently dismissed without leave to amend “Plaintiffs’ fraud and consumer
19 protection claims to the extent they rely on allegations of affirmative misrepresentations rather
20 than omissions, as well as Plaintiffs’ post-approval, post-July 2012 failure-to-warn claims.” ECF
21 No. 123 at 12. Of relevance to Gilead’s motion for summary judgment, the Court concluded that
22 Plaintiffs’ design-defect claims, pre-approval failure-to-warn claims, and post-approval, pre-July
23 2012 failure-to-warn claims were not preempted. Id. at 12–24; ECF No. 123 at 8–11.
24 Now before the Court is Gilead’s motion for summary judgment on common issues, in
25 which it seeks summary judgment on all of Plaintiffs’ claims. ECF No. 1126.
26 II. JURISDICTION
27 The Court has jurisdiction under 28 U.S.C. § 1332(a).
1 III. LEGAL STANDARD
2 Summary judgment is proper when a “movant shows that there is no genuine dispute as to
3 any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a).
4 A dispute is genuine only if there is sufficient evidence “such that a reasonable jury could return a
5 verdict for the nonmoving party,” and a fact is material only if it might affect the outcome of the
6 case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). When deciding a motion for
7 summary judgment, the court must draw “all justifiable inferences” in the nonmoving party’s
8 favor and may not weigh evidence or make credibility determinations. Id. at 255.
9 Where the party moving for summary judgment would bear the burden of proof at trial,
10 that party “has the initial burden of establishing the absence of a genuine issue of fact on each
11 issue material to its case.” C.A.R. Transp. Brokerage Co. v. Darden Rests., Inc., 213 F.3d 474,
12 480 (9th Cir. 2000). Where the party moving for summary judgment would not bear the burden of
13 proof at trial, that party “must either produce evidence negating an essential element of the
14 nonmoving party’s claim or defense or show that the nonmoving party does not have enough
15 evidence of an essential element to carry its ultimate burden of persuasion at trial.” Nissan Fire &
16 Marine Ins. Co. v. Fritz Cos., 210 F.3d 1099, 1102 (9th Cir. 2000). If the moving party satisfies
17 its initial burden of production, the nonmoving party must produce admissible evidence to show
18 that a genuine issue of material fact exists. Id. at 1102–03. It is not the court’s duty “to scour the
19 record in search of a genuine issue of triable fact”; instead, the nonmoving party must “identify
20 with reasonable particularity the evidence that precludes summary judgment.” Keenan v. Allan,
21 91 F.3d 1275, 1279 (9th Cir. 1996) (quoting Richards v. Combined Ins. Co., 55 F.3d 247, 251
22 (7th Cir. 1995)) . If the nonmoving party fails to make the required showing, the moving party is
23 entitled to summary judgment. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986).
24 IV. DISCUSSION
25 A. Design Defect
26 1. Preemption
27 This Court has previously explained the analytical framework for the “demanding” defense
1 manufacturing context:
2 First, courts must determine whether a drug manufacturer may
independently take action that complies with both state and federal
3 law. An action is independent under this analysis if the
manufacturer can take such action without prior FDA approval, even
4 if the FDA may subsequently reject approval of the action post hoc.
If independent action is not possible, then the state-law claims are
5 preempted. If independent action is possible, then the claims are
preempted only if there is clear evidence that the FDA would not
6 grant approval.
7 ECF No. 75 at 11–12. The preemption analysis begins with considering a manufacturer’s duties
8 under both state and federal law. Id. at 12 (citing Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 480
9 (2013); PLIVA, Inc. v. Mensing, 564 U.S. 604, 611 (2011)). In their briefs on the motion to
10 dismiss, the parties did not “attempt[] to describe Gilead’s duties under any particular state law,”
11 and “the Court assume[d] without deciding that the state laws invoked by Plaintiffs required
12 Gilead to use TAF rather than TDF, and to use a lower dose of TDF before submitting Stribild to
13 the FDA for approval.” Id. at 12–13.
14 Gilead now argues that the laws of the relevant states require a manufacturer “to market
15 and distribute a reasonably safe product.”2 ECF No. 1126 at 24–25. It further argues that a
16 manufacturer therefore has no duty “to design a safer product in the abstract that may or may
17 never become available to consumers.” Id. at 24 (emphasis added). However, the allegations in
18 this case do not occur in the abstract. Plaintiffs do not argue that Gilead is liable because it had an
19 independent duty to design drugs containing TAF in a vacuum. Instead, they allege that the TDF
20 drugs they consumed were defective because Gilead failed to consider TAF as a safer alternative
21 and that, instead of seeking approval for the TDF drugs, Gilead should have offered a different
22 formulation for FDA approval. There is no dispute that Gilead distributed TDF drugs that were
23 consumed by Plaintiffs, and it is to those drugs that the relevant duty applies. Even if, as Gilead
24 argues, no duty arises from a drug manufacturer to a consumer until a transaction occurs, the
25 transactions occurred in this case when Plaintiffs purchased Gilead’s TDF drugs.
26 The Court discusses two states as illustrative. First, under Illinois law, “[t]he doctrine of
27
1 strict liability was not intended to encompass injuries resulting from a ‘product’ which is in an
2 unmarketable state and which had not yet been released into the stream of commerce by sale or
3 display to the consumer.” Genaust v. Ill. Power Co., 343 N.E.2d 465, 470 (Ill. 1976). Gilead
4 attempts to characterize TAF drugs as the product “in an unmarketable state” for which strict
5 liability would not apply. Plaintiffs, however, do not claim injury from the “unmarketable” TAF
6 drugs. Instead, their alleged injuries are from the TDF drugs, which Gilead indisputably “released
7 into the stream of commerce.” Id. Similarly, Gilead argues that preemption is supported by
8 Arizona law, under which “[t]he essence of a negligence action based on defective design is that
9 defendant distributed a product when it was reasonably foreseeable that its design presented an
10 unreasonable risk of harm.” Jones v. Pak-Mor Mfg. Co., 700 P.2d 819, 823 (Ariz. 1985). Gilead
11 contends that Plaintiffs’ design-defect claims are preempted because Gilead requires FDA
12 approval before distributing a drug. Plaintiffs’ claims, however, are based on the distribution of
13 TDF drugs, not TAF drugs, and the inability of Gilead to distribute TAF drugs without FDA
14 approval is not relevant to the preemption analysis.
15 Plaintiffs’ design-defect claims are not preempted.
16 2. Merits
17 a. Strict Liability in Certain States
18 The parties agree that five states—Massachusetts, North Carolina, Pennsylvania, Virginia,
19 and Utah—do not recognize design-defect claims for prescription drugs based on strict liability.
20 Summary judgment is therefore granted to Gilead as to those claims.
21 b. Alabama
22 The parties dispute whether Alabama law allows design-defect claims based on strict
23 liability and negligence. In Stone v. Smith, Kline & French Laboratories, the Alabama Supreme
24 Court opined that Alabama’s adoption of comment k to Section 402A of the Restatement (Second)
25 of Torts “provides for drugs and vaccines an exception to the strict liability defined in Section
26 402A.” 447 So. 2d 1301, 1303 (Ala. 1984). It concluded “that in the case of an ‘unavoidably
27 unsafe’ yet properly prepared prescription drug, the adequacy of the accompanying warning
1 (footnote omitted).
2 Relying on Stone, courts have held that, “no . . . design defect claim for prescription drugs
3 exists [under Alabama law] apart from a challenge to the adequacy of the warning,” and that this
4 includes claims under both strict liability and negligence theories because “[t]he Alabama
5 Supreme Court has found the safety element common to both strict liability and negligence
6 claims.” Barcal v. EMD Serono, Inc., No. 5:14-cv-01709-MHH, 2016 WL 1086028, at *3 (N.D.
7 Ala. Mar. 21, 2016) (citing McMahon v. Yamaha Motor Corp., 95 So. 3d 769, 772 (Ala. 2012));
8 see also McDaniel v. Mylan, Inc., No. 7:19-cv-00209-LSC, 2019 WL 11638407, at *5 (N.D. Ala.
9 Dec. 16, 2019) (following Barcal); Tatum v. Schering Corp., 795 F.2d 925, 926 (11th Cir. 1986)
10 (“Because ethical drugs are considered unavoidably unsafe products, they are defective only when
11 not accompanied by an adequate warning.”); Cooper v. Bristol-Myers Squibb Co., Civ. Action No.
12 07-885 (FLW), 2013 WL 85291, at *10 (D.N.J. Jan. 7, 2013) (“[U]nder Alabama law, only those
13 drugs that are ‘not accompanied by ethical warnings’ may form the basis of a defective design
14 claim.” (quoting Stone, 447 So. 2d at 1304)); Moss v. Wyeth, Inc., 872 F. Supp. 2d 162, 167-68
15 (D. Conn. 2012) (listing Alabama as a state that “provide[s] all prescription drugs categorical
16 immunity from strict liability for design defects”); In Re Yasmin & Yaz (Drospirenone) Mktg.,
17 Sales Pracs. & Prods. Liab. Litig., 870 F. Supp. 2d 587, 595 (S.D. Ill. 2012) (“[U]nder Stone, with
18 a properly prepared product, the element of ‘defect’ in a drug case under [Alabama law] turns on
19 the adequacy of the warning that accompanied the product.”).
20 Plaintiffs have cited no case interpreting Stone to permit strict liability or negligence
21 claims for prescription drugs based on design defect. Although they cite three cases where “courts
22 have permitted design defect claims involving drugs or devices to proceed under Alabama law,”
23 ECF No. 1156 at 31, none of those cases engaged with the question of whether Alabama law
24 categorically bars liability for prescription drugs or devices, and it appears that the parties in those
25 cases did not raise that question. See Houston v. Bayer Healthcare Pharms., Inc., 16 F. Supp. 3d
26 1341, 1348–49 (N.D. Ala. 2014); Woodcock v. Mylan, Inc., 661 F. Supp. 2d 602, 611–12
27 (S.D.W. Va. 2009); In re Tylenol (Acetaminophen) Mktg., Sales Pracs. & Prods. Liab. Litig.,
1 The Court follows the authority of every court to have decided the question and grants
2 summary judgment to Gilead on Plaintiffs’ design-defect claims under Alabama law, under both
3 strict liability and negligence theories.
4 c. Remaining States
5 The parties agree that in the remaining jurisdictions, with two exceptions,3 the risk-utility
6 analysis applies.4 The parties also do not dispute that expert testimony is required to assist the
7 finder of fact with the risk-utility analysis, but Gilead argues that Plaintiffs have not presented
8 expert testimony on necessary issues.
9 Plaintiffs present testimony regarding the risks of TDF and the relative safety of TAF as to
10 kidney and bone toxicities—for example: that “TDF is clearly associated with kidney injury and
11 disease,” ECF No. 1157-26 ¶ 6; “Gilead did not adequately investigate the kidney toxicities or
12 TDF in its early clinical trials,” id. ¶ 10 (emphasis omitted); “TAF is much safer for the kidneys
13 than is TDF and is capable of preventing or reducing kidney injury compared to TDF,” id. ¶ 18;
14 and studies “demonstrate[d] that TAF was safer than TDF while still being at least as effective for
15 HIV control,” id. at 75. They also present testimony that “scientific evidence from multiple
16 sources that accumulated from the launch of TDF in 2001 through October of 2004 clearly
17 established a reasonable probability that TDF had serious adverse effects on kidneys and bones,”
18
19
3 The parties debate whether Nebraska and Nevada have rejected the risk-utility test in favor of a
consumer-expectations test, but they discuss that issue only in footnotes. ECF No. 1126 at 18 n.2;
20
ECF No. 1156 at 26 n.8; ECF No. 1189 at 12 n.1. The Court has previously explained that raising
arguments only in footnotes is improper. ECF No. 75 at 30 (citing Estate of Saunders v. Comm’r,
21
745 F.3d 953, 962 n.8 (9th Cir. 2014), and Sanders v. Sodexo, Inc., No. 2:15-cv-00371-JAD-
GWF, 2015 WL 4477697, at *5 (D. Nev. July 20, 2015)). Accordingly, the Court does not reach
22
the parties’ arguments about Nebraska and Nevada. Gilead may renew its arguments, if
appropriate, if individual Plaintiffs’ claims from those states come before the Court.
23
4 Gilead’s motion cites Section 6(c) of the Restatement (Third) of Torts: Product Liability, which
24
states: “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
25
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
26
class of patients.” ECF No. 1126 at 18. But Gilead has cited no authority that any jurisdiction has
adopted this stringent test. Section 6(c) “is a conscious rejection of the risk-utility test, which
27
would ask whether the manufacturer could have reasonably produced a drug just as beneficial
1 ECF No. 1157-2 ¶ 8(a); “preclinical studies with TAF confirmed it had a significant safety margin
2 over TDF,” ECF No. 1157-17 ¶ 49; and evidence before October 2004 suggested “a high
3 likelihood of TAF being a safer prodrug than TDF, primarily due to its lower systemic exposure to
4 tenofovir,” id. ¶ 56.
5 Gilead argues that testimony about the risks of TDF, without weighing those risks against
6 TDF’s undisputed benefits in treating and preventing HIV, is insufficient. The Court disagrees.
7 First, the cases relied on by Gilead for the proposition that expert testimony is required to prove a
8 design defect do not establish that experts must specifically weigh risks and benefits. See ECF
9 No. 1126-1 at 2–4. For example, Gilead relies on a Georgia case where the court stated that, at
10 summary judgment, plaintiffs “must produce evidence from an expert who is qualified to conduct
11 the risk-utility analysis and to opine that the risks inherent in [the challenged product’s] design
12 outweigh the utility or benefit derived from the product.” In re Mentor Corp. ObTape
13 Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1365 (M.D. Ga. 2010). However,
14 for that proposition, the court relied on Dean v. Toyota Industrial Equipment Manufacturing, Inc.,
15 540 S.E.2d 233 (Ga. Ct. App. 2000), which did not impose such a stringent requirement. To the
16 contrary, Dean stated that “the weighing of the risk-utility factors is to be done by the trier of
17 fact,” and that “a product’s risks and benefits will rarely be determined as a matter of law when
18 any of the Banks factors is disputed.” Id. at 237 (emphasis in original). The Banks factors include
19 “the state of the art at the time the product is manufactured” and “the manufacturer’s ability to
20 eliminate the danger without impairing the product’s usefulness or making it too expensive”—
21 issues on which Plaintiffs here have presented expert testimony. Id. (citing Banks v. ICI Americas,
22 450 S.E.2d 671, 675 & n.6 (Ga. 1994)). The Dean court explained that, “by adopting the risk-
23 utility analysis, Georgia has actually increased the burden of a defendant, in seeking a judgment as
24 a matter of law, to show plainly and indisputably an absence of any evidence that a product as
25 designed is defective.” Id. (emphasis in original). Thus, although “[t]here was also evidence
26 supporting [the defendant’s] position that the risks of the [product] as manufactured did not
27 outweigh the benefits,” entering summary judgment for the defendant was improper because “it
1 read Dean as requiring the specific type of expert testimony that Gilead contends Plaintiffs must
2 present; instead, under Dean, the evidence presented by Plaintiffs is sufficient to withstand
3 summary judgment because it raises disputes as to some of the relevant factors under Banks.
4 Similarly, that some courts have allowed expert testimony that a product’s risks outweigh its
5 benefits does not mean that such testimony is required to prove a design defect. See, e.g.,
6 Dalbotten v. C.R. Bard, Inc., No. 1:20-cv-00034-SPW, 2023 WL 1068771, at *2 (D. Mont.
7 Jan. 27, 2023) (“Whether a product is ultimately defective under Montana law is a question solely
8 for the jury, but an expert is permitted to testify that the filter suffered from several flaws and that,
9 in his opinion, the risks outweighed the benefits without that testimony constituting a legal
10 opinion.”).
11 Second, the Court is not persuaded by Gilead’s argument that presenting evidence that a
12 reasonable alternative design existed is insufficient to create a disputed fact over whether a design
13 was defective. Gilead has cited no authority, and the Court has located none, for the proposition
14 that a plaintiff cannot withstand summary judgment on a design-defect claim by presenting
15 evidence of a reasonable alternative design. To the contrary, courts have denied summary
16 judgment when plaintiffs have introduced such evidence. E.g., In re Xarelto (Rivaroxaban)
17 Prods. Liab. Litig., No. MDL 2592, 2017 WL 3140422, at *5–6 (E.D. La. July 21, 2017); In re
18 Tylenol (Acetaminophen) Mktg., 2015 WL 7075949, at *14–19; Hunt v. McNeil Consumer
19 Healthcare, 297 F.R.D. 268, 273–74 (E.D. La. 2014).5 Similarly, the Georgia Supreme Court has
20 described “the reasonableness of choosing from among various alternative product designs and
21 adopting the safest one if it is feasible” as “the ‘heart’ of design defect cases,” and explained that a
22 manufacturer cannot avoid liability if the plaintiff “adduce[s] evidence that a feasible alternative
23 design, which could have prevented or minimized the plaintiff’s injury, was available at the time
24
5 The Tylenol court concluded: “Viewing all the facts in the light most favorable to the plaintiff, a
25
reasonable jury could find that a feasible design existed at the time of [the decedent’s] death and
the defendants breached their duty to market a safe product.” 2015 WL 7075949, at *19. Gilead
26
argues that this means “that plaintiffs still must prove that a defendant ‘breached their duty to
market a safe product’” in addition to proving the existence of a reasonable alternative design.
27
ECF No. 1189 at 12. However, this Court reads Tylenol as stating that a jury could conclude that
1 the manufacturer made its design, manufacturing, and marketing decisions.” Banks, 450 S.E.2d at
2 674 (quoting 78 A.L.R.4th 154); id. at 675. And, in Mississippi, “a plaintiff establishes a design
3 defect by proving a product could have been made safer by the adoption of a reasonable
4 alternative design,” and, “once sufficient evidence has been presented to the judge so the judge
5 can determine that reasonable people could conclude a reasonable alternative design could have
6 been practically adopted, the issue can be entrusted to a trier of fact.” Williams v. Bennett, 921 So.
7 2d 1269, 1275 (Miss. 2006) (citing Restatement (Third) of Torts: Prod. Liab. § 2 (1998)). While
8 Plaintiffs’ evidence of a reasonable alternative design may not ultimately convince a jury that
9 Gilead’s TDF drugs were defectively designed, Gilead has not persuaded the Court that no
10 reasonable juror could find such evidence dispositive. Accordingly, summary judgment on
11 Gilead’s remaining design-defect claims is denied.
12 B. Negligence
13 To the extent Plaintiffs’ negligence claims are based on the presence of a design defect,
14 summary judgment is denied for the reasons discussed above. Gilead also seeks summary
15 judgment on the question of whether Plaintiffs can prevail on a negligence claim if they fail to
16 “prove that the product was unreasonably dangerous.” ECF No. 1126 at 27.
17 The Court rejects Gilead’s argument to the extent it asserts it cannot be held liable for
18 negligence if it is not liable under a strict-liability theory. E.g., Toner v. Lederle Lab’ys, 828 F.2d
19 510, 513 (9th Cir. 1987) (explaining that negligence and strict liability law “require[] the jury to
20 examine the case from two different points of view,” such that “it is reasonable” to read jury
21 verdicts finding negligence but not strict liability “as saying that” the defendant’s failure to
22 develop an allegedly safer product “was unreasonable conduct, although the danger posed by the
23 product itself was not greater than an ordinary consumer would reasonably expect”). In addition,
24 as stated in cases relied on by Gilead, “a manufacturer may act negligently without its product
25 being unreasonably dangerous.” Slisze v. Stanley-Bostitch, 979 P.2d 317, 320 (Utah 1999); see
26 also Morden v. Continental AG, 611 N.W.2d 659, 673 (Wis. 2000) (negligence theory requires
27 “an underlying product defect,” but the plaintiff in a negligence action need not “show that the
1 However, this does not mean that all negligence claims can be successful in the absence of
2 an unreasonably dangerous product. In Slisze, for example, the Utah Supreme Court concluded
3 that a manufacturer cannot be “negligent in simply marketing a product that is less safe than
4 another,” and noted that it had “never, nor has any other jurisdiction, recognized a duty on the part
5 of a manufacturer to refrain from marketing a non-defective product when a safer model is
6 available, or a duty to inform the consumer of the availability of the safer model.” 979 P.2d at
7 320. Thus, Gilead is entitled to summary judgment on negligence claims based on these asserted
8 duties under Utah law.
9 The Slisze court cited no authority for its conclusion that no other jurisdiction has
10 recognized these duties, and this Court does not find the opinion persuasive on that question.
11 Prentis v. Yale Manufacturing Co., in which the court stated that “the plaintiff must, in every case,
12 in every jurisdiction, show that the product was defective,” is similarly not persuasive because it
13 cites no out-of-state authority. 365 N.W.2d 176, 181–82 (Mich. 1984) (emphasis in original).
14 In the absence of briefing from the parties regarding specific duties Plaintiffs assert under
15 each jurisdiction’s negligence laws, the Court declines to rule at this time which particular claims
16 are supported by each jurisdiction’s laws—aside from the Utah claims discussed above. If
17 appropriate, Gilead may renew its arguments in case-specific summary judgment motions. In
18 preparing for each early trial case, the parties shall meet and confer so that it is clear what duties,
19 if any, Plaintiffs contend Gilead breached.
20 C. Failure to Warn
21 Gilead argues that both Plaintiffs’ pre-approval and post-approval failure-to-warn claims
22 are preempted.
23 1. Pre-approval
24 Gilead concedes that state laws require it to “provide adequate warnings and instructions to
25 consumers” but argues that Plaintiffs’ pre-approval failure-to-warn claims are preempted because
26 it “cannot do so without FDA’s approval of the proposed initial label.” ECF No. 1126 at 31
27 (emphasis omitted). However, Gilead again “has cited no federal law that would prevent a drug
1 drug.” ECF No. 75 at 18 (order denying motion to dismiss pre-approval failure-to-warn claims as
2 preempted). Nor has Gilead cited any authority for the proposition that FDA approval is
3 dispositive of a pre-approval failure-to-warn claim—i.e., that FDA approval establishes that a drug
4 manufacturer has complied with its duty to provide adequate warnings. To the contrary, the
5 Supreme Court has characterized as a “fundamental misunderstanding” the position “that the
6 FDA, rather than the manufacturer, bears primary responsibility for drug labeling,” and explained
7 that the manufacturer “is charged both with crafting an adequate label and with ensuring that its
8 warnings remain adequate as long as the drug is on the market.” Levine, 555 U.S. at 570–71.
9 Although “the labeling language must not deviate from that which was approved by the FDA,
10 [a manufacturer] still possesse[s] the ability to implement stronger warning language into labeling,
11 by submitting stronger warning language for FDA approval”; thus, “the mere fact that the FDA
12 approved, at various times, labeling language proposed by [the manufacturer] . . . do[es] not offer
13 conclusive proof of preemption.” In re Actos (Pioglitazone) Prods. Liab. Litig., No. 12-cv-00064,
14 2014 WL 60298, at *7 (W.D. La. Jan. 7, 2014). Plaintiffs’ pre-approval failure-to-warn claims are
15 not preempted.
16 2. Post-approval
17 Plaintiffs argue that “[p]ost-approval failure to warn claims against brand manufacturers
18 are not preempted where the manufacturer can take independent action to strengthen its warnings
19 via the ‘changes being effected” (CBE) regulation.” ECF No. 1156 at 36. The Supreme Court has
20 explained the FDA drug labeling requirements as follows:
21 The FDA’s premarket approval of a new drug application includes
the approval of the exact text in the proposed label. See 21 U.S.C.
22 § 355; 21 CFR § 314.105(b) (2008). Generally speaking, a
manufacturer may only change a drug label after the FDA approves
23 a supplemental application. There is, however, an FDA regulation
that permits a manufacturer to make certain changes to its label
24 before receiving the agency’s approval. Among other things, this
“changes being effected” (CBE) regulation provides that if a
25 manufacturer is changing a label to “add or strengthen a
contraindication, warning, precaution, or adverse reaction” or to
26 “add or strengthen an instruction about dosage and administration
that is intended to increase the safe use of the drug product,” it may
27 make the labeling change upon filing its supplemental application
1 Levine, 555 U.S. at 568. As this Court has explained, post-approval failure-to-warn claims against
2 brand-name manufacturers like Gilead “are not preempted if the manufacturer could
3 independently alter the drug label under the CBE regulation and there is not ‘clear evidence that
4 the FDA would not have approved a change to [the drug’s] label.’”6 ECF No. 75 at 19–20 (citing
5 Levine, 555 U.S. at 568–72) (alteration in original).
6 Changes under the CBE regulation require that there be “newly acquired information,” 21
7 C.F.R. § 314.70(c)(6)(iii), which is defined as “data, analyses, or other information not previously
8 submitted to the Agency,” 21 C.F.R. § 314.3(b). Such information “may include (but is not
9 limited to) data derived from new clinical studies, reports of adverse events, or new analyses of
10 previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a
11 different type or greater severity or frequency than previously included in submissions to FDA.”
12 Id. The Supreme Court explained that:
13 [This definition] accounts for the fact that risk information
accumulates over time and that the same data may take on a
14 different meaning in light of subsequent developments: “[I]f the
sponsor submits adverse event information to FDA, and then later
15 conducts a new analysis of data showing risks of a different type or
of greater severity or frequency than did reports previously
16 submitted to FDA, the sponsor meets the requirement for ‘newly
acquired information.’”
17
Levine, 555 U.S. at 569 (quoting 73 Fed. Reg. at 49607).
18
A defendant manufacturer is entitled to summary judgment on preemption grounds if
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“there is no newly acquired information that would justify invoking the CBE procedure.” In re
20
Zofran (Ondansetron) Prods. Liab. Litig., 57 F.4th 327, 341 (1st Cir. 2023); see also id. at n.10
21
(noting that a manufacturer “is entitled to a finding of preemption due to the lack of newly
22
acquired information”). The parties presume that determining whether “newly acquired
23
information” exists is a legal question, and the Court “follow[s] the parties’ lead.” Id. at 337
24
(citing Knight v. Boehringer Ingelheim Pharms., Inc., 984 F.3d 329, 337–38 (4th Cir. 2021)); cf.
25
26
6 The Court drew a distinction between pre-2008 and post-2008 claims based on the date of an
27
amendment to the CBE regulation. ECF No. 75 at 21–22. Gilead now argues, and Plaintiffs do
1 id. at n.7 (noting that, in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), the
2 Supreme Court decided that whether “clear evidence” of FDA disapproval exists is a question of
3 law, but the Court “seemingly left open the question whether what constitutes ‘newly acquired
4 information’ is a question or law or a question of fact”). In resolving that question, “courts may
5 have to resolve subsidiary factual disputes,” Albrecht, 139 S. Ct. at 1680 (quoting Teva Pharms.
6 USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 327 (2015)), which do not “warrant submission alone or
7 together with the larger pre-emption question to a jury,” id.
8 Gilead argues, and Plaintiffs do not dispute, that Plaintiffs bear the burden of
9 demonstrating that “newly acquired information” exists. This is in accord with the Court’s prior
10 ruling that, to survive a motion to dismiss, Plaintiffs must plead a labeling deficiency that Gilead
11 could have corrected using the CBE regulation, which includes pleading the existence of “newly
12 acquired information.” ECF No. 75 at 20–24. Additionally, although preemption is an affirmative
13 defense for which Gilead bears the ultimate burden, one court has held that the plaintiff “bears the
14 burden of coming forward with evidence sufficient to conclude that the defendant could and
15 should have availed itself of the applicable federal regulations and given a different warning(s)
16 advocated by the plaintiff,” and then the burden shifts to the defendant to present “‘clear evidence’
17 that the FDA—even if presented with such ‘new’ evidence—nonetheless would have rejected the
18 warning(s) advocated by the plaintiff.” Ridings v. Maurice, 444 F. Supp. 3d 973, 980 (W.D. Mo.
19 2020). Another court is in accord: “[I]f the plaintiff can point to the existence of ‘newly acquired
20 information’ to support a labeling change under the CBE regulation, the burden then shifts to the
21 manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling
22 change made on the basis of this newly acquired information.” Utts v. Bristol-Myers Squibb Co.,
23 251 F. Supp. 3d 644, 661 (S.D.N.Y. 2017), aff’d sub nom. Gibbons v. Bristol-Myers Squibb Co.,
24 919 F.3d 699 (2d Cir. 2019). As is the Seventh Circuit, which has concluded that preemption bars
25 claims where, at trial, the plaintiff “failed to offer evidence that [the defendant manufacturer]
26 acquired new information.” Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 815 (7th Cir. 2018). In
27 the absence of any contrary authority, the Court places the burden on Plaintiffs to establish the
1 Plaintiffs cite a variety of information that they contend was “newly acquired” under the
2 regulation. First, they argue that Gilead’s 2010 internal analysis of study 907, a pre-approval
3 clinical study, showed significant differences in urine phosphorus excretion that were not reported
4 to the FDA. However, Plaintiffs do not argue that Gilead should have modified its labeling to
5 require that type of monitoring. To the contrary, Plaintiffs’ expert, Dr. Derek Fine, agreed at his
6 deposition that he was not suggesting that the labels should have recommended monitoring urine
7 phosphate excretion; instead, he said “that it should have been further studied. It may have
8 resulted in it being on the label. . . . I haven’t said that . . . these things should have been on the
9 label. I think that . . . we should have had more knowledge about them and . . . how to use
10 them. . . .” ECF No. 1189-3 at 5 (emphasis added). Another of Plaintiffs’ experts, Dr. Michael
11 Shlipak, similarly explained that after the 902 and 907 studies, “Gilead stopped studying and
12 reporting findings of urine phosphorus wasting in randomized comparisons of TDF with
13 alternative treatments” and opined that Gilead should have “measured urine levels of phosphorus
14 in all participants of their TDF trials and presented these findings to the clinical community.”
15 ECF No. 1157-26 ¶¶ 12–13. But asserting that a manufacturer could or should have done more
16 studies—i.e., “that a manufacturer should have created the ‘newly acquired information’”—is
17 insufficient to avoid preemption under the CBE regulation. Gayle v. Pfizer Inc., 452 F. Supp. 3d
18 78, 88 (S.D.N.Y. 2020), aff’d, 847 F. App’x 79 (2d Cir. 2021).
19 Second, Plaintiffs argue that various case reports, physician statements, medical literature,
20 and research studies recommended monitoring beyond that which Gilead included in its labeling.
21 They also assert that Gilead’s 2005 analysis of its safety data in response to a request of European
22 regulators would have supported a label change. However, as Gilead correctly observes, Plaintiffs
23 have not explained how this information differed from the information that had already been
24 presented to the FDA. “[T]he question of whether there is ‘newly acquired information’ to
25 support a CBE submission” must be considered “against the backdrop of the FDA’s years-long
26 attention to, and evaluation of, the . . . safety of [TDF] drugs.” In re Incretin-Based Therapies
27 Prods. Liab. Litig., 524 F. Supp. 3d 1007, 1018–19 (S.D. Cal. 2021), aff’d on other grounds, No.
1 acquired information” where an article has been made available to the FDA or the plaintiffs do not
2 dispute that the manufacturer “submitted all clinical trial data to the FDA.” Id. at 1024–25.
3 In this case, as Gilead’s expert states, and as Plaintiffs do not dispute, the FDA history
4 involves 40 periodic post-marketing safety reports (“PSURs”) on Gilead’s TDF medications, and
5 35 FDA-approved updates “to TDF-based medications’ labeling.” ECF No. 1126-2 at 2–4. These
6 reports, each of which “consisted of hundreds or thousands of pages,” “contain[ed] post-approval
7 safety data, such as spontaneous adverse event reports, as well as information regarding
8 international regulatory compliance, ongoing clinical trials, estimated patient exposure, medical
9 literature references, and recommend labeling changes.” Id. at 2–3. In “almost every PSUR
10 starting in 2003, Gilead submitted to FDA cumulative reviews of data on kidney or bone adverse
11 effects,” including “reviews in response to requests by FDA or its international regulatory
12 counterparts.” Id. at 4–5. Plaintiffs’ experts testified at their depositions that they have no reason
13 to believe, or were offering no opinion, that Gilead withheld any adverse event reports or other
14 information from the FDA and, in fact, relied on the information given by Gilead to the FDA to
15 form their opinions.7 ECF No. 1126-5 at 37–38, 44–45, 94–95, 102–04, 112–13, 123, 126. Nor
16 have Plaintiffs introduced any evidence explaining how the information they contend is “new”
17 differs from what was presented to the FDA. That makes this case unlike those relied on by
18 Plaintiffs, where there was evidence of analyses or other evidence that the manufacturer did not
19 share with the FDA. E.g., In re Taxotere (Docetaxel) Prods. Liab. Litig., 508 F. Supp. 3d 71,
20 84–85 (E.D. La. 2020) (2006 presentation at breast cancer conference was not presented to the
21 FDA); Duncan v. Allergan, Inc., No. CV 18-8047 FMO (Ex), 2020 WL 6204563, at *6 (C.D. Cal.
22 Sept. 4, 2020) (“According to defendant’s lead safety officer for [the drug in question], defendant
23
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7 This includes testimony by one expert, Dr. Akhilesh Nagaich, that he was not “opining that
Gilead failed to satisfy any requirements relating to the reporting of adverse events” or “withheld
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data from FDA relating to adverse events.” ECF No. 1126-5 at 123, 126. Thus, the Court does
not find Nagaich’s conclusory statements in his report—that unidentified “post-approval data
26
demonstrating TDF patients were experiencing kidney and bone adverse effects” or “new research
reflecting the need for better monitoring of renal function in all TDF users broad categories”
27
“could have satisfied [the] ‘newly acquired information’ requirement,” ECF No. 1126-5 at 245
1 could have shared the relevant internal analyses with the FDA, but simply chose not to do so.”).8
2 The evidence Plaintiffs cite goes to the merits of whether Gilead’s labeling was sufficient, but
3 Plaintiffs have not demonstrated that this evidence is “newly acquired information” that would
4 have allowed Gilead to unilaterally implement labeling changes.
5 Similarly, that the FDA asked Gilead to make labeling changes in 2008 is evidence that the
6 agency would not have rejected a request from Gilead to make those changes. But Plaintiffs do
7 not explain how any of the information relied on by the FDA was not previously submitted to the
8 agency. Whether the underlying information constitutes “newly acquired information” under the
9 CBE regulation is a separate inquiry—and independent basis for finding preemption—from the
10 question of whether the FDA would have accepted or rejected a proposed labeling change. See In
11 re Zofran, 57 F.4th at 341.
12 Plaintiffs have not met their burden of demonstrating the existence of “newly acquired
13 information” such that Gilead could have made a labeling change without FDA approval under the
14 CBE regulation. This is the sole basis on which Plaintiffs argue their post-approval failure-to-
15 warn claims are not preempted, and the Court therefore grants summary judgment to Gilead on
16 these claims.
17 D. Fraud
18 The Court granted—without opposition from Plaintiffs—Gilead’s motion to dismiss fraud
19 and consumer protection claims based on misrepresentations, so only fraud claims based on
20 omissions remain in this case. ECF No. 123 at 7–8. Consequently, Plaintiffs’ argument that their
21 fraud claims are not preempted because “Gilead told doctors not to monitor serum phosphorus,
22 even though it was in the label” is not persuasive, as this is a misrepresentation rather than an
23 omission claim. ECF No. 1156 at 39 (emphasis omitted). Similarly, claims regarding other
24
8 In a third case relied on by Plaintiffs, an unpublished opinion from the Eleventh Circuit, the court
25
noted that medical literature and reports of renal impairment would have been sufficient to support
a stronger monitoring instruction, but the court did not address whether the identified information
26
had previously been presented to the FDA. Blackburn v. Shire U.S., Inc., No. 20-12258, 2022 WL
16729466, at *2 (11th Cir. Nov. 7, 2022). It did, however, conclude that the identified sources
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were included in the definition of “newly acquired information” under 21 C.F.R. § 314.3(b),
1 alleged misrepresentations, such as “marketing TDF as ‘extremely safe’ with ‘no toxicities,’”
2 “dismissing TDF-associated kidney and bone toxicity as merely a competitive issue, not a ‘real’
3 one,” and “publicly announc[ing] that TAF was not sufficiently differentiated from TDF,” are not
4 part of this lawsuit. Id. at 40.
5 To the extent Plaintiffs’ fraud claims are based on inadequate labeling, they are preempted
6 for the reasons discussed above.
7 Plaintiffs also assert fraud claims based on promotional and marketing materials. They
8 affirmatively “do not claim that Gilead should have provided additional or stronger warnings in
9 those materials that were not FDA-approved,” but they do “claim that Gilead downplayed and
10 undercut the FDA-approved warnings that appeared in its label, including by concealing important
11 safety information and omitting the true risks of TDF and the importance of patient monitoring in
12 its promotional and other communications with physicians.” ECF No. 1156 at 39. Claims based
13 on alleged omissions in promotional and marketing materials of information contained in FDA-
14 approved labels are not preempted. Although “advertising and promotional materials are
15 considered labeling” and so “must be consistent with the drug’s approved labeling,” Strayhorn v.
16 Wyeth Pharms., Inc., 737 F.3d 378, 394 (6th Cir. 2013), that principle does not bar claims based
17 on representations or omissions that do not conflict with the approved labeling. City and County
18 of San Francisco v. Purdue Pharma L.P., 491 F. Supp. 3d 610, 665–68 (N.D. Cal. 2020).
19 Plaintiffs’ fraud claims also rest in part on their contentions that “Gilead decided to keep
20 secret the positive results of TAF clinical study 1101, which showed that a much lower dose of
21 TAF was just as, if not more effective, than TDF,” and that Gilead failed to disclose the reasons it
22 delayed TAF development. ECF No. 1156 at 40. Plaintiffs do not dispute that Gilead could not
23 have promoted TAF as “safe or effective” until after it had been approved by the FDA. 21 C.F.R.
24 § 312.7(a). Nor do they dispute that Gilead could not advertise that TAF was safer than TDF
25 unless TAF was “demonstrated to be safer or more effective . . . by substantial evidence or
26 substantial clinical experience,” 21 C.F.R. § 202.1(e)(6)(ii), a showing that Plaintiffs do not
27 contend was made during the relevant time period. However, Gilead has cited no authority that it
1 theory—it stopped TAF development to avoid harming TDF sales. These claims are therefore not
2 preempted.
3 The Court nonetheless grants summary judgment to Gilead on these claims because, even
4 if Gilead owed a duty to disclose such information, Plaintiffs have presented no evidence of
5 materiality, which Plaintiffs do not contest is an element of their claims.9 See, e.g., Restatement
6 (Second) of Torts § 538 (defining “material” information as information as to which a reasonable
7 person “would attach importance to its existence or nonexistence in determining [their] choice of
8 action” or “the maker of the representation knows or has reason to know that its recipient regards
9 or is likely to regard the matter as important in determining [their] choice of action, although a
10 reasonable [person] would not so regard it”). Study 1101 concluded that TAF “show[ed] greater
11 potency than [TDF] in reducing plasma levels of HIV-1 RNA” and “showed a safety profile
12 similar to” TDF, not that TAF was safer than TDF. ECF No. 1126-3 at 23. Plaintiffs have
13 presented no evidence that this information, about a drug that had not yet been approved by the
14 FDA and was not available on the market, would have caused physicians to have acted differently,
15 either by prescribing a different medication that was available on the market or by changing how
16 they monitored patients on Gilead’s TDF drugs. Nor have Plaintiffs introduced any evidence
17 concerning the materiality of information that Gilead may have stopped TAF development for
18 financial reasons. Gilead is therefore entitled to summary judgment on these claims.
19 E. Implied Warranty and Consumer Protection
20 Gilead argues that it is entitled to summary judgment on Plaintiffs’ implied-warranty and
21 consumer-protection claims because Plaintiffs’ other claims fail. To the extent that Plaintiffs’
22 design-defect, negligence, and fraud claims survive for the reasons discussed above, their implied-
23 warranty and consumer-protection claims also survive. Summary judgment is granted to Gilead
24 on Plaintiffs’ implied-warranty and consumer-protection claims to the extent these claims rest on
25 Plaintiffs’ failure-to-warn claims, which are preempted for the reasons discussed above.
26 Gilead also argues that Plaintiffs cannot prevail on their implied-warranty claims because
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1 “the TDF medications were highly effective in treating HIV, and Plaintiffs do not contend that
2 there was anything amiss with the FDA approval process.” ECF No. 1126 at 42. One court has
3 held that “FDA’s approval of [a defendant’s medical] device through the PMA [Premarket
4 Approval] process belies . . . a claim [for breach of implied warranty] and preempts any claim that
5 [the plaintiff’s] device was unfit for its intended purpose.” Bishoff v. Medtronic Inc., No.
6 1:09CV171, 2010 WL 4852650, at *3 (N.D.W. Va. Nov. 22, 2010). However, as Gilead
7 concedes, FDA approval is not dispositive of design-defect claims except in Michigan, where
8 Plaintiffs do not assert design-defect claims. See ECF No. 1126 at 19 (“The fact of FDA’s initial
9 approval alone . . . creates a ‘rebuttable presumption’ in some states, and serves as significant
10 evidence in other states, that the medications are not defective.”); ECF No. 1189 at 17 n.3
11 (“Plaintiffs do not assert a design claim in Michigan, where FDA approval is a complete defense.
12 See Mich. Comp. Laws § 600.2946(5).”). And it is hornbook law that “courts find goods to be
13 unfit for their ordinary purposes when they can identify one of three general types of defects,”
14 including “design defects.” 1 Matt Crockett, The Law of Prod. Warranties § 5.5; see also Ducat v.
15 Ethicon, Inc., 534 F. Supp. 3d 152, 160 (D. Mass. 2021) (“Warranty liability may be based on . . .
16 a design defect.”).
17 Finally, citing AIDS Healthcare Foundation, Inc. v. Gilead Sciences Inc., No. C 16-00443
18 WHA, 2016 WL 3648623, at *9 (N.D. Cal. July 6, 2016), aff’d, 890 F.3d 986 (Fed. Cir. 2018),
19 Gilead argues that Plaintiffs cannot prevail on consumer-protection claims by “invoking antitrust-
20 type principles to argue that Gilead acted unfairly or unconscionably.” ECF No. 1126 at 43. This
21 Court has already held that AIDS Healthcare Foundation is not dispositive and concluded that it
22 “does not warrant dismissal of any of Plaintiffs’ claims,” in part because “[c]oncluding that Gilead
23 owed no duty to its competitors says nothing about any duties Gilead might owe to consumers
24 under state tort law.” ECF No. 75 at 6–8.
25 CONCLUSION
26 For the reasons discussed above, Gilead’s motion for summary judgment on common
27 issues is granted in part and denied in part. Summary judgment is granted to Gilead on the
1 Carolina, Pennsylvania, Virginia, and Utah; (2) Plaintiffs’ strict-liability and negligence design-
2 || defect claims in Alabama; (3) Plaintiffs’ negligence claim, if no design defect is found, based on
3 an alleged duty “to refrain from marketing a non-defective product when a safer model is
4 available, or a duty to inform the consumer of the availability of the safer model,” in Utah, Slisze,
5 979 P.2d at 317; (4) Plaintiffs’ post-approval failure-to-warn claims; (5) Plaintiffs’ fraud claims
6 || based on allegedly inadequate labeling, omissions regarding TAF clinical study 1101, and
7 || omissions regarding Gilead’s alleged reasons for delaying TAF development; and (6) Plaintiffs’
8 implied-warranty and consumer-protection claims to the extent they rest on any of the above
9 || claims. Summary judgment is denied as to Plaintiffs’ remaining claims.
10 The Court does not rule on Gilead’s evidentiary objections, ECF No. 1189 at 10, because it
11 did not rely on any of the disputed evidence in ruling on Gilead’s motion.
12 IT IS SO ORDERED.
: 13 Dated: September 28, 2023 . °
M4 JON S. TIGA
15 nited States District Judge
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