Davis et al v. Actavis, Inc. et al
Filing
53
MDL CASE MANAGEMENT ORDER NO. 179 (Memorandum Opinion and Order on Actavis, Inc.'s motion for summary judgment in Davis v. Actavis, Inc., Case No. 17 C 3775), signed by the Honorable Matthew F. Kennelly on 11/4/2020: For the reasons stated in th e accompanying Memorandum Opinion and Order, the Court denies Actavis's motion for summary judgment [dkt. no. 33]. The case is set for a telephone status hearing on November 23, 2020 at 9:30 a.m. to discuss further proceedings in this matter, us ing call-in number 888-684-8852, access code 746-1053. Counsel are directed to confer and are to file a joint status report on November 18, 2020 with an agreed-upon proposal for pretrial case management or, if they cannot agree, alternative proposals with a justification for each. (mk)
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 1 of 23 PageID #:2658
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
In re Testosterone Replacement Therapy
Products Liability Litigation Coordinated
Pretrial Proceedings
(This document applies to
Davis v. Actavis, Inc., Case No. 17 C 3775)
)
)
)
)
)
)
Case No. 14 C 1748
MDL No. 2545
CASE MANAGEMENT ORDER NO. 179
(Memorandum Opinion and Order on Actavis, Inc.'s
motion for summary judgment in
Davis v. Actavis, Inc., Case No. 17 C 3775)
MATTHEW F. KENNELLY, District Judge:
Plaintiffs in this multidistrict litigation (MDL) proceeding allege that they suffered
either arterial cardiovascular injuries or injuries related to blood clots in the veins as a
result of taking prescription testosterone replacement therapy (TRT) drugs. Defendants
Actavis, Inc., Actavis Pharma, Inc., and Actavis Laboratories UT, Inc. (collectively,
Actavis) manufacture or sell Androderm, one of the TRT products at issue in this
litigation. Plaintiff Douglas L. Davis alleges that his use of Androderm in July and
August 2015 caused him to suffer a stroke in August 2015. He asserts claims against
Actavis under Florida law for design defect; failure to warn; negligence; negligent
misrepresentation; breach of implied warranty of merchantability; breach of express
warranty; fraud; redhibition; consumer protection; unjust enrichment; and punitive
damages. Plaintiff Laura C. Davis asserts a claim against Actavis under Florida law for
loss of consortium. 1
1
In this opinion, the Court refers to plaintiffs collectively as Davis.
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 2 of 23 PageID #:2659
In July 2018, a Master Settlement Agreement was executed covering cases
involving Actavis. In August 2019, Davis informed the Court that he elected not to settle
his claims. Actavis now moves for summary judgment on a single legal issue: whether
a duty exists under Florida law for a prescription drug manufacturer to provide warnings
in some manner apart from the product's FDA-approved package insert. According to
Actavis, there is no such duty, leaving Davis without any viable claim. For the following
reasons, the Court denies Actavis's motion for summary judgment.
Background
A.
Androderm
Androderm is a testosterone transdermal system, meaning a patch that delivers
testosterone to the body through the skin. The Food and Drug Administration (FDA)
approved Androderm in September 1995. The uses for which the FDA approved the
drug are not relevant for present purposes. In 2015, the FDA ordered Actavis to include
the following language in the Warning and Precautions section of the Androderm label:
5.4 Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the
cardiovascular outcomes of testosterone replacement therapy in men. To
date, epidemiologic studies and randomized controlled trials have been
inconclusive for determining the risk of major adverse cardiovascular
events (MACE) such as non-fatal myocardial infarction, non-fatal stroke,
and cardiovascular death, with the use of testosterone compared to nonuse. Some studies, but not all, have reported an increased risk of MACE
in association with use of testosterone replacement therapy in men.
Patients should be informed of this possible risk when deciding whether to
use or to continue to use ANDRODERM.
Actavis Mot. for Summ J., Ex. 4 (Androderm Label Rev. 5/2015) [35-4] § 5.4; Actavis
L.R. 56.1 Resp. [52] ¶ 6. The FDA ordered other TRT manufacturers to include the
same language in the Warning and Precautions section of their TRT product labels. In
2
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 3 of 23 PageID #:2660
May 2015, the FDA approved a new Androderm label that incorporated the required
language.
B.
Davis's Androderm prescription
Dr. J. Frank Avey prescribed Androderm for Davis on July 22, 2015. Davis filled
the prescription that same day. Davis contends (and Actavis disputes) that he used one
Androderm patch per day for the next 23 days. On August 14, 2015, Davis had a stroke
and was transported to a hospital.
Davis states that when he received his Androderm prescription, it came with
prescribing information last updated in 2013. In other words, Davis contends he
received an outdated version of the Androderm label that did not include the FDAmandated cardiovascular risk language. In support, Davis offers a photograph of the
label he contends he received. See Davis Opp. to Mot. for Summ. J., Ex. 22
(Androderm Label Rev. 11/2013) [47-8].
Actavis admits only that the photograph depicts "a copy of the Androderm Full
Prescribing Information and Patient Information, revised in 2013", which did not contain
the FDA-mandated cardiovascular risk language. Actavis L.R. 56.1 Resp. ¶¶ 37-38.
Actavis maintains that there is no admissible evidence that the photograph portrays the
copy of the Androderm label Davis received. According to Davis, Dr. Avey testified that
it is unlikely he saw the May 2015 cardiovascular risk language before he made his
prescribing decision. Actavis disputes Davis's characterization of the testimony.
C.
Davis's theory of recovery
This Court has ruled on motions for summary judgment in several cases that
were selected as bellwether trial cases in this MDL. See In re Testosterone
3
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 4 of 23 PageID #:2661
Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 430 F.
Supp. 3d 516, 523 (N.D. Ill. 2019) (CMO 166) (collecting cases). The plaintiffs in those
cases argued (among other things) that before 2015—when the defendants added the
FDA-mandated cardiovascular risk language to their TRT product labels—the labels
failed to adequately warn that TRT use increases the risk of cardiovascular injury. The
plaintiffs also argued that the defendants knew or should have known about the
increased risk well before 2015. Davis's case is different. As noted above, Dr. Avey
prescribed Androderm for Davis about two months after Actavis updated the label to
include the FDA-mandated cardiovascular risk language. Davis contends that the
Androderm he received did not include the new label and that Dr. Avey did not see the
new label before prescribing Androderm for him. Davis seeks to hold Actavis liable for
failing to adequately communicate the label change to physicians.
Davis first gave notice of this theory in a joint status report filed in November
2019. The Court has permitted Actavis to file a motion for summary judgment limited to
one issue: whether a drug manufacturer has a duty under Florida law to provide
warnings in some manner apart from the product's FDA-approved package insert. See
Actavis Mem. in Supp. of Mot. for Summ. J. (Actavis Br.) [34] at 1; Actavis Reply in
Supp. of Mot. for Summ. J. (Actavis Reply) [51] at 3. Actavis maintains that Florida law
imposes no such duty.
Discussion
Summary judgment is appropriate if the moving party "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). There is a genuine issue of material fact, and
4
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 5 of 23 PageID #:2662
summary judgment is precluded, "if the evidence is such that a reasonable jury could
return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 248 (1986). When ruling on a motion for summary judgment, a court views the
record in the light most favorable to the non-moving party and draws all reasonable
inferences in that party's favor. Id. at 255; see also, e.g., Driveline Sys., LLC v. Arctic
Cat, Inc., 936 F.3d 576, 579 (7th Cir. 2019).
A.
Florida law on failure to warn
Addressing the legal question presented here requires an understanding of
Florida tort law and the learned intermediary doctrine. Under Florida law, the
manufacturer of a defective product may be held liable under theories of negligence and
strict liability. See Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 1366 (M.D. Fla. 2015),
aff'd, 723 F. App'x 722 (11th Cir. 2018). "[A] product may be defective by virtue of . . .
an inadequate warning." Ferayorni v. Hyundai Motor Co., 711 So. 2d 1167, 1170 (Fla.
Dist. Ct. App. 1998). To prevail on a claim of failure to warn based on either negligence
or strict liability, a plaintiff must show that "the warning label was inadequate," "the
inadequacy of the warning proximately caused his injury," and "he suffered an injury
from using" the defendant's product. Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75,
77 (Fla. Dist. Ct. App. 2009).
Florida has adopted the doctrine of strict liability set forth in the Restatement
(Second) of Torts § 402A. See West v. Caterpillar Tractor Co., 336 So. 2d 80, 87 (Fla.
1976). Section 402A provides that a manufacturer who "sells any product in a defective
condition unreasonably dangerous to the user . . . is subject to liability for physical harm
thereby caused to the ultimate user" if (1) "the seller is engaged in the business of
5
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 6 of 23 PageID #:2663
selling such a product" and (2) "it is expected to and does reach the user . . . without
substantial change in the condition in which it is sold." Restatement (Second) of Torts §
402A. The rule applies even if "the seller has exercised all possible care in the
preparation and sale of his product." Id.
Comment k to Section 402A addresses "[u]navoidably unsafe products",
including prescription drugs. Restatement (Second) of Torts § 402A, cmt. k. In relevant
part, it provides that "[s]uch a product, properly prepared, and accompanied by proper
directions and warning, is not defective, nor is it unreasonably dangerous." Id.
Accordingly, the manufacturer of an unavoidably unsafe product that was properly
prepared and accompanied by adequate directions and warnings will not be strictly
liable "for unfortunate consequences attending [its] use . . . ." Id. Florida courts have
rejected a "blanket approach" that applies comment k to all prescription drugs and
instead have held "that comment k is an affirmative defense to a strict liability claim."
Adams v. G.D. Searle & Co., 576 So. 2d 728, 733 (Fla. Dist. Ct. App. 1991). To be
protected under comment k, a manufacturer must show that the product "is as safe as
current testing and research permits" and that its benefits "outweigh its known risks as
of the date the product is distributed." Id. at 732-33.
Where, as here, the manufacturer's product is a prescription drug, "the duty to
warn is directed to physicians rather than patients under the 'learned intermediary'
doctrine." Mason, 27 So. 3d at 77 (quoting Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d
102, 104 (Fla. 1989)). In Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820
(Fla. Dist. Ct. App. 1981), the court explained that a physician acts as a learned
intermediary between the manufacturer and the patient because, "[a]s a medical
6
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 7 of 23 PageID #:2664
expert," he or she can make an informed prescribing decision that "weigh[s] the benefits
of any medication against its potential dangers" for the individual patient. Id. at 822
(quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974)). So long as "the
product is properly labeled and carries the necessary instructions and warnings to fully
apprise the physician of the proper procedures for use and the dangers involved," a
manufacturer "may reasonably assume that the physician will exercise the informed
judgment thereby gained in conjunction with his own independent learning, in the best
interest of the patient." Buckner, 400 So. 2d at 823 (quoting Terhune v. A.H. Robins
Co., 90 Wash. 2d 9, 14, 577 P.2d 975, 978 (1978)). "Thus, the duty of a drug
manufacturer to warn of the dangers involved in the use of a drug is satisfied if it gives
an adequate warning to the physician who prescribes the drug." Mason, 27 So. 3d at
77 (citing Buckner, 400 So. 2d at 823). "This reasoning applies" even in a strict liability
action governed by comment k of Section 402A. Buckner, 400 So. 2d at 823.
In determining whether a warning is adequate, the "crucial question is whether" it
was "adequate to warn a physician of the possibility that [the drug] might be causing the
condition experienced by [the plaintiff]." Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683
(Fla. 1990). "While in many instances the adequacy of warnings concerning drugs is a
question of fact," Florida courts have held "that it can become a question of law where
the warning is accurate, clear, and unambiguous." Felix, 540 So. 2d at 105.
B.
Scope of a drug manufacturer's duty to warn
As a federal court sitting in diversity and applying Florida law, this Court must
make its best prediction of how the Florida Supreme Court would decide the legal issue
Actavis has presented. See, e.g., Nationwide Agribusiness Ins. Co. v. Dugan, 810 F.3d
7
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 8 of 23 PageID #:2665
446, 450 (7th Cir. 2015). If the Florida Supreme Court has not ruled on the issue,
decisions of Florida's appellate courts "control, unless there are persuasive indications
that the [Florida] Supreme Court would decide the issue differently." Id. "In the
absence of any [Florida] authority on the question, decisions from other jurisdictions
may prove instructive." Pippen v. NBCUniversal Media, LLC, 734 F.3d 610, 615 (7th
Cir. 2013).
The Florida Supreme Court has not ruled on the issue presented here.
Suggesting otherwise, Actavis highlights the court's statement in E.R. Squibb & Sons,
Inc. v. Farnes, 697 So. 2d 825 (Fla. 1997), that "[p]harmaceutical manufacturers
discharge their duty to warn the learned intermediary by way of a package insert which
accompanies each vial of vaccine." Id. at 827 (quoting the trial court's order that
granted the defendant's motion for a new trial). The court also stated that "[w]hether the
physician in fact reads the warning, or passes its contents along to the recipient of the
drug is irrelevant." Id. (quoting same). But the quoted passages must be considered in
context. The plaintiff in E.R. Squibb did not allege that he received the wrong package
insert or that his physician was unaware of the relevant warning. See id. at 826-28.
Nor did he contend that the defendant's duty to warn extended beyond placing the
warning in the drug's package insert. See id. The court in E.R. Squibb addressed only
whether (1) the warning language itself was adequate as a matter of law and (2) the
allegedly inadequate warning was the proximate cause of the plaintiff's injury. See id.
Accordingly, the quoted language does not resolve whether a drug manufacturer's duty
to warn is as limited as Actavis contends. Other cases from the Florida Supreme Court
are inapposite for substantially similar reasons. See Upjohn, 562 So. 2d at 683
8
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 9 of 23 PageID #:2666
(addressing adequacy of the warning language); Felix, 540 So. 2d at 104-05
(addressing adequacy of the warning language and whether the allegedly inadequate
warning was the proximate cause of the plaintiff's injury).
Likewise, decisions by Florida appellate courts shed little light on the question
presented. Actavis highlights the court's holding in Buckner that even if a manufacturer
"knew or should have known that the medical profession was not warning patients of
potential side effects," it had no duty to warn patients about side effects; the
manufacturer's duty to warn runs only to the doctor. Id. at 823-24; see Actavis Br. at 6.
The holding, however, was rooted in the principle that a "doctor's duty to warn patients
of possible side effects is not absolute" and that a doctor exercises medical judgment in
determining what risks to disclose to patients. Buckner, 400 So. 2d at 823-24
(emphasis added). Like the Florida Supreme Court cases discussed above, Buckner
provides little assistance here because it did not address whether a manufacturer has a
duty to warn a physician in some manner apart from the package insert. Pysz v.
Henry's Drug Store, 457 So. 2d 561 (Fla. Dist. Ct. App. 1984), and Arnold v. Novartis
Pharm. Corp., 28 F. Supp. 3d 1268 (M.D. Fla. 2014), cited by Actavis, also address
entirely different questions. See Pysz, 457 So. 2d at 562 (affirming dismissal of a failure
to warn claim against a pharmacist who filled the plaintiff's prescription); Arnold, 28 F.
Supp. 3d at 1270-71 (applying Florida law) (excluding evidence regarding the plaintiff's
theory that the drug manufacturer had a duty to warn a dentist who did not prescribe the
drug but allegedly could have mitigated the plaintiff's injury).
Davis's reliance on Brown v. Glade & Grove Supply, Inc., 647 So. 2d 1033, 1035
(Fla. Dist. Ct. App. 1994) and MacMurdo v. Upjohn Co., 444 So. 2d 449, 450-51 (Fla.
9
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 10 of 23 PageID #:2667
Dist. Ct. App. 1984), is equally misplaced. In Brown, where the court stated that a
warning may be defective "as a result of its location and the manner in which the
warning is conveyed", the allegedly defective product was a tractor. See Brown, 647
So. 2d at 1035. Therefore, the principles underlying comment k and the learned
intermediary doctrine were not in play. In MacMurdo, the court stated that "it is for the
jury to determine if a particular warning is adequate under the circumstances."
MacMurdo, 444 So. 2d at 450-51. The issue in MacMurdo, however, was the adequacy
of the warning language and there was no indication that the physician (or the plaintiff)
lacked access to it. See id. 2 The same is true of Cornelius v. Cain, No. CACE 01020213(02), 2004 WL 48102 (Fla. Cir. Ct. Jan. 5, 2004), which the Court located in its
independent research. See id. at *4 ("Because the FDA-approved package insert for
OxyContin contained accurate, clear, and unambiguous warnings, [the defendant drug
manufacturer] satisfied its duty to warn under Florida law."). Finally, Mason addressed
only whether the plaintiff established "that the allegedly deficient warning was the
proximate cause of his injury." Mason, 27 So. 3d at 76.
Two federal cases applying Florida law come closer to addressing the issue that
Actavis presents but ultimately miss the mark. See Metz v. Wyeth, LLC, 872 F. Supp.
2d 1335 (M.D. Fla. 2012), aff'd, 525 F. App'x 893 (11th Cir. 2013); Guarino v. Wyeth,
LLC, 719 F.3d 1245 (11th Cir. 2013). Metz and Guarino concerned injuries allegedly
resulting from use of the prescription drug metoclopramide. See Metz, 872 F. Supp. 2d
at 1337; Guarino, 719 F.3d at 1247. The plaintiffs in both cases asserted negligence
2
Moreover, the Florida Supreme Court later disapproved MacMurdo and held that the
adequacy of a warning can become a matter of law where the warning is "accurate,
clear, and unambiguous." Felix, 540 So. 2d at 105.
10
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 11 of 23 PageID #:2668
claims against manufacturers of generic metoclopramide, advancing a theory similar to
Davis's: they contended that the generic manufacturers "fail[ed] to take additional steps
to warn doctors and/or consumers of information already appearing in, or recently
added to," the drug label. Metz, 872 F. Supp. 2d at 1340; see also Guarino, 719 F.3d at
1248 (similar).
In Guarino, the court held that the plaintiff's claim was preempted under federal
law because, as the Supreme Court explained in PLIVA, Inc. v. Mensing, 564 U.S. 604
(2011), federal law "demand[s] that generic drug labels be the same at all times as the
corresponding brand-name drug labels." Mensing, 564 U.S. at 618 (holding that statelaw failure to warn claims against generic drug manufacturers were preempted because
it would be impossible for the manufacturers "to comply with both their state-law duty to
change the label and their federal-law duty to keep the label the same"); see Guarino,
719 F.3d at 1248-49. The court in Guarino observed that if a generic drug manufacturer
sent physicians additional communications about the drug's warning label, it would be
suggesting—contrary to the "duty of sameness" described in Mensing—that there is a
therapeutic difference between the generic and brand-name versions of the drug. Id. at
1249 (quoting Mensing, 564 U.S. at 616). Accordingly, the court determined that the
plaintiff's failure to communicate claim was preempted. Guarino, 719 F.3d at 1250. In
Metz, by contrast, the court stated that "it is arguable that claims based on [the generic
manufacturer's] failure to more effectively communicate the warnings contained in the
FDA approved label survive preemption under Mensing." Metz, 872 F. Supp. 2d at
1343.
Both courts then determined that even if the failure to communicate claims were
11
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 12 of 23 PageID #:2669
not preempted, they failed on the merits because of Florida's learned intermediary
doctrine. In Guarino, the court observed that there was no dispute that the warning
language was clear and unambiguous and was provided in the drug label. Guarino, 719
F.3d at 1250. Therefore, the court concluded that the generic manufacturer "satisfied its
duty to provide [the plaintiff's] physician—the learned intermediary—with information
regarding" the relevant risk. Id. In Metz, the court similarly determined that the
warning—which was "accurate, clear, and unambiguous" and "available both in the
package insert" and on the FDA website—"satisfied [the generic manufacturer's] duty to
provide Plaintiff's treating physician with adequate information about the risks
associated with metoclopramide use." Metz, 872 F. Supp. 2d at 1344-45.
Actavis argues that the decisions on the merits in Metz and Guarino support its
argument that under Florida law, a prescription drug manufacturer has no duty "to
provide warnings in any manner apart from, or in addition to, the FDA-approved
package insert that accompanies the drug to the pharmacy." Actavis Br. at 1; see also
Actavis Reply at 11. Davis responds that Metz and Guarino are inapplicable because
the defendants in those cases, unlike Actavis here, were generic drug manufacturers
subject to the preemption principles explained in Mensing.
The Court recognizes that in Metz and Guarino, the courts determined that even
if the plaintiffs' failure to communicate claims were not preempted, they failed under
Florida law. See Actavis Reply at 11 (arguing that the courts in Metz and Guarino
construed Florida law to "address[] the very theory [Davis is] trying to pursue now").
Nonetheless, the Court agrees with Davis that because the decisions in Metz and
Guarino were so heavily grounded in preemption principles, they provide little support
12
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 13 of 23 PageID #:2670
for Actavis's position. The discussion of the duty to warn was somewhat abbreviated in
both cases, and it is difficult for this Court to determine whether the analysis would have
been the same for a brand-name manufacturer. The Court also notes that in a case
cited by neither side, a Florida circuit court dismissed a plaintiff's claims against a
generic metoclopramide manufacturer, including a failure to communicate claim, as
preempted or barred by Florida's learned intermediary doctrine. See Dietrich v. Wyeth,
Inc., 502009CA021586XXXXMB, 2012 WL 12314992, at *2 (Fla. Cir. Ct. Nov. 26, 2012)
(citing Metz and Guarino with approval). The district court of appeal affirmed, but only
on the ground that the claims were preempted. See Dietrich v. Actavis, Inc., 138 So. 3d
1163, 1163 (Fla. Dist. Ct. App. 2014). The appellate court's approach in Dietrich
bolsters this Court's conclusion that Metz and Guarino do not reliably signal whether a
Florida court would endorse the narrow definition of the duty to warn that Actavis
presses.
Due to the absence of Florida authority on the question presented, the Court
turns to other jurisdictions for guidance. Actavis points to Sherman v. Pfizer, Inc., 8
Wash. App. 2d 686, 440 P.3d 1016 (2019), review denied sub nom. Sherman v. Pliva,
Inc., 194 Wash. 2d 1015, 452 P.3d 1241 (2019), another case in which a plaintiff
alleged that a generic metoclopramide manufacturer failed to communicate
strengthened warnings "to the physician community in ways other than in the package
insert," such as through Dear Doctor letters. Sherman, 8 Wash. App. 2d at 699-701,
440 P.3d at 1023-1024. The court did not address preemption and determined that
under the Washington Product Liability Act (WPLA)—which "closely mirrors" section
402A—a prescription drug manufacturer has no duty to "provide additional warnings
13
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 14 of 23 PageID #:2671
beyond those that are provided with the product." Id. at 701-02, 440 P.3d at 1024-25
(internal quotation marks omitted); see also id. (noting that the WPLA requires warnings
to be "provided with products"; comment k to Section 402A similarly states that
unavoidably safe products must be "accompanied by proper directions and warning";
and warnings for prescription drugs are found in package inserts) (internal quotation
marks omitted). Actavis contends that a Florida court would reach the same conclusion
because both jurisdictions follow comment k of Section 402A and provide the same
rationale for applying the learned intermediary doctrine. Compare id. at 696, 440 P.3d
at 1022 ("[I]f the product is properly labeled and carries the necessary instructions and
warnings to fully apprise the physician of the proper procedures for use and the dangers
involved, the manufacturer may reasonably assume that the physician will exercise . . .
informed judgment . . . in the best interest of the patient." (quoting Terhune, 90 Wash.
2d at 14, 577 P.2d at 978)) with Buckner, 400 So. 2d at 823 (quoting same from
Terhune).
The Court is not persuaded that the Florida Supreme Court would rely on
Sherman to hold that a drug manufacturer has no duty to provide warnings in any
manner other than the FDA-approved package insert. First, as Davis notes, there was
no allegation in Sherman that the wrong package insert accompanied the plaintiff's
prescription. Although Florida law is clear that a manufacturer's duty to warn runs to the
physician, a patient's receipt of the wrong package insert arguably has relevance to the
scope of the manufacturer's duty, given comment k's requirement that unavoidably safe
products be "accompanied by proper directions and warning." Restatement (Second) of
Torts § 402A, cmt. k (emphasis added). Actavis, moreover, provides no support for its
14
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 15 of 23 PageID #:2672
contention that it lacks control over whether a patient receives the appropriate package
insert. See Actavis Reply at 12. Accordingly, that argument does not support a finding
that Florida courts would adopt Actavis's position on the scope of its duty to warn.
Second, the court agrees with Davis that Sherman has little applicability here
because the defendant was a generic drug manufacturer. True, the court in Sherman
did not address preemption. See Sherman, 8 Wash. App. 2d at 690 n.1, 440 P.3d at
1019 n.1. But in holding that "a drug manufacturer's duty to warn is limited to providing
a package insert that accompanies the product," the court relied on Metz and Guarino.
See Sherman, 8 Wash. App. 2d at 702, 440 P.3d at 1025. As already explained, Metz
and Guarino are uninformative on the scope of a brand-name manufacturer's duty to
warn because they are colored by preemption principles applicable only to generic
manufacturers. Because Sherman relies on Metz and Guarino, it suffers from the same
flaw. Finally, although Washington courts follow comment k and offer the same
reasoning as Florida courts for applying the learned intermediary doctrine, the same can
be said of other states where courts have indicated that a drug manufacturer's duty to
warn is broader than Actavis argues it is. The Court discusses some of those cases
below. In short, the similarities Actavis identifies between Washington and Florida law
are not, on their own, strong indicators that the Florida Supreme Court would follow
Sherman.
Davis cites several cases for the proposition that a drug manufacturer has a duty
to warn physicians not only through the package insert but also through other means.
The court first disposes of the cases it finds uninformative. One is Tatum v. Schering
Corp., 795 F.2d 925 (11th Cir. 1986), where the Eleventh Circuit, applying Alabama law,
15
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 16 of 23 PageID #:2673
noted that "[t]here is evidence that [the brand-name drug manufacturer's] method of
calling attention to a change in warning . . . is inconsistent with the practice of other drug
manufacturers." Id. at 928. Neither the district court nor the Eleventh Circuit considered
how that evidence affected the plaintiff's failure to warn claim, see id., so the Court does
not factor Tatum into its analysis.
Davis also cites In re Zyprexa Products Liability Litigation, 489 F. Supp. 2d 230
(E.D.N.Y. 2007), arguing that the court held that "even after Dear Doctor letters [about a
label change] were sent", "a jury could still find the mode of warning was insufficient."
Davis Opp. to Mot. for Summ. J. (Davis Opp.) [43] at 10. That is not exactly what the
court said. In the cited passage, the court was discussing the "latest date beyond which
it was unreasonable" for a doctor to be unaware of a label change. See In re Zyprexa,
489 F. Supp. 2d at 245. The court determined that although it would be reasonable to
conclude that the so-called "cutoff" date was when the manufacturer sent the Dear
Doctor letters, the cutoff date ultimately was for the jury to decide. Id. The court
reached that conclusion because the plaintiff had offered evidence that the defendant's
sales personnel misrepresented safety information in communications with doctors
during the relevant time. Id. It is unclear whether the court was discussing the duty to
warn (as opposed to the independent issue of proximate cause), and it is also unclear
what state's law the court was applying. Therefore, In re Zyprexa is not useful for
present purposes.
Finally, Shipley v. Forest Laboratories, Inc., No. 1:06-cv-00048-TC, 2015 WL
4199739 (D. Utah July 13, 2015) (applying Utah law), has little persuasive value
because the issue there was whether the manufacturer should have notified physicians
16
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 17 of 23 PageID #:2674
of an upcoming label change—not whether it had a duty to communicate a published
recent label change to physicians. See id. at *13-14. Similarly, Sterling Drug, Inc. v.
Yarrow, 408 F.2d 978 (8th Cir. 1969) (applying South Dakota law), does not sway the
Court in either direction because it was not a case where the defendant allegedly failed
to communicate a warning that it had recently been required to add to package inserts.
See id. at 985-88, 991-92. Rather, it appears that the defendant first warned of the
relevant risk by sending Dear Doctor letters, and the plaintiff argued that the defendant
should have instructed its sales representatives to warn physicians about the risk before
the Dear Doctor letters were sent. See id.
Davis's citation to In re Levaquin Products Liability Litigation, 700 F.3d 1161 (8th
Cir. 2012), is more helpful. In Levaquin, where Minnesota law applied, a brand-name
drug manufacturer added warning language to the label in 2001. The plaintiff alleged
that the manufacturer negligently failed to "take adequate steps to alert doctors to the
information in the 2001 warning." Id. at 1164, 1165. The court observed that there is
disagreement among states "about whether simply changing the package insert
warnings insulates a drug manufacturer from failure-to-warn liability" and that Minnesota
courts have not decided the issue. Id. at 1167. The court stated that "[m]any courts . . .
have held a properly worded package insert is a sufficient warning as a matter of law, at
least when it is combined with an entry in the PDR [Physician' Desk Reference]." Id.
(citing cases applying Kentucky, Maryland, Tennessee, and District of Columbia law). 3
By contrast, the court noted that in Sterling, it concluded that "when the dangers of the
3
The PDR is "a common medical publication that contains label information about
numerous drugs." Id. at 1164.
17
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 18 of 23 PageID #:2675
prolonged use of [a] drug . . . became reasonably apparent, it was not unreasonable to
find that the [manufacturer] should have employed all its usual means of
communication, including [sales representatives], to warn the prescribing physicians of
these dangers." Id. at 1167 (quoting Sterling, 408 F.2d at 992). The court determined
that it need not decide the scope of the duty to warn as a matter of law "because, on the
narrow facts of th[e] case," the jury was not unreasonable in finding that the defendant
"had reason to know it needed to do more to inform physicians of the 2001 warning,
such as sending 'Dear Doctor' letters or directing sales representatives to warn
physicians directly." Levaquin, 700 F.3d at 1167.
The decision in Levaquin supports Davis's position that there may be
circumstances where a drug manufacturer's duty to warn extends beyond placing the
warning in the package insert. Actavis asks the Court to disregard Levaquin, but its
arguments are unpersuasive. First, Actavis contends that there is no evidence here that
it should have known it needed to take extra steps to communicate the May 2015 label
change. The premise of Actavis's motion, however, was that the Court should decide
the scope of its duty to warn as a matter of law and ignore the factual record. For
present purposes, therefore, the relevant principle from Levaquin is that a drug
manufacturer does not necessarily discharge its duty to warn by placing the warning in
the package insert—not whether the circumstances underlying that conclusion are
identical to those in this case. Second, Actavis contends that there was unquestionably
a risk associated with the product in Levaquin, whereas the Androderm cardiovascular
risk language states only that the risk information is "inconclusive." Actavis Reply at 10.
Actavis has pressed several variations of this argument in this litigation, each time
18
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 19 of 23 PageID #:2676
without success. As the Court has explained, the reference to inconclusive risk
information does not compel acceptance of Actavis's position that there is no causal
association between Androderm use and increased cardiovascular risk. See, e.g.,
CMO 166, 430 F. Supp. 3d at 539.
Levaquin is directly relevant to the scope of a drug manufacturer's duty to warn,
and there is no indication that the court's decision turned on a feature of Minnesota law
that Florida law lacks. Like Florida, Minnesota applies the learned intermediary doctrine
because "the physician, as the prescriber of a drug, is in the best position to give a
highly individualized warning to a patient based on the physician's knowledge of the
patient and the inherent risks of the drug." Kociemba v. G.D. Searle & Co., 680 F.
Supp. 1293, 1305 (D. Minn. 1988); see Mulder v. Parke Davis & Co., 288 Minn. 332,
335 & n.1, 181 N.W.2d 882, 885 & n.1 (1970) (confirming that Minnesota applies the
learned intermediary doctrine). Unlike Florida, Minnesota merges strict liability and
negligence for design defect claims and has not expressly adopted comment k. See
Kociemba v. G.D. Searle & Co., 695 F. Supp. 432, 434 (D. Minn. 1988). For design
defect cases, however, the Minnesota Supreme Court has adopted a "negligence-like
'reasonable care' standard" that "implicitly acknowledges" the policy considerations
reflected in comment k. Id. Relevant here, Minnesota's standard attempts to
encourage development of prescription drugs by limiting a manufacturer's liability to
circumstances where it "fails to adequately warn the user of the reasonable dangers
inherent in the product." Id. Florida law similarly shields a drug manufacturer from
liability where the product's instructions and warnings "fully apprise the physician of the
proper procedures for use and the dangers involved." Buckner, 400 So. 2d at 823
19
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 20 of 23 PageID #:2677
(quoting Terhune, 90 Wash. 2d at 14, 577 P.2d at 978). Considering Florida's
expectation that a manufacturer will "fully apprise" a physician of a drug's risks, the
Court concludes that the Florida Supreme Court likely would recognize—as did the
court in Levaquin—that there may be circumstances where fully apprising physicians of
risk information requires more than placing a warning in the package insert.
The Florida Supreme Court's decision in Aubin v. Union Carbide Corp., 177 So.
3d 489 (Fla. 2015), provides additional support for this conclusion. There, the court
discussed a learned intermediary defense available to suppliers of hazardous nonmedical goods. See id. at 515 ("The Second and Third Restatements both recognize
that a manufacturer may be able to rely on an intermediary to relay warnings to the end
user . . . ."). The court stated that if a manufacturer fails to "adequately convey the
danger to the intermediary or take steps to ensure that the intermediary would
adequately warn the end user, a manufacturer may not be reasonable in relying on an
intermediary to pass along such a crucial warning to the end user." Id. (emphasis
added). "The reasonableness of a manufacturer's reliance on an intermediary to
convey the warnings to the end user," moreover, is "impacted by the dangerousness of
the product." Id.
The learned intermediary defense discussed in Aubin is distinct from the learned
intermediary doctrine applicable to claims involving prescription drugs. But there is no
question that prescription drugs can be very dangerous and that physicians can best
serve as learned intermediaries when they are fully aware of those dangers. If the
Florida Supreme Court were asked whether a prescription drug manufacturer's duty to
warn is invariably limited to providing a warning via the package insert, there is reason
20
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 21 of 23 PageID #:2678
to believe it would draw an analogy to the learned intermediary principles discussed in
Aubin and answer in the negative—at least in the situation where, as in this case,
regulatory authorities have recently mandated a change in the package insert's
warnings.
The Court's independent research revealed another case that is on point: Baker
v. St. Agnes Hospital, 70 A.D.2d 400, 421 N.Y.S.2d 81 (App. Div. 1979). There, a New
York appellate court held that a drug manufacturer must not only "keep abreast of
knowledge of its products" but also "take such steps as are reasonably necessary to
bring that knowledge to the attention of the medical profession." Id. at 406, 421
N.Y.S.2d at 85. The court added, "[t]he greater the potential hazard of the drug, the
more extensive must be the manufacturer's efforts to make that hazard known to the
medical profession." Id. at 406, 421 N.Y.S.2d at 85-86. The court's analysis was
guided by the principle, encompassed in comment k, that a drug manufacturer may
avoid liability where its product is "pure and accompanied by adequate warnings." Id. at
405, 421 N.Y.S.2d at 85. The court also recognized that physicians rely on drug
manufacturers' representations about their products. Id.
In Baker, the drug's package insert carried the relevant warning but the plaintiff's
physician testified that he did not see it before he made his prescribing decision. Id. at
402, 406, 421 N.Y.S.2d at 83-84, 86. Noting that the drug posed "extremely grave"
dangers and that there are well-known methods for apprising doctors of a drug's risks—
including updating the PDR and sending Dear Doctor letters—the court declined to hold
as a matter of law that the defendant's "decision to limit its warning to its package
inserts was reasonable and therefore sufficient." Id. at 407, 421 N.Y.S.2d at 86; see
21
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 22 of 23 PageID #:2679
also id. at 406, 421 N.Y.S.2d at 85 ("[N]o matter how detailed and accurate, an
uncommunicated warning is no warning at all."). Baker is still good law. See, e.g.,
Trisvan v. Heyman, 305 F. Supp. 3d 381, 400-02 & n.16 (E.D.N.Y. 2018) (where the
relevant warning was available on the FDA website at the time of the prescribing
decision, dismissing a failure to warn claim without prejudice to amend with "nonconclusory allegations as to why [the plaintiff] believes Defendants failed to provide
warnings to his physicians") (citing Baker, 700 A.D.2d at 407, 421 N.Y.S.2d at 86).
As with Levaquin, there is no indication that the court's decision in Baker was
rooted in a unique feature of New York law. Like Florida, New York considers a product
to be defective if it lacks an adequate warning. See Trisvan, 305 F. Supp. 3d at 399.
To prevail on a failure to warn claim, a New York plaintiff, like a Florida plaintiff, must
show that the warning was inadequate and that the failure to provide an adequate
warning was the proximate cause of his injuries. See id.; Mason, 27 So. 3d at 77. Drug
manufacturers can raise comment k as a defense in New York, and New York follows
the learned intermediary doctrine because a physician's role is to assess a drug's risks
and benefits and make an informed decision based on a patient's individual
circumstances. See Abrams v. Bute, 138 A.D.3d 179, 186-87, 27 N.Y.S.3d 58, 64-65
(App. Div. 2016). New York courts, like Florida's, expect drug manufacturers to make
physicians fully aware of a drug's risks. See, e.g., id. at 186, 27 N.Y.S.3d at 65 ("The
manufacturer's duty is to warn of all potential dangers in its prescription drugs that it
knew, or, in the exercise of reasonable care, should have known to exist." (internal
quotation marks omitted)). Finally, the courts in Baker and Aubin both supported the
principle that the more dangerous a product, the more vigilant the manufacturer must be
22
Case: 1:17-cv-03775 Document #: 53 Filed: 11/04/20 Page 23 of 23 PageID #:2680
in ensuring that the end-user receives a warning. See Baker, 70 A.D.2d at 406, 421
N.Y.S.2d at 85-86; Aubin, 177 So. 3d at 515. This Court predicts that if it considered
the question posed here, the Florida Supreme Court would share the Baker court's view
on the scope of a drug manufacturer's duty to warn.
For the foregoing reasons, the Court disagrees with Actavis that under Florida
law, a prescription drug manufacturer has no duty to provide warnings in a manner
apart from the FDA-approved package insert. In reaching this result, the Court
recognizes that it must take care not to expand Florida law "beyond the boundaries
established" in the state's jurisprudence. King v. Damiron Corp., 113 F.3d 93, 97 (7th
Cir. 1997) (internal quotation marks omitted); AbbVie Reply at 7 (quoting same). Florida
courts have not addressed the question Actavis presents, and there is ample support for
the conclusion that Florida courts would reject Actavis's narrow interpretation of the duty
to warn. Therefore, the Court denies Actavis's motion for summary judgment. 4
Conclusion
For the foregoing reasons, the Court denies Actavis's motion for summary
judgment [dkt. no. 33]. The case is set for a telephone status hearing on November 23,
2020 at 9:30 a.m. to discuss further proceedings in this matter, using call-in number
888-684-8852, access code 746-1053. Counsel are directed to confer and are to file a
joint status report on November 18, 2020 with an agreed-upon proposal for pretrial case
management or, if they cannot agree, alternative proposals with a justification for each.
________________________________
MATTHEW F. KENNELLY
United States District Judge
Date: November 4, 2020
4
Given this conclusion, is unnecessary for the Court to address Actavis's argument that
it had no special relationship with Dr. Avey that created an expanded duty to warn.
23
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?