Andrea Guarino v. Wyeth, LLC , 719 F.3d 1245 ( 2013 )

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[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
No. 12-13263
________________________
D.C. Docket No. 8:10-cv-02885-JSM-TGW
ANDREA GUARINO,
Plaintiff - Appellant,
versus
WYETH, LLC,
SCHWARZ PHARMA, INC.,
TEVA PHARMACEUTICALS USA, INC.,
Defendants - Appellees,
________________________
Appeal from the United States District Court
for the Middle District of Florida
________________________
(June 25, 2013)
Before HULL, WILSON and FARRIS,* Circuit Judges.
* Honorable Jerome Farris, United States Circuit Judge for the Ninth Circuit, sitting by
designation.
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WILSON, Circuit Judge:
Plaintiff Angela Guarino appeals the district court’s dismissal of her claims
against the brand-name manufacturers of the prescription drug Reglan, Wyeth LLC
and Schwarz Pharma, Inc. (collectively, the “Brand Manufacturers”), and grant of
summary judgment in favor of Teva Pharmaceuticals USA, Inc. (Teva), the
manufacturer of its generic equivalent (metoclopramide), on her claims of
negligence, strict liability, breach of warranty, misrepresentation and fraud, and
negligence per se. Guarino alleges that she developed tardive dyskinesia after
taking generic metoclopramide manufactured by Teva for a period of greater than
12 weeks, contrary to administrative guidance issued by the Food & Drug
Administration (FDA). We conclude that Guarino’s claims against Teva are
preempted by federal law and that even if they were not preempted they would fail
on the merits. We similarly conclude that Florida law recognizes no cause of
action against the brand manufacturer of a drug when a plaintiff admits to having
only taken the generic form of that drug. We affirm.
I. Background
The facts are largely undisputed. In May 2007, Guarino received a
prescription for metoclopramide, a medication often sold under the brand name
Reglan, used to treat symptomatic gastroesophageal reflux and recurrent diabetic
gastric stasis. Guarino suffered from abdominal pain and various digestive
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problems, and her doctor prescribed metoclopramide in the hope that it would
alleviate her symptoms. She took the generic form of the drug from May through
August of 2007 and alleges that, as a result of taking the drug for a period of time
exceeding twelve weeks, she developed tardive dyskinesia. Tardive dyskinesia is a
neurological disorder characterized by abnormal movements of the facial muscles,
tongue and limbs. Because use of metoclopramide for prolonged periods is
associated with tardive dyskinesia, the FDA has strengthened the warning label for
the drug several times. In 2004, three years before Guarino was prescribed the
medication, the FDA changed the label to explicitly provide that “[t]herapy should
not exceed 12 weeks in duration.” And in 2009, two years after Guarino took the
medication, the FDA ordered a black box warning—its strongest—cautioning
against taking the medication for over twelve weeks.
Guarino sued Teva and the Brand Manufacturers, alleging negligence, strict
liability, breach of warranty, misrepresentation and fraud, and negligence per se.
The gravamen of her claims was that the defendants failed to adequately warn
medical providers of the risks associated with long-term use of metoclopramide.
After Guarino filed her complaint, the Supreme Court decided PLIVA, Inc. v.
Mensing, ––– U.S. ––––, 131 S. Ct. 2567, 2578 (2011), in which it held that
because the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301–399f,
mandates that generic manufacturers label their drugs identically to brand-name
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drugs, lawsuits against generic manufacturers for failure to warn or for the
inadequacy of the drug’s labeling are preempted by federal law. The district court
then granted Teva’s motion to dismiss based upon Mensing, holding that Guarino’s
failure-to-warn claims against Teva were preempted. The district court next
granted the Brand Manufacturers’ motion for summary judgment, finding that
because Guarino never took brand-name Reglan and only took generic
metoclopramide, the Brand Manufacturers could not be liable to her because they
did not manufacture or sell the product she ultimately used. This appeal followed.
II. Discussion
On appeal, Guarino primarily argues that her negligence claim against Teva
is not preempted insofar as it alleges a “failure to communicate” the 2004 label
change to medical providers. That is, she no longer claims that Teva’s warning
labels were themselves inadequate, but now contends that Teva is liable for failing
to make medical providers aware of—i.e., failing to communicate—the change in
labeling. Guarino also avers that the district court erred in granting summary
judgment to the Brand Manufacturers on her misrepresentation claim, arguing that
because the Brand Manufacturers knew that their warning labels would be relied
upon by consumers of the generic formulations of their drugs, they can be held
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liable for fraud and misrepresentation even though Guarino never consumed their
product. 1 We address each argument in turn.
A. The Generic Manufacturer
We first explain why Guarino’s claims against Teva do not survive Mensing
and are preempted by federal law. We then explain why, even if her claims against
Teva were not preempted by federal law, they would fail in any event. “We review
a district court’s order dismissing a complaint de novo, taking all well-pleaded
facts as true and construing them in the light most favorable to the nonmoving
party.” Meyer v. Greene, 710 F.3d 1189, 1194 (11th Cir. 2013).
1. Preemption
The Supremacy Clause of our Constitution establishes that “the Laws of the
United States . . . shall be the supreme Law of the Land . . . any Thing in the
Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const.,
art. VI, cl. 2. In accordance with that principle, when state law conflicts with
federal law, state law must give way. See Odebrecht Const., Inc. v. Sec’y, Fla.
Dep’t of Transp., — F.3d —, No. 12-13958, 2013 WL 1862714, at *3 (11th Cir.
May 6, 2013). “Conflict preemption . . . arises in instances where (1) compliance
with both federal and state regulations is a physical impossibility, or (2) the
1
Guarino only challenges the district court’s dismissal of her negligence claim against
Teva and grant of summary judgment for the Brand Manufacturers on her fraud and
misrepresentation claim. She has abandoned all other claims. See Holland v. Gee, 677 F.3d
1047, 1066 (11th Cir. 2012).
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challenged state law stands as an obstacle to the accomplishment and execution of
the full purposes and objectives of Congress.” Fresenius Med. Care Holdings, Inc.
v. Tucker, 704 F.3d 935, 939 (11th Cir. 2013) (internal quotation marks omitted).
In Mensing, the Supreme Court confronted a case involving the preemption
of failure-to-warn claims against a generic manufacturer of metoclopramide. 131
S. Ct. at 2573. The plaintiffs in Mensing sued PLIVA after they ingested generic
metoclopramide produced by PLIVA and later developed tardive dyskinesia. Id.Because “[f]ederal law . . . demanded that generic drug labels be the same at all
times as the corresponding brand-name drug labels,” the Court held it would be
impossible for generic drug manufacturers to unilaterally change their labels to
comply with any duty to warn sounding in state law. Id. at 2578. State-law
failure-to-warn claims against generic manufacturers were therefore preempted.
Id. (“[I]t was 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.”).
Applying Mensing here, we agree with the district court that Guarino’s
claims against Teva are preempted by federal law. As explained in Mensing,
generic manufacturers operate under a “duty of sameness,” which requires that
their labels be at all times identical to the brand-name label of the same drug. Id. at
2576. “Whether a warning is placed on the label on the bottle or in letters to
distributors, any state law duty requiring generic manufacturers to act unilaterally
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in this area is preempted by federal law.” Morris v. PLIVA, Inc., 713 F.3d 774,
776–77 (5th Cir. 2013) (per curiam). Because each of Guarino’s claims against
Teva is premised upon an allegedly inadequate warning, they are all preempted by
federal law.
Guarino’s attempt to elude Mensing by clothing her allegations as “failure-
to-communicate” claims rather than failure-to-warn claims does not alter our
analysis. No matter the garb in which she attempts to present them, Guarino’s
claims are at bottom allegations regarding Teva’s failure to warn her of the dangers
of long-term metoclopramide use, and they therefore cannot escape Mensing’s
grasp. As the Fifth Circuit recently stated in rejecting the identical argument that
“claims concerning a failure to communicate approved warnings” are not
preempted: “On the contrary, Mensing forecloses such claims because failure to
‘communicate’ extends beyond just a label change.” Id. at 777 (emphasis
omitted); see also Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011) (denying,
on remand from the Supreme Court, plaintiff’s motion for supplemental briefing
arguing failure-to-communicate claim); Smith v. Wyeth, Inc., 657 F.3d 420, 423
(6th Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012).
Were we to accept the failure-to-communicate theory, generic manufacturers
such as Teva would need to take affirmative action to notify consumers, doctors, or
pharmacists of FDA-approved changes to the drug label in order to avoid liability.
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Yet “[b]ecause the duty of sameness prohibits the generic manufacturers from
taking such action unilaterally, they are dependent on brand-names taking the
lead.” Morris, 713 F.3d at 777; see Mensing, 131 S. Ct. at 2576 (“[I]f generic drug
manufacturers, but not the brand-name manufacturer, sent [additional
communications such as ‘Dear Doctor’ letters], that would inaccurately imply a
therapeutic difference between the brand and generic drugs and thus could be
impermissibly misleading.” (internal quotation marks omitted)). That fact is
determinative here. We embrace the Fifth Circuit’s reasoning and similarly reject
the failure-to-communicate theory of liability, as it is preempted by federal law.
Morris, 713 F.3d at 777 (explaining that “[u]nder federal law, the inquiry is
whether the brand-name manufacturers sent out a warning,” and “[b]ecause no
brand-name manufacturer sent a warning based on the 2004 label change, the
generic manufacturers were not at liberty to do so”); see also Mensing, 131 S. Ct.
at 2576 (“[W]e conclude that federal law did not permit the Manufacturers to issue
additional warnings through Dear Doctor letters.”). 2 Where federal and state law
2
The Sixth Circuit’s recent decision in Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir.
2013), is not to the contrary. In Fulgenzi, the plaintiff alleged that the generic manufacturer
failed to update its label when the brand manufacturer strengthened the Reglan warning;
therefore, the claim against the generic manufacturer was not preempted because “not only could
[the generic manufacturer] have independently updated its labeling to match that of the branded
manufacturer . . . it had a federal duty to do so.” Id. at 584. In the present case, Guarino does
not allege that Teva failed to update its label once the Brand Manufacturers strengthened it, so
Fulgenzi is inapplicable.
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conflict, state law must yield. The district court did not err in concluding that
Guarino’s claims against Teva are preempted.
2. The Learned Intermediary Doctrine
Even if we were to hold that Guarino’s claims against Teva were not
preempted by federal law, they would fail on the merits. Under Florida law, “it is
clear that the manufacturer’s duty to warn of [a prescription drug’s] dangerous side
effects [is] directed to the physician rather than the patient.” Felix v. Hoffmann-
LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989). That is so because the prescribing
physician, acting as a “learned intermediary” between the manufacturer and
consumer of the drug, weighs the drug’s benefits against its potential harms in
deciding whether it is appropriate to the patient’s course of treatment. Id. “The
learned intermediary rule is a corollary to the rule that a manufacturer of
prescription drugs or products discharges its duty to warn by providing the
physician with information about risks associated with those products.”
Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995). “Pharmaceutical
manufacturers discharge their duty to warn the learned intermediary by way of a
package insert which accompanies each vial of vaccine.” E.R. Squibb & Sons, Inc.
v. Farnes, 697 So. 2d 825, 827 (Fla. 1997) (internal quotation marks omitted); see
Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 822 (Fla. Dist. Ct. App. 1981)
(“A manufacturer of a dangerous commodity, such as a drug, does have a duty to
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warn but when the commodity is a prescription drug we hold that this duty to warn
is fulfilled by an adequate warning given to those members of the medical
community lawfully authorized to prescribe, dispense and administer prescription
drugs.” (footnote omitted)).
Guarino does not allege that Teva failed to update its label to incorporate the
2004 FDA label change. It is therefore undisputed that the metoclopramide
furnished by Teva included a clear, unambiguous warning that “[t]herapy should
not exceed 12 weeks in duration.” Neither can Guarino argue that this warning
was itself inadequate, because any claim based upon the content of the warning
label is preempted pursuant to Mensing. See 131 S. Ct. at 2578 (explaining that
“[f]ederal law . . . demand[s] that generic drug labels be the same at all times as the
corresponding brand-name drug labels”). Teva thus satisfied its duty to provide
Guarino’s physician—the learned intermediary—with information regarding the
risks of long-term metoclopramide use. In the present context, that is all Florida
law requires. “Whether the physician in fact reads the warning, or passes its
contents along to the recipient of the drug is irrelevant.” Farnes, 697 So. 2d at 827(internal quotation marks omitted); see also Buckner, 400 So. 2d at 823.
Ultimately, then, it does not matter whether we treat Guarino’s claims against Teva
as preempted by federal law or on the merits, because under either mode of
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analysis, the same result obtains: Guarino’s claims against Teva must fail, and the
district court properly granted Teva’s motion to dismiss.
B. The Brand Manufacturers
Guarino submits that the district court erred in granting summary judgment
for the Brand Manufacturers on the ground that Florida law does not permit the
consumer of a generic drug to seek damages from the brand-name manufacturer if
the consumer did not ingest the brand-name version of the drug. We review the
district court’s grant of summary judgment de novo, viewing the evidence and
drawing all reasonable inferences in the light most favorable to the nonmoving
party. Latimer v. Roaring Toyz, Inc., 601 F.3d 1224, 1232 (11th Cir. 2010).
Where, as here, the material facts are undisputed, the question reduces to a legal
one, and summary judgment is appropriate if the Brand Manufacturers are entitled
to judgment as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322,
106 S. Ct. 2548, 2552 (1986).
Every court in Florida to consider the question has concluded that the brand
manufacturer of a prescription drug cannot be held liable for injuries suffered by
consumers who ingested only the generic form of a drug. See Metz v. Wyeth LLC,
830 F. Supp. 2d 1291, 1293 (M.D. Fla. 2011) (“The vast majority of courts, in
Florida and elsewhere, that have addressed the issue now before the Court have
consistently held that consumers may not bring claims for negligence, fraud, strict
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liability, misrepresentation, or breach of warranty against a brand name
pharmaceutical manufacturer when the consumers only ingested generic versions
of the drug manufactured by third parties.”); Howe v. Wyeth Inc., No. 8:09-CV-
610-T-17AEP, 2010 WL 1708857, at *3 (M.D. Fla. Apr. 26, 2010); Levine v.
Wyeth Inc., 684 F. Supp. 2d 1338, 1343 (M.D. Fla. 2010); Dietrich v. Wyeth, Inc.,
No. 50-2009-CA-21586, 2009 WL 4924722, at *2 (Fla. Cir. Ct. Dec. 21, 2009);
Sharp v. Leichus, No. 2004-CA-0643, 2006 WL 515532, at *2 (Fla. Cir. Ct. Feb.
17, 2006), aff’d, 952 So. 2d 555 (Fla. Dist. Ct. App. 2007) (per curiam) (affirming
without written opinion). As one court explained, “[i]t is well-settled under
Florida law that a plaintiff may only recover from the defendant who manufactured
or sold the product that caused the injuries in question.” Sharp, 2006 WL 515532,
at *2. We see no reason to doubt this interpretation of the law. Bravo v. United
States, 577 F.3d 1324, 1326 (11th Cir. 2009) (per curiam) (“[W]e are bound to
follow an intermediate state appellate court unless there is persuasive evidence that
the highest state court would rule otherwise.” (internal quotation marks omitted));
see McMahan v. Toto, 311 F.3d 1077, 1080 (11th Cir. 2002). At any rate, no
Florida court has recognized a potential cause of action against a brand
manufacturer by the consumers of a generic product, and considerations of comity
and federalism counsel that we proceed gingerly when venturing into uncharted
waters of state substantive law. See Douglas Asphalt Co. v. QORE, Inc., 657 F.3d
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1146, 1154 (11th Cir. 2011) (“It is not the function of federal courts to expand state
tort doctrine in novel directions absent state authority suggesting the propriety of
doing so.”). We therefore decline to manufacture such a claim out of whole cloth
here.
Although Guarino suggests that the Florida Supreme Court’s decisions in
Conley v. Boyle Drug Co., 570 So. 2d 275 (Fla. 1990), and Engle v. Liggett Group,
Inc., 945 So. 2d 1246 (Fla. 2006) (per curiam), support her novel theory of liability
under Florida law, those decisions are actually to the contrary. In Conley, the court
did permit liability based upon a manufacturer’s market share where it was
impossible to determine which pharmaceutical manufacturer had actually produced
the drug ingested by the plaintiff. 570 So. 2d at 281–83. But the court also made
abundantly clear that “an individual defendant may exculpate itself from liability
by proving by a preponderance of the evidence that it did not produce or market
the type of [pharmaceutical drug] taken by the plaintiff’s mother.” Id. at 286; see
also id. (“Where a plaintiff can identify a specific tortfeasor as causing her injury
and traditional remedies are thus available, we see no reason for resort to a remedy
based on the concept of risk contribution.”). Thus, and because it affirmatively
provides for no liability when we know with certitude that a given manufacturer
did not produce the allegedly dangerous product, Conley does not cut in favor of
liability here, but against it.
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Engle offers no solace either. In Engle, the Florida Supreme Court affirmed
the reversal of judgments against certain cigarette manufacturers in part because “it
[was] undisputed that the Liggett defendants did not manufacture or sell any of the
products that allegedly caused injury to the individual plaintiff representatives.”
Engle, 945 So. 2d at 1276. Guarino suggests that her case is different from Engle
because one of her claims sounds in fraud rather than negligence or products
liability, but we are not persuaded. Even if we accepted that reading of the law—
which we do not—it remains that nothing in Engle, Conley, or otherwise actually
supports the theory upon which Guarino premises her case: that a fraud claim
against a defendant known not to have manufactured the allegedly offensive
product is cognizable under Florida law. 3 And as a matter of fact, we think the
better reading of those cases is that the Florida courts have expressly rejected such
a view. See Dietrich, 2009 WL 4924722, at *2 (“Engle and Conley are only two
more recent cases in a long and unbroken line of Florida authority holding that a
product manufacturer cannot be liable, regardless of the claim or theory asserted,
when the plaintiff did not use or consume that manufacturer’s product.”); see also
3
Guarino suggests that the Third District Court of Appeal’s decision in Rey v. Philip
Morris, Inc., 75 So. 3d 378 (Fla. Dist. Ct. App. 2011), review denied, 99 So. 3d 944 (Fla. 2012),
supports her view of liability. We disagree. Rey permitted a claim of civil conspiracy against a
tobacco company to proceed despite the fact that the plaintiff had only used a coconspirator’s
product. Id. at 381–82. “The law of civil conspiracy is striking in its extension of liability to a
co-conspirator which may not have caused any direct injury to the claimant.” Id. at 383. In
other words, conspiracy is different. Guarino has not brought a civil conspiracy claim in this
case, so the reasoning employed in Rey is simply inapposite.
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Conley, 570 So. 2d at 286 (explaining that the market-share theory of liability
“may not be used in conjunction with allegations of fraud, breach of warranty or
strict liability”). We discern no error in the district court’s grant of summary
judgment in favor of the Brand Manufacturers.
Our conclusion is fortified by the fact that the overwhelming national
consensus—including the decisions of every court of appeal and the vast majority
of district courts around the country to consider the question—is that a brand-name
manufacturer cannot be liable for injuries caused by the ingestion of the generic
form of a product. See, e.g., Bell v. Pfizer, Inc., — F.3d —, No. 12-1674, 2013
WL 2661189, at *3–4 (8th Cir. June 14, 2013) (rejecting negligence,
misrepresentation, and fraud claims against the brand manufacturer of
metoclopramide, and explaining that that “[a]n overwhelming majority of courts
considering this issue . . . have rejected [plaintiff’s] theory of liability” (internal
quotation marks omitted)); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 182–
83 (5th Cir. 2012) (per curiam), petition for cert. filed, 81 U.S.L.W. 3519 (U.S.
Mar. 7, 2013) (No. 12-1093); Smith, 657 F.3d at 423–24 (“The plaintiffs’
argument—that the name-brand defendants’ liability stems from the fact that the
regulatory structure governing name-brand and generic drugs makes it foreseeable
that patients and their physicians will rely on the name-brand labels to use and
prescribe generic drugs—has been rejected by all but one of the courts that have
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considered it.”); Mensing, 658 F.3d at 867 (expressly reinstating the portion of the
opinion holding that brand-name manufacturers cannot be held liable under
Minnesota law for damage caused by generic drugs); Foster v. Am. Home Prods.
Corp., 29 F.3d 165, 170–71 (4th Cir. 1994); Gardley-Starks v. Pfizer, Inc., — F.
Supp. 2d —, No. 4:10-CV-099-SA-JMV, 2013 WL 139900, at *5 (N.D. Miss. Jan.
10, 2013) (“The Court concludes that Mississippi law, consistent with the
vast majority of courts to consider this issue, would not recognize a cause of
action—however styled—against a brand manufacturer for injuries caused by use
of its competitors’ generic product.”); see also id. at *5 n.4 (noting the defendants’
citation to “sixty-six decisions applying the law of twenty-three different
jurisdictions holding that brand-name manufacturers of a drug may not be
held liable under any theory for injuries caused by the use of a
generic manufacturer’s product”). But see Kellogg v. Wyeth, 762 F. Supp. 2d 694,
708–09 (D. Vt. 2010); Wyeth, Inc. v. Weeks, — So. 3d —, No. 1101397, 2013 WL
135753, at *19 (Ala. Jan. 11, 2013), reh’g granted (June 13, 2013); Conte v.
Wyeth, Inc., 85 Cal. Rptr. 3d 299, 310 (Cal. Ct. App. 2008). Although only the law
of Florida controls the outcome here, the cases denying recovery to plaintiffs
bringing claims identical to those we confront in this case are legion, and this
mountain of authority steels us in our determination that Florida law does not
recognize a claim against the brand manufacturer of a prescription drug when the
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plaintiff is known to have consumed only the generic form. We find no error in the
district court’s grant of summary judgment in favor of the Brand Manufacturers.
III. Conclusion
We affirm the district court’s dismissal of Guarino’s claims against Teva as
preempted by federal law and because, preemption aside, the learned intermediary
doctrine prevents Guarino from stating a claim upon which relief can be granted
under Florida law. We similarly affirm the district court’s grant of summary
judgment in favor of the Brand Manufacturers because Florida law does not permit
an injured consumer to recover from the brand manufacturer of a prescription drug
if the consumer is known to have ingested only the generic form of that drug. We
are mindful that the disposition of this case may leave Guarino and those similarly
situated without a remedy in cases such as these, but as federal judges we are
bound merely to interpret and apply the law as promulgated by Congress and the
political divisions of government. See Mensing, 131 S. Ct. at 2581–82
(acknowledging “the unfortunate hand that federal drug regulation has dealt [the
plaintiffs] and others similarly situated,” but noting that “it is not this Court’s task
to decide whether the statutory scheme established by Congress is unusual or even
bizarre” (internal quotation marks omitted)); see also id. at 2592 (Sotomayor, J.,
dissenting) (“If a consumer takes a brand-name drug, she can sue the manufacturer
for inadequate warnings. . . . If, however, she takes a generic drug, as occurs 75
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percent of the time, she now has no right to sue.”). Thus, and insofar as Guarino
seeks redress for her injuries, such redress lies with Congress or the Florida
legislature, not with this Court.
AFFIRMED.
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