Monk v. Wyeth Pharmaceuticals, Inc., et al
ORDER GRANTING IN PART AND DENYING IN PART 21 Motion to Dismiss ; GRANTING IN PART AND DENYING IN PART 22 Motion to Dismiss; It is Further ORDERED that any status update by the Parties should be provided the Court by June 5, 2017. In addition, the parties are further ORDERED to provide scheduling recommendations in accordance with the Courts form (available at Docket no. 15) by June 5, 2017. Signed by Judge Xavier Rodriguez. (wg)
UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF TEXAS
SAN ANTONIO DIVISION
JO ANN MONK, Individually and as '
Personal Representative of the Estate of '
WYETH PHARMACEUTICALS, INC., ET '
Civil Action No. SA-16-CV-1273-XR
On this date, the Court considered Defendant Teva Pharmaceuticals’ Motion to Dismiss
(Docket no. 21), Defendants Eon Labs and Sandoz Inc.’s Motion to Dismiss (Docket no. 22), and
the corresponding responses and replies. After careful consideration, the motions to dismiss are
GRANTED IN PART AND DENIED IN PART.
Plaintiff’s Factual Allegations
Jesse Monk had atrial fibrillation. Docket no. 18 at 6. Doctors prescribed amiodarone as a
treatment. Id. He never received a Medication Guide describing certain risks associated with his
use of amiodarone and his pharmacy did not have Medication Guides to provide to him. Id. at 7.
After taking amiodarone as prescribed for approximately eight years, Monk died in January
2015. Id. at 1, 6. His autopsy revealed that the cause of death was amiodarone poisoning. Id. at 8.
Monk’s spouse, Jo Ann Monk, is the plaintiff in this lawsuit, and brings claims individually and
as personal representative of Jesse Monk’s estate. Id. at 1. Defendants Teva Pharmaceuticals
USA, Inc., Eon Labs, Inc., and Sandoz, Inc. are distributors of a generic form of amiodarone. Id.
at 6. Defendants are required by Food and Drug Administration (“FDA”) regulations and the
Food, Drug, and Cosmetics Act (“FDCA”) to provide Medication Guides to Monk via his
pharmacy. Id at 7–8; see 21 C.F.R. § 280.24(b).
Jesse Monk was prescribed amiodarone “off label”—that is, for a use for which it was not
fully approved by the FDA. Id. at 6. In particular, amiodarone was approved by the FDA through
a limited “special needs” process, meaning that it was only approved “as a drug of last resort for
patients suffering from documented recurrent life-threatening ventricular fibrillation and
ventricular tachycardia when these conditions would not respond to other available antiarrhythmic drugs and therapies.” Id. at 5–6. Despite being approved only for these purposes,
doctors prescribed amiodarone to Monk for treatment of atrial fibrillation. Id.
When Monk had his prescription filled at a local Walgreen’s pharmacy, he was never
given a Medication Guide. Id. at 7. According to the complaint, Monk did not know that he was
prescribed amiodarone off label or of the risks of taking amiodarone, the Medication Guide
would have given him this information, and he would not have taken amiodarone had he been
fully informed. Id.
Plaintiff’s live complaint asserts causes of action for negligence, negligence per se, and
[Defendants] have a duty to market amiodarone in such a way as to avoid
unreasonable harm to patient consumers. [Defendants] were required to provide a
Medication Guide . . . They failed to comply with that requirement and in doing
so breached parallel Texas State law duties. [Defendants’] failure to provide
amiodarone Medication Guides as required breached the Texas state common law
duty to adequately warn of risks association with prescription medicines.
Id. at 11.
Defendant Teva filed a motion to dismiss on March 14, 2017. Docket no. 21. Defendants
Eon and Sandoz filed a similar motion that same day. Docket no. 22.
The FDA’s Drug Approval Framework 1
Brand-name prescription drugs must be approved by the FDA before they go to market.
Docket no. 18 at 5. To begin this process, the sponsor of a drug submits a new drug application
(“NDA”). Id. NDAs include a litany of information relating to a drug’s safety, effectiveness,
proposed uses, warnings, and potential adverse reactions. Id. In 1984, Wyeth, a pharmaceutical
company that was initially named as a defendant in this lawsuit but has since been voluntarily
dismissed by Plaintiff, sponsored approval of amiodarone under the brand name Cordarone. Id.
at 5; see also Docket no. 20. In doing so, however, Cordarone obtained FDA approval under an
abbreviated “special needs” process whereby a drug is not subject to the full rigor of an NDA but
is approved only for certain, limited “special needs.” Docket no. 18 at 5. As such, Cordarone
“was approved only as a drug of last resort for patients suffering from documented recurrent lifethreatening ventricular fibrillation and ventricular tachycardia when these conditions would not
respond to other available anti-arrhythmic drugs and therapies.” Id. at 5–6.
The above procedure applied only to the initial approval of a Wyeth’s brand-name
formulation of amiodarone, but the remaining defendants in this action are manufacturers of a
generic form of amiodarone. Id. at 5. As such, they are governed by a slightly different
In 1984, through the Hatch–Waxman Amendments, Congress modified these
procedures for generic drug manufacturers, creating an expedited process for
approving generic drugs. See DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, Pub. L. 98–417, 98 Stat. 1585 (codified in scattered
sections of 21 and 35 U.S.C.). In essence, these amendments allow a generic drug
manufacturer to piggy-back on the FDA approval of a brand name drug—greatly
accelerating the process for receiving approval—provided that the generic drug
has active ingredients and labeling identical to that of the FDA-approved brand
name drug. PLIVA, Inc. v. Mensing, 564 U.S. 604, 612–13, n. 2 (2011). After the
This background is taken from prior case law and the allegations in Plaintiff’s live complaint; it is meant
merely to provide context for the factual and legal contentions in this case and not as a comprehensive primer on
FDA requirements and regulations.
generic drug receives approval, the generic manufacturer is prohibited from
making changes to the drug itself or from unilaterally changing the drug’s label.
See Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2471 (2013).
Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 676 (5th Cir. 2014) (citations modified).
Defendants all received FDA approval to manufacture, market, sell, and distribute their
generic formulas of amiodarone. Docket no. 18 at 6. Accordingly, they were required by the
FDA and FDCA to provide certain labels, warnings, and information. Id. Most notably for
purposes of this lawsuit, the FDCA and its regulations require generic drug manufacturers to
disseminate Medication Guides:
(b) Each manufacturer who ships a container of drug product for which a Medication
Guide is required under this part is responsible for ensuring that Medication Guides are
available for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to distributors, packers, or
authorized dispensers to permit the authorized dispenser to provide a Medication
Guide to each patient receiving a prescription for the drug product; or
(2) Providing the means to produce Medication Guides in sufficient numbers to
distributors, packers, or authorized dispensers to permit the authorized dispenser
to provide a Medication Guide to each patient receiving a prescription for the
drug product. . . .
(e) Each authorized dispenser of a prescription drug product for which a Medication
Guide is required under this part shall, when the product is dispensed to a patient (or to a
patient’s agent), provide a Medication Guide directly to each patient (or to the patient’s
agent) unless an exemption applies under 208.26.
21 C.F.R. § 208.24(b), (e); see also McLeod v. Sandoz, Inc., 4:16-CV-01640-RBH, 2017 WL
1196801, at *9 (D.S.C. Mar. 31, 2017) (“Specifically, 21 C.F.R. § 208.24 provides that ‘[e]ach
manufacturer who ships a container of drug product for which a Medication Guide is required
under this part is responsible for ensuring that Medication Guides are available for distribution to
Defendants attack Plaintiff’s state law claims in three ways. First, they argue that these
claims are preempted by federal law under Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S.
341 (2001). Second, they argue that Plaintiff has not pled the existence of a duty under Texas
law because the learned intermediary doctrine requires pharmaceutical distributors to give
warnings only to prescribing physicians rather than directly to patients. Third, they argue that
Texas law does not recognize a negligence per se claim based on alleged violations of the FDCA
or FDA regulations. More generally, Defendants also argue that Plaintiff’s complaint does not
meet federal pleading standards because it does not differentiate its allegations as between the
For the following reasons, most of these arguments fail. The only one of Defendants’
arguments that succeeds is that Plaintiff’s negligence per se claims should be dismissed; to this
extent, the motions to dismiss are GRANTED. In all other respects, the motions are DENIED.
Standard of Review
“To survive a motion to dismiss, a complaint must contain sufficient factual matter,
accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556
U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A claim
for relief must contain: (1) “a short and plain statement of the grounds for the court’s
jurisdiction”; (2) “a short and plain statement of the claim showing that the pleader is entitled to
the relief”; and (3) “a demand for the relief sought.” FED. R. CIV. P. 8(a). In considering a motion
to dismiss under Rule 12(b)(6), all factual allegations from the complaint should be taken as true,
and the facts are to be construed favorably to the plaintiff. Fernandez-Montez v. Allied Pilots
Assoc., 987 F.2d 278, 284 (5th Cir. 1993). To survive a 12(b)(6) motion, a complaint must
contain “more than labels and conclusions, and a formulaic recitation of the elements of a cause
of action will not do.” Twombly, 550 U.S. at 555.
Plaintiff properly alleges that Defendants did not comply with the applicable federal
Initially, the Court dispenses with an argument asserted by Defendants Sandoz and
Eon—that Plaintiff’s complaint does not allege that Sandoz and Eon violated any FDA
regulations. In particular, Sandoz and Eon argue that Plaintiff does not allege their noncompliance with § 208.24(b) because “[t]he mere allegation that [they] did not provide
Medications Guides to the Decedent’s pharmacy is not sufficient to allege a violation of this
regulation.” Docket no. 22 at 8. With reference to the regulatory language quoted above, they
point out that one way a manufacturer complies with the regulations is by “[p]roviding the means
to produce Medication Guides,” meaning that their failure to provide Medication Guides itself
does not violate the regulations. See 21 C.F.R § 208.24(b)(2).
Sandoz and Eon misread the allegations of the complaint. They focus narrowly on
Plaintiff’s allegation that “Medication guides were not provided to that pharmacy by . . . Eon,
Sandoz, or any of their distributors.” Docket no. 18 at 7. Plaintiff, however, goes further by
adding the following allegations: “Defendants failed to provide a Medication Guide that would
reach Jesse Monk,” id. at 3; “Jesse Monk’s pharmacy did not have Teva, Eon, or Sandoz
Medication Guides to provide Jesse Monk as these defendants each failed to distribute them as
required,” id. at 7. Though the complaint does not track the regulatory language verbatim, the
allegation that the pharmacy did not have the Medication Guides necessarily follows from the
premise that the pharmacy lacked the Guides themselves and the means to produce them.
Sandoz and Eon also argue that § 208.24(e) imposes no legal obligation to ensure actual
delivery of a Medical Guide to a patient. Instead, they argue, this regulation applies only to
authorized distributors, which the pharmacy is but they are not. Sandoz and Eon ignore that
subsection (e) does not absolve manufacturers of the requirements of subsection (b) but instead
imposes separate requirements on authorized distributors in addition to those imposed on
manufacturers. As explained above, the complaint adequately alleges that Sandoz and Eon did
not comply with subsection (b); thus, whether they also complied with subsection (e) is
irrelevant. Accordingly, Sandoz and Eon’s argument that the complaint does not adequately
allege a violation of the applicable federal regulations is without merit.
Under state law, Plaintiff adequately alleges negligence claims but does not adequately
allege negligence per se claims.
a. Plaintiff’s state law claims are not preempted by Buckman.
Defendants argue that under the Supreme Court’s decision in Buckman, Plaintiff’s Texas
law claims that are based on Defendants’ failure to provide an FDA-required Medication Guide
are preempted. 531 U.S. 341, 352–53 (2001); see also 21 U.S.C. § 337(a) (“[A]ll such
proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the
name of the United States.”). Buckman dealt with “fraud-on-the-FDA” claims involving a
medical device manufacturer allegedly using fraudulent tactics to obtain FDA approval for a
device and plaintiffs subsequently bringing private causes of action against that manufacturer for
its misrepresentations to the FDA. 2 531 U.S. at 345–46. Recognizing that private, state law
causes of action for fraud-on-the-FDA conflict with federal law because they skewed “a
somewhat delicate balance of statutory objectives” covered by the FDA, the Supreme Court
found that these claims were preempted. Id. at 348. The broader lesson from Buckman, which
Defendants seek to invoke here, is that state law claims that exist “solely by virtue” of FDCA
requirements are preempted. Buckman, 531 U.S. 341, 352–53 (2001); see also Perdue v. Wyeth
After two failed attempts to obtain FDA approval for its device, the manufacturer split the device into
component parts and obtained piecemeal FDA approval for these parts. Buckman, 531 U.S. at 345–46.
Pharm., Inc., 209 F. Supp. 3d 847, 851 (E.D.N.C. 2016) (holding that a state law claim is
preempted under Buckman if “‘the existence of these federal enactments is a critical element in
[plaintiff’s] case,’ and [if] a plaintiff’s claims ‘exist solely by virtue of the FDCA . . .
requirements.’” (quoting Buckman, 531 U.S. at 352)). Indeed, this preemptive effect of Buckman
has been extended beyond the fraud-on-the-FDA context by some courts. See, e.g., Perdue, 209
F. Supp. 3d at 851–52.
Crucially, however, the Buckman Court distinguished preempted “fraud-on-the-agency”
claims from those based on “traditional state tort law principles of the duty of care,” recognizing
that “certain state-law causes of actions that parallel federal safety requirements” are not
preempted. Buckman, 531 U.S. at 352–53; see also Perdue, 209 F. Supp. 3d at 847 (noting that a
state law claim is not preempted under Buckman if it rests on “‘traditional state tort law
principles of the duty of care,’ the establishment of which ‘predated the federal enactments in
question.’ . . . In this manner, Buckman does not extend so far as to restrict ‘certain state-law
causes of actions that parallel federal safety requirements.’” (quoting Buckman, 531 U.S. at
352)). This distinction is logical—the reason for preempting fraud-on-the-agency claims is
primarily to protect the “somewhat delicate balance of statutory objectives” that could be skewed
by interference from private enforcement, but pre-existing state law tort principles alone do not
implicate that same concern.
Recently, the Fifth Circuit addressed a claim similar to this one involving a
pharmaceutical company’s failure to provide FDA-required warnings. In Eckhardt v. Qualitest
Pharmaceuticals, Inc., the plaintiff attempted to assert a cause of action based on generic drug
manufacturers’ failure to provide the plaintiff or his physician with any FDA-approved warnings.
751 F.3d 674, 679 (5th Cir. 2014). Ultimately, the Fifth Circuit affirmed the district court’s
dismissal of these claims because the plaintiff did not make adequate factual allegations. Id.
Before doing so, however, the court indicated that because “failing to provide FDA-approved
warnings would be a violation of both state and federal law, this is a parallel claim that is not
preempted.” Id. (emphasis added).
Other decisions from this Court have followed Eckhardt. In Mitchell v. Wyeth, a case
involving similar allegations based on generic amiodarone manufacturers’ failure to provide
Medication Guides, Magistrate Judge Mark Lane recommended that the district court deny the
pharmaceutical defendants’ motion to dismiss:
[Defendant] argues that under Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341, 349 n.4 (2001), [plaintiff] does not have a private right
of action to the manufacturer’s duty to provide the Medication Guide. However,
despite rejecting a variety of allegedly parallel state tort claims as preempted by
Mensing and Bartlett, the Fifth Circuit recently held in Eckhardt v. Qualitest
Pharms., Inc., 751 F.3d 674, 679 (5th Cir. 2014), that an allegation that generic
drug manufacturers “failed to provide [plaintiff] or his physician with any of the
FDA-approved warnings . . . would be a violation of both state and federal law,
[and] this is a parallel claim that is not preempted.” Id. at 679–80. . . .
To the extent [plaintiff] seeks to allege that Defendants failed to comply
with their obligation to supply distributors with the FDA-required Medication
Guides, and this failure proximately caused [the decedent] to take amiodarone
without knowledge of the FDA-approved warnings, such a claim would survive
federal preemption under Eckhardt’s reasoning.
Case No. 1:16-CV-574-LY-ML, Docket no. 73 at 8–9 (W.D. Tex. Jan. 1, 2017) (some citations
omitted). The district court summarily adopted this recommendation after a de novo review. Id.
at Docket no. 75 (W.D. Tex. Feb. 9, 2017). Judge Lane previously made similar
recommendations in two more amiodarone cases. See Rusk v. Wyeth, Case No. 1:14-CV-549LY-ML, 2015 WL 3651434 (W.D. Tex. June 11, 2005); 3 Priest v. Sandoz, Case no. 1:15-CV-
“Plaintiffs in this case allege that [defendant] was responsible for providing an FDA-mandated
‘Medication Guide.’ Plaintiffs further allege that [the decedent] never received the Medication Guide, and that ‘the
Pharmacies’ assert ‘no manufacturer’ was providing the Guides to pharmacists or patients. To the extent Plaintiffs
seek to allege that Sandoz failed to comply with its obligation to supply distributors with the FDA-required
822-ML-LY, Docket no. 65 (W.D. Tex. December 29, 2016). 4 As in Mitchell, the district court
summarily adopted both of these recommendations after conducting a de novo review. Rusk,
Case no. 1:14-CV-549-LY, Docket no. 46 (W.D. Tex. October 16, 2015); Priest, Case no. 1:15CV-822-LY, Docket no. 67 (W.D. Tex. January 31, 2016).
Defendants challenge Eckhardt and its progeny for failing to provide reasoning based in
Texas law to support the proposition that these Medication Guide claims allege a breach of a
parallel duty under Texas law. Defendants ignore, though, that regardless of the explanation in
Eckhardt, this Court is bound by Fifth Circuit precedent, which expressly recognizes that a claim
for failure to provide FDA-approved warnings alleges “a violation of both [Texas] and federal
law” and that such a claim “is a parallel claim that is not preempted.” 751 F.3d at 679.
Defendants also seek to avoid the Eckhardt line of cases by arguing that “neither Mitchell
nor Eckhardt contains any substantive preemption analysis under Buckman whatsoever.” E.g.,
Docket no. 30 at 8. In Mitchell, Judge Lane’s recommendation addressed the argument that
Buckman preempted the plaintiff’s Medication Guide claim. Mitchell, Case No. 1:16-CV-574LY-ML, Docket no. 73 at 8. Defendants may disagree with the analysis or object to its depth, but
to say that the recommendation does not contain such an analysis is incorrect. As to Eckhardt,
whether the court meant that the parallel claims were preempted under Buckman or under
another source of preemption is irrelevant because the court found that “failing to provide FDAMedication Guides, and this failure proximately caused [the decedent] to take amniodarone [sic] without knowledge
of the FDA-approved warnings, such a claim would survive federal preemption under Eckhardt’s reasoning.” Rusk,
2015 WL 3651434 at *7 (citations omitted).
“[D]espite rejecting a variety of allegedly parallel state tort claims as preempted . . . the Fifth Circuit
recently held in Eckhardt v. Qualitest Pharms., Inc., 751 F.3d 674, 679 (5th Cir. 2014) that an allegation that generic
drug manufacturers ‘failed to provide [plaintiff] or his physician with any of the FDA-approved warnings . . . would
be a violation of both state and federal law, [and] this is a parallel claim that is not preempted.’ Id. at 679–80 . . . To
the extent Plaintiff seeks to allege that [defendant] failed to comply with its obligation to supply distributors with the
FDA-required Medication Guides, and this failure proximately caused [the decedent] to take amiodarone without
knowledge of the FDA-approved warnings, such a claim would survive federal preemption under Eckhardt’s
reasoning.” Priest, Case no. 1:15-CV-822-ML-LY, Docket no. 65 at 11–12 (W.D. Tex. December 29, 2016).
approved warnings would be a violation of state and federal law . . . [and] is a parallel claim.”
Because “certain state-law causes of actions that parallel federal safety requirements” are not
preempted under the express language of Buckman, 531 U.S. at 353, and the Fifth Circuit in
Eckhardt found that claims for failing to provide FDA approved warnings (like Plaintiff’s here)
are indeed parallel claims, this Court, at most, takes the simple step of connecting the rule of
Buckman with the finding of Eckhardt. 5
Other case law does not warrant a contrary result. Defendants cite a variety of cases from
the Fifth Circuit dealing with other pharmaceutical claims, but none of these cases dealt with the
potential preemptive effect of Buckman on state law negligence claims such as the ones here. A
large number of these cases involved fraud-on-the-FDA claims, like those in Buckman that the
Supreme Court found skewed the “somewhat delicate balance of statutory objectives” involved
in FDA regulation. See, e.g., Estes v. Lanx, Inc., 660 F. App’x. 260, 261 (5th Cir. 2016). Another
case cited by Defendants, Morris v. PLIVA, Inc., deals specifically with a pharmaceutical
manufacturer’s labeling of its products, and was not a barrier to the Fifth Circuit’s subsequent
decision in Eckhardt (or any of Judge Lane’s recommendations). 713 F.3d 774, 777–78 (5th Cir.
2013). Defendants also cite a variety of cases from district courts outside the Fifth Circuit that
have found similar claims to be preempted, but these cases interpret other states’ laws and lack
the binding guidance of a case like Eckhardt. See, e.g., McDaniel v. Upsher-Smith Pharm., Inc.,
216CV02604JPMCGC, 2017 WL 657778, at *4 (W.D. Tenn. Jan. 26, 2017) (interpreting
Tennessee law and correctly characterizing Eckhardt as “only persuasive and not binding
The court in Eckhardt may well have meant that Buckman does not preempt these claims, undermining
Defendants’ argument entirely. Still, Defendants are correct that the court did not mention Buckman by name. At
most, it is possible that the court never analyzed whether Buckman would also warrant preemption in light of its
finding that the state law claims there paralleled federal law.
In sum, the Court finds that Plaintiff’s claims are not preempted because under Buckman,
parallel claims are not preempted, and under Eckhardt, claims such as Plaintiff’s are parallel
b. The learned intermediary doctrine does not bar Plaintiff’s claims at this
Under Texas law, “[t]he elements of a negligence cause of action are the existence of a
legal duty, a breach of that duty, and damages proximately caused by the breach.” IHS Cedars
Treatment Ctr. of DeSoto, Tex., Inc. v. Mason, 143 S.W.3d 794, 798 (Tex. 2004). Thus, in order
to state a cause of action for negligence, Plaintiff must allege the existence of a legal duty under
Texas law. Whether Plaintiff has done so turns on Texas’ learned intermediary doctrine.
Texas law has long limited a manufacturer or supplier’s duty to warn end users of its
products in certain situations where an intermediary separates the supplier from the end user. See
Alm v. Aluminum Co. of Am., 717 S.W.2d 588, 591 (Tex. 1986) (“[A] manufacturer or supplier
may, in certain situations, depend on an intermediary to communicate a warning to the ultimate
user of a product.”). The Texas Supreme Court in Alm—a products liability case involving the
manufacture of an aluminum bottle cap—hypothesized about the applicability of this doctrine in
the prescription drug context while summarizing the reasoning and holdings from lower Texas
In some situations, courts have recognized that a warning to an intermediary
fulfills a supplier’s duty to warn ultimate consumers. For example, when a drug
manufacturer properly warns a prescribing physician of the dangerous
propensities of its product, the manufacturer is excused from warning each patient
who receives the drug. The doctor stands as a learned intermediary between the
manufacturer and the ultimate consumer. Generally, only the doctor could
understand the propensities and dangers involved in the use of a given drug. In
this situation, it is reasonable for the manufacturer to rely on the intermediary to
pass on its warnings. However, even in these circumstances, when the warning to
the intermediary is inadequate or misleading, the manufacturer remains liable for
injuries sustained by the ultimate user.
Id. at 591–92 (citations omitted). The Texas Supreme Court ultimately found that there was some
evidence in the record to support the jury’s finding that the warnings given by the manufacturer
of the bottle cap to the bottler (i.e., the intermediary) were inadequate. Id. at 593
Picking up on this language from Alm, the Texas Supreme Court later held that the
learned intermediary doctrine applies to a pharmaceutical manufacturer’s duty to warn
consumers of dangers associated with prescription drugs. Centocor, Inc. v. Hamilton, 372
S.W.3d 140, 156 (Tex. 2012). Previously, the Texas Supreme Court “[had] not considered a case
that squarely present[ed] the applicability of the learned intermediary doctrine within the context
of prescription drug products-liability cases.” Id. at 157. But in Centocor, the court extended the
rule to such a situation:
[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users
of its product’s risks by providing adequate warnings to the intermediaries who
prescribe the drug and, once fulfilled, it has no further duty to warn the end users
directly. But as we have previously indicated, when the warning to the prescribing
physician is inadequate or misleading, the prescription drug manufacturer
remains liable for the injuries sustained by the patient.
Id. at 15 (emphasis added).
Plaintiff correctly highlights the emphasized language from Centocor. Unlike
Defendants’ characterization of Plaintiff’s argument, this language does not signify an exception
to the learned intermediary doctrine, but rather is the rule itself. Where warnings to a learned
intermediary are adequate, a drug manufacturer fulfills its duty to warn end users of its products
under Texas law, but this result occurs only if the drug manufacturer provided adequate
warnings. Accordingly, the application of the learned intermediary doctrine does not bar
Plaintiff’s claims, as this Court recognized in Mitchell. Case No. 1:16-CV-574-LY-ML, Docket
no. 73 at 8–9 (“Texas’s learned intermediary doctrine also does not defeat this cause of action.”).
Plaintiff has pled that Defendants failed to provide adequate warnings of the dangers of their
products, and under Texas law, this sufficiently states a claim. Whether those warnings were in
fact adequate—such that the learned intermediary doctrine would shield Defendants from
liability—can be considered at the summary judgment phase after the parties have conducted
discovery on the issue.
c. Plaintiff’s negligence per se claims are dismissed.
Defendants argue that Plaintiff’s negligence per se claim should be dismissed because
Texas law does not recognize a cause of action for negligence per se based on alleged violations
of the FDCA. Docket no. 21 at 14. The Court agrees.
“Negligence per se is a tort theory whereby courts use statutes or regulations to define the
standard of reasonably prudent conduct.” Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591,
594 (W.D. Tex. 2002) (citing Carter v. William Sommerville & Son, Inc., 584 S.W.2d 274, 278
(Tex. 1979)). The Court has relatively little guidance on this question because neither the Fifth
Circuit nor the Texas Supreme Court has stated whether a violation of the FDCA and FDA
regulations can give rise to a negligence per se claim. Hackett, 246 F. Supp. 2d at 594.
To support their arguments, Defendants rely primarily on Hackett, where this Court
found that Texas law did not recognize such a claim. 246 F. Supp. 2d at 546. The Court was
persuaded by the thorough analysis of a Texas trial court, which found that under the applicable
factors set forth by the Texas Supreme Court, the FDCA and FDA regulations did not give rise to
a cause of action for negligence per se under Texas law. Id. (discussing and following Baker v.
Smith & Nephew Richards, Inc., Case No. 95-58737, 1999 WL 811334, at *8–11 (Tex. Dist.
June 7, 1999)6). At least two other federal district courts in Texas have relied on Hackett and
Baker to summarily find that “Texas courts . . . refuse to recognize a cause of action for
negligence per se based on violations of the [FDCA] and FDA regulations.” Holland v. HoffmanLa Roche, Inc., 3-06-CV-1298-BD, 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (quoting
Hackett, 246 F. Supp. 2d at 594); see also Jackson v. Tae Jin Kim, 2:02-CV-200, 2004 WL
6040969, at *4 (E.D. Tex. Sept. 27, 2004) (citing Baker, 1999 WL 811334 at *8). The Court is
persuaded by the cases cited by Defendants, and agrees that Texas law likely does not recognize
a cause of action for negligence per se based solely on the violation of the FDCA and FDA
Plaintiff’s arguments to the contrary are unavailing. First, Plaintiff argues that the cases
cited by Defendants were summary judgment decisions that came long after the pleadings stage.
Hackett’s dismissal of the negligence per se claims, however, came on a Rule 12(c) motion for
judgment on the pleadings. 246 F. Supp. 2d at 593–94. Further, all of these cases, despite being
postured as summary judgment decisions, conducted a legal (not factual) analysis of negligence
per se claims. Plaintiff next relies on an out-of-circuit decision interpreting Oklahoma law as
recognizing a negligence per se claim in these circumstances, but this case is far from binding in
any respect and is countered by other out-of-circuit decisions that reach the opposite result.
Compare Docket no. 28 at 13 (citing Howard v. Zimmer, 718 F.3d 1209, 1210 (10th Cir. 2013)
for the proposition that Oklahoma law recognizes FDA-based negligence per se claims) with
Talley v. Danek Medical, Inc., 179 F.3d 154, 157–61 (4th Cir. 1999) (finding that Virginia law
did not permit plaintiff to enforce certain violations of FDA regulations through a negligence per
se claim). Finally, Plaintiff argues that Judge Lane permitted similar negligence per se claims to
Baker was affirmed, but the appellate court expressly withheld a ruling on this question. See McMahon v.
Smith & Nephew Richards, Inc., Case No. 14-99-00616-CV, 2000 WL 991697, at *3, n. 2 (Tex. App.—Houston
[14th Dist.] July 20, 2000, no pet.).
proceed in his recommendations in Rusk and Priest, but as Defendants note, Judge Lane never
analyzed these claims; the refusal to dismiss these claims sua sponte, especially in the absence of
argument from the parties, is not an affirmation of the validity of these claims. Accordingly,
Plaintiff’s negligence per se claims are dismissed.
Plaintiff’s complaint is not deficient for failing to differentiate its allegations among the
Finally, the Court dispenses with Defendants Sandoz and Eon’s argument that Plaintiff’s
complaint is inadequate for failing to differentiate its allegations as to each of the three
defendants. Docket no. 22 at 13. Though Plaintiff’s complaint does not separate its allegations, it
specifically identifies each defendant and specifically describes all Defendants’ allegedly
wrongful conduct. See, e.g., Docket no. 18 at 6 ¶ 31; 7 ¶ 39; 7–8 ¶ 40; 11 ¶ 57–61. The fact that
Plaintiff accuses all three defendants of the same wrongdoings is not a basis for dismissal.
For the foregoing reasons, Defendant Teva’s motion to dismiss (Docket no. 21) and
Defendants Sandoz and Eon’s motion to dismiss (Docket no. 22) are GRANTED IN PART AND
DENIED IN PART. In their Rule 26 Report, the parties indicated that they would provide a
status report by May 22, 2017. Docket no. 27. In preparation for a status conference (which will
be set at a later time) the parties are ORDERED to provide this status update by June 5, 2017. In
addition, the parties are further ORDERED to provide scheduling recommendations in
accordance with the Court’s form (available at Docket no. 15) by June 5, 2017.
It is so ORDERED.
SIGNED this 11th day of May, 2017.
UNITED STATES DISTRICT JUDGE
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?