Rusk et al v. Novartis Pharmaceuticals Corporation et al

Filing 34

REPORT AND RECOMMENDATIONS that Defendants 21 Motion to Dismiss be GRANTED WITHOUT PREJUDICE. It is further RECOMMENDED that Plaintiffs Motion for Leave to Amend be GRANTED. Specifically, the undersigned RECOMMENDS that Plaintiffs be granted leave to amend only their claims for wrongful off-label promotion and failure to supply adequate Medication Guides, as the remainder of their claims for relief related to the manufacture, marketing, distribution, and sale of amniodarone, Compl. at 131, are preempted as a matter of law. Signed by Judge Mark Lane. (klw)

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TEXAS
AUSTIN DIVISION
JOHN ANTHONY RUSK and JUDY
RUSK, individually and as Administrator of
the Estate of JOHN ANTHONY RUSK,
Plaintiffs,
V.
WYETH-AYERHERST
LABORATORIES, INC.; SANDOZ INC.;
TEVA PHARMACEUTICALS USA INC.;
BARR LABORATORIES, INC.; AND
EON LABS;
Defendants.

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A-14-CV-00549-LY-ML

REPORT AND RECOMMENDATION
OF THE UNITED STATES MAGISTRATE JUDGE
TO THE HONORABLE LEE YEAKEL
UNITED STATES DISTRICT JUDGE
Before the Court are the Motion to Dismiss [Dkt. # 21] filed by Defendant Sandoz, Inc.
(“Sandoz”), the Response in opposition thereto filed by Plaintiffs [Dkt. #27], and Sandoz’ Reply
in support thereof [Dkt. #29]. 1
The Motions were referred by United States District Judge Lee Yeakel to the undersigned
for a Report and Recommendation as to the merits pursuant to 28 U.S.C. § 636(b), Rule 72 of the
Federal Rules of Civil Procedure, and Rule 1(d) of Appendix C of the Local Rules of the United
States District Court for the Western District of Texas. After reviewing the pleadings, the
relevant case law, as well as the entire case file, the undersigned issues the following Report and
Recommendation to the District Court.

1

This Motion to Dismiss addresses claims against Sandoz only and does not implicate the Complaint against
the other four defendants named as parties in this case.

1

I. BACKGROUND
This is a product liability action against the makers and promoters of Cordarone® and its
generic version, amniodarone. Cordarone is a pharmaceutical that was approved by the FDA in
1985 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 anti-arrhythmic drugs and therapies.” Compl. at ¶¶ 41-42. Amniodarone is the
FDA-approved generic bioequivalent of Cordarone. Id. at ¶ 45.
A. John Anthony Rusk’s Use of Amniodarone
Plaintiffs allege John Anthony Rusk died from taking amniodarone, a generic version of
Cordarone. Compl. ¶ 47. According to the Complaint, Mr. Rusk was prescribed a 90-day course
of amniodarone as a treatment for atrial fibrillation, an “off-label” use of the drug. Id. at ¶ 47-48.
Mr. Rusk filled his prescription on August 24, 2011 and took the drug as prescribed. Id. at ¶48.
Mr. Rusk did not receive a Medication Guide, which outlines the risks and benefits of the drug,
with his prescription. Id. at ¶ 50. He was not informed of the potentially fatal side effects
associated with the drug. Id. Mr. Rusk was not aware that his use of the drug was an “off-label”
use. Id. at ¶ 52.
Amniodarone’s manufacturers are responsible for ensuring that Medication Guides are
available for distribution to patients. 21 C.F.R. § 208.24. It is the end distributor (such as a
pharmacy), however, that is responsible for actually providing the Medication Guide to the
patient. See id. Mr. Rusk’s prescription was filled by a CVS pharmacy. Compl. at ¶ 48, n. 14.
Plaintiffs allege that “According to the Pharmacies, no manufacturer is providing them or the
patient’s [sic] medication guides.” Compl. at ¶ 137. The amniodarone tablets contained in Mr.
Rusk’s prescription were marked with an NDC number identifying Defendant Sandoz as their
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marketer, manufacturer, and distributor. Id. at ¶ 49. Plaintiffs assert Sandoz failed to ensure that
the Medication Guide was provided to Rusk. Id. at ¶ 50.
In the spring of 2012, Mr. Rusk began experiencing many of the side effects outlined in
the amniodarone Medication Guide, including shortness of breath, wheezing, impaired vision,
and leg, stomach, and chest cramps. Id. at ¶¶ 56, 58. Mr. Rusk died on May 1, 2012 at the age
of 84. Id. at ¶ 59. Plaintiffs allege amniodarone-induced lung disease was a cause of death. Id.
Plaintiffs have sued various pharmaceutical companies, including Sandoz, the maker of
the amniodarone prescribed to Mr. Rusk. Plaintiffs allege the Defendants, specifically including
Sandoz, were aware of increasing reports of adverse events related to off-label use of
amniodarone between 1985, when Cordarone was initially approved in an abbreviated procedure,
through the time it was prescribed to Mr. Rusk in 2011, through direct reports from health care
providers and consumers, multiple official FDA label revision requirements, and through the
FDA’s Adverse Event Reporting System (AERS). Id. at ¶¶ 61-83; 86-90. Plaintiffs allege the
Defendants, specifically including Sandoz, nevertheless aggressively marketed amniodarone as a
safe, first-line drug for various off-label cardiac therapies, such as that prescribed for Mr. Rusk.
Id. at ¶¶ 92-96, 103-106. Plaintiffs allege the generic manufacturers, including Sandoz, actively
promoted and “pushed” off-label use of amniodarone both through direct marketing and through
“piggybacking” on the off-label marketing efforts of Defendant Wyeth, the manufacturer of the
brand-name version of the drug. Id. at ¶¶ 92-105.
Based on these factual allegations, Plaintiffs assert claims under Texas state law that the
wrongful death of John Anthony Rusk was “directly and proximately caused by the negligent
actions of the Defendants as related to the manufacture, marketing, distribution, and sale of
Cordarone®/Amniodarone as described herein.” Id. at ¶ 131. Plaintiffs further allege the
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Defendants “are guilty of gross negligence for failure to provide the FDA required medication
guide,” id. at ¶ 138, and the failure to provide Mr. Rusk the medication guide was a direct and
proximate cause of Plaintiff’s damages. Id. at ¶ 139. Defendant Sandoz has responded with a
motion to dismiss, alleging that all of Plaintiffs’ claims are preempted by FDA regulations and
that, in the alternative, Plaintiff’s generalized factual allegations are insufficient to satisfy
Federal Rule of Civil Procedure 12(b)(6) and, to the extent Plaintiffs’ claims sound in fraud,
Federal Rule of Civil Procedure 9(b). See generally Mot. Dism. [Dkt. #21].
B. The Unique Regulatory Framework Applicable to Generic Drugs
Plaintiffs’ allegations must be read against the backdrop of the comprehensive regulatory
scheme affecting the manufacture and sale of pharmaceuticals in the United States. Pursuant to
the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA regulates the approval of both
brand name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand name); 21 C.F.R.
§314.94(a)(8) (generic). The amniodarone manufactured by Sandoz is a generic; therefore the
court will focus here on the regulatory scheme applicable to generic drugs.
Generic drugs are “designed to be a copy of a reference listed drug (typically a brand
name drug), and thus identical in active ingredients, safety and efficacy.” PLIVA, Inc. v.
Mensing,____ U.S. ____, 131 S.Ct. 2567, 2574 (2011). Recognizing this “duty of sameness,”
the approval requirements for generic drugs are streamlined to require only submission of an
Abbreviated New Drug Application (ANDA) showing a generic drug is identical in all material
respects to a previously-approved reference drug. 21 U.S.C. § 355(j)(2)(A). These streamlined
regulations require that the “labeling proposed [for an ANDA] is the same as the labeling
approved for the [brand name drug].” Mensing, 131 S.Ct. at 2574 (citing 21 U.S.C. §
355(j)(2)(A)(v); 21 U.S.C. § 355(j)(4)(G)). Therefore, an ANDA applicant need only
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demonstrate that its “warning label is the same as the brand name’s” to receive FDA approval.
Mensing, 131 S.Ct at 2574.

Upon receiving FDA approval of an ANDA, the only duty

incumbent upon a generic manufacturer under federal law with respect to its warnings is an
ongoing “duty of sameness” — to ensure its generic drug’s labeling remains identical to the
Reference Listed Drug (“RLD”) to which it is required to remain equivalent. Id. at 2574-75.
Generic manufacturers are prohibited from independently changing their labeling in any respect
without prior FDA approval. Id. at 2577 (“Federal drug regulations, as interpreted by the FDA,
prevented the manufacturers from independently changing their generic drugs’ safety labels.”);
see also 21 C.F.R. § 314.150(b)(10) (authorizing FDA to revoke approval of a generic drug if its
labeling “is no longer consistent with that for the listed drug”).
This continuing federal “duty of sameness” extends beyond the labeling to the design of
the drug as well. See generally Mutual Pharm. Co., Inc. v. Bartlett, ___ U.S. ____, 133 S.Ct.
2466 (2013).

To gain and keep ANDA approval, generic manufacturers must show their

products are bioequivalent to the brand name or reference listed drug. See 21 U.S.C.
§355(j)(2)(A)(i)-(iii) (ANDA applicants must demonstrate that a generic drug contains the same
active ingredients; employs the same route of administration; presents the same dosage form; and
exhibits the same strength as its brand name counterpart). As the Mensing court explained,
federal law explicitly requires a generic drug to be “identical [to its branded equivalent] in active
ingredients, safety, and efficacy,” just as each generic drug must “ensur[e] that its warning label
is the same as the brand name’s.” Mensing, 131 S.Ct at 2574 n.1. Because of this broadly
applicable “duty of sameness,” the Supreme Court has held in both Mensing and Bartlett that
product liability claims against generic drug manufacturers based on theories of “failure to warn”

5

or “design defect” are preempted by federal law. Mensing, 131 S.Ct. at 2577-78; Bartlett, 133
S.Ct. at 2480.
II. STANDARD OF REVIEW
Federal Rule of Civil Procedure 12(b)(6) allows the court to dismiss a claim that, on its
face, “fails to state a claim upon which relief may be granted.” In reviewing a motion to dismiss
for failure to state a claim, the court must accept as true all well-pleaded facts in the complaint,
and must view the allegations as a whole in the light most favorable to the non-movant. Scanlan
v. Texas A&M Univ., 343 F.3d 533, 536 (5th Cir. 2003); Collins v Morgan Stanley Dean Witter,
224 F.3d 496, 498 (5th Cir. 2000).
Although Federal Rule of Civil Procedure 8 mandates only that a pleading contain a
“short and plain statement of the claim showing that the pleader is entitled to relief,” this
standard demands more than unadorned accusations, “labels and conclusions,” “a formulaic
recitation of the elements of a cause of action,” or “naked assertion[s]” devoid of “further factual
enhancement.” Bell Atl. v. Twombly, 550 U.S. 544, 555-57, 127 S. Ct. 1955, 1965-66 (2007).
Thus, in considering a motion to dismiss, the court must initially identify pleadings that are no
more than legal conclusions not entitled to the assumption of truth, then assume the veracity of
well-pleaded factual allegations and determine whether those allegations plausibly give rise to an
entitlement to relief. Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S. Ct. 1937, 1950 (2009). If not,
“the complaint has alleged–but it has not ‘show[n]’–‘that the pleader is entitled to relief.’” Id.
(quoting FED. R. CIV. P. 8(a)(2)).
To the extent a complaint alleges claims sounding in fraud, Federal Rule of Civil
Procedure 9(b) requires that plaintiffs go a step further: the underlying factual circumstances
must be plead “with particularity.” Id. “Put simply, Rule 9(b) requires ‘the who, what, when,
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where, and how’ to be laid out.” Benchmark Elecs. v. J.M. Huber Corp., 343 F.3d 719, 724 (5th
Cir. Tex. 2003) (citing Williams v. WMX Techs., Inc., 112 F.3d 175, 179 (5th Cir. 1997)).
III. ANALYSIS
A.

Preemption of Claims Based on Failure to Warn or Design Defect

Defendants assert Plaintiffs’ claims fail as a matter of law because they are preempted by
Mensing, 131 S.Ct. at 2577-78, and Bartlett, 133 S.Ct. at 2480. As noted above, Mensing holds
that federal law preempts state law tort claims premised on alleged failure to warn of risks of
generic drugs, because such claims conflict with federal law requiring generic manufacturers to
conform their warnings to the equivalent brand name product. 131 S.Ct. at 2577-78. The
Supreme Court reinforced and expanded Mensing’s scope to include design defect claims and
claims alleging a duty to withdraw from the market in Bartlett, 133 S.Ct. at 2480.
The Fifth Circuit has adopted a broad reading of both Mensing and Bartlett, upholding
dismissals of a wide variety of claims whose factual allegations boil down to complaints of
“failure to warn” or “design defect” as preempted by federal law. See, e.g., Lashley v. Pfizer,
Inc., 750 F.3d 470, 474 and n.3 (5th Cir. 2014) (rejecting “parallel” state tort claims as
preempted and noting in dicta that “failure to warn is the ‘only valid claim’ in a suit for personal
injuries caused by prescription drugs in Texas); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th
Cir. 2013) (Mensing forecloses all claims alleging “failure to communicate” approved warnings,
and further preempts claims based on failure to test and inspect the product because “any ‘useful’
reporting [of the test results]—at least from the standpoint of those injured—would ostensibly
consist of some sort of warning”); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 186 (5th Cir.
2012) (“Post-Mensing, . . . a seeming majority of federal district courts to consider other state-

7

law tort claims have found them to be preempted based on the fact that the plaintiffs’ claims are
failure-to-warn claims under different names.”).
B.

Negligent or Fraudulent “Off Label” Promotion Claims May Survive

Despite its unhesitating application of Mensing and Bartlett preemption to a wide variety
of claims implicating the federal “duty of sameness” in the labeling and design of generic drugs,
the Fifth Circuit has recently “decided not to decide” whether a claim for negligent or fraudulent
off-label promotion of a generic drug can survive Mensing and Bartlett preemption.

See

Whitener v. Pliva, Inc., No. 14-30468, 2015 U.S. App. LEXIS 5774, *10 (5th Cir. Apr. 9, 2015)
(per curiam) (not designated for publication). The Whitener appellate court squarely recognized
that “to the extent the Whiteners’ claims were based on the defendants’ affirmative promotion of
metoclopramide for use during pregnancy [an off-label use], the district court was ‘unwilling to
conclude that such a claim fails as a matter of law.’” Id. at *4 (quoting Whitener v. Pliva, No.
10-1552 Section “L” (4), 2011 U.S. Dist. LEXIS 140053, *15 (E.D. Louisiana Dec. 6, 2011)).
Nevertheless, the district court ultimately granted summary judgment on the grounds that the
plaintiffs had failed to establish causation on this potential cause of action, and the Fifth Circuit
“affirm[ed] the district court’s dismissal of the Whiteners’ claim . .. without reaching whether the
Whiteners’ off-label-promotion claim is a viable theory of recovery.” Id. at *10.
The Fifth Circuit’s non-decision is, to date, the only federal appellate decision addressing
the effect of Mensing and Bartlett preemption on allegedly wrongful “off label” promotional
activities. However, the Whitener district court decision, reasoning that negligent or fraudulent
off-label promotional activities would not be preempted by the “duty of sameness,” is in line
with the opinions of several district courts to have considered the issue. For example, in Arters
v. Sandoz, the United States District Court for the Southern District of Ohio specifically
8

considered the off-label promotion of amniodarone by Sandoz—the same generic drug and the
same generic drug manufacturer before this court— and found that the plaintiffs’ legal theories
“based on the idea that defendants promoted the drug in a fraudulent or unreasonably dangerous
way” for off label use would not be preempted by federal law, because “Nothing in the FDCA
requires defendants to promote their drug for an off-label use, nor is the federal law otherwise at
odds with the negligence, breach of implied warranty, and fraud claims brought by plaintiffs.”
921 F. Supp. 2d 813, 819-20 (S.D. Ohio 2013).
Earlier this year, in the related context of medical device regulation, the District of
Hawaii considered similar preemption arguments in Beavers-Gabriel v. Medtronic, No. 1300686 JMS-RLP, 2015 U.S. Dist. LEXIS 2522 (D. Hawaii, Jan. 9, 2015). The court found no
preemption where “Plaintiff’s allegations are not directed to the Infuse Device’s labeling—
rather, Plaintiff asserts that Defendants failed to disclose relevant information regarding off-label
uses of the Infuse Device to both the FDA and [plaintiff].” Id. (emphasis in original). A District
Court in the Southern District of Texas may have put it best: “[T]he Court declines to find that
any and all conduct that falls within the Plaintiffs’ allegations of promoting Risperdal for offlabel uses in an illegal scheme necessarily fall within the concept of the regulation of labeling.”
Elmore v. Gorsky, No. 2:12-CV-00347, 2012 U.S. Dist. LEXIS 177793, *8-9 (S.D. Tex. Dec. 17,
2012) (emphasis in original).

Thus, while it is clear under Mensing that Sandoz “has no

mechanism to unilateral provide any additional warnings relevant to the off-label use” of its
drugs, several courts have found “the Mensing analysis changes if a generic defendant actively
promotes the drug for off-label use in violation of federal law.” Whitener v. Pliva, No. 10-1552
Section “L” (4), 2012 U.S. Dist. LEXIS 127993, *6 (E.D. Louisiana, Sept. 10, 2012) (emphasis
in original). The Fifth Circuit has declined to foreclose claims for wrongful off-label promotion,

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despite its otherwise broad application of Mensing preemption. Whitener, 2015 U.S. App.
LEXIS 5774, *10. It therefore appears that a claim for wrongful off-label promotion of a generic
drug is potentially viable under current Fifth Circuit law. Id.
1.

Elements of Wrongful “Off Label” Promotion Claims

Sandoz argues that, even if a claim for wrongful off-label marketing is not preempted,
Plaintiffs have failed to plead it with sufficient specificity to survive a motion to dismiss. Mot.
Dism. [#21] at 12-18. The Whitener district court decision is instructive in terms of what must
be plead to establish a claim for wrongful off-label marketing (assuming such a claim exists.)
2011 U.S. Dist. LEXIS 140053, *16. “If Plaintiffs wish to pursue such a claim they should plead
sufficient factual content regarding what marketing or promotional representations were made,
by which Defendants, to whom, and how those statements violated applicable federal law.” Id.

2

2. Plaintiffs Should Be Granted Leave to Re-Plead This Claim
The Complaint as it stands alleges, inter alia:
•

Rusk’s specific amniodarone prescription was manufactured by Sandoz, Compl.
at ¶ 49;

•

Defendants, “respectively, jointly and severally” had actual and constructive
knowledge of severe (including fatal) side effects from off-label uses of
amniodarone, including the side effects suffered by Mr. Rusk, from direct reports
of adverse advents to the manufacturer by the purchasing healthcare provider or
end-user patient, or through the FDA’s Adverse Event Reporting System (AERS).
Id. at ¶¶ 86-88.

2

On summary judgment, the Whitener plaintiffs failed to establish causation because, although they had
identified specific acts of off-label promotion, they had failed to obtain deposition testimony or other evidence that
these promotions caused the plaintiff’s doctor to issue the off-label prescription. Whitener, 2015 U.S. App. LEXIS
5774, *10-12. Allegations of a “complex scheme to promote metoclopramide through congresses, doctors, and
medical journals” was not substantiated by any evidence showing that the doctors “clinical judgment was itself
influenced, in some indirect way, by the defendants’ promotional activities.” Id. (emphasis in original).

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•

Sandoz “and/or its agents’ pharmaceutical sales representatives actively promoted
their generic amniodarone in the stream of commerce for the ‘off-label’ uses
openly promoted by Defendant Wyeth.” Id. at ¶ 94.

•

Defendants, “respectively, jointly, and severally, concealed information about
catastrophic injuries and death, and thousands of serious adverse medical events
from the FDA, health care professionals, and consumers, including Anthony
Rusk.” Id. at ¶ 97

•

While Defendants “respectively, jointly and severally, concealed this adverse
event information, they simultaneously engaged in a massive and fraudulent
marketing and promotional scheme in which they aggressively and fraudulently
promoted Cordarone®/amiodarone for uses never authorized by the FDA. In fact,
Defendants marketed, promoted, and ‘pushed’ Cordarone®/amiodarone, not as a
drug of last resort, but as a drug suitable as an initial therapy and to treat non-lifethreatening heart conditions.” Id. at ¶ 100.

•

“Defendants’ affirmative misrepresentations and omissions have so infected the
market in the United States that physicians and consumers relied on Defendants’
fraud, respectively, to the detriment of their patients and themselves.” Id. at ¶
107.

Sandoz contends these allegations are not specific enough to identify to whom or how Sandoz
allegedly fraudulently marketed off-label use of amniodarone or concealed adverse events
resulting from off-label use. Mot. Dism. [#21] at 17-18. The undersigned agrees. See FED. R.
CIV. P. 9(b) (“In alleging fraud or mistake, a party must state with particularity the circumstances
constituting fraud or mistake.”)
Plaintiffs have sought leave to amend their complaint. Resp. [# 27] at 2. Leave to amend
should be freely granted, particularly where the circumstances suggest amendment would not be
futile. FED. R. CIV. P. 15(a)(2). In this case, Plaintiff’s claims for wrongful off-label promotion
are not clearly foreclosed as a matter of law. Whitener, 2015 U.S. App. LEXIS 5774, *10. It is
possible they will be able to amend their complaint to allege facts establishing both wrongful offlabel promotion and reliance with the specificity required by Rule 9(b).

11

Should Plaintiffs wish to pursue this claim, they must amend their Complaint to identify,
at a minimum, the promotional activities undertaken by agents or representatives of Sandoz to
influence the specific physicians involved in Mr. Rusk’s treatment to prescribe amniodarone offlabel and/or the actions taken by agents or representatives of Sandoz to conceal from Mr. Rusk’s
physicians the risks associated with the off-label use of amniodarone in patients like Mr. Rusk.
See Whitener, 2011 U.S. Dist. LEXIS 140053, *16; see also Beavers-Gabriel, 2015 U.S. Dist.
LEXIS 2522, *16 (requiring that a complaint alleging fraudulent off-label promotion “include
allegations making ‘the connection between Defendants’ alleged misdeeds and Plaintiff and
Plaintiff’s

phyisicians—i.e.,

that

Plaintiff

and

Plaintiff’s

physicians

relied

on

the

misrepresentations.’”) (quoting Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1038
(D. Hawaii 2014).
D.

Failure to Supply FDA “Medication Guide” Claims May Survive

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.
Plaintiffs in this case allege that Defendant Sandoz was responsible for providing an FDAmandated “Medication Guide.” Compl. at ¶¶ 50, 54. Plaintiffs further allege that Mr. Rusk
never received the Medication Guide, id. at ¶ 50, and that “the Pharmacies” assert “no
manufacturer” was providing the Guides to pharmacists or patients. Id. at ¶ 137. To the extent
Plaintiffs seek to allege that Sandoz failed to comply with its obligation to supply distributors
with the FDA-required Medication Guides, and this failure proximately caused Mr. Rusk to take

12

amniodarone without knowledge of the FDA-approved warnings, such a claim would survive
federal preemption under Eckhardt’s reasoning. 751 F.3d at 679.
1.

Elements of Failure to Supply FDA Medication Guide Claim

Defendant Sandoz again asserts that, even if the alleged failure to supply a Medication
Guide is viable as a matter of law, it has not been adequately alleged in this case. Mot. Dism.
[#21] at 19. Recently, the District Court for the Northern District of Alabama considered what
would be required to plead a claim for failure to provide an FDA-mandated Medication Guide.
Stevens v. Teva Pharmaceuticals, No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D.
Alabama, Oct. 1, 2014). “Without a well-founded allegation that Huntsville Hospital Pharmacy
[the pharmacy that filled the plaintiff’s prescription] failed to provide a Medication Guide to
Plaintiff because defendants did not supply the Guide to the pharmacy along with the
medication, as required by 21 C.F.R. § 208.24, this claim cannot survive.” Id. at *8.
2. Plaintiffs Should be Granted Leave to Re-Plead this Claim
Plaintiffs have generally alleged that unknown pharmacies have complained about not
receiving Medication Guides from unknown manufacturers. Compl. at ¶ 137. There is no
allegation in the Complaint, however, that the CVS that filled Mr. Rusk’s prescription was
unable to provide him a Medication Guide because Sandoz failed to supply one to CVS. See
Stevens, 2014 U.S. Dist. LEXIS 180568 at *8. Therefore, Plaintiffs have not plead this claim
with sufficient factual specificity to raise it above the level of “a sheer possibility that the
defendant has acted unlawfully.” Id. (citing Iqbal, 556 U.S. at 678). Because there is no
suggestion that amendment of this claim would be futile, Plaintiffs should be granted leave to replead their claim for failure to provide a Medication Guide with the requisite specificity. FED. R.
CIV. P. 15(a)(2).
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IV. RECOMMENDATIONS
In accordance with the foregoing, the undersigned RECOMMENDS that Defendant’s
Motion to Dismiss [#21] be GRANTED WITHOUT PREJUDICE.
The undersigned further RECOMMENDS Plaintiffs’ Motion for Leave to Amend be
GRANTED. Specifically, the undersigned RECOMMENDS that Plaintiffs be granted leave to
amend only their claims for wrongful off-label promotion and failure to supply adequate
Medication Guides, as the remainder of their claims for relief “related to the manufacture,
marketing, distribution, and sale of amniodarone,” Compl. at ¶ 131, are preempted as a matter of
law.
V. OBJECTIONS
The parties may file objections to this Report and Recommendation. A party filing
objections must specifically identify those findings or recommendations to which objections are
being made. The District Court need not consider frivolous, conclusive, or general objections.
See Battles v. United States Parole Comm’n, 834 F.2d 419, 421 (5th Cir. 1987).
A party's failure to file written objections to the proposed findings and recommendations
contained in this Report within fourteen (14) days after the party is served with a copy of the
Report shall bar that party from de novo review by the District Court of the proposed findings
and recommendations in the Report and, except upon grounds of plain error, shall bar the party
from appellate review of unobjected-to proposed factual findings and legal conclusions accepted
by the District Court. See 28 U.S.C. § 636(b)(1)(C); Thomas v. Arn, 474 U.S. 140, 150-53, 106
S. Ct. 466, 472-74 (1985); Douglass v. United Services Automobile Ass’n, 79 F.3d 1415 (5th Cir.
1996)(en banc).

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To the extent that a party has not been served by the Clerk with this Report &
Recommendation electronically, pursuant to the CM/ECF procedures of this District, the Clerk is
ORDERED to mail such party a copy of this Report and Recommendation by certified mail,
return receipt requested.

SIGNED June 11, 2015
_______________________________
MARK LANE
UNITED STATES MAGISTRATE JUDGE

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