Akman v. Bayer Healthcare Pharmaceuticals, Inc. et al
Filing
38
MEMORANDUM OPINION AND ORDER granting 29 Motion for Judgment on the Pleadings. (Written Opinion) Signed by Chief Judge John R. Tunheim on 11/4/2020. (HAZ)
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UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
IN RE: FLUOROQUINOLONE
PRODUCTS LIABILITY LITIGATION
THIS DOCUMENT RELATES TO:
Jennifer Akman v. Bayer Health Care
Pharmaceuticals, Inc., Cobalt
Laboratories, Inc. AKA Cobalt
Laboratories LLC, and Actavis Pharma Co.
Case No. 0:17-cv-00260-JRT.
MDL No. 2642 (JRT)
MEMORANDUM OPINION AND ORDER
GRANTING JUDGMENT ON THE
PLEADINGS AND GRANTING LEAVE TO
AMEND THE COMPLAINT
Master Docket Case No. 0:15-md-02642
Christopher Nidel, NIDEL LAW PLLC, 1615 New Hampshire Avenue
Northwest, Washington, D.C. 20009; Christopher T. Nace, PAULSON &
NACE PLLC, 1025 Thomas Jefferson Street Northwest, Suite 810,
Washington, D.C. 20007, for plaintiff.
Michael J. Suffern, ULMER & BERNE LLP, 600 Vine Street, Suite 2800,
Cincinnati, Ohio 45202; Kimberly Lewis Beck, HILLIARD MARTINEZ
GONZALES, 201 East 5th Street, Suite 1900, Cincinnati, Ohio 45202, for
defendants.
Defendants Cobalt Laboratories and Actavis Pharma, succeeded by Teva Canada,
manufacturers of generic ciprofloxacin, filed a Motion for Judgment on the Pleadings
asking the Court to dismiss Plaintiff Jennifer Akman’s case because her claims under
District of Columbia law are preempted by federal law. Plaintiff Akman argues that her
claims, related to injuries caused by ciprofloxacin, are not preempted and, in the
alternative, asks for leave to amend. The Court finds that Akman’s D.C. law claims based
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on Generic Defendants’ failure to update their pharmaceutical product information to
match FDA-approved warnings are not facially preempted by federal law. But because
Akman has not pleaded sufficient allegations or explanations of the source of her claims
under D.C. law, the Court will grant Akman leave to amend her complaint.
BACKGROUND
In November 2013, Plaintiff Jennifer Akman was prescribed Cipro or its generic
equivalent, ciprofloxacin. (Notice of Removal, Ex. A (“Compl.”) ¶ 15, Jan. 17, 2017, Docket
No. 1-1.) Akman stopped taking the medication within 24 hours because of a severe
adverse reaction. (Compl. ¶ 16.) Akman continues to suffer nerve damage and other
injuries from the medication. (Id. ¶ 18.)
On November 15, 2016, Akman filed a Complaint against Bayer Healthcare Inc.,
Bayer Corporation, 1 Cobalt Laboratories, Inc. AKA Cobalt Laboratories LLC (“Cobalt”), and
Actavis Pharma Company, succeeded by Teva Canada (“Teva”), in the Superior Court of
the District of Columbia (the “Initial Complaint”). (Id. ¶¶ 5–14.) Defendants Cobalt and
Teva (collectively, “Generic Defendants”), are manufacturers of generic pharmaceutical
products, including ciprofloxacin. (Id. ¶ 13–14.) Akman alleges that, on August 15, 2013,
the FDA issued an updated warning about the risk of peripheral neuropathy from use of
Cipro and ciprofloxacin, but Generic Defendants had not updated their labels and other
The Bayer Defendants were dismissed from the case pursuant to a stipulation of dismissal on
November 9, 2019. (Order Stip. Dismissal, Nov. 19, 2019, Docket No. 28.)
1
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product information in compliance with the August 2013 mandate at the time Akman was
prescribed ciprofloxacin in November 2013. (Id. ¶¶ 53–55; see also id. ¶¶ 95, 102, 121.)
The case was removed to the U.S. District Court for the District of Columbia on
January 17, 2017, (Notice of Removal, Jan. 17, 2017, Docket No. 1), and then transferred
to the District of Minnesota on January 27, 2017 to be consolidated for pretrial
proceedings as part of In re: Fluoroquinolone Products Liability Litigation, Multi-District
Litigation No. 2642 (the “Fluoroquinolone MDL”). (Notice of Transfer, Jan. 27, 2017,
Docket No. 14.) Generic Defendants filed Answers on February 6, 2017. (Answer by
Actavis, Feb. 6, 2017, Docket No. 19; Answer by Cobalt, Feb. 6, 2017, Docket No. 20.)
On February 27, 2017, Akman filed an Amended Complaint by completing the
Fluoroquinolone MDL Short Form Complaint, which incorporates the allegations of the
MDL Master Complaint (“Short Form Complaint”). (Am. Compl. ¶¶ 1, 15–16, Feb. 27,
2017, Docket No. 21.) In her Short Form Complaint, Akman alleged that she was injured
by generic ciprofloxacin and that D.C. law supports her generics-related claim. (Id. ¶ 8.)
On July 31, 2020, Generic Defendants filed a Motion for Judgment on the Pleadings
pursuant to Federal Rule of Civil Procedure 12(c), arguing that Akman failed to state a
claim against them. (Mot. J. Pleadings, Jul. 31, 2020, Docket No. 29.) Akman asks the
Court to grant leave to amend if the Court finds that the allegations pleaded in the Initial
Complaint are insufficient to support her failure to update theory. (Pl.’s Mem. Opp. at
13, Aug. 21, 2020, Docket No. 34.)
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DISCUSSION
I.
STANDARD OF REVIEW
When evaluating the merits of a motion for judgment on the pleadings pursuant
to Federal Rule of Civil Procedure 12(c), the Court applies the same legal standard that
applies to a motion to dismiss for failure to state a claim under Rule 12(b)(6). Ashley
County v. Pfizer, Inc., 552 F.3d 659, 665 (8th Cir. 2009). As such, to survive a motion for
judgment on the pleadings, a complaint must contain sufficient factual allegations to state
a plausible claim for relief. See Clemons v. Crawford, 585 F.3d 1119, 1124 (8th Cir. 2009).
A court accepts as true all facts pleaded by the nonmoving party and draws all reasonable
inferences from the pleadings in favor of that party. Id. Without more, merely reciting
the elements of a cause of action is insufficient, and legal conclusions asserted in the
complaint are not entitled to the presumption of truth. Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009).
A party may amend its pleading by leave of court, which “shall be freely given when
justice so requires.” Fed. R. Civ. P. 15(a)(2). Amendment of pleadings is to be liberally
allowed. Thompson–El v. Jones, 876 F.2d 66, 67 (8th Cir. 1989). Thus, “absent a good
reason for denial—such as undue delay, bad faith or dilatory motive, repeated failure to
cure deficiencies by amendments previously allowed, undue prejudice to the non-moving
party, or futility of amendment—leave to amend should be granted.” Id.
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II.
ANALYSIS
A. Operative Complaint
As an initial matter, the parties dispute whether the Court should consider the
allegations in Akman’s Initial Complaint since she had to file the Short Form Complaint
after the case was transferred to the Fluoroquinolone MDL. Cases consolidated for multidistrict litigation pre-trial proceedings ordinarily retain their separate identities. Gelboim
v. Bank of America Corp., 574 U.S. 405, 413 (2015). The individual pleadings do not merge
if the master complaint is “not meant to be a pleading with legal effect,” but rather is
“only an administrative summary of the claims brought by all the plaintiffs.” Id. at 413
n.3 (citation omitted). Additionally, “a court presiding over an MDL must take steps to
ensure that efficiency does not trump fundamental fairness and that the desire for
certainty does not deprive any individual party of substantive rights.” In re Gen. Motors
LLC Ignition Switch Litig., No. 14-MC-2543, 2015 WL 3619584, at *1 (S.D.N.Y. June 10,
2015).
In this MDL, the Court has issued pretrial orders (“PTO”) explaining that the short
form complaint and incorporated master complaint should be filed rather than
standalone complaints. Pretrial Order 1 states that “the [Plaintiffs’ Steering Committee]
also shall file . . . a Short Form Complaint, which shall be an abbreviated form that
Plaintiffs will complete in lieu of filing standalone complaints.” (PTO 1 at § 12.B, Feb. 12,
2016, MDL No. 15-2642, Docket No. 76.) Pretrial Order 3 likewise states that “[t]here
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shall be a separate short form complaint filed for each individual plaintiff. No plaintiff
shall file a non-short form complaint in this MDL.” (PTO 3 at 5, Mar. 1, 2016, MDL No. 152642, Docket No. 95.) The master complaint, as incorporated in the short form complaint,
is intended to have legal effect.
For Akman’s case, however, the allegations and theories leveraged against the
Generic Defendants, named in both the Initial Complaint and the Short Form Complaint, 2
would be lost if the Court disregards the contents of the Initial Complaint, since the Short
Form Complaint and Master Complaint do not include allegations supporting claims
directly against generic manufacturers of ciprofloxacin. Because the purpose of an MDL
is to manage pretrial proceedings, not to eliminate the individual character of each case,
the Court will address the Initial Complaint to determine whether Akman’s proffered
theory of liability is preempted by federal law.
B. Federal Preemption of State Law Claims
Akman’s Initial Complaint asserts various tort and statutory claims under D.C. law
against Generic Defendants based on the theory that they failed to update their product
information after the FDA approved an updated warning for Cipro and its generic
Defendants argue that they are not properly joined as Defendants in this case because they are
not named in the Master Complaint. Akman named the Generic Defendants in the Initial
Complaint and the Short Form Complaint in the space provided for litigants to identify “Other”
defendants. As such, the Court finds that the Generic Defendants are properly parties to the
action irrespective of which complaint is operative.
2
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equivalent in August 2013. Generic Defendants argue that Akman’s claims are preempted
by federal law. The Supreme Court has issued two pivotal decisions about federal
preemption of state law claims against generic drug manufacturers under the HatchWaxman Amendments to the Food, Drug, and Cosmetic Act (“FDCA”) based on
impossibility preemption. Impossibility preemption exists where it is “impossible for a
private party to comply with both state and federal requirements.” Freightliner Corp. v.
Myrick, 514 U.S. 280, 287 (1995) (quotation omitted).
In PLIVA, Inc. v. Mensing, the Supreme Court found that state law claims for failure
to warn based on the inadequacy of a generic drug’s labeling are preempted by federal
law because “the warning labels of a brand-name drug and its generic copy must always
be the same—thus, generic drug manufacturers have an ongoing federal duty of
‘sameness.’” 564 U.S. 604, 613, 618 (2011). Claims asserting that generics should have
stronger warnings, when their labels were the same as the brand-name counterpart, are
preempted by impossibility because federal law prohibits a generic drug manufacturer
from unilaterally strengthening the warnings on its product’s labeling. See id. at 618. In
Mutual Pharm. Co. v. Bartlett, the Supreme Court extended impossibility preemption
under the FDCA to prohibit state law design defect claims against generic drug
manufacturers because a generic drug manufacturer is prohibited from unilaterally
redesigning its product. 570 U.S. 472, 483–84 (2013). In other words, pursuant to
Mensing and Bartlett, plaintiffs cannot maintain claims that state law requires generic
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drug manufacturers to provide stronger warnings or safer designs than their brand-name
counterparts because complying with state law—i.e. providing a different warning or
design than a brand-name—would result in violating the federal law duty of sameness.
The failure to update scenario presented by Akman differs from the claims in both
Mensing and Bartlett. Akman asserts that, at the time she received the ciprofloxacin, the
Generic Defendants’ product information was not the same as the brand-name
equivalent. Rather, the Generic Defendants failed to update their labels to match the
brand-name after FDA approval of a new warning. Unlike Mensing and Bartlett, where
the plaintiffs argued that state law required generic manufacturers to provide more
warnings or implement a safer design for their generic drug than the brand-name drug,
Akman argues that state law merely required Generic Defendants to match their labels to
the FDA approved, brand-name version. Failure to update claims therefore can escape
preemption under Mensing and Bartlett when compliance with federal and state duties
is not only possible, but required. See Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir.
2013.) When it is possible for a generic manufacturer to provide a stronger warning
without violating the FDA’s duty of sameness and the generic manufacturer fails to do so,
a narrow path around Mensing preemption exists. See, e.g., Huck v. Wyeth, Inc., 850
N.W.2d 353, 364 (Iowa 2014).
Failure to update claims are only viable, however, to the extent that a plaintiff was
harmed by a generic manufacturer’s failure to conform their product information with
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the FDA-approved labeling. See Fulgenzi, 711 F.3d 578, 584 (holding that plaintiff’s claims
survive only to the extent that defendant’s warning was inadequate because it did not
include language from an updated FDA warning). The Fifth Circuit has expressed
disapproval of failure to update claims in general, but particularly rejected the failure to
update theory because “[t]ort liability does not arise from failure to attach an inadequate
label.” Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013). The Court agrees that a
failure to update claim asserting that even the updated warning would have been
inadequate is preempted because the generic manufacturer cannot unilaterally provide
additional warnings under the duty of sameness. However, the Court disagrees that all
failure to update claims are facially preempted, as it is possible to limit such claims to
injuries caused by a generic manufacturer’s failure to update their labels.
Even if a failure to update claim is not preempted by impossibility, it may
nonetheless be impliedly preempted if a plaintiff merely seeks to enforce the FDCA
through a private right of action. In Buckman v. Plaintiffs’ Legal Comm., the Supreme
Court held that private plaintiffs cannot bring claims for violations of the FDCA that are
not independently state law causes of action. 531 U.S. 341, 348 (2001). However, a state
law claim survives when the claim is premised on conduct that both (1) violates the FDCA
and is therefore not prohibited by impossibility preemption, and (2) would give rise to a
recovery under state law even in absence of the FDCA and therefore is not impliedly
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preempted under Buckman. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn.
2009).
The Fifth Circuit rejected the failure to update theory on the ground that such
claims are necessarily grounded in federal law, since they are about a federal labeling
requirement. Morris, 713 F.3d at 777. Although some failure to update claims could be
based only on federal law and therefore preempted, the Court finds that failure to update
claims need not always be based on federal law. When a plaintiff can show that
challenged conduct violates the FDCA, but the plaintiff is not suing simply because of the
violation, the failure to update claim falls within the preemption gap. In re Medtronic,
Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204–05 (8th Cir. 2010).
Accordingly, a failure to update claim is not conclusively preempted. 3
3
The Eighth Circuit has not squarely held whether failure to update claims are preempted,
although it has analyzed them based on the specific facts asserted, suggesting that such claims
are not facially preempted. In Fullington v. Pfizer, Inc., rather than addressing the viability of the
failure to update theory directly, the Eighth Circuit relied on the learned intermediary doctrine
to conclude that the theory was immaterial because “[a] manufacturer's inadequate warning is
not a proximate cause of a plaintiff's harm so long as the prescribing physician had independent
knowledge of the risk that the inadequate warning should have communicated.” 720 F.3d 739,
747 (8th Cir. 2013). The Eighth Circuit has relied on the learned intermediary doctrine to resolve
failure to update-based cases on at least two other occasions. See Brinkley v. Pfizer, Inc., 772
F.3d 1133, 1138 (8th Cir. 2014); Bell v. Pfizer, Inc., 716 F.3d 1087, 1098 (8th Cir. 2013). The Court
takes note, therefore, that even though failure to update claims are not necessarily preempted,
they may be difficult to prove on the merits, particularly in terms of causation between the label
and injury.
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In sum, if a plaintiff asserts a claim that (1) a generic drug manufacturer failed to
update their labels to match an FDA-approved label adopted by brand-name
manufacturers; (2) the claim is limited to the inadequacies of the non-updated label
compared to the updated label; and (3) the claim is based on state law, such as common
law negligence or a statutory duty, that would require generic manufacturers to update
their labels irrespective of federal requirements, that claim is neither preempted by the
FDCA under Mensing and Bartlett nor an attempt to assert a private right of action under
the FDCA prohibited by Buckman.
C. Sufficiency of the Pleading
Because the Court finds that failure to update claims are not necessarily
preempted by federal law, the Court must next determine whether Akman sufficiently
pleaded such a claim. There are several reasons Akman’s Initial Complaint fails to state a
claim based on the failure to update theory.
First, the Initial Complaint is not limited to inadequacies in the drug warnings due
to the failure to update. To fit within the preemption gap, Akman must allege liability
only to the extent that she was injured by Generic Defendants’ failure to update their
labels to match the August 2013 FDA-approved version. See Fulgenzi, 711 F.3d at 584.
Second, Akman’s Initial Complaint does not tie Defendants’ alleged liability for failure to
update to D.C. law. As discussed above, to avoid preemption, a failure to update claim
must be based on a state law duty for generic manufacturers to implement the latest FDA-11-
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approved information. See Riley, 625 F. Supp. 2d at 777. Third, although the Initial
Complaint does include allegations based on the failure to update theory, it also includes
allegations that sound in traditional failure to warn liability which is preempted under
Mensing, 564 U.S. at 618. It is unclear which causes of action are based on the nonpreempted failure to update theory. In sum, the Court finds that Akman’s Initial
Complaint, as well as the Short Form Complaint, are insufficient and will grant Generic
Defendants’ Motion for Judgment on the Pleadings.
D. Leave to Amend
Akman asks the Court to grant leave to amend if the Court finds that she failed to
state a claim based on her failure to update theory. See Riley, 625 F. Supp.2d at 785
(granting leave to file an amended complaint with the necessary detail to state a claim
that is not preempted by the FDCA). The Court will grant leave to amend because it finds
that amendment would not be futile, as there is a narrow path around federal preemption
of state law claims against generic drug manufacturers. Further, Akman has not engaged
in bad faith and amendment would not cause undue delay or prejudice to Defendants.
See Thompson–El, 876 F.2d at 67. Finally, since this is the first opportunity for the Court
to outline its views on the failure to update theory, the interests of justice are served by
granting Akman an opportunity to conform her pleading to the requirements for a valid
claim as described here. Accordingly, Akman shall file an amended complaint within 30
days of the entry of this Order.
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Because Akman’s case presents unique questions of law and fact as compared to
other cases in the Fluoroquinolone MDL, the Court will determine whether it is the proper
venue to hear the failure to update claims after Akman files an amended complaint. To
assist the Court in determining whether this case should remain part of the
Fluoroquinolone MDL, the parties shall submit supplemental briefing on the proper court
of adjudication within 15 days of the filing of the amended complaint.
ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that:
1. Defendants’ Motion for Judgment on the Pleadings [Docket No. 29] is
GRANTED.
2. Plaintiff’s Complaint [Docket No. 1-1] and Short Form Complaint [Docket No.
21] are DISMISSED WITHOUT PREJUDICE.
3. Plaintiff is granted leave to file an amended complaint within 30 days of the
entry of this Order.
4. Within 15 days from the filing of Plaintiff’s amended complaint, both parties
shall file memoranda addressing whether the case should be transferred back
to the U.S. District Court for the District Columbia or continue as part of the
Fluoroquinolone MDL.
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DATED: November 4, 2020
at Minneapolis, Minnesota.
_____
______
JOHN R. TUNHEIM
Chief Judge
United States District Court
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