`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`
`
`IN RE: FLUOROQUINOLONE
`PRODUCTS LIABILITY LITIGATION
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`
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`THIS DOCUMENT RELATES TO:
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`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.
`
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`Defendants Cobalt Laboratories and Actavis Pharma, succeeded by Teva Canada,
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`manufacturers of generic ciprofloxacin, filed a Motion for Judgment on the Pleadings
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`asking the Court to dismiss Plaintiff Jennifer Akman’s case because her claims under
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`District of Columbia law are preempted by federal law. Plaintiff Akman argues that her
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`claims, related to injuries caused by ciprofloxacin, are not preempted and, in the
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`alternative, asks for leave to amend. The Court finds that Akman’s D.C. law claims based
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 2 of 14
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`on Generic Defendants’ failure to update their pharmaceutical product information to
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`match FDA-approved warnings are not facially preempted by federal law. But because
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`Akman has not pleaded sufficient allegations or explanations of the source of her claims
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`under D.C. law, the Court will grant Akman leave to amend her complaint.
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`BACKGROUND
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`In November 2013, Plaintiff Jennifer Akman was prescribed Cipro or its generic
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`equivalent, ciprofloxacin. (Notice of Removal, Ex. A (“Compl.”) ¶ 15, Jan. 17, 2017, Docket
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`No. 1-1.) Akman stopped taking the medication within 24 hours because of a severe
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`adverse reaction. (Compl. ¶ 16.) Akman continues to suffer nerve damage and other
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`injuries from the medication. (Id. ¶ 18.)
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`On November 15, 2016, Akman filed a Complaint against Bayer Healthcare Inc.,
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`Bayer Corporation,1 Cobalt Laboratories, Inc. AKA Cobalt Laboratories LLC (“Cobalt”), and
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`Actavis Pharma Company, succeeded by Teva Canada (“Teva”), in the Superior Court of
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`the District of Columbia (the “Initial Complaint”). (Id. ¶¶ 5–14.) Defendants Cobalt and
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`Teva (collectively, “Generic Defendants”), are manufacturers of generic pharmaceutical
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`products, including ciprofloxacin. (Id. ¶ 13–14.) Akman alleges that, on August 15, 2013,
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`the FDA issued an updated warning about the risk of peripheral neuropathy from use of
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`Cipro and ciprofloxacin, but Generic Defendants had not updated their labels and other
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`1 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.)
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 3 of 14
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`product information in compliance with the August 2013 mandate at the time Akman was
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`prescribed ciprofloxacin in November 2013. (Id. ¶¶ 53–55; see also id. ¶¶ 95, 102, 121.)
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`The case was removed to the U.S. District Court for the District of Columbia on
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`January 17, 2017, (Notice of Removal, Jan. 17, 2017, Docket No. 1), and then transferred
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`to the District of Minnesota on January 27, 2017 to be consolidated for pretrial
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`proceedings as part of In re: Fluoroquinolone Products Liability Litigation, Multi-District
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`Litigation No. 2642 (the “Fluoroquinolone MDL”). (Notice of Transfer, Jan. 27, 2017,
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`Docket No. 14.) Generic Defendants filed Answers on February 6, 2017. (Answer by
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`Actavis, Feb. 6, 2017, Docket No. 19; Answer by Cobalt, Feb. 6, 2017, Docket No. 20.)
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`On February 27, 2017, Akman filed an Amended Complaint by completing the
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`Fluoroquinolone MDL Short Form Complaint, which incorporates the allegations of the
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`MDL Master Complaint (“Short Form Complaint”). (Am. Compl. ¶¶ 1, 15–16, Feb. 27,
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`2017, Docket No. 21.) In her Short Form Complaint, Akman alleged that she was injured
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`by generic ciprofloxacin and that D.C. law supports her generics-related claim. (Id. ¶ 8.)
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`On July 31, 2020, Generic Defendants filed a Motion for Judgment on the Pleadings
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`pursuant to Federal Rule of Civil Procedure 12(c), arguing that Akman failed to state a
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`claim against them. (Mot. J. Pleadings, Jul. 31, 2020, Docket No. 29.) Akman asks the
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`Court to grant leave to amend if the Court finds that the allegations pleaded in the Initial
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`Complaint are insufficient to support her failure to update theory. (Pl.’s Mem. Opp. at
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`13, Aug. 21, 2020, Docket No. 34.)
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 4 of 14
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`DISCUSSION
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`I.
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`STANDARD OF REVIEW
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`When evaluating the merits of a motion for judgment on the pleadings pursuant
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`to Federal Rule of Civil Procedure 12(c), the Court applies the same legal standard that
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`applies to a motion to dismiss for failure to state a claim under Rule 12(b)(6). Ashley
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`County v. Pfizer, Inc., 552 F.3d 659, 665 (8th Cir. 2009). As such, to survive a motion for
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`judgment on the pleadings, a complaint must contain sufficient factual allegations to state
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`a plausible claim for relief. See Clemons v. Crawford, 585 F.3d 1119, 1124 (8th Cir. 2009).
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`A court accepts as true all facts pleaded by the nonmoving party and draws all reasonable
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`inferences from the pleadings in favor of that party. Id. Without more, merely reciting
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`the elements of a cause of action is insufficient, and legal conclusions asserted in the
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`complaint are not entitled to the presumption of truth. Ashcroft v. Iqbal, 556 U.S. 662,
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`678 (2009).
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`A party may amend its pleading by leave of court, which “shall be freely given when
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`justice so requires.” Fed. R. Civ. P. 15(a)(2). Amendment of pleadings is to be liberally
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`allowed. Thompson–El v. Jones, 876 F.2d 66, 67 (8th Cir. 1989). Thus, “absent a good
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`reason for denial—such as undue delay, bad faith or dilatory motive, repeated failure to
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`cure deficiencies by amendments previously allowed, undue prejudice to the non-moving
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`party, or futility of amendment—leave to amend should be granted.” Id.
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 5 of 14
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`II.
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`ANALYSIS
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`A. Operative Complaint
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`As an initial matter, the parties dispute whether the Court should consider the
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`allegations in Akman’s Initial Complaint since she had to file the Short Form Complaint
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`after the case was transferred to the Fluoroquinolone MDL. Cases consolidated for multi-
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`district litigation pre-trial proceedings ordinarily retain their separate identities. Gelboim
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`v. Bank of America Corp., 574 U.S. 405, 413 (2015). The individual pleadings do not merge
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`if the master complaint is “not meant to be a pleading with legal effect,” but rather is
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`“only an administrative summary of the claims brought by all the plaintiffs.” Id. at 413
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`n.3 (citation omitted). Additionally, “a court presiding over an MDL must take steps to
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`ensure that efficiency does not trump fundamental fairness and that the desire for
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`certainty does not deprive any individual party of substantive rights.” In re Gen. Motors
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`LLC Ignition Switch Litig., No. 14-MC-2543, 2015 WL 3619584, at *1 (S.D.N.Y. June 10,
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`2015).
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`In this MDL, the Court has issued pretrial orders (“PTO”) explaining that the short
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`form complaint and incorporated master complaint should be filed rather than
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`standalone complaints. Pretrial Order 1 states that “the [Plaintiffs’ Steering Committee]
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`also shall file . . . a Short Form Complaint, which shall be an abbreviated form that
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`Plaintiffs will complete in lieu of filing standalone complaints.” (PTO 1 at § 12.B, Feb. 12,
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`2016, MDL No. 15-2642, Docket No. 76.) Pretrial Order 3 likewise states that “[t]here
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 6 of 14
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`shall be a separate short form complaint filed for each individual plaintiff. No plaintiff
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`shall file a non-short form complaint in this MDL.” (PTO 3 at 5, Mar. 1, 2016, MDL No. 15-
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`2642, Docket No. 95.) The master complaint, as incorporated in the short form complaint,
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`is intended to have legal effect.
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`For Akman’s case, however, the allegations and theories leveraged against the
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`Generic Defendants, named in both the Initial Complaint and the Short Form Complaint,2
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`would be lost if the Court disregards the contents of the Initial Complaint, since the Short
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`Form Complaint and Master Complaint do not include allegations supporting claims
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`directly against generic manufacturers of ciprofloxacin. Because the purpose of an MDL
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`is to manage pretrial proceedings, not to eliminate the individual character of each case,
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`the Court will address the Initial Complaint to determine whether Akman’s proffered
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`theory of liability is preempted by federal law.
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`B. Federal Preemption of State Law Claims
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`Akman’s Initial Complaint asserts various tort and statutory claims under D.C. law
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`against Generic Defendants based on the theory that they failed to update their product
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`information after the FDA approved an updated warning for Cipro and its generic
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`
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`2 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.
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 7 of 14
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`equivalent in August 2013. Generic Defendants argue that Akman’s claims are preempted
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`by federal law. The Supreme Court has issued two pivotal decisions about federal
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`preemption of state law claims against generic drug manufacturers under the Hatch-
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`Waxman Amendments to the Food, Drug, and Cosmetic Act (“FDCA”) based on
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`impossibility preemption. Impossibility preemption exists where it is “impossible for a
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`private party to comply with both state and federal requirements.” Freightliner Corp. v.
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`Myrick, 514 U.S. 280, 287 (1995) (quotation omitted).
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`In PLIVA, Inc. v. Mensing, the Supreme Court found that state law claims for failure
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`to warn based on the inadequacy of a generic drug’s labeling are preempted by federal
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`law because “the warning labels of a brand-name drug and its generic copy must always
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`be the same—thus, generic drug manufacturers have an ongoing federal duty of
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`‘sameness.’” 564 U.S. 604, 613, 618 (2011). Claims asserting that generics should have
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`stronger warnings, when their labels were the same as the brand-name counterpart, are
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`preempted by impossibility because federal law prohibits a generic drug manufacturer
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`from unilaterally strengthening the warnings on its product’s labeling. See id. at 618. In
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`Mutual Pharm. Co. v. Bartlett, the Supreme Court extended impossibility preemption
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`under the FDCA to prohibit state law design defect claims against generic drug
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`manufacturers because a generic drug manufacturer is prohibited from unilaterally
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`redesigning its product. 570 U.S. 472, 483–84 (2013). In other words, pursuant to
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`Mensing and Bartlett, plaintiffs cannot maintain claims that state law requires generic
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 8 of 14
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`drug manufacturers to provide stronger warnings or safer designs than their brand-name
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`counterparts because complying with state law—i.e. providing a different warning or
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`design than a brand-name—would result in violating the federal law duty of sameness.
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`The failure to update scenario presented by Akman differs from the claims in both
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`Mensing and Bartlett. Akman asserts that, at the time she received the ciprofloxacin, the
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`Generic Defendants’ product information was not the same as the brand-name
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`equivalent. Rather, the Generic Defendants failed to update their labels to match the
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`brand-name after FDA approval of a new warning. Unlike Mensing and Bartlett, where
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`the plaintiffs argued that state law required generic manufacturers to provide more
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`warnings or implement a safer design for their generic drug than the brand-name drug,
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`Akman argues that state law merely required Generic Defendants to match their labels to
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`the FDA approved, brand-name version. Failure to update claims therefore can escape
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`preemption under Mensing and Bartlett when compliance with federal and state duties
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`is not only possible, but required. See Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir.
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`2013.) When it is possible for a generic manufacturer to provide a stronger warning
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`without violating the FDA’s duty of sameness and the generic manufacturer fails to do so,
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`a narrow path around Mensing preemption exists. See, e.g., Huck v. Wyeth, Inc., 850
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`N.W.2d 353, 364 (Iowa 2014).
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`Failure to update claims are only viable, however, to the extent that a plaintiff was
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`harmed by a generic manufacturer’s failure to conform their product information with
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 9 of 14
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`the FDA-approved labeling. See Fulgenzi, 711 F.3d 578, 584 (holding that plaintiff’s claims
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`survive only to the extent that defendant’s warning was inadequate because it did not
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`include language from an updated FDA warning). The Fifth Circuit has expressed
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`disapproval of failure to update claims in general, but particularly rejected the failure to
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`update theory because “[t]ort liability does not arise from failure to attach an inadequate
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`label.” Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013). The Court agrees that a
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`failure to update claim asserting that even the updated warning would have been
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`inadequate is preempted because the generic manufacturer cannot unilaterally provide
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`additional warnings under the duty of sameness. However, the Court disagrees that all
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`failure to update claims are facially preempted, as it is possible to limit such claims to
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`injuries caused by a generic manufacturer’s failure to update their labels.
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`Even if a failure to update claim is not preempted by impossibility, it may
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`nonetheless be impliedly preempted if a plaintiff merely seeks to enforce the FDCA
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`through a private right of action. In Buckman v. Plaintiffs’ Legal Comm., the Supreme
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`Court held that private plaintiffs cannot bring claims for violations of the FDCA that are
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`not independently state law causes of action. 531 U.S. 341, 348 (2001). However, a state
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`law claim survives when the claim is premised on conduct that both (1) violates the FDCA
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`and is therefore not prohibited by impossibility preemption, and (2) would give rise to a
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`recovery under state law even in absence of the FDCA and therefore is not impliedly
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 10 of 14
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`preempted under Buckman. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn.
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`2009).
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`The Fifth Circuit rejected the failure to update theory on the ground that such
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`claims are necessarily grounded in federal law, since they are about a federal labeling
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`requirement. Morris, 713 F.3d at 777. Although some failure to update claims could be
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`based only on federal law and therefore preempted, the Court finds that failure to update
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`claims need not always be based on federal law. When a plaintiff can show that
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`challenged conduct violates the FDCA, but the plaintiff is not suing simply because of the
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`violation, the failure to update claim falls within the preemption gap. In re Medtronic,
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`Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204–05 (8th Cir. 2010).
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`Accordingly, a failure to update claim is not conclusively preempted.3
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`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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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 11 of 14
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`In sum, if a plaintiff asserts a claim that (1) a generic drug manufacturer failed to
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`update their
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`labels to match an FDA-approved
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`label adopted by brand-name
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`manufacturers; (2) the claim is limited to the inadequacies of the non-updated label
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`compared to the updated label; and (3) the claim is based on state law, such as common
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`law negligence or a statutory duty, that would require generic manufacturers to update
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`their labels irrespective of federal requirements, that claim is neither preempted by the
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`FDCA under Mensing and Bartlett nor an attempt to assert a private right of action under
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`the FDCA prohibited by Buckman.
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`C. Sufficiency of the Pleading
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`Because the Court finds that failure to update claims are not necessarily
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`preempted by federal law, the Court must next determine whether Akman sufficiently
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`pleaded such a claim. There are several reasons Akman’s Initial Complaint fails to state a
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`claim based on the failure to update theory.
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`First, the Initial Complaint is not limited to inadequacies in the drug warnings due
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`to the failure to update. To fit within the preemption gap, Akman must allege liability
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`only to the extent that she was injured by Generic Defendants’ failure to update their
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`labels to match the August 2013 FDA-approved version. See Fulgenzi, 711 F.3d at 584.
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`Second, Akman’s Initial Complaint does not tie Defendants’ alleged liability for failure to
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`update to D.C. law. As discussed above, to avoid preemption, a failure to update claim
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`must be based on a state law duty for generic manufacturers to implement the latest FDA-
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 12 of 14
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`approved information. See Riley, 625 F. Supp. 2d at 777. Third, although the Initial
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`Complaint does include allegations based on the failure to update theory, it also includes
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`allegations that sound in traditional failure to warn liability which is preempted under
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`Mensing, 564 U.S. at 618. It is unclear which causes of action are based on the non-
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`preempted failure to update theory. In sum, the Court finds that Akman’s Initial
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`Complaint, as well as the Short Form Complaint, are insufficient and will grant Generic
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`Defendants’ Motion for Judgment on the Pleadings.
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`D. Leave to Amend
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`Akman asks the Court to grant leave to amend if the Court finds that she failed to
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`state a claim based on her failure to update theory. See Riley, 625 F. Supp.2d at 785
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`(granting leave to file an amended complaint with the necessary detail to state a claim
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`that is not preempted by the FDCA). The Court will grant leave to amend because it finds
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`that amendment would not be futile, as there is a narrow path around federal preemption
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`of state law claims against generic drug manufacturers. Further, Akman has not engaged
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`in bad faith and amendment would not cause undue delay or prejudice to Defendants.
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`See Thompson–El, 876 F.2d at 67. Finally, since this is the first opportunity for the Court
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`to outline its views on the failure to update theory, the interests of justice are served by
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`granting Akman an opportunity to conform her pleading to the requirements for a valid
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`claim as described here. Accordingly, Akman shall file an amended complaint within 30
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`days of the entry of this Order.
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 13 of 14
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`Because Akman’s case presents unique questions of law and fact as compared to
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`other cases in the Fluoroquinolone MDL, the Court will determine whether it is the proper
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`venue to hear the failure to update claims after Akman files an amended complaint. To
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`assist the Court
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`in determining whether this case should remain part of the
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`Fluoroquinolone MDL, the parties shall submit supplemental briefing on the proper court
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`of adjudication within 15 days of the filing of the amended complaint.
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`ORDER
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`Based on the foregoing, and all the files, records, and proceedings herein, IT IS
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`HEREBY ORDERED that:
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`1. Defendants’ Motion for Judgment on the Pleadings [Docket No. 29] is
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`GRANTED.
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`2. Plaintiff’s Complaint [Docket No. 1-1] and Short Form Complaint [Docket No.
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`21] are DISMISSED WITHOUT PREJUDICE.
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`3. Plaintiff is granted leave to file an amended complaint within 30 days of the
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`entry of this Order.
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`4. Within 15 days from the filing of Plaintiff’s amended complaint, both parties
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`shall file memoranda addressing whether the case should be transferred back
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`to the U.S. District Court for the District Columbia or continue as part of the
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`Fluoroquinolone MDL.
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`CASE 0:17-cv-00260-JRT Doc. 38 Filed 11/04/20 Page 14 of 14
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`DATED: November 4, 2020
`at Minneapolis, Minnesota.
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` _____
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`______
`JOHN R. TUNHEIM
`Chief Judge
`United States District Court
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