United States District Court, N.D. Alabama, Southern Division
DAVID PROCTOR UNITED STATES DISTRICT JUDGE
matter is before the court on Plaintiffs Motion to Reinstate
Shire Development LLC as a Party Defendant (Doc. # 79) and
Plaintiffs Motion for Reconsideration (Doc. # 91). Both the
Motion to Reinstate (Docs. # 79, 81, 82) and the Motion for
Reconsideration (Docs. # 91, 94, 96) are fully briefed. For
the reasons stated below, the Motion to Reinstate (Doc. # 79)
is due to be denied, and the Motion for Reconsideration (Doc.
# 91) is due to be denied.
Shire U.S. Inc. and Shire LLC engage in the distribution,
marketing, and sale of the drug known as Lialda. (Doc. #41 at
¶ 8). In November 2013, Plaintiff was prescribed Lialda
for treatment of his Crohn's disease. (Id. at
¶ 39). Plaintiff took Lialda, as prescribed, from
November 2013 until February 2015. (Id.), In
September 2015, Plaintiff was diagnosed with Stage IV renal
failure and severe chronic interstitial nephritis.
(Id. at ¶ 45). On June 10, 2016, Plaintiff
filed a complaint against Shire U.S. Inc., Shire LLC, Shire
Development LLC, Shire Pharmaceutical Development, Inc., and
Shire Pharmaceuticals LLC. (Doc. # 1).
October 5, 2016, Defendants moved to dismiss Plaintiffs
claims. (Docs. # 26, 27). Plaintiff filed an opposed motion
to amend his complaint on October 24, 2016. (Doc. # 36).
After the court ordered Defendants to file a brief in support
of its opposition to Plaintiffs motion to amend (Docs. #
37-38), the court granted Plaintiff leave to amend on
November 1, 2016. (Doc. #40). On November 2, 2016, Plaintiff
filed a First Amended Complaint. (Doc. # 41). In that amended
pleading, Plaintiff asserted that Defendants'
recommendation of only "periodic" renal testing
while using Lialda, as opposed to the more specific testing
regimen detailed in his First Amended Complaint, proximately
caused his kidney injury. (Id. #41 at ¶ 26).
Specifically, Plaintiff asserted claims for failure to warn
under the Alabama Extended Manufacturers Liability Doctrine
("AEMLD") (Count One), fraud (Count Two),
suppression and concealment (Count Three), and breach of
express warranty (Count Four). (Doc. # 41).
November 16, 2016, Defendants moved to dismiss Plaintiffs
First Amended Complaint. (Docs. # 44, 45). On May 8, 2017,
the court dismissed Counts Two, Three, and Four with
prejudice and denied Defendants' motion to dismiss Count
One without prejudice. (Docs. # 53, 54). After granting
Defendants' motion to dismiss for lack of personal
jurisdiction on May 12, 2017, the court dismissed Defendants
Shire Development LLC, Shire Pharmaceutical Development,
Inc., and Shire Pharmaceuticals LLC without prejudice. (Doc.
# 56). On June 29, 2017, Plaintiff filed a Motion to Alter or
Amend Order and Motion to Amend Complaint (Doc. # 64), which
the court denied. (Docs. # 85, 86).
Motion to Reinstate Shire Development LLC as a Party
Defendant (Doc. # 79) and Plaintiffs Motion for
Reconsideration (Doc. # 91) are currently pending before the
court. In the Motion to Reinstate, Plaintiff argues that the
court should grant him leave to amend his complaint to add
Shire Development LLC as a defendant in this case because
Shire Development LLC is the holder of the New Drug
Application ("NDA") for Lialda. (Doc. # 79). In the
Motion for Reconsideration, Plaintiff asks the court to
reconsider its denial (Docs. # 85, 86) of his Motion to Alter
or Amend Order (Doc. # 64) and to allow Plaintiff to file a
Second Amended Complaint. (Doc. # 91). During an
on-the-record conference held on November 16, 2017, the court
asked the parties to brief Plaintiffs Motion for
Reconsideration so that the court, at Plaintiffs request,
could take a fresh look at Plaintiffs proposed Second Amended
Complaint (Doc. # 64-1). (Doc. # 94-1 at p. 30). The court
explores the merits of both pending motions, which are
essentially motions to amend, in turn.
Standard of Review
of the Federal Rules of Civil Procedure governs amended and
supplemental pleadings. Absent circumstances not relevant
here, a party may amend the pleadings only by leave of the
court or by written consent of the adverse party.
See Fed R. Civ P. 15(a)(2). "The court should
freely give leave when justice so requires."
Id. "Ordinarily, a party must be given at least
one opportunity to amend before the district court dismisses
the complaint." See Corsello v. Lincare, Inc.,
428 F.3d 1008, 1014 (11th Cir. 2005). That is, "[u]nless
a substantial reason exists to deny leave to amend, the
discretion of the District Court is not broad enough to
permit denial." Fla. Evergreen Foliage v. E.I.
DuPont De Nemours and Co., 470 F.3d 1036, 1041 (11th
Cir. 2006) (quotation marks omitted).
court, however, need not allow an amendment that would be
futile. See Bryant v. Dupree, 252 F.3d 1161, 1163
(11th Cir. 2001). An amendment is futile when "the
complaint as amended is still subject to dismissal."
Hall v. United Insurance Co., 367 F.3d 1255, 1263
(11th Cir. 2004) (citing Burger King Corp. v.
Weaver, 169 F.3d 1310, 1320 (11th Cir. 1999)). A court
also need not allow an amendment where there has been undue
delay, bad faith, dilatory motive, or repeated failure to
cure deficiencies by amendments previously allowed or where
allowing the amendment would cause undue prejudice to the
opposing party. See Halpin v. Crist, 405 Fed.Appx.
403, 408-09 (11th Cir. 2010) (quoting Corsello, 428
F.3d at 1014); see also Maynard v. Bd. of Regents of Div.
of Univs., 342 F.3d 1281, 1287 (11th Cir. 2003) (holding
that the district court did not abuse its discretion in
denying a motion to amend filed on the last day of discovery
because granting the motion "would have produced more
attempts at discovery, delayed disposition of the case,
likely prejudice . . . [and] there seems to be no good reason
why [the movant] could not have made the motion
earlier"). A district court may, in the exercise of its
inherent power to manage the conduct of litigation before it,
deny leave to amend a complaint, "so long as it does not
outright refuse to grant the leave without any justifying
reason." Equal Rights Center v. Niles Bolton
Assocs., 602 F.3d 597, 603 (4th Cir. 2010); see also
Reese v. Herbert, 527 F.3d 1253, 1263 (11th Cir. 2008).
explained below, because all of Plaintiff s proposed
amendments would be futile, both motions are due to be
denied. See Bryant, 252 F.3d at 1163.
Motion for ...