Blackburn v. Shire US Inc et al
MEMORANDUM OPINION. Signed by Judge R David Proctor on 5/10/2018. (KAM, )
2018 May-10 AM 10:56
U.S. DISTRICT COURT
N.D. OF ALABAMA
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SHIRE US, INC., et al.,
Case No.: 2:16-CV-963-RDP
This matter is before the court on Plaintiff’s Motion to Reinstate Shire Development LLC
as a Party Defendant (Doc. # 79) and Plaintiff’s 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.
Defendants Shire US 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 US Inc., Shire LLC, Shire Development LLC,
Shire Pharmaceutical Development, Inc., and Shire Pharmaceuticals LLC. (Doc. # 1).
On October 5, 2016, Defendants moved to dismiss Plaintiff’s 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 Plaintiff’s 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).
On November 16, 2016, Defendants moved to dismiss Plaintiff’s 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).
Plaintiff’s Motion to Reinstate Shire Development LLC as a Party Defendant (Doc. # 79)
and Plaintiff’s 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 Plaintiff’s Motion for Reconsideration so that the court, at
Plaintiff’s request, could take a fresh look at Plaintiff’s 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
Rule 15 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.”
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).
The 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.
App’x 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).
As 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 Reconsideration
As an initial matter, and as more fully detailed in the court’s prior Memorandum Opinion
(Doc. # 85) denying Plaintiff’s Motion to Alter or Amend Order (Doc. # 64), a plaintiff
represented by counsel is not entitled to the opportunity to amend his complaint without leave of
court or agreement of opposing counsel when the plaintiff has already previously amended his
complaint. See Eiber Radiology, Inc. v. Toshiba Am. Med. Sys., Inc., 673 F. App’x 925, 930
(11th Cir. 2016) (“[The Eleventh Circuit has] never required district courts to grant counseled
plaintiffs more than one opportunity to amend a deficient complaint, nor have we concluded that
dismissal with prejudice is inappropriate where a counseled plaintiff has failed to cure a deficient
pleading after having been offered ample opportunity to do so.”); see also Henley v. Turner
Broad. Sys., Inc., 267 F. Supp. 3d 1341, 1364 (N.D. Ga. 2017) (“The Court also concludes it is
unnecessary to allow Plaintiffs, who are represented by counsel, the opportunity to file a further
amended complaint.”). Although the court explained to Plaintiff’s counsel why his proposed
Second Amended Complaint was futile, the court permitted the parties to brief Plaintiff’s Motion
(See Doc. # 94-1).
The court now (and, once again) explains why
Plaintiff’s proposed Second Amended Complaint does not cure the deficiencies the court
recognized in its previous Memorandum Opinion (Doc. # 53) dismissing Plaintiff’s breach of
express warranty and fraud-based claims.
The Proposed Second Amended Complaint Does Not Cure Plaintiff’s
Breach of Express Warranty Claim
Plaintiff claims that his Second Amended Complaint properly states a breach of express
warranty claim. (Doc. # 96 at p. 8). The proposed Second Amended Complaint points to § 5.1
of the Warnings and Precautions in the 2013 Label and contends that this section provides
instructions for safe use that form the basis of the bargain. (Docs. # 64-1 at ¶¶ 268-79; 96 at p.
9). Defendants counter that the additional language in the proposed Second Amended Complaint
referencing § 5.1 of the 2013 Label do not alter Plaintiff’s breach of express warranty allegation
contained in his First Amended Complaint. (Doc. # 94 at p. 22-23). The court agrees with
Defendants. The court has already examined the 2013 Label in the context of a breach of
express warranty claim and found that the 2013 Label “cannot to be construed as an express
warranty of safeness.” (Doc. # 53 at p. 17-18). The court further noted that, to the extent that
the Lialda Label could be construed as a description of goods, its “description” is contrary to an
express warranty for safeness because it expressly states that its use may cause a number of side
(Id. at p. 18).
Plaintiff’s additional language in the proposed Second Amended
Complaint highlighting § 5.1 of the 2013 Label does not change this conclusion. Rather, the
proposed amendment simply highlights language that the court has already considered.
(Compare Doc. # 64-1 at ¶¶ 268-79 with Doc. # 53 at p. 17-18). As such, Plaintiff’s proposed
amended breach of express warranty claim does not cure the deficiencies noted in the court’s
Memorandum Opinion (Doc. # 53 at p. 17-18) and is futile. See Hall, 367 F.3d at 1263.
The Proposed Second Amended Complaint Does Not Cure Plaintiff’s
The court previously dismissed Plaintiff’s fraud-based claims in his First Amended
Complaint because these claims “failed to plead the existence of a material fact to support
[those] claims.” (Doc. # 53 at p. 19) (emphasis in original). The court also noted that if Plaintiff
had alleged that Defendants (1) “misrepresented (or concealed) the existence of certain adverse
events or potential side effects of LIALDA” or (2) “made a ‘sales pitch’ or other representation
regarding the safety of its recommended ‘periodic’ renal testing regimen.,” then the court’s
analysis of these fraud-based claims may be different. (Id. at p. 19-20). But Plaintiff has not
sufficiently made either of these allegations in his proposed Second Amended Complaint.
Rather, Plaintiff argues that his proposed Second Amended Complaint cures the deficiencies of
his fraud-based claims from his First Amended Complaint because it “explain[s] in detail why
§ 5.1 of the 2013 Label is a legally mandated statement of instructions for safe use and a material
misrepresentation regarding safe use.” (Doc. # 65 at p. 10) (citing Doc. # 64-1 at ¶¶ 188-205).
A fraud claim must comply with Federal Rule of Civil Procedure 9(b). Rule 9(b) requires
that a party alleging fraud to “state with particularity the circumstances constituting fraud.” Fed.
R. Civ. P. 9(b). Under Rule 9(b), “a plaintiff must allege: ‘(1) the precise statements, documents,
or misrepresentations made; (2) the time, place, and person responsible for the statement; (3) the
content and manner in which these statements misled the Plaintiffs; and (4) what the defendants
gained by the alleged fraud.’” Am. Dental Ass’n v. Cigna Corp., 605 F.3d 1283, 1291 (11th Cir.
2010) (quoting Brooks v. Blue Cross & Blue Shield of Fla., Inc., 116 F.3d 1364, 1380-81 (11th
Cir. 1997)). Of course, the heightened pleading requirements of Rule 9(b) must also satisfy the
plausibility mandate set forth in Twombly and Iqbal.
Plaintiff has failed to satisfy either
requirement—in both his First Amended Complaint and Second Amended Complaint.
In order to proceed on his fraud claim, Plaintiff must plausibly plead (1) a false
representation (2) of a material existing fact (3) relied upon by the plaintiff (4) who was damaged
as a proximate result of the misrepresentation. Coastal Concrete Co. v. Patterson, 503 So. 2d
824, 826 (Ala. 1987). To proceed on his fraudulent suppression claim, Plaintiff must plausibly
plead the existence of the following elements: “(1) a duty on the part of the defendant to disclose
facts; (2) concealment or nondisclosure of material facts by the defendant; (3) inducement of the
plaintiff to act; (4) action by the plaintiff to his or her injury.” Lambert v. Mail Handlers Ben.
Plan, 682 So. 2d 61, 63 (Ala. 1996). “In Alabama, a drug manufacturer ‘may be held liable for
fraud or misrepresentation (by misstatement or omission)’ based on ‘information and warning
deficiencies’ on a drug’s labelling.” Houston v. Bayer Healthcare Pharm., Inc., 16 F. Supp. 3d
1341, 1350 (N.D. Ala. 2014) (quoting Wyeth, Inc. v. Weeks, 159 So. 3d 649, 676 (Ala. 2014)).
More specifically, a plaintiff “can base her fraud and misrepresentation claims on the defendant
manufacturer’s breach of its ‘duty to warn . . . about the risks associated with the long-term use
of the drug’ in its labeling.” Id. (quoting Weeks, 159 So. 3d at 655-56).
In this case, Plaintiff’s First Amended Complaint and Second Amended Complaint
simply do not allege that Defendants failed to warn about the risks associated with the long-term
use of Lialda in its labeling. (See Docs. # 41, 64-1). Indeed, there is no question that Lialda’s
labels warned that a consumer may develop kidney damage from use of the product (as Plaintiff
did). (Docs. # 41 at ¶ 18; 64-1 at ¶ 15). Rather than asserting that Defendants failed to warn
about the risks associated with the use of Lialda, both complaints allege that the recommended
“periodic” evaluation failed to provide information regarding the safe use of Lialda, including
proper testing. (See Docs. # 41 at ¶ 22, 175, 183; 64-1 at ¶ 182). Ultimately, Plaintiff is
attempting to transform Lialda’s warning into a safety warranty in order to support its fraudbased claims. And, for the reasons explained in the court’s Memorandum Opinion, the warnings
contained in § 5.1 of the 2013 Label “cannot to be construed as an express warranty of safeness.”
(Doc. # 53 at p. 17-18).
The court agrees with Plaintiff that both AEMLD and fraud-based claims against drug
manufactures can coexist under Alabama law (even if the substance of the fraud-based claim is
essentially a products liability claim). See Weeks, 159 So. 3d at 656. However, that rule of law
does not mean that a court cannot dismiss fraud-based claims that fail to satisfy the requirements
of Rule 9(b) and the plausibility mandate set forth in Twombly and Iqbal.1 As this court
explained in its previous Memorandum Opinion when analyzing Plaintiff’s fraud-based claims:
While the court assumes the veracity of the facts contained within
Plaintiff’s amended complaint, the court is not required to afford
“conclusions” or “naked assertion[s]” a presumption of truth when
evaluating Defendants’ motion to dismiss. Twombly, 550 U.S. at
555, 557. Here, Plaintiffs’ assertion that LIALDA’s label
constituted a representation that LIALDA therapy would be safe is
just such a conclusion. Moreover, it is a conclusion not supported
by the facts in Plaintiff’s amended complaint. Plaintiff attached
LIALDA’s 2013 label to his amended complaint. And, as
addressed above, LIALDA’s label addresses in detail a wide array
of potential side effects that LIALDA users may endure and does
not state that a LIALDA user would be free from injury if that user
followed the label’s recommended testing regimen.
In its Motion to Dismiss, Defendants argued that all of Plaintiff’s claims are barred based on preemption and the
Learned Intermediary Doctrine. (Doc. # 45 at p. 17-27). Additionally, Defendants specifically challenged elements
of Plaintiff’s breach of express warranty, fraud, and concealment claims but did not include a similar elements-based
challenge for Plaintiff’s failure to warn claim. (Doc. # 45 at p. 27-31). Accordingly, the court did not specifically
address the sufficiency of Plaintiff’s failure to warn claim under Twombly and Iqbal.
(Doc. # 53 at p. 20 n.5). Plaintiff’s proposed Second Amended Complaint continues to base its
fraud-based claims on a naked assertion that the Lialda labels represented that Lialda therapy
would be safe.2 (Doc. # 64-1 at ¶ 170, 224). Therefore, the Second Amended Complaint does
not cure the First Amended Complaint’s deficiencies related to Plaintiff’s fraud-based claims and
is futile. See Hall, 367 F.3d at 1263.
Plaintiff is not entitled to leave to amend his complaint as a matter of right yet another
time. See Wagner v. Daewoo Heavy Indus. Am. Corp., 314 F.3d 541, 542-44 (11th Cir. 2002).
And, even if the court had dismissed these claims without prejudice (instead of with prejudice)
and had granted Plaintiff leave to file his proposed Second Amended Complaint, the proposed
amendments would be futile. Accordingly, the Motion for Reconsideration (Doc. # 91) is due to
Motion to Reinstate
Plaintiff contends 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 NDA for Lialda. (Doc. # 79). Defendants counter that such leave should not be
granted because this court does not have personal jurisdiction over Shire Development LLC
(Doc. # 81). For the reasons explained below, the court agrees with Defendants.
“A plaintiff seeking the exercise of personal jurisdiction over a nonresident defendant
bears the initial burden of alleging in the complaint sufficient facts to make out a prima facie
case of jurisdiction.” United Techs. Corp. v. Mazer, 556 F.3d 1260, 1274 (11th Cir. 2009). In
The court notes that Plaintiff added language in his proposed Second Amended Complaint regarding Defendants’
compliance with FDA regulations. (Doc. # 64-1 at ¶¶ 171-79). To the extent that Plaintiff is raising a claim that
Defendants violated the FDCA, these claims are precluded by 21 USC § 337(a). See Buckman Co. v. Plaintiffs’
Legal Comm., 531 U.S. 341, 349 n.4 (2001) (“The FDCA leaves no doubt that it is the Federal Government rather
than private litigants who are authorized to file suit for noncompliance with the medical device provisions . . . .”).
determining whether the exercise of personal jurisdiction over a nonresident defendant 3 is
appropriate, the court first considers a state’s long-arm statute. See Cable/Home Communication
Corp. v. Network Prods., Inc., 902 F.2d 829, 855 (11th Cir. 1990); see also Alexander Proudfoot
Co. World Headquarters L.P. v. Thayer, 877 F.2d 912, 919 (11th Cir. 1989). Alabama’s longarm statute permits personal jurisdiction to the extent it “is not inconsistent with the constitution
of this state or the Constitution of the United States.” Ala. R. Civ. P. 4.2(b). Because Alabama’s
long-arm statute allows the exercise of personal jurisdiction to the full extent permissible under
the U.S. Constitution, the court next determines whether sufficient minimum contacts exist to
satisfy the Due Process Clause of the Fourteenth Amendment so that “maintenance of the suit
does not offend ‘traditional notions of fair play and substantial justice.’” International Shoe Co.
v. Washington, 326 U.S. 310, 316 (1945) (quoting Milliken v. Meyer, 311 U.S. 457, 463 (1940));
see also Cable/Home Communication Corp., 902 F.2d at 855; Alexander Proudfoot Co., 877
F.2d at 919.
Plaintiff does not argue that this court has general jurisdiction over Shire Development
Accordingly, the court focuses on whether it has specific jurisdiction over Shire
Development LLC. As the Supreme Court has explained:
In order for a state court to exercise specific jurisdiction, the suit
must arise out of or relate to the defendant’s contacts with the
forum. In other words, there must be an affiliation between the
forum and the underlying controversy, principally, an activity or an
occurrence that takes place in the forum State and is therefore
subject to the State’s regulation. For this reason, specific
jurisdiction is confined to adjudication of issues deriving from, or
connected with, the very controversy that establishes jurisdiction.
It is undisputed that Shire Development LLC is incorporated in and has its principal place of business outside of
Alabama, does not have any office or facilities in Alabama, and does not have a registered agent for service of
process in Alabama. (See Doc. # 43-1).
Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773,
1780 (2017) (emphasis in original) (internal citations, quotations, and brackets omitted). “[A]
defendant’s placing goods into the stream of commerce ‘with the expectation that they will be
purchased by consumers within the forum State’ may indicate purposeful availment.”
McIntyre Mach., Ltd. v. Nicastro, 564 U.S. 873, 881-82 (2011) (quoting World-Wide
Volkswagen Corp. v. Woodson, 444 U.S. 286, 298 (1980)).
However, “[t]he defendant’s
transmission of goods permits the exercise of jurisdiction only where the defendant can be said
to have targeted the forum; as a general rule, it is not enough that the defendant might have
predicted that its goods will reach the forum State.” Nicastro, 564 U.S. at 882. In analyzing
specific jurisdiction, the court asks whether the defendant purposefully availed “itself of the
privilege of conducting activities within the forum State, thus invoking the benefits and
protections of its laws.” Id.
Plaintiff argues that this court’s exercise of specific jurisdiction over Shire Development
LLC is appropriate because Shire Development LLC (as the NDA holder for Lialda) placed
Lialda into the stream of commerce to reach Alabama consumers, such as himself. (Doc. # 79 at
p. 7). Plaintiff does not dispute that Shire Development LLC has not in actuality manufactured,
sold, or distributed Lialda. Rather, Plaintiff contends that Shire Development LLC, as the NDA
holder, should also be considered a “manufacturer” for the purposes of this jurisdictional inquiry.
(Doc. # 82 at p. 4). The court is skeptical of these semantics but, in any event, notes that the
word used to describe Shire Development LLC is irrelevant to whether Shire Development LLC
“targeted” the State of Alabama and has purposeful availment contacts within the State. Cf.
Nicastro, 564 U.S. at 882.
Plaintiff advances several theories as to how Shire Development LLC targeted the State
of Alabama. None of them have merit. First, Plaintiff claims that Shire Development LLC
established sufficient minimum contacts with the State “[w]hen [it] sought permission from the
FDA to manufacture, market and sell Lialda® in Alabama (and other states).” (Doc. # 82 at p.
8). But, simply seeking permission from the FDA or submitting an NDA does not rise to the
level of targeting Alabama or invoking the benefits and protections of its laws (especially when
none of these activities occurred within Alabama or were directed at Alabama). See Nicastro,
564 U.S. at 882. Second, Plaintiff argues that Shire Development LLC purposefully availed
itself to Alabama by crafting a defective label that it knew would be purchased by Alabama
residents and failing to enhance this allegedly defective label. (Doc. # 82 at p. 8). This argument
also misses the mark as “it is not enough that the defendant might have predicted that its goods
will reach the forum State.” Nicastro, 564 U.S. at 882. Finally, Plaintiff appears to present an
alter ego theory of liability, attributing the actions of the Shire entities that actually sold Lialda to
Shire Development LLC. (Docs. # 79 at p. 9 n.13; 82 at p. 8). However, Plaintiff has not
included any facts in his pleadings or any proposed added allegations in his briefing to support
such a theory. Because Plaintiff has not provided the court with any support for the proposition
that Shire Development LLC targeted the State or invoked the benefits and protections of its
laws, there is no basis for the court to reinstate Shire Development LLC as a defendant in this
action. See Nicastro, 564 U.S. at 882.
Defendants also argue that an amended complaint adding Shire Development LLC would
be futile because Plaintiff cannot state a claim against Shire Development LLC under the
AEMLD (the only remaining claim in this case). (Doc. # 81). The court finds it unnecessary to
explore this argument because, as discussed above, Shire Development LLC has had no
purposeful availment contacts with the State that support this court’s exercise of specific
jurisdiction over it in this product liability action. Because reinstating Shire Development LLC
would be futile, Plaintiff’s Motion to Reinstate (Doc. # 79) is due to be denied.
For the reasons stated above, both the Motion to Reinstate (Doc. # 79) and the Motion for
Reconsideration (Doc. # 91) are due to be denied.
A separate Order will be entered in
accordance with this Memorandum Opinion.
DONE and ORDERED this May 10, 2018.
R. DAVID PROCTOR
UNITED STATES DISTRICT JUDGE
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?