Paulsen v. Abbott Labs.
This text of 368 F. Supp. 3d 1152 (Paulsen v. Abbott Labs.) is published on Counsel Stack Legal Research, covering District Court, E.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
Robert M. Dow, Jr., United States District Judge
Plaintiff Terry Paulsen brings this action against Defendants Abbott Laboratories *1161("Abbott"), AbbVie Inc. ("AbbVie"), Takeda Pharmaceuticals U.S.A. Inc. ("TPUSA"), and TAP Pharmaceutical Products, Inc. ("TAP") (collectively "Defendants") alleging strict products liability, strict products liability-failure to warn, negligence, and negligent misrepresentation. She also asserts fraudulent misrepresentation against Abbott. Currently before the Court are motions by Abbott [144], AbbVie [150], and TPUSA/TAP [147] to dismiss the complaint with prejudice. For the reasons explained below, Defendants' motions [144; 147; 150] are granted in part and denied in part. The motion to dismiss TAP as a Defendant pursuant to Federal Rule of Civil Procedure 12(b)(5) is granted and TAP is dismissed from this action with prejudice. With regard to Defendants' motions under Rule 12(b)(6) : all Counts against TPUSA as successor in interest to TAP are dismissed with prejudice; all Counts but Count II against AbbVie are dismissed; and all claims but Counts II & V against Abbott are dismissed. The Court sets this matter for further status on April 8, 2019 at 10:00 a.m. to set a schedule for limited discovery regarding: (1) when Plaintiff's claim accrued; (2) whether the second amended complaint as to AbbVie properly relates back under Rule 15(c)(3); and (3) the roles of the remaining defendants vis-à-vis the manufacturing and development of Lupron. The parties should submit a joint status report and a proposed schedule for limited discovery no later than April 4, 2019. Finally, as an administrative matter, the motion for Rule 11 Sanctions by AbbVie, Abbott, and TPUSA [153] is stricken without prejudice in light of the notice of withdrawal filed on October 30, 2018 [180].
I. Background1
The full background of this case is set forth in the Court's previous opinion, knowledge of which is assumed here. See [111 ( Paulsen v. Abbott Labs. ,
Plaintiff's quest to hold Defendants accountable for the harms allegedly caused by the Lupron that they purportedly designed, manufactured, packaged, marketed, etc. has spawned a veritable odyssey of litigation spanning almost a decade. Although the full saga is more fully laid out in the Court's previous opinion, see [ Paulsen ,
After unsuccessfully attempting to reopen the previous case through newly-acquired counsel in April 2015, Plaintiff filed a new complaint against Abbott, TPNA, Takeda Inc., and TAP in the current action in May 2015. [ Id. ] The complaint [1] asserted seven causes of action against all the defendants including various product liability, negligence, warranty, and misrepresentation claims. See generally [1]. The defendants moved to dismiss the action in July 2015. [ Paulsen ,
After limited discovery, Judge Gottschall determined on a motion for summary judgment that there was a "genuine issue of material fact as to whether Abbott's role in the distribution chain was sufficient to create liability." [
The Court granted the motions in part and denied them in part. [ Id. at *1.] As to the Defendants' motions under Rule 12(b)(6), the Court dismissed all the claims against Takeda Inc. and Takeda Chemical Industries, Ltd. with prejudice, dismissed all the claims against TPNA without prejudice, and dismissed all but the strict liability claims against Abbott without prejudice. [ Id. ] The Court also granted Defendants' motion to dismiss TAP as a defendant pursuant to Rule 12(b)(5)"to the extent that Plaintiff is given until May 22, 2018 to serve an amended complaint upon a proper defendant (whether that is TAP or a proper successor to TAP)." [ Id. ] However, the Court granted Plaintiff leave to file an amended complaint, provided she could do so consistent with the opinion. [ Id. ]
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Robert M. Dow, Jr., United States District Judge
Plaintiff Terry Paulsen brings this action against Defendants Abbott Laboratories *1161("Abbott"), AbbVie Inc. ("AbbVie"), Takeda Pharmaceuticals U.S.A. Inc. ("TPUSA"), and TAP Pharmaceutical Products, Inc. ("TAP") (collectively "Defendants") alleging strict products liability, strict products liability-failure to warn, negligence, and negligent misrepresentation. She also asserts fraudulent misrepresentation against Abbott. Currently before the Court are motions by Abbott [144], AbbVie [150], and TPUSA/TAP [147] to dismiss the complaint with prejudice. For the reasons explained below, Defendants' motions [144; 147; 150] are granted in part and denied in part. The motion to dismiss TAP as a Defendant pursuant to Federal Rule of Civil Procedure 12(b)(5) is granted and TAP is dismissed from this action with prejudice. With regard to Defendants' motions under Rule 12(b)(6) : all Counts against TPUSA as successor in interest to TAP are dismissed with prejudice; all Counts but Count II against AbbVie are dismissed; and all claims but Counts II & V against Abbott are dismissed. The Court sets this matter for further status on April 8, 2019 at 10:00 a.m. to set a schedule for limited discovery regarding: (1) when Plaintiff's claim accrued; (2) whether the second amended complaint as to AbbVie properly relates back under Rule 15(c)(3); and (3) the roles of the remaining defendants vis-à-vis the manufacturing and development of Lupron. The parties should submit a joint status report and a proposed schedule for limited discovery no later than April 4, 2019. Finally, as an administrative matter, the motion for Rule 11 Sanctions by AbbVie, Abbott, and TPUSA [153] is stricken without prejudice in light of the notice of withdrawal filed on October 30, 2018 [180].
I. Background1
The full background of this case is set forth in the Court's previous opinion, knowledge of which is assumed here. See [111 ( Paulsen v. Abbott Labs. ,
Plaintiff's quest to hold Defendants accountable for the harms allegedly caused by the Lupron that they purportedly designed, manufactured, packaged, marketed, etc. has spawned a veritable odyssey of litigation spanning almost a decade. Although the full saga is more fully laid out in the Court's previous opinion, see [ Paulsen ,
After unsuccessfully attempting to reopen the previous case through newly-acquired counsel in April 2015, Plaintiff filed a new complaint against Abbott, TPNA, Takeda Inc., and TAP in the current action in May 2015. [ Id. ] The complaint [1] asserted seven causes of action against all the defendants including various product liability, negligence, warranty, and misrepresentation claims. See generally [1]. The defendants moved to dismiss the action in July 2015. [ Paulsen ,
After limited discovery, Judge Gottschall determined on a motion for summary judgment that there was a "genuine issue of material fact as to whether Abbott's role in the distribution chain was sufficient to create liability." [
The Court granted the motions in part and denied them in part. [ Id. at *1.] As to the Defendants' motions under Rule 12(b)(6), the Court dismissed all the claims against Takeda Inc. and Takeda Chemical Industries, Ltd. with prejudice, dismissed all the claims against TPNA without prejudice, and dismissed all but the strict liability claims against Abbott without prejudice. [ Id. ] The Court also granted Defendants' motion to dismiss TAP as a defendant pursuant to Rule 12(b)(5)"to the extent that Plaintiff is given until May 22, 2018 to serve an amended complaint upon a proper defendant (whether that is TAP or a proper successor to TAP)." [ Id. ] However, the Court granted Plaintiff leave to file an amended complaint, provided she could do so consistent with the opinion. [ Id. ]
On July 6, 2018, Plaintiff filed her second amended complaint (the "SAC"), after filing a short-lived first amended complaint in April 2018. [143.] The SAC brings four causes of action against all Defendants-strict products liability (Counts I & II), negligence (Count III), and negligent misrepresentation (Count V)-and one cause of action against Abbott alone-fraudulent misrepresentation (Count IV). Defendants have filed three motions to dismiss in response. See generally [144; 147; 150]. First, TAP moves to dismiss the claims against it with prejudice pursuant to Rule 12(b)(5). [147.] The remaining Defendants move to dismiss the claims against them under Rule 12(b)(6). TPUSA asserts that Plaintiff has failed to state a claim against it, because the facts as pled show that *1163TPUSA cannot be held liable as a successor in interest to TAP as Plaintiff claims. [147, at 3-5.] AbbVie, in turn, argues that all the claims against it are barred by the statute of limitations, and that in any case, Plaintiff has failed to state any plausible claims against it under Rule 8. See generally [150]. Finally, Abbott argues that the complaint fails to state a plausible claim against it under Rule 8 on Counts I-III and V and fails to plead fraudulent misrepresentation in Count IV with the specificity required by Rule 9(b). See generally [144]. Defendants also filed a motion for Rule 11 sanctions [153], which later was withdrawn, see [180].
II. Rule 12(b)(5) Motion to Dismiss
A. Legal Standard
Once a plaintiff files a lawsuit in federal court, the plaintiff must ensure that each defendant receives a summons and a copy of the complaint against it. Fed. R. Civ. P. 4(b), (c)(1). Unless the plaintiff can demonstrate good cause for being unable to do so, she must accomplish this service of process within 90 days of filing to avoid possible dismissal of the suit. Fed. R. Civ. P. 4(m). These service requirements serve several purposes: they "provide notice to parties, encourage parties and their counsel to diligently pursue their cases, and trigger a district court's ability to exercise jurisdiction over a defendant." Cardenas v. City of Chi. ,
"A defendant may enforce the service of process requirements through a pretrial motion to dismiss," at which point the plaintiff "bears the burden to demonstrate that the district court has jurisdiction over each defendant through effective service." Cardenas ,
B. Analysis
1. Defendant TAP
In its previous opinion, the Court granted "Defendants' previous motion to dismiss TAP as a Defendant pursuant to Rule 12(b)(5) * * * to the extent that Plaintiff shall have until May 22, 2018 to serve an amended complaint upon a proper defendant (whether that is TAP, TPNA, Abbott, AbbVie, or some other entity)." [111, at 17.] The Court further warned, that if "Plaintiff fails to serve a proper defendant by this date, TAP will be dismissed from the case." [Id. at 17-18.]
In her SAC, Plaintiff states that "all services of processes will be made to all of *1164[TAP's] successor in interest defendants who have been named in this complaint and not to TAP." [143, ¶ 3.] Plaintiff seems to have interpreted the Court's statement above to mean that because Abbott, AbbVie, and TPUSA are successors in interest to TAP, [143, at 1, ¶¶ 2-3], service of those entities suffices to effectuate service on TAP. That is not a correct reading. The Court simply intended to give Plaintiff time to effectuate service on whatever entity currently holds TAP's Lupron liabilities. See [111 at 17 ("Of course it is unclear whether TAP should be served at all. Plaintiff has variously argued that TPNA and Abbott-both properly-served Defendants-currently hold TAP's Lupron liabilities, and Abbott argues that AbbVie holds these liabilities and would thus be the proper party to sue.").]4
As to TAP itself, as the Court previously explained, "Plaintiff cannot effectively serve one corporation by serving a completely different corporation." [111, at 14 (citing Hurtado v. 7-Eleven, Inc. ,
III. Rule 12(b)(6) Motion to Dismiss
To survive a Rule 12(b)(6) motion to dismiss for failure to state a claim upon which relief can be granted, the complaint first must comply with Rule 8(a) by providing "a short and plain statement of the claim showing that the pleader is entitled to relief," Fed. R. Civ. P. 8(a)(2), such that the defendant is given "fair notice of what the * * * claim is and the grounds upon which it rests." Bell Atl. Corp. v. Twombly ,
*1165B. Analysis5
The remaining Defendants-TPUSA, Abbott, and AbbVie-again move to dismiss the SAC in its entirety for failure to plausibly state a claim against each of them under the relevant pleading standards. As it did previously, the Court will address separately the sufficiency of the complaint as to each of these remaining defendants.
1. Defendant TPUSA
In the SAC, Plaintiff again alleges that TPUSA is a wholly-owned subsidiary of Takeda Chemical Industries, Ltd. ("Takeda Ltd.") and now asserts that TPUSA is liable as a successor in interest to TAP. [143, ¶ 4.] She further alleges that when TAP dissolved in 2008, Abbott acquired all the assets, employees, and liabilities related to Lupron.6 [Id. ¶ 7.] In fact, "Abbott exchanged its 50 percent equity interest in TAP for the assets, liabilities and employees related to TAP's Lupron business." [148-2, at 3.]7 Shortly thereafter, in July 2008, TAP's remaining assets were merged into TPUSA after which TAP dissolved as a corporation. [Id. ¶ 8.] In light of these transfers, TPUSA argues that it cannot be the successor in interest to Plaintiff's claims against TAP because Abbott, and now AbbVie, received all of TAP's assets, employees, and liabilities related to Lupron. The Court agrees with TPUSA.
Plaintiff argues that TPUSA may be held liable as a successor in interest pursuant to Perimeter Realty v. GAPI, Inc. ,
2. Defendant AbbVie
AbbVie moves to dismiss every cause of action in Plaintiff's complaint on two grounds: first, on the basis that the complaint is untimely and filed outside the applicable statute of limitations; and second, for failure to state a claim. In support of the latter argument, AbbVie incorporates by reference Section II of Abbott's memorandum of law in support of its motion to dismiss [145] and Sections II & III of TPUSA and TAP's memorandum of law in support of those defendants' motion to dismiss [148].
a. Statute of Limitations8
AbbVie asserts that Plaintiff's allegations in the SAC establish that the claim against it falls outside the statute of limitations. Plaintiff retorts that because it timely filed against TAP,9 and only seeks to proceed against AbbVie as the successor in interest to TAP, its claims are not untimely. The parties' briefing raises two questions: first, does filing a timely suit against a defendant's predecessor in interest toll the statute of limitations such that the otherwise untimely later substitution or addition of the successor in interest should be treated as timely? And, if not, should the Court treat the current complaint as relating back under Rule 15(c)?
Although not cited by the parties,10 the decision in Affleck v. Hannah Marine Corp. ,
In the two years since this case was originally filed (as Case No.83 C 9028 ), the parties and the court have spent most of their efforts trying to unearth the proper defendants. Affleck originally brought this suit against Cities Services Corporation (Cities Services) and Hannah Marine Corporation (Hannah Marine). In his First Amended Complaint, plaintiff added Socony Vacuum Oil Co. (Socony) as a defendant. In the Second Amended Complaint, plaintiff substituted Gulf Oil Corporation (Gulf) for Socony on the basis that Gulf was the successor in interest to Socony. * * * It later became clear that Gulf was not a successor in interest to Socony, and therefore, the court granted Gulf's summary judgment motion and dismissed it from the case. The Third Amended Complaint named Mobil Oil Corporation (Mobil), the true successor in interest to Socony, as a defendant. * * * the court [subsequently] dismissed plaintiff's claim against Mobil for lack of subject matter jurisdiction. * * * Plaintiff then filed a negligence case against Mobil in state court, (Affleck v. Mobil Oil Corp. ,85 L 16706 ). On Mobil's petition the case was removed, and Mobil moves to dismiss plaintiff's complaint for a number of reasons [, including the statute of limitations].
Although Affleck is not controlling, this Court finds it persuasive and is inclined to follow its rationale. Consequently, the Court must determine whether the current complaint relates back to Plaintiff's first complaint in Cardenas & Paulsen v. Abbott Labs. et al. , No. 10-cv-1745, ECF No. 1 (E.D.N.Y. April 20, 2010). AbbVie asserts that Plaintiff waived this argument by failing to respond to AbbVie's Rule 15(c) arguments. [179, at 3.] However, the Court concludes that the most logical way to read Plaintiff's argument is that as TAP's successor in interest, claims against AbbVie clearly relate back to the original complaint under Rule 15(c). Plaintiff's assertion that proceeding in this manner would be inappropriate because it "treats the Second Amended Complaint as if it is an independent direct claim against AbbVie, not a claim as a successor in interest" is simply unpersuasive. [163, at 6.] First, Plaintiff has again failed to provide any support whatsoever for this argument, and the argument seems directly contrary to Affleck above. But lack of precedent aside, as the Court has already explained, the mere fact that a corporation is sued as a successor in interest does not waive all the normal procedural and substantive requirements of federal litigation. Consequently, the Court will follow Affleck 's example and determine whether Plaintiff's complaint relates back under Rule 15(c).
Rule 15(c)(1) provides that "an amendment to a pleading relates back to the date of the original pleading when the amendment changes the party or the naming of the party against whom a claim is asserted, if Rule 15(c)(1)(B) is satisfied and if, within 120 days as provided by Rule 4(m), *1168the party to be brought in by amendment (1) received notice of the action so that it will not be prejudiced in defending on the merits and (2) knew or should have known the action would have been brought against it, but for a mistake concerning the party's identity." Fed. R. Civ. P. 15(c)(1)(C).11 AbbVie first argues that Plaintiff did not make a mistake in failing to name AbbVie until now, and that as a result the Court should not allow the complaint to relate back. The fact that Plaintiff now claims that Abbott, TPUSA, and AbbVie are each liable as the successor in interest to TAP's liabilities, according to AbbVie, demonstrates that Plaintiff simply does not know which of the three companies she wants to hold liable for alleged injuries, not that she made a "mistake" as contemplated by Rule 15(c)(1)(C).
However, the line of cases cited by AbbVie predates the Supreme Court's decision in Krupski v. Costa Crociere S.p.A. ,
In Krupski , the plaintiff pursued her suit against Costa Cruise Lines N.V.-the North American sales and marketing agent of an Italian cruise ship operator, Costa Crociere S.p.A.-despite multiple filings by Costa Cruise stating that that it was not the proper party in interest. Finally, at summary judgment, the facts presented conclusively demonstrated that Krupski had not sued the right defendant and that the proper defendant was Costa Crociere.
At bottom, the Supreme Court explained, Rule 15(c)(1)(C) is intended to prevent a "windfall for a prospective defendant who understood, or should have understood that he escaped suit during the limitations period only because the plaintiff misunderstood a crucial fact about his identity." Krupski ,
*1169Rather, "information in the plaintiff's possession is relevant only if it bears on the defendant's understanding of whether the plaintiff made a mistake regarding the proper party's identity."
Krupski explicitly rejected the notion that "any time a plaintiff is aware of the existence of two parties and chooses to sue the wrong one, the proper defendant could reasonably believe that the plaintiff made no mistake."
[A] plaintiff might know that the prospective defendant exists but nonetheless harbor a misunderstanding about his status or role in the events giving rise to the claim at issue, and she may mistakenly choose to sue a different defendant based on that misimpression. That kind of deliberate but mistaken choice does not foreclose a finding that Rule 15(c)(1)(C)(ii) has been satisfied.
This reading is consistent with the purpose of relation back: to balance the interests of the defendant protected by the statute of limitations with the preference expressed in the Federal Rules of Civil Procedure in general, and Rule 15 in particular, for resolving disputes on their merits. [ ]
Following Krupski , the Seventh Circuit has instructed that,
[t]he only two inquiries that the district court is now permitted to make in deciding whether an amended complaint relates back to the date of the original one are, first, whether the defendant who is sought to be added by the amendment knew or should have known that the plaintiff, had it not been for a mistake, would have sued him instead or in addition to suing the named defendant; and second, whether, even if so, the delay in the plaintiff's discovering his mistake impaired the new defendant's ability to defend himself.
Joseph v. Elan Motorsports Techs. Racing Corp. ,
As AbbVie correctly notes, some courts have refused to allow a complaint to relate back where a plaintiff makes a deliberate choice not to discover the identity of the new defendant, appearing to conflate "deliberate choice" with "lack of diligence." See White ,
Apparently aware of that admonition, AbbVie argues that there is simply no way-eight years since the original lawsuit was filed, and more than five years since AbbVie assumed Lupron's liabilities-that AbbVie knew or should have known that, absent some mistake, this action would have been brought against it. [151, at 13.] It is true that the other defendants in this case have argued in previous motions that Plaintiff should be pursuing AbbVie rather than them. See, e.g., [26, at 4 ("The pharmaceutical products business, including Lupron, went to AbbVie Inc. * * * Today, as Abbott's counsel has already explained to plaintiff's counsel, Abbott has no relationship to Lupron whatsoever.") ]. However, the same was true in Krupski . See
In light of this precedent and AbbVie's arguments, the Court concludes that the correct course of action in this case is to defer the question of whether the SAC properly relates back and to permit AbbVie to raise the question in a motion for summary judgment. This course will permit the parties to develop the factual record regarding any prejudice that AbbVie may have incurred as a result of the delay in being added as a defendant in this case and its assertion that the entire case was untimely when Plaintiff first filed her suit in 2010.
b. Failure to Plead Each Defendant's Actions Independently
Incorporating the argument by reference, AbbVie next asserts that Plaintiff has failed to state a claim because she has not pled facts to show exactly what each defendant did to harm her. Instead, *1171AbbVie explains, the SAC lumps Defendants together and alleges that "All Defendants" were involved in some undefined way in each of the tortious actions alleged in the SAC, except for her fraudulent misrepresentation claim that she asserts against Abbott alone.
Both Seventh Circuit and Georgia law require that a plaintiff structure her complaint such that each individual defendant knows what it did that allegedly harmed the plaintiff. See, e.g., Bank of Am., N.A. v. Knight ,
Here, Plaintiff's complaint largely mirrors the one dismissed in Brazil I . She alleges that,
At all times herein mentioned, the Defendant[s] Abbott and TAP, jointly, severally, acting in concert, with or through others, their partners, agents, servants and/or employees, the companies they own, control, or for whose actions they are responsible, manufactured, compounded, tested, distributed, recommended, marketed, labeled and packaged, merchandized, advertised, promoted, sold, purchased, prescribed, and administered the Lupron and the Plaintiff used, took, or injected with.
[143, at ¶ 25.] Georgia courts faced with "lump" allegations generally dismiss the allegations without prejudice and/or order repleading. See, e.g., F.D.I.C. v. Briscoe ,
c. Count I (Strict Liability - Design Defect)
Because Plaintiff has sued AbbVie as the successor interest to TAP, if Plaintiff has stated a claim against TAP, she has stated a claim against AbbVie. The Court therefore analyzes whether Plaintiff has stated a claim against TAP in the SAC.
*1172To state a claim for strict products liability under Georgia law, a plaintiff must allege that "(1) the defendant manufactured the allegedly defective product; (2) the allegedly defective product was not merchantable and reasonably suited for its intended use when the defendant sold it; and (3) the allegedly defective product proximately caused the plaintiff's injuries." Edwards v. Wis. Pharmacal Co., LLC ,
The Court's previous decision recognized that there is some doubt as to whether Abbott, TAP, or Takeda Ltd. manufactured the Lupron at issue in this case.
The Court concludes that it is only appropriate on this motion to dismiss to consider the allegations that are set out in Plaintiff's complaint in analyzing whether Plaintiff has adequately stated a claim for each cause of action. Judge Gottschall assumed in her opinion that the parties agreed that Takeda Ltd. was the manufacturer, but Judge Gottschall did not specifically rule on summary judgment that Takeda Ltd. (and only Takeda Ltd.) was the manufacturer of Lupron.
See Paulsen ,
Georgia courts have repeatedly explained that alleging that a group of defendants engaged in a laundry list of actions is not sufficient to state a claim that a particular defendant "is a manufacturer, distributor, supplier, or seller of the product at issue." See, e.g., Brazil I ,
Under Georgia law, "[t]there are three general categories of product defects: manufacturing defects, design defects, and marketing/packaging defects." Banks v. ICI Americas, Inc. ,
Before examining whether Plaintiff has adequately pled a design defect claim, the Court must consider Defendants' argument that conflict preemption bars design defect claims such as Plaintiff's. First, the Court agrees that any claims by Plaintiff that TAP should have changed the formulation of Lupron is preempted by FDA regulations that prohibit a change in the formulation of a drug once it has been approved. See Brazil v. Janssen Research & Dev. LLC ,
The question of whether the Supreme Court's decision in Mutual Pharmaceutical Co., Inc. v. Bartlett ,
However, Brazil I also noted that a plaintiff must plead facts that establish there is in fact a design defect.
*1174Id. at 1337-38. In Brazil I , the plaintiff failed to allege such a defect given that she merely alleged that the drug could cause diabetic ketoacidosis, without providing any facts that tied that harm to a design or manufacturing defect. Id. at 1338. Referencing Bailey v. Janssen Pharmaceutica, Inc. , 288 Fed. App'x. 597, 607 (11th Cir. 2008), as persuasive authority, the court explained that the plaintiff should have provided at least some possible mechanisms for how the drug caused her injury. Id. at 1338 n.5.
Here, Plaintiff has simply alleged that "as a direct and proximate result of the defective and unsafe condition of Lupron, Plaintiff * * * [suffered] negative effects on bone mineral density, osteoporosis, and/or osteopenia." [143, ¶ 31.] As explained by Brazil I , simply alleging the harm that resulted from the use of drug is not sufficient to establish a design or manufacturing defect under Georgia law. The Court must therefore dismiss this claim against TAP and AbbVie as the alleged successor in interest to TAP.
d. Count II (Strict Liability - Failure to Warn)15
With regard to Count II, AbbVie again argues that the claim must be dismissed because Plaintiff has failed to allege which of the Defendants, specifically, was responsible for the manufacturing, designing, etc. of the Lupron in question. However, as noted above, Plaintiff's complaint specifically alleges that "TAP's purpose, pursuant to the joint venture agreement, was to develop , manufacture, market and sell human pharmaceutical products * * * including Lupron * * *." [143, ¶ 6.] Consequently, the Court looks to see if Plaintiff has sufficiently alleged facts to state a failure to warn claim against TAP.
Even if a product is not defective, a manufacturer of a product may still be liable under a strict liability failure to warn theory. Brazil II ,
Here, Plaintiff alleges on information and belief that as early as October 22, 1990, TAP and Abbott were aware of the continued bone loss incurred by users of Lupron. [143, ¶ 15.] Plaintiff also points to an April 1998 report that TAP submitted to the FDA in which researchers disclosed that more than a third of the women in their study who had taken Lupron"did not 'demonstrate either partial reversibility' or 'a trend toward return' of bone mass in the six months after they stopped taking the drug." [Id. ¶ 14.] Finally, Plaintiff points to the fact that in 2001 the FDA approved a "Lupron 'add-back therapy,' designed to counteract the harmful bone-depleting effects of Lupron." [Id. ¶ 15]. Although, as in Brazil II , the question is close, the Court concludes that these facts are sufficient to show that TAP/Abbott knew that there was a substantial risk of bone depletion with Lupron.
With regard to the latter two elements, Plaintiff has alleged that "the warnings and information which were given to the medical community and women consumers did not accurately reflect the severity and permanence of symptoms, duration, scope, or severity of the potential side effects, health concerns, and risks of Lupron." [143, ¶ 35.] "Had adequate warnings or instructions regarding permanent bone loss side effects been provided, Plaintiff would not have used, taken, or received administration of Lupron, and would not have suffered the harmful side effects, other injuries and damages described herein." [Id. ¶ 38.] Plaintiff further alleges that an "Abbott detail person, who visited [Plaintiff's physician's] office, characterized Lupron as appropriate, safe and effective for patients with her medical condition [ (endometriosis ) ]." [Id. ¶ 21.] According to Plaintiff, "neither she nor her physician were made aware, by Abbott or TAP, of the serious threat to her bone health posed by the use of Lupron for her endometriosis."16 [Id. ] Plaintiff concludes that she would have never taken Lupron if she had been apprised of the risks involved. [Id. ¶ 38.] The allegations suffice to plead a failure to warn claim. Compare [143, ¶¶ 21, 35, 38, 39] with Brazil II ,
*1176e. Count III (Negligence)
AbbVie next argues that Plaintiff's complaint is too vague and conclusory to plead any of the elements of a negligence claim under governing law. In Georgia, to state a claim for negligence, a Plaintiff must allege: (1) "a legal duty to conform to a standard of conduct raised by the law for the protection of others against unreasonable risks of harm;" (2) "a breach of this standard;" (3) "a legally attributable causal connection between the conduct and the resulting injury;" and (4) "some loss or damage flowing to the plaintiff's legally protected interest as a result of the alleged breach of the legal duty." Moore v. Mylan Inc. ,
Plaintiff's allegations are once again insufficient to state a claim for negligence. Plaintiff again lists various acts that purportedly constitute negligence by TAP and Abbott, including negligently (1) "formulating, analyzing, designing, fabricating manufacturing, supplying, distributing, advertising, promoting, packaging, marketing, selling and recommending Lupron in its defective condition, Defendant Abbott and TAP knew or should have known;" (2) "failing to identify, eliminate, and/or reduce the risks and hazards associated with the intended and foreseeable use of the Lupron ;" and (3) "failing to advise Plaintiff and her physician the dangers associated with the use of Lupron." [143, ¶¶ 45(a)-(c).] While Plaintiff has now alleged various specific duties that those negligent acts allegedly breached, see [id. ¶¶ 42-43], as the Court noted in its analysis of Count I above, Plaintiff has still not pled any facts to show how exactly Abbott or TAP were negligent as it pertains to any manufacturing or design errors.
By contrast, the specific risks allegedly posed by Lupron laid out in the SAC, see [id. ¶¶ 44(a)-(c) ], do support the conclusion that Abbott/TAP had a duty to warn Plaintiff's physician of those risks.17 However, Plaintiff's allegation that Abbott/TAP failed to advise her physician of *1177the dangers associated with the use of Lupron is simply too conclusory to state a claim.18 Cf. Henderson ,
Plaintiff has not provided any factual detail about what the warning label did or not did not state, and the Court simply cannot infer negligence where a plaintiff has not provided any factual details about either a defendant's action(s)-i.e. what they or their agents said or failed to say- and how those actions influenced Plaintiff's physician's decision to inject her with Lupron. The Court will therefore grant the motion to dismiss as to Count III.
f. Count V (Negligent Misrepresentation)
Finally, AbbVie argues that Plaintiff has still failed to state a claim for negligent misrepresentation against TAP, and therefore it. To state a claim for negligent misrepresentation, Plaintiff must show " '(1) the defendant's negligent supply of false information to foreseeable persons, known or unknown; (2) such persons' reasonable reliance upon that false information; and (3) economic injury proximately resulting from such reliance.' " Marquis Towers, Inc. v. Highland Grp. ,
The Court previously dismissed this claim because Plaintiff had not identified any specific misrepresentations by Abbott or TAP on which Plaintiff relied. See Paulsen ,
[A] few days before her injection with Lupron, an Abbott drug detail person personally contact Plaintiff's physician, *1178Dr. Perry[,] at his office * * * and expressly represented the safety and effectiveness of Lupron [,] that [it] would effectively treat Plaintiff's reproductive tract ailment, [and] that there is [sic] no long term adverse effect.
[143, ¶ 50.] As AbbVie correctly points out, however, this allegation was not included in her negligent misrepresentation count, except by a reference to all the other allegations in her complaint. That is a dangerous way to proceed, for it is neither this Court's, nor the Defendants', duty to "piece together allegations and construct a claim it suspects a plaintiff might have intended to bring." Intellicig USA LLC v. CN Creative Ltd. ,
First, multiple district courts, applying Georgia law, have held that "Georgia does not recognize a claim for misrepresentation apart from a failure to warn claim in products liability cases." In re Bard IVC Filters Prod. Liab. Litig. ,
Instead, the Court will dismiss the claim against AbbVie because Plaintiff has still not identified any specific misrepresentations by TAP on which Plaintiff's physician relied.19 Plaintiff again generally alleges that her physicians "detrimentally relied on Defendants' misrepresentations in treating Plaintiff with Lupron," but only identifies one specific misrepresentation. And, that single misrepresentation was purportedly made by an agent of Abbott, not TAP. Although Plaintiff need not plead these claims with specificity, she must still meet the plausibility standard of Rule 8. Paulsen ,
3. Defendant Abbott
Abbott moves to dismiss every cause of action in Plaintiff's complaint on two grounds: first, that it cannot be held liable *1179as the successor in interest to AbbVie; and second, for failure to state a claim.
a. Liability as Successor in Interest and Failure to Plead Each Defendant's Actions Independently
First, Abbott moves to dismiss all the claims against it to the extent Plaintiff asserts that Abbott is liable as the successor in interest to TAP. As explained above, based on Plaintiff's amended complaint, the Court can only conclude that AbbVie is the proper successor in interest to TAP. Thus, Plaintiff may not state a claim against Abbott as the successor in interest to TAP.
Additionally, like AbbVie, Abbott moves to dismiss all the claims against it because Plaintiff has not sufficiently pled what each defendant allegedly did to harm her. But Plaintiff named both Abbott and TAP in nearly every one of her allegations of wrongdoing. Moreover, as explained above, even if the Court were inclined to dismiss the claims against Abbott on that ground, it would be with leave to replead. Rather than simply have Plaintiff duplicate each paragraph as to each defendant, the Court will look to see if Plaintiff has adequately pled facts that state a claim against Abbott.
b. Counts I & III (Strict Liability - Design Defect & Negligence)
Counts I and III fail against Abbott for the same reasons they failed against TAP (AbbVie). In Count I, Plaintiff has simply not alleged any facts to show a design defect. Likewise, in Count III, Plaintiff has not provided any more factual basis for the Court to conclude that Abbott acted negligently than she did with regard to TAP.20 Consequently, both Counts I & III are dismissed as to Abbott as well.
c. Count II (Strict Liability - Failure to Warn)
Although the Court has concluded that Plaintiff may proceed on Count II against AbbVie, whether she may proceed against Abbott is a much more difficult question. The question is whether Plaintiff has properly alleged facts such that the Court may treat Abbott as the manufacturer of Lupron. Unlike TAP-whose purpose under the joint venture agreement between Takeda Ltd. and Abbott was allegedly to develop, manufacture, market and sell products, including Lupron, [143, ¶ 6]-Plaintiff merely alleges that Abbott and TAP, "jointly, severally, acting in concert * * * manufactured, compounded, tested, distributed, recommended, marketed, labeled and packaged, merchandised, *1180advertised, promoted, [and ] sold" the Lupron she was injected with, [id. ¶ 25]. The question is whether the Court must, or may, take notice of additional information put forward by the parties in the previous motion for summary judgment, and in support and defense of the now withdrawn motion for sanctions.
First, Judge Gottschall concluded on a motion for summary judgment that there was a genuine issue of material fact whether Abbott was a proper party at interest in this lawsuit. See [95, at 12 ("the court finds that genuine issues of material fact exist as to whether Abbott's involvement Abbott's involvement in Lupron's distribution was sufficient" for a finding of liability) ]. However, that ruling assumed Illinois strict liability law applied, and as this Court subsequently determined, Georgia law applies to the substantive claims in this case. Paulsen ,
The more difficult question is whether the Court should, or even may, take judicial notice of all the documents that Plaintiff submitted in response to Defendants' motion for sanctions. Unlike a motion for sanctions in which a court may consider materials outside the pleadings, see Triad Assocs., Inc. v. Chicago Hous. Auth. ,
Additionally, none of the cases cited by Defendants stand for the proposition that where a plaintiff has explicitly named a Defendant and alleged that they had some role in a laundry list of actions without providing any more specific details, the Court should dismiss the case as a matter of law. For example, Quashie v. Olympus Am., Inc. the court explained that
Although Plaintiff insisted at the hearing that all Defendants here are somehow involved in the manufacturing, production, and sale of the Q180V, the Amended Complaint contains no specific facts to support this assertion.[ ] This general pleading prevents the Defendants from knowing which one or which ones Plaintiff alleges to have manufactured a defective product.
In sum, for the reasons explained above, the Court declines to dismiss Count II against Abbott at this time.
d. Count V (Negligent Misrepresentation)
Unlike AbbVie, as to which Plaintiff has not provided any specific representations, Plaintiff alleges that an Abbott drug detail person contacted her physician at his office in Athens Georgia and "expressly represented the safety and effectiveness of Lupron [,] that [it] would effectively treat Plaintiff's reproductive tract ailment, [and] that there [would be] no long term adverse effect." [143, ¶ 50.]21 Abbott asserts that even with this allegation, Plaintiff's complaint still fails to state a claim.22
As the Court has previously explained, all of Plaintiff's claims are constrained by the learned intermediary doctrine. See, e.g., *1182Catlett v. Wyeth, Inc.,
Abbott asserts that the claim fails because Plaintiff has pled no facts to show that her prescribing physician would have made a different decision if he had received different information. [177, at 13.] Abbott has not, however, provided any case law to support that proposition. Thus, the Court must simply look to the allegations on their own merits.
First, although the question is an extremely close one, the Court concludes that the Abbott agent's alleged representation that Lupron had no long-term adverse effects when as discussed above, Defendants knew or should have known of a significant risk of long-term, permanent bone depletion constitutes the negligent supply of false information. Plaintiff has also alleged that Plaintiff's physicians relied on that representation, among others, when deciding to treat Plaintiff with Lupron. [143, ¶ 61.] And, finally Plaintiff has certainly alleged that she suffered an economic injury. In light of these allegations, the Court concludes that Plaintiff has alleged sufficient facts to survive a motion to dismiss.
e. Count IV (Fraudulent Misrepresentation)
Abbott asserts that Plaintiff's allegations to support her claim of fraudulent misrepresentation sill do not meet the heightened pleading standards of Rule 9 to state a claim. Specifically, Abbott asserts, among other things, that Plaintiff has failed to adequately plead scienter.
To state a claim for fraud under Georgia law, Plaintiff must allege "(1) a false representation by the defendant; (2) scienter; (3) intention to induce the plaintiff to act or refrain from acting; (4) justifiable reliance by the plaintiff[;] and (5) damage to the plaintiff." Barnes ,
Under Georgia law, an allegation that defendants knew or should have known that their statements were false asserts constructive knowledge, not the scienter required for fraud.
*1183WESI, LLC v. Compass Envtl., Inc. ,
As in WESI, LLC , Plaintiff's allegations are insufficient to state a claim for fraudulent misrepresentation. Plaintiff first alleges that Abbott "knew or should have known * * * the specific representation to Plaintiff's physician * * * was false." [143, ¶ 51.] She then alleges that Abbott knew or should have known "that serious long-term health problems are associated with Lupron." [Id. ¶ 51.] In fact, nowhere in her entire complaint does Plaintiff ever specifically allege that Abbott or any other defendant knew of the harmful side effects of Lupron that could possibly affect women and did affect Plaintiff. Rather, at every point in the SAC, Plaintiff has alleged that the Defendants knew or should have known of these dangers. These are exactly the kind of allegations that Hertz Corp. , WESI, LLC , and other courts have specifically found insufficient to state a claim for fraud under Georgia law. Hertz Corp. ,
4. Fraud on the FDA Allegations
In paragraphs 20 and 54 of her complaint, Plaintiff alleges that TAP/Abbott made affirmative and/or negligent misrepresentations to the FDA regarding Lupron. [143, ¶¶ 20, 54.] Any claims based on those allegations are preempted by the Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Committee , which held that "plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law."
5. Leave to Amend
Finally, Defendants request that any and all dismissals be with prejudice. In deciding whether to dismiss with prejudice (and foreclose any attempts to amend the complaint) this Court is mindful that the Court should "freely give leave [to amend] when justice so requires." Fed. R. Civ. P. 15(a)(3). However, leave is not to be automatically granted. Johnson v. Cypress Hill,
Here, Plaintiff has now had three attempts to plead in this case, multiple opportunities in the previous case, and the opportunity to conduct at least some discovery *1184in the prosecution of the previous motion to dismiss. The Court has now twice concluded that she has alleged sufficient facts to proceed on at least some of her claims. At this point, the Court is convinced that any further repleading as to TPUSA would be futile, given that Plaintiff's allegations clearly show AbbVie to be TAP's only possible successor in interest.
With regard to Abbott and AbbVie, after three complaints the Court is convinced that another complaint and a further round of motions to dismiss would be a waste of judicial resources. The events at issue in this case occurred in 2004, were discovered in 2008, were first subject to suit in 2010, reasserted in a refiled suit in 2015, addressed in motion for summary judgment in 2017, a motion to dismiss in 2018, and now, finally, a second motion to dismiss in 2019. It is time to move this case forward. Consequently, the Court will not consider any motion for leave to file an amended complaint until the parties resolve the issues flagged by Defendants in this latest round of briefing that go to the heart of this action's viability, namely: (1) whether the entire suit is untimely; (2) whether the complaint as to AbbVie may relate back; and (3) the actual roles played by Abbott and TAP vis-à-vis the manufacturing, packaging, and distribution of Lupron. However, at the end of that discovery and the resolution of any motions for summary judgement, should Plaintiff discover facts that lead her to conclude that she should amend her complaint, she may file a motion seeking leave to file an amended complaint.
IV. Conclusion
For the reasons explained above, Defendants' motions [144; 147; 150] are granted in part and denied in part. Pursuant to Federal Rule of Civil Procedure 12(b)(5), TAP is dismissed from this action with prejudice. With regard to Defendants' motions under Rule 12(b)(6), all Counts against TPUSA as successor in interest to TAP are dismissed with prejudice; all claims but Count II against AbbVie are dismissed; and all claims but Counts II & V against Abbott are dismissed. The Court sets this matter for further status on April 8, 2019 at 10:00 a.m. to set a schedule for limited discovery regarding: (1) when Plaintiff's claim accrued; (2) whether the second amended complaint as to AbbVie properly relates back under Rule 15(c)(3) ; and (3) the roles of the remaining defendants vis-à-vis the manufacturing and development of Lupron. The parties should submit a joint status report and a proposed schedule for limited discovery no later than April 4, 2019. Finally, as an administrative matter, the motion for Rule 11 Sanctions by AbbVie, Abbott, and TPUSA [153] is stricken without prejudice in light of the notice of withdrawal filed on October 30, 2018 [180].
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Cite This Page — Counsel Stack
368 F. Supp. 3d 1152, Counsel Stack Legal Research, https://law.counselstack.com/opinion/paulsen-v-abbott-labs-illinoised-2019.