United States District Court, N.D. Illinois, Eastern Division
LISA N. RINGELESTEIN and DONALD RINGELESTEIN, Plaintiffs,
JOHNSON & JOHNSON, JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT, LLC, AND JANSSEN PHARMACEUTICALS, INC., Defendants.
MEMORANDUM OPINION AND ORDER
and Donald Ringelestein, a married couple, brought this
diversity suit against several pharmaceutical companies,
alleging negligence, strict liability, breach of warranty,
loss of consortium, fraud, and fraudulent concealment arising
from their marketing of Levaquin, a prescription drug. Docs.
26, 39. Defendants have moved under Federal Rule of Civil
Procedure 12(b)(6) to dismiss the fraud and fraudulent
concealment claims. Doc. 27. The motion is granted in part
and denied in part.
resolving a Rule 12(b)(6) motion, the court assumes the truth
of the operative complaint's well-pleaded factual
allegations, though not its legal conclusions. See Zahn
v. N. Am. Power & Gas, LLC, 815 F.3d 1082, 1087 (7th
Cir. 2016). The court must also consider “documents
attached to the complaint, documents that are critical to the
complaint and referred to in it, and information that is
subject to proper judicial notice, ” along with
additional facts set forth in Plaintiffs' brief opposing
dismissal, so long as those additional facts “are
consistent with the pleadings.” Phillips v.
Prudential Ins. Co. of Am., 714 F.3d 1017, 1020 (7th
Cir. 2013). The facts are set forth as favorably to
Plaintiffs as those materials allow. See Pierce v.
Zoetis, 818 F.3d 274, 277 (7th Cir. 2016). In setting
forth those facts at this stage, the court does not vouch for
their accuracy. See Jay E. Hayden Found. v. First
Neighbor Bank, N.A., 610 F.3d 382, 384 (7th Cir. 2010).
manufacture Levaquin, an antibiotic in the fluoroquinolone
family. Doc. 39 at ¶ 12, 19. From 2009 to 2015,
Defendants conveyed information to the public concerning
Levaquin's safety; the complaint does not specify the
exact nature of that information. Id. at ¶ 15.
During that time, the FDA drafted a report, which was not
made public, detailing links between Levaquin and
mitochondrial toxicity, ALS, Alzheimer's, and
Parkinson's disease. Id. at ¶¶ 16-17.
When an FDA advisory committee met in 2015 to consider
fluoroquinolone drugs, an FDA employee stated that those
drugs (including Levaquin) could result in multi-system
disability. Id. at ¶ 18-19. The FDA now
Disability” as the set of “adverse reactions
involving neuromuscular, neuropsychiatric, peripheral
neuropathy, sense, skin and cardiovascular symptoms.”
Id. at ¶ 20. Plaintiffs allege that Defendants
knew this information but did not share it with the public,
Plaintiffs, or Plaintiffs' physicians. Id. at
Ringlestein was prescribed and used Levaquin in June 2010 and
April 2013. Id. at ¶¶ 28-30. After using
the drug, she developed several health problems, including:
orthopedic issues, neurological issues, mental status
changes, fatigue, constant pain, loss of balance[, ]
incoordination, cardiovascular issues including racing of the
heart, impaired cognitive function, an inability to tolerate
cold temperatures, muscle twitching, numbness, tingling and
crawly skin, burning sensations on her feet, severe anxiety,
tingling in spine, neuropathy, and other symptoms,
conditions, dysfunction and injury.
Id. at ¶ 34. In 2012 and 2013, Lisa underwent a
variety of orthopedic surgeries, and in May 2014 she was
diagnosed with “multiple tendon ruptures likely
secondary to Levaquin.” Id. at ¶¶
35-39. In August 2015, after further assessments, a physician
diagnosed Lisa with chronic pain and mitochondrial
impairment/fluoroquinolone toxicity. Id. at
¶¶ 41-43. Her symptoms continue to this day.
Id. at ¶ 40.
allege that Defendants “concealed and provided
inadequate information and warnings as to Levaquin.”
Id. at ¶ 46. They further allege that
Defendants made representations through national advertising,
promotional campaigns, and other marketing materials that
were “false, misleading, materially incorrect in fact,
and were made knowingly, intentionally, and/or willfully to
deceive.” Id. at 16 ¶ 79.
elements of common law fraud are: (1) a false statement of
material fact; (2) defendant's knowledge that the
statement was false; (3) defendant's intent that the
statement induce the plaintiff to act; (4) plaintiff's
reliance upon the truth of the statement; and (5)
plaintiff's damages resulting from reliance on the
statement.” Connick v. Suzuki Motor Co., 675
N.E.2d 584, 591 (Ill. 1996); see also Geschke v. Air
Force Ass'n, 425 F.3d 337, 345 (7th Cir. 2005)
(same). A fraud plaintiff in federal court must comply with
Rule 9(b), which provides that “[i]n alleging fraud
…, a party must state with particularity the
circumstances constituting fraud … .”
Fed.R.Civ.P. 9(b). “This ordinarily requires describing
the ‘who, what, when, where, and how' of the fraud,
although the exact level of particularity that is required
will necessarily differ based on the facts of the
case.” Anchor Bank, FSB v. Hofer, 649 F.3d
610, 615 (7th Cir. 2011); see also Vicom, Inc. v.
Harbridge Merch. Servs., Inc., 20 F.3d 771, 777 (7th
Cir. 1994) (“[T]he reference to
‘circumstances' in the rule requires the plaintiff
to state the identity of the person who made the
misrepresentation, the time, place and content of the
misrepresentation, and the method by which the
misrepresentation was communicated to the plaintiff.”)
(some internal quotation marks omitted).
fraud claim does not satisfy Rule 9(b). The complaint makes a
variety of allegations that, when the dots are connected in a
particular way, could give notice of the offending conduct.
While that might suffice for ordinary pleading under Rule
8(a)(2), which requires only “a short and plain
statement of the claim showing that the pleader is entitled
to relief, ” it does not suffice under Rule 9(b), which
requires plaintiffs to “state with particularity the
circumstances constituting fraud.” For example, the
complaint alleges that Defendants made representations
“regarding the characteristics of and the quality of
Levaquin and Levofloxacin, [which] were false, misleading,
materially incorrect in fact, and were made knowingly,
intentionally and/or willfully to deceive.” Doc. 39 at
16 ¶ 79. However, the complaint does not describe
how those representations were misleading.
Elsewhere, the complaint alleges that Levaquin “was
represented to be safe and free from latent defects, for use
as directed on the label.” Id. at ¶¶
56, 60. However, the complaint does not say who made
those representations. And while the complaint makes passing
references to labels and package inserts, id. at
¶¶ 19, 32, 56, 60, 79, it does not specify their
content or attach them as exhibits. In sum, while one might
possibly connect the dots in a way that yields viable fraud
allegations, the complaint itself does not do so. That is
insufficient under Rule 9(b), so Count VI is dismissed, with
the dismissal being without prejudice to repleading.
See Runnion v. Girl Scouts of Greater Chi. &
Nw. Ind., 786 F.3d 510, 519 (7th Cir. 2015)
(“Ordinarily … a plaintiff whose original
complaint has been dismissed under Rule 12(b)(6)
should be given at least one opportunity to try to amend her
complaint … .”).