Ringelestein et al v. Johnson & Johnson et al

Filing 45

MEMORANDUM Opinion and Order written by the Honorable Gary Feinerman on 5/31/2017.Mailed notice(jlj, )

UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
LISA N. RINGELESTEIN and DONALD
RINGELESTEIN,
Plaintiffs,
vs.
JOHNSON & JOHNSON, JOHNSON AND JOHNSON
PHARMACEUTICAL RESEARCH AND
DEVELOPMENT, LLC, AND JANSSEN
PHARMACEUTICALS, INC.,
Defendants.

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16 C 4970
Judge Gary Feinerman

MEMORANDUM OPINION AND ORDER
Lisa 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.
Background
In 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

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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).
Defendants 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 identifies “Fluoroquinolone-Associated 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
¶ 27.
Lisa 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.

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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 ¶¶ 3539. 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.
Plaintiffs 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.
Discussion
I.

Fraud Claim
“The 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.” AnchorBank, 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)

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(“[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).
Plaintiffs’ 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

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dismissed under Rule 12(b)(6) should be given at least one opportunity to try to amend her
complaint … .”).
II.

Fraudulent Concealment
”In order to state a claim for fraudulent concealment, a plaintiff must allege that the

defendant concealed a material fact when he was under a duty to disclose that fact to [the]
plaintiff.” Connick, 675 N.E.2d at 593. Defendants first argue that the fraudulent concealment
claim suffers from a Rule 9(b) particularity problem. Doc. 27 at 6. That is incorrect. The
complaint alleges that Defendants concealed their knowledge of certain potential side effects of
Levaquin. Doc. 39 at ¶¶ 15-16, 20, 23-24, 89-91.
Defendants next argue that they were under no duty to disclose safety information
regarding Levaquin to Plaintiffs. Doc. 27 at 6. That is incorrect as well. A duty to disclose
arises where “plaintiff and defendant are in a fiduciary or confidential relationship,” or where
“plaintiff places trust and confidence in defendant, thereby placing defendant in a position of
influence and superiority over plaintiff.” Connick, 675 N.E.2d at 593. Illinois courts have yet to
decide whether the relationship between a pharmaceutical company and persons who use its
drugs fits the bill, though in Guvenoz v. Target Corp., 30 N.E.3d 404 (Ill. App. 2015), the court
assumed an affirmative answer after the pharmaceutical company defendants did not contest the
issue. Id. at 425.
Common sense suggests that pharmaceutical companies are in a “position of superiority”
over patients who use their drugs. After all, the companies are well-positioned to understand the
potential side effects of their drugs in a way their lay patients are not. See Wyeth v. Levine, 555
U.S. 555, 578-79 (2009) (“[M]anufacturers have superior access to information about their
drugs, especially in the postmarketing phase as new risks emerge.”). True enough, tort liability

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for drug makers has traditionally been limited by principles such as the learned intermediary
doctrine, which provides that if the prescribing physician is adequately warned of a drug’s risks,
the patient has no failure to warn claim against the pharmaceutical company. See Happel v. WalMart Stores, Inc., 766 N.E.2d 1118, 1126 (Ill. 2002). But Defendants have not raised the learned
intermediary doctrine as a defense, and even if they had, its application would be questionable,
certainly on the pleadings. See In re Testosterone Replacement Therapy Prods. Liability Litig.,
2017 WL 1836443, *8 n.2 (N.D. Ill. May 8, 2017) (expressing doubt that the learned
intermediary doctrine would apply were, as here, a pharmaceutical company’s marketing
materials were directed not only to physicians, but to the general public as well).
In In re Neurontin Marketing, Sales Practices, and Prods. Liability Litig., 618 F. Supp.
2d 96 (D. Mass. 2009), the MDL court noted that “[i]n the products liability area, courts have
routinely held that a manufacturer of a drug has a duty to warn physicians, and in some cases,
warn patients, about the dangers of the administration of a drug.” Id. at 110 (emphasis added).
The court ultimately held that “a manufacturer of a pharmaceutical has a duty to disclose to
physicians and patients material facts about the risks of the drug.” Ibid. That decision did not
involve Illinois law, but there is no basis in the Illinois cases to conclude that Illinois courts
would reach a different result.
For these reasons, the court concludes that under Illinois law, a pharmaceutical company
has a duty to disclose known risks of its drugs to patients and their physicians. This defeats
Defendants’ contention that Plaintiffs’ fraudulent concealment claim should be dismissed on the
ground that such a duty does not exist.

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Conclusion
Defendants’ motion to dismiss is granted as to the fraud claim and denied as to the
fraudulent concealment claim. Plaintiffs have until June 21, 2017 to file an amended complaint
with a repleaded fraud claim. If Plaintiffs amend the complaint, Defendants shall answer or
otherwise plead to the amended complaint by July 12, 2017; if Plaintiffs do not amend the
complaint, Defendants shall answer the surviving portions of the current complaint by June 28,
2017.

May 31, 2017
United States District Judge

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