Guvenoz v. Target Corp. , 2015 IL App (1st) 133940 ( 2015 )

2015 IL App (1st) 133940
No. 1-13-3940
Opinion filed March 27, 2015
FIFTH DIVISION
IN THE
APPELLATE COURT OF ILLINOIS
FIRST DISTRICT
NICOLE GUVENOZ, Individually and as ) Appeal from the Circuit Court
Representative of the Estate of Lewis Guvenoz, ) of Cook County.
Deceased, )
)
Plaintiff-Appellee, )
)
v. ) No. 12 L 005162
)
TARGET CORPORATION and TEVA )
PHARMACEUTICALS USA, INC., )
)
Defendants-Appellants ) The Honorable
) Moira S. Johnson,
(Joshua Rosenow, M.D. ) Judge, presiding.
)
Defendant). )
JUSTICE GORDON delivered the judgment of the court, with opinion.
Presiding Justice Palmer and Justice McBride concurred in the judgment and opinion.
OPINION
¶1 Plaintiff Nicole Guvenoz is the widow of Lewis Guvenoz (Lewis), a 39-year-old
father of five who became a spastic quadriplegic and then died allegedly as a result of taking
a generic drug marketed by defendant Target Corporation, Inc. (Target), and manufactured
No. 1-13-3940
by defendant Teva Pharmaceuticals USA, Inc. (Teva). The third defendant, Dr. Joshua
Rosenow, who was one of Lewis's physicians, is not a party to this appeal.
¶2 This is a permissive interlocutory appeal that this court allowed pursuant to Illinois
Supreme Court Rule 308(a), which permits this court to consider purely legal questions
certified by the trial court for our review. Ill. S. Ct. R. 308(a) (eff. Feb. 26, 2010). In the case
at bar, after the trial court denied defendants' motions under sections 2-615 and 2-619 of the
Code of Civil Procedure to dismiss (735 ILCS 5/2-615, 2-619 (West 2012)), defendants
moved the trial court to certify certain legal questions, which the trial court did over
plaintiff's objection. The trial court also granted defendants' motion to stay proceedings until
the resolution of their application for leave to appeal.
¶3 The certified questions drafted by defendants are stated in their entirety in the
Background section below and concern whether federal law preempts the types of state-law
claims made by plaintiff.
¶4 Defendants ask us to adopt a position, whereby consumers of generic drugs cannot
sue the brand-name manufacturer because they did not ingest the brand-name drug, 1 but they
are also barred from suing the generic manufacturer because, since federal law requires the
generic manufacturer to be in lock-step with the brand-name manufacturer, federal law then
preempts their claims, thereby leaving generic consumers without any recovery. In essence,
what defendants are arguing on this appeal and at this early pleading stage of the litigation is
that they should be able to market a drug, even assuming that they know that it is dangerous
1
The "overwhelming" majority of courts have held that generic consumers may not sue
the brand-name manufacturer. In re Darvocet, Darvon, & Propoxyphene Products Liability
Litigation, 756 F.3d 917, 938 (6th Cir. 2014).
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and useless, until the Federal Drug Administration (FDA) officially stops them, and then bear
no financial responsibility for the consequences.
¶5 We analyze the relevant case law and answer the certified questions in the last section
below.
¶6 BACKGROUND
¶7 We describe below both the allegations of plaintiff's complaint and defendants'
motion to dismiss it. The certified questions are provided in full, in section III below.
¶8 I. The Complaint
¶9 Plaintiff's first amended complaint is plaintiff's last filed complaint and the subject of
defendants' motion to dismiss, and it alleged the following:
¶ 10 Lewis Guvenoz and his wife Nicole were residents of Illinois. Lewis was given a
prescription for Darvocet and, as a result of ingesting the recommended doses, he suffered a
cardiac arrest that caused serious brain injuries. (Since the filing of this complaint and this
appeal, Lewis has died.)
¶ 11 Defendant Teva is a Delaware corporation that regularly conducts business in Cook
County, and it was involved in the manufacture, distribution, marketing, sale and labeling of
Darvocet. Defendant Target is a Minnesota corporation that regularly conducts business in
Cook County, and it was involved in the distribution and sale of Darvocet.
¶ 12 The complaint alleged 11 counts: in count I, negligence against both defendants Teva
and Target; in counts II and III, fraudulent misrepresentation against both defendants Teva
and Target; in counts IV and VI, fraudulent concealment against both defendants Teva and
Target; in count V, strict product liability and design defect against both Teva and Target; in
counts VII and VIII, violations of the Illinois Consumer Fraud and Deceptive Business
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No. 1-13-3940
Practices Act (Consumer Fraud Act) (815 ILCS 505/1 et seq. (West 2012)), against Teva and
Target; in counts IX and X, loss of consortium against Target; and in count XI, professional
negligence against Dr. Joshua Rosenow, who is not a party to this appeal.
¶ 13 Propoxyphene is an opoid analgesic prescription drug for the treatment of mild to
moderate pain, which was first approved by the FDA in 1957 and has been commercially
available in the United States since 1976 under the name of "Darvon" or, when combined
with acetaminophen, "Darvocet." Over 90% of the market share of these drugs belongs to
generic manufacturers. Defendant Teva marketed a generic form of Darvocet and distributed
it until it was withdrawn from the market in November 2010.
¶ 14 Upon information and belief, adverse event data maintained by the FDA indicated "a
staggering number" of serious adverse events associated with propoxyphene, including heart
arrhythmias. Defendants Teva and Target knew or should have known of: (1) the
correlation between the use of Darvocet and the increased risk of developing potentially fatal
heart arrhythmias; (2) that propoxyphene was ineffective, or at best, marginally effective as a
pain reliever; and (3) that any benefits of propoxyphene were outweighed by its risks,
including serious risks of cardiovascular events that could lead to death.
¶ 15 The serious health risks associated with propoxyphene and the existence of many
safer alternatives led the British government to declare a recall of the drug in 2005, because it
could not identify any group of patients for whom the drug's benefits outweighed its risks.
¶ 16 In January 2009, the FDA held an Advisory Committee meeting to address the
efficacy and safety of propoxyphene. After considering the data submitted, the committee
voted 14 to 12 against the continued marketing of the drug, and noted that additional
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information about the drug's cardiac effect would be relevant in assessing its risks and
benefits.
¶ 17 In June 2009, the European Medicines Agency recommended that the marketing
authorization for propoxyphene be withdrawn across the European Union due to safety
concerns. In the following month, July 2009, the FDA required a new safety study
addressing unanswered questions about propoxyphene's effects on the heart.
¶ 18 After the European Medicines Agency recommended the drug's withdrawal and after
the FDA required a new safety study, but just six months before the FDA ordered withdrawal
of the drug, Lewis Guvenoz was prescribed and did purchase and ingest 72 tablets of
propoxyphene between January 8, 2010, and May 13, 2010. Guvenoz's complaint alleges
that, on May 13, 2010, while taking the recommended doses of the drug, Lewis experienced
a cardiac arrest and resulting anoxic encephalopathy.
¶ 19 Just six months after Lewis's cardiac arrest, on November 19, 2010, the FDA required
manufacturers to withdraw any products containing propoxyphene, including Darvocet and
Darvon, from the United States market. The FDA determined that the risks of the drug
outweighed the benefits after a safety study showed that propoxyphene causes significant
changes to the electrical activity of the heart even when taken at recommended doses.
¶ 20 Defendants Teva and Target had actual knowledge that a "qt wave interval
prolongnation effect was associated with Propoxyphene" and that the drug "blocked ION
channels in the heart" which is associated with "pro-arrhythmia." Defendants knew that the
drug was unsafe, that its risk of cardiac injury far exceeded any benefits, and that it should
not have been marketed.
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¶ 21 The complaint does not allege that Lewis purchased and ingested propoxyphene that
was manufactured or marketed by defendants. However, defendants did not move to dismiss
on that ground, and that issue is not before us in the questions certified by the trial court. In
addition, defendants attached to their motion to dismiss a letter from plaintiff's attorney
which included a photograph of a bottle of Lewis' pills which states that the manufacturer is
"Teva Pharm," and that they were dispensed by "Target Pharmacy, 115 N. Randall Road,
Batavia, IL 60510." Also, defendant Target conceded in its memorandum in support of its
motion to dismiss: "Mr. Guvenoz's personal physician issued four separate propoxyphene
prescriptions to Mr. Guvenoz. Each time, Mr. Guvenoz presented the prescriptions to
Target's pharmacy. Plaintiffs do not dispute that Target's pharmacy dispensed the
prescriptions to Mr. Guvenoz exactly as prescribed ***."
¶ 22 II. Motion to Dismiss
¶ 23 Defendants Teva and Target filed combined motions pursuant to section 2-619.1 to
dismiss the complaint under both section 2-615 and section 2-619(a)(9). 735 ILCS 5/2-615,
2-619(a)(9), 2-619.1 (West 2012).
¶ 24 Pursuant to section 2-615, defendants Teva and Target moved to dismiss counts II,
III, IV, VII, and VIII for fraudulent misrepresentation, fraudulent concealment and violations
of the Illinois Consumer Fraud Act, on the ground that plaintiff failed to plead them with
sufficient particularity.
¶ 25 Pursuant to section 2-619(a)(9), defendants Teva and Target moved to dismiss all
counts on the ground that they are preempted by federal law. Federal preemption is the issue
before us on this permissive appeal.
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¶ 26 In support of their federal preemption argument, defendants asserted that, "at their
core," plaintiff's claims were an attack on the "sufficiency of the warnings, labeling and
disclosures" about the drug's risks. However, in plaintiff's response, she stated that, at their
core, her claims are that the drug was simply unsafe and should not have been sold at all.
Plaintiff claims that defendants are trying to shield themselves from liability simply because
the drug that Lewis ingested happened to be a generic brand and that, if the court accepts this
theory, then Illinois residents will have no recourse simply because they chose to purchase a
less expensive product. In plaintiff's surresponse brief, she stated unequivocally: "This
action is not, never has been, and never will be a failure to warn claim."
¶ 27 Plaintiff's response to defendants' motion included an affidavit from Dr. Robert
Barkin, who is a full professor at Rush University Medical College in the departments of
anesthesiology, family medicine and pharmacology, and who authored an article in 2006
entitled: "Propoxyphene: A Critical Review of a Weak Opiod Analgesic that Should
Remain in Antiquity." The affidavit stated that, from January 2010 to May 2010, Lewis
ingested 72 tablets over a 123-day period pursuant to a prescription. On May 13, 2010, the
38-year-old Lewis, who had no prior history of cardiovascular disease, experienced a cardiac
arrest in his garage and, when emergency medical technicians arrived, he had no pulse. After
his cardiac arrest, he suffered an anoxic encephalopathy from which there was no recovery.
The affidavit repeated the history of the drug that we summarized above in our description of
the complaint. Dr. Barkin concluded, to a reasonable degree of pharmacologic and scientific
certainty, that Lewis's "sudden cardiac arrest with no known antecedent pathology and
resultant anoxic encephalopathy was/is causally related to the ingestion of propoxyphene."
He further concluded that "[a]t the time propoxyphene was prescribed to [Lewis] in January
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No. 1-13-3940
2010, the drug was inherently dangerous and unsafe," and that the "unreasonably dangerous
qualities of the drug propoxyphene were well known by the pharmaceutical industry before
and during 2006."
¶ 28 On September 11, 2013, the trial court issued a written order denying defendants'
combined motion to dismiss.
¶ 29 III. The Certified Questions
¶ 30 On September 30, 2013, defendants moved the trial court: (1) for the certification of
certain legal questions for immediate appellate review pursuant to Illinois Supreme Court
Rule 308(a) (eff. Feb. 26, 2010); and (2) for a stay of the trial court's proceedings pending the
resolution of defendants' application to the appellate court for leave to appeal.
¶ 31 The questions drafted by defendants and certified by the trial court are:
"(1) Did the U.S. Supreme Court's decisions in Mutual Pharmaceutical Co. Inc. v.
Bartlett, [570 U.S. __,] 133 S. Ct. 2466 (2013), PLIVA, Inc. v. Mensing, [564 U.S. __,
__,] 131 S. Ct. 2567, 2574 (2011), and their progeny (collectively, the
'Barlett/Mensing' precedent) require the dismissal on federal preemption grounds of
an Illinois common law cause of action for negligence, alleging negligence in the
design, manufacture, or distribution of a generic drug (commonly known as
Propoxyphene) approved by the United States Food & Drug Administration (the
'FDA')?
(2) Does the Bartlett/Mensing precedent require the dismissal on federal
preemption grounds of an Illinois common law cause of action for strict product
liability/design defect, alleging unreasonable dangerousness in the design or
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No. 1-13-3940
manufacture of a generic drug (commonly known as Propoxyphene) approved by the
FDA?
(3) Does the Bartlett/Mensing precedent require the dismissal on federal
preemption grounds of an Illinois common law cause of action for fraudulent
misrepresentation, alleging false statements of material fact regarding the safety, risks
or lack of testing of a generic drug (commonly known as Propoxyphene) approved by
the FDA?
(4) Does the Bartlett/Mensing precedent require the dismissal on federal
preemption grounds of an Illinois common law cause of action for fraudulent
concealment, alleging concealment or withholding of alleged design or manufacturing
defects, lack of safety, or other unreasonably high risks associated with a generic drug
(commonly known as Propoxyphene) approved by the FDA?
(5) Does the Bartlett/Mensing precedent require the dismissal on federal
preemption grounds of a cause of action under the Illinois Consumer Fraud and
Deceptive Business Practices Act, alleging a generic drug (commonly known as
Propoxyphene) approved by the FDA?"
In sum, defendants ask the same question with respect to each of plaintiff's causes of action,
asking whether the Bartlett/Mensing precedent requires dismissal of each of this type of
state-law claim on federal preemption grounds. However, in recognition of the fact that the
lawsuit is in its early stages and the complaint could be further amended, the questions do not
ask us to assess whether plaintiff's claims, as currently alleged, are sufficient. Instead the
questions ask whether any state-law "cause of action" exists for each type of claim after the
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Bartlett and Mensing Supreme Court decisions. Nonetheless, we interpret these question in
light of plaintiff's allegations.
¶ 32 Plaintiffs objected to these certified questions and stated at oral argument before this
court that the Bartlett/Mensing precedent did not apply. The relevant events in the
Bartlett/Mensing precedent predated the Food and Drug Administration Amendments Act of
2007 (Pub. L. No. 110-85, 121 Stat. 823 (2007)) (the 2007 Act) while the events in the case
at bar all postdated it. However, since the certified questions did not address these
amendments, the parties in their briefs did not discuss them, and neither do we. As the United
States Supreme Court did, we express no view on the impact of the 2007 Act on plaintiff's
claims. PLIVA, Inc. v. Mensing, 564 U.S. __, __, 131 S. Ct. 2567, 2574 n.1 (2011) ("All
relevant events in these cases predate the Food and Drug Administration Amendments Act of
2007 [citation]. We therefore refer exclusively to the pre-2007 statutes and regulations and
express no view on the impact of the 2007 Act."); Mutual Pharmaceutical Co. v. Bartlett,
570 U.S. __, __, 133 S. Ct. 2466, 2472 (2013) (the drug was first prescribed in December
2004 and respondent was already suffering by the time the FDA ordered changes to the
labeling in 2005); Wyeth v. Levine, 555 U.S. 555, 567 (2009) ("In 2007, after [the plaintiff's]
injury and lawsuit, Congress again amended the FDCA" granting broader powers to
manufacturers to make unilateral labeling changes.).
¶ 33 On May 7, 2014, this court granted defendants' petition for leave to appeal pursuant
to Supreme Court Rule 308(a). On July 29, 2014, this court also granted plaintiff's motion to
substitute Nicole Guvenoz as representative of the estate of Lewis Guvenoz, who had since
died, and to change the caption of the case accordingly. This appeal followed.
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No. 1-13-3940
¶ 34 ANALYSIS
¶ 35 In this interlocutory appeal, we are called upon to answer certain certified questions,
which we answer below.
¶ 36 I. Rule 308
¶ 37 As stated above, we permitted this appeal pursuant to Illinois Supreme Court Rule
308(a) (eff. Feb. 26, 2010), which provides in relevant part:
"When the trial court, in making an interlocutory order not otherwise appealable,
finds that the order involves a question of law as to which there is substantial ground
for difference of opinion and that an immediate appeal from the order may materially
advance the ultimate termination of the litigation, the court shall so state in writing,
identifying the question of law involved. *** The Appellate Court may thereupon in
its discretion allow an appeal from the order."
¶ 38 After the trial court certifies the questions, the appellant must file an application
seeking an appeal with the appellate court. Ill. S. Ct. R. 308(b) (eff. Feb. 26, 2010). The
application must be "accompanied by an original supporting record." Ill. S. Ct. R. 308(c)
(eff. Feb. 26, 2010). The adverse party may then file an answer, "together with an original of
a supplementary supporting record containing any additional parts of the record the adverse
party desires to have considered by the Appellate Court." Ill. S. Ct. R. 308(c) (eff. Feb. 26,
2010). "If leave to appeal is allowed," as it was in the case at bar, "any party may request
that an additional record on appeal be prepared." Ill. S. Ct. R. 308(d) (eff. Feb. 26, 2010).
¶ 39 In the case at bar, defendants filed a supporting record, and plaintiff chose neither to
submit a supplementary supporting record nor to request that an additional record be
prepared. Thus, the record before us is solely the supporting record filed by defendants.
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¶ 40 II. Standard of Review
¶ 41 Since a Supreme Court Rule 308 petition is limited to only "a question of law" (Ill. S.
Ct. R. 308(a) (eff. Feb. 26, 2010)), our review is de novo. Seith v. Chicago Sun-Times, Inc.,
371 Ill. App. 3d 124, 133 (2007) (where an appeal concerns a question of law, we review the
trial court's order de novo). De novo review means that we perform the same analysis that a
trial judge would perform. JPMorgan Chase Bank, National Ass'n v. Ivanov, 2014 IL App
(1st) 133553, ¶ 65. Since our review is de novo, we may consider any basis appearing in
the record. Lewis v. Heartland Food Corp., 2014 IL App (1st) 123303, ¶ 7 (citing Gatreaux
v. DKW Enterprises, LLC, 2011 IL App (1st) 103482, ¶ 10); Seith, 371 Ill. App. 3d at 133.
¶ 42 Since this appeal comes to us after the trial court's denial of a motion to dismiss and
prior to the close of discovery, and since it presents a purely legal question, we accept the
allegations of the complaint as true for the purposes of this appeal. Lewis v. Heartland Food
Corp., 2014 IL App (1st) 123303, ¶ 7 (when reviewing a trial court's decision on a section 2-
615 motion to dismiss, we accept as true all well-pled facts in the plaintiff's complaint); Bank
of America, N.A. v. Adeyiga, 2014 IL App (1st) 131252, ¶ 57 (when reviewing a trial court's
decision on a 2-619 motion to dismiss, we accept as true all well-pled facts in the plaintiff's
complaint).
¶ 43 III. Federal Law
¶ 44 Defendants claim that "the Bartlett/Mensing precedent require the dismissal on
federal preemption grounds" of the types of state-law claims alleged by plaintiff.
¶ 45 "[P]re-emption is a demanding defense," and the defendant drug company has the
burden of demonstrating that it applies. Wyeth, 555 U.S. at 573 ("Wyeth has failed to
demonstrate that it was impossible for it to comply with both federal and state
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No. 1-13-3940
requirements."); see also Wyeth, 555 U.S. at 581 ("Wyeth has not persuaded us ***.").
"Congress enacted the FDCA[ 2] to bolster consumer protection against harmful products,"
not to lessen it. Wyeth, 555 U.S. at 574. The United States Supreme Court observed:
"Congress did not provide a federal remedy for consumers harmed by unsafe or ineffective
drugs in the 1938 statute or in any subsequent amendment. Evidently, it determined that
widely available state rights of action provided appropriate relief for injured consumers."
Wyeth, 555 U.S. at 574, 574 n.7 (observing that witnesses testified before the Senate that a
federal "right of action was unnecessary because common-law claims were already available
under state law").
¶ 46 Thus, the defendant drug company bears the burden of demonstrating that these state
rights are federally preempted.
¶ 47 " '[T]he purpose of Congress is the ultimate touchstone in every pre-emption case."
Wyeth, 555 U.S. at 565 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)). When
Congress enlarged the FDA's powers to protect the public and ensure the safety and
effectiveness of drugs, Congress included a statement of its intent with respect to state law:
"No provision of this Act nor any amendment made by it shall be construed as indicating any
intent on the part of the Congress to occupy the field in which such provision or amendment
operates to the exclusion of any State law on the same subject matter, unless there is a direct
and positive conflict between such provision or amendment and such State law so that the
two cannot be reconciled or consistently stand together." (Emphasis added.) Pub. L. 89-74,
§ 10, 79 Stat. 235 (1965); Wyeth, 555 U.S. at 567 (discussing Congress's intent and purpose
in the 1962 amendment).
2
The "FDCA" referred to by the Wyeth court is the Federal Food, Drug, and Cosmetic
Act (FDCA), 21 U.S.C. § 301 et seq. (Supp. I 2008).
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¶ 48 Thus, to satisfy its burden, a defendant drug company must show a direct and positive
conflict that cannot be reconciled.
¶ 49 First, we will set forth the Bartlett/Mensing precedent. Then, in the following
section, we will apply that precedent to answer the certified questions before us.
¶ 50 A. PLIVA v. Mensing
¶ 51 Mensing concerned solely failure-to-warn claims brought against generic
manufacturers. Mensing, 564 U.S. at __, 131 S. Ct. at 2572. The case was brought by two
plaintiffs who consumed the generic drug metocyclopramide, which is "commonly used to
treat digestive tract problems." Mensing, 564 U.S. at __, 131 S. Ct. at 2572. The drug was,
and is, commonly used, and there was no suggestion that it should not be. The issue was not
whether the drug should be on the market at all, but rather what warnings should accompany
it to warn the minority of people who could be adversely affected by it. Mensing, 564 U.S. at
__, 131 S. Ct. at 2572-73.
¶ 52 The Mensing plaintiffs developed tardive dyskinesia, a severe neurological disorder,
which can occur in some patients who take the drug for several years. Mensing, 564 U.S. at
__, 131 S. Ct. at 2572. Even among those patients who take the drug for several years, less
than a third, or 29%, of those patients, develop this condition. Mensing, 564 U.S. at __, 131
S. Ct. at 2572.
¶ 53 The warnings on the drug's labels and package inserts had been strengthened and
clarified several times over the years to address the potential danger associated with long-
term use. Mensing, 564 U.S. at __, 131 S. Ct. at 2572. In 1985, the package insert stated
that " '[t]herapy longer than 12 weeks *** cannot be recommended.' " Mensing, 564 U.S. at
__, 131 S. Ct. at 2572. In 2004, the label was changed to add that use should " 'not exceed
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No. 1-13-3940
12 weeks.' " Mensing, 564 U.S. at __, 131 S. Ct. at 2572. Finally, in 2009, the FDA ordered
a "black box warning" which stated that treatment " 'longer than 12 weeks should be
avoided.' " Mensing, 564 U.S. at __, 131 S. Ct. at 2572-73. The Mensing plaintiffs took the
drug in 2001 and 2002, which was when the package insert warned that " '[t]herapy longer
than 12 weeks *** cannot be recommended,' " but before the label changes in 2004 and 2009
which provided stronger warnings. Mensing, 564 U.S. at __, 131 S. Ct. at 2572-73. Thus,
the crux of plaintiffs' claims was that these label changes should have been made earlier.
Mensing, 564 U.S. at __, 131 S. Ct. at 2573.
¶ 54 The Mensing Court stated: "All relevant events in these cases predate the Food and
Drug Administration Amendments Act of 2007, 121 Stat. 823 [(FDAAA)]. We therefore
refer exclusively to the pre-2007 statutes and regulations and express no view on the impact
of the 2007 Act." Mensing, 564 U.S. at __, 131 S. Ct. at 2574 n.1.
¶ 55 The Mensing Court held that, under pre-2007 law, the generic manufacturers could
not have made the label changes earlier, because federal law required the warnings on their
labels to be the same as those on the brand-name manufacturer. Mensing, 564 U.S. at __,
131 S. Ct. at 2575-76. As a result, plaintiffs' failure-to-warn claims, which were based on
2001 and 2002 events, were preempted. Mensing, 564 U.S. at __, 131 S. Ct. at 2581.
¶ 56 The Supreme Court acknowledged that, from the "perspective" of the injured
consumer, the distinction between brand-name and generic manufacturers "makes little
sense." Mensing, 564 U.S. at __, 131 S. Ct. at 2581. The Court recognized that, if the
Mensing plaintiffs had taken "the brand-name drug prescribed by their doctors, *** their
lawsuits would not be pre-empted." Mensing, 564 U.S. at __, 131 S. Ct. at 2581. While
"acknowledg[ing] the unfortunate hand that federal drug regulation has dealt" the plaintiffs,
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the Court stated that it was not its task "to create similar pre-emption" results in federal drug
regulation. Mensing, 564 U.S. at __, 131 S. Ct. at 2581-82.
¶ 57 Like the United States Supreme Court, the federal circuit courts of appeal have also
"recognize[d] the catch-22 situation in which existing jurisprudence places" plaintiffs, in that
they "cannot obtain relief from brand-name drug manufacturers" whose products they did not
ingest, but their "claims against generic drug manufacturers are preempted." Schrock v.
Wyeth, Inc., 727 F.3d 1273, 1290 (10th Cir. 2013); Strayhorn v. Wyeth Pharmaceuticals,
Inc., 737 F.3d 378, 407 (6th Cir. 2014) ("Although we feel compelled to affirm the
[dismissal] below in light of controlling [Supreme Court] caselaw, we cannot help but note
the basic unfairness of this result" where "plaintiffs are *** caught in a classic 'Catch-22' "
barred from claims against generic manufacturers due to federal preemption and barred from
claims against brand-name manufacturers whose product they did not ingest.).
¶ 58 One federal circuit court held out the hope that state courts would address this
unfairness through the interpretation of their own states' tort laws. Lamenting the "potential
injustice" created by recent Supreme Court law, the Tenth Circuit stated: "As a federal court,
however, we have limited authority to correct this potential injustice. It is for the state
courts, rather than this panel, to engage in the delicate policy considerations predicate to the
expansion of the scope of state tort law." Schrock v. Wyeth, Inc., 727 F.3d 1273, 1290 (10th
Cir. 2013).
¶ 59 In a footnote, the Mensing Court expressed no view as to whether its holding applied
to post-2007 cases like the one here. Mensing, 564 U.S. at __, 131 S. Ct. at 2574 n.1. See
also In re Reglan/Metoclopramide Litigation, 81 A.3d 80, 83 (Pa. Super. Ct. 2013) (in light
of footnote 1 in Mensing, "we decline to find post-Act claims pre-empted"); In re
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Reglan/Metocolpramide Litigation, 74 A.3d 221, 222 (Pa. Super. Ct. 2013) (post-Act claims
are not preempted); Hassett v. Dafoe, 74 A.3d 202, 217 (Pa. Super. Ct. 2013) ("We agree
with [plaintiff] that until post-Act claims are subjected to a thorough pre-emption analysis,
dismissal of those failure to warn claims is premature."). Similarly, in Bartlett, which we
discuss below, all the relevant events occurred before 2007. Bartlett, 570 U.S. at __, 133 S.
Ct. at 2472 (the drug was first prescribed in December 2004 and respondent was already
suffering by the time the FDA ordered changes to the labeling in 2005); In re Reglan, 81
A.3d at 85 ("The FDAAA, 121 Stat. 823, was enacted on September 27, 2007.").
¶ 60 After the 2007 amendment, generic manufacturers were required to propose stronger
labeling if it was warranted, and the FDA could unilaterally order it pursuant to the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. § 355(o)(4) (Supp. I 2008)). Hassett, 74 A.3d at
217 n.13. Thus, Congress removed at least one impediment relied upon in support of
preemption: the requirement that the FDA negotiate with the lead manufacturer to strengthen
the warning label. Mensing, 564 U.S. at __, 131 S. Ct. at 2578-79. By removing at least some
of the discretion afforded the lead manufacturer that made it impossible for generic
manufacturers to comply with both state and federal law, the amendment arguably changes
the landscape for generic manufacturers and may make their situation closer to the brand-
name manufacturer that was held liable in Wyeth v. Levine, 555 U.S. 555 (2009), rather than
the generic manufacturer that was found not liable in Mensing. Hassett, 74 A.3d at 217 n.13.
In addition, Congress chose not to include an express preemption provision in the FDAAA.
In re Reglan, 81 A.3d at 89 n.5.
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¶ 61 However, the parties did not argue that the FDAAA affects our analysis of the
certified questions, so we do not consider this issue at this time. The certified questions ask
us to resolve what "the Bartlett/Mensing precedent require."
¶ 62 B. Mutual Pharmaceutical v. Bartlett
¶ 63 In Bartlett, the generic drug at issue was sulindac, which was a "NSAID," or a
nonsteroidal anti-inflammatory pain reliever. Bartlett, 570 U.S. at __, 133 S. Ct. at 2471.
"In a very small number of patients," NSAIDs caused a severe and serious skin reaction,
which the Bartlett plaintiff suffered. Bartlett, 570 U.S. at __, 133 S. Ct. at 2471-72.
NSAIDs included not only sulindac, which the Bartlett plaintiff ingested, but also common
and popular drugs, such as ibuprofen. Bartlett, 570 U.S. at __, 133 S. Ct. at 2471. Thus, the
drug at issue in Bartlett was safe and effective for the vast majority of people who took it,
and the issue concerned only "[the] very small number of patients" who suffered an adverse
and severe reaction. Bartlett, 570 U.S. at __, 133 S. Ct. at 2471.
¶ 64 The possible severe reactions were toxic epidermal necrolysis, which the Bartlett
plaintiff suffered; and its less severe cousin, Stevens-Johns Syndrome. Bartlett, 570 U.S. at
__, 133 S. Ct. at 2471. At the time that the Bartlett plaintiff was prescribed sulindac, the
drug's label warned that the drug could cause " 'severe skin reactions,' " and the drug's
package insert listed both toxic epidermal necrolysis and Stevens-Johns Syndrome as
potential adverse reactions. Bartlett, 570 U.S. at __, 133 S. Ct. at 2472. In 2005, once the
Bartlett plaintiff was already suffering, the FDA adopted additional warnings for the labeling
of all NSAIDs, including sulindac. Bartlett, 570 U.S. at __, 133 S. Ct. at 2472.
¶ 65 The trial court dismissed the Barlett plaintiff's failure-to-warn claim after her doctor
admitted that he not read either the box or the insert. Bartlett, 570 U.S. at __, 133 S. Ct. at
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No. 1-13-3940
2472. The case proceeded to trial on the plaintiff's design-defect claim alone, and a jury
awarded her over $20 million in damages. Bartlett, 570 U.S. at __, 133 S. Ct. at 2472. Thus,
only her design-defect claim was at issue on appeal. Bartlett, 570 U.S. at __, 133 S. Ct. at
2472.
¶ 66 On appeal, the First Circuit Court of Appeals held that a generic manufacturer that
was facing design-defect claims should simply stop selling the drug and thereby comply with
both federal and state law (Bartlett, 570 U.S. at __, 133 S. Ct. at 2472), even though the drug
was safe and effective for the vast majority of people taking it. Bartlett, 570 U.S. at __, 133
S. Ct. at 2471. Based on this stop-selling rationale, the First Circuit found that the Bartlett
plaintiff's design-defect claim was not preempted. Bartlett, 570 U.S. at __, 133 S. Ct. at
2472.
¶ 67 The United States Supreme Court reversed and specifically rejected the "stop-selling
rationale" set forth by the First Circuit. Bartlett, 570 U.S. at __, 133 S. Ct. at 2470. The
Court held: "In the instant case, it was impossible for [the defendant] to comply with both its
state-law duty to strengthen the warnings on sulindac's label and its federal-law duty not to
alter sulindac's label. Accordingly, the state law is pre-empted." Bartlett, 570 U.S. at __,
133 S. Ct. at 2473. The Court explained: "Our pre-emption cases presume that an actor
seeking to satisfy both his federal- and state-law obligations is not required to cease acting
altogether in order to avoid liability." Bartlett, 570 U.S. at __, 133 S. Ct. at 2477. However,
that statement was made in the context of the Bartlett case, where the drug was safe and
effective for the vast majority of the people taking it, and ceasing to act would have
benefitted only "[the] very small number" of people who suffered an adverse reaction.
Bartlett, 570 U.S. at __, 133 S. Ct. at 2471. By contrast, in the case at bar, the FDA
19
No. 1-13-3940
concluded that the public at large would not benefit from this drug and ordered it withdrawn
from the market.
¶ 68 Responding to the dissent, the Bartlett majority agreed "that federal law establishes
no safe-harbor for drug companies–but it does prevent them from taking certain remedial
measures." Bartlett, 570 U.S. at __, 133 S. Ct. at 2479. The Court stated: "Where state law
imposes a duty to take such remedial measures, it 'actual[ly] conflict[s] with federal law' by
making it ' "impossible for a private party to comply with both state and federal
requirements." ' " Bartlett, 570 U.S. at __, 133 S. Ct. at 2479 (quoting Freightliner Corp. v.
Myrick, 514 U.S. 280, 287 (1995), quoting English v. General Electric Co., 496 U.S. 72, 79
(1990)). These statements presume that a plaintiff has identified "remedial measures" which
could have reduced the drug's risks. By contrast, in the case at bar, the FDA concluded that
no remedial measures were, in fact, possible and ordered its manufacturers to withdraw it
from the market.
¶ 69 "In cases where it is impossible – in fact or by law – to alter a product's design (and
thus to increase the product's 'usefulness' or decrease its 'risk of danger'), the duty to render a
product 'reasonably safe' boils down to a duty to ensure 'the presence and efficacy of a
warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable
uses.' " Bartlett, 570 U.S. at __, 133 S. Ct. at 2480 (quoting Vautour v. Body Masters Sports
Industries, Inc., 784 A.2d 1178, 1182 (N.H. 2001)). This reasoning assumes that there exists
a warning that would cure the problem of an otherwise unreasonable risk of harm. By
contrast, in the case at bar, the FDA concluded that no warning would suffice and ordered the
drug entirely withdrawn from public sale.
20
No. 1-13-3940
¶ 70 Reconciling the Bartlett Court's unequivocal and unanimous endorsement of the
statement that "federal law establishes no safe-harbor for drug companies," with the
majority's holding that federal law does preempt "certain remedial measures," leads to the
conclusion that, where there is no possible remedy, there is no safe harbor. Bartlett, 570 U.S.
at __, 133 S. Ct. at 2479.
¶ 71 C. Summary
¶ 72 The facts in the case at bar are very different from the facts in both Bartlett and
Mensing. In the case at bar, plaintiff alleges that there was no group of patients for whom the
drug's benefits outweighed its risks. By contrast, in both Bartlett and Mensing, the drug was
safe for the vast majority of patients taking it, and only a "very small number of patients"
suffered an adverse and severe reaction. Bartlett, 570 U.S. at __, 133 S. Ct. at 2471; see also
Mensing, 564 U.S. at __, 131 S. Ct. at 2572 (a severe neurological disorder occurred in less
than a third of the patients who took the drug for several years). In the case at bar, plaintiff
alleged that the drug was simply unsafe and should not have been sold at all, and there was
no warning that could have cured the problem. By contrast, in both Bartlett and Mensing, the
problem was addressed by the FDA with an improved warning. Bartlett, 570 U.S. at __, 133
S. Ct. at 2472; Mensing, 564 U.S. at __, 131 S. Ct. at 2572-73.
¶ 73 In the case at bar, since no remedy was possible, there was no safe harbor. Bartlett,
570 U.S. at __, 133 S. Ct. at 2479. Since plaintiffs do not suggest that there was an
improved design or label that could have cured the problem, there was no "direct and positive
conflict" with the generic manufacturer's federal duty to use the same design and label as the
lead manufacturer. Pub. L. 89-74, § 10, 79 Stat. 235 (1965) (discussed in Wyeth, 555 U.S. at
568). The only remedy was to withdraw the product.
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No. 1-13-3940
¶ 74 While it made little sense in Bartlett and Mensing to require a company to withdraw
from the market a drug which is still actively used and which is safe and effective for the vast
majority of consumers, that logic has no application to plaintiff's claims, which are that this
drug is not effective and that its risks do not outweigh its benefits for the public at large.
Thus, while withdrawing the drug in Bartlett and Mensing would not have resulted in a net
public benefit, plaintiff alleges that withdrawal will result in a net public benefit and, in fact,
the FDA agreed and ordered the drug pulled from the market.
¶ 75 The issue in the case at bar is not whether the drug companies should have stopped
selling. They should have, and they did. However, defendants argue that federal law
provided them with a safe harbor for failing to stop earlier. Unfortunately for defendants, the
Bartlett Court has already rejected that idea. Bartlett, 570 U.S. at __, 133 S. Ct. at 2479.
¶ 76 For these reasons, the logic of Bartlett and Mensing does not apply to plaintiff's
claims, and their holdings do not preempt the state-law claims in this case, as we explain in
greater detail below.
¶ 77 IV. Certified Questions
¶ 78 A. Overview
¶ 79 Now, having set forth the Bartlett/Mensing precedent, we will now apply this
discussion to the specific state law claims and certified questions before us.
¶ 80 Since Bartlett, most claims against generic manufacturers have been dismissed. E.g., 3
Strayhorn, 737 F.3d at 407 ("despite the 'Catch-22' dilemma" faced by plaintiffs, "we affirm"
the trial court's dismissal); In re Fosamax (Alendronate Sodium) Products Liability Litigation
(NO. II), 751 F.3d 150, 157-58, 165 (3d Cir. 2014) (strict-liability claim against a generic
3
Although we provide only an "e.g." cite here, a more complete list of cases is provided
infra in paragraph 82, with their approximate complaint-filing dates.
22
No. 1-13-3940
manufacturer, which was based on a risk-utility analysis of an alleged design defect, was
preempted).
¶ 81 In contrast, a substantial minority of courts have allowed claims against generic
manufacturers to proceed. Fullington v. Pfizer, Inc., 720 F.3d 739, 745-47 (8th Cir. 2013)
(reversing the trial court's dismissal of plaintiff's breach of implied warranty claim and strict-
liability design-defect claim against generic manufacturers and remanding for
reconsideration); Huck v. Wyeth, Inc., 850 N.W.2d 353, 356 (Iowa 2014) (reversing summary
judgment for generic manufacturer and remanding for further proceedings on defendant's
failure to update its label with "a stronger warning approved by the FDA"); Hassett, 74 A.3d
at 215, 217 (holding that federal drug law does "not pre-empt claims based upon the
marketing of defective products, a lack of due care in testing, or a product's failure to
conform to express and implied warranties," and "fraud and misrepresentation in the
advertising and promotion of *** generic drugs," and, thus, the trial court was correct in not
dismissing those claims); In re Reglan, 81 A.3d at 96 (holding that federal preemption does
not apply to claims that "do not sound in failure to warn, arose after the passage of the 2007
Act, or involve a generic manufacturer's failure to conform its label to that of the name
brand"); Franzman v. Wyeth, Inc., 451 S.W.3d 676, 679 (Mo. Ct. App. 2014) (reversing
dismissal of plaintiff's "failure-to-warn claim relating to the Generic Defendants' failure to
update their warning labels"); Fisher v. Pelstring, 817 F. Supp. 2d 791, 805, 814, 818, 821,
823-24 (D.S.C. 2012) (denying summary judgment for generic manufacturer on claims for
failure to update, fraud by concealment, manufacturing defect and breach of implied
warranty of merchantability); see also Bell v. Pfizer, Inc., 716 F.3d 1087, 1096 (8th Cir.
2013) (remanding, 10 days before Bartlett was decided, plaintiff's "design defect and breach
23
No. 1-13-3940
of implied warranty claims" for reconsideration); In re Fosamax, 751 F.3d at 158 ("we
withhold comment on whether negligence-based design-defect claims are or are not
preempted"); Wyeth, Inc. v. Weeks, No. 1101397, 2014 WL 4055813, at *22 (Ala. Aug. 15,
2014) (a generic consumer can sue the brand-name manufacturer).
¶ 82 However, the majority of dismissing cases were in a different procedural posture
from the instant case. In re Reglan/Metoclopramide Litigation, 81 A.3d 80, 90 n.6 (Pa.
Super. Ct. 2013) (noting the importance of distinguishing between cases that "were amended
in light" of Supreme Court precedent and those that were not). In most of the dismissing
cases, the courts were asked to consider whether the complaint in front of them, which was
drafted prior to Bartlett, survived the subsequently decided Supreme Court case. Drager v.
PLIVA USA, Inc., 741 F.3d 470, 473-74 (4th Cir. 2014) (the complaint was filed before either
Mensing or Bartlett, and the trial court denied plaintiff leave to amend after Mensing); In re
Fosamax, 751 F.3d at 154 (the complaint at issue was filed on February 28, 2011, before
either Mensing or Bartlett); Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 610
(5th Cir. 2014) (the complaint was filed in March 2010, before either Mensing or Bartlett);
Schrock v. Wyeth, Inc., 727 F.3d 1273, 1278 (10th Cir. 2013) (the complaint was amended on
April 14, 2010, before either Mensing or Bartlett); Lashley v. Pfizer, Inc., 750 F.3d 470, 472-
73 (5th Cir. 2014) (the suits were filed in 2009 and June 2011, before Bartlett); Eckhardt v.
Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 677 (5th Cir. 2014) (the complaint was
amended before Bartlett); In re Darvocet, Darvon, and Propoxyphene Products Liability
Litigation, 756 F.3d 917, 925-26 (6th Cir. 2014) (the cases were consolidated prior to
Bartlett); Strayhorn, 737 F.3d at 387 (the complaints at issue were amended after Mensing
24
No. 1-13-3940
but before Bartlett); Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1136 (8th Cir. 2014) (the
complaint was amended on August 30, 2011, after Mensing but before Bartlett).
¶ 83 The courts found that the allegations, viewed from hindsight after Bartlett, were
insufficient. E.g., Eckhardt, 751 F.3d at 679-80 (although a state claim for failure to provide
FDA-approved warnings was not preempted, plaintiff failed to adequately plead it); Drager,
741 F.3d at 474-75 (plaintiff's "failure to update" claim is not before the court because he
failed to move the trial court to amend the complaint to add it); In re Darvocet, 756 F.3d at
931 (although " 'failure-to-update' claims against generic manufacturers are not preempted,"
"[p]laintiff's claims falter because they did not plead them properly"); Johnson v. Teva
Pharmaceuticals USA, Inc., 758 F.3d 605, 613 (5th Cir. 2014) (even if plaintiff could bring a
design defect claim based on "a safer alternative product" rather than "a safer alternative
design," plaintiff failed to allege the safer product in her complaint); Strayhorn, 737 F.3d at
399 (although federal law does not preempt a "failure to update" claim, plaintiff's complaint
failed to plead that the generic label "was not updated during the time that a particular
plaintiff was using its product"); Schrock, 727 F.3d at 1290 (plaintiffs failed to advance a
claim that new and scientifically significant information was not before the FDA).
¶ 84 For example, in In re Darvocet, 756 F.3d at 930, 932, which concerned the same drug
at issue in the instant case, the Sixth Circuit held that the plaintiffs had failed to adequately
plead what new information was not before the FDA or which generic manufacturers had
failed to update their labels with FDA-approved warnings.
¶ 85 The questions in front of us are different. The certified questions do not ask us to
consider the sufficiency of plaintiff's complaint but rather whether "a cause of action" could
25
No. 1-13-3940
survive under Illinois law. Plaintiff's last amended complaint was filed after Mensing but
before Bartlett. However, we do consider the questions in light of plaintiff's allegations.
¶ 86 B. Negligence
¶ 87 The first certified question asks: "Did the U.S. Supreme Court's decisions in Bartlett
Co. Inc. v. Bartlett, 123 S. Ct. 2466 (2013), PLIVA, Inc. v. Mensing, 131 S. Ct. 2507, 2574
(2011), and their progeny (collectively, the 'Barlett/Mensing precedent') require the dismissal
on federal preemption grounds of an Illinois common law cause of action for negligence,
alleging negligence in the design, manufacture, or distribution of a generic drug (commonly
known as Propoxyphene) approved by the United States Food & Drug Administration (the
'FDA')?"
¶ 88 Although the certified questions are not limited to claims against generic
manufacturers and distributors, and although at least one Illinois court has recognized a suit
by the consumer of a generic drug against a brand-name manufacturer, we interpret the
certified questions to concern only claims against generic manufacturers and distributors,
since plaintiff has not sued the brand-name manufacturer here. Dolin v. SmithKline Beecham
Corp., No. 12 C 6403, 2014 WL 804458, at *6 (N.D. Ill. Feb. 28, 2014) (holding that the
brand-name manufacturer had a duty to the generic consumer)
¶ 89 For a plaintiff to state a cause of action for negligence in Illinois, the complaint must
allege facts sufficient to establish three elements: (1) the existence of a duty of care owed to
the plaintiff by the defendant; (2) a breach of that duty, and (3) an injury proximately caused
by that breach. Calles v. Scripto-Tokai Corp., 224 Ill. 2d 247, 270 (2007); Lewis, 2014 IL
App (1st) 123303, ¶ 8 (citing Marshall v. Burger King Corp., 222 Ill. 2d 422, 430 (2006)).
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No. 1-13-3940
¶ 90 The key distinction between a negligence claim and a strict liability claim, which we
discuss later, lies in the concept of fault. Calles, 224 Ill. 2d at 270 (citing Coney v. J.L.G.
Industries, Inc., 97 Ill. 2d 104, 117 (1983)). While the focus in a strict liability claim is
primarily on the condition of the product, a defendant's fault is at issue in a negligence claim,
in addition to the product's condition. Calles, 224 Ill. 2d at 270 (citing Coney, 97 Ill. 2d at
117-18).
¶ 91 A manufacturer has a nondelegable duty to design reasonably safe products. Calles,
224 Ill. 2d at 270; Coney, 97 Ill. 2d at 117. To determine whether the manufacturer's conduct
was reasonable in a negligent-design case, a court asks whether the manufacturer should have
foreseen, in the exercise of ordinary care, that the design would be hazardous to someone.
Calles, 224 Ill. 2d at 270. To show that the manufacturer acted unreasonably, the plaintiff
must show that the manufacturer knew or should have known of the risk posed by the
product design at the time of the product's manufacture. Calles, 224 Ill. 2d at 270. In the
case at bar, plaintiff has alleged that defendants knew or should have known of the risks
posed by the drug at the time of its manufacture.
¶ 92 Defendants claim that, even if plaintiff's allegations are true, her negligence claims
are preempted under the Bartlett/Mensing precedent because federal law prevented
defendants from altering the design or warnings of the drug. However, plaintiff does not
allege that defendants should have altered either the design or the warnings of the drug.
Thus, to the extent that the Mensing/Bartlett precedent applies to post-2007 claims, it does
not bar plaintiff's negligence claims.
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No. 1-13-3940
¶ 93 C. Strict Liability
¶ 94 The second certified question asks: "Does the Bartlett/Mensing precedent require the
dismissal on federal preemption grounds of an Illinois common law cause of action for strict
product liability/design defect, alleging unreasonable dangerousness in the design or
manufacture of a generic drug (commonly known as Propoxyphene) approved by the FDA?"
¶ 95 To succeed in Illinois on a strict liability claim, a plaintiff must prove that a product
was sold in an unreasonably dangerous condition. Jablonski v. Ford Motor Co., 2011 IL
110096, ¶ 86 ("the balancing test developed for strict liability claims *** examines whether a
product is unreasonably dangerous"); Calles v. Scripto-Tokai Corp., 224 Ill. 2d 247, 254
(2007); Korando v. Uniroyal Goodrich Tire Co., 159 Ill. 2d 335, 343 (1994) (to recover for a
defective product under strict liability, a plaintiff must prove that the product left the
manufacturer in an unreasonably dangerous condition). Illinois courts utilize two tests to
determine whether a product was unreasonably dangerous: the consumer expectation test
and the risk utility test. Calles, 224 Ill. 2d at 254-56. A plaintiff may succeed by proving the
elements of either test. Calles, 224 Ill. 2d at 255. Under the consumer expectation test, a
plaintiff succeeds by proving that "the product failed to perform as an ordinary consumer
would expect when used in an intended or reasonably foreseeable manner." Calles, 224 Ill.
2d at 256. Under the risk utility test, a plaintiff succeeds by proving that "the magnitude of
the danger outweighs the utility of the product, as designed." Calles, 224 Ill. 2d at 259. See
also Jablonski v. Ford Motor Co., 2011 IL 110096, ¶ 85 (discussing the "risk-utility" test).
¶ 96 Plaintiff has alleged both that the product failed to perform as an ordinary consumer
would expect when used in the intended dosage and that the high risk of dangerous side
effects outweighed the marginal effectiveness of the product as designed. On this appeal,
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No. 1-13-3940
defendants claim that, even if these allegations are true, plaintiff's strict liability claim is
preempted under Bartlett and Mensing.
¶ 97 Neither plaintiff's claim pursuant to the consumer expectation test nor her claim
pursuant to the risk utility test under Illinois law is preempted by the Bartlett/Mensing
precedent. Defendants are liable if they inject into the market a drug that fails to perform as
an ordinary consumer would expect or that has a marginal effectiveness which is easily
outweighed by its high risks. Federal law does not provide the drug companies with a "safe-
harbor" to avoid liability for dangerous drugs (Bartlett, 570 U.S. at __, 133 S. Ct. at 2479),
and there was no direct and positive conflict with their federal duty of sameness, when the
drug should not have been sold. Pub. L. 89-74, § 10, 79 Stat. 235 (1965) (discussed in
Wyeth, 555 U.S. at 568). Assuming arguendo that Bartlett and Mensing apply to post-2007
claims, we cannot find that they preempt plaintiff's strict liability claim.
¶ 98 D. Fraudulent Misrepresentation
¶ 99 The third certified question asks: "Does the Bartlett/Mensing precedent require the
dismissal on federal preemption grounds of an Illinois common law cause of action for
fraudulent misrepresentation, alleging false statements of material fact regarding the safety,
risks or lack of testing of a generic drug (commonly known as Propoxyphene) approved by
the FDA?"
¶ 100 In Illinois, the elements of a fraudulent misrepresentation claim are: (1) a false
statement of material fact; (2) knowledge or belief of the falsity by the person making it; (3)
intention to induce the other party to act; (4) action by the other party in reliance on the truth
of the statements; and (5) damage to the other party resulting from such reliance. Doe-3 v.
McLean County Unit District No. 5 Board of Directors, 2012 IL 112479, ¶ 28 (citing Board
29
No. 1-13-3940
of Education of City of Chicago v. A, C & S, Inc., 131 Ill. 2d 428, 452 (1989)). A claim for
negligent misrepresentation has essentially the same elements as fraudulent
misrepresentation, except that the defendant's mental state is different. Doe-3, 2012 IL
112479, ¶ 28. For a negligent misrepresentation claim, a plaintiff need allege only that the
defendant was careless or negligent in ascertaining the truth of the statement, and that the
defendant had a duty to convey accurate information to the plaintiff. Doe-3, 2012 IL 112479,
¶ 28. We provided the elements of negligent misrepresentation, although the certified
question did not ask about it, in order to better illustrate the mental state required for a fraud
claim.
¶ 101 Plaintiff alleged facts to support each of the four elements of fraudulent
representation. Specifically, she alleged: (1) that, in the act of promoting and selling the
drug, defendants made false statements of material facts and advertised to the general public
that the drug was safe and effective when it was not; (2) that defendants knew the statements
they were making were false; (3) that defendants intended the general public to rely on their
statements; (4) that Lewis relied on these statements in taking the drug; and (5) that, as a
result, Lewis became seriously ill and died. At this very early stage of the litigation, we must
accept plaintiff's allegations as true. Lewis, 2014 IL App (1st) 123303, ¶ 7; Adeyiga, 2014 IL
App (1st) 131252, ¶ 57.
¶ 102 In response, defendants claim that, even if these allegations are true, defendants are
still not liable to plaintiff because her claim is preempted under the Bartlett/Mensing
precedent. Defendants argue that, even assuming arguendo that the statements were false,
defendants could not have altered them because any changes would have violated the generic
30
No. 1-13-3940
drug company's federal duty to provide the same exact statements as the brand-name or lead
manufacturer.
¶ 103 However, this response overlooks the heart of plaintiff's argument. Plaintiff is not
arguing that defendants should have altered their statements. Instead, plaintiff claims that the
very act of marketing this drug was a misrepresentation and fraud upon the public. Assuming
arguendo the truth of plaintiff's allegations, there was no way to market this drug, which was
effectively useless and full of unreasonable risk, without fraudulently misrepresenting its
qualities. According to plaintiff, this was like marketing snake oil. Thus, to the extent that
Bartlett and Mensing apply to post-2007 claims, they do not bar plaintiff's fraudulent
representation claims against defendant generic manufacturer and distributor.
¶ 104 E. Fraudulent Concealment
¶ 105 The fourth certified question asks: "Does the Bartlett/Mensing precedent require the
dismissal on federal preemption grounds of an Illinois common law cause of action for
fraudulent concealment, alleging concealment or withholding of alleged design or
manufacturing defects, lack of safety, or other unreasonably high risks associated with a
generic drug (commonly known as Propoxyphene) approved by the FDA?"
¶ 106 Defendants are correct that, in order to state a claim for fraudulent concealment, a
plaintiff must allege "that the defendant concealed a material fact when it was under a duty to
disclose to the plaintiff." W.W. Vincent & Co. v. First Colony Life Insurance Co., 351 Ill.
App. 3d 752, 762 (2004) (citing Connick v. Suzuki Motor Co., 174 Ill. 2d 482, 500 (1996)).
Defendants cite in support W.W. Vincent, which states: "The concealment of a material fact
during a business transaction is actionable if 'done "with the intention to deceive under
circumstances creating an opportunity and duty to speak." ' " W.W. Vincent, 351 Ill. App. 3d
31
 No. 1-13-3940
at 762 (quoting Perlman v. Time, Inc., 64 Ill. App. 3d 190, 195 (1978), quoting Lagen v.
Lagen, 14 Ill. App. 3d 74, 79 (1973)). "A statement that is technically true may nevertheless
be fraudulent where it omits qualifying material since a 'half-truth' is sometimes more
misleading than an outright lie." W.W. Vincent, 351 Ill. App. 3d at 762 (citing Perlman, 64
Ill. App. 3d at 195, citing St. Joseph Hospital v. Corbetta Construction Co., 21 Ill. App. 3d
925, 953 (1974)).
¶ 107 A duty to disclose a material fact may arise out of several situations. Connick, 174 Ill.
2d at 500. First, if a plaintiff and defendant are in a fiduciary or confidential relationship,
then a defendant is under a duty to disclose all material facts. Connick, 174 Ill. 2d at 500.
Second, a duty to disclose material facts may arise out of a situation where a plaintiff places
trust and confidence in a defendant, thereby placing a defendant in a position of influence
and superiority over plaintiff. Connick, 174 Ill. 2d at 500. This position of superiority may
arise by reason of friendship, agency or experience. Connick, 174 Ill. 2d at 500.
¶ 108 Defendants do not argue on this appeal that they were not in a position of superiority
to plaintiff but argue that plaintiff's claim for fraudulent concealment is preempted pursuant
to Bartlett and Messing. Thus, we assume for the purposes of this appeal that defendants
were in a position of superiority.
¶ 109 The alleged half-truths or lies which led consumers to believe that the drug was
effective and safe, when, according to plaintiff's allegations, defendants knew it was useless
and risky, state a claim for fraudulent concealment. This claim is not preempted since
plaintiff is not claiming that the statements should have been changed. Plaintiff claims
instead that there were no warnings which would have magically transformed this allegedly
useless and risky drug into a drug that was safe and effective. Thus, the only possible means
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No. 1-13-3940
of protecting the vast majority of consumers, namely, to not market this useless and risky
drug, also posed no conflict with the generic drug company's duty of sameness.
¶ 110 Thus, to the extent that the Mensing/Bartlett precedent applies to post-2007 claims, it
does not bar plaintiff's fraudulent concealment claims against the generic manufacturer and
distributor.
¶ 111 F. Statutory Claim
¶ 112 The fifth certified question asks: "Does the Bartlett/Mensing precedent require the
dismissal on federal preemption grounds of a cause of action under the Illinois Consumer
Fraud and Deceptive Business Practices Act [(815 ILCS 505/1 et seq. (West 2012))], alleging
a generic drug (commonly known as Propoxyphene) approved by the FDA?"
¶ 113 The elements of a claim for consumer fraud in Illinois are: (1) a deceptive act or
practice by the defendant; (2) the defendant's intent that the plaintiff rely on the deception;
and (3) that the deception occurred in the course of conduct involving trade and commerce.
Connick, 174 Ill. 2d at 501; 815 ILCS 505/10a (West 2012) ("Any person who suffers actual
damage as a result of a violation of this Act committed by any other person may bring an
action against such person."); 815 ILCS 505/2 (West 2012) (describing violations of the Act).
¶ 114 Plaintiff's reliance is not an element of statutory consumer fraud. Connick, 174 Ill. 2d
at 501; 815 ILCS 505/2 (West 2012) (the Act is violated "whether any person has in fact
been misled, deceived or damaged thereby"). However, a plaintiff must allege that
defendant's consumer fraud proximately caused plaintiff's injury. Connick, 174 Ill. 2d at 501.
¶ 115 The first element of consumer fraud requires a showing of a deceptive act or practice,
which the Act defines as "including but not limited to the use or employment of any
deception, fraud, false pretense, false promise, misrepresentation or the concealment,
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No. 1-13-3940
suppression or omission of any material fact, with intent that others rely upon the
concealment, suppression, or omission of such material fact, or the use or employment of any
practice described in Section 2 of the 'Uniform Deceptive Trade Practices Act', approved
August 5, 1965, in the conduct of any trade or commerce." 815 ILCS 505/2 (West 2012).
¶ 116 Plaintiff alleges: (1) that defendants engaged in deceptive practices when they
advertised the drug as safe and effective and it was not, and when they promoted the sale of
the drug through misrepresentation, concealment and omission of such material fact; (2) that
defendants intended the public to rely on their statements; and (3) that the deception occurred
during the commerce and promotion of the drug.
¶ 117 Defendant does not contest plaintiff's allegations on this appeal, arguing instead that
the claim is preempted pursuant to Bartlett and Mensing. In the sections above, we have
already addressed plaintiff's claims for defendant's alleged fraud, misrepresentation and
concealment. Plaintiff's consumer fraud claim for defendants' alleged fraud,
misrepresentation and concealment is not preempted for the same reasons.
¶ 118 Thus, to the extent that the Mensing/Bartlett precedent applies to post-2007 claims,
they do not bar plaintiff's consumer fraud claim.
¶ 119 CONCLUSION
¶ 120 We answered each of the certified questions above. In sum, to the extent that the
Mensing/Bartlett precedent applies to post-2007 claims, plaintiff's Illinois state-law claims
are not preempted.
¶ 121 The case is remanded for further proceedings consistent with this opinion.
¶ 122 Certified questions answered; remanded for further proceedings.
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