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 ) 

Representative of the Estate of Lewis Guvenoz, ) 

Deceased, ) 

 ) 

 Plaintiff-Appellee, ) 

 ) 

 v. ) 

 ) 

TARGET CORPORATION and TEVA ) 

PHARMACEUTICALS USA, INC., )

 ) 

 Defendants-Appellants ) 

 ) 

(Joshua Rosenow, M.D. ) 

 ) 

 Defendant). )

Appeal from the Circuit Court 

of Cook County. 

No. 12 L 005162 

The Honorable 

Moira S. Johnson, 

Judge, presiding. 

 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 

2 

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). 
No. 1-13-3940 

3 

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 
No. 1-13-3940 

4 

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 
No. 1-13-3940 

5 

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. 
No. 1-13-3940 

6 

¶ 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. 
No. 1-13-3940 

7 

¶ 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 
No. 1-13-3940 

8 

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 
No. 1-13-3940 

9 

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 
No. 1-13-3940 

10 

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. 
No. 1-13-3940 

11 

¶ 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. 
No. 1-13-3940 

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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 
No. 1-13-3940 

13 

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). 
No. 1-13-3940 

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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 longterm 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 
No. 1-13-3940 

15 

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 
No. 1-13-3940 

17 

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 brandname 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. 
No. 1-13-3940 

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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 
No. 1-13-3940 

19 

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 
No. 1-13-3940 

20 

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. 
No. 1-13-3940 

21 

¶ 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. 
No. 1-13-3940 

22 

¶ 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.
No. 1-13-3940 

23 

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 strictliability 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
No. 1-13-3940 

24 

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 
No. 1-13-3940 

25 

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 
No. 1-13-3940 

26 

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)). 
No. 1-13-3940 

27 

¶ 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.
No. 1-13-3940 

28 

¶ 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, 
No. 1-13-3940 

29 

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 "safeharbor" 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 
No. 1-13-3940 

30 

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 
No. 1-13-3940 

31 

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 
No. 1-13-3940 

32 

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 
No. 1-13-3940 

33 

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, 
No. 1-13-3940 

34 

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.