                                          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' 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' sections 2-615 and 2-619 motions 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

        and useless, until the Federal Drug Administration (FDA) officially stops them, and then bear

        no financial responsibility for the consequences.

            1
              The "overwhelming" majority of courts have held that generic consumers may not sue
     the brand-name manufacturer. In re Darvocet, 756 F.3d 917, 938 (6th Cir. 2014).
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¶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 Act (815 ILCS 505/1 et seq.

          (West 2012)), against Teva and Target; in counts IX and X, loss of consortium against




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          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

          information about the drug's cardiac effect would be relevant in assessing its risks and

          benefits.


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       No. 1-13-3940


¶ 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' 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.

¶ 21             The complaint does not allege that Lewis purchased and ingested propoxyphene

          which 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


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          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.

¶ 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.


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       No. 1-13-3940


          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 which we summarized above in our description

          of the complaint. Dr. Barkin concluded, to a reasonable degree of pharmacologic and

          scientific certainty, that Lewis' "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 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."




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       No. 1-13-3940


¶ 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. __, __, ] 123 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

                 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


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       No. 1-13-3940


                  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

          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


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       No. 1-13-3940


          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 U.S.

          Supreme Court did, we express no view on the impact of the 2007 Act on plaintiff's claims.

          Mensing, 564 U.S. at __, 131 S. Ct. at 2574 n.1. ("All relevant events in these cases predate

          the Food and Drug Administration Amendments Act of 2007 [citation]. We therefore refer

          exclusively to the pre2007 statutes and regulations and express no view on the impact of the

          2007 Act."); 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); 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.

¶ 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:




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                 "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(c) (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.

¶ 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 v. Ivanov, 2014 IL App (1st) 133553,


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       No. 1-13-3940


          ¶ 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 Gatreauz v. DKW

          Enterprises, L.L.C., 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. Hearland 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 failed to

          demonstrate that it was impossible for it to comply with both federal and state

          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

              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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          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 574. 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' intent and purpose in the 1962 amendment).

¶ 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


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          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

          "therapy 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 12 weeks."

          Mensing, 564 U.S. at _, 131 S. Ct. at 2572-73. 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 2573. The Mensing plaintiffs took the drug in 2001

          and 2002, which was when the package insert warned that "therapy 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.


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¶ 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 manufactures "makes little

          sense." Mensing, 564 U.S. at __, 131 S. Ct. at 2582.         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,

          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


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          [dismissal] below in light of controlling [Supreme Court] caselaw, we cannot help but note

          the basic unfairness of the 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

          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.").


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¶ 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 who was held liable in Wyeth v. Levine, 555 U.S. 555 (2009), rather than

          the generic manufacturer who 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.

¶ 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, 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


                                                      17
       No. 1-13-3940


          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

          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.


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¶ 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 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, 78-

          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




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          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 forseeable

          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.

¶ 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


                                                        20
       No. 1-13-3940


          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 which 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.

¶ 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.




                                                        21
       No. 1-13-3940


¶ 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, 751 F.3d 150, 157-58, 165 (3d Cir. 2014) (strict-

          liability claim against a generic 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 or implied warranties," and "fraud and misrepresentation in the

              3
                Although we provide only an e.g. cite here, a more complete list of cases is provided in
       ¶ 82, with their approximate complaint-filing dates.
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       No. 1-13-3940


          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, 678 (Mo. App. E.D. 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, 716 F.3d 1087, 1096 (8th Cir. 2013)

          (remanding, 10 days before Bartlett was decided, plaintiff's "design defect and breach 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 pre-empted");

          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, 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); Fosamax, 751 F.3d at 154 (the


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       No. 1-13-3940


          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, 751 F.3d 674, 677 (5th Cir. 2014) (the complaint was amended before

          Bartlett); In re Darvocet, 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 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


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       No. 1-13-3940


          plaintiff was using the product"); Schrock, 727 F.3d at 129 (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

          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


                                                       25
       No. 1-13-3940


          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 249, 270 (2007); Lewis, 2014 IL

          App (1st) 123303, ¶ 8 (citing Marshall v. Burger King Corp., 222 Ill. 2d 422, 430 (2006)).

¶ 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.




                                                       26
       No. 1-13-3940


¶ 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.

¶ 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 customer

          would expect when used in an intended or reasonably foreseeable manner." Calles, 224 Ill.


                                                       27
       No. 1-13-3940


          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,

          defendants claim that, even if these allegations are true, plaintiff's strict liability claim is pre-

          empted 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,




                                                         28
        No. 1-13-3940


           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. Jane Doe-3

           v. McLean County Unit District No. 5 Board of Directors, 2012 IL 112479, ¶ 28 (citing

           Board 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. Jane 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. Jane 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


                                                         29
        No. 1-13-3940


           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

           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?"




                                                       30
        No. 1-13-3940


¶ 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., Ltd, 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 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 which 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 (quoting

           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




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           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

           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) (the

           Act))], 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




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           damages 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,

           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.


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¶ 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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