Court of Appeals of Illinois, First District, Fifth Division
NICOLE GUVENOZ, Individually and as Representative of the Estate of Lewis Guvenoz, Deceased, Plaintiff-Appellee,
TARGET CORPORATION and TEVA PHARMACEUTICALS USA, INC., Defendants-Appellants (Joshua Rosenow, M.D. Defendant)
[Copyrighted Material Omitted]
[Copyrighted Material Omitted]
Appeal from the Circuit Court of Cook County. No. 12 L 005162. The Honorable Moira S. Johnson, Judge, presiding.
For APPELLANT TEVA: Gregory E. Ostfeld, Caitlin Annatoyn, Greenberg Traurig, LLP, Chicago, Illinois; Lori G. Cohen, Victoria Davis Lockard, Greenberg Traurig, LLP, Atlanta, Georgia.
For APPELLANT TARGET: Emily L. Hussey, Richard Foster, Donohue Brown Matthewson & Smith LLC, Chicago, Illinois; Bryan T. Pratt, Shook, Hardy & Bacon LLP, Kansas City, Missouri.
For APPELLEE: Kevin M. Forde, Joanne R. Driscoll, Forde Law Offices LLP, Chicago, Illinois; Robert J. Napleton, Bradley Z. Schulman, Motherway & Napleton, LLP, Chicago, Illinois.
JUSTICE GORDON delivered the judgment of the court, with opinion. Presiding Justice Palmer and Justice McBride concurred in the judgment and 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 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' sections 2-615 and 2-619 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, 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.
[¶5] We analyze the relevant case law and answer the certified questions in the last section below.
[¶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 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 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.
[¶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.
[¶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 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 Mut. Pharm. Co. v. Bartlett, [570 U.S.
__, __,] 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013), PLIVA, Inc. v. Mensing, [564 U.S.
__, __,] 131 S.Ct. 2567, 2574, 180 L.Ed.2d 580 (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 ...