[Drug and Device Law] Illinois Appellate Court Misapplication of Bartlett Preemption: The Monster Case of the Week
It was big news that there will be a six hour return of The X-Files, a show that dazzled us from 1993 to 2002. The "myth-arc" episodes about an alien invasion, black oil, and the disappearance of Special Agent Mulder's sister were overwrought and confusing, but the standalone entries were television at its creepy best. The bullpen of X-Files writers was stellar, including, among others, Darin Morgan and Vince Gilligan. You probably have heard of Gilligan, since he later went on to helm a program now carved on the medium's Mt. Rushmore, Breaking Bad. (Gilligan's current show, Better Call Saul, is also quite good. And the 'hero' is a lawyer!) Morgan is less well-known, but he penned some of the most admired X-Files episodes, which married humor to mystery in ways not matched since. If you want to treat yourself to three hours of splendid viewing, fire up Netflix and take in these four all-time great X-Files episodes, the first two by Morgan and the latter two by Gilligan:
* "Humbug" (season 2, episode 20): forget about who killed vaudeville - who is killing all the sideshow acts?
* "Clyde Bruckman's Final Repose" (season 3, episode 4): Peter Boyle as a sardonic psychic. Boyle and Morgan both won Emmy awards for this one.
* "Drive" (season 6, episode 2): Bryan Cranston needs to drive at top speed or his head will explode.
* "X Cops" (season 7, episode 12): In addition to the usual, shirtless drunks who get their moment of infamy on the Cops reality show, the perpetrators here might include a werewolf and Freddy Krueger.
There was a phrase for the wonderful one-off episodes of The X-Files: the “monster of the week.”
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Now we will take a look at a case that is so bad in result and reasoning that we hereby nominate it as the monster of the week. We wouldn’t be a bit surprised if it makes it onto the 2015 Worst-of list. The case is Guvenoz v. Target Corp. et al., 2015 Il. App (1st) 133940 (Ill. App. March 27, 2015). It is an interlocutory appeal in a case where it was alleged that the decedent sustained cardiac arrest after taking generic Darvocet medicine. In ruling that the claims were not preempted, the Illinois Appellate court essentially stuck a thumb in the eye of the U.S. Supreme Court by reading the Bartlett decision in such a way as to render it nonsensical. We wish that our report on the Guvenoz opinion was merely an April Fool’s Day joke. No such luck.
Here is how the Illinois Appellate court characterized the defendants’ appeal: “In essence, what defendants are arguing on this appeal and at this early stage of the litigation is that they should be able to market a drug, even assuming that they know it is dangerous and useless, until the FDA officially stops them, and then bear no financial responsibility for the consequences.” (Guvenoz, par. 4.) (The only good thing we can say about this dreadful opinion is that we like the paragraph numbering. It brings us back to our college Western Philosophy class days, where the works of Kant, Hegel, and Nietzsche came with paragraph numbering. But Kant, Hegel, and Nietzsche made a whole lot more sense than Guvenoz.) Anyway, here we are at the beginning of the opinion, and we are already impressed by the court’s restraint and impartiality. The court then goes on to set out the facts that it thinks will support its circumvention of Bartlett. We learn that in June 2009, the European Medicines Agency recommended that the marketing authorization be withdrawn across the European Union due to safety concerns. So what? That is the sort of thing that usually gets excluded from product liability cases, because different regulatory standards make foreign actions more prejudicial than probative. Why should we care what the Europeans do? They started all those hideous wars. They dress in shorts and black socks. They like soccer. They never put enough ice cubes in a drink. They are responsible for that culinary catastrophe politely called the Continental breakfast. But to the Illinois appellate court, the European action sets the stage.
After the European Medicines Agency recommended the medicine’s withdrawal, and after the FDA required a new safety study, the plaintiff’s decedent was prescribed 72 Darvocet tablets between January 8, 2010 and May 13, 2010. On that last day, he suffered a cardiac arrest. The Illinois appellate court points out that “just six months after Lewis’s [Lewis is the first name of the plaintiff’s decedent; we’ve had courts yell at us for calling parties by their first name] cardiac arrest, on November 19, 2010, the FDA required manufacturers to withdraw any products containing propoxylene, including Darvocet and Darvon, from the United States market.” (Par. 19) Let’s see if we can rephrase that: when Lewis took Darvon, it was on the market legally, and the FDA had determined that it was safe and effective.
The defendants argued that the plaintiff’s claims at their core were an attack on the sufficiency of the warnings about the drug’s risks. Not so, said the plaintiff. Rather, the claim was that the drug was simply unsafe and should not have been sold at all. Sound familiar? That is the exact-same, carbon-copy, stop-selling claim that the U.S. Supreme Court held in Bartlett was preempted. (We cannot be sure, but it looks as if the plaintiff in Guvenoz amended the complaint in the wake of Mensing, only to couch the claims along the identical lines preempted in the Bartlett case.) Why wouldn’t Bartlett preempt these claims, no matter how sympathetic the plaintiff, or how irked the court might be by the different treatment of plaintiffs depending on whether they bought cheap generic drugs or more expensive branded drugs?
The Illinois Appellate court first teases us about whether Bartlett can be distinguished because it predated the FDA Amendments Act 2007. The U.S. Supreme Court never addressed that issue. Nor did the parties in Guvenoz make that argument. So the Illinois appellate court won’t Go There. The court tells us this several times. It is as if the court is darkly hinting that if we disapprove of its brazen eradication of Bartlett, there are other avenues for getting to the required result. Maybe it is a wink to the Illinois Supreme Court, which must by now be exhausted from repeatedly overturning the lunacies from the lower courts.
Then the Guvenoz court devotes some ink to how it is the defendant’s burden to demonstrate that preemption applies. So if you do not like this decision, it is not the court’s reasoning that pushed the law off a cliff; it is because the defendant failed to meet its burden. Mensing is dispensed with because that case dealt with failure to warn claims. Along the way, the Illinois appellate court sees fit to quote a Tenth Circuit opinion “[l]amenting the ‘potential injustice’ created by” Mensing. (Par. 58) This is a court wearing its judicial heart on the sleeves of its judicial robes. Be that as it may, now all that stands in the way of the plaintiff and years of expensive litigation and the devoutly-wished-for settlement is that pesky Bartlett case. How can even the smartest, most motivated philosopher kings remove that unpleasant obstacle?
Ready? Here it comes: when the Supreme Court expressly rejected the stop-selling theory, “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. 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.” (Par. 67, citation to Bartlett omitted.) Of course, that FDA conclusion came after the plaintiff’s usage. Does the FDA’s conclusion call off preemption no matter what were the reasons behind the conclusion, or whether those reasons were earlier known by the defendant? What if a plaintiff brings a case, and the FDA has ordered no withdrawal? So, even under Guvenoz, there would be preemption, right? And then what if the FDA later does order a withdrawal? Could the case then be resurrected? We do not think so. So should wily plaintiff lawyers wait until just before the statute of limitations expires, all the while lobbying the FDA like crazy to order withdrawal of the drug? Isn’t there something odd, unworkable, and unfair about making preemption hinge on whether an agency ordered withdrawal? (Mind you, we Pennsylvania lawyers are wondering whether recent, scary interpretations of our product liability law turn on whether a product was withdrawn from the market. Call us perplexed, not hypocritical.)
It is simply unsound to suggest that an FDA-ordered withdrawal alters the preemption landscape. For example, there are heaps of device (express) preemption cases where courts held that even though a device has been recalled, the recall did not invalidate the PMA so as to preclude a preemption defense. See, e.g., Gross v. Stryker Corp., 858 F. Supp.2d 466, 474 n.13 (W.D. Pa. 2012); Steele v. Depuy, 295 F. Supp.2d 439, 445 (D.N.J. 2003); Hughes v. Boston Scientific Corp., 669 F. Supp.2d 701, 715 (S.D. Miss. 2009), rev’d on other grounds 631 F.3d 762 (5th Cir. 2011); Moore v. Sulzer Orthopedics, Inc., 337 F. Supp.2d 1002, 1004 (N.D. Ohio 2004); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1023 (E.D. Mich. 1993); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158-1163 (D. Minn. 2009), reconsideration denied No. 08-1905 (RHK/JSM), 2009 WL 294353 (D. Minn. Feb. 5, 2009), aff’d 623 F.3d 1200 (8th Cir. 2010); Blanco v. Baxter Healthcare Corp., 158 Cal.App.4th 1039, 158 Cal. App. 4th 1039, 1055-1056 (Cal. App. 2008), review denied (Cal. April 9, 2008); Gow v. Medtronic, Inc., No. CI-01, 2010 WL 3643754 (Ky. Cir. Aug. 26, 2010); In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, Nos. 27-CV-07-22446, et al., 2009 WL 3417867 (Minn. Dist. Oct. 20, 2009); Mitaro v. Medtronic, Inc., 23 Misc.3d 1122(A), 886 N.Y.S.2d 71 (table), 2009 WL 1272398, at *5 (N.Y. Sup. April 9, 2009), aff’d 73 A.D.3d 1142, 900 N.Y.S.2d 899 (N.Y. App. Div. 2010); Baker v. St. Jude Medical, 178 S.W.3d 127, 132 (Tex. App. 2005), review denied (Tex. Dec. 15, 2006), cert. denied, 128 S.Ct. 1441 (2008). Moreover, a recall is not a withdrawal of FDA approval. Compare: 21 U.S.C. § 360h(e); 21 C.F.R. §§ 810.10-18 (governing recalls), with 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46 (governing withdrawal of approval).
Or is the Guvenoz opinion saying that all it takes to nullify preemption is for the plaintiff to allege that the product should be withdrawn, whether or not the FDA ever gets around to ordering it? The Guvenoz court emphasizes that “the facts in the case at bar are very different from the facts in both Bartlett and Mensing. In the case at bar, the 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.” (Par. 72, citing Bartlett) So preemption is called off whenever the plaintiff alleges that the drug is potentially dangerous for everyone? If that’s all it takes, just watch plaintiff lawyers everywhere add a new paragraph to their boilerplate complaints with precisely that allegation. Easy-squeezey. Or easy-sleazy. And, anyway, how can the Guvenoz court characterize Bartlett the way it does when the plaintiff in Bartlett explicitly advocated that the defendant completely stop selling the product?
To the extent there is any pretense at analyzing what the Bartlett opinion actually said, we are treated to sophistry of the lowest order. The Guvenoz court several times quotes the Bartlett majority’s pronouncement that the “dissent is quite correct that federal law establishes no safe harbor for drug companies – but it does prevent them from taking certain remedial measures.” Bartlett, 133 S. Ct. 2466, 2479 (2013). The U.S. Supreme Court was making the point that the plaintiffs’ design defect claim was necessarily a nonstarter because the FDA would not permit a generic manufacturer to change the molecular formula. The FDA also would not permit a generic company to change the label, but the Bartlett plaintiff had cannily dropped the failure to warn claim (though in reality that claim, or one that smelled very like it, was repeatedly smuggled into the trial). Now watch what the Guvenoz case does with what is almost a throwaway line: “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.” (Par. 68) Thus, if the company could have somehow improved the product or its label, the plaintiffs have no case. But if the company could not have improved the product or label, the litigation may proceed. That makes no sense textually or logically. And while the Guvenoz case is busily swimming in the no-safe harbor, it completely ignores what the U.S. Supreme Court actually said in rejecting the stop-selling option: “We reject this ‘stop-selling’ rationale as incompatible with our preemption jurisprudence. Our preemption cases presume that an actor seeking to satisfy both its federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be ‘all but meaningless.’” Bartlett, 133 S. Ct. at 2477 (citations omitted). The U.S. Supreme Court also pointed out the “incoherence” of the stop-selling theory by observing that in every case where the Court had concluded there was impossibility prevention, the defendant could have avoided the direct conflict between federal law and state jury vengeance if it had stopped selling. The stop selling theory either proves too much or it proves too little. What it really proves is that result-oriented reasoning is a disaster.
The tagline in The X-Files was that “the truth is out there.” Maybe so, but you won’t find it in the Guvenoz opinion.
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Posted By Steve McConnell to Drug and Device Law at 4/01/2015 07:30:00 AM --
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