Last week we were going through the regulatory record of a drug that is now the subject of mass tort litigation.  This effort is central to assembling, per the SCOTUS Wyeth v. Levine case, “clear evidence” that the FDA would not have approved whatever label change the plaintiffs are advocating.  Then we remembered something.  It was even worse than remembering that we left the stove on, or that we left the garage door open, or that we root for the Phillies. We remembered that our case would be governed by Third Circuit precedent, and that the Third Circuit had done its best in the Fosamax case to make it impossible to get summary judgment on preemption.

As we blogged back in March, the Third Circuit in Fosamax reversed summary judgment for the manufacturer and held that it is a question for the jury whether the manufacturer had proved with clear and convincing evidence that the FDA would have disapproved the exact warning suggested by the plaintiffs.  Throwing what was really a legal issue to the jury and wrapping said issue in a heightened evidentiary standard that neither the Supreme Court nor any other court of appeals has ever adopted was doubly wrong, wrecked the law on preemption, and presented the plaintiff bar with an undeserved gift that would ultimately decrease drug innovation and increase drug prices.  What was truly bizarre about the Fosamax decision was that the FDA had, in fact, rejected the warning.  That is about as “clear” a bit of evidence as one could imagine.  But that rejection was not good enough for the Third Circuit, which wondered whether the rejection might have turned on the particular wording of the warning.

The Fosamax decision is such an obvious, pernicious error that, in the words of Tony Soprano’s crew members when another gangster becomes much too troublesome, it “has got to go.”  (The Sopranos was set in North Jersey, which is, in fact, in the Third Circuit, so the analogy isn’t too overwrought.)

The petition for certiorari in the Fosamax abomination has been filed, and it is a beauty. You can read it here.  If it doesn’t catch the Supreme Court’s eye and alert it to lower court destruction of preemption precedent, it is hard to imagine what would. To begin with, the petition does a magnificent job of doing that thing we were all taught to do in law school: stating the issue in a way that seems to compel the right – and winning – answer.  Here is the question presented according to the petition:  “Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being presented with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?” Petition at i.  See what we mean? Asking a jury to conjecture about motives is plainly silly, especially in the face of an FDA rejection of a warning.

The Third Circuit’s decision turns on dithering over whether the FDA might have approved the warning if it had been phrased slightly differently. The petition places this speculative misadventure in the context of a larger trend of lower courts erecting substantive and procedural hurdles to the preemption defense because lots of judges simply don’t like preemption.  The Fosamax decision is especially crazy because it invites “a lay jury’s psychoanalysis of why the agency had blocked compliance with local law.”  Petition at 2.  There are two key aspects of the Fosamax preemption test. First, the panel took the “clear evidence” language from Levine and twisted it into a requirement that a defendant prove it is “highly probable” that the FDA would have rejected the label change.  That bit is hard enough. But the second step really builds in the impossibility of establishing impossibility preemption: because the issue of whether the FDA would have rejected a proposed change is “counterfactual,” the question must go to the jury unless there is a “smoking gun” rejection letter from the FDA that would leave the jury no choice but to find the state-law claim preempted. Petition at 12.

This sort of manifest error needs correction, and SCOTUS has demonstrated a proclivity for granting review to correct lower court decision that limited or circumvented (or, as the petition says on page 15, “defied”) preemption. See Mensing and Bartlett.  The petition also takes us on a tour of rotten preemption decisions, such as Reckis (Mass. 2015), Mason (7th Cir. 2010), In re Prempro (8th Cir. 2009), and Hutto (La. Ct. App. 2011).  We are unsurprised to see a decision from our own Commonwealth represented in this preemption Hall of Shame:  Gurley (Pa. Super. Ct. 2015). But the Fosamax error reaches a high-water mark because it makes it virtually impossible for a brand name drug manufacturer to establish preemption, as plaintiff lawyers and their paid experts “can always dream up some ‘hypothetical’ reason why the FDA might have rejected a proposed warning – and under the decision below, that suffices to reach a lay jury.  The jury would then be asked (case-by-case) to guess as to why the federal regulator blocked the manufacturer’s state-law compliance.” Petition at 14. The way in which the rule was concretely applied in Fosamax highlights its absurdity: “[E]ven though the FDA did reject Merck’s warning, the jury could conjecture about the FDA’s reasoning and thereby conclude that the agency would not have rejected the warning had Merck improved its draftsmanship.”  Petition at 25.

The Fosamax transformation of Levine’s “clear evidence” language into a heightened “clear and convincing evidence” standard abrogates the strong default rule in civil litigation that matters are to be proved by a preponderance of the evidence. Petition at 26.  Typically, courts await direction from the legislature before raising the evidentiary burden.  But the much-abused presumption against preemption, coupled with judicial hostility to preemption, apparently works doctrinal wonders  Moreover, the requirement that the clear and convincing evidence eliminate any possibility that the FDA might have arrived at a different decision from some theoretical change in circumstances or warning language is at odds with the teaching of Mensing and Bartlett that theoretical possibilities should not dislodge preemption. (Further, as we pointed out in an earlier post, the Fosamax determination that clear evidence preemption is a matter of fact for the jury is fully at odds with Third Circuit precedent that preemption is a question of law for the court.)

The petition concludes with an incisive discussion as to how the Fosamax erosion of preemption “threatens the pharmaceutical industry and the FDA’s regulatory role.” Petition at 31.  The manufacturer in the Fosamax case voluntarily disclosed risk information to the FDA, and the FDA rejected an enhanced warning.  To be found liable under such circumstances is ridiculously unjust, and places companies in a quandary. Meanwhile, the FDA’s rejection would be merrily second-guessed by juries around the country – a veritable nationwide festival of cynical counterfactualism.

The petition is so well reasoned, and the Third Circuit’s error is so egregious, that we harbor optimism that SCOTUS will take the case and, once again, clean up the law of preemption.  Two relatively minor references in the petition caught our eye.  First, we are told that it was Justice Alito who extended the time to file the petition for certiorari.  Petition at 3. Second, there is a quote from Justice Alito’s prescient dissent in Levine, where he warned against allowing “juries in all 50 states … to contradict the FDA’s expert determinations.”  Petition at 31, quoting Levine, 555 U.S. at 626. Justice Alito comes from the Third Circuit.  We are hoping he has a keen interest in ridding the law of an error created by his home Circuit.

It is also possible that the petition will induce SCOTUS to invite the FDA, now under a more pro-defense (and, we hope, pro-preemption) commissioner, for its views.

It is quite unusual for a state trial court to depart from that state’s highest court precedent.  But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.”  If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you go with SCOTUS.  That is what happened in Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Circuit Court May 8, 2017).  To see intervening SCOTUS authority dislodge a vexing state ruling is remarkable enough.  When that SCOTUS authority compels application of preemption – well, you just know we’re going to blog about it.

The plaintiff in Russell alleged injuries from a cardiac ablation procedure in which doctors used an “SF catheter.”  The plaintiff’s claims included strict liability, design defect, negligence (including failure to test), failure to warn, breach of warranties, fraud, unjust enrichment, and violation of Kentucky’s consumer protection statute.  The defendant filed a motion for judgment on the pleadings, arguing that the SF catheter was a Class III medical device that had gone through the pre-market application (PMA) process, thereby earning the protection of conflict preemption.  That is, no state jury could, via its verdict, impose obligations on a defendant that were in any way different from the FDA’s federal scheme.

If a product went through the PMA process, product liability litigation involving that product is usually a laydown.  No matter what theories are invoked by the plaintiff, preemption applies.   Sure, there is that annoying “parallel violation” exception, which we have written about endlessly, but let’s for the moment put that aside and pretend that the Supreme Court in Riegel had never penned that unfortunate dicta, and that appellate courts around the country had not wrestled with that same dicta in ways various and often incoherent.  This doctrinal confusion really is an instance of “what the SCOTUS giveth, the SCOTUS taketh away,” for it was the Riegel decision that established medical device preemption, and it was the Riegel case that permitted the Russell court to dispense with a bothersome Kentucky precedent.

The complication in the Russell case is that the SF catheter at issue had gone through several modifications since the initial PMA approval.  The SF catheter used in the procedure was part of an FDA-approved clinical trial under the auspices of an FDA investigational device exemption (IDE).  The legal question front and center in Russell was whether the IDE regulations involve the same sort of rigorous, device-specific safety requirements as the PMA process, such that full-blown preemption should apply.  The Russell court held that they did, and that preemption therefore foreclosed all of the plaintiff’s claims.

The plaintiff resisted preemption by contending that the SF catheter at issue did not receive PMA approval until 14 months after the procedure.  On the date of the procedure, all the SF catheter had going for it was an IDE, and a Kentucky Supreme Court decision back in 1997, Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997), had held that certain state law claims were not preempted in a case involving an intraocular lens used during a clinical trial under an IDE.  That non-preemption ruling would seem to be squarely relevant and binding precedent — save for Riegel, which SCOTUS decided 11 years after Niehoff.

The facts in Niehoff were distinguishable from Russell in two significant ways: (1) the product in Niehoff never received PMA approval, whereas the SF Catheter in Russell had, and (2) unlike the plaintiff in Niehoff, the plaintiff in Russell had signed a lengthy, FDA approved consent form acknowledging that the medical procedure in question was investigational. Even aside from those factual distinctions, the Russell court concluded that Riegel and its progeny made clear that the IDE procedure involved the same rigorous safety review process as pertains to a PMA, and that preemption applied. We do not know of a single IDE case after Riegel that has failed to apply extensive PMA preemption. Put another way, an IDE was much more like the PMA process covered by Riegel preemption than like the 510(k) substantial equivalence process that the earlier Lohr decision held did not merit preemption.  Plus there is the additional fact that the device in Riegel had gone through the PMA supplemental process, making it very like the SF catheter in terms of FDA posture.  (It really pays to read the details of a case, not just the headnotes.)

Once the Russell court decided that Riegel preemption applied to the SF catheter, the rest was easy.  Would the causes of action impose requirements different from or additional to the federal requirements?  The answer for every claim in the complaint was Yes.  And now inevitably, we come to the issue of whether there was a parallel violation alleged.  The Russell court reasoned that such a parallel violation must include: (1) a violation of a specific federal regulation (that “specific” is important and right away makes the Russell decision better than most), (2) a violation of an identical state law duty, and (3) a showing that violation of the federal rule caused the injuries. The plaintiff’s claims failed this test.  For one, the plaintiff alleged no deviation from the IDE requirements. Beyond that, the plaintiff’s claims essentially demanded that the defendant do more (secure a more detailed informed consent) or say more (additional warnings) than required by the federal scheme.  That is the stuff of preemption, not any parallel violation, and the court dismissed all of the plaintiff’s claims with prejudice.

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up the posts each week. We cannot say how blogworthiness relates to spongeworthiness, but we do know that the former involves asking a few questions, one of which is “is this just the same old same old?” In other words, even if the decision comes from a product liability case with a drug or device and addresses something that we think matters, we will not write about it if it adds nothing more than being another decision like we have seen many times before. Maybe it will be added to some cheat sheet or other compilation post, but it will not be worthy of its own post on this illustrious blog. (So illustrious are we that have noticed other blogs trying to rip off our name in the hopes that they will confuse search engines into directing traffic their way.)

When Levine came out with its misreading of the CBE regulation and novel “clear evidence” standard for impossibility preemption, we certainly did not think it would become so commonplace for prescription drug manufacturers—branded, in particular, although the liability of generics was not much of a concern then—to win warnings claims based on preemption. We are not yet there, but we can envisage a day where wins like in Seufert v. Merck Sharp & Dohme Corp., No. 13cv2928, 2016 WL 3369512 (S.D. Cal. May 11, 2016), just end up in our handy-dandy Levine cheat sheet For now, Seufert is still blogworthy.

Here are the basic facts. Plaintiffs sued over allegedly inadequate (absent) warnings on a purported risk of pancreatic cancer with two anti-diabetes drugs—the same compound is in each, with one adding metformin—within a class of drugs called incretin mimetics or incretin-based therapies. There are a number of approved drugs in this class, including one with its active ingredient derived from Gila monster venom. The two at issue were approved in 2009 and 2010 and there has been some degree of attention by FDA to a proposed risk of pancreatic cancer since they came on the market. It is not clear if plaintiffs contended that there was pre-marketing evidence of a pancreatic cancer risk specific to these two drugs, but we assume they did not have much if anything. In 2009, FDA reviewed adverse event data for the class of drugs and concluded “a causal association . . . is indeterminate as this time.” In 2013, FDA issued a “Drug Safety Communication” stating that it was analyzing the issue of pancreatitis and pancreatic cancer with the class of drugs, but that “it had not reached a new conclusion regarding whether incretin mimetics cause pancreatic cancer, and advised health care professionals to continue following the prescribing recommendations in the drug labeling”—which did not mention pancreatic cancer. Based on the plaintiffs’ case numbers, it looks like this Communication started them suing.

Continue Reading Another Prescription Drug Warnings Preemption Decision