Welcome to our annual Elysium tour, in which we electronically acknowledge the sweet nectar of victory flowing from the top ten drug/device product liability decisions of the year. It’s time to salute those fortunate decisions that brought the judicial Midas touch to our clients’ cases. We echo what we said last year: “we’re looking for nothing but pleasant news . . . [a]nd make no mistake about it, there’s plenty to celebrate this year.”
Occasionally, a court will do something decidedly anti-Dionysian, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re expecting pleasant dithyrambs from 2019’s paragons of judicial reasoning.
Before the Great Panathenaia begins, we remind readers that our scope of coverage is limited. Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined). Cases are decided each year that significantly impact what we do, even though not involving prescription medical products. So, we’ll tip our collective pilei to In re Amendments to the Florida Evidence Code, 278 So.3d 551 (Fla. 2019) (discussed here), not really a “case” at all, but a monumental step forward for Florida law – adopting a Daubert-based standard for admissibility of expert witnesses. Kudos also to two talc wins, State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019) (discussed here), granting mandamus to disapprove venue abuse in St. Louis; and Johnson & Johnson Talcum Powder Cases (Echeverria), 249 Cal. Rptr. 3d 642 (Cal. App. 2019) (discussed here), j.n.o.v.ing several parts (including punitive damages) of an absurd $400+ million verdict and granting a new trial as to the rest due to inadequate causation evidence. Also noteworthy is Fitzpatrick v. Wendy’s Old Fashioned Hamburgers, ___ N.E.3d ___, 2019 WL 5792847 (Mass. App. Nov. 7, 2019) (discussed here), the first express appellate condemnation of plaintiff-side “reptile” tactics. Finally, we recognize American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (discussed here), for holding that the First Amendment precludes governmental mandate of a controversial “safety” statement in product advertising.
Enough with the introductions. Now, let’s proceed with the panegyrics.
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). Even though Albrecht has enough aspects we don’t like to be named simultaneously as our sixth worst case, the Court’s disposition of the core preemption issues promises to be so beneficial to all defendants that Albrecht is also our number one best case for 2019. Already, it wiped out our worst case of 2017, as well as two decisions that otherwise might have made this year’s bottom ten. The impact of Albrecht’s holding that preemption is always a question of law for the court – including resolution of any subsidiary factual disputes – should have numerous beneficial effects. The Third Circuit’s ill-fated “clear and convincing evidence” standard likewise vanished with the “question of fact” misnomer, and with no facts for juries to decide, the summary judgment “most favorable to nonmovant” standard for viewing facts also drops out (it hasn’t applied in analogous patent litigation). Albrecht thus removed pro-plaintiff thumbs from the evidentiary scale in preemption cases. In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments. Courts can no longer cop out, or kick the can down the road, with the excuse of “disputed” facts. Since expert testimony on questions of law is improper, obfuscation of preemption issues by paid “FDA experts” should lessen. Also, with preemption as a discrete legal issue, separate from trial, arguments for interlocutory review of adverse preemption decisions improve (although judicial factual determinations, where present, may well get appellate “clearly erroneous” deference). These points improve defense chances in all preemption cases, implied or express, since a level playing field should also greatly assist defeating FDCA intensive “parallel violation” claims in PMA preemption cases. Other useful points include the Court’s first discussion of “overwarning” as a policy concern. Albrecht omitting any “presumption” about preemption in its extensive Levine (2009-1) discussion, instead using only the older “assumption” language. The last vestiges of the so-called “presumption against preemption” are now in doubt. Albrecht also doubled down on the FDA changes-being-effected (“CBE”) regulation defining Levine’s safe harbor against impossibility preemption, which creates preemption arguments for everything that CBE doesn’t cover. Even the reformulated FDA “fully informed” gloss on Levine “clear evidence” opens the door to the FDA itself answering that question (see the above 95% reference). Likewise, the decision’s discussion of “force of law” also cuts both ways, and should restrict plaintiffs’ ability to rely on warning letters and other FDA actions lacking the required legal status. Since preemption is the strongest defense our side has, all these favorable holdings and implications make Albrecht our number one decision for 2019. We analyzed Albrecht on multiple occasions, most notably here and here, and will undoubtedly do so again.
- Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019). Gibbons is a two-fer. Its preemption ruling is extremely helpful – affirming in all respects the district court’s extensive and expansive preemption rulings based, not on Levine (2009-1) clear evidence, but on the “newly acquired information” limitation in the FDA’s CBE regulation. Those rulings showed the strength of “newly acquired evidence” as a separate preemption basis, enough to be our top district court decision in 2017. Gibbons also confirmed that Mensing (2011+1)/Bartlett (2013+1) preemption is indeed of universal applicability, and not limited (as plaintiffs argued) to generic drug cases. Thus, whenever FDA pre-approval is required for a given alteration in the design or warning of a drug (or device), the Mensing independence principle mandates preemption. Gibbons also confirms the value of TwIqbal in preemption cases, upholding preemption where plaintiffs failed to plead any “newly acquired information” that could get them into Levine’s CBE preemption safe harbor. Gibbons demonstrates the power of preemption – an entire MDL went down to defeat. That’s one. The second part of Gibbons strongly confirmed that defendants can properly remove cases to federal court before service of process on a “forum defendant” that would otherwise prevent removal. That’s what the statute said, so that’s what defendants can do. Litigation tourist plaintiffs have exploited the archaic “forum defendant rule” to create mass torts in their favored locales, even though their target defendant is otherwise diverse and would be exposed to pro-plaintiff “home cooking” in such places. For handing defendants wins in both preemption and removal, Gibbons comes in second only to a Supreme Court decision. We goggled over Gibbons here.
- Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019) (here). Preemption, again. Hey, it’s our strongest defense. In this pre-market approval case, the plaintiff sought to prove the FDCA violation necessary to support a “parallel violation” claim on what amounted to res ipsa loquitur – asserting that a device malfunction allows the inference, not just of a product defect, but of a regulatory violation (but don’t ask the plaintiff what it was). Weber became the first appellate court to hold that plaintiffs can’t do that. Res ipsa loquitur may allow inference of a product defect, but not a violation of any particular regulation. Instead, to avoid preemption, a plaintiff must show that the defendant device deviated from the device’s pre-market approval requirements or some other applicable FDA standard. The FDA approves devices knowing they can malfunction. Since full compliance can’t eliminate malfunctions, no inference of regulatory violation from a mere malfunction is possible. A secondary, and helpful, ruling in Weber was that a factual description of clinical trial results did not create any express warranty that every device would always perform within that description. Such a mandatory guarantee was “different from” applicable FDA requirements, and thus also preempted. We welcomed Weber here.
- In re 3M Bair Hugger Litigation, 924 N.W.2d 16 (Minn. App. 2019). The appellate decision that put an end to the Bair Hugger litigation rates as our best state-court decision of 2019. The opinion described what we called the “Dostoyevskian” origins of the litigation, stirred up by the jilted inventor of the device, who left the company under a legal cloud, invented a competing device, and then tried to use this product liability litigation as a tool either to obtain a competitive edge or to force the defendant to buy his company. Suffice it to say, that it did not end well for plaintiffs – particularly since the FDA disagreed with the inventor’s supposed “scientific” study of comparative device safety. Of course, the thrice-jilted inventor also served as plaintiffs’ expert in the litigation. Minnesota doesn’t follow Daubert, but in Bair Hugger that hardly mattered. The novel scientific theory touted by plaintiffs and their expert wasn’t generally accepted, so all the Bair Hugger claims failed on causation grounds. The best legal ruling in Bair Hugger was that the Frye test (Minnesota’s version, anyway) applied to both methods and to ultimate opinions. In other words, even when an expert is devious enough to manipulate accepted methods to reach a crazy result, the craziness of the result is sufficient to require exclusion. We gave Bair Hugger a big hug here.
- Robinson v. Davol, Inc., 913 F.3d 690 (7th Cir. 2019). Robinson was our best Daubert decision of the year. Plaintiff had a medical device – later recalled – implanted. Plaintiff also died from after implantation of the device. Plaintiff’s problem was that the two didn’t relate to each other. The recall did not involve any risk pertinent to the the decedent’s death. Plaintiffs’ three experts tried, but failed. The first simply wasn’t competent to make such a diagnosis. He was a “biomedical engineer” but didn’t know the medical issues surrounding the death. The second, the coroner who performed the autopsy, and later hired as a plaintiff-side expert, was properly excluded on the procedural ground of not being timely disclosed as a retained expert, since those opinions went beyond the autopsy. The third expert made up a novel causation theory, but had no pre-existing science to support his ipse dixit. He claimed to have seen it happen in his other patients, but refused to identify the patients or produce relevant medical records. Nor did the decedent’s medical records or autopsy contain any support. The Seventh Circuit found that opinion the paradigm of unreliability. No “differential diagnosis” worthy of the name was conducted, because the expert lacked any basis for ruling in the device as a possible cause. We recommended Robinson here.
- Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019). Mostly because of preemption, we don’t run across many product liability decisions involving generic drugs anymore. Sherman points out other reasons, besides preemption, why this is so. All of the usual inadequate warning claims would have been preempted (or might have been in the trial court; we can’t tell) so plaintiff appealed duty-to-update allegations and a claim that warnings should have been given “in ways other than the package insert.” Didn’t work. Turns out the prescriber didn’t rely on package inserts for drug risks at all. Preemption or no, non-reliance on an allegedly inadequate warning kills causation. Preemption probably would have taken out the “other ways” claim, but a quirk of the Washington product liability statute got there first. Warning claims by statute are limited to material “provided with the product.” The statute says what it says, so non-label-based claims don’t fly in Washington state. We saluted Sherman here, and, the Washington Supreme Court has since denied review. 2019 WL 6682200 (Wash. Dec. 5, 2019).
- In re Genentech, Inc., Herceptin (Trastuzumab) Marketing & Sales Practices Litigation, 367 F. Supp.3d 1274 (N.D. Okla. 2019). As was the case last year with Gustavsen (2018+2), garbage, no-injury class actions claiming dosage-related economic losses tend to produce favorable rulings. The product, a biologic, cannot be easily produced (if at all) in exactly identical units, so the FDA approved it for marketing within plus-or-minus weight tolerances around a specified midpoint. Plaintiffs claimed (in a class action, of course) that anything less than the specified midpoint shorted them out of valuable product. That’s the opposite of the aforementioned Gustavsen case, where too-large doses allegedly wasted valuable product. But the result was the same – preemption. First, FDA regulations specifically permitted “reasonable variation in dose, creating a direct, and preemptive, conflict. Second, plaintiffs could not challenge the FDA classification of the product. Third, a “draft guidance,” particularly one after-the-fact, did not create any enforceable FDA requirements that could be violated. Third, plaintiffs misinterpreted an FDA compliance guide to invent an exact dosage number that did not, in fact, exist. Finally, to comply with plaintiffs’ demands for exact dose would require a change in manufacturing processes requiring prior FDA approval, meaning preemption under the Mensing (2011+1) independence principle. We note that Genentech is currently on appeal, and given the numerous FDA-related arguments, our side of that appeal should be helped by Albrecht’s ruling that judges simply decide, straight up, which side is correct on preemption issues. We grooved on Genentech here. The district court’s decision is currently on appeal.
- Greager v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2019 WL 5549524 (N.D. Ill. Oct. 28, 2019). Historically, generic preemption has been very extensive, whereas the role of preemption in over-the-counter (“OTC”) drugs has been rather more limited. Thus, a lot of liability potentially depends on which side of that line generic OTC drugs fall. This question of first impression was answered in Greager, and its application of generic preemption is good news for any potential defendant manufacturer of generic OTC products. The drive-a-truck-through exception to OTC express preemption in the FDCA doesn’t affect application of generic preemption, because Mensing (2011+1)/Bartlett (2013+1) preemption is based on implied impossibility preemption. Implied and express preemption operate independently, meaning that the express saving clause (which is limited to “this section” in any event) doesn’t restrict the wide scope of implied generic preemption. The duty of sameness applies to OTC as well as prescription generics. For this potential impact on litigation over an entire class of drugs, Greager makes our list. We gloried in Greager, here.
- In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323 (S.D.N.Y. 2019). Simply the name of the injury plaintiffs were claiming in this latest tort-based assault on contraceptive choice indicates severe Daubert problems ahead – “idiopathic intracranial hypertension.” “Idiopathic” means an unknown cause. And that’s what happened. In 2018, the Daubert hammer came down on these claims, in a decision that was the first of our honorable mentions that year. But in an MDL, plaintiffs never give up no matter how weak their position. So despite all their experts being excluded, they claimed that they could prove that the drug caused “idiopathic” injury without any experts at all. Mirena held that argument was just as dumb as it sounded to us. Reviewing the law of all 50 states, Mirena found that, without exception, this kind of technical causation issue absolutely required expert support. Further, general causation was a requirement for all tort claims. As for the rather disorderly mess of non-expert “evidence” that plaintiffs claimed could prove causation, that “end run” was simply “unsustainable.” Last and least, plaintiffs’ Seventh Amendment challenge to an MDL-wide ruling was rejected. MDL Daubert decisions are a two-way street, a plaintiff loss has the same litigation-wide scope that plaintiffs claim when they win. We not only made much of Mirena, here, but Mirena inspired us to create our own 50-state survey of expert-required causation decisions here.
- Forrest Laboratories v. Feheley, 2019 WL 5485548, __ So.3d __ (Ala. Oct. 25, 2019). What is our only state high court decision in the top ten doing way down here? Because, frankly, the result should have been obvious. As we discussed at the time, in 2015 the Alabama legislature statutorily abolished the misguided innovator liability theory that a divided Alabama Supreme Court had created the year before in Weeks (2014-1). This statute even timed its effective date to match with the very day that Weeks was decided. So, of course, plaintiffs claimed that this statute either hadn’t, or couldn’t abrogate Weeks. In Feheley that Alabama Supreme Court held that, yes, the legislature had actually abolished innovator liability. Not surprisingly, this result was mandated by “the plain meaning of the words as written by the legislature.” Plaintiffs’ last-ditch constitutional argument also failed. Thus, the same court that decided Weeks accepted that its ruling had been overturned by the legislature as a co-equal branch of government. That’s great, but the legislative intent was so obvious that plaintiff should have been laughed out of court rather than being able to appeal all the way to the state’s highest court. We focused on Feheley here.
So these are our top ten picks as the best drug/medical device decisions of 2019. While our list seems preemption heavy (4 of 10), that’s actually no different than 2018 or 2017. Our picks reflect the simple fact that, where preemption exists, there is no stronger defense.
But we’re not done. 2019 was another good defense year (aside from opioids, which we can’t discuss for client reasons), so we found more than ten deserving decisions. Thus, here are our runners up, the next ten good 2019 decisions that didn’t quite crack our top ten.
Honorable Mentions: (11) Cerveny v. Aventis, Inc., 783 F. Appx. 804 (10th Cir. 2019), ended litigation that produced top-ten decisions in 2017 and 2016, holding that a claim about pregnancy warnings didn’t make any sense where the plaintiff only took the drug before being pregnant − with the added bonus of rejecting the post-Albrecht argument that preemption can’t be based on citizen petitions filed by non-manufacturers (here). (12) In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 358 F. Supp.3d 418 (E.D. Pa. 2019), demonstrates how personal jurisdiction can win cases, even where the plaintiffs aren’t litigation tourists (here). (13) In Nowell v. Medtronic Inc., 372 F. Supp.3d 1166 (D.N.M. 2019), the same judge who had, several years earlier, questioned the learned intermediary rule under New Mexico law resoundingly reaffirmed the rule’s application (here and here). (14) Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), would probably cracked the top ten had it been published, due to its first-in-the-nation post-Albrecht appellate ruling that FDA experts aren’t needed to decide “legal” preemption issues. The defendant won because plaintiff’s purported “violations” misconstrued FDA regulations (here). (15) Ideus v. Teva Pharmaceuticals USA, Inc., 361 F. Supp.3d 938 (D. Neb. 2019), rejected contraceptives and direct-to-consumer advertising as exceptions to Nebraska’s learned intermediary rule, and held the defendant’s warnings adequate as a matter of law (here). (16) Powers v. Merck & Co., 773 F. Appx. 304 (6th Cir. 2019), exemplifies how the Vaccine Act has killed off vaccine-related litigation, ruling that an intentionally added substance cannot be a “contaminant” (here). (17) Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. 2019), landed a one-two punch – first, the manufacturer’s warning was adequate as a matter of law, and second, since it was impossible for mere distributors to alter drug labels, preemption barred those claims (here). (18) Davis v. McKesson Corp., 2019 WL 3532179 (D. Ariz. Aug. 2, 2019), demonstrates that, for Daubert reasons, the other side’s second assault on gadolinium contrast agents will be much less successful than the first (2010-5) (here). (19) In McNeil-Williams v. DePuy Orthopaedics, 384 F. Supp.3d 570 (E.D.N.C. 2019), another court rejected the Stengel (2013-2) proposition that ordinary inadequate warning claims are somehow “parallel” to novel failure-to-report claims. No such claim exists in North Carolina (here). (20) Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4806271 (Conn. Super. Sept. 11, 2019). The best state trial court decision of the year. While ostensibly affirming this particular plaintiff’s verdict, it thoughtfully held that the claims most plaintiffs pursue in this mass tort are preempted, for the same “newly acquired information” rationale discussed, above, in Gibbons (here).
Our 2019 collection of cases concludes with a couple of near misses: Hindermyer v. B. Braun Medical, Inc., ___ F. Supp.3d ___, 2019 WL 5881073 (D.N.J. Oct. 30, 2019) (here), and Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019) (here).
Reviewing our prior lists of best and worst decisions, as already mentioned, the Supreme Court in Albrecht vacated the worst case of 2017, In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017). Recently the Third Circuit remanded the preemption issue to the trial court, so we’ll be watching what happens. More generally, we’re pleased to report that of our thirteen previous worst cases of the year (2017 had two), almost half are no longer good law, by reason of outright reversal (2017-1; 2016-1; 2012-1), legislative abrogation (2014-1; 2007-1), or being limited to their facts by subsequent rulings (2010-1). By contrast, all twelve of our annual best cases are still good law.
From this year’s lists, A.Y. (2019-3) is the subject of a pending reargument petition in the Pennsylvania Superior Court. From last year’s lists, on the dark side, Hammons (2018-3), has an appeal pending before Pennsylvania Supreme Court. All of those other rotten tomatoes appear to be final, at least on direct appeal. All of 2018’s top ten also seem to be concluded, with denial of certiorari in Dolin (2018+5). There is more activity, however, among the honorable mentions, as discussed above, Mirena (2018-11) will undoubtedly be appealed. An appeal to the Kentucky Supreme Court has been granted in the Russell (2018+17) IDE preemption case. Further appeal was denied in Caltagirone (2018+16), another preemption case, and an appeal was withdrawn in Byrd (2018+19). The others appear final.
As we thought last year at this time, the cy pres Supreme Court appeal in Frank v. Gaos turned into a rather good standing decision. See Frank v. Gaos, 139 S. Ct. 1041 (2019). The cy pres issues remain unresolved.
A quick and dirty review of the last few years of our earlier top/bottom ten lists found nothing suggesting further appeals or other consideration of the resolutions reached in those cases.
Looking forward, we know that an appeal from the adverse post-Safe Medical Devices Act §510(k) preemption decision in In re Bard IVC Filters Products Liability Litigation, 2017 WL 5625547 (D. Ariz. Nov. 22, 2017), is pending in the Ninth Circuit. A win would have a huge upside – recognizing express 510(k) preemption on the basis of the 1990 rewriting of the Medical Device Amendments – whereas a loss would leave our side basically where it is now. Closer to home, the Pennsylvania Supreme Court has a significant non-prescription medical product expert evidence decision pending (Walsh) on theories that could create some version of industry-wide liability. Pennsylvania Superior Court has a pending appeal (Emmet) on comment k and medical devices, as well as a pending non-prescription medical product en banc appeal (Murray) on corporate registration to do business as “consent” to personal jurisdiction. Bexis has filed amicus briefs in all of those appeals.
Finally, on the administrative front, we still haven’t seen any real FDA movement on its long-delayed promise to address the First Amendment obsolescence of its 1950s-vintage “intended use” regulations. Nothing concerning off-label use issues appears in the FDA Commissioner’s recent comprehensive remarks on the direction of the Agency. It appears, however, that the FDA itself has decided to go into the business of truthful promotion of off-label use. The FDA also released, last September, a “Medical Device Safety Action Plan,” available here. An interesting aspect of this plan is the National Evaluation System for health Technology (“NEST”), which is intended “to be an active surveillance and evaluation system.” Id. at 6. That should be one more nail in the coffin of claims predicated on failure to report, since if something’s serious, the FDA will probably learn about it (and thus be statutorily required to act, 21 U.S.C. §355(o)(4)(A)) independently of any reporting of adverse events.
Legislatively, there is a lot of talk about “high drug prices,” but whether that will actually result in legislation is questionable. We think that any legislation should address the high and increasing “tort tax” that all the litigation we write about is imposing on prescription medical products. All those crazy verdicts that we see – from Philadelphia, St. Louis, California, and elsewhere – would (if they stand up on appeal) only be satisfied by higher prices for all of the targeted defendants’ products, and the same goes for MDL settlements and litigation costs.