Ending the year on a high note is one thing that the Blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, 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 looking for nothing but pleasant news in going through our list of the best decisions of 2018. And make no mistake about it, there’s plenty to celebrate this year.
Before we continue, let us explain one thing. Our list is limited to cases involving drugs or medical devices. Every year has cases that significantly impact our sandbox, even though they’re not within the drug/device arena to which we’re devoted. Thus, we’ll tip our hat to Forman v. Henkin, 93 N.E.3d 882 (N.Y. 2018) (discussed here), which resoundingly reaffirmed defendants’ rights to complete discovery of plaintiffs’ social media. Another hat tip goes to Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 902 F.3d 147 (3d Cir. 2018) (discussed here), with a full-throated endorsement of removal before service in the first squarely on-point appellate decision. Finally, we like DeLeon v. BNSF Railway Co., 426 P.3d 1 (Mont. 2018) (discussed here), which answered in the negative a consent-to-jurisdiction question the United States Supreme Court had left open in 2017.
But as to those cases, we’re like movie reviewers going to off-Broadway plays. We can find plenty to like, but it’s not what we specialize in. It’s time for us to start giving the old two thumbs up to some really good decisions. Let’s start the show; the envelopes, please:
- McNair v. Johnson & Johnson, 818 S.E.2d 852 (W. Va. 2018). After the T.H. (2017-1A) and Rafferty (2018-1) decisions, we were fearful that the innovator liability tide might be turning against litigation sanity and towards the “everybody should recover for anything” philosophy of our opponents. Then, along came the West Virginia Supreme Court of Appeals in McNair with a victory for traditional product liability concepts, and also demonstrating this isn’t the same court it used to be. Indeed, McNair reads like a decision by the California Supreme Court, that is, by Justice Traynor fifty years ago, before the craziness set in. Like Traynor’s work, the McNair opinion is all about chain-of-sale, manufacturer-responsibility, and cost-spreading. Indeed, West Virginia’s former off-the-deep-end approach to the learned intermediary rule in Karl (2007-1), haunted the plaintiff here, since the statute that legislatively overruled Karl was also phrased in terms of the liability of drug “manufacturers,” and was cited as such in McNair. Moreover, McNair threw the plaintiffs’ “let’s all evade preemption” arguments back in their face, following the Supreme Court’s example, in the generic preemption cases, of refusing to “distort” the law to reach a certain result. And you know what? We keep an innovator liability scorecard (that is, both good and bad results), and there hasn’t been a single decision since McNair adopting innovator liability. McNair broke a worrisome trend, concerning an even more worrisome theory of liability, and for that reason, it’s number one on our good list in 2018. We marveled at McNair, here.
- Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018). Gustavsen gets our nod as the best preemption decision of 2018. It was about eye drop dosage, but where Gustavsen will be felt is in design defect claims. The First Circuit (often not our favorite court) framed the preemption argument straight-forwardly – was the product change that the plaintiffs (lots of plaintiffs; this was one of those bogus no-injury class action strike suits) sought a “major change” that required FDA pre-approval to implement? If so, then the Mensing independence principle mandated preemption, because it was impossible to square the necessity for agency pre-approval with the common law’s demand for immediate action. But what is a “major change”? Gustavsen extensively reviewed the FDA regulatory scheme, and concluded that changes to the dosage of a drug (here, eye drops) were major changes. But the decision relies on the same FDA material we’ve looked to, and that classifies as “major” anything that significantly impacts the safety or effectiveness of an FDA-regulated product. Think about that. A change that doesn’t significantly affect product safety won’t change the outcome and can’t be an alternative design. The bright-line approach in Gustavsen, means “ha det” to pretty much all design defect claims, including those involving 510(k) medical devices. Sometimes really bad cases make really good law, and Gustavsen is a prime example. We gloried in Gustavsen here.
- In re Accutane Litigation, 191 A.3d 560 (N.J. 2018). We remember a time, not so long ago, when the New Jersey Supreme Court had never affirmed the exclusion of an expert witness under a Daubert-like rationale – indeed New Jersey law didn’t even resemble Daubert, which is one reason it attracted litigation tourists from all over the country seeking places at mass tort feeding troughs spread around various New Jersey vicinages. In many ways, the long-running Accutane litigation was for years the epitome of what was wrong with the state’s mass tort system. Not now. In Accutane, the court found “little difference” between federal Daubert standards and those New Jersey follows, at least after Accutane. A terrible intermediate appellate Accutane decision (2017-6) letting everything in under a “flexible” standard and less-than abuse of discretion appellate review was reversed on practically every point, with the result that some 2,000 accumulated junk Accutane cases are finally dismissed as scientifically baseless – a determination made years ago by federal courts under Daubert. Following the discussion in Accutane, defendants should have no problem relying on the Reference Manual on Scientific Evidence in New Jersey state cases. Whether or not it will be called “Daubert” going forward, New Jersey now requires “rigorous” gatekeeping for expert witness testimony, including “proper” applications of “methodology,” skepticism of animal studies and “lower forms of [scientific] evidence.” Because of unpleasant experiences, we’re particularly gratified by the court’s criticism and limitation on Bradford-Hill opinions. Hello Daubert, and goodbye to Accutane litigation. We adulated Accutane here.
- Conklin v. Medtronic, Inc., ___ P.3d ___, 2018 WL 6613311 (Ariz. Dec. 18, 2018). In this late-breaking addition to our list, Arizona’s highest court unanimously gave the boot to the notion of a preemption-busting state-law “warning” claim for failure to report adverse events to the FDA – and thus consigns the Ninth Circuit’s abysmal contrary prediction of Arizona law in Stengel (2013-2) to the dustbin of history. Relying heavily on the court’s recent adoption of the learned intermediary rule in Watts (2016+1), Conklin’s rejection of failure to report as a tort duty was simple, and sweet: a manufacturer of a prescription medical product (Conklin’s rationale applies to both drugs and devices) is only obligated to provide adequate warnings to a plaintiff’s prescribing/treating physician. The FDA isn’t a learned intermediary, therefore the plaintiff’s postulated duty does not exist. Nor could there be causation, because the FDA is not obligated to do anything with the adverse reports it does receive. Since there is no underlying state-law duty, plaintiffs were really attempting to enforce the FDA’s reporting requirements, which they can’t do under Buckman preemption and the corresponding absence of any private right to enforce the FDCA. Another nice tidbit about Conklin is it being (we believe) the first state high court to recognize the abolition of the presumption against preemption in express preemption cases. Conklin might have ranked even higher, but failure-to-report claims are something of a sideshow and we don’t know of any such claim that’s ever supported an adverse verdict. We congratulated Conklin here.
- This entry is from the non-RS side of the blog. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018). One of the big casualties of Levine (2009-1) was the preemption arguments offered by manufacturers of selective serotonin reuptake inhibitors (“SSRIs”) on the risk of suicidality. We always thought they had a pretty good FDA regulatory history to support preemption, but with one exception (Dobbs (2011+8)), SSRI preemption arguments simply got massacred in the wake of Levine. That is until Dolin. The Seventh Circuit focused on 2007 as the critical time period of FDA review. 2007 was when the FDA told the defendant to stop using a product specific warning in favor of class-wide labeling that the plaintiff argued was inadequate. Thereafter, the defendant tried several times unsuccessfully to get the FDA to change its mind. That was clear evidence as a matter of law, the unanimous Seventh Circuit concluded, whether or not the pro-plaintiff standards of Fosamax (2017-1) were applied. The preemption facts were that good: “The FDA said no, repeatedly.” Not only was Dolin a big win for preemption, but the Seventh Circuit’s ruling also precluded possible certification of another lurking issue – innovator liability – to the Illinois Supreme Court, something that would have been risky for innovators. We don’t know how many similar SSRI cases are still out there, but Dolin validates defendants’ preemption arguments. We (non-RS) discussed Dolin here.
- In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018). The decision In the district court, we described as “the best Wisconsin law decision we have ever seen.” Well, the Seventh Circuit affirmance was just as good, and much more binding. The learned intermediary rule is now controlling law in all Wisconsin federal courts (a couple of which had refused to apply it). Not only that, the rule applies to medical devices, and there is no heeding presumption to help plaintiffs with Wisconsin warning claims. Sounding like us, the Seventh Circuit declared that appellate authority supported the learned intermediary rule in 48 states (according to our headcount, everywhere save South Dakota and Vermont). As a consequence of the learned intermediary rule applying, summary judgment was affirmed on the basis the surgeon using the device already knew about the risks in question and did not rely on (or even read) the purportedly inadequate warnings. Adding another state firmly to the roster of learned intermediary adopters is a big deal, and NexGen does so in style. We applauded Nexgen here.
- In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation (No II) MDL 2502, 892 F.3d 624 (4th Cir. 2018). Aside from preemption, the only defense that can wipe out an entire MDL in one fell swoop is Daubert. That was the fate of Lipitor MDL claims regarding diabetes risk in 2016, in a decision that was our #7 best of that year. This year, the Fourth Circuit affirmed in all respects. Co-morbidity is no substitute for causation. We particularly enjoyed the circuit court’s refusal to allow reliance on non-statistically relevant epidemiology in a supposed Bradford-Hill based causation opinion. After affirming the analysis that mowed down all of the plaintiffs’ experts, the court rejected plaintiffs’ attempt to prove causation without any experts as “farcical” and “steeped in speculation.” Finally, plaintiffs’ procedural argument that summary judgment was only appropriate against the bellwether plaintiffs, and that all other cases should have been remanded. The Fourth Circuit refused to countenance what would have amounted to use of one-way classes in MDLs. Since all the MDL plaintiffs would have relied on the MDL plaintiffs’ experts, had they presented admissible opinions, the converse is also true – all of the MDL plaintiffs’ cases required expert testimony, and thus fail when their designated experts are excluded. We lauded Lipitor here.
- Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018). One recurrent, vexing issue in PMA preemption is what happens when the plaintiff claims injury from a multi-component device construct and not all of the components are pre-market approved. In what we think is a decision of first impression at the appellate level, Shuker got the right answer – claims attacking the PMA components are preempted, while claims solely involving other, 510(k) cleared, components are not. Plaintiff’s argument that the presence of any non-PMA components precludes any preemption got nowhere. Off-label use of medical devices in this way is contemplated by the FDCA and does not displace preemption. Shuker also made a favorable personal jurisdictional ruling, affirming dismissal of claims against another defendant because, after BMS (2017+1), the “stream of commerce” theory of personal jurisdiction was no longer viable. That ended decades of Third Circuit avoidance of the issue. So, with two good rulings on two of the Blog’s crown jewels, preemption and personal jurisdiction, why isn’t Shuker higher on our list? Well, Shuker also dropped a gratuitous footnote essentially refusing to follow the Supreme Court’s abolition of the presumption against preemption. We complained about that here. If not a crown jewel, the presumption is, at minimum, one of our pet peeves. So, eighth it is. We shook Shuker out, here.
- In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018). If this case seems eerily familiar, it is – it also showed up as #5 on our worst of 2018 decisions. Yes, the same case. Why? Well, for all of the problems with the court’s legal rulings that we discussed last week, the fact remains that the court reversed a half-billion dollar verdict, and it did so due to “the district court’s evidentiary errors and [Ps’ counsel Mark] Lanier’s deception.” The bellwether trial had been “an almost uninterrupted flow of unduly prejudicial and irrelevant information to the jury.” How prejudicial? How about tying the defendant to Saddam Hussein? Totally irrelevant, concluded the Fifth Circuit. How about allegations of corporate racism? A “spectacle,” held the court. And more − suicide, cancer, tobacco industry, transvaginal mesh – a true smorgasbord of prejudicial error. But that, alone, wouldn’t have overcome the later questionable legal rulings. Calling out Mark Lanier by name for “unequivocal decept[ion]” of the jury, did, however. It seems that Lanier told the jury that certain experts were testifying for free when they were really being “bought” (the court’s word) by way of about $65,000 of contributions to their favored charities. Because these “falsehoods marred plaintiffs’ victory,” a new trial was ordered. Like Longfellow’s little girl, when Pinnacle Hip was bad, it was horrid, but when it was good it was very, very good indeed. Thus, this decision has the singular distinction of placing on both our top and bottom ten lists simultaneously. We parsed Pinnacle Hip here.
- In re Bard IVC Filters Products Liability Litigation, 289 F. Supp.3d 1045 (D. Ariz. 2018). Prior to the Pelvic Mesh MDL, a defendant’s medical device clearance by the FDA under its 510(k) substantial equivalence clearance process was routinely admitted. But arguments falsely equating preemption and admissibility have since gained traction, most notably in Eghnayem (2017-2) and- Cisson (2016-2), where the court affirmed as not an abuse of discretion the exclusion of all mention of the FDA in a medical device design defect case as more prejudicial than probative. We think that such a result is unsupportable and gives juries an inaccurate perception of how medical devices are designed, but at this point, we’re fighting that battle all over again, with recent appellate authority against us. Thus, it was a very big deal when we received a published victory on this issue in Bard IVC, expressly disagreeing with those decisions and their no preemption = inadmissibility rationale, and holding instead that 510(k) clearance is relevant both to risk/utility design defect and punitive damages. Admission of FDA evidence would be less likely to confuse the jury than its exclusion. For going against an erroneous tide, we consider Bard IVC to be the most significant drug/device trial court decision of 2018. We evaluated Bard IVC here.
So there they are, our top ten picks for the best drug/medical device decisions of 2018. As good as these are, though, they’re not enough. 2018 was a very good year for the defense, and the Blog was pleased to present far more than ten noteworthy outcomes where the right side of the “v.” prevailed. As is our custom, here are then next ten good decisions of 2018 that couldn’t quite make our top ten.
Honorable Mentions: (11) You know it’s been a good year for the defense when an MDL-wide Daubert win only scores an honorable mention, but we’re not complaining about In re Mirena IUS Levonorgestrel-Related Products Liability Litigation, 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018) (discussed here and here). (12) McDaniel v. Upsher-Smith Laboratories, Inc., 893 F.3d 941 (6th Cir. 2018), was the first appellate decision that shot down the latest plaintiff preemption dodge, that a manufacturer somehow owes a duty not only to make FDA-mandated medication guides available, but to ensure that third parties (pharmacists or physicians) actually give them to patients (discussed here). (13) There isn’t much generic drug product liability litigation anymore, but Guilbeau v. Pfizer, Inc., 880 F.3d 304 (7th Cir. 2018), was pretty darn good in deep-sixing one of the few arguments those plaintiffs had left, holding that a “reference listed drug” designation didn’t stop (or even slow down) preemption. We put it on our A-list here. (14) The New Jersey Supreme Court issued a second In re Accutane Litigation, decision − 194 A.3d 503 (N.J. 2018) – on choice of law, holding that by coming to New Jersey, mass tort litigation tourists must accept New Jersey law, including the presumption of adequacy of FDA-approved warnings. Bye-bye to several hundred more plaintiffs. Not ranked higher because all choice of law decisions can cut both ways (discussed here). (15) A common plaintiff tactic to drive up a case’s nuisance value, unreasonable discovery demands, was sanctioned (in the sense of imposing costs) in Vallejo v. Amgen, Inc., 903 F.3d 733 (10th Cir. 2018), and the sanctions were affirmed. It’s about time (discussed here). (16) Although unusual, sometimes good things do happen in Pennsylvania, such as the unanimous affirmance of Buckman preemption of off-label promotion claims in Caltagirone v. Cephalon, Inc., 190 A.3d 596 (Pa. Super. 2018) (discussed here). (17) Russell v. Johnson & Johnson, ___ S.W.3d ___, 2018 WL 5851101 (Ky. App. Nov. 9, 2018), affirmed IDE preemption, holding that contrary pre-Riegel precedent from the Kentucky Supreme Court was no longer valid (discussed here). (18) Tutwiler v. Sandoz, Inc., 726 F. Appx. 753719024 (11th Cir. 2018), rejected several common plaintiff arguments on the learned intermediary rule under Alabama law (discussed here). (19) Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111 (N.D.N.Y. 2018), is the first decision recognizing that, because the FDA must approve any attempt to discuss off-label use in the label, Mensing impossibility preemption bars challenges to the adequacy of warnings about off-label risks. Would have ranked higher had the opinion been better written (discussed here). (20) Henson v. Dep’t of Health & Human Services, 892 F.3d 868 (7th Cir. 2018). Plaintiffs often resort to Freedom of Information Act (“FOIA”) requests to supplement ordinary discovery, and in Henson, denial of FOIA requests to the FDA was affirmed as to trade secrets, internal FDA memoranda, and medical/personnel records. Such appellate decisions are uncommon (discussed here).
Right in the middle of our compiling this post, Conklin was decided, and we had to reorder things. Thus, we also thought we’d acknowledge the following near misses: In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings, 2018 WL 3303269 (N.D. Ill. July 5, 2018) (here); Blackburn v. Shire U.S., Inc., 2018 WL 2159927 (N.D. Ala. May 10, 2018) (here); Gravitt v. Mentor Worldwide, LLC, 289 F. Supp.3d 877 (N.D. Ill. 2018) (here).
Looking back over our previous best and worst decisions, first and foremost we’re watching the Supreme Court’s consideration of Fosamax implied preemption in Merck v. Albrecht (see here). This appeal is from In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), which we ranked as the worst case in all of 2017. We’d like to see it flip and become our best case of 2019. If we’re really lucky, Albrecht might even repair some of the damage done by Levine (2009-1), the worst case in the entire history of the Blog.
We’ve already discussed how the sixth worst case of 2017 was reversed in Accutane and how Stengel v. Medtronic, our second worst case of 2013, was just gutted by Conklin. The rest of the bottom ten of 2017, unfortunately look like they’re over with. Of our 2017 top ten and honorable mentions, only Utts (2017+6) still faces a pending appeal. Fingers crossed. We’ve already discussed the Lipitor affirmance of a 2017 honorable mention decision. Inge v. McClelland, the New Mexico wrongful conduct rule case (2017+15), was affirmed in a non-precedential opinion. Inge v. McClelland, 725 F. Appx. 634 (10th Cir. 2018). Everything else appears final.
We quickly reviewed our earlier top/bottom ten lists. Nothing else looks changed, good or bad.
Going forward, other than Albrecht, we’re watching with interest to see if the Supreme Court reaches the cy pres issues in Frank v. Gaos, or whether they go off on a standing tangent, leaving cy pres for some other day (here). A petition for certiorari was just filed in the Dolin case (2018+5) discussed above. Another pending appeal that we’re watching is Burningham v. Wright Medical (here), in which the Utah Supreme Court will decide if comment k applies to medical devices in the same way it applies to drugs. Oral argument is January 9, 2019. There is also another Pinnacle Hip appeal in the works, since the MDL judge proceeded with another consolidated trial in the face of a request from the Fifth Circuit that the practice cease. There are also several pending Pennsylvania appeals (non-drug/device, for the moment) concerning general personal jurisdiction by consent/registration to do business, one of which has been accepted for en banc review.
Finally, on the administrative front, the FDA’s 2013 attempt to blow up generic implied preemption was officially interred not long ago. FDA initiatives to make the post-SMDA 510(k) process even more rigorous, and to formalize regulations for the “de novo” review process for Class II devices might eventually pay preemption-related dividends, but right now are only in the early stages of the administrative process. We have not seen any recent FDA movement on truthful off-label promotion and the First Amendment. Legislatively, Congress seems essentially paralyzed on anything having to do with prescription medical products and product liability, and with a divided Congress in 2019, that seems unlikely to change any time soon.
At this point 2018 is essentially in the books. Happy New Year to all of our readers, and – for those of you on the right side of the “v.,” good luck and much success in 2019. For those of you on the other side, check this out.