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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.

When we’re trying to decide whether to see a movie, one place we turn for advice is the Rotten Tomatoes website. We visited the site recently to see what those purveyors of overripe fruit had to say about “The Favourite,” which attracted our attention with an interesting trailer that preceded “The Crimes of Grindelwald.”  Hint – the reviewers liked it much better than the movie we had seen – maybe we will, too.  While on the site we noticed a feature, “24 Worst Movie Remakes,” which listed the most negative “Tomatometer” scores subtracting the remake from the original. Of the 24, thankfully, we’ve only seen one.

We thought about that when compiling this year’s bottom ten worst drug/medical device product liability decisions of 2018.  We sure don’t want any remakes of these!  Of course, here, there’s little positive to subtract from to start with.  These clunkers start out with such awful scores that it’s hard to imagine much worse – we wish.   Unfortunately, this marks our twelfth year of doing this, so we’ve previously reviewed 110 (actually 111 – 2017 had two worsts) other similarly bad decisions. So yes, actually we can imagine worse.

Anyway, let’s stop imagining things and get on with the dreary job of discussing the ten worst prescription medical product liability litigation decisions of 2018. If any of these fiascos were yours, feel free to cry on our shoulders.  It’s not like it’s never happened to us (for instance, see 2013-2), so we know what it can be like.  But don’t worry, we’ll all feel less depressed next week, when we say “Happy New Year” with our best decisions – no rotten tomatoes needed.

Here goes nothing:

  1. Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018). Last year’s extra number one worst case (2017-1A) was a state supreme court’s recognition of the liability uber alles theory of innovator liability. This purely result-oriented claim is contrary to the most fundamental precepts of product liability, since liability does not follow a defendant’s profit from the sale of the product as a “cost of doing business,” but rather follows the path of least legal resistance – given that product liability claims against generics are preempted − from the generic drug to the original innovator drugmaker that actually lost profits due to generic competition. Because innovator liability is so potentially dangerous – imposing liability for the 90% of the market that is generic on the 10% that is branded – a similar decision by the Massachusetts Supreme Court takes home the number one spot again this year. Innovator liability is sought only because of preemption of direct generic claims, and Rafferty quite frankly admitted that the cause of action it created was a preemption dodge. Unlike last year’s case, Rafferty concealed its tort radicalism with a fig leaf. Instead of negligence, Rafferty required “recklessness” on the part of the defendant as a prerequisite to innovator liability. While trumpeting this scienter requirement as “circumscribing” liability “for public policy reasons,” Rafferty actually gutted the limitation by choosing a dumbed-down definition of recklessness that really amounts to little more than negligence. We don’t doubt that plaintiffs will easily plead recklessness, and thereby jack up the prices of other drugs, since by definition the defendant didn’t sell the one that hurt anyone. After Rafferty, generic drug plaintiffs get a unique second bite at the apple that no other product liability plaintiffs enjoy when the real manufacturer is for any reason judgment-proof. For deliberately tossing aside decades of product liability principles so that generic drug users can have someone – the wrong someone – to sue, Rafferty is the biggest judicial rotten tomato of 2018. We ripped Rafferty here.
  2. Campbell v. Boston Scientific Corp., 882 F.3d 70 (4th Cir. 2018). We hate consolidated, multi-plaintiff trials almost as much as we hate innovator liability. Consolidated trials are such a favorite tool of settlement-bludgeoning MDL judges, that we have adopted the hard line of “just say no” to MDLs – and even more to having any trials at all in any MDL. The law used to reject multi-plaintiff consolidations as virtually inherent abuses of judicial discretion, but MDLs have the deleterious effect of sacrificing legal principle to settlement. Last year it was the Eghnayem (2017-2) decision from the Eleventh Circuit allowing 4 plaintiffs to be tried together. This year’s decision means that now two Courts of Appeals have sanctioned this deliberately prejudicial procedure. If anything, Campbell is worse, because the jury, plainly unable to keep the cases straight, returned almost identical verdicts for each of four plaintiffs. Identical verdicts used to be a Due Process red line, but not in Campbell. After Campbell, it looks like MDLs may freely sacrifice the American legal tradition of separate trials to whatever judges want to do in the name of efficiency. Because that’s simply not right, Campbell is the second worst decision of 2018 and a poster child for why the “pre-trial” restriction in the MDL statute should be enforced according to its terms. We criticized Campbell here.
  3. Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018). Pennsylvania is well on its way towards being a national personal jurisdiction outlier. Hammons is one reason why. To start with, Hammons was the only decision we were aware of in the entire country – and that includes other Pennsylvania decisions that should have been binding – holding that a defendant, not the plaintiff asserting jurisdiction, bore the burden of proof of proving lack of personal jurisdiction. Beyond that, the Court sandbagged the defendant, resting its jurisdictional decision on “evidence” that had not even been considered when the issue was decided at the trial court level (later introduced for non-jurisdictional purposes at trial). Finally, Hammons based personal jurisdiction on contacts with Pennsylvania that were not relevant to the theories of liability that the non-resident, litigation tourist plaintiff was pursuing, making a mockery of any sort of causal relationship in the context of the post-BMS “arising from”/”relating to” test for specific personal jurisdiction. Thus, Pennsylvania now has the dubious distinction of having unconstitutionally expansive appellate decisions on both general and specific jurisdiction. “Grasping” and “exorbitant” jurisdictional theories, you’ve got a friend in Pennsylvania. We hammered Hammons here.
  4. Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018). Godelia continued the Eleventh Circuit’s string of lousy decisions from last year (see 2017-2, 2017-7, and 2017-8). The court reversed a finding of PMA preemption where the plaintiff offered only a warning letter that did not even involve the type of problem that the plaintiff’s decedent encountered. Godelia’s excuse was that the warning letter was “not all-inclusive.” Godelia completes the Eleventh Circuit’s descent from one of the strongest to one of the weakest TwIqbal jurisdictions, allowing an allegation of “violation of the federal regulations noted above” (previously described as “not all-inclusive”) to plead a parallel manufacturing defect claim. Vague regulatory allegations were okay, as long as the FDA said the regulations were violated in the warning letter, and so were purely speculative causation allegations. As long as the plaintiff alleged a manufacturing defect, warranty, or misrepresentation claim, PMA preemption was defeated, even if the claim wasn’t actually based on the alleged FDCA violations. Warranty claims, which usually fail Florida’s privity requirements where prescription medical products are involved, survived because of alleged oral statements by sales representatives. That the device required a prescription does not require dismissal for lack of privity where direct contacts with a sales rep are alleged. And, of course, the court doubles down on Mink’s (2017-8) deliberate misapplication of Florida negligence per se legislative intent requirement. We didn’t post on Godelia before, but it was indeed God awful.
  5. In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018). Wait a minute. The court reversed a half-billion dollar verdict and roasted plaintiffs’ counsel for improper conduct. How could this case be on the bottom ten list? The answer lies in the court’s grant of only a new trial. The Pinnacle Hip decision also made a number of legal rulings that range from questionable to atrocious. The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board. Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue. Even if there wasn’t any precedent (which there was) expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity. Another flaw was allowing plaintiffs to offer a different product as a purported alternative design. The Fifth Circuit used to be good on this, but allowing an alternative design claim that the product shouldn’t have been composed of what the FDA allowed it to be made of really pushes the boundary. Two oddball liability theories also received a green light: “nonmanufacturer seller” and “negligent undertaking.” We also don’t like allowing “objective” evidence (that is, paid expert testimony on what a “reasonable” physician would have done) to substitute for what the plaintiff’s prescriber actually did in evaluating warning causation under the learned intermediary rule. Finally, the court also rejected a preemption argument – but frankly it wasn’t the right preemption argument, so we don’t take off many points there. We pummeled Pinnacle Hip for these deficiencies here.
  6. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 300 F. Supp.3d 732 (D. Md. 2018). The worst trial court decision of 2018 came from an MDL. No surprise. One of our objections to MDLs is their bending over backwards to let questionable claims continue, in pursuit of settlement leverage against defendants. BHR was propelled higher (lower?) on our list since the contortions in this case were aimed against PMA preemption, perhaps our favorite defense (and certainly the strongest). Anything that so much as contained a whiff of an FDCA violation became an unpreempted parallel claim, so what began as a Supreme Court waiver comment has just about swallowed Riegel’s preemptive rule in this MDL. BHR also distinguished Buckman into almost nothingness – if an FDCA violation is not a “critical” element of a negligence per se claim, it becomes hard to see what would be. PMA products have largely avoided MDLs since Sprint Fidelis, but BHR appears determined to be exception. We bashed BHR here.
  7. Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45 (Pa. Super. 2018). Our second bottom ten case from Pennsylvania affirmed a half-million dollar Philadelphia verdict for gynecomastia – a “condition” that another court this year found not “serious” as a matter of law. No wonder Philadelphia attracts litigation tourists from all over the country. The litigation tourist in Stange was from Wisconsin. That’s enough to knock Stange a notch or two, since out of state decisions screwing up other states’ laws rarely get much attention from the affected states’ judges. The chief Pennsylvania law goof in Stange was on expert witnesses – applying a “novel” science limitation that was eliminated by the Pennsylvania Supreme Court in an asbestos case called Betz. On top of this, the court reversed the Philadelphia mass tort judge’s holding that New Jersey law applied to punitive damages, since the defendant was headquartered there, and that’s where all corporate conduct would have happened. New Jersey has a statute that precludes punitive damages for FDA-approved products. The court sent the case back to the trial court for a comparison with Wisconsin law even though (as we discussed here) a prior ruling by the same court – binding under Pennsylvania appellate practice – had already determined that the law of the corporate domicile applies to punitive damages choice of law issues. As that prior decision involved a Pennsylvania-domiciled defendant, Stange really applied the choice of law rule, “heads, plaintiffs win; tails, defendants lose.” That alone would qualify for this list. Stange is indeed strange, as we pointed out, here.
  8. A.F. v. Sorin Group USA, Inc., ___ F. Supp.3d ___, 2018 WL 4680022 (S.D.N.Y. Sept. 28, 2018). A.F. comes in at number eight on our list because it ignores the role of federal courts sitting in diversity jurisdiction, and also because (unlike the decisions that follow) it’s published. As is so often the case with federal decisions embracing novel liability theories, A.F. is a preemption case. The theory that survived dismissal – failure to report adverse events to the FDA – is an ill-concealed preemption dodge. But that didn’t stop A.F. What makes the case worse is (as we discussed here) New York courts have affirmatively rejected tort liability based on a variety of claims based upon alleged failures to make reports to governmental agencies. Failure to report claims are not a matter of first impression in New York. Not only that, but the same FDA-related claim had been rejected by another New York court not long before. A.F. is on our list because it ignores both Erie principles and existing New York law. We explained the awfulness of A.F. here.
  9. Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018). Sumpter is another court-assisted preemption dodge case. This time the dodge is “manufacturing defect.” In what way did the device fail to meet specifications? The complaint doesn’t say, and the court doesn’t care – as evidenced by its reliance on one of the most widely reviled (and not just by us) PMA preemption decisions, Hofts (2009-5). As long as the product departed from its “intended result,” that’s enough. A plaintiff can “extrapolate” from the alleged injuries. That amounts to res ipsa loquitur, and a rather loose sort, at that. But Sumpter’s worse than that. Res ipsa loquitur only allows inference of a “defect”; Sumpter uniquely allowed the plaintiff to get by with an inference of FDCA violation from the mere fact of an alleged device failure. Missouri has become the opposite of the “Show Me State.” Sumpter is more like “don’t need to show me anything.” We discussed how Sumpter is septic here and here.
  10. Tryan v. Ulthera, Inc., 2018 WL 3955980 (E.D. Cal. Aug. 17, 2018). The Tryan decision got preemption wrong on so many levels that we didn’t know what to make of it. The claims themselves were farcical. Plaintiffs weren’t even injured. They claimed only that they were told the device was “approved” rather than “cleared,” and wouldn’t have purchased it had they known it was a 510(k) device. Thus, Tryan was through and through a private claim for violations of the FDCA. Without the FDCA, the plaintiffs’ claimed distinctions would never have existed. Thus, it’s a private action totally dependent on the FDCA and barred by that act’s prohibition against private enforcement. But Tryan got sidetracked on express preemption – not an issue – and never recovered. Tryan reasoned as if there were a “parallel claim” exception, but no such thing exists in implied preemption. “Mirroring” the FDCA only makes implied preemption stronger, since the FDCA precludes private enforcement (except for an exception only relevant to food). The result? A class action alleging that “FDA approved” and “FDA cleared” are so different that otherwise uninjured consumers should receive damages. Tryan is thus a travesty, as we explained here.

That’s our bottom ten, and that’s quite enough as far as we’re concerned. Time for a shower, to feel clean again, and for some egg nog to get back in the holiday spirit. Our spirit will be back next week, as we award legal Oscars instead of rotten tomatoes when we review the ten best drug/device decisions of 2018.  Finally, we’ve heard it said that there is no war on Christmas, but there is a war on Thanksgiving – and Christmas has won.  In that spirit, we wish everyone Happy Holidays.


We’ve heard that we should welcome some new subscribers, who aren’t that interested in drug and device litigation, per se, but have been attracted by our coverage of personal jurisdiction issues relating to tort litigation generally.  Thanks for joining.  Here is a brief description of our available personal jurisdiction resources.

First, we maintain a personal jurisdiction “cheat sheet.”  Because we don’t believe in doing the other side’s work for them, a cheat sheet contains only decisions with favorable results for defendants.  The current cheat sheet contains a complete list of decisions rejecting so-called “jurisdiction by consent” going back to the 1950s.  The cheat sheet is updated at least monthly with new, favorable cases.  The current cheat sheet also lists decisions since Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), that deny personal jurisdiction under its “arising from”/”related to” test.

There is a second cheat sheet, no longer maintained, that includes all favorable decisions on a corporation not being “at home” for purposes of general jurisdiction.  Since this issue is essentially settled, we ceased updating it when BMS was decided.

There’s much more.  Under our “state-by-state research” tab, located at the top of the blog’s home page, readers can find personal jurisdiction research under the “procedural law” heading inside the tab.  We have a 50-State Survey on General Jurisdiction Through Consent by Registration To Do Business that was first published on 12/18/2017 and has been maintained since then.  If you need to know about the current status of this question in any jurisdiction, this post is a good place to start.

We have another tab for “General Research,” which includes links to all of the blog’s posts that contain legal research (as opposed to posts about individual cases, or other miscellaneous posts such as the one you are reading right now).  There are a lot of personal jurisdiction posts on various subjects:

Personal Jurisdiction – Arising out of/Relating to test (1/22/2018)

Personal Jurisdiction – Burden of proof (7/2/2018)

Personal Jurisdiction – Claim-by-claim analysis (1/11/2018)

Personal Jurisdiction − Class actions – (1/26/2018)

Personal Jurisdiction − Class actions – (11/20/2017)

Personal Jurisdiction – Consent by registering to do business (7/23/2018)

Personal Jurisdiction – Consent by registering to do business (3/5/2015)

Personal Jurisdiction – Discovery from third-parties (6/23/2016)

Personal Jurisdiction – Dormant commerce clause (2/22/2018)

Personal Jurisdiction – Dormant commerce clause (7/5/2016)

Personal Jurisdiction – Fifth Amendment/federal causes of action (2/19/2018)

Personal Jurisdiction – Litigation tourism (10/20/2017)

Personal Jurisdiction – Stream of commerce theory (3/12/2018)

Personal Jurisdiction – Waiver (4/23/2018)

With this research, always note the date of the post.  Unlike our cheat sheets, and our 50-state survey, these jurisdictional research posts are not updated.

Finally, in our “Topic” list, there is a listing for “Personal Jurisdiction.”  This will take you to a chronological list of every one of our personal jurisdiction posts.  The blog has been around for over ten years, so working through this topic is a little like drinking from a fire hose.  There are 96 posts under this topic, including all of those listed above.  Most of them are discussions of individual cases, and they often cover more than one topic.  Here is a list of them with individual links.

Another Missouri Talc Verdict Is Wiped Out On Personal Jurisdiction (7/12/2018)

Personal Jurisdiction through Alter Ego Fails in Illinois (6/29/2018)

New Philly Opinion Rejects Personal Jurisdiction Via Corporate Registration Consent (6/13/2018)

Yo, Canada! Oy, Vermont! (6/11/2018)

Hot and Not So Hot (6/4/2018)

No Jurisdiction Over NDA Holder Who Did Not Make The Drug (5/16/2018)

Some Ideas About Innovator Liability (5/10/2018)

Pinnacle Hip – Fifth Circuit Legal Rulings (5/7/2018)

A Ray of Hope for Innovator Liability (4/20/2018)

Post-BMS: Jurisdiction over Subsidiary ≠ Jurisdiction over Parent (4/9/2018)

You Can Use BMS To Oppose Class Certification, Too (3/22/2018)

N.D. Illinois Dismisses Accutane Case for Lack of Personal Jurisdiction (3/14/2018)

Third Time Not Quite the Charm (3/6/2018)

California Superior Court Refuses to Allow Discovery in Aid of “Litigation Tourism” in Consolidated Xarelto Litigation (2/16/2018)

Missouri Federal Court Rejects Effort to Limit the Effect of BMS (2/1/2018)

Ending The Year With Another Good Personal Jurisdiction Decision (12/29/2017)

More of What You Will See on Personal Jurisdiction Following BMS (11/21/2017)

MDL Direct Filing & Personal Jurisdiction (10/16/2017)

Lucky Seven – Multi-Plaintiff Misjoinder Fails in Illinois Post-BMS (10/9/2017)

Talcum Plaintiffs Can’t Show Personal Jurisdiction In Show Me State (9/8/2017)

Oral Argument before the Fifth Circuit Starts in a Couple of Hours on the Writ of Mandamus Filed in the Pinnacle Hip Implant Litigation (8/4/2017)

New Favorable Risperdal Decisions (8/16/2017)

Personal Jurisdiction Moves Front and Center in the Pinnacle Hip Implant MDL (8/8/2017)

Post-BMS Personal Jurisdiction is Pretty Straightforward (7/18/2017)

What You Will See On Personal Jurisdiction Following BMS (7/13/2017)

California Is At It Again On Personal Jurisdiction (7/7/2017)

Breaking News − Bristol-Myers Squibb Slams The Door On Litigation Tourism (6/19/2017)

Supreme Court Resolves Longstanding Hague Convention Service Issue (6/9/2017)

Breaking News − Personal Jurisdiction – The Sound of One Shoe Dropping (5/30/2017)

Supreme Court Expands Forum-Shopping Crackdown (5/29/2017)

Briefing Completed in Half-Billion-Dollar Verdict in Pinnacle MDL (5/12/2017)

The Other Supreme Court 4/25 Personal Jurisdiction Argument (5/1/2017)

Supreme Court 4/25 Personal Jurisdiction Argument (4/27/2017)

Guest Post – Eighth Circuit FINALLY Hears Litigation Tourism Issue (4/18/2017)

Solicitor General Urges Supreme Court to Reverse California’s Ill-Conceived Version of “Specific Jurisdiction” (3/16/2017)

More on Missouri – What To Expect and Not To Expect After Norfolk Southern v. Dolan (3/6/2017)

Litigation Tourism Ended In Missouri (3/1/2017)

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case (1/19/2017)

Alter Ego and Agency – A Different Spin on Jurisdiction (12/23/2016)

Amicus Briefs Not So Friendly to California Supreme Court’s Dreadful BMS Personal Jurisdiction Decision (11/23/2016)

M.D. Tenn. Bids Adieu to Out-of-State Class Reps (11/2/2016)

Misjoined Plaintiffs Can’t Be Used to Forum Shop (11/1/2017)

M.D. Pa. Finds No Specific Personal Jurisdiction over Parent Company (10/4/2016)

Pennsylvania’s Long Arm Overreaches the Constitution and Bauman (9/30/2016)

Hotel California Stays Open: Another Look At Specific Jurisdiction in BMS (9/16/2016)

Breaking News – California High Court Expands “Specific” Personal Jurisdiction To Recreate “Exorbitant” Personal Jurisdiction Rejected by Daimler v. Bauman (8/29/2016)

Television, Personal Jurisdiction, and Whether Corporate Knowledge Can be Imputed from Internet Drivel (8/24/2016)

Bauman Jurisdictional Limits Dismember Three More Misjoined Multi-Plaintiff Complaints (7/25/2016)

Zofran MDL Jurisdictional Analysis Bounces Non-Missouri Plaintiffs (5/11/2016)

Breaking News – No General Jurisdiction by Consent in Delaware (4/19/2016)

Bauman Personal Jurisdiction In-House Counsel Checklist (4/4/2016)

Breaking News – No Circuit Split (Yet) Over Post-Bauman General Jurisdiction by Consent (3/18/2016)

MDL Decision Debunking the Pendent Jurisdiction Fallacy Post-Bauman (3/8/2016)

Personal Jurisdiction and Choice of Law (2/23/2016)

Another No Show For Personal Jurisdiction In The Show Me State (9/18/2015)

California Dreaming: The Bite of Bauman, the Perfume of Preemption, the Stink of Stengel (8/19/2015)

Missouri Court Applies Bauman; Merely Doing Business Did Not Show Enough for Personal Jurisdiction (7/15/2015)

Check-Out Time at the Hotel California? (6/26/2015)

More Plaintiffs Go Home (Eventually and Based on Bauman) (4/17/2015)

We’re Not in Kansas: No General Jurisdiction After Bauman (4/10/2015)

Breaking Bauman News from California (11/19/2014)

Breaking News: Win On Post-Bauman Personal Jurisdiction Avoids Fraudulent (Mis)Joinder Pitfalls (11/11/2014)

Daimler (Bauman) As a Removal Tool in Multi-Plaintiff Cases 10/23/2014)

Personal Jurisdiction, Preemption, Pleadings and Proximate Cause (10/7/2014)

Interesting Cases Sent By Users (Part 1) Personal Jurisdiction (8/14/2014)

Hotel California: You Can Check Out Anytime You Like, But . . . (8/8/2014)

Sweet Home [Fill in the Blank] − A Sea Change In Personal Jurisdiction? (4/18/2014)

An OxyContin Decision That Addresses Everything from Negligence Per Se Claims to Personal Jurisdiction (4/8/2014)

Breaking News – Two New Supreme Court Decisions (1/14/2014)

No D.C. Personal Jurisdiction = No Loose D.C. Statute of Limitations = No Case (11/06/2013)

Breaking News – A TwoFer (10/29/2013)

Another Homework Failure By Plaintiffs (5/15/2012)

More Comments on Personal Jurisdiction (7/19/2011)

Personal Jurisdiction 2.0 (7/14/2011)

The Supreme Court Reins in “Stream of Commerce” Personal Jurisdiction (6/28/2011)

SG Takes Defense Side In Brown Personal Jurisdiction Case (11/19/2010)

Defense Personal Jurisdiction Briefs Filed (11/12/2010)

Personal Jurisdiction – A Primer (10/21/2010)

As all these posts demonstrate, we have devoted a great deal of time and effort to helping our defense-side readers understand personal jurisdiction and then use it to help win their cases and try to rein in rampant litigation tourism by plaintiffs.  We even identified Bauman as a case to watch, before it ever went to the Supreme Court:

In any event, we may not be waiting long for an answer.  In Bauman v. DaimlerChrysler Corp., ___ F.3d ___, 2011 WL 1879210 (9th Cir. May 18, 2011), the Supreme Court’s bête noir, the Ninth Circuit, allowed the exercise of general jurisdiction over a foreign corporation on a dumbed-down agency test based solely on the defendant’s “right to control” its wholly-owned American subsidiary.  Id. at *11-12.  The result in Bauman is little different than what the Supreme Court rejected in Brown, in that a defendant doing no business in a jurisdiction is exposed to suit there over anything and everything, and would be equally exposed to litigation anywhere its subsidiary operates, which is everywhere it sells products.

If the unanimous Court in Brown meant what it said about general personal jurisdiction, then Bauman is wrongly – badly wrongly – decided.  We expect a certiorari petition in Bauman.  We won’t give odds on the Court’s accepting the appeal, as another long snooze may be in the offing, but if it does, our money would be on reversal.

(Emphasis added).  Now there’s a bet that paid off, big-time.

Personal jurisdiction is right up there with Daubert and preemption as one of the biggest pro-defense developments of our legal careers.  You can bet we’re going to keep thinking and writing about it.

Happy New Year!

It’s been 3 ½ years since we last updated our index to our online research resources.  That’s almost ⅓ of the total life of the blog, which started in way back in 2006.  We’ve been blogging now for well over ten years.  Our first substantive research post, on the presumption against preemption, was published that November.  We are now up to over 3400 separate posts of greater or lesser import.

We use this blog regularly as a research tool, and we regularly pass posts along to others in our firms when they ask. We suspect that a lot of you do, too.  Even for us, it becomes progressively more difficult to find what we’ve already posted – particularly when we want to do it quickly.  Given that we’re the authors of (almost) all these posts, and presumably we remember at least something about them, we can only guess how difficult accessing our posts must be for the rest of our readers.  We’ve tried with categories and tags, describing the topics, but not only are they less than 100% accurate, but they’re less than 100% consistent, since each member of the blogging team treats them a little differently.  Beyond that, some of our more heavily used topics, like preemption with nearly 500 posts, are quite unwieldy to sort through.  We’d guess that over half of all of our categories have over 100 posts.

We like to know where things are too.  One of the many reasons we write the blog is to provide our clients with more value for less.  The ripple effects, of course, go beyond our clients to the industry as a whole and the defense community as a whole.  But if another law firm saves a mutual client X dollars by using one of our posts to get a leg up on a research topic, we still think we’re providing extra value, even if indirectly.  In order to do that, we can’t be re-inventing the wheel, any more than in our billable matters.  Using free – or at least non-billable – blog research seems like an eminently reasonable step for any of us to take.

The alternative would be to keep things internal and not share.  But then why blog at all?  Our basic philosophy that defense wins anywhere help defendants everywhere – whether that win is in Philadelphia or Poughkeepsie, Los Angeles or Laramie, D.C. or Des Moines.  Value is value, whether billed to a client or not.  We are acutely aware that not every defendant and not every case can independently justify the depth of research we do.  But we are egotistical enough to think our research could be beneficial to the defense of just about any case.  So we’ve decided to share … again.

What follows is a really boring post. We’re lawyers, not librarians, but we’re going to try to organize things so that people who want to use our research posts (as opposed to our single-case posts and other stuff) can find them.  For “value,” it is hard to beat “free.”

So, if you’re looking to be entertained, come back tomorrow.  But if you’re a defendant or a defense lawyer who might actually want to use the blog’s research resources, you’ll want to save this post somewhere.

Here’s how we go about this.

Our serious research is of four overall types.  First, are our scorecards.  These compile all cases that we know of, pro or con, on a topic.  Scorecards are updated on an ongoing basis, so the date of the post is not particularly important.  Keep in mind, that, because we’re not in the business of doing the other side’s research for them, scorecards only address subjects where historically the defense usually wins.  That’s why we had to retire our prescription drug preemption scorecard after Wyeth v. Levine, 555 U.S. 555 (2009).

Second, are our cheat sheets.  These address subjects where the weight of precedent is more mixed.  Cheat sheets only contain favorable precedent – that is, where the defense side won.  Cheat sheets are also updated on an ongoing basis, although often not as religiously as our scorecards.  When using cheat sheets, always be aware that adverse precedent exists, but is not listed in the cheat sheet.

On numerous occasions, we’ve either discussed other topics, frequently on a nation-wide basis. Sometimes we’ve organized such research in 50-state fashion, with the headers formally divided on a state-by-state basis.  We’ll keep to that division here.  So, third, we’ll list our state-by-state research topics.

Fourth, and finally, we’ll follow that with our remaining nationwide research organized by topic.  We’re also including the date of the post, so you’ll know how current the research is, because with only a few exceptions, our research posts other than scorecards and cheat sheets is not updated.


Post-Riegel Pre-Market Approved Device Preemption Scorecard

Post-Mensing Generic Drug Preemption Scorecard

Innovator Liability in Generic Drug Cases Scorecard

Cross-Jurisdictional Class Action Tolling (of the statute of limitations) Scorecard

Lack of Compensable Injury Scorecard


Post-Bauman Personal Jurisdiction Cheat Sheet (updated through BMS)

Post-BMS Personal Jurisdiction Cheat Sheet

Post-Levine Drug/Vaccine Preemption Cheat Sheet

Class Action Denial In Federal Court Cheat Sheet

Class Action Denial In State Court Cheat Sheet

TwIqbal Cheat Sheet

FDA Adverse Event Reports Cheat Sheet

Duty to Test Cheat Sheet

E-Discovery for Defendants Cheat Sheet

Lone Pine Cheat Sheet


Substantive Law:

Causation – Heeding presumption (11/7/14)

Causation – Physician failure to read warnings (10/28/11) and (10/17/13) – this second one is updated

Comment k/Unavoidably Unsafe Product – How states have applied Restatement §402A, comment k (10/8/08) and (4/28/11)

Comment k/Unavoidably Unsafe Product – Non-implanted medical devices (8/4/17)

Consumer Fraud – Extraterritoriality rejected (9/13/07)

Consumer Fraud – Learned intermediary rule (10/10/16)

Consumer Fraud – Recovery of damages for personal injury (4/15/11)

Duty – Corporate credo (11/18/16)

Duty to Recall – States rejecting duty (8/11/11)

Fraud on the Market – Cases rejecting fraud on the market causation theories outside of the federal securities law context (1/25/10)

Hospitals – Strict liability (11/16/12)

Innovator Liability (7/18/14) (updated)

Innovator Liability – Analogous bare metal defense (1/8/15)

Learned Intermediary Rule – Applicability to exempt pharmacists from liability (2/24/11)

Learned Intermediary Rule − Consumer fraud (10/10/16)

Learned Intermediary Rule – Financial ties as purported exception (8/3/17)

Learned Intermediary Rule – Medical device cases (7/10/08)

Learned Intermediary Rule – States adopting it by level of court (7/5/07 – occasionally updated), and again (6/2/11)

Market Share Liability – Who has it, who doesn’t (7/15/10)

Medical Monitoring – Who has it, who doesn’t (4/15/09)

Misuse – In pari delicto defense (8/23/07)

Nuisance – Municipal cost recovery rule (5/3/07)

Preemption – Embedded fraud on the FDA claims (9/3/09)

Product Liability – Adoption of the Restatement (Third) of Torts, Products Liability §2 (9/10/10)

Punitive Damages – Adoption of one to one ratio in large-damage cases (8/18/11)

Punitive Damages – How much increase in risk is necessary (11/9/15)

State Of The Art Defense – Precedent applying defense in prescription drug/medical device litigation (3/20/09)

Procedural law:

Discovery – Informal physician interviews, who allows them and who doesn’t (12/18/08 – sometimes updated), and here (8/16/07)

Expert Witnesses – Whether defense experts, because defendants do not bear the burden of proof, must testify to a reasonable degree of medical certainty (8/4/11)

Personal Jurisdiction – Jurisdiction through registration to do business (12/18/17)

Removal – Pre-service removal (10/1/09) and again (5/26/11)


Substantive law:

3D Printing (2/5/15)

Administrative Law –Exclusion of administrative standards that are more lax than legal standards (4/8/10)

Administrative law – No private FDCA right of action (2/18/10)

Artificial Intelligence (7/24/17)

Biomaterials Access Act (8/19/16)

Bulk Suppliers – Liability (11/29/12)

Causation – Duty to Report (9/19/16)

Causation – Increased risk/lost chance (11/30/15)

Causation – Individualized reliance (9/19/13)

Causation – Plaintiff conduct (9/18/17)

Causation – “Regulatory causation” (1/19/17)

Causation – Risks plaintiff never suffered (4/24/17)

Comment k/Unavoidably Unsafe Product – Application to medical devices (1/12/12)

Comment k/Unavoidably Unsafe Product – PMA devices (11/30/17)

Consumer Fraud – Lack of damages (2/5/09)

Consumer Fraud – Prescription medical products not “consumer” goods (2/10/12), and again (6/25/15)

Consumer Fraud – Regulatory compliance as defense (5/24/07) and (3/6/14)

Co-Promoters – Cases rejecting liability (12/7/11)

Damages – Phantom damages (discounted medical bills) (10/9/14)

Decisions in MDL – State law decisions in out-of-state MDLs (4/25/13)

Design Defect – Alternative design requirement in medical device cases (8/8/13), and again (12/12/17)

Design Defect – Manufacturing defect comparison (6/30/16)

Design Defect – Pre-approval design defect (5/8/17)

Distributors – Limits to liability (2/10/15)

Duty to Report − Causation (9/19/16)

Duty to Train or Advise Physicians – Decisions rejecting (9/15/11) and (5/30/13)

Duty to Update Claims (9/12/16)

Emotional Distress – Defeating emotional distress claims in drug/device litigation (2/3/11)

Experimental/Investigational Drugs – No duty to supply (3/15/12)

FDA – Warning letters lack force of law (9/3/15)

First Amendment – Defense to tort liability (12/14/12)

First Amendment – Off-label promotion (1/13/16), and again (1/15/16)

Fraud – Promotion of off-label use not fraudulent (7/27/12)

Fraud On The Market – Causation (2/17/12)

Heeding Presumption – New York law (10/8/15)

Heeding Presumption – Precedent rejecting presumption (7/2/09)

Homeopathic Products (8/11/15)

Informed Consent – Off-label use need not be disclosed (6/21/07), again (1/14/10), and yet again (10/20/11)

Junk Faxes (7/29/15)

Learned Intermediary Rule – Adoption (3/3/16)

Learned Intermediary Rule – Burden of proof where prescriber testimony nonexistent (3/10/14)

Learned Intermediary Rule – Direct to consumer (non)exception (1/20/11)

Learned Intermediary Rule – Non-physicians as intermediaries (2/20/17)

Learned Intermediary Rule – Physician as “consumer” in consumer expectation test (5/7/12)

Learned Intermediary Rule – Policy reasons for rule (7/6/07)

Learned Intermediary Rule – Warning causation cannot be proved by “reasonable doctor” expert (4/19/07)

Medicare Secondary Payer – Recovery from attorneys (1/16/17)

Medical Malpractice – Off-label use and the standard of care (11/2/12), and again (2/13/17)

Medical Malpractice – Standard of care (12/12/17)

Medication Guides – Claims about (2/21/14)

Negligence – Duty (9/17/09)

Negligence Per Se – State-law defenses to FDCA-based negligence per se actions (2/7/08), and again (2/12/09)

Negligent Design – Alternative design requirement (2/27/17)

Off-Label Use – State authority to regulate (1/27/17)

Pharmacogenomics (5/26/15)

Preemption – 510(k) preemption post-Lohr (9/24/15), and again (4/22/16), and yet again (8/22/16), and once again (10/30/17)

Preemption – Buckman applies to fraud on agencies other than the FDA (9/25/08)

Preemption – Design defects in branded drugs (1/1/16), and again (8/18/17)

Preemption – Failure to contraindicate claims (6/26/17)

Preemption – Failure to recall claims (9/28/12)

Preemption – First Amendment (8/27/15), and again (12/9/15)

Preemption – Fraudulent concealment in PMA context (11/29/17)

Preemption – FDA prosecutorial discretion (10/5/12)

Preemption – Generic drugs, various topics (4/5/12)

Preemption – HIPAA and informal defense interviews of treating physicians (2/15/07)

Preemption – Injunction against selling FDA-approved product (2/9/16)

Preemption – OTC/monograph drugs (11/25/08), and again (12/12/16)

Preemption – Off-label warnings (12/19/13), and again (3/20/17), and yet again (9/20/17)

Preemption – Peer review material discovery (11/5/15)

Preemption – PMA devices and good manufacturing practices (9/14/14)

Preemption – PMA devices where the classification has arguably changed (10/7/10)

Preemption – PMA plaintiffs can’t establish parallel FDCA violation by res ipsa loquitur (1/26/12)

Preemption – Branded drug impossibility preemption post-Levine – non-NDA-holder, boxed warnings, major changes, failure to recall (8/22/14), and again (8/13/15)

Preemption – Post-Riegel parallel violation claims (6/26/08), and again (12/18/08), and yet again (7/30/09)

Preemption – Presumption against preemption (11/15/06), and again (10/30/17)

Preemption – Product development protocol (9/6/11)

Preemption – Question of law (3/28/17)

Preemption – Transitional devices (10/31/13)

Product Liability – Definition (2/16/17)

Publisher Liability – Is a publisher of a pharmaceutical warnings, who is not a drug manufacturer, liable for substantive errors or omissions in what it publishes? (4/7/11) and again (7/18/13)

Punitive Damages – Compliance as a defense (3/8/07), and again (11/5/09)

Punitive Damages – No constitutional right to obtain (4/30/12)

Punitive Damages – Territoriality (12/29/06)

Punitive Damages – Warnings as a defense (2/24/12)

Recalls – Duty to recall, subsequent remedial measures and other recall-related issues (9/24/09)

Res Ipsa Loquitur – Broken medical devices are not ipso facto defective (12/31/09)

Restatement (Third) §6(c) – Adoption or rejection (5/3/11)

Sales Representatives – Duties when present in operating room (9/23/11)

Sales Representatives – Fraudulent joinder (7/14/09)

Warnings – Boxed warnings as adequate as a matter of law (7/10/17)

Warnings – Causation issues (5/8/08), and again (10/2/08)

Warnings – Expert proof requirement in learned intermediary rule cases (6/11/09)

Warnings – No duty to warn about competing products (7/19/07)

Warnings – Overwarning (1/9/14)

Warnings – Plaintiffs can’t assert failure to warn of risks they never suffered (10/26/07), and again (4/1/10), and yet again (4/24/17)

Warnings – Statistics (11/13/14)

Warranty – Application of learned intermediary rule to bar claims (11/10/11)

Procedural law:

Adverse Event Reports – Rejecting their use, either as evidence or as a basis of expert testimony (6/7/07)

Attorney/Client Privilege – Ex employees (11/28/16)

Bankruptcy – Judicial estoppel of plaintiff not listing claim as asset (9/25/12)

Class Actions – Ascertainability (1/23/15)

Class Actions – Cross jurisdictional statute of limitations tolling (3/22/07)

Class Actions – Cy pres (10/15/09)

Class Actions – Personal jurisdiction (11/20/17)

Class Actions – Punitive damages (7/17/09), and again (2/26/09)

Class Actions – Single issue certification (11/19/09)

Courts – Conflict in precedents (4/12/17)

Daubert – 2.0 relative risk standard for more likely than not (12/28/07)

Discovery – Cost sharing (5/15/17)

Daubert – Differential diagnosis as faulty methodology (5/7/09)

Discovery – Counsel’s ability to speak with his/her own during an ongoing deposition (2/10/11)

Discovery – Deposing current FDA employees (5/22/13)

Discovery – Litigation holds (4/3/14)

Discovery – Lone Pine orders (8/11/08)

Discovery – Predictive coding/technology assisted review of documents (3/24/16)

Discovery – Protection of customer lists from discovery (4/2/09)

Discovery – Scope after 2015 rules amendments (4/25/16)

Discovery – Translation of non-English documents not required (7/9/08)

Erie Doctrine – Obligation to be conservative in making state-law predictions (11/28/06), and again (5/13/11)

Evidence – Exclusion of animal studies (7/19/07)

Evidence – Exclusion of corporate ethics expert (7/19/07)

Evidence – Exclusion of foreign regulatory standards (8/7/07), and again (6/30/11)

Evidence – Exclusion of fraud on the FDA evidence (7/19/07)

Evidence – Exclusion of warning letters (4/21/10)

Evidence – FDA §510k clearance (7/5/12)

Evidence – Sham affidavits (9/25/17)

Evidence – Warning changes as subsequent remedial measures (2/2/10)

Expert Witnesses – Legal conclusions are inadmissible (2/9/08), and again (3/14/08)

Expert Witnesses – Postmortem redistribution (4/18/12)

Expert Witnesses – Suzanne Parisian (8/9/12) and again (8/14/13), and yet again (3/30/17)

Expert Witnesses – Testimony on corporate intent, ethics, and similar subjects is inadmissible (5/19/2011)

Expert Witnesses – Videotaping expert product examinations (4/2/15)

Joinder – Misjoinder (1/7/10)

Judicial Notice – FDA-related materials (9/20/07), and again (4/17/08), and yet again (7/2/09)

Multidistrict Litigation – Direct filing (10/16/17)

Personal Jurisdiction − Class actions – (11/20/17)

Personal Jurisdiction – Consent by registering to do business (3/5/15)

Personal Jurisdiction – Dormant commerce clause (7/5/16)

Personal Jurisdiction – Litigation tourism (10/20/17)

Personal Jurisdiction – Third-party subpoenae (6/23/16)

Pleading – Moving to dismiss MDL master complaints (8/20/09)

Pleading – TwIqbal − “And/or” pleading (7/23/09)

Pleading – TwIqbal − Fraudulent joinder (6/15/12), and again (7/9/12), and yet again (4/19/13)

Pleading –TwIqbal − Generally (12/2/11)

Pleading – TwIqbal − “Otherwise negligent” pleading (11/23/12)

Pleading – TwIqbal − PMA preemption cases (12/9/10)

Pleading – TwIqbal − Product liability cases generally (8/6/09)

Pleading – TwIqbal − Removal to federal court (11/18/10)

Pleading – TwIqbal − State court (10/29/09)

Pleading –TwIqbal – Various dismissal grounds (5/16/12)

Removal – Bad faith and fraudulent joinder (7/18/16)

Removal – “Order or other paper” (3/22/13)

Removal – Various removal issues (misjoinder, TwIqbal, consent) (10/1/09)

Standing – No private FDCA cause of action (6/7/12)

Trial – Consolidated multi-plaintiff trials (12/16/11)

Trial – Gag orders (6/28/16)

Wikipedia (1/23/17)

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 happy news in going through our list of the best decisions of the year.  And make no mistake about it, there’s plenty to celebrate this year.

Before we do, we should explain one thing. Our list is limited to cases involving drugs and medical devices.  Every year some cases significantly impact our sandbox, even though their facts put them outside the drug/device arena.  Thus, we’ll give a shout out to the Supreme Court’s BNSF Railway Co. v. Tyrrell, 137 S.Ct. 1549 (2017), decision holding once and for all that Bauman is not limited to corporations incorporated in other countries.  A couple of other jurisdictional decisions of the same ilk are Aspen American Insurance Co. v. Interstate Warehousing, Inc., ___ N.E.3d ___, 2017 WL 4173349 (Ill. Sept. 21, 2017) (litigation over a fish warehouse), and State ex rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (another railroad case), both of which took long strides in shutting down litigation tourism in key states.  Given the universal importance of jurisdiction, any one of these may well have more impact on particular clients’ cases than some of the decisions appearing on our list.

Enough preliminaries. Time to start celebrating good decisions:

  1. Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773 (2017). To the surprise of absolutely nobody who has been a regular reader of the blog, the “BMS” decision is our pick for the best decision of the year.  After the Court said “we really mean it” about the “at home” requirement of general personal jurisdiction in Bauman, litigation tourist plaintiffs simply shifted the same broad jurisdictional arguments to specific jurisdiction.  The California appellate courts immediately signed on, with a “sliding scale” that in practice allowed jurisdiction over all mass torts anywhere. That decision, which we tagged as the worst of 2016, is no more.  In BMS an 8-1 majority put the kibosh on what it described as a “loose and spurious form of general jurisdiction.”  Plaintiffs cannot obtain specific jurisdiction by osmosis – because some other plaintiffs who actually lived in the state in question could bring the same type of claim.  Rather, the conduct “giving rise” to the suit, such as the injury and the alleged tort, must happen in the state, so that there is “harm” in the state and to the state’s residents.  Equally significant, plaintiffs’ “last ditch” argument based on the presence of an in-state co-defendant, also failed.  Personal jurisdiction requirements “must be met as to each defendant” separately.  Merely “contracting with” an in-state entity failed miserably.  The beneficial effects of BMS in curbing litigation tourism have been immediate and widespread, if not total.  The abusive 99-plaintiff complaints, with a one or two plaintiffs in the jurisdiction and a the same in the defendant’s home state to defeat diversity, are being carved up and dismissed.  BMS jurisdictional issues caused havoc with the plaintiffs’ litigation strategies in both talc litigation and the Pinnacle Hip MDL.  BMS is forcing mass torts to change.  It’s not perfect, but a massive improvement on where our clients were before.  We celebrated BMS here, and to help our side, have written quite a few posts on how BMS can be beneficial in various situations.
  2. Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127 (Cal. App. 2017).  Our second case also arises from California, and is a major preemption win for non-generic drug manufacturers (in this case, OTC) post-Levine (2009-1).  Typical for California at the time, plaintiffs were litigation tourists from overseas.  They won $55 million for SJS-TENS – a condition that tends to produce big verdicts and big decisions.  Most significantly, Trejo all but dooms design defect claims in the nation’s largest state.  Mensing/Bartlett preemption, using the “independence principle,” rendered such claims “impossible” because significant design changes (here, changing the active ingredient) require prior FDA approval.  Trejo was the first appellate court to apply this reasoning to OTC drugs (we’re 4-0 overall outside generics), and did so although “product liability” claims were expressly saved from express (not implied) preemption.  Trejo also came down hard on plaintiff’s “alternative design” being an active substance not approved by the FDA, holding such an alternative design to be no alternative at all, but merely an indirect argument for removing an FDA-approved drug from the market.  Also, Trejo made an important state-law ruling, that only “risk/utility,” and not “consumer expectation,” is a viable design defect theory for a complex product such as an OTC drug – a holding that should apply a fortiori to products that require a doctor’s prescription.  Finally, as to warnings, the court held that a defense verdict on strict liability and a plaintiff verdict on negligence were fatally inconsistent – providing some level of deterrence against plaintiffs seeking multiple bites at the liability apple.  Trejo is final.  Plaintiff unsuccessfully appealed to the California Supreme Court.  We toasted Trejo here.
  3. Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017).  Affirming last year’s ninth best decision, the Tenth Circuit’s opinion attests to the revived strength of implied preemption in prescription drug cases after Levine (2009-1).  Although summary judgment for the defendant was reversed in part on a minor point (warning causation – but only because the issue hadn’t been litigated in the district court), the big-deal preemption arguments were affirmed:  (1) “clear evidence” established that the FDA would not have entertained plaintiff’s proposed warning; (2) the FDA’s rejection of a citizen’s petition (a harassment technique favored by plaintiff-side organizations) was “clear evidence” that a manufacturer’s similar attempt would also be rejected, since the scientific standards are identical; and (3) an FDA rejection, for lack of scientific evidence, necessarily preempts tort claims from all earlier times, since even less data would exist at those earlier times.  Item two created a split with the Massachusetts high court in Reckis (2015-1), but the Cerveny plaintiffs did not seek certiorari in the Supreme Court.  Plaintiffs also tried to interpose Fosamax (2017-1), but the Tenth Circuit affirmed preemption anyway, given the “smoking gun” strength of the citizen’s petition evidence.  Cerveny created a much needed “bright line” in the murky post-Levine preemption landscape, eliminating older claims.  When we celebrated Cerveny here, we opined that the surviving warning claim was extremely weak, since it turned on risks the plaintiffs did not encounter.  We have since been proven right about that, so the only drawback in this powerful pro-preemption decision has disappeared.
  4. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 858 F.3d 787 (3d Cir. 2017).  Next to preemption, Daubert is the strongest defense available to the good guys – capable (in our personal experience) of ending entire MDLs with a single motion.  That’s what happened with this MDL claiming that Zoloft (similar allegations have been made about this entire class of drugs) causes birth defects.  The science says the opposite, the district court followed the science (2015+9), and this year the Third Circuit affirmed.  Even with an uncalled-for second chance, plaintiffs could not offer scientifically valid general causation evidence.  Plaintiffs lost on several grounds.  Their claims of teratogenicity had no epidemiologic support.  What they did have – statistically insignificant results and cherry-picked “trend analysis” – couldn’t support a Bradford-Hill, or even weight-of-the-evidence (which the court did not adopt), analysis.  The expert’s meta-analysis was result-driven, with no inclusion/exclusion criteria beyond what would help plaintiffs win.  Generally, the methodology was inconsistent and unexplained.  As the most significant Daubert decision of the year, signaling the end of an entire MDL, we rate it number four, although we could do without some of the dictum.  We examined Zoloft here.
  5. United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).  Fraud on the FDA was eliminated as a viable theory in Buckman, right?  Largely, but not entirely.  Applying basic preemption principles, Buckman held that state-law claims alleging that, but for “fraudulent” information, the FDA would have done something different than it actually did were inherently preempted, since only the FDA has authority to decide if it has been defrauded.  But the False Claims Act is a federal statute, and preemption does not apply between two competing federal requirements, so FCA plaintiffs have attempted to use fraud on the FDA as a basis for statutory liability.  In Nargol the First Circuit, expanding upon the rationale it first adopted in D’Agostino (2016+4), said “no” – and that is one of the most plaintiff-friendly FCA courts around.  Unless the FDA actually found fraud, causation is entirely speculative, since the FDA hasn’t changed its decision, plaintiffs are necessarily pursuing a counterfactual hypothesis.  Also, if the “fraud” had been material, the FDA would have done something, so that’s another necessary FCA element that such claims lack.  Materiality is a “demanding standard.”  Nargol had no patience with plaintiffs dissing of 510(k) clearance – that “process constitutes the government’s method of determining whether a device is safe and effective,” through which “the FDA affirmatively deemed the product safe and effective.”  Nargol also analogized to Buckman, finding the same concerns also weighed against allowing the FCA to become a vehicle for second-guessing FDA regulatory decisions.  Because Nargol stands in opposition to decisions like Cisson (2016-2) on the import of 510(k) and Fosamax (2017-1) on letting juries second-guess the FDA, it made our list even though it’s not classic product liability.  We gave Nargol our nod here.
  6. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. 2017).  Did we mention already that preemption is powerful enough to shut down an entire MDL with a single ruling?  That’s exactly what happened in Utts, the only trial-level decision to make our top-ten list this year.  Not only that, Utts stomped all over litigation against new-generation blood thinners, which we think is particularly meritless, since bleeding is about as well-known and inherent risk of these products as anything imaginable.  Utts engaged in the most extensive discussion we’ve yet seen of implied preemption of warning claims for lack of “newly acquired evidence” (the prerequisite to allowing unilateral warning “strengthening” under the FDA’s CBE regulations).  MDLs, in particular, are likely to spawn “newly acquired evidence” preemption arguments, because they have many plaintiffs spread out over the product’s entire timeline.  Supposed “deficiencies” in the earliest information are thus the only warning-related claims that can benefit all plaintiffs in an MDL.  In Utts none of the nine different types of risk information that plaintiffs alleged should have been beefed up differed materially from the information the FDA considered in approving the drug; hence no information was “newly acquired”; hence preemption.  Nor could Fosamax (2017-1) apply, since “clear evidence” only becomes an issue after a plaintiff demonstrates “newly acquired evidence.”  Aside from preemption, Utts also features defense-friendly discussions of:  (1) the FDA’s reporting system; (2) the drawbacks of overwarning; (3) comparative claims; (4) California’s state-of-the-art defense; and (5) warnings being adequate as a matter of law. Utts is a long opinion, and every word is worth reading.  We went nuts over Utts here.
  7. Johnson & Johnson v. Fortenberry, ___ So.3d ___, 2017 WL 4699593 (Miss. Oct. 19, 2017).  The Mississippi Supreme Court reversed a multi-million dollar plaintiff verdict for two important reasons.  First, the label’s warnings about the risk in question were adequate as a matter of law.  That’s a significant victory in and of itself – before we point out that the drug was an atypical antipsychotic, the risk was tardive dyskinesia, and the warning was classwide labeling.  The high court declared a lot of labels adequate in a lot of cases.  As we pointed out, that means that the defense wins without even having to consider physician-specific causation arguments.  Second, a state high court declaring that the purported tort of “negligent marketing” does not exist is also a big deal.  Plaintiffs use this claim as a vehicle for admitting “marketing” evidence, that is, irrelevant promotional evidence to which the prescriber was not exposed, and for seeking punitive damages.  In Mississippi, at least, that cause of action has failed.  Oh, yes, the court also affirmed the trial court’s determination that, as a matter of law, plaintiff failed to make a case for punitive damages.  We let out a rebel yell over this result, here.
  8. Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Say you bought a product.  It had exactly the characteristics it was represented to have, worked in the manner it was supposed to, and didn’t hurt you in the slightest.  Could you then sue because the product wasn’t designed in some other way that might somehow have made it more efficient or “better”?  Can you then generalize your complaint across an entire class action?  If you say yes, then you agree with the Third Circuit in Cottrell (2017-4).  If you say no, then keep reading.  In one of Judge Posner’s final opinions, he reversed class certification in a case alleging that eye-drops (yes, the drops themselves) were too large, and thus were a suboptimal use of the fluid.  The drops were exactly as represented and not injurious.  Eike found the claim bogus in several ways.  It attacked an FDA-approved design.  It purported to invoke a duty not just to make a safe and effective product, but to make the “best” product possible – with “best” being unobtainable because it is only defined by plaintiffs’ experts.  There was no standing because there had been no injury.  “[T]hat a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret.”  We eulogized Eike (and Posner) here.
  9. State ex rel. Bayer Corp. v. Moriarty, ___ S.W.3d ___, 2017 WL 6460354 (Mo. Dec. 19, 2017).  Very late in the year, the Missouri Supreme Court recognized that Bauman and BMS have changed the parameters of personal jurisdiction, and unanimously granted mandamus  – a much tougher standard than ordinary appeal – holding that a multi-plaintiff, misjoined complaint (92 plaintiffs, 85 from out of state) against a device manufacturer could not create jurisdiction over the claims of non-resident plaintiffs against a non-resident defendant.  The court ordered the existing complaint dismissed.  “At home” means a lot more than just doing business, so no general jurisdiction.  As the court had ruled previously, registering to do business does not constitute consent to general jurisdiction, because it would “result in universal personal jurisdiction for corporations complying with registration statutes in many states.”  Nor was there specific jurisdiction, since the contacts of “other plaintiffs” was not enough to create the necessary “affiliation between the forum and the underlying controversy.”   Plaintiffs would have to show some specific facts about their claims and Missouri that would not “simply be another way of gaining general jurisdiction over [defendant] in the many states,” and could try on remand.  Because Moriarity was so recently decided, we haven’t blogged about it yet, but we expect to.
  10. In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  Wait a cotton-picking minute here.  The defendant lost; mandamus denied.  What is this case doing in a pro-defense top-ten list?  Why?  Because the defendant didn’t really lose, although the relief sought was denied.  Mandamus is very hard to get.  The writ requires three elements, and one of them is that an eventual ordinary appeal is not an adequate remedy.  Waste of time and money between here and there doesn’t count, and the Depuy defendant didn’t clear that hurdle.  But the defense won the other two, more substantive, elements.  A majority held that the MDL-wide order concerning waiver of jurisdictional defenses was not only wrong, but “patently erroneous” and a “clear” abuse of discretion.  Waivers must be explicit; this one wasn’t; resulting in “grave error.”  Second, mandamus was “particularly appropriate” because the error had ramifications “beyond the immediate case” because the MDL ruling purported to extend to almost 10,000 MDL cases.  Reminds us of the original Batman.  These rulings – embodied in a precedential decision – were a huge loss for the MDL plaintiffs, which they recognized, since they moved for rehearing en banc, even though not technically “aggrieved.”  Although not an order (because mandamus was denied), the panel “requested” the MDL judge to vacate the offending order and halt further “bellwether” trials pending resolution of other, pending appeals.  That request was refused, and what in all likelihood was a pointless trial thereafter ensued.  All in all, this result was a rare appellate intervention into the workings of an MDL, and given what happened afterwards, it appears that one such intervention will not be enough.  We covered the oral argument, and then delighted in Depuy, here.

So there you have it, the drug/medical device decisions that we consider to be the ten best of 2017.  But we like good decisions, and 2017 featured a lot more than ten blogworthy outcomes favorable to the right side of the “v.”   As usual, we’re listing another ten good decisions for 2017 that fell just short of cracking our top ten.

These are our Honorable Mentions:  (11) Sidney Hillman Health Center v. Abbott Laboratories, 873 F.3d 574 (7th Cir. 2017).  Rejecting proof of causation of causation/damages in RICO off-label promotion suit as inadequate as a matter of law.  We applauded adherence to traditional causation standards here.   (12) In re Mirena IUD Products Liability Litigation, ___ F. Appx. ___, 2017 WL 4785947 (2d. Cir. Oct. 24, 2017).  Another affirmance of an MDL-ending Daubert order (2016+6) that, if precedential, would almost surely have made the top ten.  We cheered exclusion of plaintiffs’ ipse dixit, ginned up for litigation opinions here.  (13) M.M. v. Pfizer, Inc., 806 S.E.2d 800 (W. Va. 2017).  A state high court deciding that Michigan plaintiffs couldn’t escape adverse applicable statutes.  Plaintiffs brought that on themselves, as we explained here.  (14) United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017).  The FCA is an “awkward vehicle . . . for punishing off-label promotion schemes.”  The relators’ lack of personal knowledge meant they couldn’t overcome TwIqbal, as we discussed here.  (15) Inge v. McClelland, 257 F. Supp.3d 1158 (D.N.M. 2017).  A detailed and articulate reaffirmation of the principle that plaintiffs can’t recover for injuries caused by their own criminal acts, which the rise of opioid litigation makes all the more timely.  See our post here.  (16) Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So. 3d 665 (Fla. App. 2017).  This Florida appellate court has forgotten more Florida law than the Eleventh Circuit (2017-8) ever knew, particularly on negligence per se issues, as we explained here.  (17) In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 226 F. Supp.3d 557 (D.S.C. 2017) & In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 227 F. Supp.3d 452 (D.S.C. 2017).  Another MDL-ending Daubert decision, holding that, while a viable claim could exist for a particular dosage at certain times, not one of the scattershot solicited plaintiffs in the entire MDL met those criteria.  We loved Lipitor here.  (18) Barraza v. C.R. Bard Inc., ___ F.R.D. ___, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017).  In over twenty years, not a single product liability/personal injury class action has survived a contested appeal.  That losing streak was not broken by medical monitoring allegations involving a medical device, as we reported here.  (19) In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  As we explained here, innovator liability poses an existential threat to branded drug manufacturers.  Thus, a decision rejecting such liability in six states is worthy of attention, which we gave here.  (20) Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. 2017).  Judicial Watch specializes in vast conspiracy theories, but the conspiracy alleged in its first foray into product liability was only half-vast.  Here, we tallied up the resulting favorable preemption, TwIqbal, and other substantive law rulings as the entire complaint was dismissed with prejudice.

Perusing our best and worst from 2016, the worst of 2016 became the best of 2017 with the BMS loss at the California Supreme Court turning into a win in the United States Supreme Court.  Of our ten “worst of the year” cases between 2007 and 2016, fully half of them are no longer good law (BMS and Bartlett (2012-1) outright reversed; Weeks (2014-1) and Karl (2007-1) overturned by statute; and Wimbush (2010-1) limited to its facts after Bartlett (2013+1).  Given what it takes to get to number one (either the best or the worst) that’s not a bad track record at all for the good guys.  Also, as we’ve mentioned, 2017’s worst stinker remains pending in the United States Supreme Court, with decent prospects.  By contrast, every single one of our top ten best over the past decade is still standing tall.

Going down last year’s list, we already mentioned (2017-3) the Missouri affirmance of Barron (2016-3).  An appeal in T.H. v. Novartis (2016-5) is pending, and that California Supreme Court decision – good or bad − will certainly make next year’s lists (unless decided before the end of this year).  The Pinnacle Hip entry from last year (2106-6) is on appeal, representing another decision likely to make one of next year’s lists. Certiorari was denied in another adverse jurisdictional decision (2016-8), and as far as we can tell none of the other baddies are going anywhere.  On our good list, we already mentioned the Mirena (2016+6) and Cerveny (2016+9) affirmances, an appeal in Lipitor (2016+7) is pending (4th Cir. #17-1140) and will be argued early in 2018.  Further appellate review was denied in Niedner (2016+3).  Everything else appears final.

Looking over earlier top/bottom ten lists, we lost Incretin (2015+10) to a non-substantive, unpublished reversal just a couple of weeks ago.  Jeez, the Ninth Circuit is slow.  We lost Fosamax (2013+7) to the Third Circuit’s horrible decision (2017-1) that leads this year’s bottom 10 list.  MDLs move even more slowly.  None of the other top/bottom ten cases had their status changed in 2017.

Going forward, as we’ve already discussed, 2018 could go down as the “year of innovator liability” – good or bad – with two more state high courts poised to decide the same issue that California went south on the other day.  On that same subject, there’s also that Case That Must Not Be Named in the Seventh Circuit.  The Fifth Circuit will finally have its say on the Pinnacle Hip (2016-6) rulings, and other appeals arising from that MDL.  The New Jersey Supreme Court will be reviewing several aspects of the long-running Accutane litigation.

Finally, on the administrative front, the FDA’s proposal (discussed here and here) to amend the “intended use” regulations has been in limbo for some time, with the Agency – under new management – having to formulate a First Amendment position on truthful off-label promotion that is reflective of current jurisprudential realities.  Congress has before it a bill, passed by the House of Representatives, that (as we discussed here) would alleviate some of the worst mass tort abuses that we unfortunately have to live with every day.  Maybe the Senate will pass something similar in 2018, but we’re not counting any chickens just yet.

Now it’s time to ring down the curtain on 2017 – barring something big happening in the next couple of days.  We wish all our readers good health and good cheer in 2018.  To our readers on the right side of the “v.,” we also wish a productive and successful New Year.

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s.

Guess what?  In a development that we weren’t entirely surprised to see happen, the California Supreme Court recognized not only innovator liability, but innovator liability in perpetuity, later during the same day that our 2017 “worst of” post was published, which coincidentally was the first day of winter.  Winter is not just coming, it’s now here.  California’s tort climate just became much colder for our pharmaceutical clients.

So we’re publishing this addendum to this week’s “worst of” post.  This year there will be two number one worst of the worsts.  Given everything else that’s happened in 2017, we suppose that is appropriate.

  1. T.H. v. Novartis, 2017 WL 6521684, slip op. (Cal. Dec. 22, 2017).  Innovator liability, which effectively shifts 100% of potential liability for drug injuries to the 10% of the drug market that branded drugs represent, received the nod of all seven justices in this 4-3 decision. Y et, remarkably, the majority took the view that “the burden on brand-name drug manufacturers” to warn “those who are prescribed the generic version of the drug is zero.”  That attitude, an insouciance towards any policy supporting prescription drugs (Brown cited not at all by the majority, and only once, parenthetically, by the somewhat less restrained concurrence) was apparent throughout.  The result is pharmaceutical companies being disfavored, even compared to asbestos manufacturers. The same dismissively pro-plaintiff attitude that recently caused the same court to invite all mass tort plaintiffs to sue in California (2016-1) rears its ugly head again.  T.H. defined negligence “duty” broadly and vaguely – “each person has a duty to use ordinary care and is liable for injuries caused by his failure to exercise reasonable care in the circumstances” – so that it could characterize even this vast expansion of liability to non-manufacturers as some sort of “exception” to the a general rule that allegations of negligence make anyone liable to everyone for anything.  But then T.H. inconsistently discounted a mountain of contrary federal precedent because federal courts aren’t supposed to predict novel expansion of state-law liability.  At least Sindell, bad as it was, was honest about its unprecedented result.  T.H. is not the first time we’ve seen an opinion putting the “duty” rabbit in the hat like this to support a novel liability theory; Lance (2014-2) did the same to allow a stop-selling “negligence” theory.  Lance has preemption problems, and T.H. might, too, at least on the case-specific off-label use facts.  The majority appears to believe that off-label risk warnings can be added “unilaterally,” which they can’t.  Somewhere, Justice Traynor, who conceived of product liability as ensuring the liability followed profit from product sales and ability to control product quality, must be spinning in his grave.  Innovator liability violates both principles, and also lets off the hook the party that profited from the product and directly controlled its risk.  Almost as bad – and even more extreme – is the second holding that innovator liability is effectively perpetual.  Bookending California’s expansive “product line” form of successor liability, T.H. creates “product line” predecessor liability; so that even sale of all rights to the product before (here, six years before) the relevant product sale does not extinguish liability.  It must have been a clear day, since the majority was able to foresee forever.  On this issue T.H. was 4-3 (with the vote of a randomly selected “assigned” justice being the difference), with the dissenters rightly focusing on:  (1) lack of control over a successor’s warnings; (2) overwarning of scientifically questionable risks; (3) insufficient deterrence of the actual product manufacturers; (4) “destabilization” of the pharmaceutical industry by perpetual, unlimited liability; (5) liability spillover to other products; (6) an unrealistic attitude towards corporate transactions; (7) relative lack of moral blame; and (8) unavailability of insurance for risks of competing products and the resultant increase in the price of branded drugs.  Although T.H. is a bit less blunt in expressing the motivations for its novel liability holding than Weeks (2014-1), the California court’s underlying intent to use common-law liability to hold branded drugs hostage to federal action eliminating generic preemption is found in both in the majority’s footnote 2 and the first paragraph of the concurrence.  We trashed T.H. here, and will undoubtedly be doing that again.

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.”  We’re remembering that today because, frankly, dealing with all the lows at once can get depressing.  That, however, is the purpose of today’s post.  We’re looking at the bottom ten worst prescription medical product liability litigation decisions of 2017.

All these lumps of coal in our defense-oriented stockings is enough to give us all a case of seasonal depression.  These cases, while hardly candidates for a Hallelujah Chorus, do remind us of a different sort of Hallelujah – the kind we want over with as soon as possible.  So let’s get on with it already.  If you were on the receiving end any of these cases atrocities, we feel your pain.  We’ve been there (see 2013 -2), and we know what you went through.  That said, we’ll feel better next week, when we welcome the New Year with the our best decisions, after having taken this week’s purgative.

So let’s start purging:

  1. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  It’s hard to screw up the our most important defense – preemption − law in more different ways in one case than Fosamax did. The MDL court had found preemption because the FDA had actually considered the risk in question, several times, after obtaining classwide information, leading to a detailed section on that risk in 2011. Plaintiffs, as always demanded more, a causal warning that the FDA had rejected. They lost, under Levine’s (2009-1) “clear evidence preemption standard, back in 2014, and scores of claims were dismissed. Typical of the muddle that MDLs make of litigation these days, an appeal took three years to decide. Definitely not worth the wait. To avoid preemption on facts where the FDA had actually rejected the warning the plaintiff wanted, the Third Circuit did two things. First, ignoring prior Supreme Court precedent, the Third Circuit created an unprecedented heightened evidentiary standard for implied preemption, converting Levine’s requirement of “clear evidence” into a requirement for “clear and convincing” evidence. In eight years since Levine, no court had gone there (and no court has since). Second, to make things even worse, after putting a thumb on the evidentiary scale, the court then declared preemption – the determination that the FDA “would have” rejected a label change – was a question of fact, not law. That’s right, juries get to speculate, after hearing both side’s warring FDA “experts” (current FDA employees can’t be called as witnesses without the Agency’s consent) about what the FDA might have done. That ruling goes beyond unprecedented, since it flies in the face of more supposedly binding Third Circuit precedent than we have fingers. Nor could anything be more destructive of FDA authority than to let juries speculate about what the agency might have done with hypothetical warnings, and reach differing conclusions about the same drug in different cases. Under Fosamax, summary judgment on preemption is possible only when “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed . . . warning.” In other words, never – since the FDA had, in fact, rejected it. We decried this “lawless” result here. In addition, we cheered on the defendant’s certiorari petition and supporting amicus briefs, while pointing out other courts that rejected the Third Circuit’s misguided reasoning. And there is a glimmer of hope. The Supreme Court has asked for the Solicitor General’s views on the case, which tells us that this appeal has a pretty decent chance of being granted.
  2. Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017).  Eghnayem is the year’s outstanding example of MDL abuse.  Leery of MDL “bellwether” cases turning into  Stalinist show trials, featuring multi-plaintiff consolidation and punitive damages, the defendant declined to waive its Lexecon rights limiting MDL trials.  Didn’t work.  Shades of Stalin chasing Trotsky to Mexico: the MDL judge chased the defendant back to Florida, obtained a temporary commission and tried the case there – with four plaintiffs, punitive damages claims, and all of the adverse evidentiary rulings that have come to characterize that MDL.  All four plaintiffs won nearly identical (two exactly $6,722,222) verdicts of over $6 million apiece.  We have pointed out elsewhere at length how multi-plaintiff consolidations are inherently prejudicial to defendants, hence their use in MDLs as a means of pressuring defendants to pay big bucks to settle.  In Eghnayem, the Eleventh Circuit let it stand – despite the almost identical verdicts that should be a red flag demonstrating that the jury abandoned any effort to consider the cases separately.  “Confusing or not,” it was not an abuse of discretion to consolidate product liability cases (including warning claims, which change over time) involving similar injuries from similar products.  Contrary to almost every other case, even “identical damage awards” “are not sufficient evidence of juror confusion.”  Nor did admission of otherwise inadmissible warning (state of the art) and damages evidence preclude consolidation.  It’s a terrible appellate precedent, we think the first allowing product liability consolidation outside of asbestos.  Compared to that, the court’s affirmance of exclusion of §510k clearance evidence – another unfortunate hallmark of this litigation, although virtually unheard-of previously – is secondary.  We excoriated Eghnayem here, and recommended changes to the MDL statute to prevent such abuses here.
  3. Barron v. Abbott Laboratories, Inc., 529 S.W.3d 795 (Mo. 2017).  The intermediate appellate decision in this case alone was enough to make #3 on our bottom ten list last year. But for a couple of colossal federal appellate screw ups, affirmance of the $38 million ($23 million in punitives) verdict by the Missouri Supreme Court would have moved up a notch or two.  The big problem was venue and joinder – the trick of Missouri forum shopping that allowed a Minnesota plaintiff to have her case tried in St. Louis.  The Missouri Supreme Court dodged the issue holding that any error “by either failing to transfer venue or failing to sever the claims” was harmless because no “prejudice” from trial in St. Louis was shown.  How one would ever show prejudice, short of a lynch mob at the door, is unclear.  Rulings like this are what keep plaintiffs coming back to certain jurisdictions for more.  On warnings, the court held that because the defendant did not trash its own product as being riskier than other similar products, the warning wasn’t “accurate.”  As to punitive damages, the court held that a “black box warning is not relevant” because all contrary evidence is to be “disregarded” in evaluating the verdict.  Incredible – millions in punitives for a risk with a boxed warning.   We blasted Barron here as a poster child for why Missouri needs tort reform to put an end to blatant forum shopping.  That didn’t happen, but something else did (wait till next week) that has made a big difference.
  4. Cottrell v. Alcon Laboratories, 874 F.3d 154 (3d Cir. 2017).  Two Third Circuit cases are in the bottom five this year, and sure enough, the composition of the panels, here and in Fosamax, overlapped substantially.  The question in Cottrell was standing, specifically whether an otherwise uninjured consumer of a product could sue because the product wasn’t made and priced in a way that the consumer thought would be better or cheaper.  The same theory had been called “absurd” in a prior Third Circuit (unfortunately nonprecedential) opinion, but this panel never found a novel tort theory it couldn’t adopt.  Creating a circuit split, Cottrell allowed a would-be class action (all these ridiculous cases start as class actions) alleged “injury in fact” because the claims arose from consumer protection statutes. That the claim made no practical or economic sense, because consumers can’t force manufacturers to make different products, was irrelevant because when considering standing the merits didn’t matter. TwIqbal, what TwIqbal? Calling the defendant’s actions “unfair” was enough. When we started writing this blog, the Third Circuit had strong standing requirements that barred no-injury class actions; after Cottrell, the court has fallen to the bottom. At least in this case, unlike Fosamax, there was a dissent. We castigated Cottrell here.
  5. Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017).  The learned intermediary rule means that the duty of the manufacturer is to provide an adequate warning to the plaintiff’s treating physicians, right?  Not if you’re the Washington Supreme Court.  In an unprecedented ruling, Taylor opens up an entirely new front in prescription medical product litigation by ruling that, despite the rule, there exists a separate duty to provide warnings to a hospital, where the product actually was sold to the hospital, which many drugs and devices are.  This ruling potentially opens up hospitals to claims that they failed to stop doctors from using/prescribing products, and creates a second chain of warning causation that now must be negated.  On top of that, Taylor deviated from what had been consistent Washington precedent applying comment k to all prescription drugs and medical devices (Bexis filed an unsuccessful amicus brief on this issue), and held that strict liability can apply anytime a plaintiff asserts that warnings were inadequate.  We trashed Taylor here.
  6. In re Accutane Litigation, 165 A.3d 832 (N.J. App. Div. 2017).  At 15 years, Accutane litigation may well be the second longest running mass tort (after asbestos, of course) in New Jersey.  For a long time that was due a certain one-woman wrecking crew in Atlantic County.  She was kicked upstairs shortly after the defendant in Accutane sought recusal, and the mass tort has outlived her.  However her ghost haunts Accutane still, as Accutane (particularly footnotes 5 and 9) demonstrates.  New Jersey’s approach to expert evidence has sometimes been called “relaxed.”  However, Accutane goes from relaxed to supine.  Plaintiffs’ experts were allowed to avoid and discount multiple epidemiologic studies finding no statistically increased risk at all.  Far from the law lagging science, as is the case (at least rhetorically) with Daubert in the federal courts, Accutane declared that “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  It disregarded the usual hierarchy of scientific evidence, putting animal studies and single-patient case reports on the same level as statistically significant epidemiology.  Where did “general acceptance” go?  Everywhere else but New Jersey, Accutane cases alleging intestinal issues have been dismissed as a matter of law for lack of scientific basis.  Here, some two thousand cases have been resuscitated. We abhorred the Accutane result here, and praised the defense appellate arguments here.  Now, as with Fosamax there is hope.  Earlier this month the New Jersey Supreme Court granted the defendant’s appeal and will decide the scientific issues in Accutane for itself.
  7. Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017).  Christiansen is another example of the problems with bellwether trials in MDL litigation, illustrating how trial and appellate courts will bend over backwards to obtain and affirm plaintiff verdicts.  In Christiansen the jury initially returned a defense verdict.  That was not the result the MDL judge wanted, so he told the jurors that perhaps they did not “fully understand” the case and instructed them to try again, because a no defect finding was supposedly “inconsistent” with a finding of misrepresentation.  Duly admonished, the jury changed its mind and returned a verdict for the plaintiff.  Amazingly, the Eleventh Circuit let that second verdict stand.  In and of itself, that would be bad, but probably too much of a one-off situation to warrant the bottom ten.  However, the Eleventh Circuit went on to disregard the across-the-board application of comment k decreed by the relevant state’s (Utah) highest court.  Comment k only applies to drugs, not medical devices (or at least 510k medical devices) because only drugs are “approved.”  No Utah – indeed no court anywhere – has ever distinguished between prescription drugs and prescription medical devices in this fashion.  Utah law had never even required proof of FDA approval of anything for comment k to apply.  This kind of liability-enhancing, Erie-ignoring ruling on state law is, we believe, a consequence of the bellwether system, which causes disproportionate investment of time and effort in particular trials, which in turn pressures appellate courts to find some way to affirm, so that investment is not wasted.  We chastised Christiansen here.
  8. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017).  A terrible trifecta for the Eleventh Circuit.  Shades of Bush v. Gore – this time Mink thinks that it knows more about Florida law than the Florida state courts do.  As a general proposition, the Florida Supreme Court has required, for over two decades, that before any use of negligence per se, such use must be consistent with legislative intent.  That means, as a matter of state law, FDCA-based negligence per se claims fail, because the FDCA famously included §337(a), which expressly provides for exclusive government enforcement.  This legislative intent requirement further means that “parallel claims” of FDCA violations do not exist in Florida, and so an unbroken string of state and federal decisions had held.  Until Mink.  The court’s reasoning was bluntly result oriented.  Florida law could not be that way, Mink declared, because otherwise plaintiffs suing over allegedly defective PMA medical devices would be out of court. That’s true, but as the Supreme Court noted in Riegel, that is precisely what preemption does. For taking a blunt instrument to a long-standing requirement of state law for no reason other than to preserve an exception to preemption that this particular state has chosen not to recognize, Mink belongs in this list.  We skinned Mink here.
  9. Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017).  In an ugly decision, the Ninth Circuit reversed a Daubert exclusion in Wendell.  Given the appellate abuse of discretion standard applicable to Daubert decisions, that amounts to a decree that this type of expert testimony must be admitted.  What type of opinion was it?  It was litigation-driven, without a scrap of independent research.  It was unsupported by epidemiology, or even animal studies.  Even the “science” cited by the excluded experts did not address the drug combination plaintiff had used.  Nor had the experts excluded, as a possible cause, the underlying condition that the drug was used to treat.  Instead of science, Wendell was blinded by the supposed “highly qualified” credentials of the experts.  Qualification and methodology are supposed to be separate inquiries under Daubert.  Linus Pauling, for example, won two Nobel prizes, but as to cancer cures he was a quack.  Ditto William Shockley and eugenics.  Further, the “differential diagnosis” technique is notoriously lax, and Wendell was far to credulous about what a proper differential diagnosis must include – and exclude.  The worst Daubert decision of the year in our sandbox.  We whacked Wendell here.
  10. Dunson v. Cordis Corp., 854 F.3d 551 (9th Cir. 2017).  Back in 2014, we awarded a Ninth Circuit en banc decision, Corber v. Xanodyne, our #4 best case rating.  Corber held that a California request for “coordination” triggered CAFA’s mass action provision and supported removal to federal court.  Unfortunately, with Dunson, Corber has now been distinguished into seeming oblivion.  Apparently en banc doesn’t matter much in the Ninth Circuit.  It certainly didn’t in Dunson.  Request for “pre-trial” consolidation – no CAFA.  Request for bellwether trials – no CAFA unless the result would be “binding” on the other cases, which is vanishingly rare.  Basing the bellwether request on need to avoid inconsistent results?  Not specific enough.  After Dunson, we wonder how much is left of Corber.  Form appears to be triumphing over substance.  We derided Dunson here.

So that’s the bottom ten. Unfortunately, the other side did better than usual this year – this is the first time in blog history that every one of the dregs cases has been an appellate decision.  As for the near misses, we’d put United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), at the top of the list, since it allowed fraud on the FDA theories in False Claims Act cases, and we hate cases that purport to give private plaintiffs ways to get around Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

That’s quite enough, thank you.  We’re ready to bring this exercise in the gnashing of teeth and rending of clothes to a close.  Stay tuned, however.  Next week, we take the litigation roller coaster up rather than down when we review the ten best drug/device decisions of 2017.

Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence.  Last week, we visited the abyss, naming our 2016 Bottom Ten.  This week we go in the opposite direction, to the mountaintops.  So join us for a Happy Old Year as we revisit the top ten best judicial decisions of 2016 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices.

One caveat, since we’re limiting ourselves to cases involving drugs and medical devices, we’ve necessarily omitted some significant 2016 decisions that, while outside the blog’s sweet spot, have significant positive implications for drugs and medical devices.  So on the way to the ten peaks, give a fond wave to the Supreme Court’s partial elimination of the presumption against preemption, the Third Circuit’s extending Mensing/Bartlett preemption beyond generic drugs, the Second Circuit’s rejection of general jurisdiction by consent, and New Jersey’s rejection of bogus talc experts.  Some of these cases may well have more overall impact on our clients’ cases than what appears on our list.

Time to start climbing.

  1. Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944 (Ariz. 2016).  All in all, it was a very good year for the learned intermediary rule. With new legislation in West Virginia, we completed our learned intermediary 50-state survey this year, now with positive authority from every state.  Epitomizing the renaissance of the learned intermediary rule is Watts, in which the Arizona Supreme Court resoundingly adopted the rule, after decades of spurning plaintiff-side appeals from favorable intermediate appellate decisions.  Reversing a plaintiff-side sneak attack that made our 2015 lousy list (2015-6), the Arizona high court agreed with the policy foundations for the rule, rejected attacks on the rule as “outdated,” and adopted the Third Restatement version (Arizona tends to follow current ALI Restatements). Turning to the peculiar rationale the lower court had used to avoid the rule, Watts held that the learned intermediary rule and Arizona’s joint tortfeasor contribution statute were fully compatible.  Adding an exclamation point, the court definitively trashed, once and for all, an argument based on the Arizona constitution’s “anti-abrogation” clause that the other side had trotted out for decades in support of any number of expansive liability theories. For leading the learned intermediary rule renaissance, Watts gets this year’s number one designation.  We blogged about the good news in Watts here and here.
  2. Glennen v. Allergan, Inc., 202 Cal. Rptr. 3d 68 (Cal. App. 2016).  Good appellate decisions in California are not easy to come by.  Glennen affirmed dismissal on PMA preemption grounds of one of these novel causes of action that seem endemic to both the Golden State and to PMA preemption cases.  Glennen embraces the “narrow gap” formulation of express and implied preemption in PMA device cases.  A claim for failure to train surgeons in the product’s use fails on both counts. Vague FDA regulations that do not expressly address training are “open to a particular manufacturer’s interpretation,” so “allowing them to serve as a basis for a claim would lead to differing safety requirements.”  Further, these manufacturing practice regulations only apply to the manufacturing practice itself, and not to the training of surgeons. The FDA does not regulate the practice of medicine.  Further, the claim is impliedly preempted because no California state duty exists that requires medical device manufacturers to offer physician training programs.  In the absence of any recognized state duty, any training-related claim must be solely based on the FDCA – but the FDCA allows no private enforcement, leading to implied preemption under Buckman.  We particularly like this type of Buckman preemption because it is simultaneously a rejection of the underlying state cause of action, which in Glennen diverges from a different Court of Appeal’s prior bad ruling in Scott v. C.R. Bard (2014-7). Glennen finishes by reaffirming another useful proposition, that medical device manufacturers are not responsible for how doctors using their products choose to practice medicine. This favorable California appellate decision on our clients’ strongest defense (where it exists) is number two on our list. We discussed Glennen here.
  3. Niedner v. Ortho-McNeil Pharmaceutical, Inc., 58 N.E.3d 1080 (Mass. App. 2016).  Massachusetts can be another difficult jurisdiction for our clients, as both this year’s (2016-7) and last year’s (2015-1) bottom ten lists demonstrate.  But nothing is impossible.  In Niedner, the plaintiff made a frontal assault on innovative contraceptive technology with a “design defect” theory against a time-released contraceptive patch that alleged as an “alternative design” a different type of contraceptive product altogether (birth control pills).  The court saw this claim for what it was – a backhanded attempt to hold the more convenient patch technology per se defective by alleging that only a different type of technology, with a different suite of risks and benefits, should have been sold.  A different product, even though directed at the same general need, is not an alternative design.  Bravo!  The plaintiff’s warning claim failed as well, because the warnings addressed the risk at issue “in no less than four places” and were thus adequate as a matter of law.  As an appellate win that also strikes a blow for reproductive freedom, Niedner is our number three peak decision. We lauded Niedner here.
  4. D’Agostino v. EV3, Inc., ___ F.3d ___, 2016 WL 7422943 (1st Cir. Dec. 23, 2016). This late addition caused us to revise our list.  We hate fraud on the FDA claims with a passion (Bexis thought up the preemption theory that became Buckman, and Buckman cites Bexis), so even though D’Agostino is a False Claims Act claim, rather than straight product liability, its outright rejection of a fraud on the FDA claim masquerading as an FCA action is our highest ranked federal decision of the year.  The main claim was straight out of Buckman – that the defendant sought a narrow FDA approval for a device while intending to promote broader uses off-label.  The allegedly defrauded party, the FDA, didn’t make any reimbursement claims.  Merely that the false intended use statements “could have” influenced FDA approval is not enough.  The FDA knew all about these allegations for years and never instituted any enforcement action, therefore the claims flunked the “demanding” materiality standard for implied certification FCA claims.  To allow fraud on the FDA claims despite Agency inaction “would be to turn the FCA into a tool with which a jury of six people could retroactively eliminate the value of FDA approval and effectively require that a product largely be withdrawn from the market even when the FDA itself sees no reason to do so.”  The court also discusses how this type of claim would create the same “practical effects” that supported preemption in Buckman.  Here, without preemption (the FCA being a federal statute), the failure of the FDA to act on the purported fraud defeats causation as a matter of law.  Fraud on the FDA claims are more properly the province of a government prosecution (FCA or otherwise) than lone-wolf private parties.  As an extra, added bonus, the First Circuit also rejects:  (1) a failure-to-train theory as inadequately pleaded on both the “false” and “claim” aspects of the FCA, (2) a manufacturing defect claim not tied to the submission of false claims, and (3) the proposition that design improvements render all prior designs of a device “defective” for purposes of establishing falsity.  We delighted in D’Agostino here.
  5. Wagner v. Teva Pharmaceuticals USA, Inc., 840 F.3d 355 (7th Cir. 2016).  Wagner was the best appellate decision on preemption in the federal system this year – although not as significant as several last year (2015+1 through 3).  Wagner involved generic drug preemption, and its most significant contribution to preemption jurisprudence was as the first appellate precedential determination (something we knew all along) that nothing in the 2007 FDAAA did anything that changed the generic drug “sameness” requirement in any way that affected preemption.  Wagner also recognized the comprehensive nature of generic preemption, because precluding warning, design, and stop selling claims is an extremely broad reach.  Failure to update also failed.  First, it wasn’t pleaded, and even if it had been, it couldn’t have been causal.  Not bad for the same circuit the decided the awful Bausch case.  We discussed Wagner here.
  6. In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396 (S.D.N.Y. 2016).  Things seem to run in cycles.  While there were fewer major preemption wins this year than in the past, there were more Daubert victories. The Mirena whopper of an opinion (93 pages in F. Supp.) is the best Daubert decision of this bunch.  Plaintiffs offered four general and specific causation experts, and all of them were excluded, for a litany of Daubert sins.  One expert “reverse-engineered” his utterly untested theory “to fit the desired outcome.”  That wasn’t reliable methodology.  Another attempted to judge whether the product had “sharp edges” by feel.  That didn’t pass muster either, nor did his attempt to extrapolate from animal studies.  Yet another expert speculated about an untested and unvalidated causal mechanism, relied solely on anecdotal case reports, ignored contrary literature, and had no non-litigation-related expertise.  Guess what, she didn’t make it earlier.  The fourth opined only as to specific causation, but without any admissible general causation opinions he failed, too.  Conversely, the plaintiffs barely scratched the seven defense medical experts with their Daubert motions, with all but one minor category of testimony (about “lawsuit-generated scientific misinformation”) held admissible.  The court also addressed regulatory experts, but with plaintiffs’ causation case going down the tubes, that hardly mattered.  We blogged about Mirena here, and about the MDL-wide summary judgment order that followed here.
  7. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 174 F. Supp.3d 911 (D.S.C. 2016).  Right behind the Mirena Daubert decision (only three weeks later) is the one in Lipitor.  Once again, plaintiffs offered four causation experts; once again all four went down, in whole or in part.  The “part” had to do with dosage.  While there was scientific evidence for causation (diabetes) at the highest dose, there was none at the three lower dosage levels, which the vast majority of the plaintiffs in the MDL had taken.  As to the three lower doses:  (1) plaintiffs’ epidemiologist had no epidemiology; (2) a second expert’s only apparent methodology was cherry-picking anything that supported his a priori conclusions and ignoring the rest; (3) a third expert violated a court order requiring separate consideration of all four dose levels and offered a “methodology” that consisted solely of “reading articles” and picking those that supported her a priori conclusions; (4) the fourth and final expert copied the methodological failings of the third expert, and likewise failed to segregate his opinions by dose.  As a result, the great majority of another MDL bites the dust.  We rate Lipitor slightly below Mirena because of the remainder left behind.  We discussed Lipitor here.
  8. Flagg v. Stryker Corp., 819 F.3d 132 (5th Cir. 2016) (en banc).  En banc decisions by federal appellate courts are rare, and those relating to removal issues even rarer.  Flagg decided a longstanding removal issue affecting literally hundreds of cases in Louisiana – whether the state-law requirement to present medical malpractice claims to a state review panel before suing meant that non-diverse Louisiana doctors joined as defendants in violation of state law were fraudulently joined and could not defeat diversity jurisdiction.  A Fifth Circuit panel held, sua sponte, that joinder was not fraudulent and thus no jurisdiction existed, in a decision that garnered a dishonorable mention from us in 2015.  By an 11-4 margin, the en banc court reversed, refusing to reward plaintiffs who deliberately violated state law.  Joinder was illegal under state law, and since the propriety of removal is decided as of the date of removal, the possibility that a claim might later be found to exist didn’t matter.  Thus, jurisdiction exists, and hundreds of plaintiffs don’t get a second bite at the apple in state court (remember, subject matter jurisdiction is non-waivable).  We don’t rank Flagg any higher because, while important, the issue is limited to (as far as we know) Louisiana.  We raised Flagg here.
  9. Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203 (D. Utah 2016).  In the wake of last year’s big win in Yates (2015+1), 2016 saw a steady stream of favorable implied preemption cases involving non-generic drugs (collected here).  Cerveny is the most significant of that group, in that it adds some clarity to the Supreme Court’s Levine (2009-1) “clear evidence” standard.  In contrast to mostly “know it when I see it” decisionmaking, Cerveny draws a preemptive line whenever the FDA rejects scientific support for a purported product risk as insufficient.  From that moment backwards, all warning claims regarding that risk are preempted, since the FDA’s rejection is “clear evidence” that it would have also rejected a warning about that risk at any earlier point, since the quantum of evidence at all earlier times would necessarily be at least as deficient (if not even more paltry).  Nor did it matter that the FDA’s rejection came in the context of citizen’s petition, since the scientific standards governing both are the same.  Other risks that the plaintiff did not suffer were irrelevant because no change in the warning could have been causal.  We celebrated Cerveny here.
  10. In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016) (“Accutane I”), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016) (“Accutane II”).  Yes, they’re state trial court orders, but between them they grant summary judgment on learned intermediary rule causation to an impressive 160 of 162 plaintiffs.  Practically every permutation of learned intermediary warning causation is addressed.  Accutane I held under the laws of 35 jurisdictions that warning causation under the learned intermediary rule necessarily fails where the death or disappearance of the actual prescriber precludes the affirmative testimony necessary to satisfy a plaintiff’s burden of proof.  The heeding presumption by itself was insufficient to establish a prima facie causation case.  Accutane II finds causation lacking as to 74 plaintiffs in fifteen states where affirmative prescriber testimony established one or more of the following situations:  (1) the prescriber already knew the risk; (2) the prescriber did not read the warnings at all; (3) the prescriber did not think risk was severe enough to matter; (4) the prescriber made an affirmative decision not to warn the particular patient; and (5) nothing the prescriber learned afterwards would have changed the prescription decision or the warnings given to the patient.  We detailed the Accutane rulings here.

That’s our top ten, but as usual our side’s noteworthy wins in 2015 didn’t stop with ten.  Thus, we’re acknowledging ten more favorable decisions this year that fell just short of climbing our ten peaks.

Here are our Honorable Mentions:  (11) In re Bard IVC Filters Products Liability Litigation, ___ F.R.D. ___, 2016 WL 4943393 (D. Ariz. Sept. 16, 2016).  Major discovery decision imposing “proportionality” limits to discovery even in MDLs, and calling out other opinions for subverting the new “relevance” scope of discovery.  We applauded this shot across the judiciary’s bow here.  (12) De la Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. 2016).  De la Paz also came very close to making our top ten, due to detailed causation discussions about several oddball claims often asserted to avoid PMA preemption, but a leave to replead (never acted upon) dropped it to honorary mention status.  We praised De la Paz here.  (13) In re Zoloft (Sertraline hydrochloride) Products Liability Litigation, 176 F. Supp. 3d 483 (E.D. Pa. 2016).  Daubert defeats an entire MDL, but since the most critical ruling was last year (2015+9), it’s in our honorable mentions this time.  We celebrated the demise of the Zoloft MDL here.  (14) Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016).  A number of 2016 opinions preempted claims against innovator drugmakers under Mensing/Bartlett.  Brazil is the best of them (except maybe for a case just decided this week).  We discussed what went right, here.  (15) In re Testosterone Replacement Therapy Products Liability Litigation, 164 F. Supp.3d 1040 (N.D. Ill. Feb. 18, 2016).  The definitive take-down of the bogus concept of “pendent personal jurisdiction.”  We pumped the Testosterone decision here.  (16) Hochendoner v. Genzyme Corp., 823 F.3d 724 (1st Cir. 2016).  We don’t like duty to supply claims involving shortages of non-defective drugs.  Here the court found no standing because no particularized injury (except for one plaintiff) could be traced to the shortage.  A nice appellate win, but on an esoteric issue.  We hailed Hochendoner here.  (17) Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016).  Another somewhat esoteric appellate decision – applying the learned intermediary rule to pharmacies.  We prescribed Carista here.  (18) In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 3281032 (N.D. Ill. June 10, 2016).  It’s rare to get Lone Pine order in a drug/device product liability MDL, so savor this one.  We did, here.  (19) Aaron v. Medtronic, Inc., ___ F. Supp.3d ___, 2016 WL 5242957 (W.D. Ohio Sept. 22, 2016).  Another favorable and comprehensive PMA preemption dismissal, this time involving off-label promotion issues.  We (the non-RS side, that is) added Aaron here.  (20) DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016).  Had DeBons been published, it probably cracks our top ten.  DeBons explains why prescription medical products can’t be subjected to the class action mania that has engulfed the food industry in California, which is important.  We detailed DeBons, here.

Looking over our 2015 lists, we’re already mentioned the Arizona Supreme Court’s reversal in Watts (2015-6) and the favorable subsequent proceedings in the Zoloft (2015+9) MDL.  In Amarin (2015+6), the FDA raised the white flag and settled.  On the minus side, certiorari was denied in Reckis (2015-1), and it looks like Drake (2015-9) settled, since the appeal we mentioned last year was dismissed.

The best news on older cases, however, was the demise of another bottom-ten number one, State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007) (2007-1), this time at the hands of a West Virginia statute explicitly restoring the learned intermediary rule.  This is our tenth year preparing top/bottom 10 lists, and of our previous worst of the worst, the bad boys from 2014 (Weeks, by statute), 2012 (Bartlett, reversed), 2010 (Wimbush, limited to its facts by Yates (2015+1), and now 2007 have all been overturned.  That’s a 40% reversal rate on the biggest stinkers out there – not bad at all, while not losing any of our own.  We hope by next year, we’ll be up to half, by adding 2008 (Conte) to our scalp collection, but it being California, anything can happen.

Going forward, the California Supreme Court’s Bristol-Myers-Squibb atrocity (2016-1) is being appealed to the United States Supreme Court.  Here’s hoping….  We’ve already mentioned T.H. v. Novartis (2016-5) pending in the California Supreme Court (see prior paragraph).  The Pinnacle Hip (2016-6) rulings will eventually be appealed, but not quite yet.   Perhaps some others will be appealed as well, but we have no solid information.

Finally, on the administrative front, as we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption is effectively dead, given the election results (and even before that).  The FDA’s proposal (discussed here) to amend the “intended use” regulations is still hanging fire, with First Amendment-related comments that the Agency will have to address.  The FDA also has off-label promotion on its plate after last month’s two-day conference.  We’re not holding our breath, but politically things could be much different in the coming year (and not just with the FDA).  Maybe we get to play a little offense on legislative matters, for once.

We thus close our books on 2016 – barring some last minute development.  To all our readers – particularly those on the right side of the “v.”, we wish a happy and productive New Year.

The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s collection of coal in our collective stockings is as justifiable a cause for seasonal affective disorder as almost anything we can think of, since we do not discuss politics on the blog.

So here we go. Don’t shoot us, we’re only digital piano players.  If any of these cases is yours, we sympathize.  We’ve been there (see 2013 -2), and we know how it feels.  We can’t wait for next week we get to toast in the New Years with the best, instead of drowning our sorrows with the worst.

Continue Reading The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015.  These are results that put the “happy” in Happy New Year – which we wish all our readers as the year in question draws to its inevitable close.

So, with cannons sounding for the plaintiffs involved, we give to you our picks for the ten best judicial decisions of 2015 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices.

  1. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., ___ F.3d ___, 2015 WL 8538119 (6th Cir. Dec. 11, 2015).  This year’s number-one arrived relatively late, but it was definitely worth the wait. When we first read Bartlett (2013 +1), we were struck by the Court going out of its way to state expressly that the FDA-pre-approval requirement for design changes applied to all prescription drugs.  That reference to “branded or generic” had to have a purpose.  Yates is the first court of appeals expressly applying the logic that all design changes requiring prior FDA review are preempted.  Post-approval, the FDA must review all “major” or “moderate” changes to drug design, rendering simultaneous compliance with an immediate state-law duty to use a different design impossible.  A “pre-approval” design defect claim (that the defendant should have submitted a different design to the FDA in the first instance, was speculative and would have required FDA approval of the different design in any case.  This “never-start selling” claim was also preempted because it was the same as the “stop-selling” claim rejected in Bartlett.  States cannot preclude the sale of what the FDA approved.  The bad Wimbush case (2008 -1) – from the same court of appeals (indeed, both originating in N.D. Ohio) – is limited to its facts (a drug already removed from the market), and doesn’t prevent preemption of design defect claims where the FDA continues to approve the product.  Application of a good No. 1 decision to confine a bad No. 1 decision is indicative of another good No. 1 decision.  Beyond that, Yates-based preemption would erase the non-generic stop-selling claim allowed in Pennsylvania in Lance (2014 -2).  Yates suggests that design defect claims against branded prescription drugs (and eventually §510k devices) are on their way out.  We wasted no time yacking about Yates here.
  2. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  Over the last couple of years, there have been a lot of good trial court decisions on off-label promotion and preemption (most, but not all, involving Infuse).  None of those decisions was better than Caplinger (2013 +9).  Because it was so good (a complete dismissal), Caplinger could be appealed.  This year it was affirmed, and the affirmance was just as good.  Off-label use does not provide plaintiffs with a get-out-of-preemption-free card.  If Congress had wanted to exempt off-label use (which it knew about, see 21 U.S.C. §396), from preemption, it would have done so expressly.  Claims that would require changes to labels or design are “different from or in addition to” what the FDA approved and are preempted.  Challenges to the legality of purported off-label promotion are purely matters of federal law and thus aren’t equivalent to any recognized state-law claim.  Indeed, to the extent plaintiffs identified any federal regulations at all, their claims “substantially exceed[ed]” them.  Adulteration/misbranding are FDCA, not state-law, violations.  If Congress wishes to set a different balance, it can, but until it does, all the plaintiffs’ litany of claims about off-label use/promotion of a PMA medical device are preempted.  The fact that plaintiffs have sought Supreme Court review in Caplinger (#15-321) only underscores its significance as a preemption milestone.  We celebrated Caplinger here and here.  Full disclosure:  Reed Smith is involved in Caplinger, so consider this entry a non-RS post.
  3. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).  Where it exists, federal preemption is the strongest defense our clients have.  So it shouldn’t be much of a surprise that our top three decisions are all appellate courts recognizing that FDCA-related preemption extends to new areas.  Celexa was the first appellate decision recognizing that Mensing (2011 +1) impossibility preemption cannot be limited to generic drugs.  Celexa was brought by some rather self-important plaintiffs seeking, under state law, to enjoin the sale of an FDA-approved drug because the efficacy data on which approval was based was allegedly wrong.  That presented a problem – the efficacy data at issue had already been reviewed by the FDA, and plaintiffs offered nothing new.  Since the rationale Levine (2009 -1) employed against preemption was that innovator manufacturers were free to change their labels based on “new” information (the changes being effected (“CBE”) exception), a label-related claim that fell outside the scope of the CBE exception, here, that involved only “old” information, was preempted.  While this type of informational claim isn’t all that common, the principle that Celexa established – that Mensing’s implied preemption logic extended beyond generic drugs – is critical.  We pointed out the broader implications of Celexa here.
  4. David v. Medtronic, Inc., 188 Cal. Rptr.3d 103 (Cal. App. 2015).  CAFA provides that actions including more than 100 plaintiffs are removable to federal court as “mass actions.”  Predictably, the other side started filing complaints with dozens (but never 100) of blatantly misjoined plaintiffs from all over the country with nothing in common except suing over the same drug/device.  There would always be a couple of plaintiffs from the forum state, and a couple of plaintiffs from the defendant’s home state to destroy diversity as another ground for removal.  This gamesmanship has been particularly widespread in California. The David decision goes a long way to putting a stop to this in the nation’s largest and most litigious state by affirming severance of all the out-of-state plaintiffs on the basis of forum non conveniens, since the defendant wasn’t based in California either.  There were Bauman personal jurisdictional problems with the case, and the court recognized that the “same transaction” standard for joinder wasn’t met by anybody anywhere in the country claiming the same injuries from the same product.  The medical treatments were different, and so were the doctors, hospitals, and the informational and temporal context in which each individual case arose.  The non-California claims could be brought in those plaintiffs’ home states, so litigation tourists go away and stop clogging our courts. Peripheral claims against nominal defendants don’t count against forum non conveniens, and if plaintiffs chose, they could continue with those peripheral claims in California.  We harmonized with David’s beautiful music here, and put the decision in perspective here.  Full disclosure:  David is a Reed Smith case, so this entry is also non-RS.
  5. Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis United States LLP, 806 F.3d 71 (2d Cir. 2015).  We admit we were a bit depressed after the Third Circuit went south in the Avandia decision (2015 -3).  Then along came the Second Circuit to cheer us up again.  Like Avandia, SBA was a third-party payer RICO case; unlike Avandia court of appeals shut the SBA plaintiffs down.  The allegations had a Buckman-like tinge – that a questionable clinical study supported FDA approval, and then the defendants promoted off-label.  Because RICO is a federal statute, however, preemption isn’t a defense.  But causation is.  SBA rejected the doctors-don’t-matter refrain from Avandia.  To the contrary, prescribing physicians are central where prescription medical products are concerned.  “Generalized proof of causation was impossible because of the intervening actions of prescribing physicians.”  The varying effects of differing misrepresentations on independent decision makers make causation impossible to prove on anything but an individualized basis.  Against an FDA-approved drug, plaintiffs could not claim that “nobody” would have used it had the purported “true” risks been know.  That is “stop selling” by another name.  Nor could plaintiffs avoid the learned intermediaries’ role with “simplistic” statistical analysis.  Plaintiffs could not get to a class action by dumbing down the elements of their substantive claims.  Thus some inordinately long-running litigation (more than seven years) finally came to an end.  We bid SBA adieu here.
  6. Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). Holy cow.  Bye-bye baby.  Outta here! When we (well, Bexis) started advocating the First Amendment as a defense in the off-label promotion context twenty years ago, there wasn’t much traction.  Bone Screw cases turned out to be much easier to win on other grounds. Fast forward two decades − past WLF, Pearson, Western States, Sorrell (2011 +5), and Caronia (2012 +7) − and things sure have changed.  At least in the Second Circuit, thanks to Caronia, truthful off-label promotion is First Amendment-protected speech, which the FDA (and, by extension, private plaintiffs) cannot prosecute.  Amarin was the first case in which the regulated manufacturer went head-to-head with the FDA, stuck it out, and won in court.  The plaintiff company’s science wasn’t what the FDA considered “substantial evidence,” but it was valid science.  What the plaintiff company wanted to tell potential prescribing physicians was truthful, properly disclaimed, and thus not “false or misleading” even though it concerned off-label use.  The FDA doesn’t want to appeal.  We went yard over Amarin here and here.
  7. Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 135 S. Ct. 1378 (2015).  It’s from the Supreme Court and it involves prescription drugs, but it’s not directly applicable to product liability. It is relevant to, and reinforces, first, the Buckman preemption rationale against private enforcement of statutes like the FDCA where private enforcement is not allowed; and, second, why alleged violations of vague regulations cannot escape preemption.  Armstrong involved a Medicare statute, not the FDCA, but the reasoning is the same – indeed Buckman is a fortiori because the FDCA’s prohibition against private enforcement is express, whereas that in Armstrong was only “implied.” The implication came from the statute’s provision of a single remedy for violations, one conferring no rights to individuals.  No private enforcement was allowed because “express provision of one method” of enforcement “suggests that Congress intended to preclude others.”  On the second point, the Medicaid statute’s requirements were vague, and thus “judicially unadministrable,” providing a second basis for Congress wanting the remedy that it provided to be exclusive. The same reasoning should preempt the holdings of a number of courts allowing “parallel” claims purporting to enforce vague FDA manufacturing-related regulations.  We discussed the implications of Armstrong here.
  8. State ex rel. J.C. v. Mazzone, 772 S.E.2d 336 (W. Va. 2015).  Just as in California (see Martin, above), forum-shopping litigation tourists took it on the chin in West Virginia.  Instead of Bauman, however, this case was decided solely on old fashioned forum non conveniens grounds.  It was the same game playing, though – dozens of out-of-state plaintiffs misjoined in the same complaint.  Because neither the plaintiffs nor the defendant was from West Virginia, and plaintiffs could all sue in their states of residence, West Virginia was an inconvenient forum.  The ordinarily “great deference” given to a plaintiff’s choice of forum is diminished where a nonresident sues over matters not arising in the state.  The defendant’s difficulty in obtaining discovery from fact witnesses in plaintiffs’ home states worked sufficient “injustice” to support the forum non conveniens finding.  All of the considerations discussed by the court would be the same in any litigation tourist case against an out-of-state corporation, thus Mazzone, if followed by the trial courts of West Virginia, effectively ends multi-plaintiff, out-of-state, CAFA avoiding complaints in this state.  We explained the significance of Mazzone here.
  9. In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  The best Daubert decision of 2015 was either this one or a similar decision (both excluding the same expert) in the Lipitor MDL.  We chose this one because Zoloft involved a higher degree of Daubert difficulty, since there actually were some (older, smaller, and otherwise less persuasive) studies that reached adverse, statistically significant results. The plaintiffs, and their result-oriented statistical expert, were ultimately done in by more recent, more powerful studies that refuted the supposed connection between cardiac birth defects and Zoloft that plaintiffs’ expert tried very hard to invent.  This was a do-over – plaintiffs had their first batch of experts all excluded under Daubert − so this guy was their last chance, and they knew it.  Everything was heavily litigated, and, the lengthy opinion thoroughly addressed Daubert issues like a priori reasoning, statistical significance and p-values, cherry-picking, after-the-fact statistical manipulations, confounding, and re-analysis of published data.  Daubert is the second strongest MDL defense strategy (after preemption) and as the year draws to a close, the result here means that all the cases in the Zoloft MDL are likely subject to summary judgment.  We analyzed Zoloft here, after complaining about the do-over here.
  10. In re Incretin-Based Therapies Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).  The Levine (2009 -1) clear evidence test for implied preemption in prescription drug cases can be met – that’s the lesson of Incretin.  It’s tough, but it can be done, and successful preemption can shut down an entire MDL.  Plaintiffs claimed that the drug caused a disease (pancreatic cancer).  Trouble is, the FDA decided time and time again that any causal link was “indeterminate” and shouldn’t appear on the drug’s label.  Plaintiffs’ experts could manipulate the data (such as notoriously inaccurate – the court acknowledged this – adverse event reports) all they wanted, but the fact remained that the FDA had looked at everything and said “no.”  Hence, preemption existed under Levine’s “would have rejected” standard, which the court refused to make worse than the Supreme Court already had.  The court recognized that, when the FDA calls for data from all manufacturers of a class of drugs, it has more evidence at its fingertips than any one of the competing manufacturers, which was unlike Levine.  Nor is it necessary that the FDA definitively rule out causation; a conclusion that causation hasn’t been shown to the FDA’s regulatory standards is enough.  Finally, plaintiffs cannot avoid preemption by arguing fraud on the FDA.  That’s preempted, too, and plaintiffs can’t second-guess the FDA’s administrative process. What the FDA considers, or not, is within the discretion of the Agency.  A final plus factor in Incretin was that both federal and state judges had heard argument of the motion, and the state judge agreed.  We announced that Christmas had come early in Incretin-land here and mentioned the state-court’s concurrence here.

That’s our top ten, but as usual our side’s noteworthy wins in 2015 didn’t stop with ten. Thus, we’re acknowledging ten more favorable decisions this year that fell just short of cracking our top ten.

Continue Reading “May the Odds Be Ever in Your Favor” – The Ten Best Prescription Drug/Medical Device Decisions of 2015