Last Friday, the New Jersey Superior Court Appellate Division issued a decision filled chock-a-block with interesting rulings. Cornett v. Johnson & Johnson, 2010 WL 2867811 (N.J. Super. Ct. App. Div. July 23, 2010). Today we’ll discuss the part of the opinion that resolves the choice of law and statute of limitations issues raised by the appeal of Vonnie Cornett. Tomorrow we (read: Bexis) will analyze the rest of the opinion, which discusses device preemption, parallel claims, and off-label promotion. Those of you who can’t wait until tomorrow have the citation.

In December 2004, Vonnie Cornett’s husband Billie Cornett received a drug-eluting stent made by Cordis, a Johnson & Johnson subsidiary. On May 18, 2005, a cardiac catheterization found a subacute thrombosis in the artery with the stent. Billie died on June 1, 2005, allegedly from subacute stent thrombosis, but Vonnie did not file her complaint until September 2008, more than three years later, and she filed the complaint in New Jersey state court. The trial court granted defendants’ pre-answer motion to dismiss the complaint as untimely.

On appeal, the court had to decide whether to apply the statute of limitations of Kentucky, where the Cornetts lived, or New Jersey, where Johnson & Johnson has its headquarters and the complaint was filed. The court noted that the two states have different statutes of limitations and performed a full choice of law analysis. As you will see when we discuss how the court resolved the statute of limitations point, the decision to do an elaborate choice of law analysis was a bit curious – not necessarily wrong, just curious – because the court found the complaint time barred under either state’s statute of limitations.

On choice of law, the court applied New Jersey’s “most significant relationship” test and decided, after thorough analysis of the relevant factors, to apply Kentucky law because Kentucky was where Billie Cornett lived, received his medical care (including the stent), and allegedly suffered his injury from the stent. Id. at *5-7. Although no surprise, since most courts apply the place of injury’s law in most circumstances, often with only cursory analysis, this ruling is a big deal because it’s New Jersey. Because of the state’s pro-plaintiff reputation (and being the home of a lot of major pharma companies), hordes of out-of-state plaintiffs have descended upon New Jersey courts hoping to take advantage of, among other things, a rather broad discovery rule (it applies to wrongful death actions, for one thing).

But maybe not any more.

The Cornett court could have ended its discussion right there because the complaint clearly was untimely under the law of Kentucky, which gives plaintiffs one year to file personal injury claims (plus an additional year for representatives of decedents who died within one year of the claimed injury) and does not have a discovery rule for product liability claims. But the court went on to say that the complaint also was untimely under New Jersey’s discovery rule, and that discussion should be particularly interesting to those of you who deal with statute of limitations issues – especially in New Jersey.

New Jersey, like many states, applies a discovery rule under which the statute of limitations clock does not start to run “until the injured person discovers, or by an exercise of reasonable diligence and intelligence should have discovered that he may have a basis for an actionable claim.” Id. at *4. The Cornett court said that the diagnosis of the thrombosis in the artery where the stent was implanted five months after implantation should have made the plaintiff reasonably suspect a possible connection between the device and the decedent’s injury. Id. at *8. A reasonable person should have investigated the matter further or contacted counsel, the court said. Id.

The icing on the discovery rule cake, the court reasoned, was that plaintiff alleged it was self-evident from the cause of death that the thrombosis formed within the stent. Id. The opinion doesn’t say, but we presume that plaintiff made this allegation in the portion of the complaint that tried to show the stent caused Billie Cornett’s injuries.

A plaintiff’s own allegations can provide the best response to a discovery rule claim in drug and device cases. The facts plaintiffs plead to support their claims that they were injured by a drug or device almost always were available to the plaintiff at or near the time of the injury. The real question in many discovery rule cases is this: what has changed between the time of the injury and the filing of the complaint, when (pardon the statement of the obvious) the plaintiff clearly knew enough to file a complaint? Usually nothing has changed, which means that the plaintiff knew enough at the time of the injury to pursue a claim.

Plaintiff tried to answer that key question by arguing that the clock did not start until the medical community reached a consensus as to causation, which supposedly happened at some later time. That’s a pretty weak argument – among other things, how is a plaintiff or a court ever to know the exact date on which the medical community reaches consensus, if it ever does? – and the court made short shrift of it: “neither medical nor legal certainty is required if the state of facts would alert a reasonable person to the possibility of an actionable claim, namely, that a third party’s conduct may have contributed to the injury and the conduct might have possibly been unreasonable.” Id. at *8 (citation omitted). The court concluded that the complaint was untimely under either New Jersey or Kentucky law and affirmed its dismissal.

Tune in tomorrow for Bexis’s analysis of the more complicated preemption rulings.

On Thursday, we noted that the Ohio Supreme Court had upheld two tort reform provisions in Arbino v. Johnson & Johnson, 2007-Ohio-6948. We also said that we’d be back after we had a chance to read the decision.

We’re back.

You know what’s odd? Arbino is plainly an important case: It’s the most recent in a series of decisions in state courts ruling on the constitutionality of various types of tort reform, and it comes out of Ohio, the country’s seventh most populous state. Despite the decision’s importance, almost no one will read this puppy.

Litigators don’t care about the reasoning of this case. There’s only one thing that matters to a working lawyer: Did the court uphold the tort reform provisions (so I must live in this new environment) or did the court strike them down (so I can forget about ’em)? The court’s justification for holding as it did — constitutional issues that concern only deep thinkers and academics — simply don’t matter.

For you folks — the working lawyers — here’s the skinny: The Ohio Supreme Court upheld two aspects of tort reform against facial constitutional challenge. First, in general, Ohio Revised Code Sec. 2315.18 now limits noneconomic damages to the greater of $250,000 or three times economic damages up to a maximum of $350,000. Those limits do not apply, however, if the plaintiff suffered one of various types of severe physical injury.

Second, Ohio Revised Code Sec. 2315.21 now generally limits punitive damages in tort actions to two times the total amount of compensatory damages awarded to a plaintiff per defendant. Those limits, however, do not apply if the defendant was convicted of one of several types of felonies. Lower limits apply if the defendant is a small employer or individual. And punitive damages may not be awarded more than once against the same defendant for the same course of conduct once the maximum amount of damages has been reached, unless the plaintiff offers substantial new evidence of improper conduct by the defendant.

That’s it. Litigators now know the essence of Arbino, and they know when they’ll have to consult the new statutes to see how they apply in particular cases.

Unlike typical practicing lawyers, a few scholars will care deeply about the issues decided in Arbino. But any little summary of the case that we publish can’t possible satisfy them. Scholars will, of necessity, have to parse the decision itself.

Folks who litigate tort reform issues will also care about Arbino. For them, this will be an important precedent.

The rest of the world will never read the decision and will know only that it ignited a firestorm, with liberals complaining that the Ohio Supreme Court has been bought and paid for by business, and conservatives exulting that a court finally exercised appropriate judicial restraint, deferring to policy choices enacted by the legislature and providing some predictability to damage awards in tort cases. For examples of the outraged left, read the Daily Kos; for the business perspective, see the reaction of the National Federation of Independent Business.

For the moderately curious, however, here’s our quick trot through the decision.

First, the backstory: The Ohio legislature was Republican and the Supreme Court Democractic in the 1990s. The legislature repeatedly passed, and the Supreme Court repeatedly struck down, various attempts at tort reform.

This led to unbelievably ugly judicial elections in Ohio in the early 2000s. As of today, the Ohio legislature remains Republican, and the Ohio Supreme Court is now unanimously Republican. The legislature thus took another shot at tort reform; this time, it worked.

Chief Justice Moyer wrote the majority decision in Arbino, joined by Justices Lundberg Stratton, O’Connor, and Lanziger. Justice Cupp concurred separately, providing a fifth vote in favor of upholding all of the tort reform provisions. Justice O’Donnell dissented in part; he would have struck down the cap on noneconomic damages. And Justice Pfeifer dissented from the whole enchilada. (Ohio court watchers know that Justice Pfeifer runs as a Republican, but he consistently voted with the Democratic majority on the court in the 1990s, and he typically dissents when today’s Republican majority rules in favor of business. Outraged conservatives fume that the Ohio Supreme Court consists of seven Republicans, but only six conservatives; delighted liberals are pleased to have one voice on the court that articulates their views without regard to party affiliation.)

What were the facts? Melisa Arbino filed a product liability case against Johnson & Johnson and others claiming that she suffered blood clots and other injuries as a result of having used the Ortho Evra Birth Control Patch, a hormonal birth-control medication.

In the Arbino decision, the majority first fought its way through a thicket of Ohio Supreme Court precedents from the 1990s repeatedly striking down as unconstitutional previous efforts at tort reform. The court ultimately found that the legislature “made progress in tailoring its legislation to address the constitutional defects identified by the various majorities of this court. The statutes before us here are sufficiently different from the previous enactments so as to avoid the blanket application of stare decisis.” Slip op. at 8.

The court then upheld the limit on noneconomic damages against a series of facial constitutional challenges. The law did not violate the constitutional right to jury trial because it allowed juries to decide underlying facts and then required only that courts apply legal limits to damages based on those facts. The majority analogized to courts imposing remittitur on jury verdicts or to statutes that authorize trebling damages, which is the opposite of limiting them.

The cap does not violate the “open courts” and “right to remedy” provisions because it does not “wholly deny persons a remedy for their injuries.” Id. at 14. The cap complies with due process because the law was related to the general welfare of the public and not arbitrary or unreasonable. (The change in the Ohio Supreme Court’s political make-up is perhaps most visible here, where the majority says that one of its previous precedents, Sheward, contains an “abundance of dicta” suggesting that damage caps may violate due process, but goes on to uphold the new cap because the holding of Sheward — a 1999 case — was limited to other issues.)

The cap does not violate equal protection because it is facially neutral and bears a rational relationship to a legitimate government purpose. And the cap also survives challenges based on separation of powers and the single subject rule. Id. at 22-24.

One down; two to go.

The court declined to address the constitutionality of a tort reform provision dealing with the collateral sourse rule because Arbino lacked standing to challenge that provision. Id. at 25-26.

Two down; one to go.

Finally, the court upheld the cap on punitive damages against the same collection of constitutional challenges aimed at the noneconomic damages cap. The court again read Sheward narrowly and declined to follow its dictum that suggested that a cap on punitive damages would violate the Ohio Constitution’s right to a trial by jury. Id. at 27-33. (At this point, the gloves are off. A Democratic court would likely have said that Sheward‘s dictum was recent and directly on point, meriting deference. A Republican court instead finds the words to be mere dictum, not worthy of respect and rendered questionable by recent U.S. Supreme Court cases interpreting not the Ohio Constitution, but the U.S. Constituion.) (Mein Gott, Bexis, what are you doing? Implicitly criticizing a pro-business result that benefits our clients?) (Cut that out, Herrmann. You know full well that I didn’t write that parenthetical; you did.) (Did not.) (Did too.)

Justice Pfeifer’s dissent criticizes the majority on every score. But what we found most noteworthy was the tone of Pfeifer’s dissent. At page 50, we learn that the majority employed “shallow reasoning and shoddy logic.” At page 51, the majority’s arguments are “insubstantial, legally unsupported, and in many cases disingenuous.” At page 53, “superficial or disingenuous.” And so on. Whatever our politics, can’t we agree that the public discourse of our justices should be a little more civil?

More substantively, Pfeifer criticizes certain studies that the General Assembly relied upon in legislating because the studies were not “peer-reviewed” or “published in a scholarly journal.” Slip op. at 62. Whatever you think of the rest of the dissent, let’s hope this concept never gains traction. Legislatures are given wide range to pass laws based on their perceptions of public policy. If courts start to impose Daubert review on acts of Congress, today’s partisan battles will look like mere skirmishes in the wars that would come.

Let’s hope that the battles of 2008 don’t degenerate into that.

One of the cases we follow closely, with daily searches, is Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  It’s an implied preemption case, so while we like to think we catch all the drug/device cases anyway, Albrecht can affect preemption in a wide variety of tort situations.

We’d identified one such situation before.  Shortly after Albrecht was decided, we identified one non-drug/device where we thought the Supreme Court’s reasoning would have an impact.  The Environmental Protection Agency (“EPA”) issued a final order last August “determin[ing] that glyphosate [the principal active ingredient in RoundUp] is not likely to be carcinogenic in humans,” so that any contrary label under California’s Proposition 65 would “misbrand” the product.

Given the Albrecht court’s focus on the twin issues of actual conflict and formal agency action, we opined that “preemption [under Albrecht] should be successful in stuffing the evil genie of glyphosate cancer litigation back into regulatory bottle where it belongs.”

Last week a California appellate court decision that, in all other respects, seemed bound and determined to ensure RoundUp’s manufacturer was held liable in precisely such a case, was confronted with the same facts we discussed in our postSee Johnson v. Monsanto Co., ___ Cal. Rptr.3d ___, 2020 WL 4047332 (Cal. App. July 20, 2020).  Note:  Of necessity, our discussion will refer to the original Westlaw version of the Johnson opinion, which we have uploaded here.  We had to do that, because since then the court has removed its preemption discussion in Johnson from public view by declining to publish that portion of the opinion.

So what did Johnson decide on preemption that made the court want to cover its tracks like this?

That despite Johnson’s best efforts, the plaintiff’s warning claim was probably preempted under Albrecht – that’s what.

First, Johnson addresses implied preemption under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §136. et seq. (“FIFRA”).  See 2020 WL 4047332, at *16-19. Obviously, FIFRA is not directly of interest to our FDCA-oriented audience.  Still, Johnson gets off on the wrong foot by claiming that the presumption against preemption “guide[s] preemption jurisprudence, id. at *16, when in fact the Supreme Court abolished that presumption in express preemption cases back in 2016.  See Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) (discussed here).

According to Johnson, express preemption under FIFRA differs depending on whether the claim is for defective design, as opposed to defective warnings.  Johnson interpreted FIFRA’s express permission of state pesticide bans as permitting design defect claims as some sort of lesser included offense.  Id. at *16 (“if states are permitted to ban pesticides altogether, they must be authorized to regulate a pesticide’s defective design”).  Johnson cited Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), which contained no such holding.  Bates held the design claims “do not qualify as requirements for ‘packaging or labeling,’” but had nothing to do with the theory now advanced in Johnson.  Id. at 444 (quoting 7 U.S.C. § 136v(b)).  Even if it had, Bates also applied the now-discredited presumption against preemption in an express preemption case.  544 U.S. at 432 (among “plausible” readings, the presumption created a “duty to accept the reading disfavoring pre-emption”).  So the express preemption discussion of design defect in Johnson is, at best, outdated.

Second, as for warning claims, the FIFRA express preemption clause looks a lot like the FDCA’s.  See 7 U.S.C. § 136v(b) (as to “labeling or packaging,” a “State shall not impose or continue in effect any requirements . . . in addition to or different from those required under this subchapter”).  The first thing Johnson had to do was get around the California Supreme Court decision in Etcheverry v. Tri-Ag Service, Inc., 993 P.2d 366 (Cal. 2000), which had held:

The federal court decisions holding that FIFRA preempts state law failure-to-warn claims are numerous, consistent, pragmatic and powerfully reasoned. . . .  [W]e find their analysis persuasive and reverse the judgment of the Court of Appeal reaching the contrary conclusion.

Id. at at 368.

To avoid Etcheverry, Johnson turned to BatesJohnson drew a “parallel claims” analysis out of Bates.  2020 WL 4047332, at *18 (“a state-law labeling requirement is not pre-empted . . . if it is equivalent to, and fully consistent with, FIFRA’s misbranding provisions”) (quoting Bates, 544 U.S. at 446).  Johnson concluded it didn’t have to follow Etcheverry because it was pre-Bates.  However, at that point, legal theory ran headlong into the EPA’s consistent regulation of glyphosate, of which the aforementioned August, 2020 determination was only the latest of numerous rulings.  We fail to see – and Johnson nowhere makes clear – what the “violation” was.  The EPA simply does not require the warning plaintiff sought in Johnson.

How could Johnson get around the EPA, as well as the California Supreme Court?

By asserting that, somehow, EPA’s approval did “not have force of law.”

We recognize that [defendant] is required to seek and obtain EPA approval before changing labels for its Roundup products, and that the EPA repeatedly approved Monsanto’s labels, which do not include a cancer warning.  But Bates informs us that the existence of these requirements and actions are not enough, standing alone, to preempt state failure-to-warn claims.  Under FIFRA, registration of a pesticide is prima facie evidence that the pesticide and its labeling is consistent with FIFRA, but . . . [m]ultiple federal courts have held that the EPA’s registration of Roundup products does not have the force of law so as to preempt state failure-to-warn claims when those claims are premised on requirements consistent with FIFRA.

Johnson, 2020 WL 4047332, at *19 (citations omitted).  Thus, Johnson’s express preemption ruling on warnings ultimately relies solely on three federal district court RoundUp cases from 2016, well before EPA’s final decision.  Id.

Third, as we pointed out in our prior post, however, the world has changed.  EPA has finished its regulatory review – and under Albrecht that gives rise to implied preemption.  Defendant “insists in its opening brief that ‘impossibility preemption’ nonetheless bars [plaintiff’s] failure-to-warn claims because there is ‘clear, indeed dispositive, evidence that [the] EPA would have rejected a cancer warning had [defendant] proposed one.’”  Id.

Enter Albrecht.  During the pendency of the Johnson appeal “the U.S. Supreme Court has clarified that the question whether a federal agency would not have approved a label change (thus preempting a state-law failure-to-warn claim) is for a judge, not a jury.”  Id. (citing Albrecht).  Although conceding that Albrecht applied, id. at *20 (the “reasoning is applicable under FIFRA”), Johnson dodged on the basis of the relevant regulatory evidence being “largely presented for the first time on appeal.”  Id. at 19.

Well, of course it was.  That’s when the relevant regulatory events occurred.  But EPA’s refusal to allow a cancer warning on the basis of lack of scientific evidence in 2019-2020 would a fortiori apply to all earlier times, when there was either less or the same amount of scientific evidence.  Regulatory action happens at the regulators’ speed.  So the defendant in Johnson:

after completing its appellate briefing, . . . filed a notice of new authority and directed the court to an August 7, 2019 EPA letter to a “Registrant” declining to approve a label that included a warning about glyphosate under Proposition 65. . . .  The letter states that since the EPA has determined that glyphosate is not likely to be carcinogenic to humans, any such warning would be “false and misleading” under FIFRA.

Johnson, 2020 WL 4047332, at *19 (citations omitted).  That’s the same document that our prior Albrecht post discussed.  The defendant argued (as had we) that “this additional information shows not only that the EPA previously approved labels for Roundup products without cancer warnings, but also constitutes clear evidence that the agency would not approve cancer warnings for Roundup labels in the future.”  Id.

Fourth, plaintiff could not get around Albrecht solely by arguing lack of express preemption.  Lack of express preemption cannot “foreclose” implied preemption.  Id.  Johnson cited only to Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995), for this proposition, but it is at the heart of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as well.

[Plaintiff] also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision. . . .  To the extent [plaintiff] posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion . . . that neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’

Id. at 353 (quoting in Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000)).

Fifth, Johnson was compelled to admit that the EPA’s August 2019 determination (and certain other documents that the defendant submitted) “arguably would support an impossibility.”  2020 WL 4047332, at *20.  So, to avoid preemption, Johnson punted, declining to decide the preemption question “in the first instance.  Id.

These do not strike us as factual determinations best made for the first time on appeal, especially since the EPA’s position on glyphosate labeling appears to be evolving.

Id.  “It is no doubt true that the EPA currently takes the position that glyphosate is not harmful to humans and that a cancer warning on glyphosate is unnecessary.  But that opinion, in the abstract, is not binding on this court.”  Id. at *21.  The proper result, at this point, would be to vacate and remand to the trial court to make an Albrecht preemption ruling on a full record.  But that wasn’t going to happen in Johnson.

Moreover, that preemption dodge, we submit, is simply untrue.  The August, 2019 determination was a final ruling that a cancer warning would cause the product at issue to be “misbranded.”  That’s a “formal agency action” under Albrecht any way one views it.  See National Ass’n of Wheat Growers v. Becerra, 2020 WL 3412732, at *13 (E.D. Cal. June 22, 2020) (entering permanent injunction against the aforementioned attempt by the State of California to require a Prop. 65 cancer warning on RoundUp labels).

So to preserve the plaintiff’s verdict, Johnson simply refused to take a look.

Sixth, Johnson also claimed, rather weakly given the number of years that the EPA has been considering this question, that the appellate record did not establish that the agency had been “fully informed” before reaching its decision, as required by AlbrechtJohnson, 2020 WL 4047332, at *21.  Plainly, this verdict was destined to be upheld, no matter what, the EPA be damned.

Seventh, for its final gyration, Johnson held that it didn’t need to decide preemption (express or implied) at all.  “[E]ven if we were to conclude that FIFRA preempted [plaintiff’s] failure-to-warn causes of action . . . such a conclusion would have no effect on [the] design defect claim, which provides an independent basis to affirm the jury’s liability determination.”  Id.  Thus, Johnson sought to insulate its jerry-rigged result from further appellate review.  Given the amount of evidence that was undoubtedly introduced on the preempted warning claim, we doubt the simultaneous trial of that claim could possibly have been “harmless” error – but that’s outside the scope of this post.

In the convoluted fashion set out above, plaintiffs got away with one in Johnson.  But that result was a one-time ticket, as even Johnson suggests.  Needing more twists and turns than a Simone Biles dismount, Johnson’s evasion of Albrecht preemption ultimately rests on the non sequitur of an appellate record not containing events that only came to fruition after the matter in question was appealed.  That won’t happen again – and there’s no way, short of the EPA reversing itself, that this agency position isn’t grounded in a “full” administrative record.

There are none so blind as those who refuse to see.  Jer. 5:21 (King James version).  We’d bet our bottom dollar that the complete administrative record necessary to support implied preemption under Albrecht will be forthcoming in any and all subsequent RoundUp litigation, and that future warning-related claims of the type at issue in Johnson will end up being preempted.  No wonder the preemption discussion in Johnson ended up unpublished.

Someone asked us the other day whether spoliation sanctions could lie against a non-party for alleged loss/destruction of electronically stored information sought through a third-party subpoena.  On the one hand, assuming there is personal jurisdiction, the substantive discovery rules do not vary between parties and non-litigants subjected to valid subpoenas.  On the other hand, other than monetary sanctions, Rule 37(e), regarding discovery sanctions for spoliation appears directed solely against parties.

So we thought we’d take a look.

Initially, we should be clear that we are discussing whether a third-party subpoena creates a duty to preserve – not whether such a duty exists in the absence of any legal process.  In the latter situation there is pretty clearly no duty.  Shamrock-Shamrock, Inc. v. Remark – a recent case involving Florida state discovery rules – demanded a subpoena as a prerequisite to any third-party preservation duties:

[L]itigants may employ various legal mechanisms to impose upon a third party a duty to preserve necessary evidence.  For example, a third party may be required to produce particular evidence it possesses in response to a subpoena. . . .

In this case, there was no statute, contract, or discovery request that would impose a clearly defined duty on [a third party] to preserve any potentially relevant evidence.  Thus, a duty would arise only through [the party’s] purported knowledge of [the] pending litigation. . . .   As such, [plaintiff] would like us to announce that [the third party] owed a duty to it based on the foreseeability of litigation.  Considering the traditional approach to defining legal duty, we decline to do so. Indeed, such a broad pronouncement would be tantamount to declaring a general legal duty on any nonparty witness to anticipate the needs of others’ lawsuits.  There are innumerable circumstances in which a nonparty to litigation may have evidence relevant to a case and may know of its relevance.  But that knowledge, by itself, should not give rise to a duty to safeguard the evidence in anticipation of litigation.

271 So. 3d 1200, 1205–06 (Fla. App. 2019) (rejecting independent action for spoliation for lack of duty) (citation omitted).  Accord In re Delta/AirTran Baggage Fee Antitrust Litigation, 770 F. Supp.2d 1299, 1307-08 (N.D. Ga. 2011) (rejecting “sweeping and novel theory of spoliation” that a subpoena served in different litigation could create a preservation duty to plaintiffs in other litigation).  But see Woods v. Scissons, 2019 WL 3816727, at *4 (D. Ariz. Aug. 14, 2019)  (third party’s spoliation “imputed” to party absent any subpoena at all where spoliator was “not a disinterested non-party”).

Nor are we addressing third-party subpoenas directed against the federal government (such as the FDA).  These are governed by departmental regulations issued pursuant to United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).  We addressed that issue, here.

The first place we tried, the Sedona Principles, downloadable here, turned out to be a dud.  The “meat” in the principles is in what are called “comments.”  Comment 5(a) has a section on “Preservation by non-party in response to Rule 45 subpoena,” which states:

Case law concerning the preservation obligations of a subpoenaed non-party in litigation is not well defined.  Some courts have noted that the issuance of a subpoena creates a duty to preserve.  However, since Rule 45 imposes duties on the requesting party and the court to shield a non-party from undue burden and expense, there may be some question whether an overbroad subpoena creates a duty to preserve.

Sedona Principles, Public Comment Version, at 44 (3d ed. 2017) (footnotes omitted).  The Principles simply suggest that a “good practice for the requesting party” is to “to engage the non-party in good faith discussions about the scope of the subpoena, sources of potentially responsive ESI, and the costs of preserving and producing relevant ESI.”  Id.

The footnotes cited one case, In re Napster, Inc. Copyright Litigation, 462 F. Supp.2d 1060 (N.D. Cal. 2006), but in that case the third-party subpoena target had, by the time sanctions were sought, been joined as a party.  Id. at 1065.  Further, the third–party target “acknowledged a duty to preserve documents . . . based on plaintiffs’ subpoena.”  Id. at 1068.  Thus the issue we’re interested in was effectively conceded in Napster.

The question seems to arise most frequently in connection with securities litigation subject to the stay provisions of the Private Securities Litigation Reform Act, which imposes preservation obligations only on “parties” during the duration of the stay.  15 U.S.C. §78u-4(b) (3)(C)(i).  Several courts have decided to improve upon the statute by permitting “preservation subpoenas” directed at third parties in order “to impose an affirmative duty on those parties to preserve the evidence.”  New York State Teachers’ Retirement Systems v. General Motors Co., 2015 WL 1565462, at *5 (E.D. Mich. April 8, 2015).  “[P]reservation subpoenas . . . impose[] a legal obligation on third parties to take reasonable steps to preserve relevant documents.”  In re Heckmann Corp. Securities Litigation, 2011 WL 10636718, at *5 (D. Del. Feb. 28, 2011).  In In re Tyco International, Ltd., Securities Litigation, 2000 WL 33654141 (D.N.H. July 27, 2000), such subpoenas would “give specified third parties notice of the action and impose upon them only a duty to preserve certain relevant evidence,” id. at *5, but had to be particularized, and could not “call for the preservation of an open-ended, boundless universe of materials.”  Id. at *4 (citation and quotation marks omitted).  Tyco relied on a similar order entered in In re Grand Casinos, Inc. Securities Litigation, 988 F. Supp. 1270 (D. Minn. 1997), holding that third-party subpoenas “would further Congress’ intent by subjecting relevant evidence to a ‘stay put’ directive . . . in [the hands] of third-parties,” which in turn strongly implied that a subpoena imposed a preservation duty on the third party receiving it..  Id. at 1272.  See Avenue Capital Management II, LP v. Schaden, 2015 WL 758521, at *3 (D. Colo. Feb. 20, 2015) (“preservation subpoenas . . . put those parties on notice of their duty to preserve certain documents”); In re Refco, Inc., 2006 WL 2337212, at *4 (S.D.N.Y. Aug. 8, 2006) (“courts have generally permitted plaintiffs in PSLRA actions to issue subpoenas [to] specified third parties [that] . . . impose upon them . . . a duty to preserve certain relevant evidence in their possession”).  None of these cases have involved any claim that a third-party’s preservation obligation extended to actions taken before any subpoena was received – indeed, the rationale is the opposite, these subpoenas are justified precisely to create the sought after duty.  See Neibert v. Monarch Dental Corp., 1999 WL 33290643, at *1 (N.D. Tex. Oct. 20, 1999) (“The only obligation imposed on the identified non-parties by the proposed subpoenas . . . is that they not destroy any records presently in their possession or which come into their possession at a later date”).

Similar results have occurred in a number of non PSLRA cases.  In City of Lindsay v. Sociedad Quimica y Minera de Chile S.A., 2012 WL 2798966, at *5 (E.D. Cal. July 9, 2012), the court assumed that it could hold in contempt “any third party that fails to comply with the issued subpoenas,” which assumes that such subpoenas necessarily impose a duty to preserve on a third-party recipient.  Id. at *5.  See In re Broiler Chicken Grower Litigation, 2017 WL 3841912, at *4 (E.D. Okla. Sept. 1, 2017) (“subpoenas to third parties [will] ensure that they too retain evidence”); Garcia v. Target Corp., 276 F. Supp. 3d 921, 925 (D. Minn. 2016) (“third-party subpoenas” mean that “third parties will be on notice of any obligation to preserve evidence”); Bright Solutions for Dyslexia, Inc. v. Doe 1, 12015 WL 5159125, at *3 (N.D. Cal. Sept. 2, 2015) (“the entities that have the information . . . are not parties and thus have no duty to preserve absent a court order”); Johnson v. U.S. Bank National Ass’n, 2009 WL 4682668, at *2 (S.D. Ohio Dec. 3, 2009) (third party subpoena obliges recipient “to describe responsive documents and protect them for subsequent production”); In re Rosenthal, 2008 WL 983702, at *8 (S.D. Tex. March 28, 2008) (third-party who “disregards a subpoena . . . may be found in contempt”).  Again, these cases all seem (in some, the discussion is quite brief) to focus on post-subpoena evidence.  See Swetic Chiropractic & Rehabilitation Center, Inc. v. Foot Levelers, Inc., 2016 WL 1657922, at *3 (S.D. Ohio April 27, 2016) (a “non-party . . . does not have a duty to preserve information absent a court order”); Koncelik v. Savient Pharmaceuticals, Inc., 2009 WL 2448029, at *2 (S.D.N.Y. Aug. 10, 2009) (it “is certain is that without preservation subpoenas, the third party corporations in possession of potentially relevant information are free to destroy that information”).

Some cases do suggest that no independent preservation duty arises even from receipt of a third-party subpoena.  Gambino v. Payne, 2015 WL 1823754 (W.D.N.Y. April 22, 2015), stated flatly that “the only duty under a subpoena to preserve materials is when the served party claims a privilege or protection from the subpoena and has to preserve the materials until the privilege or protection issue is settled.  Id. at *5.  In Comeens v. Harden Manufacturing Corp., 2014 WL 12650101 (N.D. Ala. April 3, 2014), the plaintiffs “fail[ed] to explain how issuing third-party subpoenas” would be any more effective at preserving documents “than the anti-spoliation letters [they had] already issued.  Id. at *2.  Goodman v. Praxair Services, Inc., 632 F. Supp. 2d 494 (D. Md. 2009), conducted an elaborate “control” analysis concerning allegedly spoliated documents held by a third party, id. at 515-16, that would have been entirely unnecessary if the third-party itself had a preservation obligation.  Id. at 516 (“conclud[ing] that [defendant] did not have the sufficient legal authority or practical ability to ensure the preservation of documents prepared by” the third party).  In Novak v. Kasaks, 1996 WL 467534, at *2 (S.D.N.Y. Aug. 16, 1996), the court separately ordered “that all non-parties upon whom subpoenas have been served in this action are to preserve all documents and other materials responsive to such subpoenas.”

Courts also tend to be more sensitive to burdens imposed on nonparties by overly broad third-party subpoenas.  Rule 45 itself requires requesting parties to “take reasonable steps to avoid imposing undue burden or expense on a person subject to the subpoena.”  Fed. R. Civ. P. 45(d)(1).  “[I]t has been consistently held that ‘non-party status’ is a significant factor to be considered in determining whether the burden imposed by a subpoena is undue.”  United States v. Amerigroup Illinois, Inc., 2005 WL 3111972, at *4 (N.D. Ill. Oct. 21, 2005) (citations omitted).  Thus, “[n]on-parties have a different set of [discovery] expectations” and “concern for the unwanted burden thrust upon non-parties is a factor entitled to special weight in evaluating the balance of competing needs.”  Cusumano v. Microsoft Corp., 162 F.3d 708, 717 (1st Cir. 1998) (citations omitted).  “[T]he undue burden calculus is more protective of non-parties than it is for parties.”  Charles v. Quality Carriers, Inc., 2010 WL 396356, at *1 (S.D. Ind. Jan. 28, 2010).

[T]he considerations of proportionality, efficiency, and judicial economy that govern the [subpoena] requests are case-specific. . . .  Plaintiffs have not identified any non-PSLRA case where a court lifted a stay while a motion to dismiss was pending to permit the serving of document preservation subpoenas on hundreds let alone thousands of third-parties covering a 10-year time period and thousands of products.

In re Broiler Chicken Antitrust Litigation, 2017 WL 1682572, at *5 (N.D. Ill. Apr. 21, 2017).  “[N]on-parties have greater protections from discovery and that burdens on non-parties will impact the proportionality analysis.”  Hume v. Consolidated Grain & Barge, Inc., 2016 WL 7385699, at *3 (E.D. La. Dec. 21, 2016) (quoting E. Laporte & J. Redgrave, “A Practical Guide to Achieving Proportionality Under New Federal Rule of Civil Procedure 26,” 9 Fed. Cts. L. Rev. 19, 57 (2015)).  “[T]he Court should be particularly sensitive to weighing the probative value of the information sought against the burden of production on the non party.”  Fears v. Wilhelmina Model Agency, Inc., 2004 WL 719185, at *1 (S.D.N.Y. Apr. 1, 2004).

[I]t is not [the subpoenaed persons’] lawsuit and they should not have to pay for the costs associated with someone else’s dispute.  Not only is it fundamentally unfair for non-parties to bear the significant litigation costs of others, but also if this Court were to allow litigating parties . . . to impose such a burden on non-parties, then the likelihood of cooperation by non-parties in the future would be placed in jeopardy.

Guy Chemical Co. v. Romaco AG, 243 F.R.D. 310, 313 (N.D. Ind. 2007).

We’ve discussed the law essentially straight up in this post.  In any given case we could find ourselves on either side of the issue.

The other day Law 360 published a piece, “Bristol-Myers Unlikely To Shake Up Class Action Landscape,” which opined that, “in the end, the effect of Bristol-Myers on the national class action landscape is likely to be minimal.”  One basis for that conclusion was “[I]t is unlikely that a majority of federal appellate courts will find that Bristol-Myers applies in class action cases.”  To support that proposition, the article states:

To date, an apparent majority of district courts, including in the Eleventh, Fifth, Ninth and District of Columbia Circuits, have held that Bristol-Myers has no application to a class action, as opposed to a mass tort action.

The article cites: Becker v. HBN Media Inc., ___ F. Supp.3d ___, 2018 WL 3007922, at *2 (S.D. Fla. June 6, 2018) (“The Court is persuaded [that] . . . Bristol-Myers does not apply to class actions”); Sanchez v. Launch Technical Workforce Solutions LLC, 297 F. Supp.3d 1360, 1369 (N.D. Ga. 2018) (“Bristol-Myers simply reaffirms controlling due-process law and does not apply to federal class actions”); Molock v. Whole Foods Market, Inc., 297 F.Supp.3d 114, 126 (D.D.C. 2018) (“the court agrees with Plaintiffs and concludes that Bristol-Myers does not apply to class actions”); In re Morning Song Bird Food Litigation, 2018 WL 1382746, at *5 (S.D. Cal. March 19, 2018) (“the Court finds Bristol-Myers inapplicable to this suit which involves a class action”); Casso’s Wellness Store & Gym LLC v. Spectrum Laboratory Products Inc., 2018 WL 1377608, at *5 (E.D. La. March 19, 2018) (“the Court does not construe Bristol-Myers as barring its exercise of jurisdiction over the purported nonresident plaintiffs’ claims in the instant putative class action”).

As contrary authority, the article cites two cases: DeBernardis v. NBTY Inc., 2018 WL 461228, at *2 (N.D. Ill. Jan. 18, 2018) (“it is more likely than not based on the Supreme Court’s comments about federalism that the courts will apply BMS to outlaw nationwide class actions . . . where there is no general jurisdiction over the Defendants”), and Wenokur v. AXA Equitable Life Insurance Co., 2017 WL 4357916, at *4 n.4 (D. Ariz. Oct. 2, 2017) (“The Court . . . lacks personal jurisdiction over the claims of putative class members with no connection to Arizona”).

We found that sort of odd, as in our last look at this issue – way back on January 26, 2018 – found the caselaw to stand at 12-2 in favor of applying Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), to curtail multi-jurisdictional class actions where the effect of certification would be a class of non-resident plaintiffs suing a non-resident corporate defendant.  None of the cases cited in the 360 article as restricting BMS due process principles was decided at that point, whereas both of the cases extending BMS due process to all state-law litigation had been and therefore were cited in our prior post.

Could the law really have shifted so drastically over the last few months?

The answer is no.

The first thing we need to do is not compare apples and oranges.  This blog is concerned, first and foremost, with product liability litigation.  That means we’re interested mostly in litigation that has its roots in state – not federal – law and is in federal court due to diversity jurisdiction.  Thus, our most recent post was about “the issue of BMS and nationwide class actions under state law.”  Our previous post likewise examined “our prediction . . . that personal jurisdiction would become a major obstacle to nationwide class actions based on state laws.”  The emphasis added in both instances is to underscore that we’re not concerned with class action litigation brought under federal statutes.  We have a separate post examining the caveat in BMS about federal Due Process under the Fifth Amendment.  Our main takeaway from that post is that due process in diversity cases is analyzed under the Fourteenth Amendment as construed in BMS.

Of the six cases cited in the 360 article, 3½ involved federal statutory claims:  Becker, 2018 WL 3007922 (Telephone Consumer Protection Act), Sanchez, 297 F. Supp.3d 1360 (Fair Credit Reporting Act), Casso, 2018 WL 1377608 (Telephone Consumer Protection Act), and Morning Song Bird, 2018 WL 1382746 (RICO & state consumer protection statutes).  So right there, we subtract three of the six from the article’s list because they don’t involve what we care about.  We also chide the court in Morning Song Bird for failing to distinguish between the state and federal claims in its analysis.

By contrast, almost all (but two) of the cases we cited in our prior posts involve state-law causes of action:

In favor of applying BMS to state-law class actions:

DeBernardis v. NBTY, Inc., 2018 WL 461228 (N.D. Ill. Jan. 18, 2018) (consumer protection); LDGP, LLC v. Cynosure, Inc., 2018 WL 439122 (N.D. Ill. Jan. 16, 2018) (consumer protection and common law); McDonnell v. Nature’s Way Products, LLC, 2017 WL 4864910 (N.D. Ill. Oct. 26, 2017) (consumer protection); Wenokur, 2017 WL 4357916 (D. Ariz. Oct. 2, 2017) (insurance); Spratley v. FCA US LLC, 2017 WL 4023348 (N.D.N.Y. Sept. 12, 2017) (economic loss product liability); Plumbers’ Local Union No. 690 Health Plan v. Apotex Corp., 2017 WL 3129147 (E.D. Pa. July 24, 2017) (consumer fraud); Famular v. Whirlpool Corp., 2017 WL 2470844 (S.D.N.Y. June 7, 2017) (consumer protection and warranty); Demedicis v. CVS Health Corp., 2017 WL 569157 (N.D. Ill. Feb. 13, 2017) (consumer fraud); Bauer v. Nortek Global HVAC LLC, 2016 WL 5724232 (M.D. Tenn. Sept. 30, 2016) (economic loss product liability); Matus v. Premium Nutraceuticals, LLC, 2016 WL 3078745 (C.D. Cal. May 31, 2016) (consumer protection); Demaria v. Nissan N.A., Inc., 2016 WL 374145 (N.D. Ill. Feb. 1, 2016) (consumer protection).

Opposed to applying BMS to class actions:

In re Chinese-Manufactured Drywall Products Liability Litigation, 2017 WL 5971622 (E.D. La. Nov. 30, 2017) (product liability); Fitzhenry-Russell v. Dr. Pepper Snapple Group, Inc., 2017 WL 4224723 (N.D. Cal. Sept. 22, 2017) (consumer protection).

So, before we commence any new research of our own, the tally is 11 (2d, 3d 6th, 7th, & 9th Circuits) to 4 (5th, 9th & DC Circuits) in favor of applying a single due process standard to personal jurisdiction questions to all courts applying state law.

The research isn’t hard to do.  Look at all cases that cite BMS and mention “class action,” and separate the wheat (state-law claims) from the chaff (everything else).

We found six additional cases supporting application of BMS due process principles to state-laws class actions not cited in the 360 article.  In an OTC drug case, the court declared:

Nothing in Bristol-Myers suggests that it does not apply to named plaintiffs in a putative class action; rather, the Court reaffirmed a generally applicable principle − that due process requires a “connection between the forum and the specific claims at issue.”  That principle applies whether or not the plaintiff is a putative class representative.

Al Haj v. Pfizer Inc., 2018 WL 1784126, at *6 (N.D. Ill. April 13, 2018).  In Chavez v. Church & Dwight Co., 2018 WL 2238191 (N.D. Ill. May 16, 2018), a food-related, consumer fraud action, the court determined that “[n]othing in Bristol-Myers suggests that its basic holding is inapplicable to class actions; rather, the Court announced a general principle − that due process requires a ‘connection between the forum and the specific claims at issue.”  Id. at *10 (citation and quotation marks omitted).  Chavez also rejected the notion that absent class members should simply be ignored:

Further, the Court is unpersuaded by the reliance of some district courts on the fact that the citizenship of unnamed class members is disregarded for purposes of determining diversity − that is, subject matter − jurisdiction.  The question here is not whether this Court has subject matter jurisdiction, but whether, consistent with due process, this Court may exercise specific personal jurisdiction over a defendant with regard to claims that have no connection with this state beyond their similarity to claims asserted by other plaintiffs who are residents of this state.

Id. at *11. See Hickman v. TL Transportation, LLC, 2018 WL 3388307, at *7 & n.2 (E.D. Pa. July 12, 2018) (“Plaintiffs have not presented any reason for distinguishing Bristol-Myers from this [state-law] action”; distinguishing federal-law class actions); In re Samsung Galaxy Smartphone Marketing & Sales Practices Litigation, 2018 WL 1576457, at *2 (N.D. Cal. March 30, 2018) (dismissing non-resident named plaintiffs under BMS); Anderson v. Logitech, Inc., 2018 WL 1184729, at *1 (N.D. Ill. March 7, 2018) (“[A] nationwide class action is not significantly different from a mass tort suit involving a multitude of individual claims.  The putative nationwide class action claims are stricken.”); Howe v. Samsung Electronics America, Inc., 2018 WL 2212982, at *4 (N.D. Fla. Jan. 5, 2018) (“Rule 23 does not expand a court’s personal jurisdiction over a defendant.  Absent a statute providing otherwise, a defendant who is not subject to personal jurisdiction on an individual claim also is not subject to jurisdiction on a class-action claim.”).

What about additional courts refusing to apply BMS to state-law class actions?

Zero, zilch, nada.

Beyond the 3½ cases in the 360 article, we found nothing – at most, plaintiffs managed to delay consideration of personal jurisdiction until some later time, such as class certification.  E.g., Blitz v. Monsanto Co., 2018 WL 1785499, at *2 (W.D. Wis. April 13, 2018).

So the tally now stands at 17 (from the 2d, 3d 6th, 7th (lots), 9th & 11th Circuits) to the same 4 (5th, 9th & DC Circuits).

Moreover, even as to federal statutory class actions, it’s breakeven, at best for class action plaintiffs seeking to evade BMS.  Our additional results are:

Pro-BMS:  Practice Management Support Services, Inc. v. Cirque du Soleil, Inc., 301 F. Supp.3d 840, 864-66 (N.D. Ill. 2018); Garcia v. Peterson, No. CV H-17-1601, 2018 WL 3496740, at *8 (S.D. Tex. July 20, 2018); America’s Health & Resource Center, Ltd. v. Promologics, Inc., 2018 WL 3474444, at *4 (N.D. Ill. July 19, 2018); Jackson v. Bank of America, N.A., 2018 WL 2381888, at *6-7 (W.D.N.Y. May 25, 2018); Horowitz v. AT&T, Inc., 2018 WL 1942525, at *15-16 (D.N.J. April 25, 2018).  That’s five additional cases.

Anti-BMSGarcia v. Peterson, ___ F. Supp.3d ___, 2018 WL 3496740, at *8 (S.D. Tex. July 20, 2018); Tickling Keys, Inc. v. Transamerica Financial Advisors, Inc., 305 F. Supp. 3d 1342, 1350-51 (M.D. Fla. 2018); Morgan v. U.S. Xpress, Inc., 2018 WL 3580775, at *5-6 (W.D. Va. July 25, 2018); Weisheit v. Rosenberg & Assocs., LLC, 2018 WL 1942196, at *5 (D. Md. April 25, 2018).  Four more cases.

We strongly agree, however, with the second premise of the 360 article, that BMS might not have much additional overall effect because it is already “extremely difficult” for plaintiffs to pursue multi-state class actions under the predominance criteria of Rule 23.  Indeed, the recent opinion in Langan v. Johnson & Johnson Consumer Cos., ___ F.3d ___, 2018 WL 3542624 (2d Cir. July 24, 2018), underscores precisely that point:

We are not convinced that the district court here undertook the requisite considered analysis of the variations in state law and the potential need for subclasses that might result from those variations. Although both parties submitted complicated and conflicting summaries of the state consumer protection laws in eighteen states, the district court’s analysis consisted of one paragraph.  In that paragraph, it is our view that the district court did not sufficiently engage with [defendant’s] arguments about reliance, instead concluding that “it appears” that none of the states’ high courts have insisted on reliance. The other identified differences − including whether intent to deceive is required, and whether causation can be presumed − were not discussed. . . .  We believe that more precise and greater depth of analysis is required to comport with the “close look” required by the precedent.  Accordingly, we remand the case to the district court to conduct a more thorough analysis.

Id. at *8 (citations omitted).

The practical difference is, however, significant.  Dismissal for lack of personal jurisdiction is a Rule 12 motion, which may be made before a defendant has to incur the time and expense of discovery.  Application of BMS to class actions is largely a legal question, so we on the defense side have an obligation to our clients to try to get rid of as much of a case as possible as early as possible.  So even if the net result wouldn’t be much different, we’d rather not have to wait until Rule 23 comes into play.

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time.  It’s another example of plaintiffs throwing mud against the wall to see if it will stick; anything to divert attention from a weak merits case concerning the injuries actually being claimed.

Sometimes plaintiffs argue that, even though they never encountered a particular risk, it was so severe and downright scary that if they had only been warned about that risk, they wouldn’t have used the product.  Trouble is, while that argument could be causal in a “but for” sense (assuming plaintiffs aren’t lying), it’s not causal in the legal, or proximate, sense.  One of the major tort treatises explains the difference:

More centrally, the injury suffered must be within the class of injury that the warning requirement was meant to avoid.  For example, the plaintiff, if properly warned that asbestos might cause cancer, might have ceased to work around asbestos.  A failure to give such a warning could result in liability if the plaintiff did develop cancer as a result of asbestos exposure.  But the failure to provide such a warning would not result in liability if the plaintiff, not being warned, kept her job and lost a hand in a job-related machine accident.  In that example, failure to warn would be a cause in fact – the plaintiff would have been elsewhere, not working at the machine, if a proper warning had been given – but it is not a proximate legal cause.  It is not, in other words, within the risk that a warning was designed to avoid.

Dan B. Dobbs, The Law of Torts, at 1018 (2001).

Federal appellate decisions similarly reject this sort of “causation” over and over, initially in cases involving non-prescription products.  Most commonly, asbestos plaintiffs have been precluded from introducing evidence of cancer when they had no such injury, or even a significant risk.  See O’Banion v. Owens Corning Fiberglass Corp., 968 F.2d 1011, 1013 (10th Cir. 1992) (“evidence of cancer is so prejudicial that in the absence of expert medical testimony that ‘a reasonable degree of medical certainty’ exists that the plaintiff will develop cancer, such evidence should be excluded”) (applying Oklahoma law); Smith v. A.C. & S, Inc., 843 F.2d 854, 859 (5th Cir. 1988) (cancer evidence in non-cancer case “is highly inflammatory and understandably incites the passions and fears of most reasonable individuals”) (applying Louisiana law); Jackson v. Johns-Manville Sales Corp., 750 F.2d 1314, 1321 (5th Cir. 1985) (same) (applying Mississippi law); In re Related Asbestos Cases, 543 F. Supp. 1152, 1160 (N.D. Cal. 1982) (excluding reference to cancer “in any cases in which the plaintiff has not contracted cancer”).

The same result has occurred in automotive product liability.  For example, in Kane v. Ford Motor Co., 450 F.2d 315 (3d Cir. 1971), the plaintiff started out claiming one type of brake defect in a car, but then shifted to a different defect claim at trial.  The Third Circuit affirmed exclusion of such evidence, because it was “irrelevant to appellant’s theory of the case.”  Id. at 316.  See Fields v. Volkswagen of America, Inc., 555 P.2d 48, 58 (Okla. 1976) (excluding recall where “the defect mentioned in the recall letter is not the defect claimed to have cause the [plaintiff’s injury]”); Johnson v. Ford Motor Co., 988 F.2d 573, 578-80 (5th Cir. 1993) (affirming exclusion of five other incidents that different car models and different claims of mechanical defect); Olson v. Ford Motor Co., 410 F. Supp. 2d 869, 873-75 (D.N.D. 2006) (excluding automotive recalls where the reason for recall differed from plaintiff’s alleged product defect); Jordan v. General Motors Corp., 624 F. Supp. 72, 77 (E.D. La. 1985) (same).

But we’re more interested in prescription medical product liability litigation.

In our sandbox, the New York Court of Appeals rejected failure to warn of risks the plaintiff had not suffered in Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993), where the plaintiff claimed that a drug should have been contraindicated in patients with a history of depression – but personally had no history of depression.  “Since it is undisputed that [plaintiff] had no history of mental depression, we are not concerned with the adequacy of the Contraindications section of the insert.  Id. at 1313. See McFadden v. Haritatos, 448 N.Y.S.2d 79, 81 (N.Y.A.D. 1982) (“Since there was no showing” that plaintiff “had a history of that condition,” the allegedly inadequate warnings “are not applicable”).

Other state appellate courts agree.  A Texas appellate court in Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513 (Tex. App. 2007), entered judgment n.o.v. on a warning claim, where the prescriber knew of the risk that the plaintiff encountered − rejecting allegations of inadequate warnings about diabetes (“[n]othing in the record suggests that [plaintiff] was diabetic”), and several general surgical risks (“[a]ssuming that the general . . . risk factors . . . could form the basis of an appropriate warning, there is no evidence that the lack of such a warning caused [plaintiff’s] injury”).  Id. at 519.

In King v. Danek Medical, Inc., 37 S.W.3d 429 (Tenn. App. 2000), one of Bexis’ Bone Screw cases, the plaintiffs’ expert attempted to opine about a condition that the plaintiffs did not have.  Same result:

[Plaintiffs’ expert] did not attempt to testify that either [plaintiff] developed [that condition] as the result of their implants. . . .  The theoretical possibility that some [products] of other manufacturers can cause various bone problems, without proof that it occurred to these plaintiffs because of the products of these defendants, cannot defeat summary judgment.

Id. at 446-47.

Likewise, in Peterson v. Parke Davis & Co., 705 P.2d 1001 (Colo. App. 1985), the court affirmed rejection of a proposed jury instruction that would have required the defendant to warn about every possible drug risk:

[T]he request for an instruction that [defendant] had a duty to warn of all known dangers was properly denied.  In a failure to warn case, the plaintiff has the burden of proving that the manufacturer gave inadequate warning of the danger which caused the injury.

Id. at 1004.

Here in Pennsylvania, plaintiffs tried warning claims about the risk of injuries they never suffered in both the breast implant and fen-phen mass torts – failing both times.  In fen-phen litigation, plaintiffs alleging primary pulmonary hypertension (“PPH”) were precluded from arguing that better warnings about valvular heart disease (“VHD”) (and vice versa) would have made a difference, even when a prescriber would not have been deterred by better warnings about the injury (PPH) the plaintiff actually had:

In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation.  Therefore, as a matter of law, there is no proximate, causal connection between [defendant’s] failure to disclose the risk of VHD and [plaintiff’s] specific injury.

Cochran v. Wyeth, Inc., 3 A.3d 673, 681 (Pa. Super. 2010); accord Owens v. Wyeth, 2009 WL 3244890, at ??? (C.P. Phila. Co. Aug. 17, 2009) (“the only warnings properly at issue in a failure to warn case are those relating to the condition to which the plaintiff alleges to have suffered”), aff’d mem., 6 A.3d 572 (table), 2010 WL 2965014, at *5-6 (Pa. Super. 2010) (adopting trial court’s reasoning).

Likewise, in breast implant litigation, the Pennsylvania mass tort court held that liability for inadequate warnings about risks not encountered was too broad to be permitted:

If I accept plaintiffs’ argument, the law will be permitting recovery for a risk that the plaintiff assumed because the plaintiff might have made a different decision as a result of knowing of other risks for which the plaintiff did not experience any harm.

In re Silicone Breast Implant Litigation, 64 D. & C. 4th 21, 25-26 (C.P. Allegheny Co. 2003).  Recovery for warnings about risks that never happened “would have a reach that extends far beyond the purposes for the [duty to warn] doctrine.”  Id. at 26.

The same has proven true with mass torts in other state courts.  In re NuvaRing Litigation, 2013 WL 1874321, at *23 (N.J. Super. Law Div. April 18, 2013) (“any failure to notify the FDA of increased [other] risks would not affect the adequacy of the warning with respect to the . . . cause of [plaintiff’s] death”); Hedrick v. Genentech Inc., 2011 WL 5902794, at ??? (Cal. Super. Oct. 20, 2011) (“liability should be limited when a plaintiff does not suffer the unwarned-of injury”) (applying Massachusetts law).

In federal court, the plaintiffs in Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315, 321 (5th Cir. 2002) (applying Texas law), “never assert[ed] that they were part of a risk group that should have been warned.”  Id. at 321.  Their warning claims were therefore “absurd”:

To find causation, we would have to infer the absurd − for example, that an extra warning, though inapplicable to [the lead plaintiff], might have scared her and her doctor from [the drug].  Such reasoning is too speculative to establish Article III standing.

Id.

In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), the plaintiff alleged that his prescriber “would have read and heeded a warning” about not to prescribe two drugs together.  Turns out that didn’t happen.  The other drug was prescribed later by somebody else.  The warning to the first prescriber had nothing to do with plaintiff’s eventual injury.  Therefore, no causation as a matter of law:

[I]t is undisputed that [plaintiff] did not ingest the [two drugs] concomitantly . . . until . . . his prescribing physician was [somebody else]. . . .  That [the first prescriber] might have heeded a warning. . .about possible adverse effects were he to prescribe [the two drugs together] is of no significance given the facts before us.

Id. at 1020.

In Mills v. United States, 764 F.2d 373 (5th Cir. 1985) (applying Louisiana law), the adverse reaction that the plaintiff suffered was the subject of thorough warnings – so plaintiff claimed that warnings about other conditions were inadequate.  The court held that, since, plaintiff didn’t have those injuries the alleged lack of warnings about them were irrelevant.

The question of the adequacy of the warnings must be confined to consideration of whether the warnings were sufficient to inform the plaintiff of the risk of the particular condition or disease which allegedly caused his injury or death. . . .  [A] determination that warnings were inadequate with respect to some other condition does not bear on our conclusion that [plaintiff] was adequately informed of the risk of severe allergic reaction to the swine flu vaccine.

Id. at 379.

Likewise, in Novak v. United States, 865 F.2d 718 (6th Cir. 1989) (applying Ohio law), the plaintiff lacked any scientific evidence that the product could cause her condition, and therefore claimed inadequate warnings about a different risk she never suffered.  Amazingly, the district court allowed the switch.  The court of appeals did not, and reversed:

There was, therefore, no reason for the defendant to make the references deemed important or vital by the district court, and there was no duty on the part of the defendant to warn about any of these conditions.  Particularly, the district court erred in finding the warning inadequate, negligent, and insufficient because it did not specifically caution those who may have experienced [the other condition].  It was not proven that [plaintiff] had actually suffered from [that condition]. . . .

Id. at 726.  See In re Avandia Marketing, Sales Practices & Products Liability Litigation, 639 Fed. Appx. 874, 879 n.8 (3d Cir. 2016) (expert opinion had “no impact” on causation when based on a study that “dealt with a population of which [plaintiff] was not a part”) (applying Pennsylvania law); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1336 (9th Cir. 1985) (“collateral misconduct unrelated to the specific injury suffered by the plaintiffs” properly excluded) (applying Oregon law).

Numerous other cases have reached the same conclusion. In Stahl v. Novartis Pharmaceuticals Corp., 2000 WL 33915848 (E.D. La. Nov. 29, 2000), aff’d, 283 F.3d. 254 (5th Cir. 2002), the plaintiff’s prescriber knew all about the drug’s alleged risks that he suffered.  Id. at *4.  Thus, plaintiff alleged inadequate warnings about other more serious conditions that he didn’t have.  Summary judgment granted:

[T]his Court is unpersuaded by [plaintiff’s] complaints that the warnings did not warn of death, liver failure, and the need for transplant.  [Plaintiff] has not suffered any of those injuries and is, therefore, precluded from imposing a duty to warn regarding those injuries not suffered. . . .  [A] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained.

Id. (citation and quotation marks omitted).  See also Vakil v. Merck & Co., 2016 WL 7175638, at *6 (D.N.J. Dec. 7, 2016) (“Defendants cannot be held accountable for failing to warn Plaintiff of a symptom he never experienced”); Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673, at *4 (E.D. La. Feb. 17, 2016) (“The only specific . . . that supports the plaintiff’s failure-to-warn claim is that the FDA issued a safety announcement warning [about] ketoacidosis. But the plaintiff does not allege (at least coherently) that she ever suffered from ketoacidosis”; warning claim dismissed); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *3 (N.D. Ala. Oct. 31, 2013) (“warnings for a wide range of conditions from which decedent did not allegedly suffer . . . would not have had any effect on him”; motion to dismiss granted); Austin v. Bayer Pharmaceuticals Corp., 2013 WL 5406589, at *7 (S.D. Miss. Sept. 25, 2013) (“Plaintiff failed to state a claim for the failure to warn of side effects which Plaintiff did not suffer”); Harris v. Eli Lilly & Co., 2012 WL 6732725, at *3 (N.D. Ohio Dec. 28, 2012) (“For a plaintiff to succeed on an inadequate warning claim, the risk about which the manufacturer allegedly failed to warn must be the same risk which harmed the plaintiff.”) (following Ohio Rev. Code §2307.76(A)(1)); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *4 (N.D. Ohio July 30, 2012) (same); Mason v. Smithkline Beecham Corp., 2010 WL 2697173, at *5 n.3 (C.D. Ill. July 7, 2010) (“a warning is only inadequate if it fails to list risks or side effects that do occur”); Harrington v. Biomet, Inc., 2008 WL 2329132, at *6 (W.D. Okla. June 3, 2008) (“no evidence” that two allegedly inadequate warnings caused plaintiff’s alleged injuries; summary judgment granted); Hernandez v. Ciba-Geigy Corp. USA, 200 F.R.D. 285, 295 (S.D. Tex. 2001) (dismissing plaintiffs who “do not plead that the[ir] children suffered any injuries or side effects of which [defendant] allegedly failed to warn”) (applying Texas law).

We’ve observed many times that multi-district litigation all too often becomes a breeding ground for bogus claims, and warning claims asserting injuries that plaintiffs don’t actually have is no exception.  Plaintiffs in Pelvic Mesh litigation have repeatedly advanced similar bogus warning claims based on risks they had not encountered, and lost each time.  The MDL judge granted an in limine motion against such evidence in Tyree v. Boston Scientific Corp., 2014 WL 5445769 (S.D.W. Va. Oct. 22, 2014):

I agree that evidence of complications that no plaintiff experienced is irrelevant and lacking in probative value. For the claims that require evidence of injury (strict liability for failure to warn, strict liability for design defect, and negligence), only the injuries experienced by the complainant are relevant.  Strict liability . . . requires the plaintiff to show . . . that the defect was the probable cause of her injuries. . . .  [E]vidence that the [the product] causes injuries not experienced by the plaintiffs has little probative value.  Moreover, elaborating on injuries that the plaintiffs did not incur risks needless presentation of cumulative evidence.

Id. at *6 (citations and quotation marks omitted) (emphasis original).  Accord Hall v. Boston Scientific Corp., 2015 WL 856786, at *5 (S.D.W. Va. Feb. 27, 2015) (“Evidence of complications that the plaintiff has not experienced is irrelevant and lacking in probative value.  For the claims that require evidence of injury, only the injuries experienced by the complainant are relevant.”) (applying Wisconsin law); Eghnayem v. Boston Scientific Corp., 2014 WL 5465741, at *7 (W.D. Va. Oct. 28, 2014) (same) (applying Florida law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 505234, at *10 (S.D.W. Va. Feb. 5, 2014) (excluding purported cancer risk where plaintiff “does not have cancer or allege any injuries related to an increased risk of cancer”) (applying Texas law); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 WL 457544, at *2 (S.D.W. Va. Feb. 3, 2014) (“secondary infections were not ‘a fact in issue’ because [plaintiff] did not experience a secondary infection”) (applying Texas law).

Other MDL cases reaching the same result include:

In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1352860, at *4, 7 (E.D. La. April 13, 2017) (excluding expert testimony about cancer where “cancer was not an issue for either Plaintiff”) (defense testimony); Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556, 564 (D.N.J. 2013) (“Plaintiff, however, did not suffer from transient ischemic stroke.  Thus, this study is irrelevant to Plaintiff’s claim”) (applying Texas law); Carr-Davis v. Bristol Myers-Squibb Co., 2013 WL 322616, at *5 (D.N.J. Jan. 28, 2013) (“because the studies are not relevant to Decedent’s condition, then the failure to inform the physicians of such findings cannot establish causation”) (applying Missouri law); Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *6 n.11 (D.N.J. Jan. 7, 2013) (plaintiff “does not link those potential warnings to his personal circumstances”) (applying Alabama law); Thrope v. Davol, Inc., 2011 WL 470613, at *32 (D.R.I. Feb. 4, 2011) (“[n]othing in [the surgeon’s] account indicates that he handled the [product] in a manner that [defendant] failed to warn against”; judgment as a matter of law granted) (applying North Carolina law); In re Fosamax Products Liability Litigation, 2010 WL 1257299, at *5 (S.D.N.Y. March 26, 2010) (“Plaintiff cannot establish proximate cause without evidence [of a] failure to warn of the specific risk that allegedly materialized”) (applying Florida law); In re Rezulin Products Liability Litigation, 331 F. Supp.2d 196, 200-01 (S.D.N.Y. 2004) (alleged inadequate warning about risk plaintiff did not suffer held “quite beside the point”; “95 percent of the patients who took [the drug] suffered no liver injury” so “there is no evidence from which a trier of fact reasonably could conclude that these plaintiffs’ treating physicians would not have prescribed Rezulin even if plaintiffs are right as to the warning concerning liver toxicity”); In re Rezulin Products Liability Litigation, 2004 WL 1802960, at *3 (S.D.N.Y. Aug. 13, 2004) (“these plaintiffs do not claim to have suffered any liver injury” so “that there may have been a breach of the duty to warn of liver toxicity for which patients suffering from liver dysfunction may recover does not avail these plaintiffs”) (footnotes omitted), vacated in part on other grounds, 2004 WL 2009445 (S.D.N.Y. Sept. 8, 2004) (applying Mississippi and Texas law); Greiner v. Medical Engineering Corp., 99 F. Supp.2d 759 (W.D. La. 2000) (breast implants; “[a] claimant cannot seek to impose a duty to warn on a manufacturer of damage not sustained”), aff’d, 243 F.3d 200 (5th Cir. 2001); In re Norplant Contraceptive Products Liability Litigation, 1997 WL 81094, at *1 (E.D. Tex. Feb. 21, 1997) (“whether the [product] warnings were not adequate with respect to an injury not alleged is not relevant to whether physicians were adequately warned of Plaintiffs’ alleged injuries”).

Punitive Damages

Finally, one other argument that plaintiffs sometime advance about alleged failures to warn of risks that they didn’t actually encounter is that such non-causal failures to warn are relevant to “punitive damages.”

We don’t think so, and this time the argument is constitutionally based. Evidence of inadequate warnings about risks not encountered by plaintiffs is solely relevant to injuries suffered (if at all) by persons other than the plaintiff who is before the court.  That’s a punitive damages no-no.

In considering punitive damages, the United States Supreme Court first held:

A defendant’s dissimilar acts, independent from the acts upon which liability was premised, may not serve as the basis for punitive damages. . . .  Due process does not permit courts, in the calculation of punitive damages, to adjudicate the merits of other parties’ hypothetical claims against a defendant under the guise of the reprehensibility analysis.”

State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408, 422-23 (2003).

A few years later, the Court decided that, “[t]o permit punishment for injuring a nonparty victim would add a near standardless dimension to the punitive damages equation.”  Philip Morris USA v. Williams, 549 U.S. 346, 354 (2007).  Williams therefore flatly declared it unconstitutional to base punitive damages on allegations of harm to absent third parties (such as other people suffering different injuries):

We did not previously hold explicitly that a jury may not punish for the harm caused others. But we do so hold now. . . .  [W]e believe the Due Process Clause prohibits a State’s inflicting punishment for harm caused strangers to the litigation.

Id. at 357.  Thus, “it is particularly important that States avoid procedure that unnecessarily deprives juries of proper legal guidance.  Id. at 355.  It is “constitutionally important” to insure that “the jury will ask the right question, not the wrong one.”  Id.

[W]here the risk of. . .misunderstanding is a significant one – because, for instance, of the sort of evidence that was introduced at trial or the kinds of argument the plaintiff made to the jury – a court, upon request, must protect against that risk.  Although the States have some flexibility. . ., federal constitutional law obligates them to provide some form of protection in appropriate cases.

Id. at 357 (emphasis added).

Admission of warning/risk evidence beyond that involving the plaintiff in question constitutes a state-law “procedure” doing the exact opposite of what the Supreme Court required in Williams.  With respect to punitive damages, such evidence is inherently suspect because by definition it places before the jury “injury . . . inflict[ed] upon those who are, essentially, strangers to the litigation.”  Id. at 353.

In Skibniewski v. American Home Products Corp., 2004 WL 5628157 (W.D. Mo. April 1, 2004), after State Farm, but before Williams, the court excluded evidence of “any alleged side effect or risk of the products at tissue other than the side effect or risks that allegedly harmed plaintiff” both generally, and in response to a punitive damages argument.  Id. at *12-13.

[F]ailure to warn of a medical condition plaintiff does not have cannot serve as the basis of a failure to warn claim and . . . evidence regarding injuries plaintiff does not have is irrelevant.  Because plaintiff does not have [certain conditions], evidence of these should be excluded.

Id. at *7. See Ray v. Allergan, Inc., 863 F. Supp.2d 552, 565 (E.D. Va. 2012) (punitive damages argument based on all persons taking a drug for a condition, regardless of injury, required new trial under Williams); Schilf v. Eli Lilly & Co., 2010 WL 3909909, at *6 (D.S.D. Sept. 30, 2010) (evidence about a different drug “are irrelevant to Plaintiffs’ claim for punitive damages” under Williams); In re Fosamax Products Liability Litigation, 647 F. Supp.2d 265, 284-85 (S.D.N.Y. 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams); In re Prempro Products Liability Litigation, 2007 WL 4189510, at *3 (Mag. E.D. Ark. Nov. 15, 2007), adopted, 2007 WL 4189497 (E.D. Ark. Nov. 21, 2007) (under Williams evidence “will not be permitted to testify regarding [defendant’s] general badness or badness in the specific areas which are not connected to [plaintiff’s] injury”). See also Branham v. Ford Motor Co., 701 S.E.2d 5, 24 (S.C. 2010) (punitive damages theory that “invited the jury to punish [defendant] for all [product-related] deaths and injuries, rather than the “harm to [plaintiff],” was improper under Williams); Pedroza v. Lomas Auto Mall, Inc., 2009 WL 1300944, at *4-5 (D.N.M. April 2, 2009) (conduct occurring after a plaintiff’s injury cannot be used to support punitive damages under Williams) (non-product liability case); Berardi v. Village of Sauget, 2008 WL 2782925, at *5-6 (S.D. Ill. July 17, 2008) (other allegedly similar incidents could not be admitted to prove punitive damages) (non-product liability case).

So there you have it.  Evidence of alleged product defects, that did not give rise to the harm that the plaintiff actually encountered, should be irrelevant and inadmissible in product liability litigation, no matter what the rationale offered for their admissions.  Such evidence is a smoke screen and a side show offered when a plaintiff is trying to distract attention from a lousy liability case.

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

Here’s some more inside baseball on grounds for removing cases from state to federal court.  In brief, the issue is this: does the “bad faith” standard added to the removal statute (28 U.S.C. §1446(c)(1)) in 2011 approximate the fraudulent joinder standard so that fraudulent joinder becomes a form of “bad faith” not subject to the one-year limit otherwise imposed on removals by reason of diversity of citizenship?  Fraudulent joinder is also an exception the “voluntary/involuntary” rule.  E.g., Crockett v. R.J. Reynolds Tobacco Co., 436 F.3d 529, 532 (5th Cir. 2006); Mayes v. Rapoport, 198 F.3d 457, 461 n.8 (4th Cir. 1999); Insinga v. LaBella, 845 F.2d 249, 254 (11th Cir. 1988).

We wish to acknowledge the assistance of Emily Kimmelman, a Reed Smith 2016 summer associate, in compiling the research for this post.

In 2011 (effective January 6, 2012), Congress passed the Federal Courts Jurisdiction & Venue Clarification Act (the “JVCA”).  The JVCA did a number of things, which we discussed here (back then (in 2011), we were most interested in Congress having left intact the statutory language that allows removal before service).  What we’re discussing today is the JVCA’s creation of a “bad faith” exception in 28 U.S.C. §1446(c)(1).  Specifically, §1446(c)(1) provides for diversity jurisdiction removal, even after one year if “the district court finds that the plaintiff has acted in bad faith in order to prevent a defendant from removing the action.”

Nothing is certain, except the controversy over how the bad faith exception interacts with the fraudulent joinder exception to the voluntary-involuntary rule.  Everybody knows the standard for fraudulent joinder.  It exists where “there is no reasonable basis in fact or colorable ground supporting the claim against the joined defendant, or no real intention in good faith to prosecute the action against the defendants or seek a joint judgment.”  In re Briscoe, 448 F.3d 201, 217 (3d Cir. 2006).

Continue Reading Fraudulent Joinder & Bad Faith – Explaining Another Removal Muddle

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  As that post described in detail, Reckis involved devastating injuries to a 7-year-old child whose toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin   The jury awarded $50 million in compensatory damages, and awarded $6.5 million in loss-of-consortium damages to each of the child’s parents.

After trial, defendants moved for JNOV, arguing, inter alia, that they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption.  Under Wyeth v. Levine, defendants’ argument seemed airtight. Under Levine, 555 U.S. 555, 571 (2009), there is “impossibility preemption” – preemption because it is impossible to comply with both state and federal requirements – when there is “clear evidence that the FDA would not have approved” the labeling change the plaintiffs seek.  Plaintiffs’ failure-to-warn claim argued that the Children’s Motrin label should have contained certain specific language related to TEN. But the FDA had already rejected identical language when that language was the subject of a Citizen Petition.   Could there be any clearer evidence than an FDA decision rejecting the very language plaintiffs identified?   The Reckis court apparently thought so, since “actually did not” wasn’t “clear” enough for that court.  Even though the substantive FDCA standards were identical, the court speculated that it could have made a difference if the FDA had considered a manufacturer’s request instead of a third party’s petition, 471 Mass. at 290, a rationale that impermissibly assumes that the FDA doesn’t always adhere to its own evidentiary standards.  The Reckis court’s refusal to recognize preemption under any set of facts was so blatant that we concluded, “If the Supreme Court meant what it said in Levine, evidently it will have to say so again.”And the Court will have that opportunity, if it chooses to seize it. On August 18, defendants filed their Petition for a Writ of Certiorari, posing this question:  “Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA’s rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA-rejected language to its drug’s labeling.” Johnson & Johnson v. Reckis, 2015 WL 6083499 (U.S.) at *i.

Continue Reading J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s Motrin Case

In our initial post about Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), we stated up front that we didn’t think that Tincher changed Pennsylvania law applicable to prescription medical products much, if at all.

We wrote:

For prescription products, the short answer is “not much..” . . . Largely as a result of concerns over liability for scientifically undiscovered risks . . . in Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (another case Bexis briefed) the Court excluded prescription medical products entirely from Azzarello strict liability using Restatement §402A, comment k . . . .  Thus Tincher’s reworking of strict liability doesn’t affect prescription medical products because that theory wasn’t applicable in the first place.  Indeed, one of Bexis’ worries about the Third Restatement was that eventually it might call the Hahn strict liability exemption into question.  Without the Third Restatement, that doesn’t happen.

Just because we said so, however, doesn’t make it so.  We’ve learned recently that at least one plaintiff’s lawyer has created an argument for the opposite position – that Tincher supposedly opens up wide vistas of strict liability in prescription medical product cases – and has asserted it in certain medical device litigation in which none of your bloggers are participants.  One of our readers sent us that brief (a publicly filed document) and asked us to comment.

So we will, but we’re not identifying either the case or the plaintiff’s lawyer – if you’re reading, you know who you are.

To us, the plaintiff’s proposition is, in one word, absurd.  It makes no sense that Tincher, which was primarily devoted to moving strict liability design defect cases closer to negligence, would somehow expand strict liability sub silentio (that’s legal Latin for “without explicitly saying so”) in the prescription medical product area, while simultaneously reining it in everywhere else.  There are three fundamental reasons why Tincher cannot be read in that fashion.

Continue Reading Don’t Mix Apples & Bricks – Tincher Didn’t Change Pa. Drug/Device Law